CPT Code: 87880/87880QW* Sensitivity: 97.9% Specificity: 97.3% Specimen: Throat Swab SAS™ StrepAlert ® is a lateral-flow, membranebased immuno­­ assay for the qualitative d ­ etection of Group A ­ treptococcal antigen S ­ from throat swab ­ pecimens. Group A Strep is s one of the most ­ erious causes of ­ pper res u spiratory ­nfections, and the major cause of i pharyngitis which, if left ­ ntreated, can u lead to ­ erious complications such as s r ­ heumatic fever, ­ cute sinusitis, scarlet a fever and ­ lomerulonephritis. g • CLIA-waived and Non-waived • Simple, easy-to-use procedure • Room temperature storage • 18-month shelf life * “QW” modifier is added to report use of CLIA‑waived test systems for Medicare/­ edicaid claims. M Reliable Diagnostic Tests

1. Add 3 drops of Reagent A, and 3 drops of Reagent B to the Extraction Tube. 2. Place the specimen swab into the e ­ xtraction tube and mix the solution thoroughly by swirling the swab v ­ igorously. Allow the swab to soak for at least 1 minute but no longer than 15 minutes. Remove all liquid from the swab by rolling it against the side of the extraction tube and then squeezing the swab between the flexible sides. 3. Place dipstick into extraction tube. ­ Gently stir for 10-15 seconds. Test Results 5 Minutes Read results after 5 minutes and no later than 10 minutes. One line indicates negative...