Dec. 2, 2020—Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received emergency use authorization from the FDA. The semiquantitative serology test detects antibodies against the SARS- CoV-2 spike protein. Semiquantitative testing can also 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.
“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, said in a press statement. “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.”
The laboratory-based Elecsys Anti-SARS-CoV-2 S test provides a numerical result from 0.40 to 250 U/mL as well as a qualitative result. It runs on Roche’s Cobas e analyzers.
Roche will begin shipping the test to U.S. laboratories in the next week. LabCorp will be the first lab to offer the testing option in the United States.