en

Calcium
07P57
Calcium Reagent Kit G71246R02
B7P570
Read Highlighted Changes: Revised February 2018.

07P5720
07P5730
Instructions must be carefully followed. Reliability of assay results Warnings and Precautions
cannot be guaranteed if there are any deviations from these •
instructions. • For In Vitro Diagnostic Use
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NAME •
Alinity c Calcium Reagent Kit Safety Precautions
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INTENDED USE CAUTION: This product requires the handling of human specimens.
The Alinity c Calcium assay is used for the quantitation of calcium in It is recommended that all human-sourced materials be considered
human serum, plasma, or urine on the Alinity c analyzer. potentially infectious and handled in accordance with the OSHA
Standard on Bloodborne Pathogens. Biosafety Level 2 or other
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SUMMARY AND EXPLANATION OF THE TEST appropriate biosafety practices should be used for materials that
The majority of calcium in the body is present in bones. The contain or are suspected of containing infectious agents.3-6
remainder of the calcium is in serum and has various functions.
For example, calcium ions decrease neuromuscular excitability, The following warnings and precautions apply to:
participate in blood coagulation, and activate some enzymes.
Hypercalcemia can result from hyperparathyroidism, hypervitaminosis
D, multiple myeloma, and some neoplastic diseases of bone.1 Long-
term lithium therapy has been reported to cause hyperparathyroidism WARNING Contains methylisothiazolone.
in some individuals, with resulting hypercalcemia.2 H315 Causes skin irritation.
Hypocalcemia can result from hypoparathyroidism, hypoalbuminemia, H317 May cause an allergic skin reaction.
renal insufficiency, and pancreatitis.1
H319 Causes serious eye irritation.
Calcium has traditionally been difficult to measure accurately and Prevention
precisely, and a large variety of methods have been developed.
P261 Avoid breathing mist / vapors / spray.
Among these are flame photometry, oxalate precipitation
P264 Wash hands thoroughly after handling.
with titration, atomic absorption spectrophotometry, EDTA
chelation, and more recently calcium dye complexes which are P272 Contaminated work clothing should not be
measured spectrophotometrically. Examples of calcium dyes are allowed out of the workplace.
o-cresolphthalein complexone and Arsenazo III, the latter being the P280 Wear protective gloves / protective
dye used for calcium determination in this method. clothing / eye protection.
Response
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PRINCIPLES OF THE PROCEDURE P305+P351+P338 IF IN EYES: Rinse cautiously with water
Arsenazo-III dye reacts with calcium in an acid solution to form a for several minutes. Remove contact
blue-purple complex. The color developed is measured at 660 nm lenses, if present and easy to do.
and is proportional to the calcium concentration in the sample. Continue rinsing.
Methodology: Arsenazo III P337+P313 If eye irritation persists: Get medical
For additional information on system and assay technology, refer to advice / attention.
the Alinity ci-series Operations Manual, Section 3. P302+P352 IF ON SKIN: Wash with plenty of water.
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REAGENTS P333+P313 If skin irritation or rash occurs: Get
medical advice / attention.
Kit Contents
P362+P364 Take off contaminated clothing and wash
Alinity c Calcium Reagent Kit 07P57
it before reuse.
NOTE: Some kit sizes are not available in all countries. Please
Disposal
contact your local distributor.
P501 Dispose of contents / container in
Volumes (mL) listed in the table below indicate the volume per
accordance with local regulations.
cartridge.
Safety Data Sheets are available at www.abbottdiagnostics.com or
07P5720 07P5730
contact your local representative.
Tests per cartridge 400 1500
For a detailed discussion of safety precautions during system
Number of cartridges 10 10
operation, refer to the Alinity ci-series Operations Manual, Section 8.
per kit
Tests per kit 4000 15 000 Reagent Handling
16.5 mL 51.7 mL • Upon receipt, place reagent cartridges in an upright position for
8 hours before use to allow bubbles that may have formed to
Active ingredients: arsenazo-III dye (0.94 mmol/L), sodium dissipate.
acetate (271 mmol/L). Preservative: methylisothiazolone • If a reagent cartridge is dropped, place in an upright position for
hydrochloride (0.04 %). 8 hours before use to allow bubbles that may have formed to
dissipate.
• Do not invert reagent cartridges prior to use.

