6, Rue Ibn Ennafis - Z.I. Lac 3 Tunisie
Tél. : 71 182 500 - Fax : 71 182 250
www.biomaghreb.com
IVD
FT En 41 Date of updating : 10/ 2020 Version B
IN VITRO DIAGNOSTIC USE
Manufacturer Use by In Vitro Diagnostic Temperature
Limitation
Catalogue number See insert Keep away
from light
Sufcient
for < n > essais
Batch number
CLINICAL SIGNIFICANCE
Streptolysin O is a toxic immunogenic exoenzyme produced by - heamolitic Streptococci of groups
A, C and G. Measuring the ASO antibodies are useful for the diagnostic of rheumatoid fever, acute
glomerulonephritis and streptococcal infections. Rheumatic fever is an inflammatory disease affec-
ting connective tissue from several parts of human body as (skin, heart, joints, etc…) and acute
glomerulonephritis is a renal infection that affects mainly to renal glommerulus.
PRINCIPLE
Detection of antistreptolysin O (ASO) antibodies by agglutination reaction on card of latex particles
sensitized with stabilized streptolysin O. The reagent is standardized to the WHO.
REAGENT COMPOSITION
Latex ASO
(Ready to use)
Homogenize carefully before use
(1 drop = 50 µl)
Positive control
(Ready to use)
Dropper bottle
(1 drop = 50 µl)
Negative control
(Ready to use)
Dropper bottle
(1 drop = 50 µl)
Card Card for carrying out the test
Stirrers stirrers for mixing reagents and samples
SAFETY CAUTIONS
Biomaghreb reagents are intended for use by qualified personnel for in vitro use (do not pipette by
mouth).
• Refer to the current MSDS available on request or on www.biomaghreb.com.
• Check the integrity of the reagents before use.
• Disposal of waste: comply with applicable legislation.
For safety reasons, treat any specimen or reagent of biological origin as potentially infectious. Ob-
serve the applicable legislation.
SAMPLE PREPARATION
Sera fresh or stored at -20°C, showing complete coagulation.
Reject any lipemic or contaminated serum. Do not use plasma.
PRESERVATION AND STABILITY
Store at 2-8°C until the expiration date indicated on the box.
PROCEDURE
Bring reagents and test sera to room temperature (18-25°C).
1) Qualitative test
Place successively on the card :
• drop of the positive control
• 1 drop of negative control
• 1 drop of the serum to be tested
Next to each deposit; add, using the vertical dropper, 1 drop of well homogenized ASO Latex Reagent.
Mix with a stirrer.
Make a slow rotational movement to the card. Note the appearance of agglutination in exactly 3
minutes.
◊ RESULT
› Positive reaction (agglutination) :
Presence of antistreptolysin O antibodies at a level higher than 200 Ul/ml (pathological threshold).
› Negative reaction (homogeneous suspension) :
Absence of antistreptolysin O antibodies or presence at a level lower than 200 Ul/ml.
2) Semi quantitative test
Prepare a series of dilutions of the test serum in 9 g/l NaCI solution. Repeat the test for each dilution
in the same way as for the qualitative test and look for the last dilution still giving agglutination. The
concentration of the test serum in ASO is estimated by multiplying the titer obtained by the sensitivity
threshold of the test 200 Ul/ml.
X reagent sensitivity (200 lU/ml).
NORMAL VALUE
Up to 200 lU/ml
INTERPRETATION
Streptococcol A infections disease can be complicated by acute Rheumatoid arthitis, acute glome-
nula nephritis.
Essential biological diagnostic is immunologic-as no bacteria were found in late streptococci
infection.
The anti-streptolynine O antibodies is rate more than 200 lU/ml in 80% of streptococci infections.
A repeated test is recommended 15 days later as 200 lU/ml represents the pathological limit
detection.
BIBLIOGRAPHIE
-Alouf, J.E. and Raymond, M. Biochimie, 56 (1973). Bach, G. -Wiatr, R.A., Anderson, T.O. and
Chealte, E.: Amer, J.Clin. Path., 52 (1969).
-Halbert, S.P.: Ann. N.Y. Acad. Sci. 103 (1963) Klein. G.C,
-Baker C.N. and Jones. W.L. Appl. Microblol., 21, 999 (1979).
-Klein, G.C, Manual of Clin. Immunology, Ame, Soc. Microbiol, p. 264 (1976)
-Schimidt, K., Mueller-Eckardt, Ch. and Beckmann, A: Rheumatol, 29 (1970).
ASO LATEX
Serological detection of antistreptolysin
O antibodies on latex particles
