Magnesium

en
08P19
Magnesium Reagent Kit G71159R06
B8P190
Read Highlighted Changes: Revised November 2018.

08P1920
08P1930
Instructions must be carefully followed. Reliability of assay results ll
REAGENTS
cannot be guaranteed if there are any deviations from these
instructions.
Kit Contents
Alinity c Magnesium Reagent Kit 08P19
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NAME NOTE: Some kit sizes are not available in all countries. Please contact your local distributor.
Alinity c Magnesium Reagent Kit Volumes (mL) listed in the table below indicate the volume per cartridge.

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INTENDED USE 08P1920 08P1930

The Alinity c Magnesium assay is used for the quantitation of Tests per cartridge 360 (serum/plasma) 360 (serum/plasma)
magnesium in human serum, plasma, or urine on the Alinity c 240 (urine) 240 (urine)
analyzer. Number of cartridges per kit 2 10
Magnesium measurements are used in the diagnosis and treatment Tests per kit 720 (serum/plasma) 3600 (serum/plasma)
of hypomagnesemia (abnormally low plasma levels of magnesium) 480 (urine) 2400 (urine)
and hypermagnesemia (abnormally high plasma levels of 68.1 mL 68.1 mL
magnesium). 17.9 mL 17.9 mL
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SUMMARY AND EXPLANATION OF THE TEST Active ingredients: Isocitrate dehydrogenase (2.2 U/mL), D-Isocitrate potassium salt
Magnesium is an essential nutrient which is involved in many (1.47 mg/mL). Preservative: sodium azide (0.1%).
biochemical functions. It has a structural role in nucleic acids and Active ingredient: NADP (8.37 mg/mL). Preservative: sodium azide (0.1%).
ribosomal particles, is required as an activator for many enzymes,
and has a role in energy producing oxidative phosphorylation. Warnings and Precautions
The normal body contains 21 to 28 g magnesium, more than 50% •
of which is complexed with calcium and phosphate in bone. Only • For In Vitro Diagnostic Use
approximately 1% of the total magnesium is found in the extracellular
•
fluid. It tends to enter and leave cells under the same conditions
as potassium. Approximately 35% of plasma magnesium is protein- Safety Precautions
bound, mainly to albumin, and therefore changes in albumin CAUTION: This product requires the handling of human specimens.
concentration may affect magnesium. It is recommended that all human-sourced materials be considered
Hypomagnesemia results in impairment of neuromuscular potentially infectious and handled in accordance with the OSHA
function, carbohydrate intolerance, and cardiac arrhythmias. Standard on Bloodborne Pathogens. Biosafety Level 2 or other
Hypermagnesemia results in hypotension, bradycardia, and appropriate biosafety practices should be used for materials that
respiratory depression, among other conditions. contain or are suspected of containing infectious agents.1-4
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PRINCIPLES OF THE PROCEDURE The following warnings and precautions apply to:
Magnesium present in the sample is a cofactor in an enzymatic Contains sodium azide and polyethylene glycol octylphenyl ether.
reaction with isocitrate dehydrogenase. The rate of increase in EUH032 Contact with acids liberates very toxic gas.
absorbance at 340 nm, due to the formation of NADPH, is directly H402* Harmful to aquatic life.
proportional to the magnesium concentration. H412 Harmful to aquatic life with long lasting
Isocitrate dehydrogenase effects.
D-isocitric acid + NADP 2-oxoglutarate + CO2 + NADPH Prevention
P273 Avoid release to the environment.
Mg2+
Disposal
Methodology: Enzymatic P501 Dispose of contents / container in
For additional information on system and assay technology, refer to accordance with local regulations.
the Alinity ci-series Operations Manual, Section 3.
* Not applicable where regulation EC 1272/2008 (CLP) has been
implemented.
The following warnings and precautions apply to:
Contains sodium azide.
EUH032 Contact with acids liberates very toxic gas.
P501 Dispose of contents / container in
accordance with local regulations.
Safety Data Sheets are available at [Link] or
contact your local representative.
For a detailed discussion of safety precautions during system
operation, refer to the Alinity ci-series Operations Manual, Section 8.

