FDA Authorizes Use of COVID-19 Antibody Test

May 5, 2020

Roche received FDA Emergency Use Authorization for its anti-SARS-CoV-2 antibody test, Elecsys.

The FDA has issued an Emergency Use Authorization (EUA) for Roche’s antibody test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Elecsys), which is among the most recent EUAs that the FDA has put into action in response to the coronavirus disease 2019 (COVID-19) pandemic. 

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” Thomas Schinecker, chief executive officer of Roche Diagnostics, said in a statement. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

The Elecsys anti-SARS-CoV-2 serology test is an immunoassay for the in-vitro qualitative antibody detection, including immunoglobulin G, to SARS-CoV-2 in human serum and plasma.

Antibody tests are 1 of the 2 available testing methods for SARS-CoV-2; although a viral test will detect a present infection, an antibody test alerts of previous exposure to the virus, as well as the presence of antibodies that will fight against it.

Given the fast-moving nature of the pandemic and tireless work and collaboration by the public and private sector, Roche hopes that their antibody test will aid in evaluating immunity to COVID-19.

According to data from 5272 samples, the serology test has a specificity greater than 99.8% and sensitivity of 100% (14 days post-PCR confirmation), which facilitates reliable results about one’s exposure to COVID-19. The test additionally showed no cross-reactivity to the 4 human coronaviruses that cause the common cold, effectively minimizing the chance of false positives.

Roche intends to provide tens of millions of tests during the month of May in the United States and in countries that accept the CE mark.

“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support health care systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO of Roche Group. "I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”

References:

1. Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark. News Release. Roche; May 3, 2020. Accessed May 5, 2020.https://www.roche.com/media/releases/med-cor-2020-05-03.htm.