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• Reagents are susceptible to the formation of foam and bubbles. Specimen Type Collection Vessel
Bubbles may interfere with the detection of the reagent level in Plasma Collection tubes
the cartridge and cause insufficient reagent aspiration that may
Acceptable anticoagulants are:
adversely affect results.
Lithium heparin (with or without gel
For a detailed discussion of reagent handling precautions during
barrier)
system operation, refer to the Alinity ci-series Operations Manual,
Section 7. Sodium heparin
Urine (random Bottle containing 1 to 2 mL of 6 mol/L
Reagent Storage specimens or timed HCL in order to prevent calcium salt
Storage Maximum Additional Storage specimens collected precipitation.7
Temperature Storage Time Instructions over intervals shorter
Unopened 15 to 30°C Until Store in upright position. than 24 hours)
expiration Urine (24 hour) Bottle containing 20 to 30 mL of 6 mol/L
date HCl in order to prevent calcium salt
Onboard System 30 days precipitation.7
Temperature
Opened 15 to 30°C Until Store in upright position. • Liquid anticoagulants may have a dilution effect resulting in lower
expiration Do not reuse containers, concentration values for individual specimens.
date original reagent caps, or • The instrument does not provide the capability to verify specimen
replacement caps due to types. It is the responsibility of the operator to verify that the
the risk of contamination correct specimen types are used in the assay.
and the potential to Specimen Conditions
compromise reagent • For accurate results, serum and plasma specimens should be
performance. free of fibrin, red blood cells, and other particulate matter. Serum
Reagents may be stored on or off the system. If removed from the specimens from patients receiving anticoagulant or thrombolytic
system, store reagents with new replacement caps in an upright therapy may contain fibrin due to incomplete clot formation.
position at 15 to 30°C. For reagents stored off the system, it is • For accurate results, plasma specimens should be free of
recommended that they be stored in their original trays or boxes to platelets and other particulate matter. Ensure centrifugation is
ensure they remain upright. adequate to remove platelets.
For information on unloading reagents, refer to the Alinity ci-series • To prevent cross contamination, use of disposable pipettes or
Operations Manual, Section 5. pipette tips is recommended.
Indications of Reagent Deterioration Preparation for Analysis
Deterioration of the reagents may be indicated when a calibration • Follow the tube manufacturer’s processing instructions for
error occurs or a control value is out of the specified range. collection tubes. Gravity separation is not sufficient for specimen
Associated test results are invalid, and samples must be retested. preparation.
Assay recalibration may be necessary. • Specimens should be free of bubbles. Remove bubbles with an
For troubleshooting information, refer to the Alinity ci-series applicator stick before analysis. Use a new applicator stick for
Operations Manual, Section 10. each specimen to prevent cross-contamination.
To ensure consistency in results, recentrifuge specimens prior to
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INSTRUMENT PROCEDURE testing if
The Alinity c Calcium assay file must be installed on the Alinity c • they contain fibrin, red blood cells, or other particulate matter.
analyzer prior to performing the assay.
NOTE: If fibrin, red blood cells, or other particulate matter are
For detailed information on assay file installation and viewing and observed, mix by low speed vortex or by inverting 10 times prior to
editing assay parameters, refer to the Alinity ci-series Operations recentrifugation.
Manual, Section 2.
Prepare frozen specimens as follows:
For information on printing assay parameters, refer to the Alinity ci-
• Frozen specimens must be completely thawed before mixing.
series Operations Manual, Section 5.
• Mix thawed specimens thoroughly
For a detailed description of system procedures, refer to the Alinity
• Visually inspect the specimens. If layering or stratification is
ci-series Operations Manual.
observed, mix until specimens are visibly homogeneous.
Alternate Result Units • If specimens are not mixed thoroughly, inconsistent results may
Edit assay parameter "Result Units" to select an alternate unit. be obtained.
Conversion formula:
Specimen Storage
(Concentration in Default result unit) x (Conversion factor) =
Specimen Maximum
(Concentration in Alternate result unit) Type Temperature Storage Time Special Instructions
Default Result Unit Conversion Factor Alternate Result Unit Serum/ 20 to 25°C 7 days8
mg/dL 0.25 mmol/L Plasma
2 to 8°C 3 weeks8, 9
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SPECIMEN COLLECTION AND PREPARATION -20°C 8 months8
FOR ANALYSIS
Specimen Types Urine 20 to 25°C 2 days8 Acidify to pH < 2
The specimen types listed below were verified for use with this 2 to 8°C 4 days8, 9 Acidify to pH < 2
assay. -20°C 3 weeks8 Acidify to pH < 2
Other specimen types, collection tube types, and anticoagulants
have not been verified with this assay.
Specimen Type Collection Vessel
Serum Serum tubes (with or without gel barriers)

