FDA Authorizes First Serology Test That Detects COVID-19 Neutralizing Antibodies

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for GenScript USA Inc.’s “cPass SARS-CoV-2 Neutralization Antibody Detection Kit” as the world’s first serology test that detects neutralizing antibodies (NAbs) from recent or prior SARS-CoV-2 infection.

These NAbs bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. It blocks the ability of the virus to enter a cell. The EUA for of this test is limited to authorized laboratories, certified under the Clinical Laboratory.

The FDA has already issued EUAs to more than 50 antibody (serology) tests that only detect the presence of binding antibodies, which bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells.

The cPass antibody detection kit is the first commercially available test that detects NAbs in patient samples without the use of live virus. However, the effect of NAbs for SARS-CoV-2 in humans is still being researched.

The detection of the presence of NAbs can also be performed in most standard laboratories with a turnaround time of just about one hour.

The kit will also help in current COVID-19 investigations of sero-prevalence, assessment of herd immunity, longevity of protective immunity, efficacy of different vaccine candidates as well as tracking infection in animals.

The FDA warns that patients not use the results from this test to stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work.

The regulator also reminds patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.

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