ACUSERA

THIRD PARTY CONTROLS

 ACUSERA
True third party controls offering
complete test menu consolidation
 01 BENEFITS

03 ISO REQUIREMENTS

04 CONSOLIDATION

05 COMMITMENT TO QUALITY

06 ANTIOXIDANTS

10 BLOOD GAS

14 CARDIAC

18 CLINICAL CHEMISTRY

32 COAGULATION AND HAEMATOLOGY

36 DIABETES AND WHOLE BLOOD

40 IMMUNOASSAY

48 IMMUNOLOGY / PROTEINS

54 LIPIDS

58 SPECIALITY AND RESEARCH

68 THERAPEUTIC DRUGS

72 TOXICOLOGY

80 URINE

84 CUSTOMISED QUALITY CONTROL SERA

90 INTERLABORATORY DATA MANAGEMENT

94 EXTERNAL QUALITY ASSESSMENT

102 CALIBRATION VERIFICATION SETS

110 ANALYTE INDEX

127 RANDOX - A GLOBAL DIAGNOSTIC SOLUTIONS PROVIDER

128 CONTACT US

1
 BENEFITS

For more than 35 years Randox has been shaping the future of clinical diagnostics with our
pioneering high quality, cost effective laboratory solutions. With approximately 70% of clinical
decisions based on laboratory test results, it is essential that the results provided are accurate and
reliable in order to prevent potential misdiagnosis or inappropriate treatment.

Quality Control is our passion; we believe in producing high quality material that can help streamline procedures, whilst saving time
and money for laboratories of all sizes and budgets. With an extensive product offering comprising third party quality controls &
calibrators, interlaboratory data management, external quality assessment, and calibration verification, you can count on Randox to
deliver trustworthy results time and time again. Just ask one of our 60,000 users worldwide.

Commutability
All Acusera controls are designed to react to the test system in the same manner as the patient sample,
helping to meet ISO 15189:2012 requirements whilst reducing inconvenient and costly shifts in QC results
when reagent batch is changed.

Accurate Target Values

Our unique value assignment process utilises thousands of independent labs globally, ensuring
availability of highly accurate, robust target values for a wide range of instruments and methods,
ultimately eliminating the need to spend time and money assigning in-house.

True Third Party Controls

Manufactured independently, the Acusera range delivers unbiased performance assessment with
any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously
eliminating the need for multiple instrument dedicated controls.

Shelf Life
With a shelf life of up to four years for lyophilised controls and two years for liquid controls, you can
benefit from continuity of lot supply whilst reducing the frequency of new lot validation studies, thus
saving time and money.

Consistency
Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly
from lot to lot.You can therefore be sure of receiving the same standard of product time and time again.

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 BENEFITS

Traceability
The values assigned to both our calibrators and control materials are traceable to a recognised reference
material or reference measurement procedure meeting ISO 17511 and ISO 18153 requirements.

Consolidation
Specialising in consolidation, the Acusera range of multi-analyte controls is designed to reduce the number
of individual controls required to cover your test menu, ultimately reducing costs, preparation time and
storage space.

Clinically Relevant Levels

The presence of analytes at key decision levels not only helps to ensure accurate instrument performance
but maximises laboratory efficiency by eliminating the need for additional low/high level controls at extra
expense.

Reduced Waste
The unrivalled working stability of the Acusera control range helps to keep waste and costs to a minimum.

Flexible Options
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the
Acusera portfolio has a solution to suit all laboratory preferences.

Custom Controls
Randox is a market leader in the manufacture of customised quality controls designed to meet the
individual and unique requirements of even the most specialised laboratories.

For more information about Randox and for our full range of products,
please visit randoxqc.com, or contact your local Randox representative.

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 ISO REQUIREMENTS

Acusera; helping you to meet ISO 15189:2012 requirements.

Third Party Controls

“Use of independent third party control materials should be considered, either instead of, or in addition to, any control
materials supplied by the reagent or instrument manufacturer”

As true third party controls, the Acusera range has been designed to provide an unbiased, independent assessment of performance;
our Acusera controls have not been manufactured in line with, or optimised for use with any particular reagent, method or
instrument.

Commutability
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible
to patient samples”

All Acusera controls are 100% commutable, ensuring they behave in the same manner as a patient sample thus providing an
accurate reflection of test system performance.

Clinically Relevant Levels

“The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical
decision values, which ensure the validity of decisions made”.

The inclusion of analytes at clinical decision levels will not only eliminate the need to purchase additional low/high level controls but
will help to ensure accurate instrument performance.

Data Management
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure.
When the quality control rules are violated and indicate that examination results are likely to contain clinically
significant errors, the results shall be rejected.... Quality Control data shall be reviewed at regular intervals to detect
trends in examination performance”.

Acusera 24•7 provides instant access to an unrivalled range of features including QC multi-rules, interactive charts, live peer group
data, automatic calculation of Measurement Uncertainty & Sigma Metrics & our unique dashboard interface, all designed to speed
up the review process and provide at-a-glance performance assessment.

EQA
“The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment
or proficiency testing schemes”.

The Randox International Quality Assessment Scheme (RIQAS), is used by more than 45,000 laboratory participants in 124
countries and accredited to ISO 17043. As a result, we have RIQAS users on every continent who are registered for one or more
of our 32 flexible EQA programmes, utilising the available data to ensure the quality and reliability of their results.

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 CONSOLIDATION

Consolidate and Save with Randox Acusera

Randox is a leading provider of multi-analyte, true third party controls covering more than 390 parameters.The unique combination
of analytes facilitates effective consolidation, helping your laboratory to reduce costs without compromising on performance or
quality. Unlike some competitor products, our Acusera Controls are manufactured with analytes present at clinically relevant decision
levels, eliminating the need to purchase additional high or low level controls, at extra expense.

How can consolidating with Randox Acusera benefit you?

With Randox Acusera you could consolidate up to 6 competitor controls into one Acusera control, reducing the amount of storage
space required for your QC material, as well as saving valuable time and money for your laboratory. The following examples have
been selected to highlight areas where Acusera can help you effectively consolidate your control purchases.

Immunoassay Premium Plus Control

Competitor Controls Randox Control Impressively covering 54 analytes including tumour
markers, therapeutic drugs and routine immunoassay
tests, the Acusera Immunoassay Premium Plus control has
been uniquely designed to eliminate the need for four or
Immunoassay Acusera Immunoassay
more controls, dramatically reducing costs and time. The
Premium Plus added advantage of ultra-low levels of Ferritin, Vitamin
Tumour Markers
B12 and TSH will help to ensure accurate performance
Anaemia Monitoring at key decision levels and further reduce the number of
controls required. - turn to page 44 for more information
Therapeutic Drugs

Competitor Controls Randox Control

Liquid Assayed Chemistry Premium Plus Control

Uniquely combining up to 99 analytes including; routine
chemistry, immunoassays, lipids, therapeutic drugs,
proteins and cardiac markers in a single vial, you can Immunoassay Acusera Liquid Assayed
experience effective consolidation and significant cost Chemistry Premium Plus
Routine Chemistry
savings. The presence of CRP and other proteins at
elevated levels will not only help to ensure accurate Proteins

instrument performance at key decision levels but Therapeutic Drugs

fur ther reduce the number of individual controls
Cardiac Markers
required. - turn to page 26 for more information
Lipids

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 COMMITMENT TO QUALITY

Randox is committed to quality at every stage of the production process from research and
development to customer support. This commitment has been recognised through official
accreditation to both national and international standards including UKAS and ISO.

Accreditation to international standards ensures confidence in the quality and consistency of the
products and services provided by Randox, and demonstrates compliance to internationally agreed
standards.

The United Kingdom Accreditation Service (UKAS) is the only national accreditation body recognised by the
government to assess against internationally agreed standards.

RIQAS systems and procedures have been accredited with UKAS approval to ISO/IEC 17043:2010
“Conformity assessment - General requirements for proficiency testing”
UKAS

The International Organisation for Standardisation (ISO) is the largest developer and publisher of international
standards in the world. In 2003, Randox was accredited with
ISO 13485:2003 approval.

ISO 13485:2003 relates to the design/development, manufacture, service and distribution of in vitro
diagnostic medical devices, in vitro diagnostic test kits, in vitro diagnostic reagents and in vitro diagnostic
analysers.
ISO 13485:2003
ISO 13485:2003 highlights the requirements for a quality management system where an organisation needs
to prove its ability to provide medical devices and other related services that consistently meet regulatory
requirements.

Many of our quality controls and calibrators are FDA cleared and therefore appropriate for clinical use in the
USA. In order for an IVD to be approved for sale in the USA it must not only be safe for use and effective
FDA Cleared
but it must also satisfy the requirements set out in part 820 title 21 of the Code of Federal Regulations
published by the FDA.

Many of our Quality Control (QC) products are CE certified and carry the CE mark. CE marking on a
product indicates that the product complies with and has satisfied the essential requirements set out by the
In Vitro Diagnostic (IVD) Medical Devices Directive 98/79/EC. It also demonstrates the fact the product
is fit for its intended purpose.

The CE mark is also a declaration from the manufacturer that the product has met all legislation in relation to
CE Mark health and safety and where required, has been assessed in accordance with this legislation.

CE marking is essential for products to be placed on the market and sold in the European Union (EU). It also
ensures the free movement of products within the EFTA and EU.

Canadian
Medical Device Many Randox products, including our quality controls and calibrators, are licensed for use in Canada. Before
an IVD device can be sold in Canada, it must meet the requirements set out in the Therapeutic Products
Regulations
Directorate. Health Canada reviews all medical devices to assess their safety, effectiveness and quality before
from Health they are authorised for sale.
Canada

5
Free radicals are highly reactive molecules that seek stability by gaining other electrons. In their
attempt to do this they often attack nearby molecules, resulting in cellular or systemic damage.
Antioxidants act by preventing or slowing the damage caused by these free radicals. A reduction
in total antioxidant status has been identified in several disease states, such as cancer and heart
disease. Our Acusera Antioxidant Quality Controls are lyophilised for enhanced stability and cover
a range of antioxidants ideal for both clinical and research use.

ANTIOXIDANT
CONTROLS

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 ANTIOXIDANTS

Antioxidant Product Range

Product Description Size Cat. No. Page No.
Glutathione Reductase Control 10 x 5 ml GR2608 8
Glutathione Reductase Calibrator 10 x 5 ml GR2609 8
Glutathione Peroxidase (Ransel) Control 10 x 1 ml SC692 8
Glutathione Peroxidase (Ransel) Calibrator 10 x 1 ml SC10154 8
Superoxide Dismutase (Ransod) Control 10 x 1 ml SD126 8
Total Antioxidant Status (TAS) Control 10 x 5 ml NX2331 9
Total Antioxidant Status (TAS) Calibrator 10 x 1 ml NX2615 9

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

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 ANTIOXIDANTS

Glutathione Reductase Control and Calibrator

A bovine based control designed for use in the routine monitoring of accuracy and precision. This product is compatible for use on most clinical
chemistry analysers.

• Lyophilised for enhanced stability

• Stable to expiry date at 2°C to 8°C
• Reconstituted stability of 1 day at 2°C to 8°C or 8 hours at 15°C to 25°C

Description Size Cat. No.

Glutathione Reductase Control 10 x 5 ml GR2608
Glutathione Reductase Calibrator 10 x 5 ml GR2609

Glutathione Peroxidase (Ransel) Control and Calibrator

A bovine based, whole blood control designed for use in the routine monitoring of accuracy and precision. This product is compatible for use on most
clinical chemistry analysers.

• Lyophilised for enhanced stability

• Stable to expiry date at 2°C to 8°C
• Reconstituted stability of 3 days at 2°C to 8°C

Description Size Cat. No.

Ransel Control 10 x 1 ml SC692
Ransel Calibrator 10 x 1 ml SC10154

Superoxide Dismutase (Ransod) Control

A bovine based, whole blood control designed for use in the routine monitoring of accuracy and precision. This product is compatible for use on most
clinical chemistry analysers.

• Lyophilised for enhanced stability

• Stable to expiry date at 2°C to 8°C
• Reconstituted stability of 10 days at 2°C to 8°C

Description Size Cat. No.

Ransod Control 10 x 1 ml SD126

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 ANTIOXIDANTS

Total Antioxidant Status (TAS) Control and Calibrator

A human based control designed for use in the routine monitoring of accuracy and precision. This product is compatible for use on most clinical
chemistry analysers.

Control
• Lyophilised for enhanced stability
• Stable to expiry date at 2°C to 8°C
• Reconstituted stability of 2 days at 2°C to 8°C or 12 hours at 15°C to 25°C

Calibrator
• Lyophilised for enhanced stability
• Approximately 1.5 mmol/l
• Stable to expiry date at 2°C to 8°C
• Reconstituted stability of 2 days at 2ºC to 8°C or 28 days at -20°C

Description Size Cat. No.

Total Antioxidant Status Control 10 x 5 ml NX2331
Total Antioxidant Status Calibrator 10 x 1 ml NX2615

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Blood Gas tests can provide crucial information for medical professionals in acute care environments.
As such, the results they produce must be accurate and reliable to ensure correct patient diagnosis and
subsequent treatment. Used in both clinical laboratories and at the point-of-care, our Acusera Blood
Gas Controls have been designed to ensure ease-of-use and peace of mind. The liquid ready-to-use
format ensures that no preparation time is needed and controls can be easily stored both on the ward
and in the laboratory at 2ºC to 8ºC.

BLOOD GAS
CONTROLS

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 BLOOD GAS

Blood Gas Product Range

Product Description Size Cat. No. Page No.
Blood Gas Control Level 1 30 x 1.8 ml BG5001 12

Blood Gas Control Level 2 30 x 1.8 ml BG5002 12

Blood Gas Control Level 3 30 x 1.8 ml BG5003 12

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

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 BLOOD GAS

Blood Gas Control

Analytes
Bicarbonate Glucose pH Sodium
Calcium Lactate pO2
Chloride pCO2 Potassium

Combining 10 parameters including electrolytes and lactate, the Acusera Blood Gas control is designed to meet the demands of today’s blood gas analysers.
Supplied in convenient, easy to open ampoules and in a liquid ready-to-use format, preparation is kept to an absolute minimum, making this control ideally
suited for POC testing. As a true third party control, assayed target values are provided, ensuring unbiased performance assessment.

• Liquid ready-to-use
• Aqueous material
• Stable to expiry date at 2ºC to 8ºC
• Once opened, controls should be analysed within 1 minute for pH and blood gas analytes; for electrolyte measurements, the control
should be analysed within 1 hour of opening

Description Size Cat. No.

Blood Gas Control Level 1 30 x 1.8 ml BG5001
Blood Gas Control Level 2 30 x 1.8 ml BG5002
Blood Gas Control Level 3 30 x 1.8 ml BG5003

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 BLOOD GAS

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The accurate diagnosis of a potentially life threatening cardiac event is essential in order to avoid
misdiagnosis and/or incorrect treatment. The Acusera Cardiac Controls have been designed to
cover a wide range of cardiac markers at clinical decision levels, eliminating the need for additional
low level controls at extra expense. Available in a choice of both liquid ready-to-use and lyophilised
formats, they are ideal for use at the point-of-care and in the laboratory. Manufactured from 100%
human serum, a matrix similar to that of the patient sample is guaranteed.

CARDIAC
CONTROLS

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 CARDIAC

Cardiac Product Range

Product Description Size Cat. No. Page No.
Tri-Level Cardiac Control 3 x 1 ml CQ3100 16
Tri-Level Cardiac Control 3 x 2 ml CQ3259 16
Liquid Cardiac Control Level 1 3 x 3 ml CQ5051 16
Liquid Cardiac Control Level 2 3 x 3 ml CQ5052 16
Liquid Cardiac Control Level 3 3 x 3 ml CQ5053 16
Liquid BNP Control (Beckman Access / Beckman Dx1) Level 1 3 x 1 ml CQ5133 16
Liquid BNP Control (Beckman Access / Beckman Dx1) Level 2 3 x 1 ml CQ5134 16
Liquid BNP Control (Beckman Access / Beckman Dx1) Level 3 3 x 1 ml CQ5135 16
Liquid BNP Control (Abbott Architect) Level 1 3 x 1 ml CQ5136 16
Liquid BNP Control (Abbott Architect) Level 2 3 x 1 ml CQ5137 16
Liquid BNP Control (Abbott Architect) Level 3 3 x 1 ml CQ5138 16
Liquid BNP Control (Siemens Advia Centaur) Level 1 3 x 1 ml CQ5139 16
Liquid BNP Control (Siemens Advia Centaur) Level 2 3 x 1 ml CQ5140 16
Liquid BNP Control (Siemens Advia Centaur) Level 3 3 x 1 ml CQ5141 16
Myoglobin Calibrator Series 4 x 1 ml MY2456 17
CK-MB Control 10 x 2 ml CK1212 17
CK-MB Calibrator 10 x 1 ml CK2393 17
High Sensitivity Troponin T Control 3 x 3 ml CQ5080 17
H-FABP Control Level 1 3 x 1 ml FB4026 17
H-FABP Control Level 2 3 x 1 ml FB4027 17
H-FABP Calibrator Series 6 x 1 ml FB3134 17

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

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 CARDIAC

Cardiac Control
Analytes
CK (Total) CK-MB (Mass) Myoglobin Troponin T
CK-MB (Activity) Homocysteine Troponin I

The Acusera Cardiac Control was designed for the routine monitoring of accuracy and precision. Assayed, instrument specific values and ranges are
provided for 7 common cardiac markers, eliminating the need to spend time assigning target values in-house. The availability of two convenient pack sizes
ensures suitability for all laboratory throughputs.

• Lyophilised for enhanced stability

• 100% human serum
• Cut off levels for Troponin I and T in-line with international recommendations
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC or 28 days at -20ºC
Description Size Cat. No.
Tri-Level Cardiac Control 3 x 1 ml CQ3100
Tri-Level Cardiac Control 3 x 2 ml CQ3259

Liquid Cardiac Control

Analytes
CK-MB (Mass) Digoxin Myoglobin Troponin I
D-dimer hsCRP NT-proBNP Troponin T

A comprehensive control designed for use in the routine monitoring of accuracy and precision. Assayed instrument specific target values and ranges are
provided for 8 cardiac markers on a wide range of chemistry, immunoassay & POCT instruments, eliminating the need to spend time assigning target values in-
house. The convenient liquid ready-to-use format will dramatically reduce preparation time, while an open vial stability of 30 days for all analytes will minimise
waste and reduce costs.Three individual levels are available spanning the complete clinical range, helping to ensure accurate performance at key decision levels.

• Liquid ready-to-use
• 100% human serum
• Suitable for use in POC testing
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Liquid Cardiac Control Level 1 3 x 3 ml CQ5051
Liquid Cardiac Control Level 2 3 x 3 ml CQ5052
Liquid Cardiac Control Level 3 3 x 3 ml CQ5053

Liquid BNP Controls

Dedicated BNP control designed for use in the routine monitoring of accuracy and precision. Instrument dedicated material is supplied liquid ready-to-
use with assayed values ensuring specific analyser requirements are met, while maintaining user convenience.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Liquid BNP Control (Beckman Access / Beckman Dx1) Level 1 3 x 1 ml CQ5133
Liquid BNP Control (Beckman Access / Beckman Dx1) Level 2 3 x 1 ml CQ5134
Liquid BNP Control (Beckman Access / Beckman Dx1) Level 3 3 x 1 ml CQ5135
Liquid BNP Control (Abbott Architect) Level 1 3 x 1 ml CQ5136
Liquid BNP Control (Abbott Architect) Level 2 3 x 1 ml CQ5137
Liquid BNP Control (Abbott Architect) Level 3 3 x 1 ml CQ5138
Liquid BNP Control (Siemens Advia Centaur) Level 1 3 x 1 ml CQ5139
Liquid BNP Control (Siemens Advia Centaur) Level 2 3 x 1 ml CQ5140
Liquid BNP Control (Siemens Advia Centaur) Level 3 3 x 1 ml CQ5141
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 CARDIAC

Myoglobin Calibrator Series

Dedicated third party calibrator designed for use in the calibration of Myoglobin immunoturbidimetric assays.

• Lyophilised for enhanced stability

• Prepared from purified human Myoglobin in a stabilised matrix
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 30 days at 2ºC to 8ºC or 6 months at -20ºC

Description Size Cat. No.

Myoglobin Calibrator Series 4 x 1 ml MY2456

CK-MB Control and Calibrator

Analytes
CK-MB (Activity) CK-NAC

A dedicated true third party CK-MB control designed for the routine monitoring of both accuracy and precision. Assayed target values and ranges are
provided for serum start, substrate start and CK-NAC methods eliminating the need to spend time assigning target values in-house.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

CK-MB Control 10 x 2 ml CK1212
CK-MB Calibrator 10 x 1 ml CK2393

High Sensitivity Troponin T Control

Delivering a true third party solution for Roche instruments, the Acusera High Sensitivity Troponin T control will ensure unbiased performance assessment.
Assayed target values are provided close to the 99th percentile reference range (14ng/l) helping to deliver accurate performance at key decision levels.

• Lyophilised for enhanced stability

• 100% human serum
• Very low Troponin T levels around 14.5ng/l (0.0145ng/ml)
• Stable to expiry at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

High Sensitivity Troponin T Control 3 x 3 ml CQ5080

Heart Type Fatty Acid Binding Protein (H-FABP) Control and Calibrator Set
Dedicated controls and calibrators designed for use in the routine monitoring and calibration of the Randox H-FABP assay.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry at 2ºC to 8ºC
• Reconstituted stability of 35 days at 2ºC to 8ºC and 8 weeks at -20ºC

Description Size Cat. No.

H-FABP Control Level 1 3 x 1 ml FB4026
H-FABP Control Level 2 3 x 1 ml FB4027
H-FABP Calibrator Series 6 x 1 ml FB3134

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Our clinical chemistry controls are suitable for a range of integrated analyser systems and
methods. To cover all laboratory requirements, our flexible Clinical Chemistry Controls contain
up to 100 analytes, delivering effective consolidation and cost savings. Available in a choice of
assayed/unassayed, liquid/lyophilised, premium/premium plus and human/bovine formats, options
are available to suit all laboratory sizes and budgets.

CLINICAL CHEMISTRY
CONTROLS

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 CLINICAL CHEMISTRY

Clinical Chemistry Product Range

Product Description Size Cat. No. Page No.
Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557 20
Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558 20
Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048 21
Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049 21
Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069 22
Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070 22
Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071 22
Liquid Chemistry Premium Plus Level 1 12 x 10 ml LUL5093 22
Liquid Chemistry Premium Plus Level 2 12 x 10 ml LUN5094 22
Liquid Chemistry Premium Plus Level 3 12 x 10 ml LUE5095 22
Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530 23
Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532 23
Assayed Chemistry Premium Plus Level 2 & 3 2 x 5 x 5 ml HS2611 23
Chemistry Premium Level 2 12 x 5 ml HN5067 24
Chemistry Premium Level 3 12 x 5 ml HE5068 24
Liquid Assayed Chemistry Premium Level 2 12 x 5 ml LAN4216 25
Liquid Assayed Chemistry Premium Level 3 12 x 5 ml LAE4217 25
Liquid Assayed Chemistry Premium Plus Level 1 12 x 5 ml LAL4213 26
Liquid Assayed Chemistry Premium Plus Level 2 12 x 5 ml LAN4214 26
Liquid Assayed Chemistry Premium Plus Level 3 12 x 5 ml LAE4215 26
Bovine Chemistry Assayed Level 1 20 x 5 ml AL1027 27
Bovine Chemistry Assayed Level 2 20 x 5 ml AN1026 27
Bovine Chemistry Assayed Level 3 20 x 5 ml AE1032 27
Bovine Chemistry Precision Level 1 20 x 5 ml SL1084 28
Bovine Chemistry Precision Level 2 20 x 5 ml SN1085 28
Bovine Chemistry Precision Level 3 20 x 5 ml SE1086 28
Clinical Chemistry Calibration Serum Level 2 20 x 5 ml CAL2350 29
Clinical Chemistry Calibration Serum Level 3 20 x 5 ml CAL2351 29
Ammonia Ethanol Control Level 1 6 x 2 ml EA1366 29
Ammonia Ethanol Control Level 2 6 x 2 ml EA1367 29
Ammonia Ethanol Control Level 3 6 x 2 ml EA1368 29
Aldolase Calibrator 3 x 1 ml AD5000 30
Aldolase Control Level 2 3 x 1 ml AD5001 30
Aldolase Control Level 3 3 x 1 ml AD5002 30
Bilirubin Elevated Serum 10 x 3 ml BE454 30
Liquid Bilirubin Control Level 1 3 x 3 ml BR10172 30
Liquid Bilirubin Control Level 2 3 x 3 ml BR10173 30
Glycerol Control 3 x 5 ml GY1369 30
Multi Calibrator 3 x 2 ml MC1382 31
Multi Control Level 1 5 x 2 ml MC1379 31
Multi Control Level 2 5 x 2 ml MC1380 31
Multi Control Level 3 5 x 2 ml MC1381 31
Glutamine Control Level 1 5 x 5 ml GM1376 31
Glutamine Control Level 2 5 x 5 ml GM1377 31
Glutamine Control Level 3 5 x 5 ml GM1378 31
Glutamine Calibrator 3 x 5 ml GM1375 31
TxB Cardio Control Level 1 3 x 3 ml TXB5125 31
TxB Cardio Control Level 2 3 x 3 ml TXB5126 31
TxB Cardio Control Level 3 3 x 3 ml TXB5127 31
TxB Cardio Calibrator Series 6 x 3 ml TXB3132 31
TxB Cardio Sample Diluent 3 x 100 ml TXB2814 31

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

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 CLINICAL CHEMISTRY

Precision Chemistry Premium Plus Control

Analytes
Cardiac Prolactin Ferritin Chloride
CK (Total) PSA (Total) Haptoglobin Cholinesterase
Myoglobin T3 (Free) Immunoglobulin A (IgA) Creatinine
Troponin I T3 (Total) Immunoglobulin E (IgE) D-3-Hydroxybutyrate
T4 (Free) Immunoglobulin G (IgG) gGT
Drugs GLDH
T4 (Total) Immunoglobulin M (IgM)
Carbamazepine Glucose
TSH Prealbumin
Digoxin Iron
Vitamin B12 Protein (Total)
Gentamicin Iron (TIBC)
Transferrin Iron (UIBC)
Lithium
Paracetamol Lipids Lactate
Phenobarbital Apolipoprotein A-I Routine Chemistry Lactate Dehydrogenase (LDH)
Phenytoin Apolipoprotein B α-HBDH
LAP
Salicylate Cholesterol (HDL) Acid Phosphatase (Prostatic)
Cholesterol (Total) Acid Phosphatase (Total) Lipase
Theophylline Magnesium
Tobramycin NEFA Albumin
Alkaline Phosphatase (ALP) Osmolality
Valproic Acid Triglycerides Phosphate (Inorganic)
ALT (GPT)
Vancomycin Potassium
Proteins Amylase
Amylase (Pancreatic) Sodium
Immunoassay α-1-Acid Glycoprotein Urea
AST (GOT)
α-Fetoprotein (AFP) α-1-Antitrypsin Bicarbonate Uric Acid (Urate)
CEA Ceruloplasmin Bile Acids
Cortisol Complement C3 Bilirubin (Direct) Trace Metals
Folate Complement C4 Bilirubin (Total) Copper
hCG CRP Calcium Zinc

Our Precision Chemistry Premium Plus control conveniently covers 86 analytes; including a wide range of proteins, lipids and immunoassays making it
perfect for consolidation. As an unassayed, third party control it is suitable for use with a wide range of clinical chemistry platforms.