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Analyze fresh specimens if possible. Automated Dilution Protocol
Avoid multiple freeze/thaw cycles. Serum/ Plasma
Guder et al. suggest storage of frozen specimens at -20°C for no If using an automated dilution protocol, the system performs a
longer than the time intervals cited above.10 dilution of the sample and automatically calculates the concentration
Each laboratory may establish a range around -20°C from either the by multiplying the result by the dilution factor. For details on
freezer manufacturer’s specifications or your laboratory standard configuring automated dilutions, refer to the Alinity ci-series
operating procedure(s) for specimen storage. Operations Manual, Section 2.
Stored specimens must be inspected for particulates. If present, mix Urine
with a low speed vortex or by inversion and centrifuge the specimen If using an automated dilution protocol, the system performs a
to remove particulates prior to testing. dilution of the sample and automatically calculates the concentration
Specimen Shipping by multiplying the result by the dilution factor. For details on
configuring automated dilutions, refer to the Alinity ci-series
Package and label specimens in compliance with applicable state,
Operations Manual, Section 2.
federal, and international regulations covering the transport of clinical
specimens and infectious substances. Manual Dilution Procedure
Dilute the sample with saline (0.85% to 0.90% NaCl).
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PROCEDURE The operator must enter the dilution factor in the Specimen or
Materials Provided Control tab of the Create Order screen. The system will use this
07P57 Alinity c Calcium Reagent Kit dilution factor to automatically calculate the concentration of the
sample and report the result.
Materials Required but not Provided
If the operator does not enter the dilution factor, the result must be
• Alinity c Calcium assay file
manually multiplied by the appropriate dilution factor before reporting
• 08P6001 Alinity c Multiconstituent Calibrator Kit the result. If a diluted sample result is less than the lower value of
• Commercially available controls containing calcium the measuring interval of 2.0 mg/dL (0.50 mmol/L), do not report the
• Saline (0.85% to 0.90% NaCl) for specimen dilution result. Rerun using an appropriate dilution.
For information on materials required for operation of the instrument, For detailed information on ordering dilutions, refer to the Alinity ci-
refer to the Alinity ci-series Operations Manual, Section 1. series Operations Manual, Section 5.
For information on materials required for maintenance procedures,
Calibration
refer to the Alinity ci-series Operations Manual, Section 9.
For instructions on performing a calibration, refer to the Alinity ci-
Assay Procedure series Operations Manual, Section 5.
For a detailed description of how to run an assay, refer to the Alinity Calibration is stable for approximately 30 days (720 hours), but
ci-series Operations Manual, Section 5. is required with each change in reagent lot. Verify calibration with
• If using primary or aliquot tubes, refer to the Alinity ci-series at least 2 levels of controls according to the established quality
Operations Manual, Section 4 to ensure sufficient specimen is control requirements for your laboratory. If control results fall outside
present. acceptable ranges, recalibration may be necessary.
• To minimize the effects of evaporation, verify adequate sample This assay may require recalibration after maintenance to critical
cup volume is present prior to running the test. parts or subsystems or after service procedures have been
• Minimum sample volume requirements: performed.
–– Sample volume for single test: 2.6 µL. Quality Control Procedures
NOTE: This amount does not include the dead volume As appropriate, refer to your laboratory standard operating
plus the additional over-aspiration volume. For total sample procedure(s) and/or quality assurance plan for additional quality
volume requirements, refer to the Alinity ci-series Operations control requirements and potential corrective actions.
Manual, Section 4. • Two levels of controls (normal and abnormal) are to be run every
• Refer to the Alinity c Multiconstituent Calibrator Kit package 24 hours.
insert and commercially available control material package insert • If more frequent control monitoring is required, follow the
for preparation and usage. established quality control procedures for your laboratory.
• For general operating procedures, refer to the Alinity ci-series • If quality control results do not meet the acceptance criteria
Operations Manual, Section 5. defined by your laboratory, sample results may be suspect.
• For optimal performance, it is important to perform routine Follow the established quality control procedures for your
maintenance as described in the Alinity ci-series Operations laboratory. Recalibration may be necessary. For troubleshooting
Manual, Section 9. Perform maintenance more frequently when information, refer to the Alinity ci-series Operations Manual,
required by laboratory procedures. Section 10.
Sample Dilution Procedures • Review quality control results and acceptance criteria following a
Serum/ Plasma change of reagent or calibrator lot.
Samples with calcium values exceeding 24.0 mg/dL (6.00 mmol/L) Commercial controls should be used according to the guidelines
are flagged with the code "> 24.0 mg/dL" (6.00 mmol/L) and may and recommendations of the control manufacturer. Concentration
be diluted with either the Automated Dilution Protocol or the Manual ranges provided in the control package insert should be used only
Dilution Procedure. for guidance.
Urine For any control material in use, the laboratory should ensure that the
matrix of the control material is suitable for use in the assay per the
Samples with calcium values exceeding 24.0 mg/dL (6.00 mmol/L)
assay package insert.
are flagged with the code "> 24.0 mg/dL" (6.00 mmol/L) and may
be diluted with either the Automated Dilution Protocol or the Manual Quality Control Guidance
Dilution Procedure. Refer to “Basic QC Practices” by James O Westgard, Ph.D. for
guidance on laboratory quality control practices.11
Verification of Assay Claims
For protocols to verify package insert claims, refer to Verification of
Assay Claims in the Alinity ci-series Operations Manual.

