Direct Test Includes Eight Circulating Influenza Viruses

The test can report results in about an hour through a proprietary process that eliminates nucleic acid extraction, a time consuming technique typically employed by molecular tests.

The US Food and Drug Administration (FDA; Silver Springs, MD, USA) has granted 510(k) clearance to the test kit which is classified as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity. The additional eight strains for which FDA cleared analytical reactivity are: H7N9, H3N2 (both the Minnesota and Indiana strains) as well as H1N1 (2011), H3N2 (the Ohio and Texas strains) and influenza B (Brisbane and Wisconsin strains). Of particular concern are the novel avian influenza A strain H7N9, which can cause death in as many as one third of infected patients, and the H3N2v, which infects humans more easily than other swine influenza virus.

The Simplexa Flu A/B & RSV Direct kit (Focus Diagnostics; Cypress, CA, USA) used with the 3M Integrated Cycler is a real-time polymerase chain reaction (RT-PCR) molecular test for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

Michelle Tabb, PhD, vice president of research and development for Focus Diagnostics, said, “Timely diagnosis is critical to effective management of infectious diseases like influenza. By providing fast, reliable results in about an hour, our Simplexa platform helps physicians quickly diagnose and treat patients. These changes to our Simplexa test reflect our vision to develop high quality molecular tests that deliver critical insights to improve outcomes and empower better health.”

Related Links:
US Food and Drug Administration 
Focus Diagnostics