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Sterp A INTENDED USE
The Strep A Rapid Test Cassette (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Strep A
antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

Strep A SUMMARY
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious
infections such as pharyngitis, respiratory infection, impetigo,endocarditis, meningitis, puerperal sepsis, and arthritis.1 Left untreated,
these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 Traditional identification
procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require
24 to 48 hours or longer.3,4
The Strep A Rapid Test Cassette (Throat Swab) is a rapid test to qualitatively detect the presence of Strep A antigen in throatswab
specimens, providing results within 5 minutes. The test utilizesantibodies specific for whole cell Lancefield Group A Streptococcus to
selectively detect Strep A antigen in a throat swab specimen.

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