Specimen: Test Procedure Intended Use
Specimen: Test Procedure Intended Use
Specimen: Test Procedure Intended Use
URIC ACID T FL may cause interference in the Trinder reaction.(1,2) a comparison between Chema and a commercially availa-
To avoid interference, the blood withdrawal should be per- ble product gave the following results:
AU F100 CH 5 x 20 ml formed before drug administration.
Uric acid T FL Chema = x
AU F250 CH 5 x 50 ml SPECIMEN
Uric acid competitor = y
Serum, plasma heparinate. Oxalate, citrate and fluoride n = 85
AU F402 CH 4 x 100 ml could yeld a small decrease of uric acid. Urine.
Uric acid is stable 5 days at 4-25°C.
INTENDED USE Dilute urine sample 1:10 with deionized water.
y = 0.9832x - 0.0883 mg/dl r2 = 0.999
Reagent for quantitative in vitro determination of uric acid WASTE DISPOSAL
in biological fluids. TEST PROCEDURE
This product is made to be used in professional labora-
SUMMARY OF TEST tories.
Wavelenght: 546 nm (allowed 510 ÷ 560 nm)
In humans, uric acid is the major product of the catabolism Lightpath: 1 cm P501: Dispose of contents according to national/interna-
of the purine nucleosides, adenosine and guanosine. The Temperature: 37°C tional regulations.
daily synthesis rate of uric acid is approximately 400 mg;
dietary sources contribute another 300 mg. In men con- dispense: blank standard sample REFERENCES
suming a purine-free diet, the total body pool of exchan- 1) N-acetylcysteine interference of Trinder-based assays.
reagent 1 ml 1 ml 1 ml
geable urate is estimated at 1200 mg; this same value is Genzen JR, Hunsaker JJ, Nelson LS, Faine BA, Krasowski
estimated to be 600 mg in women. water 25 µl - - MD. Clin Biochem. 2016 Jan;49(1-2):100-4
standard - 25 µl - 2) Drug interference in Trinder reaction.
PRINCIPLE OF THE METHOD Wiewiorka O, Čermáková Z, Dastych M. Euromedlab
sample - - 25 µl
Uric acid in sample is oxidized to allantoin in presence of the 2017. ISSN 1437-4431
enzyme uricase and H2O2 is generated. The H2O2 reacts Mix, incubate at 37°C for 5 minutes. 3) Barham D., Trinder P. - Analyst, 97 142 (1972)
with ADPS and 4-aminoantipyrine in the presence of pero- Read absorbances of standard (As) and samples (Ax) 4) Fossati P., Prencipe L., Berti G. - Clin. Chem. 26, 277
xidase to form a violet dye. The intensity of color formed against reagent blank. (1980).
is proportional to the uric acid concentration and can be 5) Tietz Textbook of Clinical Chemistry, Second Edition,
measured photometrically to 546 (510 - 560) nm. RESULTS CALCULATION Burtis-Ashwood (1994).
Serum/plasma sample: 6) Milena Jelikic-Stankov, Predrag Djurdjevic and Dejan
KIT COMPONENTS Stankov - J. Serb. Chem. Soc, 68 (8-9), 691-698 (2003).
For in vitro diagnostic use only. uric acid mg/dl = Ax/As x 5 (standard value)
The components of the kit are stable until expiration date MANUFACTURER
on the label. Random urine sample: Chema Diagnostica
Keep away from direct light sources. Via Campania 2/4
uric acid mg/dl = Ax/As x 5 x 10 60030 Monsano (AN) - ITALY - EU
UA T R1 F100: 4 x 20 ml (liquid) blue cap (standard value and dilution) phone +39 0731 605064
F250: 4 x 50 ml (liquid) blue cap fax +39 0731 605672
F402: 4 x 80 ml (liquid) blue cap 24 hours urine sample (uric acid mg/24h): e-mail: [email protected]
website: http://www.chema.com
UA T R2 F100: 1 x 20 ml (liquid) red cap uric acid mg/24h = Ax/As x 5 x 10 x diuresis (dl)
F250: 1 x 50 ml (liquid) red cap SYMBOLS
(standard value, dilution and diuresis in dl)
F402: 1 x 80 ml (liquid) red cap
EXPECTED VALUES in vitro diagnostic medical device
Composition in the test: phosphate buffer pH 7.0, ADPS ≥ 0.2 Serum/plasma samples:
mM, 4-aminoantypyrine 0.3 mM, uricase ≥ 450 U/l, POD > Men: 3.5 - 7.2 mg/dl (0.21 - 0.42 mmol/l) batch code
2500 U/l, surfactant. Women: 2.6 - 6.0 mg/dl (0.15 - 0.35 mmol/l) catalogue number
Standard: uric acid 5 mg/dl - 5 ml 24h urine: temperature limit
250 - 750 mg/24h (1.50 - 4.50 mmol/l) use by date
Store all components at 2-8°C.
Each laboratory should establish appropriate reference caution
MATERIALS REQUIRED BUT NOT SUPPLIED
intervals related to its population. consult instructions for use
Current laboratory instrumentation. Spectrophotometer
UV/VIS with thermostatic cuvette holder. Automatic micro- QUALITY CONTROL AND CALIBRATION
pipettes. Glass or high quality polystyrene cuvettes. Saline It is suggested to perform an internal quality control. For
solution. this purpose the following human based control sera are
REAGENT PREPARATION available:
QUANTINORM CHEMA
Code F100: add 5 ml of reagent R2 to a bottle of reagent
with normal or close to normal control values
R1.
QUANTIPATH CHEMA
Code F250: add 12.5 ml of reagent R2 to a bottle of reagent
with pathological control values.
R1.
If required, a multiparametric, human based calibrator is
Code F402: add 20 ml of reagent R2 to a bottle of reagent
available:
R1.
AUTOCAL H
If reagents are mixed in reduced quantities, mix 4 parts of
reagent R1 with 1 part of reagent R2.
Please contact Customer Care for further information.
Stability of working reagent: use preferably within 15 days
at 2-8°C, away from light sources. TEST PERFORMANCE
Stability of unmixed reagents: up to expiration date on Linearity
labels at 2-8°C; the method is linear up to 30 mg/dl.
Stability since first opening of vials of unmixed reagents: If the value is exceeded, it is suggested to dilute sample
use preferably within 60 days at 2-8°C. 1+9 with saline and to repeat the test, multiplying the result
PRECAUTIONS by 10.
UA T R1: Danger. Causes serious eye damage (H318).
Causes skin irritation (H315). Wear Sensitivity/limit of detection (LOD)
protective gloves. Eye protection (P280). IF the limit of detection is 0.04 mg/dl.
ON SKIN: Wash with plenty of water
(P302+P352). IF IN EYES: Rinse cautiously with water for Interferences
several minutes. Remove contact lenses, if present and no interference was observed by the presence of:
easy to do. Continue rinsing (P305+P351+P338). Imme- hemoglobin ≤ 50 mg/dl
diately call a doctor (P310). If eye irritation persists: get bilirubin ≤ 33 mg/dl
medical advice (P337+P313). lipids ≤ 1200 mg/dl