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The US Food and Drug Administration (FDA) has approved the first point-of-care (POC) antibody test for COVID-19, under an emergency use authorization (EUA).
In July, the FDA first granted EUA to the Assure COVID-19 IgG/IgM Rapid Test Device [Assure Tech (Hangzhou) Co, Ltd] for use in certain laboratories to help identify people with antibodies to SARS-CoV-2, an indicator of recent or prior infection.
The antibody test uses fingerstick blood samples. With the new POC authorization, the test can be performed in physicians’ offices, hospitals, urgent care centers, and emergency departments. The test eliminates the need to send samples to a central laboratory 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,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
“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,” Hahn added.
The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA-authorized COVID-19 POC serology test. It is available by prescription only.
The FDA said it’s unclear how long antibodies persist following SARS-CoV-2 infection and whether antibodies confer protective immunity. Patients and providers “should not interpret results from a serology test as telling them they are immune, or have any level of immunity, from the virus,” the agency cautioned.
Even with a positive antibody test result, individuals should continue to take steps to protect themselves and others, such as continuing to practice social distancing, wearing masks, or refraining from returning to work, the FDA explained.
They noted that SARS-CoV-2 serology tests can’t diagnose an active infection, because they only detect antibodies that the immune system develops in response to the virus — not the virus itself.
“It is also important to remember that in a population with low prevalence, even high-performing antibody tests may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Thus, it is necessary to consider that the results from two serology tests may be needed to generate reliable results,” the FDA said.