Roche gets FDA emergency approval for its COVID-19 antibody test

The FDA has granted emergency use authorization to Roche for the use of its COVID-19 antibody test. 

Antibody tests, which detect if someone has been infected and recovered from COVID-19, are seen by experts as key to understanding the spread of mild and asymptomatic cases of the disease, according to The Wall Street Journal. 

Most commercially available antibody tests aren't deemed accurate enough, and the FDA has only approved 10 of them. 

Roche said its test is 100 percent accurate in detecting COVID-19 antibodies and 99.8 percent accurate at ruling out the presence of COVID-19 antibodies, meaning only 2 in every 1,000 samples would produce false negatives, according to the Journal

In most infectious diseases, antibodies prevent someone from becoming infected a second time, but because COVID-19 is so new, scientists don't know how long antibodies last after recovering from the disease or whether they protect against a second infection. 

Roche already has begun shipping its antibody test, which can produce results in 18 minutes, to labs around the world and said it would increase production capacity to high double-digit millions per month. 

Read the full news release here

More articles on supply chain:
COVID-19 testing update: Where the US stands now
LabCorp offering free antibody tests for anyone with provider order
Kaiser building $14M COVID-19 testing facility

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Featured Webinars

Featured Whitepapers