FDA grants emergency use authorization to Roche SARS-CoV-2 antibody test

Roche Diagnostics’ new Elecsys SARS-CoV-2 antibody test gained emergency use authorization (EUA) from the United States Food and Drug Administration (FDA) this week, granting a new blood test to test those who may have been exposed to COVID-19.

The test detects antibodies directed against the SARS-CoV-2 spike protein, an area that allows the virus to bind to a host cell receptor and enter the host cell. Coincidentally, this is the area many current vaccine candidates seek to block. Elecsys could measure antibody response and track their growth over time, offering a numerical result and a qualitative result on such concentration.

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

Elecsys runs on Roche’s cobas e analyzers, which are widely available at labs and point of care institutions. The company states that its addition could help measure patients’ immune responses and guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying potential antibody-bearing donors.

Convalescent plasma therapy, which consists of plasma separated and removed from a patient’s blood, to be replaced by that from a donor laced with antibodies, is a route that has likewise garnered much scientific attention since the start of the COVID-19 outbreak. The theory behind it is to help ill patients fight off the virus through the antibodies of others.