Weavr Health has submitted an Emergency Use Authorization (EUA) request to the US Food and Drug Administration (FDA) for its Silk Covid-19 Rapid Antibody Test. When authorised, the company’s test could be the first Covid-19 antibody test delivering testing results for IgG and IgM antibodies within ten minutes. The Silk is a lateral flow test, which requires a fingerstick blood draw, offering easy administration for home use. The EUA request will allow the distribution and use of the test at non-healthcare and point of care settings for individuals 18 years and older.
Roche has received a CE mark for its SARS-CoV-2 Antigen Self Test Nasal. The test is expected to be available in packs of five at all pharmacies and other locations in countries accepting the CE mark. An earlier version of the test is already available for home tests in European countries since February 2021. The test is integrated with NAVIFY Pass, Roche’s digital solution that displays all information related to Covid-19 result and vaccine status through a unique QR code.
LivFul and Global Access Diagnostics (GAD) have entered into a new partnership to provide a number of Covid-19 test kits, starting with rapid antigen tests, to low and middle incomes countries. GAD’s Covid-19 rapid antigen tests have a reported sensitivity of 90.6% and a specificity of 100%. The WHO recommends a minimum of 80% sensitivity and >97% specificity to minimize false positives.