FDA Approves First Test to Detect Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection |
Clinical News
eMediNexus Coverage from: 
FDA Approves First Test to Detect Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

0 Read Comments                

The U.S. Food and Drug Administration has authorized the first serology test to detect neutralizing antibodies from recent or prior SARS-CoV-2 infection. These antibodies bind to a specific part of a pathogen and have been observed in a laboratory setting to diminish SARS-CoV-2 infection of cells. An emergency use authorization (EUA) was issued by the FDA for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which detects this type of antibody.

The FDA has already issued EUAs to over 50 antibody (serology) tests; however, these tests identify the presence of binding antibodies. These antibodies bind to a pathogen but do not necessarily decrease the infection. The effect of neutralizing antibodies for SARS-CoV-2 in humans is still under research.

The FDA has warned that patients must not use the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, which include social distancing, wearing masks, etc… (FDA, November 6, 2020)

To comment on this article,
create a free account.
Sign Up to instantly read 30000+ free Articles & 1000+ Case Studies
Create Account

Already registered?

Login Now