Chembio Earns CE Mark for Two COVID-19 Tests

New York-based Chembio has been granted CE mark certification for two COVID-19 tests, the DPP SARS-CoV-2 antigen and IgM/IgG tests.

The antigen test uses a test cartridge, a micro-reader analyzer and a nasal swab to detect coronavirus antigens in 20 minutes. The IgM/IgG test detects antibodies in the blood produced in response to COVID-19 infection. It generates results within 15 minutes using finger-stick, venous whole-blood, plasma or serum samples and a micro-reader analyzer.

The company has entered into a distribution agreement with Luas Diagnostics, which will begin sales of the tests immediately and serve as the exclusive commercial partner for Chembio products in the UK and Ireland.