Roche said its cobas SARS-CoV-2 & Influenza A/B test had won Emergency Use Authorization approval from the US Food and Drug Administration (FDA) (Photo: FABRICE COFFRINI/AFP via Getty Images).

Swiss pharmaceutical giant Roche said on Friday (17) it had developed an antibody test that it hopes to roll out in May to detect people previously infected with Covid-19, even those who displayed no symptoms.

Roche said in a statement that it had developed the Elecsys Anti-SARS-CoV-2 immunoassay, which using a blood sample can detect antibodies to determine the body’s immune reaction to the novel coronavirus that causes Covid-19.

Research teams around the world have been racing to develop such so-called serology tests for the virus, known as SARS-CoV-2, that has sparked the global pandemic with more than 2.1 million infections and over 141,000 deaths.

“Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms,” the Roche statement pointed out.

It added that such tests could also allow screening within high risk groups like healthcare workers to determine if they may already have developed a certain level of immunity, Roche said.

“Once we understand more about the immunity of Covid-19, it could also help society return faster to normality,” it said.

Roche said it was working with the US Food and Drug Administration (FDA) to ensure “emergency use authorisation” to bring its test to market, and said it would also be made available in markets that accept the European CE-mark certification.

The company said it aimed to produce tens of millions of the new test by June, and said it would subsequently “further scale up production as fast as possible.”

Roche said the tests can be processed using multiple models of its analysers already in use in hospitals and reference laboratories around the world.


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