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Uric Acid
08P56
Uric Acid Reagent Kit G71317R05
B8P560
Read Highlighted Changes: Revised December 2017.

08P5620
08P5630
Instructions must be carefully followed. Reliability of assay results
08P5620 08P5630
cannot be guaranteed if there are any deviations from these
instructions. 39.5 mL 63.4 mL

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NAME 15.7 mL 24.0 mL
Alinity c Uric Acid Reagent Kit Active ingredients: ascorbic oxidase 3500 U/L, HMMPS
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INTENDED USE 100 mmol/L. Preservative: methylchloroisothiazolinone 0.02 %.
The Alinity c Uric Acid assay is used for the quantitation of uric acid Active ingredients: 4-aminoantipyrine 4 mmol/L,
in human serum, plasma, or urine on the Alinity c analyzer. peroxidase 2000 U/L, and uricase 880 U/L. Preservative:
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SUMMARY AND EXPLANATION OF THE TEST methylchloroisothiazolinone 0.02 %.
Uric acid is a metabolite of purines, nucleic acids, and Warnings and Precautions
nucleoproteins. Consequently, abnormal levels may be indicative of •
a disorder in the metabolism of these substances. Hyperuricemia • For In Vitro Diagnostic Use
may be observed in renal dysfunction, gout, leukemia, polycythemia,
•
atherosclerosis, diabetes, hypothyroidism, or in some genetic
diseases. Decreased levels are present in patients with Wilson’s Safety Precautions
disease.1, 2 CAUTION: This product requires the handling of human specimens.
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PRINCIPLES OF THE PROCEDURE It is recommended that all human-sourced materials be considered
potentially infectious and handled in accordance with the OSHA
The Uric Acid assay is a two-part reaction. Uric acid is oxidized to
Standard on Bloodborne Pathogens. Biosafety Level 2 or other
allantoin by uricase with production of hydrogen peroxide (H2O2).
appropriate biosafety practices should be used for materials that
The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-
contain or are suspected of containing infectious agents.3-6
sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) in the presence
of peroxidase (POD) to yield a quinoneimine dye. The resulting The following warnings and precautions apply to:
change in absorbance at 604 nm is proportional to the uric acid
concentration in the sample.
The two-part ( / ) configuration of this assay allows reduction of
interference from ascorbic acid by inclusion of ascorbic oxidase in
the portion of the assay.1 DANGER Contains boric acid and
methylchloroisothiazolinone.
Uricase
H317 May cause an allergic skin reaction.
Uric
+ O2 + 2H2O Allantoin + CO2 + H2O2 H360 May damage fertility or the unborn child.
acid
H316* Causes mild skin irritation.
POD Prevention
H2O2 + 4-AAP + HMMPS Quinoneimine dye P201 Obtain special instructions before use.
P261 Avoid breathing mist / vapors / spray.
Methodology: Uricase P280 Wear protective gloves / protective
For additional information on system and assay technology, refer to clothing / eye protection.
the Alinity ci-series Operations Manual, Section 3. P272 Contaminated work clothing should not be
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REAGENTS allowed out of the workplace.
Kit Contents Response
Alinity c Uric Acid Reagent Kit 08P56 P308+P313 IF exposed or concerned: Get medical
advice / attention.
NOTE: Some kit sizes are not available in all countries. Please
P302+P352 IF ON SKIN: Wash with plenty of water.
contact your local distributor.
P333+P313 If skin irritation or rash occurs: Get
Volumes (mL) listed in the table below indicate the volume per
medical advice / attention.
cartridge.
P362+P364 Take off contaminated clothing and wash
08P5620 08P5630 it before reuse.
Tests per cartridge 300 500 Disposal
Number of cartridges per kit 4 10 P501 Dispose of contents / container in
Tests per kit 1200 5000 accordance with local regulations.
* Not applicable where regulation EU 1272/2008 (CLP) or OSHA
Hazard Communication 29CFR 1910.1200 (HCS) 2012 have been
implemented.

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 Indications of Reagent Deterioration
The following warnings and precautions apply to:
Deterioration of the reagents may be indicated when a calibration
error occurs or a control value is out of the specified range.
Associated test results are invalid, and samples must be retested.