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Reagent Handling Alternate Result Units
• Reagents are shipped refrigerated. Edit assay parameter "Result Units" to select an alternate unit.
• Upon receipt, place reagent cartridges in an upright position for Conversion formula:
8 hours before use to allow bubbles that may have formed to (Concentration in Default result unit) x (Conversion factor) =
dissipate. (Concentration in Alternate result unit)
• If a reagent cartridge is dropped, place in an upright position for Default Result Unit Conversion Factor Alternate Result Unit
8 hours before use to allow bubbles that may have formed to mg/dL 0.411 mmol/L
dissipate. mg/dL 0.823 mEq/L*
• Reagents are susceptible to the formation of foam and bubbles.
Bubbles may interfere with the detection of the reagent level in * NOTE: For information only. The mEq/L alternate result unit is not
the cartridge and cause insufficient reagent aspiration that may included in the assay parameter “Result Units”.
adversely affect results. ll
SPECIMEN COLLECTION AND PREPARATION
For a detailed discussion of reagent handling precautions during FOR ANALYSIS
system operation, refer to the Alinity ci-series Operations Manual,
Section 7. Specimen Types
The specimen types listed below were verified for use with this
Reagent Storage assay.
Storage Maximum Additional Storage Other specimen types, collection tube types, and anticoagulants
Temperature Storage Time Instructions
have not been verified with this assay.
Unopened 2 to 8°C Until Store in upright position.
Specimen Type Collection Vessel Special Conditions
expiration
date Serum Serum tubes (with or Use nonhemolyzed
without gel barrier) specimens.
Onboard System 30 days
Temperature Plasma Collection tubes
Opened 2 to 8°C Until Store in upright position. Acceptable
expiration anticoagulants are:
Do not reuse original
date reagent caps or Lithium heparin (with
replacement caps due to or without gel barrier)
the risk of contamination Sodium heparin
and the potential to Urine (24 hour) Collect specimens Do not use more
compromise reagent in a container with than 2.5 mL 6N HCl
performance. boric acid or 20 to per 100 mL of urine.
30 mL of 6N HCl to Excess hydrochloric
Reagents may be stored on or off the system. If removed from the prevent precipitation acid may cause
system, store reagents with new replacement caps in an upright of magnesium elevated results with
position at 2 to 8°C. For reagents stored off the system, it is complexes.5 this methodology. Do
recommended that they be stored in their original trays or boxes to not exceed 10 g/L
ensure they remain upright. boric acid.
For information on unloading reagents, refer to the Alinity ci-series
Operations Manual, Section 5. • The instrument does not provide the capability to verify specimen
types. It is the responsibility of the operator to verify that the
Indications of Reagent Deterioration correct specimen types are used in the assay.
Deterioration of the reagents may be indicated when a calibration
error occurs or a control value is out of the specified range. Specimen Conditions
Associated test results are invalid, and samples must be retested. • For accurate results, serum and plasma specimens should be
Assay recalibration may be necessary. free of fibrin, red blood cells, and other particulate matter. Serum
For troubleshooting information, refer to the Alinity ci-series specimens from patients receiving anticoagulant or thrombolytic
Operations Manual, Section 10. therapy may contain fibrin due to incomplete clot formation.
• For accurate results, plasma specimens should be free of
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INSTRUMENT PROCEDURE platelets and other particulate matter. Ensure centrifugation is
The Alinity c Magnesium assay file must be installed on the Alinity c adequate to remove platelets.
analyzer prior to performing the assay. • To prevent cross contamination, use of disposable pipettes or
For detailed information on assay file installation and viewing and pipette tips is recommended.
editing assay parameters, refer to the Alinity ci-series Operations
Manual, Section 2.
Preparation for Analysis
• The Magnesium assay is susceptible to interference from
For information on printing assay parameters, refer to the Alinity ci-
hemoglobin. Refer to the Interference section of this package
series Operations Manual, Section 5.
insert for additional details.
For a detailed description of system procedures, refer to the Alinity
• Follow the tube manufacturer’s processing instructions for
ci-series Operations Manual.
collection tubes. Gravity separation is not sufficient for specimen
preparation.
