NEW YORK — Ortho Clinical Diagnostics said on Tuesday that it has received the CE mark for its Vitros SARS-CoV-2 Antigen test that allows its use with additional samples and viral transport media.
The test, which runs on the company's automated Vitros platform, first received CE marking in October for use with nasopharyngeal swab specimens. With the new CE mark, the test can be used with nasal samples, which are more convenient to collect, Raritan, New Jersey-based Ortho said.
Additionally, the test can now be used with three additional viral transport media (VTM) options including the Vitros SARS-CoV-2 Antigen Test include Saline or Phosphate Buffered Saline, as well as Trinity Biotech's Bartels FlexTrans and the World Health Organization's VTM formulation. The test had previously been CE marked for use with the US Centers for Disease Control and Prevention's VTM formulation, Copan Diagnostics' universal transport medium, and Hardy Diagnostics' R99 VTM.
The test received Emergency Use Authorization from the US Food and Drug Administration in January.