URIC ACID

7D76-20
30-3142/R3

URIC ACID
This package insert contains information to run the Uric Acid assay on the ARCHITECT c Systems™ and the
AEROSET System.

NOTE: Changes Highlighted

NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be followed
accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in
this package insert.

Customer Support
United States: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative

Symbols in Product Labeling

Calibrators 1 and 2 Catalog number/List number

Concentration Serial number

Authorized Representative in the
Consult instructions for use
European Community

Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

Reagent 1

ABBOTT LABORATORIES ABBOTT

Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
September 2006
©2002, 2006 Abbott Laboratories

1
NAME SPECIMEN COLLECTION AND HANDLING
URIC ACID Suitable Specimens
Serum, plasma, and urine are acceptable specimens.
INTENDED USE
• Serum: Use serum collected by standard venipuncture techniques
The Uric Acid assay is used for the quantitation of uric acid in human
into glass or plastic tubes with or without gel barriers. Ensure
serum, plasma, or urine.
complete clot formation has taken place prior to centrifugation.
Separate serum from red blood cells or gel as soon after collection
SUMMARY AND EXPLANATION OF TEST as possible.
Uric acid is a metabolite of purines, nucleic acids, and nucleoproteins. Some specimens, especially those from patients receiving
Consequently, abnormal levels may be indicative of a disorder in the anticoagulant or thrombolytic therapy, may take longer to complete
metabolism of these substances. Hyperuricemia may be observed their clotting processes. Fibrin clots may subsequently form in these
in renal dysfunction, gout, leukemia, polycythemia, atherosclerosis, sera and the clots could cause erroneous test results.
diabetes, hypothyroidism, or in some genetic diseases. Decreased
levels are present in patients with Wilson’s disease.1,2 • Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
PRINCIPLES OF PROCEDURE heparin (with or without gel barrier) and sodium heparin. Ensure
centrifugation is adequate to remove platelets. Separate plasma from
The Uric Acid assay is based on the methods of Trivedi and red blood cells or gel as soon after collection as possible.
Kabasakalian.3,4 Uric acid is oxidized to allantoin by uricase with
the production of hydrogen peroxide (H2O2). The H2O2 reacts with • Urine: 24 hour urine specimens are preferred. To prevent urate
4-aminoantipyrine (4-AAP) and 2,4,6-tribromo-3-hydroxy benzoic acid precipitation and adjust the pH, add 10 mL of sodium hydroxide
(TBHB) in the presence of peroxidase to yield a quinoneimine dye. [500 g/L (12.5 N)] to the collection bottle before collection of the
The resulting change in absorbance at 548 nm is proportional to the specimen.9
uric acid concentration in the sample. Random specimens or specimens timed over shorter intervals are also
Methodology: Uricase acceptable for analysis. Adjust the specimen pH to > 8.0 by dropwise
addition of sodium hydroxide [500 g/L (12.5 N)]. Check the pH often
REAGENTS during the addition of sodium hydroxide to the specimen.
NOTE: Reference ranges provided are for 24 hour excretion.
Reagent Kit
7D76 Uric Acid is supplied as a liquid, ready-to-use, single reagent Refer to specimen collection tube manufacturer’s instructions for
kit which contains: processing and handling requirements.
For total sample volume requirements, refer to the instrument-specific
10 x 84 mL ASSAY PARAMETERS section of this package insert and Section 5 of
Estimated tests per kit: 4,497 the instrument-specific operations manual.
Calculation is based on the minimum reagent fill volume per kit. Specimen Storage
Serum, plasma, and urine
Reactive Ingredients Concentration
Maximum Storage Bibliographic
4-Aminoantipyrine 0.5 mmol/L Temperature
Serum/Plasma Urine Reference
TBHB 1.75 mmol/L 20 to 25°C 3 days 4 days at pH > 8 10
Uricase > 120 U/L 2 to 8°C 7 days no recommendation 10, 11
Peroxidase > 500 U/L -20°C 6 months no recommendation 10
TRIS Buffer 50 mmol/L Guder et al.10 suggest storage of frozen specimens at -20°C for
no longer than the time intervals cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
REAGENT HANDLING AND STORAGE laboratories to establish a range around -20°C for specimen storage.
Reagent Handling This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
Remove air bubbles, if present in the reagent cartridge, with a new procedure(s) for specimen storage.
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize NOTE: Stored specimens must be inspected for particulates. If present,
volume depletion, do not use a transfer pipette to remove the bubbles. mix and centrifuge the specimen to remove particulates prior to testing.

