US FDA gives EUA to Roche for COVID-19 antibody test

Roche has won emergency approval from the US Food and Drug Administration (FDA) for an antibody test to determine whether people have ever been infected with the coronavirus, informed the company.

Thomas Schinecker, Roche’s head of diagnostics, said the company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a month by the end of the year.

Roche, which also makes molecular tests to identify active COVID-19 infections, said its antibody test has a specificity rate exceeding 99.8 per cent and sensitivity of 100 per cent, meaning tests would show very few false positives and no false negatives.

Roche said its test relies on intravenous blood draws, with higher accuracy than finger-prick tests.

“If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein. You have to have very, very high specificity. Even 0.1 per cent or 0.2 per cent makes a difference,” Schinecker said.

Similar antibody tests have also been developed by companies including US-based Abbott Laboratories, Becton Dickinson and Italy’s DiaSorin.

Abbott has said the specificity and sensitivity of its test are 99.5 per cent and 100 per cent respectively. Diasorin has said its Liason XL test has 97.4 per cent sensitivity and 98.5 per cent specificity.

Roche did not disclose a price for its test but said that it would be identical worldwide.

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