ABX Pentra Uric Acid CP

ABX Pentra
Ref.: A11A01670
Volume R1: 60 ml
Uric Acid CP
Volume R2: 15 ml

Intended use 2007/04/05

A93A00282B US
Diagnostic reagent for quantitative in-vitro
determination of Uric Acid in serum, plasma
A11A01670
by colorimetry.
60 ml

Clinical Interest (1,2) 15 ml

Uric acid is the final product of endogenic and exogenic (food origin)
purine catabolism (adenosine and guanidine). This transformation
takes place mainly in the liver. Approximatively 75% of uric acid is
eliminated by kidneys, the rest is released in the gastro-intestinal
tractus where it will be degraded by the intestinal flora. Uric acid is
not very soluble in water; uratic microcrystals can form in the urines
when the concentration is abnormally high. This phenomenal can also HORIBA ABX
BP 7290
occur in the plasma, the microcrystals break up preferentially in joints 34184 Montpellier- cedex 4 - France
causing painful inflammations (commonly known as gout). The
increase of uric acid in the serum can result of several causes as:
increase of purine production, metabolism disorders (Lesch-Nyhan
syndrome as exemple), dietary troubles, increase of nuclear acid turn- ABX Pentra Uric Acid CP should be used according to this reagent
over, particulary during tumoral cellular proliferation, leukaemias, notice. HORIBA ABX cannot guarantee its performance if used
psoriasis, cytostatic treatment, renal disorders... otherwise.
Seric hypouricaemia is more unusual. This decrease can be observed in
differents cases as : defect of renal elimination ( Fanconi syndrome),
Handling
Hodgkin disease for exemple.
Remove the caps of the cassette, place in the refrigerated ABX Pentra
400 reagent compartment.
Method (3) If present, remove foam by using a plastic pipette.
Enzymatic determination of uric acid using the following reactions
(Trinder method):
Calibrator
Uricase For calibration, use:
Uric acid + 2H2O + O2 Allantoin + CO2 + H2O2 ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
Peroxidase
2H2O2 + 4AAP + EHSPT Quinoneimine
Mg++ Control
For internal quality control, use:
(EHSPT = N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) n-Toluidine, 4 AAP = 4-aminoantipyrine)
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 ml (lyophilisate)
Reagents ABX Pentra P Control, Ref. A11A01654 (not included)
ABX Pentra Uric Acid CP is ready-to-use. 10 x 5 ml (lyophilisate)
Reagent 1: Phosphate buffer, pH 7.00 125 mmol/l
EHSPT 1.38 mmol/l Each control should be assayed daily and/or after each calibration.
Ascorbate oxidase ≥ 1100 U/l The frequency of controls and the confidence intervals should
correspond to laboratory guidelines and country-specific directives.
Bovine albumin 0,2 %
The results must be within the range of the defined confidence limits.
Sodium azide < 0,1 %
Each laboratory should establish a procedure to follow if the results
Reagent 2: 4-aminoantipyrine 1.8 mmol/l exceed these confidence limits.
Uricase ≥ 700 U/l
Peroxidase ≥ 7,500 U/l Materials required but not provided
Ferrocyanide 250 µmol/l • Automated clinical chemistry analyser: ABX PENTRA 400
Bovine albumin 0,2 % • Calibrator: ABX Pentra Multical, Ref. A11A01652
Sodium azide < 0,1 % • Controls: ABX Pentra N Control, Ref. A11A01653, and
Form-0846 Rev. 2

ABX Pentra P Control, Ref. A11A01654

• Standard laboratory equipment

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
Uric Acid CP

Specimen Detection limit:

• Serum. The detection limit is determined according to the Valtec protocol (5)
• Plasma in lithium heparin. and equals 0.19 mg/dl.

