First At-Home COVID-19 Serology Test From Symbiotica Granted EUA By FDA

Source : Medtech Insight

The first at-home serology test has been granted emergency use authorization (EUA) by the US Food and Drug Administration, the agency announced on 6 April.

The COVID-19 Self-Collected Antibody Test System made by developer Symbiotica Inc. uses a fingerstick to collect a blood sample. The prescription-only test allows for people 18 and older to collect their own sample, while an adult must collect a sample for people ages 5 to 17.

The sample is then analyzed at a Symbiotica lab, which will determine whether a person has been exposed to SARS-CoV-2, the virus that causes COVID-19.

The FDA’s authorization “will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” Center for Devices and Radiological Health director Jeff Shuren said.

The FDA stressed, however, that the Symbiotica test “should not be used to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.”

By Shawn M. Schmitt