A molecular diagnostic platform that detects Group A Streptococcus (GAS) infections in eight minutes or less was awarded a CLIA (Clinical Laboratory Improvement Amendments) waiver by the [US] Food and Drug Administration, which paves the way for its use in a broad range of healthcare settings.

The Alere Inc. (Waltham, MA, USA) i Strep A test, which was initially approved for diagnostics use in the USA in April 2015, now joins the Alere i Influenza A & B assay as the first-ever molecular tests to receive a CLIA waiver.

Alere i Strep A detects GAS bacteria in throat swab specimens using the company's proprietary Molecular in Minutes (MIM) isothermal nucleic acid amplification technology (iNAT). Unlike polymerase chain reaction (PCR) tests, iNAT does not require lengthy and complex thermocycling or DNA purification and can therefore deliver PCR-caliber results more quickly and in a broad range of settings. Thus rapid (less than eight minutes) GAS diagnostics will be available in a broad range of healthcare settings, including physician offices, hospital emergency rooms, and retail and walk-in clinics in the USA.

“Strep A is highly transmissible, and prompt treatment is critical to reducing the spread of the infection to others. With CLIA waiver for the Alere i Strep A test, we can help link more people to early treatment by bringing rapid molecular diagnosis to even more settings where they seek health care,” said Avi Pelossof, global president of infectious disease at Alere.

Related Links:
Alere Inc.