Stability (4): 3 days at room temperature. Accuracy and Precision:

• Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
Reference range (2)
tested 20 times according to the recommendations found in the Valtec
Each laboratory should establish its own reference ranges. The values
protocol (5).
given here are used as guidelines only.
Mean value mg/dl CV %
Serum, plasma: Women: 26 - 60 mg/l
Control specimen 1 4.62 0.45
2.6 - 6 mg/dl
Control specimen 2 11.63 0.34
155 - 357 µmol/l
Specimen 1 2.53 1.24
Men: 35 - 72 mg/l
Specimen 2 4.58 0.91
3.5 - 7.2 mg/dl
Specimen 3 7.19 1.02
208 - 428 µmol/l
• Reproducibility (total precision)
Storage and Stability 2 specimens of low and high levels and 2 controls are tested in
Reagents, in unopened cassettes, are stable up to the expiry date on duplicate for 20 days (2 series per day) according to the
the label if stored at 2-8° C. recommendations found in the CLSI (NCCLS), EP5-A protocol (6).
Stability after opening: refer to the paragraph "Performance on ABX
Mean value mg/dl CV %
Pentra 400".
Control specimen 1 4.64 2.81
Control specimen 2 11.73 1.39
Assay Procedure
Test instructions for automated systems other than ABX Pentra 400 are Specimen 1 4.67 2.64
available on request (not available in the USA). Specimen 2 6.74 2.51

Waste Management
1. Please refer to local legal requirements.
2. These reagents contain less than 0.1 % of sodium azide as a
preservative. As sodium azide may react with lead and copper to
form explosive metal azides, these reagents should be disposed of
by flushing with copious amounts of water.
General Precautions
1. Reagent, for professional in-vitro diagnostic use only.
2. Gently agitate any turbid reagents before use.
3. The reagent cassettes are disposable and should be disposed of in
accordance with the local legal requirements.
4. Please refer to the MSDS associated with the reagent.
Measuring Range:
The assay confirmed a measuring range from 0.18 mg/dl to 23.59 mg/
dl, providing an upper linearity limit of 25.00 mg/dl, with an
automatic post-dilution up to 75.00 mg/dl.
The reagent linearity is determined according to the recommendations
found in the CLSI (NCCLS), EP6-A protocol (7).
Correlation:
132 patient samples (serum/plasma) are correlated with a commercial
reagent taken as reference according to the recommendations found
in the CLSI (NCCLS), EP9-A2 protocol (8). Values ranged from 0.18 to
23.59 mg/dl.
The equation for the allometric line obtained is:
Y = 0.95 x + 0.09 with a correlation coefficient r2 = 0.996.

Interferences:
Performance on ABX Pentra 400
The performance data listed below have been obtained on the ABX Haemoglobin: No significant influence is observed up to 500 mg/dl
Pentra 400 analyser. Triglycerides: No significant influence is observed up to 612.5 mg/dl
(as Intralipid®, representative of lipemia)
Number of tests: 220 tests. Total Bilirubin: No significant influence is observed up to 36 mg/dl
On board Reagent Stability: Direct Bilirubin: No significant influence is observed up to 30 mg/dl
Once opened, the reagent cassette placed in the refrigerated ABX
Conversion factor:
Pentra 400 compartment is stable for 41 days.
µmol/l x 0.168 = mg/l
Sample volume: 5 µl/test µmol/l x 0.0168 = mg/dl

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
Uric Acid CP

Calibration stability:
The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.

The calibration stability is at least 15 days.

Note: A recalibration is recommended when reagent lots change, and

when quality control results fall outside the range established.

Application releasea: 2.02

Warning
It is the user's responsibility to verify that this document is applicable
to the reagent used.

Reference
1. First, M.R., Renal function. Clinical Chemistry: Theory, Analysis,
Correlation. 4ème Ed. Kaplan, L.A., Pesce, A.J., Kazmierczack, S.C.,
(Mosby Inc. eds St Louis USA), (2003), 477-appendice.
2. Tietz, N.W. Clinical guide to laboratory tests, 3rd Ed, (W.B.
Saunders eds. Philadelphia USA), (1995), 624.
3. Fossati,P., Prencipe,L. et Berti, G. Use of 3,5-dichloro-2-hydroxy-
benzenesulfonic acid 4-aminophenazone chromogenic system in
direct enzymatic assay of uric acid in serum and urine. Clin.Chem.
1980,26,227.
4. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-
Books Verlagsgesellshaft; 1998, p.208-214.
5. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
6. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19, No. 2,
february 1999.
7. Evaluation of the Linearity of Quantitative Analytical Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.
16, april 2003.
8. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2, Vol.
22, No. 19, 2002.

a.Modification from index A to B: new application release.

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
Uric Acid CP

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com