The US Food and Drug Administration (FDA) has approved Focus Diagnostics' Simplexa Flu A/B & RSV Direct Kit for eight additional influenza strains, which are considered to pose major health risks this winter.
The latest additional analytical reactivity clearance, which comes after the FDA granted 510(k) clearance to the test kit in July 2012, includes Flu A H7N9 and H3N2v, among a range of strains.
Focus Diagnostics infectious diseases medical director Hollis Batterman said: "Influenza viruses constantly evolve, and virus subtypes can quickly develop and infect large populations.
"It is vital that the tests can detect the recently circulating and geographically diverse strains."
The Simplexa Flu kit on the 3M Integrated Cycler has been a real-time RT-PCR molecular test that had achieved FDA approval for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs.
Further, the kit is claimed to be the first to achieve FDA approval for molecular detection of influenza A, B and respiratory syncytial virus.
Batterman added: "The studies we’ve performed with our Simplexa Influenza/RSV assay reflect our commitment to making sure health care providers have access to molecular infectious disease tests that are highly robust and use the most innovative technologies.
The test can also report results in about an hour through a proprietary method which gets rid of nucleic acid extraction, which is originally a time consuming technique typically used by molecular tests.
The test kit with the eight additional strains can be purchased directly in the US and internationally via the global distribution network of Focus Diagnostics.