• Specimens should be free of bubbles. Remove bubbles with an
applicator stick before analysis. Use a new applicator stick for
each specimen to prevent cross contamination.
To ensure consistency in results, recentrifuge specimens prior to
testing if
• they contain fibrin, red blood cells, or other particulate matter.
NOTE: If fibrin, red blood cells, or other particulate matter are
observed, mix by low speed vortex or by inverting 10 times prior to
recentrifugation.

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Specimen Storage Sample Dilution Procedures
Maximum Serum/Plasma
Storage Samples with a magnesium value exceeding
Specimen Type Temperature Time Special Instructions 9.50 mg/dL (3.90 mmol/L) are flagged with the code "> 9.50 mg/dL"
Serum/ 20 to 25°C 7 days6 (> 3.90 mmol/L) and may be diluted with either the Automated
Plasma Dilution Protocol or the Manual Dilution Procedure.
2 to 8°C 7 days6, 7
Urine
-20°C 1 year6 Urine samples are diluted 1:2.97 by the system using the Standard
Urine 20 to 25°C 3 days6 Acidify to pH < 2. dilution option, then the system corrects the concentration by
multiplying the result by the dilution factor. All samples should
2 to 8°C 3 days6, 7 Acidify to pH < 2. be initially tested using the STANDARD (1:3) Dilution Protocol.
-20°C 1 year6 Acidify to pH < 2. If a sample result is greater than the upper value of the
measuring interval of 26.35 mg/dL (10.83 mmol/L), this sample
Avoid multiple freeze/thaw cycles. should be retested using the 1:9 Automated Dilution Protocol.
Guder et al. suggest storage of frozen specimens at -20°C for no If the result obtained is within the analytical measuring interval
longer than the time intervals cited above.6 of 1.81 to 26.35 mg/dL (0.74 to 10.83 mmol/L), the sample
Each laboratory may establish a range around -20°C from either the should not be diluted. Urine samples with values exceeding
freezer manufacturer’s specifications or your laboratory standard 26.35 mg/dL (10.83 mmol/L) are flagged with the code
operating procedure(s) for specimen storage. "> 26.35 mg/dL" (> 10.83 mmol/L) and may be diluted with either the
Stored specimens must be inspected for particulates. If present, mix Automated Dilution Protocol or the Manual Dilution Procedure.
with a low speed vortex or by inversion and centrifuge the specimen Automated Dilution Protocol
to remove particulates prior to testing. Serum/Plasma
Specimen Shipping If using an automated dilution protocol, the system performs a
Package and label specimens in compliance with applicable state, dilution of the sample and automatically calculates the concentration
federal, and international regulations covering the transport of clinical by multiplying the result by the dilution factor. For details on
specimens and infectious substances. configuring automated dilutions, refer to the Alinity ci-series
Operations Manual, Section 2.
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PROCEDURE Urine
Materials Provided The system performs a 1:8.90 dilution of the sample and
08P19 Alinity c Magnesium Reagent Kit automatically calculates the concentration by multiplying the result
Materials Required but not Provided by the dilution factor.
• Alinity c Magnesium assay file Manual Dilution Procedure
• 08P6001 Alinity c Multiconstituent Calibrator Kit Dilute the sample with saline (0.85% to 0.90% NaCl) using a
recommended dilution of 1:2.
• Commercially available controls containing magnesium
The operator must enter the dilution factor in the Specimen or
• Saline (0.85% to 0.90% NaCl) for specimen dilution
Control tab of the Create Order screen. The system will use this
For information on materials required for operation of the instrument,
dilution factor to automatically calculate the concentration of the
refer to the Alinity ci-series Operations Manual, Section 1.
sample and report the result.
