Cleartest light Strep-A cassette test

The CLEARTEST® light Strep A rapid test as test cassette, is a chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigens in human throat swabs for the diagnosis of Group A Streptococcus infections. The test is intended for professional in vitro use only.

Streptococcus pyogenes is an immobile gram-positive coccus that contains the Lancefield group A antigens, which can cause severe infections such as pharyngitis, respiratory tract infections, impetigo, endocarditis, meningitis, puerperal sepsis and arthritis. If left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscesses. Traditional identification procedures for group A streptococcal infections involve isolating viable organisms and identifying them using techniques that take 24 to 48 hours or longer. The test uses antibodies specific for whole-cell Lancefield group A streptococci to selectively detect Strep A antigens in a throat swab.

Performance characteristics

Sensitivity, specificity and accuracy

Strep A strip rapid test

• Sensitivity: 95.1 % (95 % CI*: 89.6 % - 98.2 %)
• Specificity: 97.8 % (95 % CI*: 95.8 % - 99 %)
• Accuracy: 97.1 % (95 % CI*: 95.3 % - 98.4 %)

3 step procedure (sample collection, preparation, testing)

Test evaluation after 5 minutes

Can be performed with throat swab

Store sealed pouch at room temperature or refrigerated (2 - 30 °C). Do not freeze.