The Strep-A Rapid Test is a rapid test used to qualitatively detect Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

· FDA Cleared and CLIA Waived

· 95% Overall accuracy in Rare & 1+ colonies vs Culture (Gold Standard)

· Sensitivity of 97%

· Specificity of 95%

· Easy-to-read results ready within 5 minutes

Each kit box includes:

· 25 Test Strips

· Disposable Extraction Tubes

· Sterile Swabs (Dacron)

· Reagent A (2M Sodium Nitrite)

· Reagent B (0.4M Acetic Acid)

· Positive Control

· Negative Control

· Procedure Card

· Package Insert

For professional in vitro diagnostic use only