For information on materials required for maintenance procedures,
If the operator does not enter the dilution factor, the result must be
refer to the Alinity ci-series Operations Manual, Section 9.
manually multiplied by the appropriate dilution factor before reporting
Assay Procedure the result. If a diluted sample result is less than the lower value of
For a detailed description of how to run an assay, refer to the Alinity the measuring interval of 0.60 mg/dL (0.25 mmol/L) for the serum/
ci-series Operations Manual, Section 5. plasma application and 1.81 mg/dL (0.74 mmol/L) for the urine
• If using primary or aliquot tubes, refer to the Alinity ci-series application, do not report the result. Rerun using an appropriate
Operations Manual, Section 4 to ensure sufficient specimen is dilution.
present. For detailed information on ordering dilutions, refer to the Alinity ci-
• To minimize the effects of evaporation, verify adequate sample series Operations Manual, Section 5.
cup volume is present prior to running the test. Calibration
• Minimum sample volume requirements: For instructions on performing a calibration, refer to the Alinity ci-
–– Sample volume for single test: 3.2 µL (serum/plasma); 1.6 series Operations Manual, Section 5.
µL (urine). Calibration is stable for approximately 30 days (720 hours), but
NOTE: This amount does not include the dead volume is required with each change in reagent lot. Verify calibration with
plus the additional over-aspiration volume. For total sample at least 2 levels of controls according to the established quality
volume requirements, refer to the Alinity ci-series Operations control requirements for your laboratory. If control results fall outside
Manual, Section 4. acceptable ranges, recalibration may be necessary.
• Refer to the Alinity c Multiconstituent Calibrator Kit package This assay may require recalibration after maintenance to critical
insert and commercially available control material package insert parts or subsystems or after service procedures have been
for preparation and usage. performed.
• For general operating procedures, refer to the Alinity ci-series Quality Control Procedures
Operations Manual, Section 5. As appropriate, refer to your laboratory standard operating
• For optimal performance, it is important to perform routine procedure(s) and/or quality assurance plan for additional quality
maintenance as described in the Alinity ci-series Operations control requirements and potential corrective actions.
Manual, Section 9. Perform maintenance more frequently when • Two levels of controls (normal and abnormal) are to be run every
required by laboratory procedures. 24 hours.
• If more frequent control monitoring is required, follow the
established quality control procedures for your laboratory.

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• If quality control results do not meet the acceptance criteria Urine9
defined by your laboratory, sample results may be suspect. Range (mg/day) Range (mmol/day)
Follow the established quality control procedures for your 24 hour 72.9 to 121.5 3.00 to 5.00
laboratory. Recalibration may be necessary. For troubleshooting
information, refer to the Alinity ci-series Operations Manual, 24-Hour Urinary Excretion
Section 10. To convert results from mg/dL to mg/day (24-hour urinary excretion):
• Review quality control results and acceptance criteria following a 24-hour excretion = [(V × c) ÷ 100] mg/day
change of reagent or calibrator lot. Where:
Commercial controls should be used according to the guidelines V = 24-hour urine volume (mL)
and recommendations of the control manufacturer. Concentration c = analyte concentration (mg/dL)
ranges provided in the control package insert should be used only for To convert results from mmol/L to mmol/day (24-hour urinary
guidance. excretion):
For any control material in use, the laboratory should ensure that the 24-hour excretion = [(V × c) ÷ 1000] mmol/day
matrix of the control material is suitable for use in the assay per the
Where:
assay package insert.
V = 24-hour urine volume (mL)
Quality Control Guidance
c = analyte concentration (mmol/L)
Refer to “Basic QC Practices” by James O Westgard, Ph.D. for
guidance on laboratory quality control practices.8 ll
SPECIFIC PERFORMANCE CHARACTERISTICS
Verification of Assay Claims Representative performance data are provided in this section.
For protocols to verify package insert claims, refer to Verification of Results obtained in individual laboratories may vary.
Assay Claims in the Alinity ci-series Operations Manual. The Alinity c analyzer and the ARCHITECT c System utilize the same
reagents and sample/reagent ratios.
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RESULTS
Unless otherwise specified, all studies were performed on the Alinity
Calculation c analyzer.
The Alinity c Magnesium assay utilizes the Linear data reduction
Precision
method to generate a calibration and results.
Within-Laboratory Precision
For information on alternate result units, refer to the INSTRUMENT
Serum/Plasma
PROCEDURE, Alternate Result Units section of this package insert.