• Lyophilised for enhanced stability

• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Precision Chemistry Premium Plus Level 2 20 x 5 ml UN1557
Precision Chemistry Premium Plus Level 3 20 x 5 ml UE1558
Serum Diluent 20 x 5 ml MS5007

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 CLINICAL CHEMISTRY

Liquid Chemistry Premium Control

Analytes
Cardiac Immunoassay Ceruloplasmin Bilirubin (Total)
CK (Total) α-Fetoprotein (AFP) Complement C3 Calcium
Myoglobin CEA Complement C4 Chloride
Troponin T Cortisol CRP Cholinesterase
Folate Ferritin Creatinine
Drugs hCG Haptoglobin D-3-Hydroxybutyrate
Carbamazepine Prolactin Immunoglobulin A (IgA) gGT
Digoxin PSA (Total) Immunoglobulin E (IgE) GLDH
Ethanol T3 (Free) Immunoglobulin G (IgG) Glucose
Gentamicin T3 (Total) Immunoglobulin M (IgM) Iron
Lithium T4 (Free) Prealbumin Iron (TIBC)
Paracetamol T4 (Total) Protein (Total) Iron (UIBC)
Phenobarbital TSH Transferrin Lactate
Phenytoin Vitamin B12 Lactate Dehydrogenase (LDH)
Salicylate Routine Chemistry LAP
Theophylline Lipids α-HBDH Lipase
Valproic Acid Apolipoprotein A-I Acid Phosphatase (Prostatic) Magnesium
Vancomycin Apolipoprotein B Acid Phosphatase (Total) Osmolality
Cholesterol (HDL) Albumin Phosphate (Inorganic)
Electrophoresis Cholesterol (LDL) Alkaline Phosphatase (ALP) Potassium
α-1-Globulin Cholesterol (Total) ALT (GPT) Sodium
α-2-Globulin Lipoprotein (a) Amylase Urea
Albumin Triglycerides Amylase (Pancreatic) Uric Acid (Urate)
b-Globulin AST (GOT)
g-Globulin Proteins Bicarbonate Trace Metals
α-1-Acid Glycoprotein Bile Acids Copper
α-1-Antitrypsin Bilirubin (Direct) Zinc

Containing 92 analytes, our Liquid Chemistry Premium control covers, routine chemistry, immunoassays, therapeutic drugs, cardiac markers and more,
making it perfect for consolidation and cost savings. Supplied in a convenient liquid format for ease-of-use; minimal preparation is required. As an unassayed,
true third party control it is designed for use in the routine monitoring of precision and is suitable for use with all major instruments and methodologies.

• Liquid for ease-of-use

• Human based serum
• Stable to expiry date at -20ºC to -70ºC
• Open vial stability of 7 days at 2ºC to 8ºC
• Typical values provided for all analytes

Description Size Cat. No.

Liquid Chemistry Premium Level 2 12 x 5 ml LUN5048
Liquid Chemistry Premium Level 3 12 x 5 ml LUE5049

21
 CLINICAL CHEMISTRY

Liquid Chemistry Premium Plus Control

Analytes
Cardiac Immunoassay Proteins Bile Acids
CK (Total) α-Fetoprotein (AFP) α-1-Acid Glycoprotein Bilirubin (Direct)
Myoglobin CEA α-1-Antitrypsin Bilirubin (Total)
Troponin T Cortisol b-2-Microglobulin Calcium
DHEA Sulphate Ceruloplasmin Chloride
Drugs Folate Complement C3 Cholinesterase
Amikacin FSH Complement C4 Creatinine
Caffeine Growth Hormone (GH) CRP D-3-Hydroxybutyrate
Carbamazepine hCG Ferritin gGT
Digoxin Luteinising Hormone (LH) Haptoglobin GLDH
Ethanol Progesterone Immunoglobulin A (IgA) Glucose
Gentamicin Prolactin Immunoglobulin E (IgE) Iron
Lithium Testosterone Immunoglobulin G (IgG) Iron (TIBC)
Paracetamol T Uptake Immunoglobulin M (IgM) Iron (UIBC)
Phenobarbital T3 (Free) Prealbumin Lactate
Phenytoin T3 (Total) Protein (Total) Lactate Dehydrogenase (LDH)
Salicylate T4 (Free) Transferrin LAP
Theophylline T4 (Total) Lipase
Valproic Acid TSH Routine Chemistry Magnesium
Vancomycin Vitamin B12 α-HBDH Osmolality
Acid Phosphatase (Prostatic) Phosphate (Inorganic)
Electrophoresis Lipids Acid Phosphatase (Total) Potassium
α-1-Globulin Apolipoprotein A-1 Albumin Sodium
α-2-Globulin Apolipoprotein B Alkaline Phosphatase (ALP) Urea
Albumin Cholesterol (HDL) ALT (GPT) Uric Acid (Urate)
b-Globulin Cholesterol (LDL) Amylase
g-Globulin Cholesterol (Total) Amylase (Pancreatic) Trace Metals
Lipoprotein (a) AST (GOT) Copper
Triglycerides Bicarbonate Zinc

Comprising 101 analytes in total, the Acusera Liquid Chemistry Premium Plus control is one of the most comprehensive available. Our vast analyte menu
allows complete consolidation, eliminating the need to purchase additional controls at extra expense. As an unassayed, third party control it is ideal for
monitoring precision on a wide range of laboratory analysers. Presented in a convenient liquid format for ease-of-use, minimal preparation is required.

• Liquid for ease-of-use

• Human based serum
• High levels of CRP and other proteins eliminate the need for separate controls
• Stable to expiry date at -20ºC to -70ºC
• Open vial stability of 7 days at 2ºC to 8ºC
• Typical values provided for all analytes

Description Size Cat. No.

Liquid Chemistry Premium Plus Level 1 12 x 5 ml LUL5069
Liquid Chemistry Premium Plus Level 2 12 x 5 ml LUN5070
Liquid Chemistry Premium Plus Level 3 12 x 5 ml LUE5071
Liquid Chemistry Premium Plus Level 1 12 x 10 ml LUL5093
Liquid Chemistry Premium Plus Level 2 12 x 10 ml LUN5094
Liquid Chemistry Premium Plus Level 3 12 x 10 ml LUE5095

22
 CLINICAL CHEMISTRY

Assayed Chemistry Premium Plus Control

Analytes
Cardiac PSA (Total) Routine Chemistry Glucose
CK (Total) T3 (Total) α-HBDH Iron
T4 (Free) Acid Phosphatase (Non-Prostatic) Iron (TIBC)
Drugs T4 (Total) Acid Phosphatase (Prostatic) Lactate
Digoxin TSH Acid Phosphatase (Total) Lactate Dehydrogenase (LDH)
Gentamicin Vitamin B12 Albumin LAP
Lithium Alkaline Phosphatase (ALP) Lipase (Colorimetric)
Paracetamol Lipids ALT (GPT) Lipase (Turbidimetric)
Salicylate Apolipoprotein A-1 Amylase Magnesium
Theophylline Apolipoprotein B Amylase (Pancreatic) Osmolality
Tobramycin Cholesterol (HDL) AST (GOT) Phosphate (Inorganic)
Cholesterol (Total) Bicarbonate Potassium
Electrophoresis NEFA Bile Acids Sodium
α-1-Globulin Triglycerides Bilirubin (Direct) Urea
α-2-Globulin Bilirubin (Total) Uric Acid (Urate)
Albumin Proteins Calcium
b-Globulin Immunoglobulin A (IgA) Chloride Trace Metals
g-Globulin Immunoglobulin G (IgG) Cholinesterase Copper
Immunoglobulin M (IgM) Creatinine Zinc
Immunoassay Protein (Total) D-3-Hydroxybutyrate
Cortisol Transferrin gGT
Folate GLDH

One of our most popular controls, the Acusera Assayed Chemistry Premium Plus Control, combines a comprehensive 70 analytes in a single vial for
maximum efficiency. As a true third party control, assayed instrument, method and temperature specific target values are provided for an extensive range
of clinical chemistry analysers, reducing the need to assign values in-house. Also provided are electrophoresis targets as a % breakdown of total protein.

• Lyophilised for enhanced stability

• Human based serum
• Typical Osmolality values: Level 2 is 300 mOsm/kg, Level 3 is 370 mOsm/kg
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Assayed Chemistry Premium Plus Level 2 20 x 5 ml HN1530
Assayed Chemistry Premium Plus Level 3 20 x 5 ml HE1532
Assayed Chemistry Premium Plus Level 2 & 3 2 x 5 x 5 ml HS2611
Serum Diluent 20 x 5 ml MS5007

23
 CLINICAL CHEMISTRY

Chemistry Premium Control

Analytes
Cardiac Immunoglobulin M (IgM) AST (GOT) Lactate
CK (Total) Protein (Total) Bilirubin (Direct) Lactate Dehydrogenase (LDH)
Transferrin Bilirubin (Total) LAP
Drugs Calcium Lipase
Lithium Routine Chemistry Chloride Magnesium
α-HBDH Cholinesterase Phosphate (Inorganic)
Lipids Acid Phosphatase (Prostatic) Creatinine Potassium
Cholesterol Acid Phosphatase (Total) gGT Sodium
Triglycerides Albumin GLDH Urea
Alkaline Phosphatase (ALP) Glucose Uric Acid (Urate)
Proteins ALT (GPT) Iron
Immunoglobulin A (IgA) Amylase Iron (TIBC)
Immunoglobulin G (IgG) Amylase (Pancreatic) Iron (UIBC)

Our Chemistry Premium control is designed for use in the routine monitoring of accuracy and precision. As a true third party control, assayed target
values and ranges are provided for the most common methods. Combining a total of 40 analytes including routine chemistry and proteins, this control will
contribute to effective consolidation and cost savings in any laboratory.

• Lyophilised for enhanced stability

• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Chemistry Premium Level 2 12 x 5 ml HN5067
Chemistry Premium Level 3 12 x 5 ml HE5068
Serum Diluent 20 x 5 ml MS5007

24
 CLINICAL CHEMISTRY

Liquid Assayed Chemistry Premium

Analytes
Cardiac Immunoassay Ceruloplasmin Calcium
CK (Total) α-Fetoprotein (AFP) Complement C3 Chloride
Myoglobin CEA Complement C4 Cholinesterase
Troponin T Cortisol CRP Creatinine
Folate Ferritin D-3-Hydroxybutyrate
Drugs hCG Haptoglobin gGT
Carbamazepine Prolactin Immunoglobulin A (IgA) GLDH
Digoxin PSA (Total) Immunoglobulin E (IgE) Glucose
Ethanol T3 (Free) Immunoglobulin G (IgG) Iron
Gentamicin T3 (Total) Immunoglobulin M (IgM) Iron (TIBC)
Lithium T4 (Free) Prealbumin Lactate
Paracetamol T4 (Total) Protein (Total) Lactate Dehydrogenase (LDH)
Phenobarbital TSH Transferrin LAP
Phenytoin Vitamin B12 Lipase
Salicylate Routine Chemistry Magnesium
Theophylline Lipids α-HBDH Osmolality
Valproic Acid Apolipoprotein A-1 Acid Phosphatase (Total) Phosphate (Inorganic)
Vancomycin Apolipoprotein B Albumin Potassium
Cholesterol (HDL) Alkaline Phosphatase (ALP) Sodium
Electrophoresis Cholesterol (LDL) ALT (GPT) Urea
α-1-Globulin Cholesterol (Total) Amylase Uric Acid (Urate)
α-2-Globulin Lipoprotein (a) Amylase (Pancreatic)
Albumin Triglycerides AST (GOT) Trace Metals
b-Globulin Bicarbonate Copper
g-Globulin Proteins Bile Acids Zinc
α-1-Acid Glycoprotein Bilirubin (Direct)
α-1-Antitrypsin Bilirubin (Total)

A comprehensive chemistry control designed to reduce the number of individual controls required by combining 90 analytes, including routine chemistry,
proteins, therapeutic drugs, lipids, electrophoresis and more. Supplied in a convenient liquid format for ease-of-use, minimal preparation is required. As a
true third party control, assayed target values are provided for most major analysers, ensuring unbiased performance assessment.

• Liquid for ease-of-use

• Human based serum
• Assayed instrument specific target values and ranges
• Stable to expiry when stored at -20ºC to -70ºC
• Open vial stability of up to 7 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid Assayed Chemistry Premium Level 2 12 x 5 ml LAN4216
Liquid Assayed Chemistry Premium Level 3 12 x 5 ml LAE4217

25
 CLINICAL CHEMISTRY

Liquid Assayed Chemistry Premium Plus Control

Analytes
Cardiac Immunoassay Proteins Bilirubin (Direct)
CK (Total) α-Fetoprotein (AFP) α-1- Acid Glycoprotein Bilirubin (Total)
Myoglobin CEA α-1-Antitrypsin Calcium
Troponin T Cortisol b-2-Microglobulin Chloride
DHEA Sulphate Ceruloplasmin Cholinesterase
Drugs Folate Complement C3 Creatinine
Amikacin FSH Complement C4 D-3-Hydroxybutyrate
Caffeine hCG CRP gGT
Carbamazepine Luteinising Hormone (LH) Ferritin GLDH
Digoxin Progesterone Haptoglobin Glucose
Ethanol Prolactin Immunoglobulin A (IgA) Iron
Gentamicin PSA (Total) Immunoglobulin E (IgE) Iron (TIBC)
Lithium T Uptake Immunoglobulin G (IgG) Lactate
Paracetamol T3 (Free) Immunoglobulin M (IgM) Lactate Dehydrogenase (LDH)
Phenobarbital T3 (Total) Prealbumin LAP
Phenytoin T4 (Free) Protein (Total) Lipase
Salicylate T4 (Total) Transferrin Magnesium
Theophylline Testosterone Osmolality
Valproic Acid TSH Routine Chemistry Phosphate (Inorganic)
Vancomycin Vitamin B12 α-HBDH Potassium
Acid Phosphatase (Total) Sodium
Electrophoresis Lipids Albumin Urea
α-1-Globulin Apolipoprotein A-1 Alkaline Phosphatase (ALP) Uric Acid (Urate)
α-2-Globulin Apolipoprotein B ALT (GPT)
Albumin Cholesterol (HDL) Amylase Trace Metals
b-Globulin Cholesterol (LDL) Amylase (Pancreatic) Copper
g-Globulin Cholesterol (Total) AST (GOT) Zinc
Lipoprotein (a) Bicarbonate
Triglycerides Bile Acids

Uniquely combining up to 99 analytes including; routine chemistry, immunoassays, lipids, therapeutic drugs, proteins and cardiac markers in a single vial,
laboratories can experience effective consolidation and significant cost savings. The presence of CRP and other proteins at elevated levels will not only
ensure accurate instrument performance at key decision levels but further reduce the number of individual controls required. As a true third party control,
assayed target values are provided for most major instruments.

• Liquid for ease-of-use

• Human based serum
• Assayed instrument specific target values and ranges
• High levels of CRP and other proteins eliminate the need for multiple controls
• Stable to expiry when stored at -20ºC to -70ºC
• Open vial stability of up to 7 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid Assayed Chemistry Premium Plus Level 1 12 x 5 ml LAL4213
Liquid Assayed Chemistry Premium Plus Level 2 12 x 5 ml LAN4214
Liquid Assayed Chemistry Premium Plus Level 3 12 x 5 ml LAE4215

26
 CLINICAL CHEMISTRY

Bovine Chemistry Assayed Control

Analytes
Cardiac Lipids ALT (GPT) Iron (TIBC)
CK (Total) Cholesterol Amylase Lactate
NEFA AST (GOT) Lactate Dehydrogenase (LDH)
Drugs Triglycerides Bicarbonate Lipase
Lithium Bile Acids Magnesium
Proteins Bilirubin (Direct) Osmolality
Immunoassay Protein (Total) Bilirubin (Total) Phosphate (Inorganic)
Cortisol Calcium Potassium
PSA (Total) Routine Chemistry Chloride Sodium
T3 (Total) α-HBDH Creatinine Urea
T4 (Free) Acid Phosphatase (Prostatic) D-3-Hydroxybutyrate Uric Acid (Urate)
T4 (Total) Acid Phosphatase (Non-Prostatic) gGT
Vitamin B12 Acid Phosphatase (Total) GLDH Trace Metals
Albumin Glucose Copper
Alkaline Phosphatase (ALP) Iron Zinc

Designed for use in the routine monitoring of accuracy and precision, this comprehensive bovine based, assayed control provides method, instrument
and temperature specific values for a unique combination of 46 analytes. Due to its bovine serum matrix and inclusion of common veterinary markers;
NEFA, Bile Acids, Lactate and D-3 Hydroxybutyrate, the Acusera Bovine Chemistry Assayed Control delivers a cost effective solution especially suited to
veterinary laboratories.

• Lyophilised for enhanced stability

• Bovine based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Bovine Chemistry Assayed Level 1 20 x 5 ml AL1027
Bovine Chemistry Assayed Level 2 20 x 5 ml AN1026
Bovine Chemistry Assayed Level 3 20 x 5 ml AE1032
Serum Diluent 20 x 5 ml MS5007

27
 CLINICAL CHEMISTRY

Bovine Chemistry Precision Control

Analytes
Cardiac Lipids AST (GOT) Lactate Dehydrogenase (LDH)
CK (Total) Cholesterol Bicarbonate Lipase
Triglycerides Bile Acids Magnesium
Drugs Bilirubin (Direct) Osmolality
Lithium Proteins Bilirubin (Total) Phosphate (Inorganic)
Protein (Total) D-3-Hydroxybutyrate Potassium
Immunoassay Calcium Sodium
Cortisol Routine Chemistry Chloride Urea
PSA (Total) α-HBDH Creatinine Uric Acid (Urate)
T3 (Total) Acid Phosphatase (Prostatic) gGT
T4 (Free) Acid Phosphatase (Total) GLDH Trace Metals
T4 (Total) Albumin Glucose Copper
Alkaline Phosphatase (ALP) Iron Zinc
ALT (GPT) Iron (TIBC)
Amylase Lactate

Covering 43 analytes including Bile Acids, Lactate and D-3-Hydroxybutyrate in a bovine serum matrix, the Acusera Bovine Chemistry Precision Control is
ideally suited to veterinary laboratories. As an unassayed, third party control it is suitable for use on a wide range of chemistry systems.

• Lyophilised for enhanced stability

• Bovine based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Bovine Chemistry Precision Level 1 20 x 5 ml SL1084
Bovine Chemistry Precision Level 2 20 x 5 ml SN1085
Bovine Chemistry Precision Level 3 20 x 5 ml SE1086
Serum Diluent 20 x 5 ml MS5007

28
 CLINICAL CHEMISTRY

Clinical Chemistry Calibration Serum

Analytes
Cardiac Routine Chemistry Bilirubin (Total) Lipase
CK (Total) α-HBDH Calcium Magnesium
Acid Phosphatase (Non-Prostatic) Chloride Osmolality
Drugs Acid Phosphatase (Prostatic) Cholinesterase Phosphate (Inorganic)
Lithium Acid Phosphatase (Total) Creatinine Potassium
Albumin D-3-Hydroxybutyrate Sodium
Lipids Alkaline Phosphatase (ALP) gGT Urea
Cholesterol ALT (GPT) GLDH Uric Acid (Urate)
Triglycerides Amylase (Pancreatic) Glucose
Amylase (Total) Iron Trace Metals
Proteins AST (GOT) Iron (TIBC) Copper
Protein (Total) Bicarbonate Lactate Zinc
Bile Acids Lactate Dehydrogenase (LDH)
Bilirubin (Direct) LAP

Comprising 42 analytes in a single vial, this multi-analyte, third party calibrator is designed for use with a wide range of clinical chemistry platforms. Assayed,
instrument, method and temperature specific values are supplied, ensuring accurate and reliable instrument calibration.

• Lyophilised for enhanced stability

• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Clinical Chemistry Calibration Serum Level 2 20 x 5 ml CAL2350
Clinical Chemistry Calibration Serum Level 3 20 x 5 ml CAL2351

Ammonia Ethanol Control

Analytes
Ammonia Ethanol

This dedicated Ammonia/Ethanol control comes in a highly convenient, liquid ready-to-use format ensuring no preparation is required. As a true third
party control, assayed target values are provided, ensuring unbiased performance assessment while eliminating the need for in-house value assignment.

• Liquid ready-to-use
• Aqueous material
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Ammonia Ethanol Control Level 1 6 x 2 ml EA1366
Ammonia Ethanol Control Level 2 6 x 2 ml EA1367
Ammonia Ethanol Control Level 3 6 x 2 ml EA1368

29
 CLINICAL CHEMISTRY

Aldolase Control and Calibrator

This dedicated Aldolase control is specifically designed to monitor the accuracy and precision of Aldolase on a wide range of chemistry analysers. Supplied
in a lyophilised format for enhanced stability, this control and calibrator set comes in a convenient 1ml vial.

• Lyophilised for enhanced stability

• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC

Description Size Cat. No.

Aldolase Calibrator 3 x 1 ml AD5000
Aldolase Control Level 2 3 x 1 ml AD5001
Aldolase Control Level 3 3 x 1 ml AD5002

Bilirubin Elevated Serum

Analytes
Bilirubin (Direct) Bilirubin (Total)

Acusera Bilirubin Elevated Serum is a bovine based serum designed for use in the monitoring of accuracy and precision. This product is suitable for
monitoring paediatric bilirubin levels and contains method specific target values and ranges.

• Lyophilised for enhanced stability

• Bovine serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC

Description Size Cat. No.

Bilirubin Elevated Serum 10 x 3 ml BE454

Liquid Bilirubin Control

Analytes
Bilirubin (Direct) Bilirubin (Total)

Providing a true third party solution for the measurement of Bilirubin, the Acusera Liquid Bilirubin Control is designed to deliver an unbiased, independent
assessment of analytical performance. Two levels are available covering the required clinically relevant decision levels for paediatric testing.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid Bilirubin Control Level 1 3 x 3ml BR10172
Liquid Bilirubin Control Level 2 3 x 3ml BR10173

Glycerol Control
Dedicated Glycerol control for use in the routine monitoring of accuracy and precision. Supplied in a lyophilised format for enhanced stability, this control
comes with assayed target values for most major chemistry analysers.

• Lyophilised for enhanced stability

• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Glycerol Control 3 x 5 ml GY1369

30
 CLINICAL CHEMISTRY

Multi Control and Calibrator

Analytes
Ammonia Glucose Glutamate Lactate

This multi-analyte control and calibrator is designed for use in the routine monitoring of accuracy and precision. Supplied in a convenient liquid ready-to-use
format no preparation is required.

• Liquid ready-to-use
• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

Multi Calibrator 3 x 2 ml MC1382
Multi Control Level 1 5 x 2 ml MC1379
Multi Control Level 2 5 x 2 ml MC1380 *FOR BIOTECHNOLOGY INDUSTRIAL USE.
Multi Control Level 3 5 x 2 ml MC1381 Not for use in diagnostic procedures.

Glutamine Control and Calibrator

This dedicated Glutamine control is supplied in a lyophilised format for enhanced stability. Manufactured using 100% human material, it is designed to
mimic patient samples, ensuring accurate test system performance.

• Lyophilised for enhanced stability

• 100% human material
• Stable to expiry at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Glutamine Control Level 1 5 x 5 ml GM1376
Glutamine Control Level 2 5 x 5 ml GM1377
Glutamine Control Level 3 5 x 5 ml GM1378 *FOR BIOTECHNOLOGY INDUSTRIAL USE.
Glutamine Calibrator 3 x 5 ml GM1375 Not for use in diagnostic procedures.

