FDA Issues EUA for First Point-of-Care COVID-19 Antibody Test

September 24, 2020

The Assure test is the only FDA authorized COVID-19 point-of-care serology test.

The FDA has issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for the novel coronavirus disease 2019 (COVID-19).

The Assure COVID-19 IgG/IgM Rapid Test Device joins the nearly 50 serology tests that have been granted EUA status in response to the pandemic. The POC test was initially authorized for emergency use by some labs in July to aid in identifying those with antibodies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which demonstrates a recent or prior infection with COVID-19.

The Assure test is a lateral flow assay, authorized for use with venous whole blood, serum, plasma, and fingerstick whole blood, uses a blood sample from a patient’s fingertip to run the test. It is currently the only COVID-19 POC serology test authorized by the FDA.

Although diagnostic research has quickly progressed amid the pandemic, the FDA emphasized the fact that there are still many unknowns about the nature of SARS-CoV-2 and immune responses in infected individuals, including how long antibodies persist, and whether the presence of antibodies leads to immunity. Individuals should therefore not use this most recent, or any, serology test to decide to stop taking precautions against the virus.

Moreover, antibody tests should not be used to indicate an active COVID-19 infection, according to the FDA; these POC tests detect the development of antibodies in response to the virus, not the virus itself.

“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 M. Hahn, MD. “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.”

As of the FDA’s announcement of the EUA, the Assure test is available by prescription only. The agency expressed their commitment to expanding access to COVID-19 testing.

Reference:

  1. Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19. News Release. FDA; September 23, 2020. Accessed September 24, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19.