Omega Diagnostics Group Gains CE Mark for Its Visitect COVID-19 Antigen Test
UK-based Omega Diagnostics has received CE mark certification for its Visitect COVID-19 antigen test for self-testing.
The test, which can detect the SARS-CoV-2 virus that causes COVID-19 from nasal swabs, has a sensitivity of 93.2 percent and a specificity of 97.8 percent.
The test has yet to be approved under the UK’s new coronavirus test device approvals regulation introduced on Nov. 1, 2021. The UK authorities have requested additional field study data, the company said.