California diagnostic firm Innova Medical Group announced on Wednesday that its Innova SARS-CoV-2 Antigen Rapid Qualitative Test has received CE marking for self-testing.

The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).

New guidelines from WHO strongly recommend offering self-testing for hepatitis C virus (HCV) as an additional approach to HCV testing services. WHO releases the new guidelines – its first on HCV self-testing – during the International AIDS Society Conference 2021.