A study was performed based on guidance from CLSI EP05-A2.
Flags Testing was conducted using 1 lot of the Alinity c Magnesium
Some results may contain information in the Flags field. For a Reagent Kit, 1 lot of the Alinity c Multiconstituent Calibrator Kit, 1 lot
description of the flags that may appear in this field, refer to the of commercially available controls, and 1 instrument. Three control
Alinity ci-series Operations Manual, Section 5. levels were assayed in a minimum of 2 replicates at 2 separate
Measuring Interval times per day on 20 different days.10
Measuring interval is defined as the range of values in mg/dL Within-Run Within-Laboratory
(mmol/L) which meets the limits of acceptable performance for Mean (Repeatability) (Total)a
linearity, imprecision, and bias. Sample n (mg/dL) SD %CV SD %CV
The measuring interval of the Alinity c Magnesium assay is Control Level 1 120 1.37 0.019 1.4 0.029 2.1
0.60 mg/dL to 9.50 mg/dL (0.25 mmol/L to 3.90 mmol/L) for Control Level 2 120 2.22 0.019 0.8 0.032 1.4
the serum/plasma application and 1.81 mg/dL to 26.35 mg/dL Control Level 3 120 3.88 0.026 0.7 0.050 1.3
(0.74 mmol/L to 10.83 mmol/L) for the urine application. a Includes within-run, between-run, and between-day variability.
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LIMITATIONS OF THE PROCEDURE Within-Run
(Repeatability)
Within-Laboratory
(Total)a
• The Magnesium assay is susceptible to interference from Mean
Sample n (mmol/L) SD %CV SD %CV
hemoglobin. Refer to the Interference section of this package
insert for additional details. Control Level 1 120 0.56 0.009 1.6 0.013 2.3
Control Level 2 120 0.91 0.008 0.9 0.013 1.4
• Acetic acid, nitric acid, and sodium fluoride interfere with
magnesium results and should not be used as urine Control Level 3 120 1.59 0.011 0.7 0.021 1.3
a Includes within-run, between-run, and between-day variability.
preservatives.
• Do not use more than 2.5 mL 6N HCl per 100 mL of urine. Urine
Excess hydrochloric acid may cause elevated results with this A study was performed based on guidance from CLSI EP05-A2.
methodology. Testing was conducted using 1 lot of the Alinity c Magnesium
• Do not exceed 10 g/L boric acid. Reagent Kit, 1 lot of the Alinity c Multiconstituent Calibrator Kit, 1
Refer to the SPECIMEN COLLECTION AND PREPARATION FOR lot of commercially available controls, and 1 instrument. Two control
ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS levels were assayed in a minimum of 2 replicates at 2 separate
sections of this package insert. times per day on 20 different days.10

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EXPECTED VALUES
Mean
Within-Run
(Repeatability)
Within-Laboratory
(Total)a
It is recommended that each laboratory determine its own reference Sample n (mg/dL) SD %CV SD %CV
range based upon its particular locale and population characteristics. Control Level 1 120 6.35 0.062 1.0 0.107 1.7
Serum/Plasma9 Control Level 2 120 10.75 0.077 0.7 0.168 1.6
Range (mg/dL) Range (mmol/L) a Includes within-run, between-run, and between-day variability.
Newborn, 2 to 4 days 1.5 to 2.2 0.62 to 0.91
Within-Run Within-Laboratory
5 months to 6 years 1.7 to 2.3 0.70 to 0.95 (Repeatability) (Total)a
Mean
6 to 12 years 1.7 to 2.1 0.70 to 0.86 Sample n (mmol/L) SD %CV SD %CV
12 to 20 years 1.7 to 2.2 0.70 to 0.91 Control Level 1 120 2.61 0.026 1.0 0.044 1.7
Adult 1.6 to 2.6 0.66 to 1.07 Control Level 2 120 4.42 0.032 0.7 0.069 1.6
NOTE: Higher values can be expected in females during menses. a Includes within-run, between-run, and between-day variability.

