Strepto Color

Intended use

STREPTO Color is a haemagglutination slide test for the rapid qualitative and semi-quantitative detection of 5 antibodies (ASLO, ASD, ASK, ASH, ANAdase) to the Group A Streptococcus antigens.

STREPTO Color offers a simple method for rapid detection of Group A Streptococcus, such may develop in streptococcal pharyngitis, rheumatic fever, pyoderma, glomerulonephritis, and other related conditions.

Currently, most clinical diagnostic laboratories perform only a single streptococcal antibody determination, the anti-streptolysin O (ASO or ASLO) tests.

Unfortunately, approximately 20% of ARF (Acute Rheumatic Fever) patients have normal serum titers of ASO. Moreover, the ASO response to streptococcal cutaneous infection is weak and inconsistent. In areas of the United States and the world in which streptococcal pyoderma-associated AGN (Acute Poststreptococcal Glomerulonephritis) are the principal streptococcal diseases, the ASO test is of very limited value. These problems may be largely overcome by measuring, in addition to ASO, serum antibodies to the other known extracellular enzymes of group A streptococci. Then STREPTO Color brings the adequate solution.

Principle

STREPTO Color is a direct agglutination slide test. The REAG reagent, brown-green colored, is composed of sheep red blood cells sensitized by exoenzyme of Group A Streptococcus (streptolysin, streptokinase, hyaluronidase, streptodornase, ANAdase), in a green dye.

The presence of anti-exoenzyme of Group A Streptococcus antibodies is revealed by haemagglutination on a light green background, visible to the naked eye. Otherwise, no agglutination is observed and the suspension remains homogeneous and brown-green colored.

Handling is simple and fast. It is performed on pure serum and the results are obtained in 2 minutes.

Simple methodology

Easy-to-read and easy-to-interpret results

The kit contains an internal quality control which allows observing a positive and a negative reaction as described below:

Reagents and material

• REAG: 1 vial containing 0.5 mL of sensitized red blood cells;
• CONTROL +: 1 vial containing 0.3 mL of positive control;
• CONTROL -: 1 vial containing 0.3 mL of negative control;
• TEST CARD: disposable reaction cards (x7).
• STICK: 50 disposable stirrers (x50)

Material required but not provided

• Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured;
• Haemolysis tubes (for semi-quantitative method)
• PBS (Phosphate buffered saline 0.15M – pH 7.2) (for semi-quantitative method)
• Contaminated waste container.

Stability and storage

• All reagents are ready-to-use.
• After opening, all reagents stored at 2-8°C, in their original state, are stable up to the expiry date indicated on the box. Do not freeze.

Performance
STREPTO Color enables the detection of anti-exoenzymes Group A, which appear frequently (more than 90% of cases) in the serum of patients with streptococcal infections (especially rheumatic fever, micropipette. glomerulonephritis, bacterial endocarditis, scarlet fever …).

The performance studies of STREPTO Color demonstrated a sensitivity and specificity above 95 %.