US FDA grants emergency use authorisation for Roche’s Covid-19 test

Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates

Follow the latest updates of the outbreak on our timeline.

Roche has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an Elecsys Anti-SARS-CoV-2 antibody test for the coronavirus (Covid-19).

The test is expected to help identify patients who have been exposed to Covid-19 and assess patients’ immune response to the SARS-CoV-2 virus. It is said to have specificity higher than 99.8% based on the measurement of 5,272 samples.

It also detected 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus, the company noted.

The test is available on Roche’s cobas e analysers, which are widely available across the hospitals and reference laboratories around the world.

The fully automated systems provide SARS-CoV-2 test results in 18 minutes with a test throughput of approximately 300 tests an hour.

Roche Group CEO Severin Schwan said: “Thanks to the enormous efforts of our dedicated colleagues, we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the Covid-19 health crisis.

“I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support healthcare systems around the world with a reliable tool to better manage the Covid-19 health crisis.”

Meanwhile, Roche has started shipping the new antibody test to laboratories worldwide. The company plans to scale up its manufacturing capabilities to supply several million tests a month.