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