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RESULTS ll
SPECIFIC PERFORMANCE CHARACTERISTICS
Calculation Representative performance data are provided in this section.
The Alinity c Calcium assay utilizes the Linear data reduction method Results obtained in individual laboratories may vary.
to generate a calibration and results. The Alinity c analyzer, and the ARCHITECT c System and AEROSET
For information on alternate result units, refer to the INSTRUMENT System utilize the same reagents and sample/reagent ratios.
PROCEDURE, Alternate Result Units section of this package insert. Unless otherwise specified, all studies were performed on the Alinity
c analyzer.
Flags
Some results may contain information in the Flags field. For a Precision
description of the flags that may appear in this field, refer to the Within-Laboratory Precision
Alinity ci-series Operations Manual, Section 5. A study was performed based on guidance from CLSI EP05-A2.
Testing was conducted using 1 lot of the Alinity c Calcium Reagent
Measuring Interval
Kit, 1 lot of the Alinity c Multiconstituent Calibrator Kit, and 1 lot of
Measuring interval is defined as the range of values in mg/dL
commercially available controls and 1 instrument. Three controls
(mmol/L) which meets the limits of acceptable performance for
were assayed in a minimum of 2 replicates at 2 separate times per
linearity, imprecision, and bias.
day on 20 different days for the serum assay. Two controls were
The measuring interval of the Alinity c Calcium assay is 2.0 to assayed in a minimum of 2 replicates at 2 separate times per day on
24.0 mg/dL (0.50 to 6.00 mmol/L). 20 different days for the urine assay.13
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LIMITATIONS OF THE PROCEDURE Serum
Refer to the SPECIMEN COLLECTION AND PREPARATION FOR Within-Run Within-Laboratory
ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS Mean (Repeatability) (Total)a
sections of this package insert. Sample n (mg/dL) SD %CV SD %CV

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EXPECTED VALUES Control
Level 1
120 6.9 0.05 0.8 0.07 1.0