TXB Cardio Control and Calibrator Series

Dedicated control and calibrator series for use on clinical chemistry systems to monitor the levels of the urinary metabolite 11dhTXB2.

• Liquid ready-to-use
• 100% human material
• Stable to expiry at 2ºC to 8ºC
• Open vial stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

TXB Cardio Control Level 1 3 x 3 ml TBX5125
TXB Cardio Control Level 2 3 x 3 ml TBX5126
TXB Cardio Control Level 3 3 x 3 ml TBX5127
TXB Cardio Calibrator Series 3 x 3 ml TBX3132
TXB Cardio Sample Diluent 3 x 100 ml TBX2814

31
Our true third party Coagulation and Haematology Controls have been designed to deliver an
unbiased assessment of analytical performance, while providing a matrix similar to that of the
patient. These multi-analyte controls cover the full clinical range in a single control, enabling you
to consolidate your test menu, saving both time and money.

COAGULATION AND
HAEMATOLOGY
CONTROLS

32
 COAGULATION AND HAEMATOLOGY

Coagulation and Haematology Product Range

Product Description Size Cat. No. Page No.
Coagulation Control Level 1 12 x 1 ml CG5021 34

Coagulation Control Level 2 12 x 1 ml CG5022 34

Coagulation Control Level 3 12 x 1 ml CG5023 34

Coagulation Calibrator 10 x 1 ml CG5037 34

Haematology Control 3 x 2 x 4.5 ml HM5162 35

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

33
 COAGULATION AND HAEMATOLOGY

Coagulation Control
Analytes
Analytes

Activated Partial Thromboplastin Time (APTT) Factor VII Factor XI Protein C

Anti-Thrombin III (AT III) Factor VIII Factor XII Protein S
Factor II Factor IX Fibrinogen Prothrombin Time (PT)
Factor V Factor X Plasminogen Thrombin Time (TT)

Our Coagulation Control combines 16 analytes in total, delivering a comprehensive, third party solution for laboratories carrying out both routine and
specialised coagulation tests. Comprising a variety of factor assays and basic coagulation tests, the number of individual controls required is reduced, saving costs
and time. Assayed method and instrument specific target values & ranges are provided, eliminating the need to spend time assigning target values in-house.

• Lyophilised for enhanced stability

• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 24 hours at 2ºC to 8ºC

Description Size Cat. No.

Coagulation Control Level 1 12 x 1 ml CG5021
Coagulation Control Level 2 12 x 1 ml CG5022
Coagulation Control Level 3 12 x 1 ml CG5023

Coagulation Calibrator
Analytes
Analytes

Anti-Thrombin III (AT III) Fibrinogen

The Acusera multi-analyte Coagulation Calibrator is a true third party calibrator designed for the use in the calibration of the Randox Fibrinogen and Anti-
Thrombin III assays.

• Lyophilised for enhanced stability

• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 24 hours at 2ºC to 8ºC

Description Size Cat. No.

Coagulation Calibrator 10 x 1 ml CG5037

34
 COAGULATION AND HAEMATOLOGY

Haematology Control
Analytes
BASO-X Mean Platelet Volume (MPV)
BASO -Y Monocytes (MONO)
Basophils (BASO)* % Monocytes (% MONO)
% Basophils (% BASO) Neutrophils (NEUT)
DIFF-X % Neutrophils (% NEUT)
DIFF-Y Nucleated Red Blood Cells (NRBC)*
Eosinophils (EOS) Nucleated Red Blood Cells X (NRBC-X)
% Eosinophils (%EOS) Nucleated Red Blood Cells Y (NRBC-Y)
FSC-X % Nucleated Red Blood Cells (%NRBC)
Haematocrit (HCT) Platelet Distribution Width (PDW)
Haemoglobin (HGB) Platelet Large Cell Ratio (P-LCR)
Haematopoietic Progenitor Cell (HPC) Plateletcrit (PCT)
IMIDC Platelets (PLT)
IMIRF Platelets Optical Count (PLT-O)
Immature Granulocytes (IG) Red Blood Cells (RBC)
% Immature Granulocytes (%IG) Red Blood Cell X (RBC-X)
Immature Myeloid Information (IMI) Red Blood Cell Y (RBC-Y)
Immature Platelet Fraction (IPF) Red Blood Cell Distribution Width CV (RDW-CV)
Lymphocytes (LYMPH) Red Blood Cell Distribution Width SD (RDW-SD)
% Lymphocytes (% LYMPH) Red Blood Cells Optical Count (RBC-O)
Mean Corpuscular Haemoglobin (MCH) White Blood Cells (WBC)
Mean Corpuscular Haemoglobin Concentration (MCHC) White Blood Cells Differential (WBC-D)
Mean Corpuscular Volume (MCV)

The Acusera Haematology Control combines an impressive 45 analytes, covering the full blood profile in a convenient liquid ready-to-use format, ultimately
increasing productivity and reducing the need for multiple controls. Providing a true third party solution for 5-part WBC differential Sysmex Haematology
analysers, ensuring unbiased performance assessment.

• Liquid ready-to-use
• 100% Human whole blood
• Barcoded labels enabling quick and easy sample recognition
• Stable for 70 days at 2ºC to 8°C
• Open vial stability of 14 days at 2ºC to 8°C

Description Size Cat. No. *This product may not be suitable for the control of
Haematology Control Tri-Level 3 x 2 x 4.5 ml HM5162 Basophils and NRBC on some Sysmex models.

35
This Acusera Diabetes range provides a true third party solution for key tests used in the diagnosis
and monitoring of diabetes and haemoglobin variants. Designed for use on multiple platforms, an
independent assessment of performance is guaranteed. An extended reconstituted stability of four
weeks for many controls will not only keep waste to a minimum but will help to reduce costs. As
with all Acusera controls, laboratories can expect to experience reduced preparation time and
costs without compromising on consistency or quality.

DIABETES AND
WHOLE BLOOD
CONTROLS

36
 DIABETES AND WHOLE BLOOD

Diabetes and Whole Blood Product Range

Product Description Size Cat. No. Page No.
HbA1c Control Set Level 1 and 2 2 x 2 x 0.5 ml HA5072 38
HbA1c Calibrator Series 5 x 2 ml, 1 x 8 ml HA3444 38
Liquid HbA1c Control Set Level 1 and 2 2 x 2 x 0.5 ml HA10155 38
G-6PDH Control Deficient 6 x 0.5 ml PD2617 38
G-6PDH Control Normal 6 x 0.5 ml PD2618 38
Fructosamine Control Level 1 3 x 1 ml FR2994 39
Fructosamine Control Level 3 3 x 1 ml FR2996 39
Fructosamine Calibrator 3 x 1 ml FR2993 39
Haemoglobin F and A2 Control 2 x 2 x 0.2 ml HA5083 39
Adiponectin Control Level 2 3 x 1 ml AO2801 39
Adiponectin Control Level 3 3 x 1 ml AO2802 39
Adiponectin Calibrator 4 x 1 ml AO2800 39

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

37
 DIABETES AND WHOLE BLOOD

HbA1c Control and Calibrator Series

Analytes
Haemoglobin (Total) HbA1c

The Acusera HbA1c control is designed for use in the quality control of both HbA1c and Total Haemoglobin assays. Assayed instrument and method
specific target values and ranges are provided for all major systems and methods including HPLC. A reconstituted stability of 4 weeks keeps waste to a
minimum and helps to reduce costs.

• Lyophilised for enhanced stability

• 100% human whole blood
• Treated in the same manner as a patient sample (requires pre-treatment)
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

HbA1c Control Set Level 1 and 2 2 x 2 x 0.5 ml HA5072
HbA1c Calibrator Series 5 x 2 ml, 1 x 8 ml HA3444

Liquid HbA1c Control

Analytes
%HbA1c

Delivering an assayed QC solution for HbA1c testing, our Acusera Liquid HbA1c control offers a liquid ready-to-use format ideal for both laboratory and
POCT testing. Employing our Liquid HbA1c Control in your laboratory could reduce preparation time, whilst the 30 day stability will ultimately minimise
waste and costs.

• Liquid ready-to-use
• Human based whole blood
• Treated in the same manner as a patient sample (requires pre-treatment)
• Assayed target values are supplied for HPLC
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8°C

Description Size Cat. No.

Liquid HbA1c Control Set Level 1 and 2 2 x 2 x 0.5 ml HA10155

G-6-PDH (Glucose-6-Phosphate Dehydrogenase) Control

The Randox Acusera G-6-PDH control is designed specifically to monitor the accuracy and precision of G-6-PDH assays.Two levels of control are available
covering both normal and deficient concentration ranges.

• Lyophilised for enhanced stability

• Human based whole blood
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC

Description Size Cat. No.

G-6-PDH Control Deficient 6 x 0.5 ml PD2617
G-6-PDH Control Normal 6 x 0.5 ml PD2618

38
 DIABETES AND WHOLE BLOOD

Fructosamine Control and Calibrator

The Acusera Fructosamine control is specifically designed to monitor the accuracy and precision of fructosamine assays. An extended reconstituted stability
of 28 days at 2°C – 8°C keeps waste to a minimum and helps to reduce costs.

• Lyophilised for enhanced stability

• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Fructosamine Control Level 1 3 x 1 ml FR2994
Fructosamine Control Level 3 3 x 1 ml FR2996
Fructosamine Calibrator 3 x 1 ml FR2993

Haemoglobin F & A2 Control

Analytes
Level 1 Level 2
Haemoglobin A2 (HbA2) Haemoglobin A2 (HbA2)
Haemoglobin F (HbF) Haemoglobin F (HbF)
Haemoglobin S (HbS)

The Randox Acusera Haemoglobin F and A2 control is specifically designed to monitor the precision of Haemoglobin variants associated with Thalassaemia.
As an unassayed, third party control it is suitable for use with all major systems and methods including, HPLC, Immunoassay and Glycation Specific. The
level 2 control can also be used as a position marker for Haemoglobin S elution time on HPLC assays.

• Lyophilised for enhanced stability

• 100% human whole blood
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Haemoglobin F & A2 Control 2 x 2 x 0.2 ml HA5083

Adiponectin Control and Calibrator

Designed specifically for use with the Randox Adiponectin assay, our control and calibrator will help to ensure accurate test system performance.
Supplied in a convenient liquid ready-to-use format, no preparation is required.

• Liquid ready-to-use
• Human based serum
• Stable to expiry date at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

Adiponectin Control Level 2 3 x 1 ml AO2801
Adiponectin Control Level 3 3 x 1 ml AO2802
Adiponectin Calibrator 4 x 1 ml AO2800

39
As one of the most comprehensive control ranges on the market, the Acusera Immunoassay
offering from Randox will streamline QC in any laboratory. With multiple immunoassay controls to
choose from, combining up to 54 analytes in a single vial, choice and flexibility is guaranteed. Our
unique combination of analytes enables complete test menu consolidation, ultimately reducing
costs without compromising on quality or performance. All controls in our Immunoassay range
are manufactured from 100% human serum. This matrix ensures the test system will react to the
control in the same manner as a patient sample, therefore meeting ISO 15189:2012 requirements
while also eliminating shifts in QC target values when reagent batch is changed.

IMMUNOASSAY
CONTROLS

40
 IMMUNOASSAY

Immunoassay Product Range

Product Description Size Cat. No. Page No.
Liquid Immunoassay Premium Level 1 12 x 5 ml LIA3105 42
Liquid Immunoassay Premium Level 2 12 x 5 ml LIA3106 42
Liquid Immunoassay Premium Level 3 12 x 5 ml LIA3107 42
Liquid Immunoassay Premium Tri-Level 4 x 3 x 5 ml LIA3108 42
PTH Control Level 1 3 x 2 ml PTH10110 42
PTH Control Level 2 3 x 2 ml PTH10111 42
PTH Control Level 3 3 x 2 ml PTH10112 42
Immunoassay Premium Level 1 12 x 5 ml IA2638 43
Immunoassay Premium Level 2 12 x 5 ml IA2639 43
Immunoassay Premium Level 3 12 x 5 ml IA2640 43
Immunoassay Premium Tri-Level 4 x 3 x 5 ml IA2633 43
Immunoassay Premium Plus Level 1 12 x 5 ml IA3109 44
Immunoassay Premium Plus Level 2 12 x 5 ml IA3110 44
Immunoassay Premium Plus Level 3 12 x 5 ml IA3111 44
Immunoassay Premium Plus Tri-Level 4 x 3 x 5 ml IA3112 44
Immunoassay Speciality I Level 1 5 x 2 ml IAS3113 45
Immunoassay Speciality I Level 2 5 x 2 ml IAS3114 45
Immunoassay Speciality I Level 3 5 x 2 ml IAS3115 45
Immunoassay Speciality II Level 1 5 x 1 ml IAS3117 45
Immunoassay Speciality II Level 2 5 x 1 ml IAS3118 45
Immunoassay Speciality II Level 3 5 x 1 ml IAS3119 45
Tumour Marker Control Level 2 3 x 2 ml TU5002 46
Tumour Marker Control Level 3 3 x 2 ml TU5003 46
Liquid Tumour Marker Control Level 1 6 x 3 ml TU5085 46
Liquid Tumour Marker Control Level 2 6 x 3 ml TU5086 46

Liquid Tumour Marker Control Level 3 6 x 3 ml TU5087 46

Maternal Screening Control Level 1 3 x 1 ml MSS5024 47
Maternal Screening Control Level 2 3 x 1 ml MSS5025 47
Maternal Screening Control Level 3 3 x 1 ml MSS5026 47

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

41
 IMMUNOASSAY

Liquid Immunoassay Premium Control

Analytes
17-OH-Progesterone Ethosuximide Paracetamol T3 (Free)
α-Fetoprotein (AFP) Ferritin Phenobarbital+ T3 (Total)
Aldosterone Folate Phenytoin T4 (Free)
Amikacin FSH Primidone T4 (Total)
b-2-Microglobulin+ Gentamicin Progesterone Testosterone
Carbamazepine Growth Hormone (GH) Prolactin Theophylline
CEA hCG PSA (Free) Tobramycin
Cortisol Immunoglobulin E (IgE) PSA (Total) TSH
DHEA-Sulphate Insulin Salicylate Valproic Acid
Digoxin Luteinising Hormone (LH) Sex Hormone Binding Globulin (SHBG) Vancomycin
Estriol* Oestradiol T Uptake Vitamin B12

The Liquid Immunoassay Premium Control has been designed for use in the routine monitoring of accuracy and precision of multiple instruments.
Consolidating up to 44 analytes in a single vial, employing this control can reduce the number of controls required to cover your complete test menu,
saving time and money. As a true third party control, assayed values are available for most immunoassay platforms and a wide range of analytes, including
hormones, therapeutic drugs and vitamins.

• Liquid for ease-of-use

• 100% human serum
• Stable to expiry date at -20ºC to -70ºC
• Open vial stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid Immunoassay Premium Level 1 12 x 5 ml LIA3105
Liquid Immunoassay Premium Level 2 12 x 5 ml LIA3106
Liquid Immunoassay Premium Level 3 12 x 5 ml LIA3107 *No claims are made regarding values or stability.
Liquid Immunoassay Premium Tri-Level 4 x 3 x 5 ml LIA3108 +
Not for use in the USA.

PTH Control
Analytes
Intact PTH (Parathyroid Hormone)

The Acusera PTH Control is an assayed, true third party control designed to complement our Immunoassay range, delivering an unbiased, independant
assessment of analytical performance. With an open vial stability of 30 days, waste is kept to a minimum.

• Liquid for ease-of-use

• 100% human serum
• Assayed target values and ranges for a wide range of immunoassay systems
• Stable to expiry date at -20ºC to -70ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

PTH Control Level 1 3 x 3 ml PTH10110
PTH Control Level 2 3 x 3 ml PTH10111
PTH Control Level 3 3 x 3 ml PTH10112

42
 IMMUNOASSAY

Immunoassay Premium Control

Analytes
17-OH-Progesterone DHEA-Sulphate Oestradiol T3 (Total)
1-25-(OH)2-Vitamin D* Digoxin Paracetamol T4 (Free)
25-OH-Vitamin D Estriol* Phenobarbital T4 (Total)
α-Fetoprotein (AFP) Ethosuximide Phenytoin Testosterone
ACTH+ Ferritin Primidone Testosterone (Free)*
Aldosterone+ Folate Progesterone Theophylline
Amikacin FSH Prolactin Thyroglobulin
Androstenedione Gentamicin PSA (Free) Tobramycin
b-2-Microglobulin Growth Hormone (GH) PSA (Total) TSH
C-Peptide hCG Salicylate Valproic Acid
Carbamazepine Immunoglobulin E (IgE) Sex Hormone Binding Globulin (SHBG) Vancomycin
CEA Insulin T Uptake Vitamin B12
Cortisol Luteinising Hormone (LH) T3 (Free)

Efficiently combining 51 analytes in total, the Immunoassay Premium Control is designed to cover routine immunoassay testing in a single vial. The additional
benefit of clinically relevant concentrations will not only ensure accurate performance at key decision levels, but will also eliminate the need for additional
low/high controls at extra expense. As an assayed control, instrument specific target values and ranges are provided for up to 48 analytes, including fertility,
thyroid & steroid hormones, kidney function tests, therapeutic drugs and vitamins, saving you time assigning these in-house. Manufactured using 100%
human serum, this control is designed to directly mimic a patient sample, reducing costly shifts when reagent batch is changed.

• Lyophilised for enhanced stability

• 100% human serum
• Ferritin and Vitamin B12 levels suitable for Anaemia monitoring
• TSH levels around 0.11 μU/ml in the level 1 control
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC, or up to 28 days at -20ºC

Description Size Cat. No.

Immunoassay Premium Level 1 12 x 5 ml IA2638
Immunoassay Premium Level 2 12 x 5 ml IA2639
Immunoassay Premium Level 3 12 x 5 ml IA2640 *No claims are made regarding values or stability.
+
Immunoassay Premium Tri-level 4 x 3 x 5 ml IA2633 Values may not be provided for all levels.

43
 IMMUNOASSAY

Immunoassay Premium Plus Control

Analytes
17-OH-Progesterone CEA Luteinising Hormone (LH) T3 (Total)
1-25-(OH)2-Vitamin D* Cortisol Oestradiol T4 (Free)
25-OH-Vitamin D DHEA-Sulphate Paracetamol T4 (Total)
α-Fetoprotein (AFP) Digoxin Phenobarbital Testosterone
ACTH+ Estriol* Phenytoin Testosterone (Free)*
Aldosterone+ Ethosuximide Primidone Theophylline
Amikacin Ferritin Progesterone Thyroglobulin
Androstenedione Folate Prolactin Tobramycin
b-2-Microglobulin FSH PSA (Free) TSH
C-Peptide Gentamicin PSA (Total) Valproic Acid
CA 15-3 Growth Hormone (GH) Salicylate Vancomycin
CA 19-9 hCG Sex Hormone Binding Globulin (SHBG) Vitamin B12
CA 125 Immunoglobulin E (IgE) T Uptake
Carbamazepine Insulin T3 (Free)

Impressively covering 54 analytes including tumour markers, therapeutic drugs and routine immunoassay tests, the Acusera Immunoassay Premium Plus
control has been uniquely designed to eliminate the need for four or more controls, dramatically reducing costs and time. The added advantage of ultra low
levels of Ferritin,Vitamin B12 and TSH will ensure accurate performance at key decision levels and further reduce the number of controls required. Assayed
target values are supplied for 51 analytes in this true third party control. Manufactured using 100% human serum, this control is designed to directly mimic
a patient sample, reducing costly shifts when reagent batch is changed.

• Lyophilised for enhanced stability

• 100% human serum
• Ferritin and Vitamin B12 levels suitable for Anaemia monitoring
• TSH targets are around 0.11 μU/ml in Level 1 control
• Contains routinely run tumour markers: AFP / CA15-3 / CA19-9 / CA-125 / CEA / PSA / Free-PSA
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Immunoassay Premium Plus Level 1 12 x 5 ml IA3109
Immunoassay Premium Plus Level 2 12 x 5 ml IA3110
Immunoassay Premium Plus Level 3 12 x 5 ml IA3111 *No claims are made regarding values or stability.
+
Immunoassay Premium Plus Tri-Level 4 x 3 x 5 ml IA3112 Values may not be provided for all levels.

44
 IMMUNOASSAY

Immunoassay Speciality 1 Control

Analytes
1-25-(OH)2-Vitamin D C-Peptide Osteocalcin
25-OH-Vitamin D Insulin Procalcitonin
Anti-Thyroglobulin (Anti-TG) Insulin Like Growth Factor-1(IGF-1)
Anti-Thyroperoxidase (Anti-TPO) Intact PTH (Parathyroid Hormone)

Covering 10 specialised analytes, the Acusera Immunoassay Speciality I control is designed to complement our standard immunoassay control, meeting the
demands of today’s modern laboratory. Assayed target values are supplied for all 10 analytes in this true third party control.

• Lyophilised for enhanced stability

• 100% human serum
• Assayed target values and ranges for a wide range of immunoassay systems
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of up to 5 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Immunoassay Speciality I Level 1 5 x 2 ml IAS3113
Immunoassay Speciality I Level 2 5 x 2 ml IAS3114
Immunoassay Speciality I Level 3 5 x 2 ml IAS3115

Immunoassay Speciality 1I Control

Analytes
Calcitonin Procalcitonin
Gastrin Renin

Designed for the routine monitoring of more complex, specialised analytes, the Acusera Immunoassay Speciality II control complements our standard
immunoassay controls. As a true third party control, assayed target values are supplied and unbiased performance assessment guaranteed.

• Lyophilised for enhanced stability

• 100% human serum
• Assayed target values and ranges for a wide range of immunoassay systems
• Stable to expiry date at 2ºC to 8ºC
• Reconstitutued stability of 5 days at 2ºC to 8ºC for Renin, 1 day at 2ºC to 8ºC for Procalcitonin and 8 hours at 2ºC to 8ºC for Gastrin
and Calcitonin. Stable for 28 days at -20ºC

Description Size Cat. No.

Immunoassay Speciality II Level 1 5 x 1 ml IAS3117
Immunoassay Speciality II Level 2 5 x 1 ml IAS3118
Immunoassay Speciality II Level 3 5 x 1 ml IAS3119

45
 IMMUNOASSAY

Tumour Marker Control

Analytes
α-Fetoprotein (AFP) CA 125 hCG
b-2-Microglobulin Calcitonin NSE
CA 15-3 CEA PSA (Free)
CA 19-9 CYFRA 21-1 PSA (Total)
CA 72-4 Ferritin Thyroglobulin

The multi-analyte Acusera Tumour Marker control has been designed for use in the daily monitoring of 15 routine and specialised tumour markers. This
true third party control is provided with assayed target values and ranges for all analytes, ensuring an unbiased assessment of performance for a wide range
of immunoassay instruments.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2°C to 8ºC
• Reconstituted stability of 14 days at 2°C to 8°C

Description Size Cat. No.

Tumour Marker Control Level 2 3 x 2 ml TU5002
Tumour Marker Control Level 3 3 x 2 ml TU5003

Liquid Tumour Marker Control

Analytes
α-Fetoprotein (AFP) CA 72-4 NSE
b-2-Microglobulin CA 125 PSA (Free)
CA 15-3 CEA PSA (Total)
CA 19-9 CYFRA 21-1 Thyroglobulin
CA 27-29 Ferritin Total b-hCG

The multi-analyte Acusera Liquid Tumour Marker control has been designed for use in the daily monitoring of 15 routine and esoteric tumour markers.
Conveniently supplied in a liquid ready-to-use format, no preparation is required, saving precious laboratory time. This true third party control is provided with
assayed target values and ranges for all analytes, ensuring an unbiased assessment of performance for a wide range of chemistry and immunoassay instruments.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid Tumour Marker Control Level 1 6 x 3 ml TU5085
Liquid Tumour Marker Control Level 2 6 x 3 ml TU5086
Liquid Tumour Marker Control Level 3 6 x 3 ml TU5087

46
 IMMUNOASSAY

Maternal Screening Control

Analytes
α-Fetoprotein (AFP) PAPP-A
Free b-hCG Total b-hCG
Inhibin A Unconjugated Oestriol

Delivering an assayed, multi-analyte QC solution for laboratories carrying out maternal screening, the Acusera Maternal Screening control covers a unique
combination of analytes, ensuring suitability for both First and Second Trimester screening of Down’s syndrome & Spina Bifida. By employing our Maternal
Screening Control you could replace up to three competitor controls, ultimately improving efficiency, while reducing costs and preparation time.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Maternal Screening Control Level 1 3 x 1 ml MSS5024
Maternal Screening Control Level 2 3 x 1 ml MSS5025
Maternal Screening Control Level 3 3 x 1 ml MSS5026

47
The Acusera range of Immunology/Protein Controls has been designed to be both cost effective
and convenient. Requiring no preparation or thawing, the liquid ready-to-use format will increase
productivity and efficiency in even the most demanding laboratories. Furthermore, an open vial
stability of thirty days for all analytes, with no exceptions, will reduce costs and keep waste to a
minimum.*

IMMUNOLOGY/
PROTEIN CONTROLS

* Our Acusera CSF Control comes in a lyophilised format and requires reconstitution. It has a 14 day reconstituted stability.