Assay recalibration may be necessary.
WARNING Contains methylchloroisothiazolinone. For troubleshooting information, refer to the Alinity ci-series
H317 May cause an allergic skin reaction. Operations Manual, Section 10.
Prevention ll
INSTRUMENT PROCEDURE
P261 Avoid breathing mist / vapors / spray. The Alinity c Uric Acid assay file must be installed on the Alinity c
P272 Contaminated work clothing should not be analyzer prior to performing the assay.
allowed out of the workplace. For detailed information on assay file installation and viewing and
P280 Wear protective gloves / protective editing assay parameters, refer to the Alinity ci-series Operations
clothing / eye protection. Manual, Section 2.
Response For information on printing assay parameters, refer to the Alinity ci-
P302+P352 IF ON SKIN: Wash with plenty of water. series Operations Manual, Section 5.
P333+P313 If skin irritation or rash occurs: Get For a detailed description of system procedures, refer to the Alinity
medical advice / attention. ci-series Operations Manual.
P362+P364 Take off contaminated clothing and wash
Alternate Result Units
it before reuse.
Edit assay parameter "Result Units" to select an alternate unit.
Disposal
Conversion formula:
P501 Dispose of contents / container in
accordance with local regulations. (Concentration in Default result unit) x (Conversion factor) =
(Concentration in Alternate result unit)
Safety Data Sheets are available at www.abbottdiagnostics.com or Default Result Unit Conversion Factor Alternate Result Unit
contact your local representative. mg/dL 0.059 mmol/L
For a detailed discussion of safety precautions during system
operation, refer to the Alinity ci-series Operations Manual, Section 8. ll
SPECIMEN COLLECTION AND PREPARATION
Reagent Handling FOR ANALYSIS
• Upon receipt, place reagent cartridges in an upright position for Specimen Types
8 hours before use to allow bubbles that may have formed to The specimen types listed below were verified for use with this
dissipate. assay.
• If a reagent cartridge is dropped, place in an upright position for Other specimen types, collection tube types, and anticoagulants
8 hours before use to allow bubbles that may have formed to have not been verified with this assay.
dissipate.
Specimen Type Collection Vessel Special Conditions
• Reagents are susceptible to the formation of foam and bubbles.
Serum Serum tubes (with
Bubbles may interfere with the detection of the reagent level in
or without gel
the cartridge and cause insufficient reagent aspiration that may
barrier)
adversely affect results.
Plasma Collection tubes
For a detailed discussion of reagent handling precautions during
Acceptable
system operation, refer to the Alinity ci-series Operations Manual,
anticoagulants are:
Section 7.
Lithium heparin
Reagent Storage (with or without gel
Storage Maximum Additional Storage barrier)
Temperature Storage Time Instructions Sodium heparin
Unopened 2 to 8°C Until Store in upright position. Urine (random Clean plastic or 24-hour timed urine
expiration specimens or glass container with specimens are preferred.
date timed specimens preservatives Adjust the specimen pH to
Onboard System 60 days collected over > 8.0 by dropwise addition
Temperature intervals shorter of sodium hydroxide
Opened 2 to 8°C Until Store in upright position. than 24 hours) [500 g/L (12.5N)]. Check
expiration Do not reuse original the pH often during
date reagent caps or the addition of sodium
replacement caps due to hydroxide to the specimen.
the risk of contamination Urine (24 hour) Clean plastic or To adjust the pH and
and the potential to glass container with prevent urate precipitation,
compromise reagent preservatives add 10 mL of sodium
performance. hydroxide [500 g/L
Reagents may be stored on or off the system. If removed from the (12.5N)] to the collection
system, store reagents with new replacement caps in an upright bottle before collection of
position at 2 to 8°C. For reagents stored off the system, it is the specimen.7
recommended that they be stored in their original trays or boxes to • The instrument does not provide the capability to verify specimen
ensure they remain upright. types. It is the responsibility of the operator to verify that the
For information on unloading reagents, refer to the Alinity ci-series correct specimen types are used in the assay.
Operations Manual, Section 5.

