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Regulatory Focus™ > News Articles > 2020 > 4 > FDA issues first EUA for coronavirus serology test

FDA issues first EUA for coronavirus serology test

Posted 02 April 2020 | By Zachary Brennan 

FDA issues first EUA for coronavirus serology test

In a move that could help the US better understand who has already had COVID-19, the US Food and Drug Administration (FDA) on Thursday provided the first Emergency Use Authorization (EUA) for a serology test to North Carolina-based Cellex Inc.

The test can detect SARS-CoV-2 antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG) that are generated as part of the human immune response to the virus. Although FDA recommends that results from serology testing should not be used as the sole basis to diagnose or exclude a coronavirus infection, the test can help detect how many people have had SARS-CoV-2, even if they did not show symptoms. 

“IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection,” FDA said in the EUA.

But the agency also said it is unknown how long IgM or IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection.

The Cellex test, which is only authorized for use in laboratories certified to perform moderate and high complexity tests, can produce results in 15 minutes.

Similarly, Becton, Dickinson and Company and BioMedomics earlier this week released another point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. But the test has yet to receive an EUA from FDA.

Dozens of other companies have notified FDA that they have validated and are offering serology tests but FDA has not reviewed the validation of those tests and the companies said they will not be pursuing EUAs.

Emergency Use Authorization for Cellex
 

Tags: coronavirus, IVD, US

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