48
 IMMUNOLOGY/PROTEIN

Immunology/Protein Product Range

Product Description Size Cat. No. Page No.
Specific Protein Control Level 1 3 x 1 ml PS2682 50
Specific Protein Control Level 2 3 x 1 ml PS2683 50
Specific Protein Control Level 3 3 x 1 ml PS2684 50
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691 50
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2692 50
Liquid CRP Control Level 2 10 x 1 ml CP2480 51
Liquid CRP Control Level 3 10 x 1 ml CP2481 51
High Sensitivity CRP Control Level 1 10 x 1 ml CP2476 51
High Sensitivity CRP Control Level 2 10 x 1 ml CP2477 51
CRP Calibrator 3 x 1 ml CP2179 51
High Sensitivity CRP Calibrator Series 6 x 2 ml CP2478 51
CRP Calibrator Series 6 x 2 ml CP2479 51
CRP Full Range Calibrator 6 x 1 ml CP2499 51
Canine CRP Control Level 2 3 x 1 ml CP2803 51
Canine CRP Control Level 3 3 x 1 ml CP2804 51
CSF Control Level 2 10 x 3 ml CF1500 51
CSF Control Level 3 10 x 3 ml CF1501 51
Liquid CSF Control Level 1 10 x 3 ml CF10138 52
Liquid CSF Control Level 2 10 x 3 ml CF10139 52
ASO Standard 5 x 1 ml LO2306 52
b-2-Microglobulin Calibrator 3 x 1 ml BM1362 52
Cystatin C Control Level 2 3 x 2 ml CYS5019 52
Cystatin C Control Level 3 3 x 2 ml CYS5020 52
Cystatin C Calibrator 5 x 2 ml CYS2699 52
Immunoglobulin Liquid Protein Calibrator 3 x 1 ml IT3861 53
IgE Calibrator Series 6 x 1 ml IE2492 53
High Sensitivity IgG Control Level 1 5 x 2 ml IT3982 53
High Sensitivity IgG Control Level 2 5 x 2 ml IT3983 53
High Sensitivity IgG Control Level 3 5 x 2 ml IT3984 53
High Sensitivity IgG Calibrator 3 x 1 ml IT3899 53
Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301 53

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

49
 IMMUNOLOGY/PROTEIN

Specific Protein Control

Analytes
α-1-Acid Glycoprotein b-2-Microglobulin Immunoglobulin A (IgA) Lambda Light Chain (Free)
α-1-Antitrypsin Ceruloplasmin Immunoglobulin E (IgE) Prealbumin
α-2-Macroglobulin Complement C3 Immunoglobulin G (IgG) Protein (Total)
α-Fetoprotein (AFP) Complement C4 Immunoglobulin M (IgM) Retinol Binding Protein (RBP)
Albumin CRP Kappa Light Chain Rheumatoid Factor (RF)
Anti-Streptolysin O (ASO) Ferritin Kappa Light Chain (Free) Transferrin
Anti-Thrombin III (AT III) Haptoglobin Lambda Light Chain

Covering a unique combination of 27 serum proteins, including; Total & Free Kappa and Lambda Light Chains, the Acusera Specific Protein Control could
replace as many as three separate controls. Supplied in a user-friendly liquid ready-to-use format with a 30 day open vial stability for all analytes, waste and
preparation time are kept to a minimum. Manufactured using 100% human serum, this control is designed to directly mimic a patient sample, reducing costly
shifts when reagent batch is changed and ensuring accurate patient testing. Assayed target values and ranges are provided for this true third party control.

• Liquid ready-to-use
• 100% human serum
• Contains both Total & Free Kappa and Lambda Light Chains
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Specific Protein Control Level 1 3 x 1 ml PS2682
Specific Protein Control Level 2 3 x 1 ml PS2683
Specific Protein Control Level 3 3 x 1 ml PS2684

Specific Protein Calibrator

Analytes
Anti-Streptolysin O (ASO) CRP Immunoglobulin A (IgA) Prealbumin
Ceruloplasmin Ferritin Immunoglobulin G (IgG) Rheumatoid Factor (RF)
Complement C3 Haptoglobin Immunoglobulin M (IgM) Transferrin
Complement C4

Multi-analyte calibrator designed for use in the routine calibration of 13 serum proteins including Ferritin, IgA, IgG and IgM. Supplied in a convenient, liquid
ready-to-use format with a working stability of 30 days, waste and time are kept to a minimum.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Specific Protein Calibrator (Liquid) 5 x 1 ml IT2691 FOR USE WITH SAMPLES THAT DO NOT REQUIRE PRE-DILUTION

Specific Protein Calibrator - Requires Pre-dilution

Analytes
α-1-Acid Glycoprotein Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM)
α-1-Antitrypsin

Multi-analyte calibrator designed for use in the routine calibration of 5 serum proteins. Supplied in a convenient, liquid ready-to-use format with a working
stability of 30 days, waste and time are kept to a minimum.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Specific Protein Calibrator (Liquid) 5 x 1 ml IT2692 FOR USE WITH SAMPLES THAT REQUIRE PRE-DILUTION

50
 IMMUNOLOGY/PROTEIN

CRP Controls and Calibrator

A choice of two dedicated CRP controls is available, covering elevated and highly sensitive levels of CRP. As true third party controls, assayed target
values are provided, ensuring unbiased performance assessment with any instrument or method. Conveniently supplied in a liquid ready-to-use format, no
preparation is required.

• Liquid ready-to-use
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid CRP Control Level 2 10 x 1 ml CP2480
Liquid CRP Control Level 3 10 x 1 ml CP2481
High Sensitivity CRP Control Level 1 10 x 1 ml CP2476
High Sensitivity CRP Control Level 2 10 x 1 ml CP2477
CRP Calibrator 3 x 1 ml CP2179
High Sensitivity CRP Calibrator Series 6 x 2 ml CP2478
CRP Calibrator Series 6 x 2 ml CP2479
CRP Full Range Calibrator 6 x 1 ml CP2499

Canine CRP Control

Dedicated CRP control uniquely designed for use in the quality control of the Randox Canine CRP assay. Supplied in a convenient, liquid ready-to-use
format and stable to expiry date, waste and preparation time is kept to an absolute minimum.

• Liquid ready-to-use
• Human CRP in a stabilised protein matrix
• Stable to expiry date at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

Canine CRP Control Level 2 3 x 1 ml CP2803
Canine CRP Control Level 3 3 x 1 ml CP2804

CSF Control
Analytes
α-1-Globulin (Electrophoresis) b-Globulin (Electrophoresis) Glucose Protein (Total)
α-2-Globulin (Electrophoresis) Chloride Immunoglobulin G (IgG) Sodium
Albumin (Electrophoresis) g-Globulin (Electrophoresis) Lactate

Multi-analyte CSF control designed for use in the routine monitoring of both accuracy and precision. As a true third party control, it is compatible for use
with a wide range of clinical analysers. Assayed target values are provided, eliminating the need to assign in-house.

• Lyophilised for enhanced stability

• Human based material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 14 days at 2ºC to 8ºC

Description Size Cat. No.

CSF Control Level 2 10 x 3 ml CF1500
CSF Control Level 3 10 x 3 ml CF1501

51
 IMMUNOLOGY/PROTEIN

Liquid CSF Control

Analytes
α-1-Globulin (Electrophoresis) Chloride High Sensitivity Immunoglobulin G (hsIgG) Protein (Total)
α-2-Globulin (Electrophoresis) γ-Globulin (Electrophoresis) High Sensitivity Immunoglobulin M (hsIgM)* Sodium
Albumin (Electrophoresis) Glucose Lactate
b-Globulin (Electrophoresis) High Sensitivity Immunoglobulin A (hsIgA)* Microalbumin

Providing a true third party solution for the measurement of 14 analytes in Cerebrospinal Fluid (CSF), the new Acusera Liquid CSF Control is designed to deliver
an unbiased, independent assessment of analytical performance, helping to ensure accurate and reliable patient testing. With an extended open vial stability of 30
days at 2ºC to 8ºC, this control will reduce waste, while remaining easy and convenient to use. Two distinct levels are available covering clinically significant ranges.

• Liquid ready-to-use
• Human based material
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Liquid CSF Control Level 1 10 x 3 ml CF10138
Liquid CSF Control Level 2 10 x 3 ml CF10139 *No claims are made regarding values or stability.

ASO Standard
Our dedicated ASO calibrator is designed for use in the calibration of immunoturbidimetric ASO assays. Compatible for use on a wide range of clinical
analysers, this calibrator is supplied in a user-friendly liquid ready-to-use format.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

ASO Standard 5 x 1 ml LO2306

b-2-Microglobulin Calibrator
Our dedicated b-2-Microglobulin calibrator is designed for use in the calibration of b-2-Microglobulin assays. With an excellent working stability of 30 days
at 2ºC to 8ºC, waste is kept to a minimum.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 30 days at 2ºC to 8ºC or 3 months at -20ºC

Description Size Cat. No.

b-2-Microglobulin Calibrator 3 x 1 ml BM1362

Cystatin C Control and Calibrator

Dedicated Cystatin C control designed for use in the routine monitoring of both accuracy and precision. Supplied in a convenient, liquid ready-to-use
format, no preparation is required. Assayed target values and ranges are provided for this true third party control.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC
Description Size Cat. No.
Cystatin C Control Level 2 3 x 2 ml CYS5019
Cystatin C Control Level 3 3 x 2 ml CYS5020
Cystatin C Calibrator 5 x 2 ml CYS2699
52
 IMMUNOLOGY/PROTEIN

Immunoglobulin Liquid Protein Calibrator

Analytes
Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM)

Calibrator series designed for use in the calibration of IgA, IgG and IgM immunoturbidimetric assays. Suitable for use with the Randox immunoglobulin
assays.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

Immunoglobulin Liquid Protein Calibrator 3 x 1 ml IT3861

IgE Calibrator
Comprising 6 levels, our IgE calibrator series is designed for use in the calibration of IgE immunoturbidimetric assays. With an excellent working stability of
28 days at 2ºC to 8ºC, waste is kept to a minimum.

• Lyophilised for enhanced stability

• Human IgE in a stabilised matrix
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

IgE Calibrator Series 6 x 1 ml IE2492

High Sensitivity IgG Control and Calibrator

Dedicated control and calibrator designed for use with the Randox hsIgG assay. Conveniently supplied in a liquid ready-to-use format with a working
stability of 30 days, waste and preparation are kept to a minimum.

• Liquid ready-to-use
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days at 2ºC to 8ºC

Description Size Cat. No.

High Sensitivity IgG Control Level 1 5 x 2 ml IT3982
High Sensitivity IgG Control Level 2 5 x 2 ml IT3983
High Sensitivity IgG Control Level 3 5 x 2 ml IT3984
High Sensitivity IgG Calibrator 3 x 1 ml IT3899

Rheumatoid Factor Calibrator Series

Comprising 5 levels, our RF calibrator series is designed for use in the calibration of RF immunoturbidimetric assays. Supplied in a user-friendly liquid ready-
to-use format and stable to expiry date, no preparation is required.

• Liquid ready-to-use
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

Rheumatoid Factor Calibrator Series 5 x 1 ml RF2301

53
Our Acusera Lipid quality controls have been manufactured from 100% human serum to ensure
they are commutable, performing in the same manner as a patient sample with minimal lot to lot
value shifts. As all of our Lipid Controls are lyophilised, they contain no stabilisers or preservatives,
which may affect the overall performance of the controls. The multi-analyte controls enable test
menu consolidation which, along with a four year shelf life from the date of manufacture, ensures
minimal waste and helps to reduce costs.

LIPID
CONTROLS

54
 LIPIDS

Lipid Product Range

Product Description Size Cat. No. Page No.
Lipid Control Level 1 5 x 1 ml LE2668 56
Lipid Control Level 2 5 x 1 ml LE2669 56
Lipid Control Level 3 5 x 1 ml LE2670 56
Lipid Control Level 1 5 x 3 ml LE2661 56
Lipid Control Level 2 5 x 3 ml LE2662 56
Lipid Control Level 3 5 x 3 ml LE2663 56
Apolipoprotein Control Level 1 3 x 1 ml LE5016 56
Apolipoprotein Control Level 2 3 x 1 ml LE5017 56
Apolipoprotein Control Level 3 3 x 1 ml LE5018 56
Apolipoprotein Calibrator 3 x 1 ml LP3023 56
Apolipoprotein Calibrator 2 3 x 1 ml LP5047 56
Direct HDL/LDL Cholesterol Calibrator (Clearance) 3 x 1 ml CH2673 57
Lipoprotein (a) Control Level 3 3 x 1 ml LP3406 57
Lipoprotein (a) Calibrator Series 5 x 1 ml LP3404 57
sLDL Control Level 1 3 x 1 ml LE5013 57
sLDL Control Level 2 3 x 1 ml LE5014 57
sLDL Control Level 3 3 x 1 ml LE5015 57
sLDL Calibrator 3 x 1 ml CH5050 57

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

55
 LIPIDS

Lipid Control
Analytes
Apolipoprotein A-1 Cholesterol (HDL) Cholesterol (Total) Triglycerides
Apolipoprotein B Cholesterol (LDL) Lipoprotein (a)

The Randox Acusera Lipid control is supplied with assayed method specific target values and ranges for 7 analytes, covering the complete lipid profile.
Unlike with many manufacturers, the material used in the production of the Randox lipid control does not contain preservatives such as Sodium Azide.
This ensures a matrix that is compatible with the patient sample and prevents interference with clearance methods of HDL and LDL. Two flexible and
convenient pack sizes are available, providing a true third party solution for laboratories of all sizes.

• Lyophilised for enhanced stability

• 100% human serum
• Sodium Azide is not present - no interference occurs with clearance methods
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Lipid Control Level 1 5 x 1 ml LE2668
Lipid Control Level 2 5 x 1 ml LE2669
Lipid Control Level 3 5 x 1 ml LE2670
Lipid Control Level 1 5 x 3 ml LE2661
Lipid Control Level 2 5 x 3 ml LE2662
Lipid Control Level 3 5 x 3 ml LE2663

Apolipoprotein Control and Calibrators

Analytes
Apolipoprotein Control Apolipoprotein Calibrator Apolipoprotein Calibrator 2
Apolipoprotein A-II Apolipoprotein A-I Apolipoprotein A-II
Apolipoprotein C-II Apolipoprotein B Apolipoprotein C-II
Apolipoprotein C-III Apolipoprotein C-III
Apolipoprotein E Apolipoprotein E

The Acusera Apolipoprotein control has been designed for the routine monitoring of 4 esoteric Apolipoprotein analytes. Complementing our Acusera
Apolipoprotein control is the Acusera Apolipoprotein Calibrator, which has been designed for use in the calibration of 6 Apolipoprotein assays on a wide
range of clinical chemistry analysers.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Control - reconstituted stability of up to 28 days at 2ºC to 8ºC for Apolipoprotein A-II and Apolipoprotein C-III, 14 days for
Apolipoprotein C-II and 8 hours for Apolipoprotein E
• Calibrator - reconstituted stability of 7 days at 2ºC to 8ºC for Apolipoprotein control A-I, B, A-II, C-II and C-III, 1 day for Apolipoprotein E

Description Size Cat. No.

Apolipoprotein Control Level 1 3 x 1 ml LE5016
Apolipoprotein Control Level 2 3 x 1 ml LE5017
Apolipoprotein Control Level 3 3 x 1 ml LE5018
Apolipoprotein Calibrator 3 x 1 ml LP3023
Apolipoprotein Calibrator 2 3 x 1 ml LP5047

56
 LIPIDS

Direct LDL/HDL Cholesterol Calibrator

Analytes
Cholesterol (HDL) Cholesterol (LDL)

The Acusera Direct LDL/HDL Cholesterol Calibrator has been designed for use in the calibration of HDL and LDL Clearance assays on clinical chemistry
analysers.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC and 1 month at -20ºC

Description Size Cat. No.

Direct LDL/HDL Cholesterol Calibrator (Clearance) 3 x 1 ml CH2673

Lipoprotein (a) Control and Calibrator

The Acusera Lipoprotein (a) control has been designed for the routine monitoring of the Randox Lipoprotein (a) assay. The Acusera Lipoprotein (a)
calibrator has been designed to calibrate Lipoprotein (a) assays on clinical chemistry analysers.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 14 days at 2ºC to 8ºC

Description Size Cat. No.

Lipoprotein (a) Control Level 3 3 x 1 ml LP3406
Lipoprotein (a) Calibrator Series 5 x 1 ml LP3404

sLDL Control and Calibrator

The Acusera sLDL Control and Calibrator have been designed for the use in the routine monitoring of both accuracy and precision.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC

Description Size Cat. No.

sLDL Control Level 1 3 x 1 ml LE5013
sLDL Control Level 2 3 x 1 ml LE5014
sLDL Control Level 3 3 x 1 ml LE5015
sLDL Calibrator 3 x 1 ml CH5050

57
Our Speciality and Research Quality Controls cover a wide range of assays employed by universities,
pharmaceutical companies, forensic laboratories and so on. Available in various formats and pack
sizes, our multi-analyte Speciality and Research controls cover a range of specialised assays.

SPECIALITY AND
RESEARCH CONTROLS

58
 SPECIALITY AND RESEARCH

Speciality and Research Product Range

Product Description Size Cat. No. Page No.
Antimicrobial Control II 3 x 1 ml AMC5035 60
Antimicrobial Control III 3 x 1 ml AMC5036 60
Growth Promoter Control 3 x 1 ml GP5003 60
Adhesion Molecules Tri-Level Control 3 x 3 x 1 ml EV3569 61
Adhesion Molecules Calibrator Series 9 x 1 ml EV3568 61
Cerebral Series I Tri-Level Control 3 x 3 x 1 ml CAB5008 61
Cerebral Array I Calibrator Series 9 x 1 ml EV3625 61
Cerebral Series II Tri-Level Control 3 x 3 x 0.5 ml CBB5009 61
Cytokine Array I Tri-Level Control 3 x 3 x 1 ml CY5006 62
High Sensitivity Cytokine Array Tri-Level Control 3 x 3 x 2 ml CY5005 62
Cytokine Array Calibrator Series 9 x 1 ml EV3561 62
Cytokine Array III Tri-Level Control 3 x 3 x 1 ml CY5012 62
Cytokine Array III Calibrator Series 9 x 1 ml EV3679 62
Cytokine Array IV Tri-Level Control 3 x 3 x 1 ml CY5011 63
Cytokine Array IV Calibrator Series 9 x 1 ml EV3658 63
Cardiac Array Control 3 x 3 x1 ml EV3691 63

Evidence Immunoassay Control 4 x 3 x 5 ml EV3570 64

Synthetic Steroids Control 3 x 1 ml EV3709 64
Synthetic Steroids Calibrator 9 x 1 ml EV3708 64
Metabolic Syndrome Array I Control 3 x 3 x 1 ml EV3757 65
Metabolic Syndrome Array I Calibrator 9 x 1 ml EV3756 65
Metabolic Syndrome Array II Control 3 x 3 x 1 ml EV3761 65
Metabolic Syndrome Array II Calibrator 9 x 1 ml EV3760 65
Thyroid Total Calibrator Series 9 x 1 ml EV3555 65
Thyroid Free Calibrator Series 9 x 1 ml EV3563 66

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

59
 SPECIALITY AND RESEARCH

Antimicrobial Control II
Analytes
Ceftiofur Streptomycin Thiamphenicol Tylosin
Quinolones (Generic) Tetracyclines (Generic)

A multi-analyte control supplied with values for 6 different antimicrobial agents used extensively in veterinary medicine.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 24 hours at 2ºC to 8ºC or 14 days at -20ºC

Description Size Cat. No.

Antimicrobial Control II 3 x 1 ml AMC5035

Antimicrobial Control III

Analytes
AHD Chloramphenicol
AMOZ Semicarbazine (SEM)
AOZ

Multi-analyte control containing values for 5 different antimicrobial agents.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Antimicrobial Control III 3 x 1 ml AMC5036

Growth Promoter Control

Analytes
b-Agonists (Clenbuterol) Nandrolone Stanozolol Trenbolone
Boldenone Ractopamine Stilbenes Zeranol
Corticosteroids

A multi-analyte control provided with accurately assigned target values and ranges for 9 different growth promoters.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 14 days at 2ºC to 8ºC

Description Size Cat. No.

Growth Promoter Control 3 x 1 ml GP5003

60
 SPECIALITY AND RESEARCH

Adhesion Molecules Control and Calibrator

Analytes
E-Selectin (E-SEL) P-Selectin (P-SEL)
Intercellular Adhesion Molecule-1 (ICAM-1) Vascular Cell Adhesion Molecule-1 (VCAM-1)
L-Selectin (L-SEL)

A multi-analyte control with target values and ranges supplied for 5 different adhesion molecules.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human recombinant material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 24 hours at 2ºC to 8ºC or 7 days at -20ºC

Description Size Cat. No.

Adhesion Molecules Tri-Level Control 3 x 3 x 1 ml EV3569
Adhesion Molecules Calibrator Series 9 x 1 ml EV3568

Cerebral Series I Control and Calibrator

Analytes
Brain Derived Neurotrophic Factor (BDNF) Glial Fibrillary Acidic Protein (GFAP)
Fatty Acid Binding Protein (FABP) Interleukin-6 (IL-6)

A multi-analyte control with target values and ranges provided for 4 analytes.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human recombinant material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 8 hours at 2ºC to 8ºC or 21 days at -20ºC

Description Size Cat. No.

Cerebral Series I Tri-Level Control 3 x 3 x 1 ml CAB5008
Cerebral Array 1 Calibrator Series 9 x 1 ml EV3625

Cerebral Series II Control

Analytes
CRP Neutrophil Gelatinase-associated Lipocalin (NGAL)
D-dimer Soluble Tumour Necrosis Factor Receptor I (sTNFRI)
Neuron Specific Enolase (NSE) Thrombomodulin (TM)

A multi-analyte control with target values and ranges provided for 6 analytes.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 8 hours at 2ºC to 8ºC or 14 days at -80ºC

Description Size Cat. No.

Cerebral Series II Tri-Level Control 3 x 3 x 0.5 ml CBB5009

61
 SPECIALITY AND RESEARCH

Cytokine Array I and High Sensitivity Cytokine Array I Controls and Calibrator
Analytes
Epidermal Growth Factor (EGF) Interleukin-6 (IL-6)
Interferon g (IFNg) Interleukin-8 (IL-8)
Interleukin-1α (IL-1α) Interleukin-10 (IL-10)
Interleukin-1b (IL-1b) Monocyte Chemoattractant Protein-1 (MCP-1)
Interleukin-2 (IL-2) Tumour Necrosis Factor α (TNFα)
Interleukin-4 (IL-4) Vascular Endothelial Growth Factor (VEGF)

Multi-analyte controls with target values and ranges provided for 12 different cytokines.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human recombinant material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 10-12 hours at 2ºC to 8ºC or 14 days at -20ºC
• High sensitivity - Reconstituted stability of 4 hours at 2ºC to 8ºC or 7 days at -20ºC

Description Size Cat. No.

Cytokine Array I Tri-Level Control 3 x 3 x 1 ml CY5006
High Sensitivity Cytokine Array I Tri-Level Control 3 x 3 x 2 ml CY5005
Cytokine Array Calibrator Series 9 x 1 ml EV3561

Cytokine Array III Control and Calibrator

Analytes
GM-CSF Interleukin-15 (IL-15)
Interleukin-5 (IL-5) Macrophage Inflammatory Protein-1 α (MIP-1α)

A multi-analyte control with target values and ranges provided for 4 analytes.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 24 hours at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Cytokine Array III Tri-Level Control 3 x 3 x 1 ml CY5012
Cytokine Array III Calibrator Series 9 x 1 ml EV3679

62
 SPECIALITY AND RESEARCH

Cytokine Array IV Control and Calibrator

Analytes
Matrix Metalloproteinase-9 (MMP-9) Soluble Tumour Necrosis Factor Receptor I (sTNFRI)
Soluble Interleukin-2-Receptor α (sIL-2Rα) Soluble Tumour Necrosis Factor Receptor II (sTNFRII)
Soluble Interleukin-6-Receptor (sIL-6R)

A multi-analyte control with target values and ranges provided for 5 analytes.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Cytokine Array IV Tri-Level Control 3 x 3 x 1 ml CY5011
Cytokine Array IV Calibrator Series 9 x 1 ml EV3658

Cardiac Array Control

Analytes
CK-MB Myoglobin
H-FABP Troponin I

Multi-analyte cardiac control designed for use in the routine monitoring of precision on clinical chemistry and immunoassay systems. This is the only
control of its type to include the novel marker heart type fatty acid binding protein (H-FABP). Three levels of control are supplied spanning the
complete clinical range.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 16 hours at 2ºC to 8ºC or 7 weeks at -80ºC

Description Size Cat. No.

Cardiac Array Control 3 x 3 x 1 ml EV3691

63
 SPECIALITY AND RESEARCH

Evidence Immunoassay Control

Analytes
CEA Progesterone T3 (Free) Testosterone
FSH Prolactin T3 (Total) TSH
Luteinising Hormone (LH) PSA (Free) T4 (Free)
Oestradiol PSA (Total) T4 (Total)

Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Evidence Immunoassay Control 4 x 3 x 5 ml EV3570

Synthetic Steroids Control and Calibrator

Analytes
17b-Clostebol Gestagens (Generic) Methyltestosterone
Ethinylestradiol Methandriol

Human based control designed for use in the routine monitoring of both accuracy and precision. Assayed target values and ranges are provided for 5
different synthetic steroids.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 3 days at 2ºC to 8ºC or 14 days at -20ºC

Description Size Cat. No.