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Specimen Conditions Assay Procedure
• For accurate results, serum and plasma specimens should be For a detailed description of how to run an assay, refer to the Alinity
free of fibrin, red blood cells, and other particulate matter. Serum ci-series Operations Manual, Section 5.
specimens from patients receiving anticoagulant or thrombolytic • If using primary or aliquot tubes, refer to the Alinity ci-series
therapy may contain fibrin due to incomplete clot formation. Operations Manual, Section 4 to ensure sufficient specimen is
• For accurate results, plasma specimens should be free of present.
platelets and other particulate matter. Ensure centrifugation is • To minimize the effects of evaporation, verify adequate sample
adequate to remove platelets. cup volume is present prior to running the test.
• To prevent cross contamination, use of disposable pipettes or • Minimum sample volume requirements:
pipette tips is recommended. –– Sample volume for single test: 3.0 µL (serum/plasma);
Preparation for Analysis 20.0 µL (urine).
• Follow the tube manufacturer’s processing instructions for NOTE: This amount does not include the dead volume
collection tubes. Gravity separation is not sufficient for specimen plus the additional over-aspiration volume. For total sample
preparation. volume requirements, refer to the Alinity ci-series Operations
• Specimens should be free of bubbles. Remove bubbles with an Manual, Section 4.
applicator stick before analysis. Use a new applicator stick for • Refer to the Alinity c Multiconstituent Calibrator Kit package
each specimen to prevent cross-contamination. insert and commercially available control material package insert
To ensure consistency in results, recentrifuge specimens prior to for preparation and usage.
testing if • For general operating procedures, refer to the Alinity ci-series
• they contain fibrin, red blood cells, or other particulate matter. Operations Manual, Section 5.
NOTE: If fibrin, red blood cells, or other particulate matter are • For optimal performance, it is important to perform routine
observed, mix by low speed vortex or by inverting 10 times prior to maintenance as described in the Alinity ci-series Operations
recentrifugation. Manual, Section 9. Perform maintenance more frequently when
Specimen Storage required by laboratory procedures.
Specimen Type Temperature Maximum Storage Time Sample Dilution Procedures
Serum/Plasma 20 to 25°C 3 days8 Serum/Plasma
Samples with a uric acid value exceeding 33.1 mg/dL (1.95 mmol/L)
2 to 8°C 7 days8, 9
are flagged with the code "> 33.1 mg/dL" (1.95 mmol/L) and may
-20°C 6 months8 be diluted with either the Automated Dilution Protocol or the Manual
Urine 20 to 25°C 4 days at pH > 88 Dilution Procedure.
2 to 8°C no recommendation8, 9 Urine
Urine samples are diluted 1:5 by the system using the Standard
-20°C unstable8
dilution option, then the system corrects the concentration by
Avoid multiple freeze/thaw cycles. multiplying the result by the dilution factor. Urine samples with values
Guder et al. suggest storage of frozen specimens at -20°C for no exceeding 250.0 mg/dL (14.75 mmol/L) are flagged with the code
longer than the time intervals cited above.8 "> 250.0 mg/dL" (14.75 mmol/L) and may be diluted with either the
Automated Dilution Protocol or the Manual Dilution Procedure.
Each laboratory may establish a range around -20°C from either the
freezer manufacturer’s specifications or your laboratory standard Automated Dilution Protocol
operating procedure(s) for specimen storage. If using an automated dilution protocol, the system performs a dilution
Stored specimens must be inspected for particulates. If present, mix of the sample and automatically calculates the concentration by
with a low speed vortex or by inversion and centrifuge the specimen multiplying the result by the dilution factor. For details on configuring
to remove particulates prior to testing. automated dilutions, refer to the Alinity ci-series Operations Manual,
Section 2.
Specimen Shipping Manual Dilution Procedure
Package and label specimens in compliance with applicable state, Dilute the sample with saline (0.85% to 0.90% NaCl).
federal, and international regulations covering the transport of clinical
The operator must enter the dilution factor in the Specimen or
specimens and infectious substances.
Control tab of the Create Order screen. The system will use this
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PROCEDURE dilution factor to automatically calculate the concentration of the
Materials Provided sample and report the result.
