Roche Elecsys Anti-SARS-CoV-2 Antibody Test Goes Live at More than 20 Initial Lab Sites in US

The Elecsys Anti-SARS-CoV-2 antibody test, which received Emergency Use Authorization from the FDA earlier this month, is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, indicating whether a person has already been infected and potentially developed immunity to the virus. Uniquely designed to identify mature (high affinity) antibodies developed late in the immune response, the Elecsys Anti-SARS-CoV-2 test has 99.8% specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. The test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

Roche has more than 3,000 analyzers that perform the antibody test installed across the US. The company is distributing millions of tests per week to US labs that can implement quickly, enable the broadest geographic reach and provide testing to areas hardest hit by COVID-19. Roche is also working to meet demand by scaling global production rapidly in an effort to expand broader access as quickly as possible.

“Roche is proud to make this highly accurate serology test available in the U.S. to determine if a person has developed antibodies to COVID-19,” said Matt Sause, President and CEO of Roche Diagnostics North America. “Reliable, high-quality antibody testing is essential to help us overcome this pandemic and will play an important role in getting people back to work. We are proud to partner with LabCorp in making this test available in the U.S.”

“Our long-standing relationship and collaboration with Roche enables us to introduce many innovative, high-quality tests for clinicians and patients, which is more important now than ever before,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Roche’s new antibody test allows LabCorp to provide more options and increase COVID-19 testing capacity as we support the country’s response to the health crisis.”