CAUTION: Reagent bubbles may interfere with proper detection of PROCEDURE

reagent level in the cartridge, causing insufficient reagent aspiration Materials Provided
which could impact results.
7D76 Uric Acid Reagent Kit
Reagent Storage
Materials Required but not Provided
Unopened reagents are stable until the expiration date when stored at
2 to 8°C. • 1E65 Multiconstituent Calibrator, 3 x 5 mL
Reagent stability is 26 days if the reagent is uncapped and onboard. • Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
WARNINGS AND PRECAUTIONS Assay Procedure
Precautions for Users For a detailed description of how to run an assay, refer to Section 5 of
1. For in vitro diagnostic use. the instrument-specific operations manual.
2. Do not use components beyond the expiration date. Specimen Dilution Procedures
3. Do not mix materials from different kit lot numbers. The ARCHITECT c Systems and the AEROSET System have automatic
4. Contains nonsterile bovine serum albumin. dilution features; refer to Section 2 of the instrument-specific operations
5. CAUTION: This product requires the handling of human specimens. manual for additional information.
It is recommended that all human sourced materials be considered Serum and plasma: Specimens with uric acid values exceeding
potentially infectious and handled in accordance with the OSHA 33.1 mg/dL (1.95 mmol/L) are flagged and may be diluted using the
Standard on Bloodborne Pathogens.5 Biosafety Level 26 or other Automated Dilution Protocol or the Manual Dilution Procedure.
appropriate biosafety practices7,8 should be used for materials that Urine: Urine samples are automatically diluted 1:10 by the system using
contain or are suspected of containing infectious agents. the Standard dilution option, then the system automatically corrects
the concentration by multiplying the result by the appropriate dilution
factor. This dilution extends urine Uric Acid linearity to 433.8 mg/dL
(25.59 mmol/L). Samples exceeding this concentration are flagged and
may be diluted using the Automated Dilution Protocol or the Manual
Dilution Procedure.