08P56 Alinity c Uric Acid Reagent Kit If the operator does not enter the dilution factor, the result must be
manually multiplied by the appropriate dilution factor before reporting
Materials Required but not Provided the result. If a diluted sample result is less than the lower value of
• Alinity c Uric Acid assay file the measuring interval of 1.0 mg/dL (0.059 mmol/L) for the serum/
• 08P6001 Alinity c Multiconstituent Calibrator Kit plasma application and 5.0 mg/dL (0.295 mmol/L) for the urine
• Commercially available controls containing uric acid application, do not report the result. Rerun using an appropriate
• Saline (0.85% to 0.90% NaCl) for specimen dilution 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,
refer to the Alinity ci-series Operations Manual, Section 9.

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Calibration N-Acetyl-4-benzoquinone Imine (NAPQI), a metabolite of
For instructions on performing a calibration, refer to the Alinity ci- Acetaminophen at very high levels may lead to falsely low results.
series Operations Manual, Section 5. N-Acetyl-L-Cysteine at therapeutically achieved concentrations may
Calibration is stable for approximately 60 days (1440 hours), but lead to falsely low results.
is required with each change in reagent lot. Verify calibration with
at least 2 levels of controls according to the established quality
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EXPECTED VALUES
It is recommended that each laboratory determine its own reference
control requirements for your laboratory. If control results fall outside
range based upon its particular locale and population characteristics.
acceptable ranges, recalibration may be necessary.
Reference Range11
This assay may require recalibration after maintenance to critical
parts or subsystems or after service procedures have been Serum/Plasma
performed. Range (mg/dL) Range (mmol/L)
Adult, Male 3.5 to 7.2 0.21 to 0.42
Quality Control Procedures
Adult, Female 2.6 to 6.0 0.15 to 0.35
As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality To convert results from mg/dL to mmol/L, multiply mg/dL by 0.059.
control requirements and potential corrective actions. Urine
• Two levels of controls (normal and abnormal) are to be run every Range (mg/day) Range (mmol/day)
24 hours. Purine-free diet
• If more frequent control monitoring is required, follow the Male < 420 < 2.48
established quality control procedures for your laboratory. Female slightly lower slightly lower
• If quality control results do not meet the acceptance criteria Low purine diet
defined by your laboratory, sample results may be suspect. Follow Male < 480 < 2.83
the established quality control procedures for your laboratory. Female < 400 < 2.36
Recalibration may be necessary. For troubleshooting information, High purine diet < 1000 < 5.90
refer to the Alinity ci-series Operations Manual, Section 10. Average diet 250 to 750 1.48 to 4.43
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot. NOTE: Reference ranges provided are for 24 hour excretion.
Commercial controls should be used according to the guidelines To convert results from mg/day to mmol/day, multiply mg/day by
and recommendations of the control manufacturer. Concentration 0.0059.
ranges provided in the control package insert should be used only for 24-Hour Urinary Excretion
guidance. To convert results from mg/dL to mg/day (24-hour urinary excretion):
For any control material in use, the laboratory should ensure that the 24-hour excretion = [(V × c) ÷ 100] mg/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 (mg/dL)
Refer to “Basic QC Practices” by James O Westgard, Ph.D. for To convert results from mmol/L to mmol/day (24-hour urinary
guidance on laboratory quality control practices.10 excretion):
Verification of Assay Claims 24-hour excretion = [(V × c) ÷ 1000] mmol/day
For protocols to verify package insert claims, refer to Verification of Where:
Assay Claims in the Alinity ci-series Operations Manual. V = 24-hour urine volume (mL)
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RESULTS c = analyte concentration (mmol/L)
Calculation ll
SPECIFIC PERFORMANCE CHARACTERISTICS
The Alinity c Uric Acid assay utilizes the Linear data reduction Representative performance data are provided in this section. Results
method to generate a calibration and results. obtained in individual laboratories may vary.
For information on alternate result units, refer to the INSTRUMENT The Alinity c analyzer and the ARCHITECT c System utilize the same
PROCEDURE, Alternate Result Units section of this package insert. reagents and sample/reagent ratios.
Flags Unless otherwise specified, all studies were performed on the Alinity
Some results may contain information in the Flags field. For a c analyzer.
description of the flags that may appear in this field, refer to the Precision
Alinity ci-series Operations Manual, Section 5. Within-Laboratory Precision
Measuring Interval Serum/Plasma
Measuring interval is defined as the range of values in mg/dL A study was performed based on guidance from CLSI EP05-A2.
