URIC ACID KIT

(URICASE ENZYMATIC METHOD)

SPECIMEN COLLECTION AND HANDLING :
Code No. Pack Name Packing (Content)
Only the specimens listed below were tested and found acceptable.
Z28 Uric Acid (10x5 ml) R1: 10x5 ml, R2: 1x50 ml, R3: 3 ml For specimen collection and preparation, only use suitable tubes or
collection containers.
Z20A Uric Acid (4x50 ml) R1: 4x50 ml, R2: 4x50 ml, R3: 3 ml
Specimen: Serum sample on an empty stomach are the recommended
specimen.
INTENDED USE:
In vitro test for the quantitative determination of Uric Acid Serum: Collect fresh serum using standard sampling tubes.
(UA) in human serum and plasma.
If processing samples in primary tubes, follow the instructions of the tube
manufacturer.
CLINICAL SIGNIFICANCE:
Uric Acid is a waste product, derived from purines of diet For sample with absorbance interference, including samples of hemolysis
and those synthesized in the body, and are one of the and turbidity, may affect the test results. Sample recollection is
principle components of non-protein nitrogen fraction of recommended.
plasma. Normally, approximately one half of body’s total
Uric Acid is eliminated and replaced each day, partly Stability: Store serum less than 3 days at 2-8°C, 1 month at -20°C.
through urinary excretion and partly through destruction in
Protected from light and avoid repeated freeze thaw cycles.
the gastrointestinal tract. The determination of the serum
Uric Acid is most helpful in the diagnosis of gout, where the
levels are chronically elevated. Serum Uric Acid levels are Centrifuge samples containing precipitate before performing the assay.
also increased when there is increased metabolism of
nucleoproteins, as seen in leukemia and polycythemia.
PROCEDURE :
Impaired renal function also leads to increased Uric Acid Reagent Preparation : Reagent 1 : Ready to use: Reagent 2 : Ready
levels. to use.
Wavelength : 546 nm (540-560 nm)
PRINCIPLE: Temperature : 37°C
In the human body uric acid is the end-product of purine Cuvette : 1 cm
metabolism. It is excreted by the kidney. Increases of uric Making working solution by dissolving a bottle of Reagent 1 with
acid in the serum plasma or urine can be due to the Reagent 2 (refer to Reagent 1 Label).
overproduction of purine containing molecules or to
insufficient excretion. The concentration is increased in Blank Standard Sample
various renal diseases, with increased cell lysis in the Working reagent 1 ml 1 ml 1 ml
presence of tumors, leukemia, toxemia of pregnancy. Deionized Water 20 µl - -
Prolonged elevation of the concentration leads to gout.
Standard - 20 µl -
CONTENTS: Sample - - 20 µl
Reagent 1 : Uric Acid (Enzyme Chromogen)
Reagent 2 : Uric Acid (Buffer)
Reagent 3 : Uric Acid Standard (6mg/dl) Mix well and incubate for 10 minutes at 37°C. Adjust zero by blank
and read the absorbance A standard, A sample.
COMPONENTS:
CALCULATION :
Reagent Component Concentration
Abs. of sample Standard Conc.
Uricase (Uricase) Uric Acid Conc. = X
->600 U/L Abs. of standard
Reagent 1 Peroxidase (POD) ->1800 U/L
4-aminophenazone (4-AAP) 0.3 mmol/L CALIBRATION :
TOOS 1.4 mmol/L Traceability : This method has been standardized against the primary
reference material.
Reagent 2 Phosphate Buffer (pH=7.8, 25) 100 mmol/L
Standard Uric acid 6 mg/dl
QUALITY CONTROL :
It is recommended to use two levels of controls at least once a day.
STORAGE & STABILITY : Values obtained should fall within a specified range.
1. Unopened reagent : Stable for 24 months at 2-8°C, protect from
Each laboratory should establish its own internal Quality control scheme
light.
and procedures for corrective action if controls do not recover within the
2. Dissolved reagent : Stable up to 7 days at 2-8°C, protect from
light. acceptable tolerances.
Expected Range :
15. Avoid microbial contamination of reagents.
Male 3.4-7.0 mg/dl 16. The reagent must be used only for the purpose intended
by suitably qualified laboratory personnel, under
Female 2.4-5.7 mg/dl
appropriate laboratory conditions.

The reference range should be determine by each hospital DEFINITION OF SYMBOLS :

to confirm with the characteristics of the region being tested.
USE BY (LAST DAY OF THE MONTH)
LIMITATIONS AND INTERFERENCE :
1. Lipemia (Intralipid) : No interference with the test results. BATCH CODE LOT
2. Hemolysis : No interference up to 100 mg/dl of hemoglobin.
3. Vc : No interference up to 100 mg/dl of Vc. DATE OF MANUFACTURE
4. Bilirubin : No interference up to 40 mg/dl of bilirubin.
The results may vary with different analyzers or calibrations.
TEMPERATURE LIMITS
For diagnostics purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical
CONSULT INSTRUCTIONS FOR USE
examination and other findings.

PERFORMANCE CHARACTERISTICS : HANDLE WITH CARE

The following performance data was obtained using

UPWARDS LAY
analyzer at 37 °C. Results obtained in indivdual laboratories
may differ.
KEEP DRY
Reagent Blank absorbance : <0.300
-
Accuracy: <
- +10%
- KEEP AWAY FROM SUNLIGHT
Measuring range : 0.49 to 20 mg/dl
Determine the samples with higher concentrations via the IN VITRO DIAGNOSTIC MEDICAL DEVICE
rerun function.
CATALOGUE NUMBER REF
Analytical Sensitivity : 0.49 mg/dl

The lower detection limit represents the lowest measurable SUFFICIENT FOR
analyte level that can be distinguished from zero. It is
calculated as three standard deviations of 21 replicates of MANUFACTURER
lowest standard.

Precision range : BIBLIOGRAPHY :

Within-run CV<4%-
Between-run R<5%-
Reproducibility was determined using human samples or
controls in an internal protocol (n=21)
Precautions and Warning :
1. For in vitro diagnostic use.
2. Avoid skin and eye contact. Avoid ingestion.
3. Disposal of used material in accordance with local
guidelines. Avoid pollution and reuse.
4. Do not use the products if interior package is damaged
during shipment.
1. The feld W,et al. Dtsch Med Wschr, 193, 98:380
2. Bergmeyer. Method of Enzymatic Analysis. Third edition.
Vol:140-146
3. The feld W, Hoffmeister H, Busch EW et al. Normal value
of serum uric acid levels in realtion to age and sex as
determined using a new enzymatic uric acid color test.
Dtsch Med Wschr.1973:98:380-869.
IVD www.jas-anz.com.au/register

ISO 9001:2015 ISO 13485:2003

5. The possibility of reagents instability or detorioration may

be considered if there is precipitation, visible exudate,
turbidity, microorganism growth, calibration results do not
meet the appropriate standard specification or control
values out of range.
6. Exercise the normal precautions required for handling all
laboratory reagents.
7. Wear protective clothing and disposable gloves while
handling the kit reagents.
8. Wash hands thoroughly after performing the test.
9. Use in ventilated area.
10. For acids, including appropriate warning for spills such
as “wipe up spills immediately and flush with water and
“should the reagents contacts eyes and skins, flush with
copious amount of water and consult physiciun.
11. For biological spills, indicate appropriate disinfectants
and disinfetion procedure.
12. Dispose of all specimens and components of the kit as
potentially infectious agents.
13. Do not use the kit or any kit components past the
indicated expiry date.
14. Do not use any other reagents from different lots in this
test, unless the reagent is designated to be used with other
lots of the same kit.