The Aptima SARS-CoV-2/Flu Assay from Hologic is now available for commercial use in North America and Europe. The test can simultaneously identify SARS-CoV-2, influenza A and influenza B. The test runs on the company’s fully automated Panther system, which can conduct over 1,000 tests in 24 hours and delivers preliminary results in nearly three hours. The assay has obtained a CE-mark for diagnostic testing in Europe and is authorised for use in Canada and the US.
Fulgent Genetics has launched a neutralising antibody test for Covid-19 for use in at-home settings. Set to be offered through Fulgent’s consumer-initiated platform, Picture Genetics, the test will aid allow users to understand what their resistance might be to an active Covid-19 infection. The finger prick test can be conducted at home to assess the neutralising antibody levels in vaccinated individuals and people who have recently recovered from Covid-19.
Scientists at the University of Massachusetts Chan Medical School in the US have completed six studies to aid in bringing over the counter, at-home Covid-19 tests to market, and are now building on their previous work to learn more about how effective and feasible the tests are for broad-based population screening and how consumers interact with the devices. The studies have been backed by the Rapid Acceleration of Diagnostics (RADx) initiative of the US National Institutes of Health. Going forward, the researcher’s work will attempt to answer questions among regulators about tradeoffs in speed of results, affordability, convenience and accuracy between rapid home antigen tests and more costly, time-consuming polymerase chain reaction (PCR) molecular tests.