Avacta has obtained CE mark for its AffiDX SARS-CoV-2 antigen lateral flow test (LFT) for usage as a self-test in the European Union and the UK. The test can detect people with an increased viral load of the SARS-CoV-2 virus from a nasal swab sample. It delivers results in 20 minutes and has demonstrated sensitivity and specificity of 98% and 99%, respectively. Avacta in collaboration with Medusa Healthcare sought approval for consumer self-testing with the test. With an exclusive deal in place between the companies to market the test across the globe, Medusa will commercialise the test as ‘MeduFlow’.
Becton, Dickinson and Company (BD) has partnered with digital health company Everly Health, Southeastern Grocers and Winn-Dixie stores to offer its Veritor At-Home COVID-19 Test for purchase. Authorised by the Food and Drug Administration under Emergency Use Authorization (EUA), the test checks for the presence of proteins from the SARS-CoV-2 virus to detect Covid-19. It utilises a smartphone camera and app to capture and interpret results and will also be offered through Amazon.com.
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genedrive has submitted an application seeking approval for its point-of-care Genedrive COV19-ID Kit in the UK under the latest Coronavirus Test Device Approvals (CTDA) regulations. The latest move comes after the company obtained CE-IVD mark for the assay. The sensitivity and specificity of the test on the complete cohort met the current requirements of the UK’s MHRA Target Product Profile for SARS-CoV-2 Point-of-Care molecular diagnostic tests. The TaqPath COVID-19 RT-PCR test of Thermo Fisher was used to compare the extended clinical validation sample cohort necessary for CTDA approval. The specificity and sensitivity of the assay were 98% in 264 samples with viral load >500 copies per ml and could identify Omicron variant.
