Roche Receives FDA Emergency Use Authorization for New COVID-19 Antibodies Test

Source: Roche

Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the FDA. The semi-quantitative serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus.

The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus cell to bind to the host cell receptor, which is required for the virus to enter the host cell.1,2 The test also provides a numerical result from 0.40-250 U/mL as well as a qualitative result.

Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time.

“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” Matt Sause, president and CEO of Roche Diagnostics Corporation, said in a company news release. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response, and supporting the development of convalescent plasma therapy to help other patients fight the disease.” 

In addition to its role in helping to measure a patient’s immune response, semi-quantitative testing can help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus. Convalescent plasma therapy is a procedure that separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor to give the ill patient antibodies to help fight the virus. 

The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available cobas e analyzers and is the latest addition to Roche’s growing diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions that help healthcare professionals diagnose COVID-19 and provide optimal patient care during the initial stages of infection and the recovery phase, as well as following the resolution of infection.

Roche will begin shipping the Elecsys Anti-SARS-CoV-2 S test to U.S. laboratories in the next week. LabCorp, an early adopter of the test with broad geographic reach, will be the first lab to offer the testing option in the United States. 

“As vaccines and other therapeutic treatments become available, it will become more important to have tests which are more specific about the levels of antibodies in patients,” Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a company news release. “We’re pleased to expand our offerings in the fight against COVID-19 and be the first national lab to offer Roche’s semi-quantitative test to the market.”


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