Roche’s COVID-19 Antibody Test Receives FDA Emergency Use Authorization

Roche (Basel, Switzerland) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new Elecsys Anti-SARS-CoV-2 antibody test to determine if a patient has been exposed to SARS-CoV-2 and developed antibodies against the virus.

Elecsys Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5272 samples, the Elecsys Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. The test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers, which are widely available around the world. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for one single test, with a test throughput of up to 300 tests/hour, depending upon the analyzer. Roche has already begun 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 US.

“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,” said Severin Schwan, CEO Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”

“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,” said Thomas Schinecker, CEO Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”