Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies

IndustryPRwire - Roche announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The 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 EUA in the United States follows the launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September.

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 to bind to a host cell receptor, which is required for the virus to enter the host cell. 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. The test provides a numerical result describing the concentration of antibodies from 0.40-250 U/mL as well as a qualitative result.

Thomas Schinecker, CEO of Roche Diagnostics Commented “Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19 Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response”.

In addition to its role in helping to measure a patient’s immune response, the test may 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 an investigational 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.

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