2
PROCEDURE (Continued) EXPECTED VALUES
Automated Dilution Protocol Reference Range (Continued)
If using the Automated Dilution Protocol, the system performs a dilution Urine
of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To set up the Diet Range (mg/day) Range (mmol/day)
automatic dilution feature, refer to Section 2 of the instrument-specific Purine-free
operations manual for additional information. Male < 420 < 2.48
Manual Dilution Procedure Female slightly lower slightly lower
Low Purine
Manual dilutions should be performed as follows:
Male < 480 < 2.83
• Use saline (0.85% to 0.90% NaCl) to dilute the sample. Female < 400 < 2.36
• The operator must enter the dilution factor in the patient or control High Purine < 1,000 < 5.90
order screen. The system uses this dilution factor to automatically Average 250 to 750 1.48 to 4.43
correct the concentration by multiplying the result by the entered
factor. To convert results from mg/day to mmol/day, multiply mg/day by
• If the operator does not enter the dilution factor, the result must be 0.0059.
multiplied by the appropriate dilution factor before reporting the result. It is recommended that each laboratory determine its own reference
NOTE: If a diluted sample result is flagged indicating it is less than the range based upon its particular locale and population characteristics.
linear low limit, do not report the result. Rerun using an appropriate 24 Hour Urinary Excretion
dilution.
To convert results from mg/dL to mg/day (24 hour urinary excretion)
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual. Where:
V = 24 hour urine volume (mL)
CALIBRATION c = analyte concentration (mg/dL)
Calibration is stable for approximately 26 days (624 hours) and 24 hour excretion = [(V × c) ÷ 100] mg/day
calibration is required with each reagent cartridge and lot number
change. Verify calibration with at least two levels of controls according to To convert results from mmol/L to mmol/day (24 hour urinary excretion)
the established quality control requirements for your laboratory. If control Where:
results fall outside acceptable ranges, recalibration may be necessary.
V = 24 hour urine volume (mL)
The urine application uses the serum calibration. c = analyte concentration (mmol/L)
For a detailed description of how to calibrate an assay, refer to 24 hour excretion = [(V × c) ÷ 1000] mmol/day
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the Multiconstituent SPECIFIC PERFORMANCE CHARACTERISTICS
Calibrator package insert.
Linearity
QUALITY CONTROL Uric Acid serum is linear up to 33.1 mg/dL (1.95 mmol/L). Uric Acid
The following is the recommendation of Abbott Laboratories for quality urine is linear up to 433.8 mg/dL (25.59 mmol/L). Linearity was verified
control. As appropriate, refer to your laboratory standard operating using Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS
procedure(s) and/or quality assurance plan for additional quality control EP6-P.13
requirements and potential corrective actions. Limit of Detection (LOD)
• Two levels of controls (normal and abnormal) are to be run every The LOD for Uric Acid serum is 0.2 mg/dL (0.01 mmol/L). The LOD
24 hours. for Uric Acid urine is 5 mg/dL (0.3 mmol/L). The LOD is the mean
• If more frequent control monitoring is required, follow the established concentration of an analyte-free sample + 2 SD, where SD = the
quality control procedures for your laboratory. pooled, within-run standard deviation of the analyte-free sample. A
• If quality control results do not meet the acceptance criteria study performed on an ARCHITECT c System and an AEROSET System
defined by your laboratory, patient values may be suspect. Follow produced an LOD for Uric Acid serum of 0.07 mg/dL (0.005 mmol/L)
the established quality control procedures for your laboratory. and an LOD for Uric Acid urine of 0.31 mg/dL (0.019 mmol/L).
Recalibration may be necessary.
Limit of Quantitation (LOQ)
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot. The LOQ for Uric Acid serum is 0.25 mg/dL (0.015 mmol/L). The LOQ
for Uric Acid urine is 0.86 mg/dL (0.051 mmol/L). The LOQ is the
RESULTS analyte concentration at which the CV = 20%.
Refer to the instrument-specific operations manual for information on Interfering Substances14
results calculations. Interference studies were conducted using CLSI protocol NCCLS
• ARCHITECT System Operations Manual—Appendix C EP7-P.15 Interference effects were assessed by Dose Response and
• AEROSET System Operations Manual—Appendix A Paired Difference methods, at the medical decision level of the analyte.
Representative performance data are given in the EXPECTED VALUES Interfering Target Observed
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this Interferent Concentration N
Substance (mg/dL) (% of Target)
package insert. Results obtained in individual laboratories may vary.
0.375 mg/dL (21.3 µmol/L) 4 5.1 93.6
Ascorbate
LIMITATIONS OF THE PROCEDURE 0.75 mg/dL (42.6 µmol/L) 4 5.1 87.5
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC 15 mg/dL (257 µmol/L) 4 5.6 94.7
Bilirubin
PERFORMANCE CHARACTERISTICS sections of this package insert. 30 mg/dL (513 µmol/L) 4 5.6 85.9
62 mg/dL (0.62 g/L) 4 5.0 108.9
Hemoglobin
EXPECTED VALUES 125 mg/dL (1.25 g/L) 4 5.0 120.1
750 mg/dL (7.5 g/L) 4 5.2 108.7
Reference Range12 Intralipid
1,000 mg/dL (10.0 g/L) 4 5.2 114.6
Serum/Plasma Ascorbate solutions at the above concentrations were prepared by
Range (mg/dL) Range (mmol/L) addition of ascorbic acid stock to human serum pools. Bilirubin solutions
Child 2.0 to 5.5 0.12 to 0.32 at the above concentrations were prepared by addition of a bilirubin
stock to human serum pools. Hemoglobin solutions at the above
Adult, Male 3.5 to 7.2 0.21 to 0.42
concentrations were prepared by addition of hemolysate to human
Adult, Female 2.6 to 6.0 0.15 to 0.35 serum pools. Intralipid solutions at the above concentrations were
To convert results from mg/dL to mmol/L, multiply mg/dL by 0.059. prepared by addition of Intralipid to human serum pools.

3
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
Interfering Substances (Continued) 1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:1541–2.
For the urine application, glucose up to 1,000 mg/dL, protein up to
50 mg/dL, sodium oxalate up to 60 mg/dL, acetic acid (8.5N) up to 2. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
6.25 mL/dL, hydrochloric acid (6N) up to 2.5 mL/dL, nitric acid (6N) up Philadelphia, PA: WB Saunders; 1995:624–5.
to 5.0 mL/dL, boric acid up to 250 mg/dL, and sodium fluoride up to 3. Trivedi R, Berta E, Rebar L. Enzymatic uric acid determination at
400 mg/dL demonstrated less than 10% interference. Ascorbate and 500 nm by Trinder method. Clin Chem 1976;22:1223.
sodium carbonate demonstrated greater than 10% interference. 4. Kabasakalian P, Kalliney S, Wescott A. Determination of uric acid
Precision in serum, with use of uricase and tribromophenol-aminoantipyrine
chromogen. Clin Chem 1973;19:522.
The imprecision of the Uric Acid serum assay is ≤ 4% Total CV.
Representative data from studies using CLSI protocol NCCLS EP5-A16 5. US Department of Labor, Occupational Safety and Health
are summarized below. Administration. 29 CFR Part 1910.1030, Occupational Exposure to
Bloodborne Pathogens.
Serum 6. US Department of Health and Human Services. Biosafety in
Control Level 1 Level 2 Microbiological and Biomedical Laboratories. HHS Publication
(CDC), 4th ed. Washington, DC: US Government Printing Office,
N 80 80 May 1999.
Mean (mg/dL) 4.9 9.6
7. World Health Organization. Laboratory Biosafety Manual. Geneva:
SD 0.02 0.04
Within Run World Health Organization, 2004.
%CV 0.4 0.4
8. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
SD 0.01 0.05
Between Run Workers from Occupationally Acquired Infections; Approved
%CV 0.3 0.5 Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
SD 0.08 0.08 Laboratory Standards Institute, 2005.
Between Day
%CV 1.6 0.9 9. Kaplan LA, Pesce AJ, editors. Clinical Chemistry Theory, Analysis,
SD 0.08 0.10 and Correlation, 2nd ed. St Louis, MO: CV Mosby; 1996:501–2.
Total
%CV 1.7 1.1
10. Guder WG, Narayanan S, Wisser H, et al. List of analytes—
preanalytical variables. Annex In: Samples: From the Patient
The imprecision of the Uric Acid urine assay is ≤ 6.1% Total CV.
to the Laboratory. Darmstadt, Germany: GIT Verlag; 1996:
Representative data from studies using CLSI protocol NCCLS EP10-A17
Annex 22–3, 42–3.
are summarized below.
11. US Pharmacopeial Convention, Inc. General notices. In: US
Urine Pharmacopeia National Formulary, 1995 ed. (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
Control Level 1 Level 2 12. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
N 50 50 Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:2210.
Mean (mg/dL) 10.4 19.9 13. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
SD 0.26 0.43 of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Within Run
%CV 2.5 2.2 Villanova, PA: The National Committee for Clinical Laboratory
SD 0.00 0.00 Standards, 1986.
Between Run
%CV 0.0 0.0 14. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
SD 0.37 0.37 Washington, DC: AACC Press; 1995:3-609–3-622.
Between Day
%CV 3.6 1.9 15. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
SD 0.45 0.57 Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA:
Total
%CV 4.3 2.9 The National Committee for Clinical Laboratory Standards, 1986.
16. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Method Comparison Performance of Clinical Chemistry Devices; Approved Guideline
Correlation studies were performed using CLSI protocol NCCLS (EP5-A). Wayne, PA: The National Committee for Clinical
EP9-A.18 Laboratory Standards, 1999.
Serum and urine results from the Uric Acid assay on the AEROSET 17. Krouwer JS, Castaneda-Mendez K, Dawson JM, et al. Preliminary
System were compared with those from a commercially available Evaluation of Quantitative Clinical Laboratory Methods; Approved
uricase methodology. Guideline (EP10-A). Wayne, PA: The National Committee for
Serum and urine results from the Uric Acid assay on an ARCHITECT Clinical Laboratory Standards, 1998.
c System were compared with the Uric Acid assay on an AEROSET 18. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
System. Bias Estimation Using Patient Samples; Approved Guideline (EP9-A).
Wayne, PA: The National Committee for Clinical Laboratory
Serum Standards, 1995.
AEROSET vs. ARCHITECT vs.
Comparative Method AEROSET TRADEMARKS
N 80 92 AEROSET and ARCHITECT are registered trademarks of Abbott
Laboratories.
Y - Intercept 0.134 -0.030
Correlation Coefficient 0.999 1.000 c System is a trademark of Abbott Laboratories.
Slope 1.074 0.982 All other trademarks, brands, product names, and trade names are the
Range (mg/dL)* 1.49 to 18.06 3.30 to 32.20 property of their respective companies.
*AEROSET Range
Urine
AEROSET vs. ARCHITECT vs.
Comparative Method AEROSET
N 79 102
Y - Intercept 0.184 -0.022
Correlation Coefficient 0.997 0.999
Slope 0.999 0.912
Range (mg/dL)* 3.35 to 64.31 5.99 to 421.32
*AEROSET Range

4
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Uric Acid Serum/Plasma—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: Uric Type: Photometric Version: 1 Assay: Uric
Number: 1010
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks Cuvette Trig 10% Detergent B*** 345
Reaction mode: End up
Primary Secondary Read times
Wavelength: 548 / 700 Main: 24 – 26 *** Select “Detergent B” for software prior to Version 2.2.
Last required read: 26
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None Uric Acid Serum/Plasma—Conventional Units

о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results
R1 о General о Calibration о SmartWash ● Results о Interpretation
Reagent: URIC0 Reagent volume: 160 Assay: Uric Result units: mg/dL
Diluent: Saline Water volume: ___ Assay defaults:
Diluent dispense mode: Type 0 Dispense mode: Type 0 Low-Linearity: 0.3†
Diluted Default High-Linearity: 33.1
Dilution name Sample sample Diluent Water Dilution factor dilution Gender and age specific ranges:
STANDARD : 3.2 ___ ___ ___ = 1:1.00 ● GENDER AGE (UNITS) NORMAL EXTREME
________ : ___ ___ ___ ___ = о Male 0 – 130 (Y) 3.5 – 7.2
________ : ___ ___ ___ ___ = о Female 0 – 130 (Y) 2.6 – 6.0
Either 0 – 130 (Y) 2.6 – 7.2
о Reaction definition о Reagent / Sample ● Validity checks
Reaction check: None

Configure result units

Maximum absorbance variation: ___ Assay: Uric
Version: 1
Result units: mg/dL
Configure assay parameters — Calibration Decimal places: 1 [Range 0 – 4]
о General ● Calibration о SmartWash о Results о Interpretation Correlation factor: 1.0000
Assay: Uric Calibration method: Linear Intercept: 0.0000

● Calibrators о Volumes о Intervals о Validity checks

Calibrator set: Calibrator level: Concentration: Uric Acid Serum/Plasma—SI Units
MCC Blank: Water 0††
Cal 1: MCC1 ‡
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ Configure assay parameters — Results
о General о Calibration о SmartWash ● Results о Interpretation
Assay: Uric Result units: mmol/L
о Calibrators ● Volumes о Intervals о Validity checks Assay defaults:
Calibrator: MCC Diluted
Calibrator level Sample sample Diluent Water Low-Linearity: 0.02†
Blank: Water 3.2 ___ ___ ___ High-Linearity: 1.95
Cal 1: MCC1 3.2 ___ ___ ___ Gender and age specific ranges:
Cal 2: MCC2 3.2 ___ ___ ___ GENDER AGE (UNITS) NORMAL EXTREME
Male 0 – 130 (Y) 0.21 – 0.42
Female 0 – 130 (Y) 0.15 – 0.35
о Calibrators о Volumes ● Intervals о Validity checks Either 0 – 130 (Y) 0.15 – 0.42
Calibration intervals:
Full interval: 624 (hours)
Calibration type:
Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks Configure result units

Blank absorbance range: _____ – _____ Assay: Uric
Span: Blank – Blank Version: 1
Span absorbance range: _____ – _____ Result units: mmol/L
Expected cal factor: 0.00 Decimal places: 2 [Range 0 – 4]
Expected cal factor tolerance %: 0 Correlation factor: 1.0000
Intercept: 0.0000

† The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
‡ Refer to concentration specified on calibrator labeling or value sheet.
†† Displays the number of decimal places defined in the decimal places parameter field.

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Uric Acid Urine—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: Uric-U Type: Photometric Version: 1 Assay: Uric-U
Number: 1041
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks Cuvette Trig 10% Detergent B*** 345
Reaction mode: End up
Primary Secondary Read times
Wavelength: 548 / 700 Main: 24 – 26 *** Select “Detergent B” for software prior to Version 2.2.
Last required read: 26
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None Uric Acid Urine—Conventional Units

о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results
R1 о General о Calibration о SmartWash ● Results о Interpretation
Reagent: URIC0 Reagent volume: 160 Assay: Uric-U Result units: mg/dL
Diluent: Saline Water volume: ___ Assay defaults:
Diluent dispense mode: Type 0 Dispense mode: Type 0 Low-Linearity: 0.1†
Diluted Default High-Linearity: 43.3†
Dilution name Sample sample Diluent Water Dilution factor dilution Gender and age specific ranges:
STD(1:10) : 18.0 3.2 162 ___ = 1:10.00 ● GENDER AGE (UNITS) NORMAL EXTREME
________ : ___ ___ ___ ___ = о
________ : ___ ___ ___ ___ = о

о Reaction definition о Reagent / Sample ● Validity checks

Reaction check: None

Configure result units

Assay: Uric-U
Maximum absorbance variation: ___ Version: 1
Result units: mg/dL
Decimal places: 1 [Range 0 – 4]
Configure assay parameters — Calibration Correlation factor: 1.0000
о General ● Calibration о SmartWash о Results о Interpretation Intercept: 0.0000
Assay: Uric-U Calibration method: Use Cal Factor/Blank
Use Cal factor from: Uric
Uric Acid Urine—SI Units

Configure assay parameters — Results

о General о Calibration о SmartWash ● Results о Interpretation
Assay: Uric-U Result units: mmol/L
Assay defaults:
Low-Linearity: 0.01†
High-Linearity: 2.55†
Gender and age specific ranges:
GENDER AGE (UNITS) NORMAL EXTREME

Configure result units

Assay: Uric-U
Version: 1
Result units: mmol/L
Decimal places: 2 [Range 0 – 4]
Correlation factor: 1.0000
Intercept: 0.0000

† The linear low value (Low-Linearity) is LOQ divided by the Standard dilution factor, then rounded up to the number of decimal places defined in
the decimal places parameter field. The linear high value (High-Linearity) is Linearity divided by the Standard dilution factor.

6
AEROSET SYSTEM ASSAY PARAMETERS

Uric Acid Serum/Plasma—Conventional Units Uric Acid Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
Uric 10 B-Line Uric 10 B-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 2.6 7.2 0.0 0.0* * * 0.0* 0.0 0.15 0.42 0.0 0.0* *
0.3** L-Linear Range-H 33.1 0.02** L-Linear Range-H 1.95
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 3.5 – 7.2 2.6 – 6.0 0 Year 0.21 – 0.42 0.15 – 0.35
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 548 / 700 24 – 26 / 0 – 0 0.0 END UP 548 / 700 24 – 26 / 0 – 0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 3.2 0.0 0 0 Rgt Name/Pos Standard 3.2 0.0 0 0 Rgt Name/Pos
Dil 1 3.2 0.0 0 0 Diluent: _____ _–__* Dil 1 3.2 0.0 0 0 Diluent: _____ _–__*
Dil 2 3.2 0.0 0 0 Type# 0 Dil 2 3.2 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 URIC061 – __* 160 0 0 Reagent 1 URIC061 – __* 160 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
____________ 1–1/1–1 0.0 – 0.0 0.0 ____________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 1 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 624 Linear 624
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 0 BLK – 1 0.0 – 0.0 3/3 0 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol BLK Abs Range Sample S.Vol DS.Vol D.Vol W.Vol BLK Abs Range
BLK Water 3.2 0.0 0 0 0.0 – 0.0 BLK Water 3.2 0.0 0 0 0.0 – 0.0
C1 MCC 1 3.2 0.0 0 0 Cal Deviation C1 MCC 1 3.2 0.0 0 0 Cal Deviation
C2 MCC 2 3.2 0.0 0 0 0.0 C2 MCC 2 3.2 0.0 0 0 0.0
FAC Limit (%) FAC Limit (%)
10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
DBILI61 Water 300 DBILI61 Water 300
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

7
AEROSET SYSTEM ASSAY PARAMETERS

Uric Acid Urine—Conventional Units Uric Acid Urine—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
Uric-U 41 B-Line Uric-U 41 B-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 0.0 0.0 0.0 0.0* * * 0.0* 0.0 0.0 0.0 0.0 0.0* *
0.1** L-Linear Range-H 43.3** 0.01** L-Linear Range-H 2.55**
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 548 / 700 24 – 26 / 0 – 0 0.0 END UP 548 / 700 24 – 26 / 0 – 0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 18.0 3.2 162 0 Rgt Name/Pos Standard 18.0 3.2 162 0 Rgt Name/Pos
Dil 1 18.0 3.2 162 0 Diluent: DILUENT D–18* Dil 1 18.0 3.2 162 0 Diluent: DILUENT D–18*
Dil 2 18.0 3.2 162 0 Type# 0 Dil 2 18.0 3.2 162 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 URIC061 – ___* 160 0 0 Reagent 1 URIC061 – __* 160 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
____________ 1–1/1–1 0.0 – 0.0 0.0 ____________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 1 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Use Cal Factor from Interval (H) Calib Mode Use Cal Factor from Interval (H)
UseFac/Blk Uric ( 10 ) 0 UseFac/Blk Uric ( 10 ) 0
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
0/0 0 BLK – 1 0.0 – 0.0 0/0 0 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol BLK Abs Range Sample S.Vol DS.Vol D.Vol W.Vol BLK Abs Range
BLK 2.0 0.0 0 0 0.0 – 0.0 BLK 2.0 0.0 0 0 0.0 – 0.0
C1 2.0 0.0 0 0 Cal Deviation C1 2.0 0.0 0 0 Cal Deviation
C2 2.0 0.0 0 0 0.0 C2 2.0 0.0 0 0 0.0

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
DBILI61 Water 300 DBILI61 Water 300
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ divided by the Standard dilution factor, then rounded up to the number of decimal places defined in
the decimal places parameter field. The linear high value (Linear Range-H) is Linearity divided by the Standard dilution factor.