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Specifications

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
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