Synthetic Steroids Control 3 x 1 ml EV3709
Synthetic Steroids Calibrator 9 x 1 ml EV3708

64
 SPECIALITY AND RESEARCH

Metabolic Syndrome Array I Control and Calibrator

Analytes
C-Peptide Interleukin-1α (1L-1α) Plasminogen Activator Inhibitor-1
Ferritin Interleukin-6 (1L-6) Resistin
Insulin Leptin Tumour Necrosis Factor α (TNFα)

A multi-analyte control with target values and ranges provided for 9 analytes associated with metabolic syndrome.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 72 hours at 2ºC to 8ºC and 7 days at -20ºC

Description Size Cat. No.

Metabolic Syndrome Array I Control 3 x 3 x 1 ml EV3757
Metabolic Syndrome Array I Calibrator 9 x 1 ml EV3756

Metabolic Syndrome Array II Control and Calibrator

Analytes
Adiponectin CRP Cystatin C

A multi-analyte control with target values and ranges provided for 3 analytes associated with metabolic syndrome.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 8 hours at 2ºC to 8ºC and 28 days at -20ºC

Description Size Cat. No.

Metabolic Syndrome Array II Control 3 x 3 x 1 ml EV3761
Metabolic Syndrome Array II Calibrator 9 x 1 ml EV3760

Thyroid Total Calibrator

Analytes
T3 (Total) T4 (Total) TSH

A comprehensive multi analyte calibrator designed for use in the calibration of the Randox Thyroid Total Array on Randox Biochip systems.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC and 28 days at -20ºC

Description Size Cat. No.

Thyroid Total Calibrator Series 9 x 1 ml EV3555

65
 SPECIALITY AND RESEARCH

Thyroid Free Calibrator

Analytes
T3 (Free) T4 (Free) TSH

A comprehensive multi analyte calibrator designed for use in the calibration of the Randox Thyroid Free Array on Randox Biochip systems.

• Lyophilised for enhanced stability

• Assayed values available for Randox Biochip systems
• 100% human material
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC and 28 days at -20ºC

Description Size Cat. No.

Thyroid Free Calibrator Series 9 x 1 ml EV3563

66
 SPECIALITY AND RESEARCH

67
Patients absorb and metabolise medication at different rates. As a result, it is simply not acceptable
to administer a standard volume to each one. Due to the problems that over and under prescribing
medication can cause, it is vital that levels are closely monitored and medical personnel can trust
that the test results they receive are accurate and reliable. Our Therapeutic Drug Controls are
manufactured from 100% human serum and have a reconstituted stability of 4 weeks, ensuring
minimal waste, thus saving your laboratory money.

THERAPEUTIC DRUG
CONTROLS

68
 THERAPEUTIC DRUG

Therapeutic Drug Product Range

Product Description Size Cat. No. Page No.
Therapeutic Drug Control Level 1 20 x 5 ml HD1667 70
Therapeutic Drug Control Level 2 20 x 5 ml HD1668 70
Therapeutic Drug Control Level 3 20 x 5 ml HD1669 70
Therapeutic Drug Calibrator 6 x 3 ml TD3417 70

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

69
 THERAPEUTIC DRUG

Therapeutic Drug Control

Analytes
Amikacin Ethosuximide Phenobarbital Tobramycin
Caffeine Gentamicin Phenytoin Valproic Acid
Carbamazepine Lithium Primidone Vancomycin
Cyclosporine Methotrexate Salicylate
Digoxin Paracetamol Theophylline

Multi-analyte therapeutic drug control covering 18 analytes at three clinically relevant levels. Method specific target values and ranges are supplied for this
true third party control. With an extended reconstituted stability of 28 days, waste is kept to a minimum.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Therapeutic Drug Control Level 1 20 x 5 ml HD1667
Therapeutic Drug Control Level 2 20 x 5 ml HD1668
Therapeutic Drug Control Level 3 20 x 5 ml HD1669

Therapeutic Drug Calibrator

Analytes
Carbamazepine Gentamicin Phenytoin Valproic Acid
Digoxin Phenobarbital Theophylline

The Acusera Therapeutic Drug calibrator has been designed for use in the calibration of 7 therapeutic drug assays on clinical chemistry analysers. An
extended stability of 28 days will help to reduce waste and costs.

• Lyophilised for enhanced stability

• 100% human serum
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 28 days at 2ºC to 8ºC or 8 weeks at -20ºC

Description Size Cat. No.

Therapeutic Drug Calibrator 6 x 3 ml TD3417

70
 THERAPEUTIC DRUG

71
The detection and treatment of toxic substances can mean life or death for a patient. As a result, it
is essential to ensure that the results you are releasing are accurate and reliable. Our controls are
available in both liquid and lyophilised formats and in a variety of matrices, providing you with the
flexibility to choose a control to suit your needs.

TOXICOLOGY
CONTROLS

72
 TOXICOLOGY

Toxicology Product Range

Product Description Size Cat. No. Page No.
Drugs of Abuse Array 1 Plus (Urine) Controls 4 x 2 x 1 ml EV3745 74
Drugs of Abuse Array 1 Plus (Urine) Calibrators 9 x 1 ml EV3744 74
Drugs of Abuse Array 1 Plus (Whole Blood) Controls 4 x 2 x 1 ml EV3750 74
Drugs of Abuse Array 1 Plus (Whole Blood) Calibrators 9 x 1 ml EV3749 74
Drugs of Abuse Array II (Urine) Controls 4 x 2 x 1 ml EV3657 74
Drugs of Abuse Array II (Whole Blood) Controls 4 x 2 x 1 ml EV3682 74
Drugs of Abuse Array II (Oral Fluid) Controls 4 x 2 x 1 ml EV3702 74
Drugs of Abuse Array II (Urine) Calibrator Series 9 x 1 ml EV3656 74
Drugs of Abuse Array II (Whole Blood) Calibrator Series 9 x 1 ml EV3687 74
Drugs of Abuse Array II (Oral Fluid) Calibrator Series 9 x 1 ml EV3701 74
Drugs of Abuse Array III (Urine) Control 4 x 2 x 1 ml EV3830 75
Drugs of Abuse Array III (Urine) Calibrator Series 9 x 1 ml EV3829 75
Drugs of Abuse Array III (Whole Blood) Control 4 x 2 x 1 ml EV3794 75
Drugs of Abuse Array III (Whole Blood) Calibrator Series 9 x 1 ml EV3797 75
Drugs of Abuse Array IV (Urine) Control 4 x 2 x 1 ml EV3835 75
Drugs of Abuse Array IV (Urine) Calibrator Series 9 x 1 ml EV3834 75
Drugs of Abuse Array IV (Whole Blood) Control 4 x 2 x 1 ml EV3809 75
Drugs of Abuse Array IV (Whole Blood) Calibrator Series 9 x 1 ml EV3808 75
Drugs of Abuse Array V (Urine) Control 4 x 2 x 1 ml EV3814 76
Drugs of Abuse Array V (Urine) Calibrator Series 9 x 1 ml EV3815 76
Drugs of Abuse Array V (Whole Blood) Control 4 x 2 x 1 ml EV3848 76
Drugs of Abuse Array V (Whole Blood) Calibrator Series 9 x 1 ml EV3847 76
Cannabinoid Calibrator Set 5 x 3 ml DA2700 76
Cannabinoid Control Level 1 5 x 3 ml DA3127 76
Cannabinoid Control Level 2 5 x 3 ml DA3128 76
Ecstasy Calibrator Set 5 x 10 ml DA2701 76
Ecstasy Control Level 1 5 x 5 ml DA3125 76
Ecstasy Control Level 2 5 x 5 ml DA3126 76
EDDP Calibrator Set 5 x 10 ml DA2702 77
EDDP Control Level 1 5 x 5 ml DA3123 77
EDDP Control Level 2 5 x 5 ml DA3124 77
Ethanol Calibrator/Control Set 5 x 10 ml DA2703 77
Multidrug Calibrator Set 5 x 10 ml DA2704 77
Multidrug Control Level 1 5 x 5 ml DA3121 77
Multidrug Control Level 2 5 x 5 ml DA3122 77
Benzodiazepines Control Level 1 5 x 5 ml DA3130 78
Benzodiazepines Control Level 2 5 x 5 ml DA3131 78
Benzodiazepines Calibrator Set 5 x 10 ml DA3129 78

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

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 TOXICOLOGY

Drugs of Abuse Array 1 Plus Controls and Calibrators

Analytes
Amphetamine Benzoylecgonine (Cocaine) MDMA Opiates
Barbiturates Buprenorphine Methadone Phencyclidine
Benzodiazepine 1 Cannabinoids Methamphetamine Tricyclic Antidepressants
Benzodiazepine 2 Creatinine

Assayed control for use in monitoring the accuracy and precision on Randox Biochip systems. Two levels of control are provided, covering the cut-off
range.

• Lyophilised for enhanced stability

• Stable to expiry date at 2ºC to 8ºC
• Urine - Reconstituted stability of 14 days at 2ºC to 8ºC
• Whole Blood – Reconstituted stability of 7 days at 2ºC to 8ºC or 14 days at -20ºC

Description Size Cat. No.

Drugs of Abuse Array 1 Plus (Urine) Controls 4 x 2 x 1 ml EV3745
Drugs of Abuse Array 1 Plus (Urine) Calibrators 9 x 1 ml EV3744
Drugs of Abuse Array 1 Plus (Whole Blood) Controls 4 x 2 x 1 ml EV3750
Drugs of Abuse Array 1 Plus (Whole Blood) Calibrators 9 x 1 ml EV3749

Drugs of Abuse Array II Controls and Calibrators

Analytes
Buprenorphine Ketamine MDMA Oxycodone II
Creatinine LSD Opiates Propoxyphene
Fentanyl Methaqualone Oxycodone I

A comprehensive control designed for use in the routine monitoring of accuracy and precision on Randox Biochip systems. Assayed values are provided
for 11 analytes.

• Lyophilised for enhanced stability

• Stable to expiry date at 2ºC to 8ºC
• Urine - Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC
• Whole Blood - Reconstituted stability of 7 days at 2ºC to 8ºC or 28 days at -20ºC

Description Size Cat. No.

Drugs of Abuse Array II (Urine) Controls 4 x 2 x 1 ml EV3657
Drugs of Abuse Array II (Whole Blood) Controls 4 x 2 x 1 ml EV3682
Drugs of Abuse Array II (Oral Fluid) Controls 4 x 2 x 1 ml EV3702
Drugs of Abuse Array II (Urine) Calibrator Series 9 x 1 ml EV3656
Drugs of Abuse Array II (Whole Blood) Calibrator Series 9 x 1 ml EV3687
Drugs of Abuse Array II (Oral Fluid) Calibrator Series 9 x 1 ml EV3701

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 TOXICOLOGY

Drugs of Abuse Array III Controls and Calibrators

Analytes
7-amino Flunitrazepam Ethyl Glucuronide Meperidine Zolpidem
Chloral Hydrate Metabolite Fentanyl Meprobamate Zopiclone
Creatinine Ketamine Zaleplon

Assayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are provided
covering the cut-off range.

• Lyophilised for enhanced stability

• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Drugs of Abuse Array III (Urine) Control 4 x 2 x 1 ml EV3830
Drugs of Abuse Array III (Urine) Calibrator Series 9 x 1 ml EV3829
Drugs of Abuse Array III (Whole Blood) Control 4 x 2 x 1 ml EV3794
Drugs of Abuse Array III (Whole Blood) Calibrator Series 9 x 1 ml EV3797

Drugs of Abuse Array IV Controls and Calibrators

Analytes
Creatinine Haloperidol Salicylate Trazodone
Dextromethorphan Ibuprofen Salicyluric Acid Tricyclic Antidepressants
Escitalopram Methylphenidate Sertraline
Fluoxetine Paracetamol Tramadol

Assayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are provided
covering the cut-off range.

• Lyophilised for enhanced stability

• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Drugs of Abuse Array IV (Urine) Control 4 x 2 x 1 ml EV3835
Drugs of Abuse Array IV (Urine) Calibrator Series 9 x 1 ml EV3834
Drugs of Abuse Array IV (Whole Blood) Control 4 x 2 x 1 ml EV3809
Drugs of Abuse Array IV (Whole Blood) Calibrator Series 9 x 1 ml EV3808

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 TOXICOLOGY

Drugs of Abuse Array V Controls and Calibrators

Analytes
Bath Salts 1 Phenylpiperazines Synthetic Cannabinoids 3
Bath Salts 2 Salvinorin Synthetic Cannabinoids 4
Benzylpiperazines Synthetic Cannabinoids 1
Mescaline Synthetic Cannabinoids 2

Assayed control for use in monitoring the accuracy and precision of the analytes above on Randox Biochip systems. Two levels of control are provided
covering the cut-off range.

• Lyophilised for enhanced stability

• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 7 days at 2ºC to 8ºC

Description Size Cat. No.

Drugs of Abuse Array V (Urine) Control 4 x 2 x 1 ml EV3814
Drugs of Abuse Array V (Urine) Calibrator Series 9 x 1 ml EV3815
Drugs of Abuse Array V (Whole Blood) Control 4 x 2 x 1 ml EV3848
Drugs of Abuse Array V (Whole Blood) Calibrator Series 9 x 1 ml EV3847

Cannabinoid Control and Calibrator

Dedicated calibrator and control set designed for the calibration and quality control of the Randox Cannabinoids assay.

• Liquid ready-to-use
• 100% human urine
• Stable to expiry date when capped and stored at 2ºC to 8ºC
• Open vial stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Cannabinoid Calibrator Set 5 x 3 ml DA2700
Cannabinoid Control Level 1 5 x 3 ml DA3127
Cannabinoid Control Level 2 5 x 3 ml DA3128

Ecstasy Control and Calibrator

Analytes
MDMA

Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ecstasy assay.

• Liquid ready-to-use
• 100% human urine
• Stable to expiry date when capped and stored at 2ºC to 8ºC
• Open vial stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Ecstasy Calibrator Set 5 x 10 ml DA2701
Ecstasy Control Level 1 5 x 5 ml DA3125
Ecstasy Control Level 2 5 x 5 ml DA3126

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 TOXICOLOGY

EDDP Control and Calibrator

Dedicated calibrator and control set designed for the calibration and quality control of the Randox EDDP assay.

• Liquid ready-to-use
• Human urine
• Stable to expiry date when capped and stored at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

EDDP Calibrator Set 5 x 10 ml DA2702
EDDP Control Level 1 5 x 5 ml DA3123
EDDP Control Level 2 5 x 5 ml DA3124

Ethanol Calibrator/Control Set

Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.

• Liquid ready-to-use
• Human urine
• Stable to expiry date when capped and stored at 2ºC to 8ºC
• Open vial stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Ethanol Calibrator/Control Set 4 x 10 ml DA2703

Multidrug Control
Analytes
Benzoylecgonine (Cocaine) Methamphetamine Secobarbital
Methadone Morphine (Opiates)

Multi-analyte control and calibrator designed for use in the quality control of the Randox Amphetamines, Barbiturates, Opiates, Cocaine and Methadone
assays.

• Liquid ready-to-use
• Human urine
• Stable to expiry date when capped and stored at 2ºC to 8ºC
• Open vial stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Multidrug Control Level 1 5 x 5 ml DA3121
Multidrug Control Level 2 5 x 5 ml DA3122
Multidrug Calibrator Set 5 x 10 ml DA2704

77
 TOXICOLOGY

Benzodiazepines Control and Calibrator

Analytes
Oxazepam

Dedicated calibrator and control set designed for the calibration and control of the Randox Benzodiazepines assay.

• Liquid ready-to-use
• Human urine
• Stable to expiry date when capped and stored at 2ºC to 8ºC
• Open vial stability of 28 days at 2ºC to 8ºC

Description Size Cat. No.

Benzodiazepines Control Level 1 5 x 5 ml DA3130
Benzodiazepines Control Level 2 5 x 5 ml DA3131
Benzodiazepines Calibrator Set 5 x 10 ml DA3129

78
 TOXICOLOGY

79
Our Acusera Urine Chemistry Controls are available in a choice of lyophilised and liquid ready-
to-use formats, covering the full range of clinical testing. With flexible options available, we have a
urine control to suit all laboratory sizes and budgets.

URINE
CONTROLS

80
 URINE

Urine Product Range

Product Description Size Cat. No. Page No.
Assayed Urine Control Level 2 12 x 10 ml AU2352 82
Assayed Urine Control Level 3 12 x 10 ml AU2353 82
Urine Precision Control Level 2 10 x 10 ml UC1502 82
Urine Precision Control Level 3 10 x 10 ml UC1503 82
Liquid Urine Control Level 2 10 x 10 ml UC5074 83
Liquid Urine Control Level 3 10 x 10 ml UC5075 83
Urinalysis Control Level 1 12 x 12 ml UC5033 83
Urinalysis Control Level 2 12 x 12 ml UC5034 83
Microalbumin Control Level 1 & 2 6 x 1 ml MA1361 83
Microalbumin Calibrator Series 6 x 2 ml MA1567 83

Liquid ready-to-use Liquid frozen Lyophilised for enhanced stability Assayed target values provided 100% human matrix

81
 URINE

Assayed Urine Control

Analytes
5-HIAA Creatinine Microalbumin Potassium
Amylase Dopamine Norepinephrine Protein (Total)
Calcium Epinephrine Normetanephrine Sodium
Chloride Glucose Osmolality Urea
Copper Magnesium Oxalate Uric Acid (Urate)
Cortisol Metanephrine Phosphate (Inorganic) Vanillylmandelic Acid (VMA)

Comprising 24 urine chemistry analytes in a single multi-analyte control, the Acusera Assayed Urine Control is designed to cover your complete test menu,
reducing costs and preparation time. Our unique 100% human urine matrix will mirror the performance of patient samples and ensure target values don’t
shift after changing reagent batch. Assayed target values and ranges are provided for this true third party control.

• Lyophilised for enhanced stability

• 100% human urine
• Stable to expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC or 14 days at -20ºC

Description Size Cat. No.

Assayed Urine Control Level 2 12 x 10 ml AU2352
Assayed Urine Control Level 3 12 x 10 ml AU2353

Urine Precision Control

Analytes
Calcium Glucose Phosphate (Inorganic) Sodium
Chloride Magnesium Potassium Urea
Creatinine Osmolality Protein (Total) Uric Acid (Urate)

Combining 12 common urine chemistry analytes in a single unassayed control, the Acusera Urine Precision control has been manufactured to monitor
precision on a wide range of clinical chemistry analysers.

• Lyophilised for enhanced stability

• 100% human urine
• Stable until expiry date at 2ºC to 8ºC
• Reconstituted stability of 5 days at 2ºC to 8ºC or 14 days at -20ºC

Description Size Cat. No.

Urine Precision Control Level 2 10 x 10 ml UC1502
Urine Precision Control Level 3 10 x 10 ml UC1503

82
 URINE

Liquid Urine Control

Analytes
Amylase Glucose pH Specific Gravity
Calcium hCG Phosphate (Inorganic) Urea
Chloride Magnesium Potassium Uric Acid (Urate)
Cortisol Microalbumin Protein (Total)
Creatinine Osmolality Sodium

Our Acusera Liquid Urine Control has been designed to consolidate up to 18 commonly used urine chemistry analytes in a single vial, reducing the number
of controls required to cover your complete test menu. Supplied in a user-friendly liquid ready-to-use format with an open vial stability of 30 days, waste
and time is kept to a minimum. Assayed target values and ranges are provided for this true third party control.

• Liquid ready-to-use
• 100% human urine
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability 30 days at 2ºC to 8ºC
Description Size Cat. No.
Liquid Urine Control Level 2 10 x 10 ml UC5074
Liquid Urine Control Level 3 10 x 10 ml UC5075

Urinalysis Control
Analytes
Albumin Glucose Nitrite Urobilinogen
Bilirubin hCG pH
Blood Ketones Protein (Total)
Creatinine Leukocytes Specific Gravity

The Acusera Urinalysis Control has been specifically designed for use in the quality control of urine test strips. Our user-friendly liquid ready-to-use format
will dramatically reduce preparation time while a stability of 30 days will keep waste to a minimum. Assayed values are provided for 13 analytes covering
a range of test strip manufacturers.

• Liquid ready-to-use
• 100% human urine
• Suitable for use in POC testing
• Stable to expiry date at 2ºC to 8ºC
• Open vial stability of 30 days or 20 immersions at 2ºC to 25ºC
Description Size Cat. No.
Urinalysis Control Level 1 12 x 12 ml UC5033
Urinalysis Control Level 2 12 x 12 ml UC5034

Microalbumin Control and Calibrator

Our Acusera Microalbumin Control & Calibrator have been developed for use in the calibration and monitoring of microalbumin immunoturbidimetric
assays. Our unique 100% human urine matrix ensures it behaves like a patient sample and reduces costly shifts when reagent batch is changed. As a true
third party control, it is compatible for use on a wide range of clinical analysers.

• Liquid ready-to-use
• 100% human urine
• Stable to expiry date at 2ºC to 8ºC
• Once opened stable to expiry date at 2ºC to 8ºC

Description Size Cat. No.

Microalbumin Control Level 1 & 2 6 x 1 ml MA1361
Microalbumin Calibrator Series 6 x 2 ml MA1567

83
Don’t see what you are looking for? No problem! Randox Quality Control can work with you to
develop a customised quality control for your laboratory. With our custom sera, you can select the
analytes, levels, format and vial size required by your laboratory, ensuring the final product meets
all your needs and guarantees you can continue to produce accurate & reliable patient results.

CUSTOMISED QUALITY
CONTROL SERA

84
 CUSTOMISED QUALITY CONTROL SERA

Consolidation

Randox will significantly consolidate your existing

For over 30 years, laboratories, EQA scheme organisers and controls. An average laboratory may rationalise from
other diagnostic companies have looked to Randox to provide 7 individual controls to a single control product
their QC needs. Randox Laboratories manufactures a full
portfolio of quality controls, calibrators and standards for over
390 analytes. In addition to ‘off the shelf ’ quality control products, Tailor Made
Randox is the world’s leading provider of customised control
materials. Customising control materials can involve adding Specify the analytes and levels you require. We
/ removing analytes, specifying concentrations or choosing can provide the levels tailored to your cut off values
alternative vial sizes.

Our principal control products are: Stability

• Antioxidants Randox lyophilised controls are stable for up to 4
• Cardiac years, reducing costly lot changes and enabling
• Clinical Chemistry use of the same lot over an extended period
• Coagulation and Haematology
• Diabetes and Whole Blood
• Immunoassay Options
• Immunology/Proteins
• Lipids
Customised controls are available in different
• Tumour Markers matrices e.g. serum, urine, aqueous
• Therapeutic Drugs and Toxicology
• Urine tests
• Specialist and Research controls such as Cytokines,
Flexibility
Growth Promoters, Antimicrobials, Cerebral Markers
and a variety of single-analyte control products.
Batch sizes manufactured between 50 – 250,000
vials. Randox can provide a wide range of vial sizes
Randox also produces custom sera for EQA schemes and
from 1 ml to 10 ml
specialised controls for research projects.

Quality is our focus during the manufacturing process, as all Quality

control products are produced to the same high specifications
using procedures complying with ISO 13485 for medical devices.
All controls are produced to high quality
State of the art clinical chemistry and immunoassay analysers are
specification, fully compliant with ISO 13485
used during the manufacturing and quality control processes.

