A rapid test for the qualitative detection of Strep A antigen in throat swab specimens. Lateral flow immunoassay technology identifies antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A carbohydrate antigen in a throat swab specimen. Aids in the early diagnosis of Group A Streptococcal infection. 97% sensitivity; 95% specificity. Accurate results in 5 minutes. Quickly diagnose and treat infections to help avoid serious complications. CLIA Waived and FDA 510(k) cleared to market. Room temperature storage.