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Accuracy Serum
This study was performed on the ARCHITECT c System. Potentially Interferent Level Magnesium Level
Representative data from serum studies using NIST SRM 956 Interfering Target
standards are summarized below. Substance Default Units Alternate Units (mg/dL) % Difference
Level 1 Level 2 Level 3 Ascorbic Acid 3.0 mg/dL 0.170 mmol/L 2.1 1.37
Target (mg/dL) 3.031 2.084 1.143 3.0 mg/dL 0.170 mmol/L 4.0 0.36
3.0 mg/dL 0.170 mmol/L 6.4 0.18
N 7 7 7
Bilirubin, 55.3 mg/dL 945.6 µmol/L 1.9 1.68
Concentration (mg/dL) 3.013 2.067 1.119 Conjugated 55.9 mg/dL 955.9 µmol/L 3.6 -2.33
% Bias -0.6 -0.8 -2.1 56.5 mg/dL 966.2 µmol/L 5.7 1.40
Bilirubin, 60.3 mg/dL 1031.1 µmol/L 2.0 1.52
Lower Limits of Measurement Unconjugated 60.5 mg/dL 1034.6 µmol/L 3.7 0.65
A study was performed based on guidance from CLSI EP17-A2. 60.9 mg/dL 1041.4 µmol/L 6.0 1.65
Testing was conducted using 3 lots of the Alinity c Magnesium
Calcium 28.0 mg/dL 7 mmol/L 2.0 2.70
Reagent Kit on each of 2 instruments over a minimum of 3 days. The 28.0 mg/dL 7 mmol/L 3.8 3.86
maximum observed Limit of Blank (LoB), Limit of Detection (LoD) 28.0 mg/dL 7 mmol/L 6.1 3.94
and Limit of Quantitation (LoQ) values are reported in the table.11 Copper 6.5 µg/mL 102.29 µmol/L 2.0 0.40
Serum/Plasma 6.5 µg/mL 102.29 µmol/L 4.0 -0.30
mg/dL mmol/L 6.5 µg/mL 102.29 µmol/L 6.3 0.63
LoBa 0.08 0.03 Glucose 1240 mg/dL 68.82 mmol/L 2.1 -0.46
LoDb 0.11 0.05 1311 mg/dL 72.76 mmol/L 4.0 -0.44
LoQc 0.17 0.07 1199 mg/dL 66.54 mmol/L 6.4 -0.54
Hemoglobin 250 mg/dL 2.5 g/L 2.1 5.24
a The LoB represents the 95th percentile from n ≥ 60 replicates of 1000 mg/dL 10.0 g/L 3.9 6.50
zero-analyte samples. 1200 mg/dL 12.0 g/L 6.4 6.66
b The LoD represents the lowest concentration at which the analyte
Intralipid 2476 mg/dL 24.76 g/L 2.0 1.36
can be detected with 95% probability based on n ≥ 60 replicates of 2471 mg/dL 24.71 g/L 3.7 0.38
low-analyte level samples. 2482 mg/dL 24.82 g/L 6.1 -2.69
c The LoQ was determined from n ≥ 60 replicates of low-analyte Iron 641 µg/dL 114.78 µmol/L 2.0 0.80
level samples and is defined as the lowest concentration at which a 641 µg/dL 114.78 µmol/L 4.0 -0.22
total allowable error of 15% or 0.3 mg/dL was met. 641 µg/dL 114.78 µmol/L 6.4 -0.92
Urine L-Dopamine 5.0 mg/dL 0.255 mmol/L 2.1 1.83
5.0 mg/dL 0.255 mmol/L 4.0 1.10
mg/dL mmol/L
5.0 mg/dL 0.255 mmol/L 6.4 1.85
LoBa 0.10 0.04
Triglyceride 3647 mg/dL 41.21 mmol/L 2.0 -2.04
LoDb 0.25 0.10 3598 mg/dL 40.66 mmol/L 4.0 -1.60
LoQc 1.68 0.69 3580 mg/dL 40.45 mmol/L 5.8 -0.47
a The LoB represents the 95th percentile from n ≥ 60 replicates of Zinc 4.3 µg/mL 65.77 µmol/L 2.0 -0.54
zero-analyte samples. 4.3 µg/mL 65.77 µmol/L 4.1 0.52
b The LoD represents the lowest concentration at which the analyte 4.3 µg/mL 65.77 µmol/L 6.4 0.67
can be detected with 95% probability based on n ≥ 60 replicates of Drug Interference
low-analyte level samples. The following drugs were tested for interference at the concentrations
c The LoQ was determined from n ≥ 60 replicates of low-analyte
indicated using an acceptance criteria of ± 7.5% from the target
level samples and is defined as the lowest concentration at which a value.