(mmol/L) which meets the limits of acceptable performance for Testing was conducted using 1 lot of the Alinity c Uric Acid Reagent
linearity, imprecision, and bias. Kit, 1 lot of the Alinity c Multiconstituent Calibrator Kit, and 1 lot
Serum/Plasma of commercially available controls and 1 instrument. Three serum
The measuring interval of the Alinity c Uric Acid assay is 1.0 to controls were assayed in a minimum of 2 replicates at 2 separate
33.1 mg/dL (0.06 to 1.95 mmol/L) for serum/plasma. times per day on 20 different days.12
Urine Within-Run Within-Laboratory
Mean (Repeatability) (Total)a
The measuring interval of the Alinity c Uric Acid assay is 5.0 to
250.0 mg/dL (0.30 to 14.75 mmol/L) for urine. Sample n (mg/dL) SD %CV SD %CV
Control Level 1 119 2.5 0.02 0.9 0.03 1.0
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LIMITATIONS OF THE PROCEDURE Control Level 2 120 6.1 0.03 0.6 0.04 0.7
Refer to the SPECIMEN COLLECTION AND PREPARATION FOR Control Level 3 119 8.3 0.04 0.5 0.07 0.9
ANALYSIS and SPECIFIC PERFORMANCE CHARACTERISTICS a Includes within-run, between-run, and between-day variability.
sections of this package insert.

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 b The LoD represents the lowest concentration at which the analyte
Within-Run Within-Laboratory
Mean (Repeatability) (Total)a can be detected with 95% probability based on n ≥ 60 replicates of
Sample n (mmol/L) SD %CV SD %CV low-analyte level samples.
c The LoQ is defined as the lowest concentration at which a
Control Level 1 119 0.15 0.003 1.7 0.003 2.0
Control Level 2 120 0.36 0.001 0.3 0.001 0.3 maximum total allowable error of ≤ 7.0 mg/dL was met.
d This value represents the observed LoQ on the ARCHITECT
Control Level 3 119 0.49 0.003 0.7 0.005 1.0
a Includes within-run, between-run, and between-day variability. System. The LoQ observed on the Alinity c analyzer supports this
LoQ.
Urine
A study was performed based on guidance from CLSI EP05-A2. Linearity
Testing was conducted using 1 lot of the Alinity c Uric Acid Reagent A study was performed based on guidance from CLSI EP06-A.14
Kit, 1 lot of the Alinity c Multiconstituent Calibrator Kit, and 1 lot of Serum/Plasma
commercially available controls and 1 instrument. Two urine controls This assay is linear across the measuring interval of 1.0 to
and one panel were assayed in a minimum of 2 replicates at 2 33.1 mg/dL (0.06 to 1.95 mmol/L).
separate times per day on 20 different days. Urine
Within-Run Within-Laboratory This assay is linear across the measuring interval of 5.0 to
Mean (Repeatability) (Total)a 250.0 mg/dL (0.30 to 14.75 mmol/L).
Sample n (mg/dL) SD %CV SD %CV
Control Level 1 120 5.6 0.08 1.4 0.09 1.5
Interference
Control Level 2 120 16.6 0.22 1.3 0.37 2.2 This study was performed on the ARCHITECT c System.
Panel 120 9.6 0.14 1.4 0.20 2.0 Potentially Interfering Endogenous Substances
a A study was performed based on guidance from CLSI EP07-A2.15
Includes within-run, between-run, and between-day variability.
Interference effects were assessed by Dose Response and Paired
Within-Run Within-Laboratory
Difference methods at the medical decision level of the analyte.
Mean (Repeatability) (Total)a
Sample n (mmol/L) SD %CV SD %CV A bias of > 7% for serum/plasma and > 10% for urine is considered
significant interference.
Control Level 1 120 0.33 0.005 1.6 0.006 1.7
Control Level 2 120 0.98 0.013 1.3 0.022 2.3 Serum/Plasma
Panel 120 0.57 0.009 1.5 0.012 2.1 Potentially Interfering Interferent Level Target Level Recovery
a Substance Default Units Alternate Units (mg/dL) (% of Target)
Includes within-run, between-run, and between-day variability.