Representative performance data are provided in this section. Results Control 120 10.3 0.07 0.7 0.10 1.0
obtained in individual laboratories may vary. Level 2
It is recommended that each laboratory determine its own reference Control 120 13.6 0.10 0.7 0.12 0.8
range based upon its particular locale and population characteristics. Level 3
Reference Range aIncludes within-run, between-run, and between-day variability.
Serum/Plasma12 Serum
Range Range Within-Run Within-Laboratory
(mg/dL) (mmol/L) Mean (Repeatability) (Total)a
Cord 8.2 to 11.2 2.05 to 2.80 Sample n (mmol/L) SD %CV SD %CV
Newborn Control 120 1.73 0.014 0.8 0.018 1.1
Premature 6.2 to 11.0 1.55 to 2.75 Level 1
0 to 10 days 7.6 to 10.4 1.90 to 2.60 Control 120 2.58 0.017 0.7 0.026 1.0
Level 2
10 days to 24 months 9.0 to 11.0 2.25 to 2.75
Control 120 3.41 0.026 0.8 0.030 0.9
Child, 2 to 12 years 8.8 to 10.8 2.20 to 2.70 Level 3
Adult 8.4 to 10.2 2.10 to 2.55 aIncludes within-run, between-run, and between-day variability.
Male > 60 years 8.8 to 10.0 2.20 to 2.50
Urine
Urine12 Within-Run Within-Laboratory
Range Range Mean (Repeatability) (Total)a
Calcium in diet (mg/day) (mmol/day) Sample n (mg/dL) SD %CV SD %CV
Calcium-free 5 to 40 0.13 to 1.00 Control 120 7.3 0.06 0.9 0.07 1.0
Low to average 50 to 150 1.25 to 3.75 Level 1
Average (800 mg/day or 20 100 to 300 2.50 to 7.50 Control 119 14.0 0.12 0.9 0.16 1.1
mmol/day) Level 2
aIncludes within-run, between-run, and between-day variability.
24-Hour Urinary Excretion
Urine
To convert results from mg/dL to mg/day (24-hour urinary excretion):
Within-Run Within-Laboratory
24-hour excretion = [(V × c) ÷ 100] mg/day (Repeatability) (Total)a
Mean
Where: Sample n (mmol/L) SD %CV SD %CV
V = 24-hour urine volume (mL) Control 120 1.83 0.015 0.8 0.017 0.9
c = analyte concentration mg/dL Level 1
To convert results from mmol/L to mmol/day (24-hour urinary Control 119 3.50 0.030 0.9 0.040 1.1
excretion): Level 2
24-hour excretion = [(V × c) ÷ 1000] mmol/day a Includes within-run, between-run, and between-day variability.
Where: Lower Limits of Measurement
V = 24-hour urine volume (mL) A study was performed based on guidance from CLSI EP17-A2.
c = analyte concentration mmol/L Testing was conducted using 3 lots of the Alinity c Calcium Reagent
To convert results from mg/day to mmol/day, multiply mg/day by Kit on each of 2 instruments over a minimum of 3 days. The Limit
0.025. To convert mmol/day to mg/day divide mmol/day by 0.025. of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation
(LoQ) values are summarized below. These representative data
support the lower limit of the measuring interval.14

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 mg/dL mmol/L Method Comparison
LoBa 0.2 0.05 A study was performed based on guidance from CLSI EP09-A3 using
LoDb 0.3 0.08 the Passing-Bablok regression method.17
LoQc, d 1.0 0.25 Correlation Concentration
Units n Coefficient Intercept Slope Range
a The LoB represents the 95th percentile from n ≥ 60 replicates of Alinity c Serum mg/dL 132 1.00 0.13 1.00 4.4 - 23.9
zero-analyte samples. Calcium vs mmol/L 132 1.00 0.03 1.00 1.09 - 5.98
b The LoD represents the lowest concentration at which the analyte ARCHITECT
can be detected with 95% probability based on n ≥ 60 replicates of Calcium
low-analyte level samples. Alinity c Urine mg/dL 130 1.00 0.05 1.00 2.3 - 21.0
c The LoQ is defined as the lowest concentration at which a
Calcium vs mmol/L 130 1.00 0.01 1.00 0.58 - 5.25
ARCHITECT
maximum allowable precision of 20 %CV was met. Calcium
d This value represents the observed LoQ on the ARCHITECT