To enable us to identify and fulfil your needs, please discuss your

requirements with your Randox representative. We are happy to Choice
consider any requirements you may have.
3 different formats – lyophilised / liquid /
liquid frozen

85
 CUSTOMISED QUALITY CONTROL SERA

Custom Control Timeline

Week 1
QC order placed by you

You run blind sample and Enables Randox to view

Randox sends blind
how the material recovers
return results to Randox sample to you
on your analyser

If end sample does

Randox manufacture Sample is despatched not meet your
customised sample to you specifications, you are under
no obligation to accept

Sample checked and

approved by you

Randox generates labels

and packages kit

Randox despatches and

delivers final product to you

Week16

86
 CUSTOMISED QUALITY CONTROL SERA

Antioxidant CSF • Phenobarbital

• Glutathione Peroxidase • α-1-Globulin • Phenytoin
• Glutathione Reductase • α-2-Globulin • Primidone
• Superoxide Dismutase • Albumin • Salicylate
• Total Antioxidant Status (TAS) • b-Globulin • Theophylline
• Chloride • Tobramycin
Blood Gas • g-Globulin • Valproic Acid
• Calcium • Glucose • Vancomycin
• Chloride • Immunoglobulin G (IgG)
• Glucose • Lactate Drugs of Abuse
• Lactate • Protein • 7-aminoflunitrazepam
• pCO2 • Sodium • 11-Nor D-9-THC-9-COOH
• pH • Acetaminophen
• pO2 Cytokine & Growth Factors • Amphetamine
• Potassium • Epidermal Growth Factor (EGF) • Barbiturates
• Sodium • Granulocyte Macrophage Colony- • Bath Salts 1+2
• Total CO2 Stimulating Factor (GMCSF) • Benzodiazepine
• Intercellular Adhesion Molecule 1 (ICAM-1) • Benzoylecgonine
Cardiac • Interferon-g (IFN-g) • Benzylpiperazines
• BNP • Interleukin-1 α (IL-1α) • Buprenorphine
• CK (Total) • Interleukin-1 b (IL-1b) • Cannabinoids
• CK-MB • Interleukin-2 (IL-2) • Chloral Hydrate Metabolite
• D-dimer • Interleukin-3 (IL-3) • Cocaine Metabolite
• Digoxin • Interleukin-4 (IL-4) • Dextromethorphan
• Heart-type Fatty Acid-Binding Protein (H-FABP) • Interleukin-5 (IL-5) • Ecstasy
• High Sensitivity Troponin T • Interleukin-6 (IL-6) • EDDP
• Homocysteine • Interleukin-7 (IL-7) • Ethanol
• hs-CRP • Interleukin-7D (IL-7D) • Ethyl Glucuronide
• Myoglobin • Interleukin-8 (IL-8) • Escitalopram
• NT-ProBNP • Interleukin-10 (IL-10) • Fentanyl
• Troponin I • Interleukin-12p (IL-12p) • Haloperidol
• Troponin T • Interleukin-13 (IL-13) • Ibuprofen
• Interleukin-15 (IL-15) • Ketamine
Cellular Adhesion Molecules • Interleukin-23 (IL-23) • LSD
• E-Selectin • Macrophage Inflammatory Protein-1 α • Meperidine
• ICAM-1 (MIP-1α) • Meprobamate
• L-Selectin • Matrix Metalloproteinase 9 (MMP-9) • Mescaline
• P-Selectin • Monocyte Chemotactic Protein-1 (MCP-1) • Methadone
• VCAM-1 • Soluble Interleukin-2 Receptor α • Methamphetamine
(SIL-2Rα) • Methaqualone
Cerebral • Soluble Interleukin-6 Soluble Receptor • Methylphenidate
• BDNF (SIL-6SR) • MDMA
• GFAP • Soluble Tumour Necrosis Factor • Morphine
• IL-6 Receptor-1 (sTNFRI) • Opiates
• NGAL • Soluble Tumour Necrosis Factor • Oxazepam
• NSE Receptor-2 (sTNFR2) • Oxycodone I
• sTNFRI • Tumour Necrosis Factor - α (TNF - α) • Oxycodone II
• Thrombomodulin • Tumour Necrosis Factor - b (TNF - b) • Phencyclidine
• Vascular Endothelial Growth Factor (VEGF) • Phenobarbital
Coagulation • Phenylpiperazines
• Activated Partial Thromboplastin Time (APTT) Diabetes • Propoxyphene
• Antithrombin III (ATIII) • Fructosamine • Salicylate
• Factor II • HbA1c • Salicyluric Acid
• Factor V • HbA2 • Salvinorin
• Factor VII • Hbf • Secobarbital
• Factor VIII • Hbs • Setraline
• Factor IX • Tramadol
• Factor X Drugs (Therapeutic) • Trazodone
• Factor XI • Acetaminophen (Paracetamol) • Tricyclic Antidepressants
• Factor XII • Amikacin • Zoleplon
• Fibrinogen • Caffeine • Zolpidem
• Plasminogen • Carbamazepine • Zopiclone
• Protein C • Cyclosporine
• Protein S • Digoxin Endocrine
• Prothrombin Time (PT) • Ethosuximide • Leptin
• Thrombin Time (TT) • Gentamicin
• Lithium
• Methotrexate

This list is not exhaustive. If the analyte you require is not present, please contact your Randox representative
87
 CUSTOMISED QUALITY CONTROL SERA

Immunoassay • Tobramycin • AST (GOT)

• 17-OH – Progesterone • TSH • b-1-Globulin
• 1-25-(OH)2-Vitamin D • Valproic Acid • Bicarbonate
• 25-OH-Vitamin D • Vancomycin • Bile Acids
• α-Fetoprotein (AFP) • Vitamin B12 • Bilirubin (Direct)
• ACTH • Bilirubin (Total)
• Aldosterone Lipids • Cholinesterase
• Amikacin • Apolipoprotein A-I • Calcium
• Androstenedione • Apolipoprotein A-II • Calcium (Ionised)
• Anti-Thyroglobulin (Anti-TG) • Apolipoprotein B • Chloride
• Anti-Thyroperoxidase (Anti-TPO) • Apolipoprotein C-II • Copper
• b-2-Microglobulin • Apolipoprotein C-III • Creatinine
• C-Peptides • Apolipoprotein E • D-3-Hydroxybutyrate
• CA 15-3 • Cholesterol (HDL)
• gGT
• CA 19-9 • Cholesterol (LDL)
• Cholesterol (Total) • g-Globulin
• CA 72-4 • Glucose
• Lipoprotein (a)
• CA 125 • GLDH
• sLDL
• Calcitonin • Iron
• Triglycerides
• Carbamazepine • Iron (TIBC)
• CEA Metabolic Syndrome • Lactate
• Cortisol • Plasminogen Activator Inhibitor-1 • Lactate Dehydrogenase (LDH)
• CYFRA 21-1 • Resistin • LAP
• DHEA-Sulphate • Lipase
• Digoxin • Magnesium
• Estriol Proteins • Osmolality
• Estriol (unconjugated) • α-1-Acid Glycoprotein • Phosphate (Inorganic)
• Ethosuximide • α-1-Antitrypsin • Potassium
• Ferritin • α-2-Macroglobulin • Sodium
• Folate • α-Fetoprotein (AFP) • Urea
• Free b-hCG • α-HBDH • Uric Acid (Urate)
• FSH • Albumin • Zinc
• Gastrin • Anti-Streptolysin O (ASO)
• Gentamicin • Anti-Thrombin III (AT III) Urine
• Growth Hormone (GH) • b-2-Microglobulin • 5-H1AA
• hCG • Ceruloplasmin • Amylase
• Immunoglobulin E (IgE) • Complement C3 • Calcium
• Inhibin A • Complement C4 • Chloride
• Insulin • CRP • Copper
• Insulin Like Growth Factor 1(IGF-1) • Cystatin C • Cortisol
• Intact PTH (Parathyroid Hormone) • Ferritin • Creatinine
• Luteinising Hormone (LH) • Haptoglobin • Dopamine
• Neuron Specific Enolase • Immunoglobulin A (IgA) • Epinephrine
• Oestradiol • Immunoglobulin E (IgE) • Glucose
• Osteocalcin • Immunoglobulin G (IgG) • hCG
• PAPP- A • Immunoglobulin M (IgM)
• Magnesium
• Paracetamol • Kappa Light Chain
• Metanephrine
• Phenobarbital • Kappa Light Chain (Free)
• Microalbumin
• Phenytoin • Lambda Light Chain
• Lambda Light Chain (Free)
• Norepinephrine
• Primidone • Normetanephrine
• Procalcitonin • Prealbumin
• Protein (Total) • Osmolality
• Progesterone • Oxalate
• Retinol Binding Protein (RBP)
• Prolactin • pH
• Rheumatoid Factor (RF)
• PSA (Free) • Phosphorous
• Transferrin
• PSA (Total) • Potassium
• Renin Routine Chemistry • Protein (Total)
• Salicylate • α-1-Globulin • Sodium
• Sex Hormone Binding Globulin (SHBG) • α-2-Globulin • Specific Gravity
• T Uptake • Albumin • Urea
• T3 (Free) • Acid Phosphatase (Prostatic) • Uric Acid (Urate)
• T3 (Total) • Acid Phosphatase (Total) • Vanillylmandelic Acid
• T4 (Free) • Albumin
• T4 (Total) • Alkaline Phosphatase (ALP)
• TBG • ALT (GPT)
• Testosterone • Amylase
• Testosterone (Free) • Amylase (Pancreatic)
• Theophylline
• Thyroglobulin

This list is not exhaustive. If the analyte you require is not present, please contact your Randox representative
88
 CUSTOMISED QUALITY CONTROL SERA

89
 24•7

Compatible for use with the Acusera range of third party controls, the Acusera 24•7 software is designed
to help laboratories monitor and interpret their QC data. Access to an impressive range of features
including interactive charts and real-time peer group data generated from our extensive database of
laboratory participants, ensures Acusera 24•7 is the most comprehensive package available.

INTERLABORATORY
DATA MANAGEMENT

90
 WHAT IS ACUSERA 24•7?

Live Online

Acusera 24•7 Live Online is an interlaboratory data management and peer group repor ting package designed
to complement the Acusera range of third par ty controls. Using Acusera 24•7 will help you to improve error
detection, reduce false rejections and ensure accurate patient test results.

Why run a peer group reporting program?

• Quickly identify trends, system errors and reagent issues, minimising expensive repeat tests
• Bridge the gap between daily quality control and external quality assessment
• Improve EQA performance by eliminating any undetected bias
• Facilitate regulatory compliance
• Reduce false rejections through the use of QC multi-rules
• Increase confidence in assigned QC target values
• Carry out rapid and effective troubleshooting leading to shorter delays in reporting

With Acusera 24•7, peer group data

is uniquely updated live, in real-time,
giving you access to the most up-to-
date information available. Access to
relevant peer group data enables rapid
and effective troubleshooting, it may
even help to identify errors earlier.

91
 FEATURES

Dashboard
The unique Dashboard interface displays any aler ted or rejected QC
results that have fallen outside user-defined performance limits and
multi-rules in the last seven days.

Acusera Advisor*
Acusera Advisor is an optional tool designed to help you select an optimum QC strategy for each individual test in use.
Not only will the advisor tool recommend a set of QC multi-rules, it will also suggest a minimum QC frequency based on
the performance of the method in question.

Interactive Charts
Levey-Jennings, Histogram and Performance Summary Char ts are
automatically generated by the software. The ability to combine
multiple data sets enables you to identify and assess trends in QC data
or a bias between instruments. It is also possible to record events such
as instrument service/maintenance on Levey-Jennings Char ts for faster
troubleshooting.

Peer Group Statistics

Uniquely updated live, in real-time, you can customise peer groups depending on your instrument, method or reagent supplier.
Peer Group Repor ting allows you to compare the performance of your own instrument and/or assay method against other
laboratories using the same lot of control. Statistics are generated from our extensive database of laboratory par ticipants.

Advanced Statistical Analysis

The Statistical Metrics Repor t incorporates %Bias, Total Error and a
Sigma score for optimum QC strategy design while the Uncer tainty
of Measurement Repor t helps to meet ISO15189:2012 requirements.

*Not available in the USA

92
 DATA ENTRY OPTIONS

Manual result entry

Easily create custom panels for faster result entry of multiple tests at once, with the option to enter single or summarised data for each
test or panel.

1. Analyser generates QC result. 2. QC result is manually entered by the user

into the Acusera 24•7 Live Online software.

Semi-automated result entry via EDI

EDI is the ideal solution for laboratories that don’t want the hassle of manual data import but still want to benefit from a reduction in
time and elimination of transcription errors.

1. An export file containing 2. The user imports the EDI file

the QC result and associated into the Acusera 24•7 Live
information is generated by Online software.
the analyser or LIS/LIMS
system.

Note: First time users must first create a new configuration for the EDI file and carry out EDI mapping.

Fully automated import of QC data direct from your LIMS

Automatically capture data directly from your LIMS with Acusera 24•7 Connect and import into Acusera 24•7 Live Online without
the need to manually import files.

• Reduce workload by eliminating manual data entry or import

• Eliminate transcription errors
• Secure real-time connection without disruption to the laboratory

Our Acusera 24•7 Connect team will work directly with you and your IT team to implement the best solution for your lab’s requirements.

1. Acusera 24•7 Connect securely collects and processes QC data directly

from the LIS/LIMS for import into Acusera 24•7 Live Online.
LIMS

Software options

Description Cat. No.

Acusera 24•7 Live Online Peer Group Activation and 12 Month License QC4218
Acusera 24•7 Live Online Peer Group 12 Month License Renewal QC4204
Acusera 24•7 Connect+ QC4205
Acusera 24•7 Live Online Upgrade from Acusera 24•7 Live QC4220

+ *
Pending site survey completion Not available in USA

93
EQA is an effective partner to your IQC plans. An EQA scheme, such as RIQAS, utilises ‘blind’ samples
to measure a laboratory’s accuracy. These ‘blind’ samples are analysed by the laboratory as though
they are patient samples and the results returned to the scheme organiser for statistical analysis.
When the analysis is complete, each participant receives a report enabling them to compare the
performance of their laboratory to other participants within their method and instrument groups.

EXTERNAL QUALITY
ASSESSMENT

94
 FEATURES AND BENEFITS

Randox International Quality Assessment Scheme

RIQAS is the largest international EQA scheme, used by more than 45,000 laboratory par ticipants in over
124 countries worldwide. This large number of par ticipants ensures an extensive database of results for many
analytical methods, directly increasing statistical validity as a result.

Benefits
Large Database of Users
• A high level of participation means peer group numbers are maximised whilst ensuring availability of data for a wide range of instruments
and methods.
User-friendly Reports
• Simple one page per parameter format enables at-a-glance performance assessment, saving valuable laboratory time.
• Complimentary multi-instrument and interlaboratory reports allow comparative performance assessment of all laboratory systems and
multiple connected laboratories.
• End-of-Cycle reports summarising performance compared to the previous cycle allow you to identify improvements in quality over time.
Cost Effective
• Our extensive range of multi-analyte programmes will reduce the number of individual programmes required to cover your test menu,
saving both time and money.
• Reduced parameter options for selected programmes offer greater flexibility, ensuring suitability for laboratories of all sizes and budgets.
• Register up to five instruments per programme at no extra cost for comparative performance assessment.
Frequency
• Frequent reporting allows early identification of system errors and implementation of any necessary corrective actions with minimum
disruption to the lab.
• With a turnaround of less than 72 hours for most reports, corrective action can be taken immediately reducing the time spent performing
expensive re-tests.
High Quality Samples
• Samples spanning clinically relevant levels, allows identification of concentration related biases and ensures accurate instrument performance.
• Human samples free from interfering preservatives increase confidence that EQA performance mirrors the performance of patient samples.
• Reference method values are provided in the Clinical Chemistry programme for selected parameters and lots.
Highly Accredited
• Programmes accepted by National and International accreditation bodies worldwide.
• Participant certificates provide evidence of participation in a reputable EQA scheme.

Participation in an EQA scheme will help

produce reliable and accurate reporting
of patient results. Quality results will
reduce time and labour costs, and most
importantly provide accurate patient
diagnosis and treatment.

95
 STANDARD REPORT

Performance data is presented in a one page per parameter format, with up to seven
sub-reports.

1
4

3
7

1 Text Section: Statistics for all methods, your method and instrument group (programme specific).

2 Histogram: Method and instrument comparison.

3 Multi-Method Stat Section: Enables assessment of the performance of each method.

4 Levey-Jennings Chart: Indicates your laboratory’s performance over the last 20 samples.

5 Target Score: This unique chart provides a numerical index of performance, allowing at-a-glance assessment.

6 %Deviation by Sample: Helps to identify trends and shifts in performance.

7 %Deviation by Concentration: Rapid assessment of concentration related biases.

Note: This example is for quantitative programmes. Other types of report are also available.

96
 RIQAS PROGRAMMES

Ammonia/Ethanol Programme+
RQ9164 (2 ml)
2 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Ammonia Ethanol

Anti-TSH Receptor Programme+

RQ9174 (1 ml)
1 Parameter
Samples every month, 1 x 12 month cycle, 12 month subscription

Anti-TSH Receptor (TRAb)

Blood Gas Programme With target scoring

RQ9134 (1.8 ml) RQ9134/A (1.8 ml)
First registered instrument Subsequent instruments
10 Parameters 10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription
pCO2 CO2(Total) K+ Lactate
pH Ca++ Na+
pO2 Cl- Glucose

BNP Programme+
RQ9165 (1 ml)
1 Parameter
Samples every month, 1 x 12 month cycle, 12 month subscription

BNP

Cardiac Programme With target scoring

RQ9127/a (1 ml) RQ9127/b (1 ml)
2 Parameters only (choose from 7) Full 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription

CK, Total CK-MB (Mass) Myoglobin Troponin T

CK-MB (Activity) Homocysteine Troponin I

Cerebrospinal Fluid Programme+

RQ9168 (3 ml)
12 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Albumin α-2-globulin (electrophoresis) g-globulin (electrophoresis) Lactate

Albumin (electrophoresis) b-globulin (electrophoresis) Glucose Protein (Total)
α-1-globulin (electrophoresis) Chloride IgG Sodium

Coagulation Programme With target scoring

RQ9135/a (1 ml) RQ9135/b (1 ml)
5 Selected parameters only Full 17 Parameters
(aPTT, PT, TT, Fibrinogen, Antithrombin III)
Samples every month, 1 x 12 month cycle, 12 month subscription

aPTT Plasminogen Factor VII Factor XII

PT (including INR) Protein C Factor VIII D-dimer*
TT Protein S Factor IX
Fibrinogen Factor II Factor X
Antithrombin III Factor V Factor XI

= Lyophilised samples = Liquid ready-to-use samples PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing

97
 RIQAS PROGRAMMES

CYFRA 21-1 Programme+

RQ9175 (1 ml)
1 Parameter
Samples every month, 1 x 12 month cycle, 12 month subscription

CYFRA 21-1 (Cytokeratin 19)

ESR Programme+
RQ9163 (4.5 ml)
1 Parameter
2 samples per quarterly distribution, 1 x 12 month cycle, 12 months subcription

ESR (Erythrocyte Sedimentation Rate)

General Clinical Chemistry Programme With target scoring

RQ9112 (5 ml) RQ9112/S (5 ml) RQ9113 (5 ml)
10 Parameters only 17 Parameters only Full 52 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, reference method values

ACE (Angiotensin Converting Enzyme) Calcium HBDH PSA

Acid Phosphatase (Prostatic) Calcium (Ionised) HDL-Cholesterol Sodium
Acid Phosphatase (Total) Chloride Iron TIBC
Albumin Cholesterol Lactate T3 (Free)
Alkaline Phosphatase Cholinesterase LD (LDH) T3 (Total)
ALT (ALAT) CK, Total (CPK) Lipase T4 (Free)
Amylase (Pancreatic) Copper Lithium T4 (Total)
Amylase (Total) Creatinine Magnesium Triglycerides
AST (ASAT) D-3-Hydroxybutyrate NEFA TSH
Bicarbonate Fructosamine Osmolality UIBC
Bile Acids gGT Phosphate (Inorganic) Urea
Bilirubin (Direct) GLDH Potassium Uric Acid
Bilirubin (Total) Glucose Protein (Total) Zinc

Glycated Haemoglobin Programme (HbA1c) With target scoring

RQ9129 (0.5ml)
2 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

HbA1c Total Haemoglobin

Haematology Programme With target scoring

RQ9118 (2 ml)
11 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription

Haematocrit (HCT) Mean Cell Haemoglobin Concentration (MCHC) Platelets (PLT) Red Cell Distribution Width (RDW)
Haemoglobin (Hb) Mean Cell Volume (MCV) Plateletcrit (PCT) Total White Blood Cell Count (WBC)
Mean Cell Haemoglobin (MCH) Mean Platelet Volume (MPV) Red Blood Cell Count (RBC)

Human Urine Programme With target scoring

RQ9115 (10 ml)
25 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription

ACR Creatinine Normetanephrine Protein (Total)

Albumin/Microalbumin Dopamine Magnesium Sodium
Amylase Epinephrine Osmolality Urea
Calcium Glucose Oxalate Uric Acid
Chloride Metanephrine Phosphate (Inorganic) VMA
Copper Norepinephrine Potassium 5-HIAA
Cortisol

= Lyophilised samples = Liquid ready-to-use samples PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing

98
 RIQAS PROGRAMMES

Immunoassay Programme With target scoring

RQ9125/a (5 ml) RQ9125/b (5 ml) RQ9125/c (5 ml) RQ9130 (5 ml)
4 Parameters only (choose from 55) 13 Parameters only (choose from 55) Full 55 Parameters Full 55 Parameters
Samples every two weeks, 2 x 6 monthly cycles, 12 month subscription (RQ9125/a, RQ9125/b, RQ9125/c), lyophilised samples
Samples every month, 1 x 12 month cycle, 12 month subscription (RQ9130)

ACTH DHEA Unconjugated 17-OH-Progesterone T4 (Free)

AFP Digoxin Paracetamol T4 (Total)
Aldosterone Estriol Total* Phenobarbital Testosterone (Free)*
Amikacin Ethosuximide* Phenytoin Testosterone (Total)
Androstenedione Ferritin Primidone* Theophylline
b-2-Microglobulin Folate Progesterone Thyroglobulin
CA125 FSH Prolactin Tobramycin*
CA15-3 Gentamicin PSA (Free) TSH
CA19-9 GH PSA (Total) Valproic Acid
Carbamazepine hCG PTH Vancomycin
CEA IgE Salicylate Vitamin B12
Cortisol Insulin SHBG 1-25-(OH)2-Vitamin D*
C-Peptide LH T3 (Free) 25-OH-Vitamin D
DHEA-Sulphate Oestradiol T3 (Total)

Immunoassay Speciality 1 Programme+ With target scoring

RQ9141 (2 ml)
10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

1-25-(OH)2-Vitamin D Anti-TG Osteocalcin Insulin

25-OH-Vitamin D Anti-TPO Procalcitonin
C-Peptide IGF-1 PTH

Immunoassay Speciality 2 Programme+

RQ9142 (2 ml)
5 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Calcitonin Procalcitonin Plasma Renin Activity Renin (Direct Concentration)

Gastrin

Immunosuppressant Programme+
RQ9159 (2 ml)
4 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Cyclosporine Everolimus Sirolimus Tacrolimus

Lipid Programme With target scoring

RQ9126/a (3 ml) RQ9126/b (3 ml)
3 Parameters only (choose from 7) Full 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription

Apolipoprotein A1 Cholesterol (Total) LDL-Cholesterol Triglycerides

Apolipoprotein B HDL-Cholesterol Lipoprotein (a)

Liquid Cardiac Programme With target scoring

RQ9136 (3 ml)
9 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

CK-MB Mass Homocysteine Myoglobin Troponin I

D-dimer hsCRP NT proBNP Troponin T
Digoxin

= Lyophilised samples = Liquid ready-to-use samples PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing

99
 RIQAS PROGRAMMES

Maternal Screening Programme With target scoring

RQ9137 (1 ml)
6 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

AFP Total hCG PAPP-A Unconjugated Oestriol

free b-hCG Inhibin A

Serology (EBV) Programme+

RQ9153 (1 ml)
3 Parameters
3 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results

Anti-EBV VCA IgG Anti-EBNA IgG Anti-EBV VCA IgM

Serology (HIV-Hepatitis) Programme+

RQ9151 (1.8 ml)
10 Parameters
5 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results

Anti-HIV-1 Anti-HCV Anti-HTLV-II HBsAg

Anti-HIV-2 Anti-HBc Anti-HTLV-1&2 Combined
Anti-HIV-1&2 Combined Anti-HTLV-I Anti-CMV

Serology (Syphilis) Programme+

RQ9154 (1 ml)
1 Parameter
3 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results

Syphilis (Methods available include immunoassay RPR, VDRL and TPHA)

Serology (ToRCH) Programme+

RQ9152 (1 ml)
12 Parameters
5 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results

Anti-Toxoplasma IgG Anti-Rubella IgM Anti-HSV1 IgG Anti-HSV 1 1gM

Anti-Toxoplasma IgM Anti-CMV IgG Anti-HSV2 IgG Anti-HSV 2 IgM
Anti-Rubella IgG Anti-CMV IgM Anti-HSV-1&2 IgG Combined Anti-HSV I + 2 IgM Combined

Specific Proteins Programme With target scoring

RQ9114 (3 ml) RQ9160 (2 ml) RQ9161 (1 ml)
26 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription

AFP b-2-Microglobulin IgA Lambda Light Chain (Total)

Albumin Ceruloplasmin IgE Prealbumin (Transthyretin)
α-1-Acid glycoprotein Complement C3 IgG Retinol Binding Protein
α-1-Antitrypsin Complement C4 IgM Rheumatoid Factor
α-2-Macroglobulin C-Reactive Protein Kappa Light Chain (Free) Transferrin
Anti Streptolysin O Ferritin Kappa Light Chain (Total)
Antithrombin III Haptoglobin Lambda Light Chain (Free)

Sweat Testing Programme+

RQ9173 (2 ml)
3 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Chloride Conductivity Sodium

= Lyophilised samples = Liquid ready-to-use samples PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing

100
 RIQAS PROGRAMMES

Therapeutic Drugs Programme With target scoring

RQ9111 (5 ml)
18 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Weighed-in values

Amikacin Ethosuximide Phenobarbital Tobramycin

Caffeine Gentamicin Phenytoin Valproic Acid
Carbamazepine Lithium Primidone Vancomycin
Cyclosporine Methotrexate Salicylic Acid
Digoxin Paracetamol (Acetaminophen) Theophylline

Trace Elements In Blood Programme+

RQ9172 (3 ml)
7 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Copper Lead Manganese Zinc

Iodine Magnesium Selenium

Trace Elements In Serum Programme+

RQ9170 (3 ml)
10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Aluminium Copper Manganese Zinc

Chromium Iodine Nickel
Cobalt Lead Selenium

Trace Elements In Urine Programme+

RQ9171 (3 ml)
11 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Cadmium Copper Magnesium Nickel

Chromium Iodine Manganese Thallium
Cobalt Lead Molybdenum

Urinalysis Programme+
RQ9138 (12 ml)
14 Parameters
Samples every 2 months, 1 x 12 month cycle, 12 month subscription

Albumin Galactose Leukocytes Specific Gravity

Bilirubin Glucose Nitrite Urobilinogen
Blood hCG pH
Creatinine Ketones Protein

Urine Toxicology Programme+

RQ9139 (5 ml)
20 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription

Benzoylecgonine d-Methamphetamine MDMA Phenobarbital

Buprenorphine EDDP Methadone Secobarbital
Cannabinoids (THC) Ethanol Nortriptyline
Cotinine* Free Morphine Norpropoxyphene
Creatinine Lorazepam Oxazepam
d-Amphetamine LSD Phencyclidine

= Lyophilised samples = Liquid ready-to-use samples PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing

Whilst every attempt is made to ensure that information is accurate and up-to-date, some information is subject to change, please contact RIQAS for current details.