Ascorbate 30 mg/dL 1703 μmol/L 3.4 95.3
Lower Limits of Measurement 30 mg/dL 1703 μmol/L 9.7 97.8
Serum/Plasma Bilirubin 40 mg/dL 684 μmol/L 3.2 93.8
A study was performed based on guidance from CLSI EP17-A2. 60 mg/dL 1026 μmol/L 9.4 98.1
Testing was conducted using 3 lots of the Alinity c Uric Acid Reagent Glucose 1000 mg/dL 55.5 mmol/L 3.0 100.1
Kit on each of 2 instruments over a minimum of 3 days. The Limit 1000 mg/dL 55.5 mmol/L 8.8 100.1
of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation Hemoglobin 2000 mg/dL 20.0 g/L 3.0 101.3
(LoQ) values are summarized below. These representative data 2000 mg/dL 20.0 g/L 8.7 98.6
support the lower limit of the measuring interval.13
Intralipid 750 mg/dL 7.5 g/L 3.1 92.7
mg/dL mmol/L 2000 mg/dL 20.0 g/L 9.1 95.4
LoBa 0.0 0.00
LoDb 0.1 0.01 Ascorbate, glucose, hemoglobin, and Intralipid samples at the
LoQc, d 0.22 0.01 above concentrations were prepared by addition of the interfering
substances to human serum pools. Bilirubin solutions at the above
a The LoB represents the 95th percentile from n ≥ 60 replicates of concentrations were prepared by addition of equal parts conjugated
zero-analyte samples. and unconjugated bilirubin to human serum pools.
b The LoD represents the lowest concentration at which the analyte
The following drugs and metabolites were tested for interference at
can be detected with 95% probability based on n ≥ 60 replicates of the concentrations indicated using an acceptance criteria of ± 7%
low-analyte level samples. from the target value.
c The LoQ is defined as the lowest concentration at which a
Interferent Level Target Level Observed
maximum total allowable error of ≤ 0.3 mg/dL was met. Interfering Substance Default Units Alternate Units (mg/dL) (% of Target)
d This value represents the observed LoQ on the ARCHITECT
Acetaminophen 200 mg/L 1324.5 μmol/L 4.1 99.3
System. The LoQ observed on the Alinity c analyzer supports this Dipyrone 100 mg/L 300.3 μmol/L 4.0 99.9
LoQ. N-Acetyl-L-Cysteine 800 mg/L 4908.0 μmol/L 2.4 90.4
Urine NAPQI 20 mg/L 134.2 μmol/L 4.1 92.1
A study was performed based on guidance from CLSI EP17-A2.
Testing was conducted using 3 lots of the Alinity c Uric Acid Reagent
Kit on each of 2 instruments over a minimum of 3 days. The Limit
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.13
mg/dL mmol/L
LoBa 0.1 0.01
LoDb 0.2 0.01
LoQc, d 2.20 0.13
aThe LoB represents the 95th percentile from n ≥ 60 replicates of
zero-analyte samples.

5
Urine 11. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical
Potentially Interfering Interferent Level Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Elsevier
Substance Target Level Recovery Saunders; 2006:2301.
(Endogenous) Default Units Alternate Units (mg/dL) (% of Target) 12. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
Albumin 50 mg/dL 500 mg/L 13.0 101.2 Precision Performance of Quantitative Measurement Methods;
Approved Guideline—Second Edition. CLSI Document EP05-A2.
50 mg/dL 500 mg/L 26.8 99.1 Wayne, PA: CLSI; 2004.
Ascorbate 200 mg/dL 11 356 μmol/L 13.1 94.9 13. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
200 mg/dL 11 356 μmol/L 28.9 95.8 Detection Capability for Clinical Laboratory Measurement Procedures;
Bilirubin 60 mg/dL 1026 μmol/L 12.5 97.7 Approved Guideline—Second Edition. CLSI Document EP17-A2.
60 mg/dL 1026 μmol/L 31.1 91.4 Wayne, PA: CLSI; 2012.
14. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
Glucose 1000 mg/dL 55.5 mmol/L 13.0 100.1 the Linearity of Quantitative Measurement Procedures: A Statistical
1000 mg/dL 55.5 mmol/L 26.6 99.7 Approach; Approved Guideline. CLSI Document EP06-A. Wayne, PA:
Hemoglobin 2000 mg/dL 20 g/L 13.0 102.4 CLSI; 2003.
2000 mg/dL 20 g/L 29.1 99.1 15. Clinical and Laboratory Standards Institute (CLSI). Interference
Testing in Clinical Chemistry; Approved Guideline—Second Edition.
Potentially Interfering Interferent Level CLSI Document EP07-A2. Wayne, PA: CLSI; 2005.
Substance Target Level Recovery 16. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
(Preservatives) Default Units Alternate Units (mg/dL) (% of Target) Washington, DC: AACC Press; 1995:3-16–3-22.
Boric Acid 1000 mg/dL 162 mmol/L 11.5 101.2 17. Clinical and Laboratory Standards Institute (CLSI). Measurement
1000 mg/dL 162 mmol/L 28.1 99.0 Procedure Comparison and Bias Estimation Using Patient Samples;
2.5N NaOH 1.0 mL/dL 25 mmol/L 12.5 102.5 Approved Guideline—Third Edition. CLSI Document EP09-A3. Wayne,
1.0 mL/dL 25 mmol/L 28.5 99.6 PA: CLSI; 2013.
6N HCL 2.5 mL/dL 150 mmol/L 11.5 97.3
Note for number formatting:
2.5 mL/dL 150 mmol/L 27.7 98.0 • A space is used as thousands separator (example: 10 000
specimens).
Urine samples at the above concentrations were prepared by addition • A period is used to separate the integer part from the fractional
of the interfering substances to human urine pools. part of a number written in decimal form (example: 3.12%).
Interferences from medication or endogenous substances may affect
results.16 ll
Key to Symbols
ISO 15223 Symbols
Method Comparison
Consult instructions for use
A study was performed based on guidance from CLSI EP09-A3 using
the Passing-Bablok regression method.17 Manufacturer
Correlation Concentration
Units n Coefficient Intercept Slope Range
Alinity c Uric Serum mg/dL 132 1.00 0.05 1.00 2.3 - 32.5 Sufficient for
Acid vs. mmol/L 132 1.00 0.00 1.00 0.14 - 1.92
ARCHITECT Temperature limitation
Uric Acid
Alinity c Uric Urine mg/dL 101 1.00 0.15 0.99 5.3 - 229.7
Acid vs. mmol/L 101 1.00 0.01 0.99 0.31 - 13.56 Use by/Expiration date
ARCHITECT
Uric Acid
In Vitro Diagnostic Medical
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BIBLIOGRAPHY Device
1. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical Lot Number
Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Elsevier
Saunders; 2006:803-808. List Number
2. Wu A, editor. Tietz Clinical Guide to Laboratory Tests, 4th ed. St. Serial number
Louis, MO: Elsevier Saunders; 2006:1098-1099.
3. US Department of Labor, Occupational Safety and Health Other Symbols
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens. Distributed in the USA by
4. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. 5th ed. Washington, DC: Information needed for United
US Government Printing Office; December 2009. States of America only
5. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Produced for Abbott by
Geneva: World Health Organization; 2004.
6. Clinical and Laboratory Standards Institute (CLSI). Protection Product of Japan
of Laboratory Workers From Occupationally Acquired Infections; Reagent 1
Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
PA: CLSI; 2014. Reagent 2
7. Kaplan LA, Pesce AJ, editors. Clinical Chemistry Theory, Analysis,
For use by or on the order of a
and Correlation, 3rd ed. St Louis, MO: CV Mosby; 1996:501–502.
8. Guder WG, Wollheim F, et al. The Quality of Diagnostic Samples, 1st physician only (applicable to USA
ed. Darmstadt, Germany: GIT Verlag GMBH; 2001:48,52. classification only).
9. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary. 1995 ed (USP 23/NF18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
10. Westgard JO. Basic QC Practices. 3rd ed. Madison, WI: Westgard
Quality Corporation; 2010.

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