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. Includes 25 Strep A Test Strips, 25 Swabs, 25 Extraction Tubes, 1-10mL Reagent A, 1-10mL Reagent B, 1-1mL Positive Control, 1-1mL Negative Control, Package Insert, Procedure Card, 25 tst/bx