The FDA has authorized the first point-of-care (POC) antibody test for COVID-19.
The Assure COVID-19 IgG/IgM rapid test device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Late yesterday, the agency announced that it has reissued that emergency use authorization (EUA) for POC use, using fingerstick blood samples. Healthcare providers will analyze the results immediately rather than sending them to a central lab for testing.
“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA commissioner Stephen Hahn in a news release. “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time-consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”
Nearly 50 serology tests have gained an EUA since the start of the pandemic. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood.
The FDA acknowledged that it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The agency cautioned individuals against interpreting results from a serology test to mean they are immune, or have any level of immunity, from the virus.
The FDA also said that people who live in areas with few reported SARS-COV-2 infections and have a positive antibody test should have a second test to rule out a false positive.
The Assure test is available by prescription only.