total allowable error of 22% was met. Interferent Level Magnesium Level
Potentially
Linearity Interfering Target
A study was performed based on guidance from CLSI EP06-A.12 Substance Default Units Alternate Units (mg/dL) % Difference
This assay is linear across the measuring interval of 0.60 mg/dL Acetaminophen 241 µg/mL 1592 µmol/L 1.9 0.75
to 9.50 mg/dL (0.25 mmol/L to 3.90 mmol/L) for the serum/ 241 µg/mL 1592 µmol/L 3.6 0.05
241 µg/mL 1592 µmol/L 5.8 0.54
plasma application and 1.81 mg/dL to 26.35 mg/dL (0.74 mmol/L to
10.83 mmol/L) for the urine application. Ibuprofen 601 µg/mL 2915 µmol/L 1.8 1.03
601 µg/mL 2915 µmol/L 3.6 1.05
Interference 601 µg/mL 2915 µmol/L 5.8 0.74
This study was performed on the ARCHITECT c System. Salicylic Acid 71.96 mg/dL 5.21 mmol/L 1.8 1.63
Potentially Interfering Substances 71.96 mg/dL 5.21 mmol/L 3.7 0.68
A study was performed based on guidance from CLSI EP07-A2.13 71.96 mg/dL 5.21 mmol/L 5.8 0.67
Representative results are summarized below. Interference Sulfapyridine 300 mg/L 1.20 mmol/L 1.5 -0.40
effects were assessed by Dose Response and Paired Difference Sulfasalazine 300 mg/L 0.754 mmol/L 1.5 1.50
methods. The following interference substances were tested at the Temozolomide 20 mg/L 0.10 mmol/L 3.5 0.26
concentrations indicated using an acceptance criteria of ± 7.5% from 20 mg/L 0.10 mmol/L 7.5 -1.11
the target value. Values in the table represent the highest levels of
Sulfapyridine and sulfasalazine solutions were prepared by addition
interferents that met the acceptance criteria at various magnesium
of the interfering substances to human serum pool. Temozolomide
concentrations.
was evaluated in human plasma.

5
Urine ll
BIBLIOGRAPHY
Studies were conducted on the ARCHITECT cSystem based 1. US Department of Labor, Occupational Safety and Health
on guidance from CLSI EP07-A2.13 Representative results are Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
summarized below. Interference effects were assessed by Dose 2. US Department of Health and Human Services. Biosafety in
Response and Paired Difference methods. The following interference Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
US Government Printing Office; December 2009.
substances were tested at the concentrations indicated using
3. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
an acceptance criteria of ± 10% from the target value. Values in Geneva: World Health Organization; 2004.
the table represent the highest levels of interferents that met the 4. Clinical and Laboratory Standards Institute (CLSI). Protection
acceptance criteria at various magnesium concentrations. of Laboratory Workers From Occupationally Acquired Infections;
Interferent Level Magnesium Level Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
Potentially PA: CLSI; 2014.
Interfering Target
5. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical
Substance Default Units Alternate Units (mg/dL) % Difference
Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Elsevier
Albumin 64.0 mg/dL 640 mg/L 4.6 1.09 Saunders; 2006:1912.
64.0 mg/dL 640 mg/L 13.8 1.24 6. Guder WG, Narayanan S, Wisser H, et al. List of analytes—
Ascorbic Acid 200 mg/dL 2000 mg/L 4.9 0.76 preanalytical variables. Annex In: Samples: From the Patient to the
200 mg/dL 2000 mg/L 15.2 1.84 Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 18–9,
Bilirubin, 59.9 mg/dL 1024.3 µmol/L 4.3 -0.68 38–9.
