URIC ACID

COD 12521 10 x 50 mL
STORE AT 2-8C
Reagents for measurement of uric acid concentration
Only for in vitro use in the clinical laboratory

URIC ACID
URICASE/PEROXIDASE
months.

PRINCIPLE OF THE METHOD

CALIBRATION

Calibration type
Calibrator replicates
Blank replicates
Calibration curve

Uric acid in the sample originates, by means of the coupled reactions described
1,2
below, a coloured complex that can be measured by spectrophotometry .

Uric acid + O2 + 2H2O

H2O2

uricase

Allantoin + CO2 +

OPTIONS

peroxidase
2 H2O2 + 4 Aminoantipyrine + DCFS

Quinoneimine + 4 H2O

multiple
3
3
-

0.200
25

0.200
25

QUALITY CONTROL

COMPOSITION
A.

Blank absorbance limit

Kinetic blank limit
Linearity limit

multiple
3
3
-

It is recommended to use the Biochemistry Control Serum level I (cod. 18005,

18009 and 18042), level II (cod. 18007, 18010 and 18043) and the Biochemistry
Control Urine (cod. 18054) to verify the performance of the measurement
procedure.

Reagent. 10 x 50 mL. Phosphate 100 mmol/L, detergent 1.5 g/L,

dichlorophenolsulfonate 4 mmol/L, uricase 0.12 U/mL, ascorbate
oxidase 5 U/mL, peroxidase 1 U/mL, 4-aminoantipyrine 0.5 mmol/L,
pH 7.8.

STORAGE

Each laboratory should establish its own internal Quality Control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerances.

Store at 2-8C.

METROLOGICAL CHARACTERISTICS
The following data were obtained using an A25 analyser. Results are
similar with A15. Details on evaluation data are available on request.

Reagent is stable until the expiry date shown on the label when stored
tightly closed and if contaminations are prevented during their use.
Indications of deterioration:

Detection limit: 0.11 mg/dL = 6.5

mol/L. Linearity limit: 25 mg/dL

Reagent: Presence of particulate material, turbidity, absorbance of the

blank over the limit indicated in "Assay parameters".

= 1487 mol/L. Repeatibility

(within run):

AUXILIARY REAGENTS
Biochemistry Calibrator (BioSystems cod. 18011) or Biochemistry
Calibrator Human (BioSystems cod. 18044).

REAGENT PREPARATION

CV

0.6 %

20

9.24 mg/dL = 550 mol/L

0.8 %

20

CV

Reproducibility (run to run):

Reagent is provided ready to use.

Mean Concentration

Reagent open and kept in the refrigerated compartment of the analyzer is stable 2

SAMPLES

Serum, plasma or urine collected by standard procedures. Dilute urine

1/10 with distilled water before measurement
Uric acid in serum or plasma is stable for 7 days at 2-8C. Heparin, EDTA,
oxalate and fluoride may be used as anticoagulants.
Uric acid in urine is stable for 4 days at room temperature if pH is adjusted
to > 8 with NaOH. Do not refrigerate.

5.30 mg/dL = 315 mol/L

1.2 %

25

9.24 mg/dL = 550 mol/L

1.7 %

25

Trueness: Results obtained with this procedure did not show systematic
differences when compared with a reference procedure. Details of the
comparison experiments are available on request.
Interferences: Hemoglobin (2 g/L), bilirubin (2.5 mg/dL) and lipemia
4
interfere. Other drugs and substances may interfere .

REFERENCE VALUES

DIAGNOSTIC CHARACTERISTICS

Serum and plasma3

Men: 3.5-7.2 mg/dL = 210-420 mol/L

In humans, uric acid is the major product of the catabolism of the purine
bases which are obtained partly from the diet and partly from in vivo
synthesis.
Increased uric acid concentration in serum and urine maybe attributable to an
overproduction of urate (increased purine synthesis) or to a defective elimination of

Women: 2.6-6.0 mg/dL = 150-350 mol/L

Urine

Mean Concentration
5.30 mg/dL = 315 mol/L

urate3.

250-750 mg/24-h = 1.5-4.5 mmol/24-h

These ranges are given for orientation only; each laboratory should
establish its own reference ranges.

Hyperuricemia is commonly associated with gout, decreased renal function,

dehydratation, myeloproliferative disorders, and other conditions not well
3,5
known .

Clinical diagnosis should not be made on the findings of a single test

result, but should integrate both clinical and laboratory data.

CALIBRATION
It is recommended to do a reagent blank every day and a calibration at least
every 2 months, after reagent lot change or as required by quality control
procedures.

ASSAY PARAMETERS
GENERAL

PROCEDURE
Volumes

Filters
Times

Test name
Analysis mode
Sample type
Units
Reaction type
Decimals
No. of replicates
Test name in patient report
Reading
Sample
Reagent 1
Reagent 2
Washing
Predilution factor
Postdilution factor
Main
Reference
Reading 1
Reading 2
Reagent 2

A25

A15

URIC ACID
mono. end point
SER/URI
mg/dL
increasing
2
1
-

URIC ACID
mono. end point
SER/URI
mg/dL
increasing
2
1

bichromatic
7.5
300
1.2
2
505
670
300 s
-

bichromatic
7.5
300

1.2
-

2
505
670
312 s
-

BIBLIOGRAPHY
1.
2.

3.
4.

5.

Barham D, Trinder P. An improved colour reagent for the determination

of blood glucose by oxidase system. Analyst 1972; 27:142-145.

Fossati
P,
Prencipe
L,
Berti
G.
Use
of
3,5-dichloro-2hydroxybenzenesulfonicacid/4-aminophenazone chromogenic system in
direct enzymic assay of uric acid in serum and urine. Clin Chem 1980;
26:227-231.

Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed.

Burtis CA, Ashwood ER, Bruns DE. WB Saunders Co, 2005.
Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.

Friedman and Young. Effects of disease on clinical laboratory tests, 4th

ed. AACC Press, 2001.

M12521i-09

BioSystems S.A. Costa Brava, 30. 08030 Barcelona (Spain)

Quality System certified according to
EN ISO 13485 and EN ISO 9001 standards

07/2013