101
Specifically designed with convenience in mind, the Acusera Verify range of linearity sets will help you
to easily meet CLIA requirements for calibration verification and assessment of linearity.

CALIBRATION
VERIFICATION SETS

102
 WHAT IS ACUSERA VERIFY?

Our liquid ready-to-use verifiers are supplied in varying levels and are available in multiple configurations to
meet the specific requirements of individual analysers while challenging the complete repor table range. All
linearity sets are supplied with complimentary data reduction software, providing instant access to repor ts and
real-time peer group data.

Benefits
• All Acusera Calibration Verification Sets are suppled in a user-friendly liquid ready-to-use format
reducing preparation time and the risk of reconstitution errors.
• Covering up to 21 analytes in a single vial you can reduce the number of individual products
required to cover your test menu whilst reducing costs and time.
• Each Calibration Verifier contains 5-6 levels designed to challenge the entire analytical measuring range.
• The availability of instrument dedicated material ensures specific instrument requirements are met.

In order to ensure the highest possible

standards in laboratory testing, CLIA
has recommended that laboratories
perform and document calibration
verification procedures at least twice
per year and/or in the event of the
following;

• Change of reagents
• Instrument maintenance
• Poor QC results
• New instrument

103
 CARDIAC

Combining up to six common cardiac markers in a single

product, the Acusera Cardiac Linearity Sets will reduce
the number of individual products required to cover your
test menu. Ensure specific instrument requirements are
met with the availability of dedicated solutions for both
Beckman & Roche Cobas systems. A minimum of five
unique levels are provided in a user-friendly, liquid ready-
to-use format, eliminating the need for manual dilution
and significantly reducing preparation time.

Solutions for Beckman analysers

Analytes Features & Benefits

CK-MB Mass | Myoglobin | Troponin I • Convenient, liquid ready-to-use format
• 5 levels provided
Ordering Details • 30 day open vial stability at 2ºC to 8ºC
Cardiac Linearity Verifiers (for Beckman systems) 5 x 2 ml LV10151 • Shelf life of 2 years

Solutions for Roche Cobas analysers

Analytes Features & Benefits

CK-MB Mass | D-Dimer | Myoglobin • Convenient, liquid ready-to-use format
NT-proBNP | Troponin T | hsTroponin T • 6 levels provided
• 30 day open vial stability at 2ºC to 8ºC
Ordering Details • Shelf life of 2 years
Cardiac Linearity Verifiers (for Roche systems) 6 x 2 ml LV10150

104
 SPECIFIC PROTEINS

A comprehensive range of serum proteins are available,

supplied in multiple configurations designed to cover your
laboratory’s test menu and ensure supplier consolidation.
Several unique options are available for both Beckman AU
and Roche Cobas systems delivering accurate assessment
of the instruments reportable range. The added advantage
of a 30 day open vial stability and liquid ready-to-use
format ensures availability of product for troubleshooting
and maintains user convenience.

Specific Proteins 1

Solutions for Beckman AU analysers

Analytes Features & Benefits

ASO | Complement C3 | Complement C4 | CRP • Convenient, liquid ready-to-use format
Ferritin | IgA | IgG | IgM | Prealbumin | Transferrin • 5 levels provided
• 30 day open vial stability at 2ºC to 8ºC
Ordering Details • Shelf life of 3 years
Protein 1 Linearity Verifiers (for Beckman AU systems) 5 x 1.5 ml LV10147

Solutions for Roche Cobas analysers

Analytes Features & Benefits

Complement C3 | Complement C4 • Convenient, liquid ready-to-use format
IgA | IgG | IgM | Transferrin • 5 levels provided (6 for IgA, IgG and IgM)
• 30 day open vial stability at 2ºC to 8ºC
Ordering Details • Shelf life of 3 years
Protein 1 Linearity Verifiers (for Roche systems) 6 x 1 ml LV10143

105
 SPECIFIC PROTEINS

Specific Proteins 2

Solutions for Beckman AU analysers

Analytes Features & Benefits

α-1-Acid Glycoprotein | α-1-Antitrypsin • Convenient, liquid ready-to-use format
b-2-Microglobulin | Ceruloplasmin | Haptoglobin • 5 levels provided
• 30 day open vial stability at 2ºC to 8ºC
Ordering Details • Shelf life of 3 years
Protein 2 Linearity Verifiers (for Beckman AU systems) 5 x 1.5 ml LV10148

Solutions for Roche Cobas analysers

Analytes Features & Benefits
α-1-Acid Glycoprotein | α-1-Antitrypsin | b-2-Microglobulin • Convenient, liquid ready-to-use format
Ceruloplasmin • 5 levels provided
• 30 day open vial stability at 2ºC to 8ºC
Ordering Details • Shelf life of 3 years
Protein 2 Linearity Verifiers (for Roche systems) 5 x 1 ml LV10144

Specific Proteins 3

Solutions for Roche Cobas analysers

Analytes Features & Benefits

ASO | CRP | Haptoglobin • Convenient, liquid ready-to-use format
• 6 levels provided (5 for Haptoglobin)
Ordering Details • 30 day open vial stability at 2ºC to 8ºC
Protein 3 Linearity Verifiers (for Roche systems) 6 x 1 ml LV10145 • Shelf life of 3 years

106
 SPECIFIC PROTEINS

Specific Proteins 4

Solutions for Roche Cobas analysers

Analytes Features & Benefits
Albumin | Prealbumin | Rheumatoid Factor • Convenient, liquid ready-to-use format
• 6 levels provided (5 for Rheumatoid Factor)
Ordering Details • 30 day open vial stability at 2ºC to 8ºC
Protein 4 Linearity Verifiers (for Roche systems) 6 x 1 ml LV10146 • Shelf life of 3 years

THERAPEUTIC DRUGS

The Acusera Therapeutic Drug Monitoring Linearity Sets are

specifically designed for use with Beckman AU systems and
are available in five unique levels spanning the instrument's
reportable range. A total of 21 therapeutic drugs are covered
in a single, liquid ready-to-use product, eliminating the need
to purchase additional material to cover your test menu while
remaining easy and convenient to use

Solutions for Beckman AU analysers

Analytes Features & Benefits

Acetaminophen | Amikacin | Caffeine | Carbamazepine • Convenient, liquid ready-to-use format
Digoxin | Disopyramide | Ethosuximide | Gentamicin • 5 levels provided
Lidocaine | Lithium | N-Acetylprocainamide | Phenobarbital • 14 day open vial stability at 2ºC to 8ºC
Phenytoin | Primidone | Procainamide | Quinidine | Salicylate
Theophylline | Tobramycin | Valproic Acid | Vancomycin

Ordering Details
Therapeutic Drug Monitoring Linearity Verifiers (for Beckman AU systems) 5 x 3 ml LV10149

107
 SOFTWARE

Acusera Verify Data Reduction Software

Complimentary data reduction software is available with all Acusera Linearity Sets. When used in combination
you can effectively challenge your instrument across the complete repor table range while ultimately helping to
ensure accurate and reliable patient testing.

What are the benefits of Acusera Verify data reduction software?

• With its straightforward design, you can enter results and review reports immediately
• Results can be measured against the expected value and peer group values
• Peer group data is updated live in real-time for faster troubleshooting
• Customisable charts allow users to add and remove data as required
• Unique traffic light system providing at-a-glance performance assessment

Providing instant access to automatically

generated charts, statistics and real-
time peer group data, the Acusera Verify
software is designed to significantly reduce
the time spent analysing data facilitating
immediate laboratory decisions.

108
 ACUSERA VERIFY

109
Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality
can result in unreliable test results, ultimately leading to misdiagnosis, inappropriate treatment and
may even be potentially life threatening to your patient. Availability of comprehensive controls
covering the full spectrum of laboratory tests is critical in order to assure quality of testing.

ANALYTE
INDEX

110
 #

B
A

111
AOZ
AHD
ACTH

AMOZ
5-HIAA

Albumin

Amylase
Aldolase

Amikacin
α-HBDH

Ammonia
ALT (GPT)
11 dhTXB2

AST (GOT)
Adiponectin

Aldosterone
Controls

17b Clostebol

Amphetamine
α-1-Antitrypsin

Acetaminophen

Apolipoprotein E
Apolipoprotein B
Androstenedione
25-OH-Vitamin D

b-2-Microglobulin
α-2-Macroglobulin

Apolipoprotein A-I

Apolipoprotein A-II

Apolipoprotein C-II

Apolipoprotein C-III
α-Fetoprotein (AFP)
17-OH-progesterone

Amylase (Pancreatic)
1-25-(OH2)-Vitamin D
7-amino flunitrazepam

α-1-Acid Glycoprotein
Coagulation and

Anti-Streptolysin (ASO)
Acid Phosphatase (Total)
Cardiac Controls

Anti-Thrombin III (AT III)

Albumin (Electrophoresis)

Alkaline Phosphatase (ALP)

b-Globulin (Electrophoresis)
Acid Phosphatase (Prostatic)
Blood Gas Controls

Anti-Thyroglobulin (Anti-TG)
α-2-Globulin (Electrophoresis)
α-1-Globulin (Electrophoresis)
Antioxidant Controls

Haematology Controls

Immunoassay Controls

Acid Phosphatase (Non-Prostatic)

Anti-Thyroperoxidase (Anti-TPO)
Diabetes and Whole Blood
Clinical Chemistry Controls

Activated Partical Thromboplastin Time (APTT)

Glutathione Reductase Control and Calibrator 8
Page

Glutathione Peroxidase (Ransel) Control and Calibrator 8

Superoxide Dismutase (Ransod) Control 8

Total Antioxidant Status Control and Calibrator 9
Blood Gas Control 12
Cardiac Control 16
Liquid Cardiac Control 16
ANALYTE INDEX

Liquid BNP Control 16

High Sensitivity Troponin T Control 17
CK-MB Control and Calibrator 17
Myoglobin Calibrator Series 17
H-FABP Control and Calibrator Series 17

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Precision Chemistry Premium Plus Control 20

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Liquid Chemistry Premium Control 21

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Chemistry Premium Control 24

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Liquid Assayed Chemistry Premium Plus Control 26

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Bovine Chemistry Assayed Control 27

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Bovine Chemistry Precision Control 27

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Clinical Chemistry Calibrator Serum 29

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Ammonia Ethanol Control 29

x
Aldolase Control and Calibrator 30
Bilirubin Elevated Serum 30
Liquid Bilirubin Control 30
Glycerol Control 30

x
Multi Control and Calibrator 31
Glutamine Control and Calibrator 31
x

TXB Cardio Control and Calibrator Series 31

x
Coagulation Control and Calibrator 34
Haematology Control 35
HbA1c Control and Calibrator Series 38
Liquid HbA1c Control 38
G-6-PDH Control 38
Fructosamine Control and Calibrator 39
Haemoglobin F & A2 Control 39
x

Adiponectin Control and Calibrator 39

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Liquid Immunoassay Premium Control 42
PTH Control 42

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Immunoassay Speciality I Control 45
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Tumour Marker Control 46

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Liquid Tumour Marker Control 46

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Maternal Screening Control 47

 x
x
x

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x
x
x
Specific Protein Control 50

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Specific Protein Calibrator 50

x
x
Specific Protein Calibrator (Requires Pre-dilution) 50
CRP Controls and Calibrator 51

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x
x
CSF Control 51

x
x
x
Liquid CSF Control 52

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ASO Standard 52

x
b-2-Microglobulin Calibrator 52
Cystatin C Control and Calibrator 52
Immunoglobulin Liquid Protein Calibrator 53
IgE Calibrator 53
High Sensitivity IgG Control and Calibrator 53
Rheumatoid Factor Calibrator Series 53

x
x
Lipid Control 56

x
x
x
x
x
x
Apolipoprotein Control and Calibrators 56
Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56
sLDL Control and Calibrator 56

x
x
x
Antimicrobial Controls 60
Growth Promoter Control 60
Adhesion Molecules Control and Calibrator 61
Cerebral Controls and Calibrator Series 61
Cytokine Array Controls and Calibrator Series 62-63
Cardiac Array Control 63
Evidence Immunoassay Control 64
x

Synthetic Steroids Control and Calibrator 64

Metabolic Sydrome I Control and Calibrator 65

x
Metabolic Sydrome II Control and Calibrator 65
Thyroid Calibrators 65-66

x
Therapeutic Drug Control and Calibrator 70

x
Drugs of Abuse Array 1 Plus Controls and Calibrators 74
Drugs of Abuse Array I1 Controls and Calibrators 74
x

Drugs of Abuse Array I1I Controls and Calibrators 75

x
Drugs of Abuse Array IV Controls and Calibrators 75
Drugs of Abuse Array V Controls and Calibrators 76
Cannabinoid Control and Calibrator 76
Ecstasy Control and Calibrator 76
EDDP Control and Calibrator 77
Ethanol Calibrator/Control Set 77
Multidrug Control 77
Benzodiazepines Control and Calibrator 78

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x

Assayed Urine Control 82

Urine Precision Control 82

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Liquid Urine Control 83

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Urinalysis Control 83
Microalbumin Control and Calibrator 83
Page

AOZ
AHD
ACTH

AMOZ
5-HIAA

Amylase
Albumin

Aldolase

Amikacin
α-HBDH

Ammonia
ALT (GPT)
11 dhTXB2

AST (GOT)
Adiponectin

Aldosterone
17b Clostebol

Amphetamine
α-1-Antitrypsin

Acetaminophen

Apolipoprotein E
Apolipoprotein B
Androstenedione
25-OH-Vitamin D

b-2-Microglobulin
α-2-Macroglobulin

Apolipoprotein A-I

Apolipoprotein A-II

Apolipoprotein C-II

Apolipoprotein C-III
α-Fetoprotein (AFP)

Amylase (Pancreatic)
17-OH-progesterone

1-25-(OH2)-Vitamin D
7-amino flunitrazepam

α-1-Acid Glycoprotein

Anti-Streptolysin (ASO)
Acid Phosphatase (Total)

Anti-Thrombin III (AT III)

Albumin (Electrophoresis)

Alkaline Phosphatase (ALP)

b-Globulin (Electrophoresis)
Acid Phosphatase (Prostatic)

Anti-Thyroglobulin (Anti-TG)
α-2-Globulin (Electrophoresis)
α-1-Globulin (Electrophoresis)

Acid Phosphatase (Non-Prostatic)

Anti-Thyroperoxidase (Anti-TPO)
ANALYTE INDEX

Urine Controls
Toxicology Controls
Therapeutic Drug Controls
Controls
Lipid Controls
Immunology / Protein

Speciality and Research

Controls

Activated Partical Thromboplastin Time (APTT)

#

B
A

112
 B

113
CRP
BNP

CEA
Blood

CK-MB
CA 125

Copper
Calcium
Caffeine
CA 72-4
CA 19-9
CA 15-3
BASO-Y

Cortisol
Chloride
BASO-X

Ceftiofur
CA 27-29
Bile Acids

Calcitonin
C-Peptide

CK (Total)
Boldenone
Bath Salts 2
Bath Salts 1

Bicarbonate
Barbiturates
Controls

Cannabinoids

Ceruloplasmin

Cholinesterase
Buprenorphine
Bilirubin (Total)

Carbamazepine

Corticosteroids
Bilirubin (Direct)

Chloramphenicol

Complement C4
Complement C3
Benzylpiperazines
Basophils (BASO)

Cholesterol (Total)
Cholesterol (LDL)
Cholesterol (HDL)
Benzodiazepines 1 + 2
Basophils % (% BASO)
Coagulation and

b-Agonists (Clenbuterol)
Cardiac Controls

Benzoylecgonine (Cocaine)

Chloral Hydrate Metabolite

Blood Gas Controls
Antioxidant Controls

Haematology Controls

Immunoassay Controls
Diabetes and Whole Blood
Clinical Chemistry Controls

Brain Derived Neurotropic Factor (BDNF)

Glutathione Reductase Control and Calibrator 8
Page

Glutathione Peroxidase (Ransel) Control and Calibrator 8

Superoxide Dismutase (Ransod) Control 8

Total Antioxidant Status Control and Calibrator 9

x
x
Blood Gas Control 12

x
x
Cardiac Control 16

x
Liquid Cardiac Control 16
ANALYTE INDEX

x
Liquid BNP Control 16
High Sensitivity Troponin T Control 17

x
CK-MB Control and Calibrator 17
Myoglobin Calibrator Series 17
H-FABP Control and Calibrator Series 17

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Bovine Chemistry Precision Control 27

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x

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x
x
x
Clinical Chemistry Calibrator Serum 29
Ammonia Ethanol Control 29
Aldolase Control and Calibrator 30

x
x
Bilirubin Elevated Serum 30

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x
Liquid Bilirubin Control 30
Glycerol Control 30
Multi Control and Calibrator 31
Glutamine Control and Calibrator 31
TXB Cardio Control and Calibrator Series 31
Coagulation Control and Calibrator 34
x
x
x
x

Haematology Control 35
HbA1c Control and Calibrator Series 38
Liquid HbA1c Control 38
G-6-PDH Control 38
Fructosamine Control and Calibrator 39
Haemoglobin F & A2 Control 39
Adiponectin Control and Calibrator 39

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Liquid Immunoassay Premium Control 42
PTH Control 42
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Immunoassay Premium Control 43
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Immunoassay Premium Plus Control 44
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Immunoassay Speciality I Control 45

x Immunoassay Speciality II Control 45
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Tumour Marker Control 46
x
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x

x
Liquid Tumour Marker Control 46
Maternal Screening Control 47
 x
x
x
x
Specific Protein Control 50

x
x
x
x
Specific Protein Calibrator 50
Specific Protein Calibrator (Requires Pre-dilution) 50

x
CRP Controls and Calibrator 51

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CSF Control 51

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Liquid CSF Control 52
ASO Standard 52
b-2-Microglobulin Calibrator 52
Cystatin C Control and Calibrator 52
Immunoglobulin Liquid Protein Calibrator 53
IgE Calibrator 53
High Sensitivity IgG Control and Calibrator 53
Rheumatoid Factor Calibrator Series 53

x
x
x
Lipid Control 56
Apolipoprotein Control and Calibrators 56

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x
Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56
sLDL Control and Calibrator 56

x
x
Antimicrobial Controls 60

x
x
x
Growth Promoter Control 60
Adhesion Molecules Control and Calibrator 61

x
Cerebral Controls and Calibrator Series 61
Cytokine Array Controls and Calibrator Series 62-63

x
Cardiac Array Control 63

x
Evidence Immunoassay Control 64
Synthetic Steroids Control and Calibrator 64

x
Metabolic Sydrome I Control and Calibrator 65

x
Metabolic Sydrome II Control and Calibrator 65
Thyroid Calibrators 65-66

x
x
Therapeutic Drug Control and Calibrator 70

x
x
x
x

Drugs of Abuse Array 1 Plus Controls and Calibrators 74

x
Drugs of Abuse Array I1 Controls and Calibrators 74

x
Drugs of Abuse Array I1I Controls and Calibrators 75
Drugs of Abuse Array IV Controls and Calibrators 75
x
x
x

Drugs of Abuse Array V Controls and Calibrators 76

x
Cannabinoid Control and Calibrator 76
Ecstasy Control and Calibrator 76
EDDP Control and Calibrator 77
Ethanol Calibrator/Control Set 77
x

Multidrug Control 77
Benzodiazepines Control and Calibrator 78

x
x
x
x
Assayed Urine Control 82

x
x
Urine Precision Control 82

x
x
x
Liquid Urine Control 83
x
x
x

Urinalysis Control 83
Microalbumin Control and Calibrator 83
Page

CRP
BNP

CEA
Blood

CK-MB
CA 125

Copper
Calcium
Caffeine
CA 72-4
CA 19-9
CA 15-3
BASO-Y

Cortisol
Chloride
BASO-X

Ceftiofur
CA 27-29
Bile Acids

Calcitonin
C-Peptide

CK (Total)
Boldenone
Bath Salts 2
Bath Salts 1

Bicarbonate
Barbiturates

Cannabinoids

Ceruloplasmin

Cholinesterase
Buprenorphine
Bilirubin (Total)

Carbamazepine

Corticosteroids
Bilirubin (Direct)

Chloramphenicol

Complement C4
Complement C3
Benzylpiperazines
Basophils (BASO)

Cholesterol (Total)
Cholesterol (LDL)
Cholesterol (HDL)
Benzodiazepines 1 + 2
Basophils % (% BASO)
b-Agonists (Clenbuterol)

Benzoylecgonine (Cocaine)

Chloral Hydrate Metabolite

ANALYTE INDEX

Brain Derived Neurotropic Factor (BDNF)

Urine Controls
Toxicology Controls
Therapeutic Drug Controls
Controls
Lipid Controls
Immunology / Protein

Speciality and Research

Controls

114
 F
E
C

G
D

115
FSH

gGT
EDDP

Folate
Estriol

GLDH
FSC-X
DIFF-Y

Gastrin
DIFF-X

Ferritin
Ethanol
Digoxin

Factor V
Factor II
D-dimer

Fentanyl
Factor X

G-6-PDH
Factor XI
Factor IX
Factor VII

Factor XII
Dopamine

Factor VIII
Creatinine

Fluoxetine
Cystatin C
CYFRA 21

Fibrinogen

Gentamicin
Epinephrine
Controls

Escitalopram
Cyclosporine

Ethosuximide

Fructosamine
Ethinylestradiol
DHEA-Sulphate

Eosinophils (EOS)

Ethyl Glucuronide
E-Selectin (E-SEL)
Dextromethorphan

Gestagens (Generic)
D-3-Hydroxybutyrate

% Eosinophils (% EOS)
Coagulation and
Cardiac Controls

g-Globulin (Electrophoresis)
Blood Gas Controls
Antioxidant Controls

Haematology Controls

Immunoassay Controls

Epidermal Growth Factor (EGF)

Fatty Acid Binding Protein (FABP)

Diabetes and Whole Blood

Glial Fibrillary Acidic Protein (GFAP)

Clinical Chemistry Controls
Glutathione Reductase Control and Calibrator 8
Page

Glutathione Peroxidase (Ransel) Control and Calibrator 8

Superoxide Dismutase (Ransod) Control 8

Total Antioxidant Status Control and Calibrator 9
Blood Gas Control 12
Cardiac Control 16

x
x
Liquid Cardiac Control 16
ANALYTE INDEX

Liquid BNP Control 16

High Sensitivity Troponin T Control 17
CK-MB Control and Calibrator 17
Myoglobin Calibrator Series 17
H-FABP Control and Calibrator Series 17

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x
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x

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Precision Chemistry Premium Plus Control 20

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Bovine Chemistry Precision Control 27

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Clinical Chemistry Calibrator Serum 29

x
Ammonia Ethanol Control 29
Aldolase Control and Calibrator 30
Bilirubin Elevated Serum 30
Liquid Bilirubin Control 30
Glycerol Control 30
Multi Control and Calibrator 31
Glutamine Control and Calibrator 31
TXB Cardio Control and Calibrator Series 31

x
x
x

x
x
x
x
x
x
Coagulation Control and Calibrator 34
x
x
x
x

x
Haematology Control 35
HbA1c Control and Calibrator Series 38
Liquid HbA1c Control 38

x
G-6-PDH Control 38

x
Fructosamine Control and Calibrator 39
Haemoglobin F & A2 Control 39
Adiponectin Control and Calibrator 39
x

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Liquid Immunoassay Premium Control 42
PTH Control 42
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Immunoassay Premium Control 43
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Immunoassay Premium Plus Control 44
Immunoassay Speciality I Control 45

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Immunoassay Speciality II Control 45
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Tumour Marker Control 46
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Liquid Tumour Marker Control 46
Maternal Screening Control 47
 x
Specific Protein Control 50

x
Specific Protein Calibrator 50
Specific Protein Calibrator (Requires Pre-dilution) 50
CRP Controls and Calibrator 51

x
CSF Control 51

x
Liquid CSF Control 52
ASO Standard 52
b-2-Microglobulin Calibrator 52

x
Cystatin C Control and Calibrator 52
Immunoglobulin Liquid Protein Calibrator 53
IgE Calibrator 53
High Sensitivity IgG Control and Calibrator 53
Rheumatoid Factor Calibrator Series 53
Lipid Control 56
Apolipoprotein Control and Calibrators 56
Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56
sLDL Control and Calibrator 56
Antimicrobial Controls 60
Growth Promoter Control 60

x
Adhesion Molecules Control and Calibrator 61

x
x
Cerebral Controls and Calibrator Series 61

x
Cytokine Array Controls and Calibrator Series 62-63
Cardiac Array Control 63

x
Evidence Immunoassay Control 64

x
Synthetic Steroids Control and Calibrator 64

x
x

Metabolic Sydrome I Control and Calibrator 65

Metabolic Sydrome II Control and Calibrator 65
Thyroid Calibrators 65-66

x
x

x
x

Therapeutic Drug Control and Calibrator 70

x

Drugs of Abuse Array 1 Plus Controls and Calibrators 74

x
x

Drugs of Abuse Array I1 Controls and Calibrators 74

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x

x
Drugs of Abuse Array I1I Controls and Calibrators 75

x
x
x

x
Drugs of Abuse Array IV Controls and Calibrators 75
Drugs of Abuse Array V Controls and Calibrators 76
Cannabinoid Control and Calibrator 76
Ecstasy Control and Calibrator 76
x

