Ortho Clinical Diagnostics, a provider of in vitro diagnostic solutions, has secured CE mark approval for its Covid-19 IgG antibody test.

The company’s VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test has been designed for the identification of IgG antibody.

Ortho has already launched Covid-19 Total test, and both tests will help in improved tracking and surveillance, patient management, and screening convalescent plasma.

In April this year, Ortho secured emergency use authorisation from the US Food and Drug FDA administration for its Covid-19 IgG antibody test. Earlier this month, the company secured CE mark approval for the total antibody test, while FDA EUA status was obtained in April.

The VITROS antibody tests have been authorised only to identify either Total or IgG antibodies from SARS-CoV-2.

Ortho’s Covid-19 tests run on fully automated analysers

Both tests run on the company’s fully automated analysers, including VITROS XT 7600 integrated system, VITROS 3600 immunodiagnostic system and VITROS 5600 integrated system.

The tests can also run on the VITROS ECi/ECiQ immunodiagnostic system, which is expected to be launched soon.

Ortho is producing the Covid-19 19 IgG antibody tests at its Pencoed facility in the UK. The company is planning to produce several million tests in the coming weeks.

Ortho Clinical Diagnostics CEO Chris Smith said: “Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity.

“During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”

In February, Ortho Clinical Diagnostics launched VITROS XT 3400 Chemistry System, to enhance its VITROS XT Solutions, a comprehensive suite of solutions for diagnostics labs.