Conjugated 59.5 mg/dL 1017.5 µmol/L 13.4 -2.41 7. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Calcium 26.0 mg/dL 6.5 mmol/L 4.9 2.39
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
27.0 mg/dL 6.8 mmol/L 15.0 3.63
8. Westgard JO. Basic QC Practices. 3rd ed. Madison, WI: Westgard
Copper 21.6 µg/dL 3.4 µmol/L 5.1 -0.08 Quality Corporation; 2010.
21.6 µg/dL 3.4 µmol/L 14.5 0.20 9. Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th ed.
Glucose 1220 mg/dL 67.71 mmol/L 5.1 -0.92 Philadelphia, PA: WB Saunders; 2006:706-708.
1237 mg/dL 68.65 mmol/L 15.6 3.04 10. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
Hemoglobin 1200 mg/dL 12.00 g/L 5.2 4.36 Precision Performance of Quantitative Measurement Methods;
1200 mg/dL 12.00 g/L 15.9 2.10 Approved Guideline—Second Edition. CLSI Document EP05-A2.
Wayne, PA: CLSI; 2004.
Phosphorus 307 mg/dL 99 mmol/L 4.5 -0.65
11. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
313 mg/dL 101 mmol/L 14.1 -0.26 Detection Capability for Clinical Laboratory Measurement Procedures;
Zinc 3504 µg/L 54 µmol/L 5.1 0.33 Approved Guideline—Second Edition. CLSI Document EP17-A2.
3504 µg/L 54 µmol/L 14.6 0.03 Wayne, PA: CLSI; 2012.
Interferent Level Magnesium Level 12. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
the Linearity of Quantitative Measurement Procedures: A Statistical
Target Approach; Approved Guideline. CLSI Document EP06-A. Wayne, PA:
Preservatives Default Units Alternate Units (mg/dL) % Difference CLSI; 2003.
Boric Acid 1000 mg/dL 10 g/L 4.8 0.07 13. Clinical and Laboratory Standards Institute (CLSI). Interference
1000 mg/dL 10 g/L 10.3 -0.63 Testing in Clinical Chemistry; Approved Guideline—Second Edition.
6N HCl 3.0 mL/dL 180 mmol/L 3.1 8.70 CLSI Document EP07-A2. Wayne, PA: CLSI; 2005.
3.0 mL/dL 180 mmol/L 9.4 8.76 14. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-410–3-414.
Urine samples at the above concentrations were prepared by 15. Clinical and Laboratory Standards Institute (CLSI). Measurement
addition of the interfering substances to human urine pools. Procedure Comparison and Bias Estimation Using Patient Samples;
NOTE: Acetic acid, nitric acid, and sodium fluoride interfere with Approved Guideline—Third Edition. CLSI Document EP09-A3. Wayne,
PA: CLSI; 2013.
magnesium results and should not be used as urine preservatives.
Note for number formatting:
Interferences from medication or endogenous substances may affect
• A space is used as thousands separator (example: 10 000
results.14
specimens).
Method Comparison • A period is used to separate the integer part from the fractional
A study was performed based on guidance from CLSI EP09-A3 using part of a number written in decimal form (example: 3.12%).
the Passing-Bablok regression method.15
In addition, serum/plasma results from the ARCHITECT Magnesium
were compared with Atomic Absorption Spectroscopy (AAS).
Correlation Concentration
Units n Coefficient Intercept Slope Range
Alinity c Serum mg/dL 122 1.00 -0.03 1.01 0.77-9.32
Magnesium vs mmol/L 122 1.00 -0.01 1.01 0.32-3.83
ARCHITECT
Magnesium Urine mg/dL 43 1.00 -0.03 0.99 2.08-24.10
mmol/L 43 1.00 -0.01 0.99 0.86-9.90
ARCHITECT Serum/ mg/dL 47 0.996 -0.19 1.0 1.00-5.00
Magnesium vs. Plasma
AAS

6
ll
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Contains Sodium Azide. Contact
with acids liberates very toxic
gas.
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Reagent 1
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For use by or on the order of a
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