System. The LoQ observed on the Alinity c analyzer supports this ll

BIBLIOGRAPHY
LoQ. 1. Jacobs DS, DeMott WR, Oxley DK, et al. Laboratory Test Handbook.
Hudson, OH: Lexi-Comp; 2001:131–133.
Linearity 2. Bendz H, Sjödin I, Toss G, et al. Hyperparathyroidism and long-term
A study was performed based on guidance from CLSI EP06-A.15 lithium therapy—a cross-sectional study and the effect of lithium
This assay is linear across the measuring interval of 2.0 to withdrawal. J Intern Med 1996;240:357–365.
24.0 mg/dL (0.50 to 6.00 mmol/L). 3. US Department of Labor, Occupational Safety and Health
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
Interference 4. US Department of Health and Human Services. Biosafety in
This study was performed on the AEROSET System. Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
Potentially Interfering Endogenous Substances US Government Printing Office; December 2009.
5. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
Interference effects were assessed by Dose Response and Paired Geneva: World Health Organization; 2004.
Difference methods, at the medical decision levels of the analyte. 6. Clinical and Laboratory Standards Institute (CLSI). Protection
Medical Decision Level 1 of Laboratory Workers From Occupationally Acquired Infections;
Interferent Level Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
Potentially PA: CLSI; 2014.
Interfering Target Level Recovery (% of 7. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical
Substance Default Units Alternate Units (mg/dL) Target)
Chemistry, 5th ed. Philadelphia, PA: WB Saunders; 2001:800.
Bilirubin 30 mg/dL 513 μmol/L 8.0 99.4 8. Guder WG, Narayanan S, Wisser H, et al. List of Analytes—
60 mg/dL 1026 μmol/L 8.0 98.2 Preanalytical Variables. Annex In: Samples: From the Patient to the
Hemoglobin 1000 mg/dL 10.0 g/L 7.6 100.3 Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 10–1,
2000 mg/dL 20.0 g/L 7.6 101.4 36–7.
9. US Pharmacopeial Convention, Inc. General notices. In: US
Intralipid 500 mg/dL 5.0 g/L 7.2 103.6
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
750 mg/dL 7.5 g/L 7.2 105.7 Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
10. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Medical Decision Level 2
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:14–15.
Potentially Interferent Level 11. Westgard JO. Basic QC Practices. 3rd ed. Madison, WI: Westgard
Interfering Target Level Recovery (% of Quality Corporation; 2010.
Substance Default Units Alternate Units (mg/dL) Target) 12. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
Bilirubin 30 mg/dL 513 μmol/L 12.7 98.8 2nd ed. Philadelphia, PA: WB Saunders; 1994:2180.
60 mg/dL 1026 μmol/L 12.7 97.4 13. National Committee for Clinical Laboratory Standards (NCCLS).
Evaluation of Precision Performance of Quantitative Measurement
Hemoglobin 1000 mg/dL 10.0 g/L 11.3 99.9
Methods; Approved Guideline—Second Edition. NCCLS Document
2000 mg/dL 20.0 g/L 11.3 99.9 EP5-A2. Wayne, PA: NCCLS; 2004.
Intralipid 500 mg/dL 5.0 g/L 10.9 102.9 14. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
750 mg/dL 7.5 g/L 10.9 104.8 Detection Capability for Clinical Laboratory Measurement Procedures;
Approved Guideline—Second Edition. CLSI Document EP17-A2.
Bilirubin solutions at the above concentrations were prepared by Wayne, PA: CLSI; 2012.
addition of a bilirubin stock to human serum pools. Hemoglobin 15. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
solutions at the above concentrations were prepared by addition of the Linearity of Quantitative Measurement Procedures: A Statistical
hemolysate to human serum pools. Intralipid solutions at the above Approach; Approved Guideline. CLSI Document EP06-A. Wayne, PA:
CLSI; 2003.
concentrations were prepared by addition of intralipid to human
16. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
serum pools. Washington, DC: AACC Press; 1995:3-115–3-124.
For the urine application, glucose up to 500 mg/dL (27.8 mmol/L), 17. Clinical and Laboratory Standards Institute (CLSI). Measurement
ascorbate up to 100 mg/dL (5.7 mmol/L), protein up to 30 mg/dL Procedure Comparison and Bias Estimation Using Patient Samples;
(0.3 g/L), hydrochloric acid (6 N) up to 2.5 mL/dL (150 mmol/L), Approved Guideline—Third Edition. CLSI Document EP09-A3. Wayne,
and boric acid up to 250 mg/dL (40 mmol/L) demonstrated ≤ 5% or PA: CLSI; 2013.
± 0.2 mg/dL (0.05 mmol/L) interference, whichever is greater. Acetic Note for number formatting:
acid (8.5 N) up to 6.25 mL/dL (531 mmol/L) and nitric acid (6 N) up • A space is used as thousands separator (example: 10 000
to 5.0 mL/dL (300 mmol/L) demonstrated > 10% interference. specimens).
Interferences from medications or endogenous substances may • A period is used to separate the integer part from the fractional
affect results.16 part of a number written in decimal form (example: 3.12%).

5
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Key to Symbols
ISO 15223 Symbols
Consult instructions for use

Manufacturer

Sufficient for

Temperature limitation

Use by/Expiration date

In Vitro Diagnostic Medical

Device
Lot Number
List Number
Serial number
Other Symbols
Distributed in the USA by
Do not shake/agitate
Information needed for United
States of America only
Produced for Abbott by
Product of Great Britain
Reagent 1
For use by or on the order of a
physician only (applicable to USA
classification only).

Alinity, ARCHITECT, and AEROSET are trademarks of Abbott

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