On May 19, 2020, Roche announced its Elecsys Anti-SARS-CoV-2 antibody test is live at more than 20 commercial and hospital lab sites throughout the U.S., with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week. The Elecsys Anti-SARS-CoV-2 antibody test received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) earlier this month.

The Roche antibody test is uniquely designed to identify mature (high affinity) antibodies developed late in the immune response, significantly reducing the chance of a false positive result. It provides 99.8 percent specificity, which is greater than previously available antibody tests. This specificity is crucial to determine reliably if a person has been exposed to the virus and has developed antibodies. Tests with lower specificity and sensitivity can lead to a high number of misidentified cases in a population. A false positive result may put a patient at risk by indicating they have antibodies when they do not.

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

The Elecsys® Anti-SARS-CoV-2 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 99.8% 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. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.