FDA issues emergency authorization for new COVID-19 antibody tests

The U.S. Food and Drug Administration (FDA) granted emergency use authorization for two novel coronavirus (COVID-19) serology tests that display an estimated quantity of antibodies present in the individual’s blood, according to an announcement released by the agency.

Both tests from Siemens, the ADVIA Centaur COV2G and Atellica IM COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

Due to these unknowns, the FDA said it cautions patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks, or returning to work.

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

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