FDA has issued an emergency use authorization for the Elecsys Anti-SARS-CoV-2 antibody test from Roche, Basel, Switzerland. The test is designed to help determine whether a patient has been exposed to the SARS-CoV-2 virus and whether the patient has developed antibodies against SARS-CoV-2.


Severin Schwan, Roche.

Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as the United States.

“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,” says Severin Schwan, chief executive officer of Roche Group. ”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.”


Thomas Schinecker, Roche Diagnostics.

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” says Thomas Schinecker, chief executive officer of Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

The Elecsys Anti-SARS-CoV-2 test is an immunoassay for the in vitro qualitative detection of antibodies (including IgG) to SARS-CoV-2 in human serum and plasma. The test has a specificity greater than 99.8% and sensitivity of 100%. As more is understood about SARS-CoV-2, the test may help to assess which patients have built up immunity to the virus. Hospitals and reference laboratories can run the test on Roche’s Cobas e analyzers, which are widely available around the world.

For more information, visit Roche.