ASO-Turbi

Presentation: ASO
R1 45 ml/R2 5 ml/R3 1 ml Ref.: 41010
Store: 2 - 8 C. Turbilatex
Diagnostic reagent for qualitative measurement of ASLO. MATERIAL REQUIRED BUT NOT PROVIDED 3. Detection limit: Values less than 20 IU/mL give non-reproducible
- Thermostatic bath at 37C. results.
Only for in vitro use in clinical laboratory (IVD) - Spectrophotometer capable of accurate absorbance readings at 540 4. Sensitivity: 0.73 mA. IU/mL.
TEST SUMMARY nm. 5. Precision:
Latex particles coated with human anti-ASO are mixed with a serum sample. - Cuvettes with 1 cm light path. Intra-assay n=10 Inter-assay n=10
Agglutination is formed when a sample containing ASO is combined with the Mean (IU/mL) 135 236 372 135 236 372
General laboratory equipment
reagent. The degree of agglutination is directly proportional to the SD 3.4 5.4 5.9 7.9 13.2 17.7
concentration of ASO in the sample. CV (%) 2.5 2.3 1.61 5.9 5.5 4.8
TEST PROCEDURE
REAGENTS COMPOSITION 1. Bring the working reagent and the photometer to 37C. 6. Accuracy: Results obtained using these reagents (y) were
2. Set spectrophotometer wavelength to 540 nm and adjust to zero compared to those obtained using a commercial reagent (x) with
Tris buffer 20 mmol/L, sodium azide 0.95 g/L.
Diluent (R1) absorbance against water. similar characteristics. 80 ASO samples ranging from 20 to 800
pH 8.2.
3. Pipette into a Cuvette: IU/mL were assayed. The correlation coefficient (r) was 0.98 and
Suspension of latex particles coated with human the regression equation was y=1.305x-7.65.
Latex (R2) Calibrator Sample
streptolysin O, sodium azide 0.95 g/L, pH 8.2
Working reagent (mL) 1 1
Human serum: ASO. The results of the performance characteristics depend on the used
Calibrator (R3) Calibrator (L) 10 - analyzer.
Concentration is stated on the vial label. Sample (L) - 10
Ref.: 41012 Control ASO/CRP/RF Level L 4. Mix and read the absorbance against blank immediately (A1) and INTERFERING SUBSTANCES
Optional after 2 minutes (A2) of the sample addition. Do not interfere:
Ref.: 41022 Control ASO/CRP/RF Level H
- Rheumatoid factors: < 300 IU/mL
PRECAUTIONS CALCULATIONS - Bilirubin: < 20 mg/dL
Components from human origin have been tested and found to be negative (A2-A1) sample - Hemoglobin: < 10 g/L
for the presence of HBsAg and HCV, and of antibody to HIV (1/2). However x Calibrator concentration = IU/mL ASO - Lipids: < 20 g/L.
handle cautiously as potentially infectious. (A2-A1) calibrator Other substances may interfere6.
Good laboratory safety practices should be followed when handling QUALITY CONTROL NOTES
laboratory reagents or human samples. SERUM CONTROLS Ref.: 41012 and Ref.: 41022 are recommended to 1- Samples with higher concentrations shoud be diluted 1/3 in NaCl
monitor the performance. 9 g/L. and retested again. The linearity limit depends on the
REAGENT PREPARATION AND STABILITY sample / reagent ratio, as well the analyzer used. It will be higher
Working reagent: Shake the latex vial gently before use. Prepare the Serum controls are recommended for internal quality control. Each
laboratory should establish its own Quality Control scheme and by decreasing the sample volume, although the sensitivity of the
necessary amount as follow: 1 mL Latex Reagent + 9 mL Diluent. corrective actions if controls do not meet the acceptable tolerances. test will be proportionally decreased.
Stable for 1 month at 2-8C.
ASO Calibrator: Reconstitute ( ) with 1.0 mL of distilled water. Stable for BIBLIOGRAPHY
1 month at 2-8C or 3 months at 20C. REFERENCE VALUES 1. I Haffejee, Quarterly Journal of Medicine 1992, New series 84; 305: 641
6
Do not freeze; frozen reagents could change the functionality of the test. Up to 200 IU/ml (adults) and 100 IU/mL. (children<5 years old) . 658
2. Alouf et al. Biocheimie 1973; 56-61
Signs of reagent deterioration: 3. M Fasani et al. Eur J Lab Med 1994; vol2.n1: 67
- Particles and turbidity indicates contamination or reagents It is suggested that each laboratory establish its own reference range. 4. E W Todd. J Exp Med 1932; 55: 267 280
deterioration. 5. Klein et al. Applied Microbiology 1970; 19: 60-61
CLINICAL SIGNIFICANCE 6. Klein et al. Applied Microbiology 1971; 21: 999-1001
All the reagents of the kit are stable up to the end of the indicated Streptolysin O is a toxic immunogenic exoenzyme produced by - 7. Young DS. Effects of drugs on clinical laboratory test, 4th ed. AACC Press,
month and year of expiry. Stored at tightly closed at 2-8C,. Do not use 1995.
reagents over the expiration date.
heamolitic Streptococci of groups A, C and G. Measuring the ASO
antibodies is useful for the diagnostic of rheumatoid fever, acute
glomerulonephritis and streptococcal infections. Rheumatic fever is an
CALIBRATION inflammatory disease affecting connective tissue from several parts of
The assay is calibrated to the ASO International Calibrator (WHO). The use human body as skin, heart, joints etc and acute glomerulonephritis is a
of other commercially available ASO calibrators is not recommended. renal infection that affects mainly to renal glommerulus.
SPECIMEN
Fresh serum. Stable 7 days at 2-8C or 3 months at 20C. Clinical diagnosis should not be made on a single test result; it should
integrate clinical and other laboratory data.
The samples with particles or fibrin should be centrifuged to eliminate them.
Do not use haemolized or lipemic samples.
REAGENT PERFORMANCE
Discard contaminated specimen 1. Linearity limit: Up to 800 IU/mL(note1) (under the described assay
conditions)
2. Prozone effect: No prozone effect was detected up to 2000 IU/mL.

CHEMELEX, S.A.
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