FDA approves Alere i Strep Test for Group A Streptococcus Infectious Diseases- Alere

Alere has announced that its Alere i Strep A test has received marketing clearance from the FDA. Alere i Strep A is the first molecular test that detects Group A Streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less. The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014.

The clinical performance of Alere i Strep A was established in a multi-center study conducted in the U.S., in which 481 throat swab specimens were evaluated with Alere i and compared to standard bacterial culture. The overall sensitivity and specificity of the Alere i Strep A was 95.9% and 94.6%, respectively. All samples generating discordant results between Alere i Strep A and bacterial culture were evaluated by a laboratory developed real-time PCR assay. Of the 6 samples negative by Alere i Strep A and positive by bacterial culture, 4 were also negative for Group A Strep by the real-time PCR assay. Of the 18 samples positive by Alere i Strep A and negative by bacterial culture, 13 were also positive for Group A Strep by the real-time PCR assay.