EDDP Control and Calibrator 77

x
Ethanol Calibrator/Control Set 77
Multidrug Control 77
Benzodiazepines Control and Calibrator 78
x
x
x

Assayed Urine Control 82

x

Urine Precision Control 82

x

Liquid Urine Control 83

x

Urinalysis Control 83
Microalbumin Control and Calibrator 83
Page

FSH

gGT
EDDP

Folate
Estriol

GLDH
FSC-X
DIFF-Y
DIFF-X

Gastrin
Ferritin
Ethanol
Digoxin

Factor V
Factor II
D-dimer

Fentanyl
Factor X

G-6-PDH
Factor XI
Factor IX
Factor VII

Factor XII
Dopamine

Factor VIII
Creatinine

Fluoxetine
Cystatin C
CYFRA 21

Fibrinogen

Gentamicin
Epinephrine

Escitalopram
Cyclosporine

Fructosamine
Ethosuximide
Ethinylestradiol
DHEA-Sulphate

Eosinophils (EOS)

Ethyl Glucuronide
E-Selectin (E-SEL)
Dextromethorphan

Gestagens (Generic)
D-3-Hydroxybutyrate

% Eosinophils (% EOS)

g-Globulin (Electrophoresis)
Epidermal Growth Factor (EGF)

Fatty Acid Binding Protein (FABP)

ANALYTE INDEX

Glial Fibrillary Acidic Protein (GFAP)

Urine Controls
Toxicology Controls
Therapeutic Drug Controls
Controls
Lipid Controls
Immunology / Protein

Speciality and Research

Controls

F
E
C

G
D

116
 I
G

117
hCG

IMIRF

Insulin
hsCRP

IMIDC
HbA1c
Glucose

H-FABP
Glycerol

GM-CSF

Inhibin A
Ibuprofen
Glutamine
Glutamate

Haloperidol

Free b-hCG
Haptoglobin
Controls

Total b-hCG

Homocysteine

Interleukin-6 (IL-6)
Interleukin-5 (IL-5)
Interleukin-4 (IL-4)
Interleukin-2 (IL-2)
Haematocrit (HCT)

Interferon-g (IFN-g)
Haemoglobin (HGB)

Haemoglobin (Total)

Interleukin-Iα (IL-lα)
Haemoglobin S (HbS)
Haemoglobin F (HbF)

Interleukin-1b (IL-1b)
Coagulation and

Glutathione Reductase

Immunoglobulin E (IgE)
Cardiac Controls

Growth Hormone (GH)

Immunoglobulin A (IgA)

Immunoglobulin G (IgG)

Immunoglobulin M (IgM)
Haemoglobin A2 (HbA2)
Blood Gas Controls

Immature Granulocytes (IG)

Antioxidant Controls

Haematology Controls

Immunoassay Controls

Glutathione Peroxidase (Ransel)

Immature Platelet Fraction (IPF)

% Immature Granulocytes (% IG)

Insulin Like Growth Factor-1 (IGF-I)

Immature Myeloid Information (IMI)
Diabetes and Whole Blood

Haemopioetic Progenitor Cell (HPC)

Clinical Chemistry Controls

High Sensitivity Immunoglobulin G (hsIgG)

Intercellular Adhesion Molecule-I (ICAM-I)

High Sensitivity Immunoglobulin M (hsIgM)
High Sensitivity Immunoglobulin A (hsIgA)
x
Glutathione Reductase Control and Calibrator 8
Page

x
Glutathione Peroxidase (Ransel) Control and Calibrator 8

Superoxide Dismutase (Ransod) Control 8

Total Antioxidant Status Control and Calibrator 9

x
Blood Gas Control 12

x
Cardiac Control 16

x
Liquid Cardiac Control 16
ANALYTE INDEX

Liquid BNP Control 16

High Sensitivity Troponin T Control 17
CK-MB Control and Calibrator 17
Myoglobin Calibrator Series 17

x
H-FABP Control and Calibrator Series 17
x

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x
x
x
x
x
Precision Chemistry Premium Plus Control 20
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Liquid Assayed Chemistry Premium Plus Control 26
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Bovine Chemistry Assayed Control 27

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Bovine Chemistry Precision Control 27

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Clinical Chemistry Calibrator Serum 29

Ammonia Ethanol Control 29
Aldolase Control and Calibrator 30
Bilirubin Elevated Serum 30
Liquid Bilirubin Control 30
x

Glycerol Control 30
x
x

Multi Control and Calibrator 31

x

Glutamine Control and Calibrator 31

TXB Cardio Control and Calibrator Series 31
Coagulation Control and Calibrator 34

x
x
x
x
x
x
x
x

Haematology Control 35
x

x
x HbA1c Control and Calibrator Series 38
Liquid HbA1c Control 38
G-6-PDH Control 38
Fructosamine Control and Calibrator 39
x
x
x

Haemoglobin F & A2 Control 39

Adiponectin Control and Calibrator 39

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Liquid Immunoassay Premium Control 42

PTH Control 42

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Immunoassay Premium Control 43

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Immunoassay Premium Plus Control 44

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Immunoassay Speciality I Control 45
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Tumour Marker Control 46

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Liquid Tumour Marker Control 46

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Maternal Screening Control 47

 x
x
x
x
x
Specific Protein Control 50

x
x
x
x
Specific Protein Calibrator 50

x
x
x
Specific Protein Calibrator (Requires Pre-dilution) 50
CRP Controls and Calibrator 51

x
x
CSF Control 51

x
x
x
x
Liquid CSF Control 52
ASO Standard 52
b-2-Microglobulin Calibrator 52
Cystatin C Control and Calibrator 52

x
x
x
Immunoglobulin Liquid Protein Calibrator 53

x
IgE Calibrator 53

x
High Sensitivity IgG Control and Calibrator 53
Rheumatoid Factor Calibrator Series 53
Lipid Control 56
Apolipoprotein Control and Calibrators 56
Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56
sLDL Control and Calibrator 56
Antimicrobial Controls 60
Growth Promoter Control 60

x
Adhesion Molecules Control and Calibrator 61

x
Cerebral Controls and Calibrator Series 61

x
x
x
x
x

x
x
x
Cytokine Array Controls and Calibrator Series 62-63

x
Cardiac Array Control 63
Evidence Immunoassay Control 64
Synthetic Steroids Control and Calibrator 64

x
x
x
Metabolic Sydrome I Control and Calibrator 65
Metabolic Sydrome II Control and Calibrator 65
Thyroid Calibrators 65-66
Therapeutic Drug Control and Calibrator 70
Drugs of Abuse Array 1 Plus Controls and Calibrators 74
Drugs of Abuse Array I1 Controls and Calibrators 74
Drugs of Abuse Array I1I Controls and Calibrators 75

x
Drugs of Abuse Array IV Controls and Calibrators 75
Drugs of Abuse Array V Controls and Calibrators 76
Cannabinoid Control and Calibrator 76
Ecstasy Control and Calibrator 76
EDDP Control and Calibrator 77
Ethanol Calibrator/Control Set 77
Multidrug Control 77
Benzodiazepines Control and Calibrator 78
x

Assayed Urine Control 82

x

Urine Precision Control 82

x
x

Liquid Urine Control 83

x
x

Urinalysis Control 83
Microalbumin Control and Calibrator 83
Page

hCG

IMIRF

Insulin
hsCRP

IMIDC
HbA1c
Glucose

H-FABP
Glycerol

GM-CSF

Inhibin A
Ibuprofen
Glutamine
Glutamate

Haloperidol

Free b-hCG
Haptoglobin

Total b-hCG

Homocysteine

Interleukin-2 (IL-2)

Interleukin-6 (IL-6)
Interleukin-5 (IL-5)
Interleukin-4 (IL-4)
Haematocrit (HCT)

Interferon-g (IFN-g)
Haemoglobin (HGB)

Haemoglobin (Total)

Interleukin-Iα (IL-lα)
Haemoglobin S (HbS)
Haemoglobin F (HbF)

Interleukin-1b (IL-1b)
Glutathione Reductase

Immunoglobulin E (IgE)
Growth Hormone (GH)

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118
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K

119
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Lactate

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Ketones

(MIP-1α)
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Magnesium

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Diabetes and Whole Blood
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Mean Corpuscular Haemoglobin (MCH)

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Glutathione Reductase Control and Calibrator 8
Page

Glutathione Peroxidase (Ransel) Control and Calibrator 8

Superoxide Dismutase (Ransod) Control 8

Total Antioxidant Status Control and Calibrator 9

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Blood Gas Control 12
Cardiac Control 16
Liquid Cardiac Control 16
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High Sensitivity Troponin T Control 17
CK-MB Control and Calibrator 17
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Liquid CSF Control 52
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Cystatin C Control and Calibrator 52
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Apolipoprotein Control and Calibrators 56
Direct LDL/HDL Cholesterol Calibrator 56

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sLDL Control and Calibrator 56
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Adhesion Molecules Control and Calibrator 61
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Evidence Immunoassay Control 64

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Page

Iron

LAP

Lipase
Leptin

MDMA
Lactate

Lithium
Ketones

(MIP-1α)
Mescaline
Magnesium

Methadone
Leukocytes

Meperidine
Iron (TIBC)

Iron (UIBC)

Methandriol

x Microalbumin
Methotrexate
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Meprobamate

Methaqualone
Lipoprotein (a)

Methylphenidate
L-Selectin (L-SEL)
Kappa Light Chain

Methamphetamine
Interleukin-8 (IL-8)

Methyltestosterone

Morphine (Opiates)
Lambda Light Chain

Monocytes (MONO)
Concentration (MCHC)
Ketamine Metabolite
Interleukin-15 (IL-15)
Interleukin-10 (IL-10)

Lymphocytes (LYMPH)
Kappa Light Chain (Free)

Monocytes % (% MONO)
Luteinising Hormone (LH)
Lambda Light Chain (Free)

% Lymphocytes (% LYMPH)

Mean Platelet Volume (MPV)

Mean Corpuscular Haemoglobin
Lactate Dehydrogenase (LDH)

Lysergic Acid Diethylamide (LSD)

Mean Corpuscular Volume (MCV)

Macrophage Inflammatory Protein-1α

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Matrix Metalloproteinase-9 (MMP-9)

Mean Corpuscular Haemoglobin (MCH)

Urine Controls
Toxicology Controls
Therapeutic Drug Controls
Controls
Lipid Controls
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Speciality and Research

Controls

Monocyte Chemoattractant Protein-1 (MCP-1)

I

L
K

120
 P
N
M

121
pH

pO2
pCO2
NEFA

Nitrite
(NGAL)

Opiates

PAPP-A
Oxalate

Prolactin

Protein S
Protein C
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Potassium

Primidone
Myoglobin

Oestradiol

Oxazepam
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Prealbumin
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NT-proBNP

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Page

Glutathione Peroxidase (Ransel) Control and Calibrator 8

Superoxide Dismutase (Ransod) Control 8

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Cardiac Control 16

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Liquid Cardiac Control 16
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CK-MB Control and Calibrator 17

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Aldolase Control and Calibrator 30
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Liquid Bilirubin Control 30
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Multi Control and Calibrator 31
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Haematology Control 35
HbA1c Control and Calibrator Series 38
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 x
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Specific Protein Calibrator (Requires Pre-dilution) 50
CRP Controls and Calibrator 51
CSF Control 51
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ASO Standard 52
b-2-Microglobulin Calibrator 52
Cystatin C Control and Calibrator 52
Immunoglobulin Liquid Protein Calibrator 53
IgE Calibrator 53
High Sensitivity IgG Control and Calibrator 53
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Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56
sLDL Control and Calibrator 56
Antimicrobial Controls 60

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Ecstasy Control and Calibrator 76
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Multidrug Control 77

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Microalbumin Control and Calibrator 83
Page

pH

pO2
pCO2
NEFA

Nitrite
(NGAL)

Opiates

PAPP-A
Oxalate

Prolactin

Protein S
Protein C
Phenytoin

Potassium

Primidone
Myoglobin

Oestradiol

Oxazepam
Osmolality

Prealbumin
Osteocalcin
Nandrolone

NT-proBNP

Paracetamol

Plasminogen

Procalcitonin

Progesterone
Phencyclidine

Platelet (PLT)
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Propoxyphene
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Oxycodone (I+II)

Plateletcrit (PCT)
Phenylpiperazines
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P-Selectin (P-SEL)
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Phosphate (Inorganic)
Neutrophils % (% NEUT)
Neuron-Specific Enolase (NSE)

Platelet Optical Count (PLT-O)

Plasminogen Activator Inhibitor

Platelet Large Cell Ratio (P-LCR)

Platelet Distribution Width (PDW)
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Neutrophil Gelatinase-associated Lipocalin

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Nucleated Red Blood Cells % (% NRBC)

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Urine Controls
Toxicology Controls
Therapeutic Drug Controls
Controls
Lipid Controls
Immunology / Protein

Speciality and Research

Controls

P
N
M

122
 S
P

T
Q

123
sLDL
Renin

Sodium
Resistin

Stilbenes
Salicylate

T Uptake

T4 (Free)
T3 (Free)
Sertraline
Salvinorin
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(RDW-CV)

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Stanozolol
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Page

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Total Antioxidant Status Control and Calibrator 9

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Cardiac Control 16
Liquid Cardiac Control 16
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High Sensitivity Troponin T Control 17
CK-MB Control and Calibrator 17
Myoglobin Calibrator Series 17
H-FABP Control and Calibrator Series 17

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Ammonia Ethanol Control 29
Aldolase Control and Calibrator 30
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Liquid Bilirubin Control 30
Glycerol Control 30
Multi Control and Calibrator 31
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TXB Cardio Control and Calibrator Series 31

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Coagulation Control and Calibrator 34

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Haematology Control 35
HbA1c Control and Calibrator Series 38
Liquid HbA1c Control 38
G-6-PDH Control 38
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Specific Protein Calibrator 50
Specific Protein Calibrator (Requires Pre-dilution) 50
CRP Controls and Calibrator 51

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CSF Control 51

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ASO Standard 52
b-2-Microglobulin Calibrator 52
Cystatin C Control and Calibrator 52
Immunoglobulin Liquid Protein Calibrator 53
IgE Calibrator 53
High Sensitivity IgG Control and Calibrator 53

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Rheumatoid Factor Calibrator Series 53
Lipid Control 56
Apolipoprotein Control and Calibrators 56
Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56

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sLDL Control and Calibrator 56

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Antimicrobial Controls 60

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Growth Promoter Control 60
Adhesion Molecules Control and Calibrator 61

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Cerebral Controls and Calibrator Series 61

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Cardiac Array Control 63

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Synthetic Steroids Control and Calibrator 64

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Metabolic Sydrome I Control and Calibrator 65
Metabolic Sydrome II Control and Calibrator 65

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Thyroid Calibrators 65-66

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Therapeutic Drug Control and Calibrator 70
Drugs of Abuse Array 1 Plus Controls and Calibrators 74
Drugs of Abuse Array I1 Controls and Calibrators 74
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Drugs of Abuse Array V Controls and Calibrators 76
Cannabinoid Control and Calibrator 76
Ecstasy Control and Calibrator 76
EDDP Control and Calibrator 77
Ethanol Calibrator/Control Set 77

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Multidrug Control 77
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Assayed Urine Control 82

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Urine Precision Control 82

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Urinalysis Control 83
Microalbumin Control and Calibrator 83
Page

sLDL
Renin

Sodium
Resistin

Stilbenes
Salicylate

T Uptake

T4 (Free)
T3 (Free)
Sertraline
Salvinorin
(RDW-SD)
(RDW-CV)

T4 (Total)
T3 (Total)
Stanozolol
PSA (Free)
PSA (Total)

Secobarbital

Theophylline
Ractopamine

Testosterone
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Thiamphenicol
Salicyluric Acid

Specific Gravity

Testosterone (Free)

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Quinolones (Generic)

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Tetracyclines (Generic)

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Receptor 11 (sTNFR I1)

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Retinol Binding Protein (RBP)

Soluble IL-6 Receptor (sIL-6R)

Synthetic Cannabinoids (1 to 4)
Superoxide Dismutase (Ransod)
Soluble Tumour Necrosis Factor
Soluble Tumour Necrosis Factor
Soluble IL-2 Receptor α (sIL-2Rα)
Red Blood Cell Distribution Width SD
Red Blood Cell Distribution Width CV
Intact PTH (Parathyroid Hormone)
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Sex Hormone Binding Globulin (SHBG)

Red Blood Cells Optical Count (RBC-O)
Urine Controls
Toxicology Controls
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Controls
Speciality and Research
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Controls
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124
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125
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Urea
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(VEGF)

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Page

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Total Antioxidant Status Control and Calibrator 9
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Liquid Cardiac Control 16
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High Sensitivity Troponin T Control 17
CK-MB Control and Calibrator 17
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Clinical Chemistry Calibrator Serum 29

Ammonia Ethanol Control 29
Aldolase Control and Calibrator 30
Bilirubin Elevated Serum 30
Liquid Bilirubin Control 30
Glycerol Control 30
Multi Control and Calibrator 31
Glutamine Control and Calibrator 31
TXB Cardio Control and Calibrator Series 31
Coagulation Control and Calibrator 34

x
x
Haematology Control 35
HbA1c Control and Calibrator Series 38
Liquid HbA1c Control 38
G-6-PDH Control 38
Fructosamine Control and Calibrator 39
Haemoglobin F & A2 Control 39
Adiponectin Control and Calibrator 39

x
x
x
x
x

Liquid Immunoassay Premium Control 42

PTH Control 42
x
x
x
x
x

Immunoassay Premium Control 43

x
x
x
x
x

Immunoassay Premium Plus Control 44

Immunoassay Speciality I Control 45
Immunoassay Speciality II Control 45
Tumour Marker Control 46
Liquid Tumour Marker Control 46
x

Maternal Screening Control 47

 x
Specific Protein Control 50

x
Specific Protein Calibrator 50
Specific Protein Calibrator (Requires Pre-dilution) 50
CRP Controls and Calibrator 51
CSF Control 51
Liquid CSF Control 52
ASO Standard 52
b-2-Microglobulin Calibrator 52
Cystatin C Control and Calibrator 52
Immunoglobulin Liquid Protein Calibrator 53
IgE Calibrator 53
High Sensitivity IgG Control and Calibrator 53
Rheumatoid Factor Calibrator Series 53

x
Lipid Control 56
Apolipoprotein Control and Calibrators 56
Direct LDL/HDL Cholesterol Calibrator 56
Lipoprotein (a) Control and Calibrator 56
sLDL Control and Calibrator 56

x
x
Antimicrobial Controls 60

x
x
Growth Promoter Control 60

x
Adhesion Molecules Control and Calibrator 61
Cerebral Controls and Calibrator Series 61

x
x
Cytokine Array Controls and Calibrator Series 62-63

x
Cardiac Array Control 63

x
Evidence Immunoassay Control 64
Synthetic Steroids Control and Calibrator 64

x
Metabolic Sydrome I Control and Calibrator 65
Metabolic Sydrome II Control and Calibrator 65

x
Thyroid Calibrators 65-66

x
x
x

Therapeutic Drug Control and Calibrator 70

x

Drugs of Abuse Array 1 Plus Controls and Calibrators 74

Drugs of Abuse Array I1 Controls and Calibrators 74

x
x
x
Drugs of Abuse Array I1I Controls and Calibrators 75
x
x
x

Drugs of Abuse Array IV Controls and Calibrators 75

Drugs of Abuse Array V Controls and Calibrators 76
Cannabinoid Control and Calibrator 76
Ecstasy Control and Calibrator 76
EDDP Control and Calibrator 77
Ethanol Calibrator/Control Set 77
Multidrug Control 77
Benzodiazepines Control and Calibrator 78

x
x
x

Assayed Urine Control 82

x
x

Urine Precision Control 82

x
x

Liquid Urine Control 83

x

Urinalysis Control 83
Microalbumin Control and Calibrator 83
Page

Zinc
TSH

Urea
Tylosin

(VEGF)

Zeronal
Zaleplon
Tramadol

Zolpidem

Zopiclone
(VCAM-1)
Troponin I
Trazadone
Transferrin

Troponin T

Vitamin B12
Trenbolone
Tobramycin

Vancomycin
Triglycerides

Valproic acid
Urobilinogen
Trimethoprim

Uric Acid (Urate)

Unconjugated Estriol
Tricyclic Antidepressants

White Blood Cells (WBC)

Vanillylmandelic Acid (VMA)
Total Antioxidant Status (TAS)

Vascular Cell Adhesion Molecule-1

Tumour Necrosis Factor α (TNFα)
ANALYTE INDEX

Vascular Endothelial Growth Factor

White Blood Cells Differential (WBC-D)

Urine Controls
Toxicology Controls
Therapeutic Drug Controls
Controls
Speciality and Research
Lipid Controls
Controls
Immunology / Protein

Z
V
T

126
 RANDOX - A GLOBAL DIAGNOSTIC SOLUTIONS PROVIDER

RX series of Clinical Analysers

The RX series combines robust hardware and intuitive software with the world leading RX series test menu, including
routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing. Renowned
for quality and reliability, the RX series boasts one of the most extensive dedicated clinical chemistry test menus on the
market guaranteeing real cost savings through consolidation of routine and specialised tests onto a single platform. This
extensive dedicated test menu of high quality reagents guarantees excellence in patient care, reducing costly test re-runs
or misdiagnosis and offers unrivalled precision and accuracy for results you can trust.

Biochemistry Reagents

Randox offers an extensive range of diagnostic reagents, giving biochemistry laboratories the oppor tunity to advance their
routine and niche testing. The Randox reagents range goes beyond routine chemistries. At Randox we re-invest significantly
in research and development to ensure we meet the ever changing needs of the laboratory. As a result, the esoteric
reagents range from Randox is extensive and includes sLDL, Lipoprotein(a), H-FABP, Cystatin C, TxBCardio, Adiponectin,
Bile Acids, Copper, D-3- Hydroxybutyrate, G-6-PDH, Non-Esterified Fatty Acids, Total Antioxidant Status and Zinc. Randox
Reagents provide a number of benefits for the laboratory: Cost savings through excellent stability, automated methods and
standards supplied with some kits; confidence in results with high performance methods, minimal interferences and wide
measuring ranges; convenience and choice with over applications for over 100 biochemistry analysers; liquid ready-to-use
reagents, a wide range of kit sizes and complementary controls and calibrators.

Biochip Array Technology

Biochip Array Technology (BAT) is an innovative assay technology for multi-analyte screening of biological samples in a rapid, accurate
and easy to use format. BAT offers highly specific tests, coupled to highly sensitive chemiluminescent detection, providing quantitative
results in easy to interpret reports. Randox BAT assays offer diagnostic, prognostic and predictive solutions across a variety of disease
areas including sexually transmitted infection, cardiovascular disease (CVD), familial hypercholesterolemia (FH), colorectal cancer and
respiratory infection.

Randox has been supplying laboratories worldwide with revolutionary

diagnostic solutions for over 30 years. Our experience and expertise
allow us to create a leading product portfolio of high quality diagnostic
tools which offer reliable and rapid diagnosis. We believe that by providing
laboratories with the right tools, we can improve healthcare worldwide.

127
 CONTACT US

Contact us for more information on any of our products and services:

Head Quarters
Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413 [email protected] randoxqc.com

International Offices

AUSTRALIA BRAZIL CHINA

Randox (Australia) Pty Ltd. Randox Brasil Ltda. Randox Laboratories Ltd.
Tel: +61 (0) 2 9615 4640 Tel: +55 11 5181-2024 Tel: +86 021 6288 6240

CZECH REPUBLIC FRANCE GERMANY

Randox Laboratories S.R.O. Laboratoires Randox Randox Laboratories GmbH
Tel: +420 2 1115 1661 Tel: +33 (0) 130 18 96 80 Tel: +49 (0) 215 1937 0611

HONG KONG ITALY INDIA

Randox Laboratories Hong Kong Limited Randox Laboratories Ltd. Randox Laboratories India Pvt Ltd.
Tel: +852 3595 0515 Tel: +39 06 9896 8954 Tel: +91 80 2802 5000

POLAND PORTUGAL PUERTO RICO

Randox Laboratories Polska Sp. z o.o. Irlandox Laboratorios Quimica Analitica Ltda Clinical Diagnostics of Puerto Rico, LLC
Tel: +48 22 862 1080 Tel: +351 22 589 8320 Tel: +1 787 701 7000

REPUBLIC OF IRELAND SLOVAKIA SOUTH AFRICA

Randox Teoranta Randox S.R.O. Randox Laboratories SA (Pty) Ltd.
Tel: +353 7495 22600 Tel: +421 2 6381 3324 Tel: +27 (0) 11 312 3590

SOUTH KOREA SPAIN SWITZERLAND

Randox Korea Laboratorios Randox S.L. Randox Laboratories Ltd. (Switzerland)
Tel: +82 (0) 31 478 3121 Tel: +34 93 475 09 64 Tel: +41 41 810 48 89

UAE USA VIETNAM

Randox Medical Equipments Trading LLC Randox Laboratories-US, Ltd. Randox Laboratories Ltd. Vietnam
Tel: +971 55 474 9075 Tel: +1 304 728 2890 Tel: +84 (0) 8 3911 0904

For technical support contact:

[email protected]

128
 LT027 MAY17

Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151
6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA.