BIOLABO

www.biolabo.fr URIC ACID U r i c a s e method

MANUFACTURER: Reagent for quantitative determination of uric acid
BIOLABO SAS, in human serum and plasma, or urines.
Les Hautes Rives
02160, Maizy, France
I REF K1501 R1 2 x 16 mL R2 1 x 8 mL

I REF K2501 R1 2 x 32 mL R2 2 x 8 mL

I REF K4501 R1 2 x 40 mL R2 1 x 20 mL

| IVD
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Made In France
[email protected]
Latest revision: www.biolabo.fr I: corresponds to significant modifications

I INTENDED USE SAFETY CAUTIONS

This reagent is designated for professional use in laboratory (automated · Refer to current Material Safety Data Sheet available on request or on
method). www.biolabo.fr
It allows the quantitative determination of uric acid in human serum and · Verify the integrity of the contents before use.
plasma, or urines. · Waste disposal: Respect legislation in force in the country.
· All specimens or reagents of biological origin should be handled as
I GENERALITIES (1) (2) potentially infectious. Respect legislation in force in the country.
I Any serious incident that has occurred in connection with the device is
Uric acid (UA) is the major product of the catabolism of the purine notified to the manufacturer and the competent authority of the Member
nucleosides, adenosine and guanosine. State in which the user and/or patient is based.
Major causes of hyperuricemia are primary gout (due to metabolic
overproduction of purines or underexcretion of uric acid), or secondary
REAGENTS PREPARATION
gout which may be due to renal diseases, administration of drugs
(diuretics or chemotherapeutic agents...) Hyperuricemia is also Ready for use.
attributable to primary defects of enzymes in the pathway of purines
metabolism or to hematologic disease. STABILITY AND STORAGE
Hypouricemia is much less common than hyperuricemia.
Stored away from light, well caped in the original vial at 2-8°C,
when stored and used as described, reagents are stable:
PRINCIPLE (1) (3)
Unopened:
Uricase acts on uric acid to produce allantoin, carbon dioxide and
· Until expiry date stated on the label of the kit.
hydrogen peroxide. Hydrogen peroxide in the presence of peroxidase
reacts with a chromogen (amino-antipyrine and dichloro- Once opened:
hydroxybenzene sulfonate) to yield quinoneimine, a red colored · 2 separated reagents are stable for at least 3 months
complex. The absorbance measured at 505 nm is proportional to the · Discard any reagent if cloudy or if reagent blank > 0.100 at 505 nm.
amount of uric acid in the specimen.
SPECIMEN COLLECTION AND HANDLING (4)
REAGENTS
Serum or Plasma (Heparin or EDTA)
R1 UA2 Buffer
Tris pH 8.0 at 25°C 50 mmol/L Urines:
Dichloro-hydroxybenzene sulfonate 3 mmol/L · Add NaOH to keep urine alkaline and to prevent uric acid
precipitation.
Potassium hexacyanoferrate (II) 53 µmol/L
· To be diluted (1+9) in demineralized water before assay
3-DDAPS 0.7 mmol/L
EDTA 2 mmol/L
Uric acid is stable in the specimen for:
Preservative · 3 days at room temperature
R2 UA2 Enzymes · 1 week at 2-8°C
· 6 months when freeze at – 20°C
Peroxidase > 2000 U/L
Amino-antipyrine 750 µmol/L
LIMITS (3) (5)
Uricase > 500 U/L
Preservative Patient under vitamin C therapy: In order to reduce acid ascorbic
interference, let stand specimen 2 hours at room temperature before
According to 1272/2008/EC Regulation, these reagents are not classified as performing the assay.
dangerous.
For a more comprehensive review of factors affecting this assay refer to
the publication of Young D.S.

MATERIAL REQUIRED BUT NOT PROVIDED

1. Basic medical analysis laboratory equipment.
2. Biochemistry Clinical Analyzer Kenza One, Kenza 240TX/ISE or
Kenza 450TX/ISE

UA2_DT_220_IFU_K1501-K2501_EN_V02_20220411
EXPECTED VALUES (4) CALIBRATION (6)
· REF 95015 Multicalibrator traceable to SRM 913
Serum or plasma mg/dL [µmol/L]
The calibration frequency depends on proper instrument functions and
Child (*) 2.0-5.5 [119-327] on the preservation of reagent.

Men 3.5-7.2 [208-428]

QUALITY CONTROL
Women (**) 2.6-6.0 [155-357]
· REF 95010 EXATROL-N Level I
Urines 250-750 mg/24h [1.48-4.43 mmol/24 h] · REF 95011 EXATROL-P Level II
· REF 95012 Urinary controls
(*) Higher value in newborn. · External quality control program
(**) Lower during pregnancy. It is recommended to control in the following cases:
Each laboratory should establish its own normal ranges for the · At least once a run
population that it serves. · At least once within 24 hours
· When changing vial of reagent
PERFORMANCES · After maintenance operations on the instrument.
If control is out of range, apply following actions:
On Kenza 240TX, at 37°C, 505 nm 1. Prepare a fresh control serum and repeat the test
Linearity Range: between 0.36 mg/dL (LQ) and 25 mg/dL 2. If control is still out of range, use a new vial of fresh calibrator
3. If control is still out of range, use a new vial of reagent and reassay
Detection limit: approx. 0.36 mg/dL If control is still out of range, please contact BIOLABO technical support
or your local Agent.
Precision:
Within- Low Normal High Between Low Normal High
run N = 20 level level Level Run N = 20 level level level PROCEDURE
Mean Mean Refer to validated application of the Kenza Analyzer used
3.03 5.93 7.61 3.15 5.90 7.41
(mg/dL) (mg/dL)
S.D. mg/dL 0.07 0.11 0.09 S.D. mg/dL 0.07 0.06 0.08
CALCULATION
C.V. % 2.3 1.9 1.1 C.V. % 2.2 1.0 1.05
The analyzer provides directly final result.
Comparison studies with commercially available reagent: Refer to the instruction of use of Kenza analyzer.
Realized on human specimens (n=116) between 1.6 and 14.1 mg/dL
REFERENCES
y = 0.9123 x + 0.2582 r = 0.9947
(1) TIETZ N.W. Text book of clinical chemistry, 3rd Ed. C.A. Burtis, E.R.
Analytical sensitivity (505 nm): approx. 0.044 abs for 1 mg/dL Ashwood, W.B. Saunders (1999) p. 1245-1250.
(2) BERNARD S. Biochimie clinique - Instruments et techniques de laboratoire -
Interferences: Diagnostiques médicaux chirurgicaux.2cd éd.1989 p153-156 Ed. MALOINE
PARIS.
Turbidity Positive interference from 0.048 abs
(3) FOSSATI, P., PRENCIPE L., and BERTI G., Use of 3.5-dichloro-2-
Total bilirubin Negative interference from 157 µmol/L Hydroxybenzene sulfonic acid / 4 Amino phenazone chromogenic system in
direct enzymatic assays of uric acid in serum and urine. Clin. Chem.:
Direct bilirubin Negative interference from 133 µmol/L 26(227-231) 1980
(4) Clinical Guide to Laboratory Test, 4th Ed., N.W. TIETZ (2006) p. 1098-1099.
Ascorbic acid Negative interference from 95 mg/dL
(5) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed. (1995)
Glucose No interference up to 964 mg/dL p 3-609 to 3-622
(6) SRM: Standard Reference Material ®
Hemoglobin Positive interference from 185 µmol/L
Other substances may interfere (see § Limits)

On the board stability: 2 months

Calibration Stability: 2 months

Make a new calibration when changing reagent batch, if quality control

results are found out of the established range and after maintenance
operations.

Performances and stability data on Kenza 450TX/ISE and Kenza One

are available on request.

IVD H2O

Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

UA2_DT_220_IFU_K1501-K2501_EN_V02_20220411