The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Assure COVID-19 IgG/IgM Rapid Test Device (Azure Biotech), the first serology point-of-care test intended for use as an aid in identifying individuals with an adaptive immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), indicating recent or prior infection.
Under a previous EUA, results from the Assure COVID-19 IgG/IgM Rapid Test Device could only be evaluated in certain CLIA-certified laboratories. Today’s reissued EUA allows for fingerstick blood samples to be tested in point-of-care settings such as a doctor’s offices, hospitals, urgent care centers and emergency rooms. The test is available only by prescription.
The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2. Once a specimen is collected, an assay buffer is added to the sample well of the test device; results should be read at 15 minutes but no later than 30 minutes. A red colored line will form next to the designated control if antibodies are present, confirming a reactive test. Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgG or IgM assay.
“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.”
The FDA, however, cautioned against interpreting results from a serology test as having any level of immunity from the virus. It is unknown at this time if the presence of antibodies confers immunity; patients should continue to practice social distancing and wear masks to protect themselves and others.
For more information visit fda.gov.
Coronavirus (COVID-19) update: FDA authorizes first point-of-care antibody test for COVID-19. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-first-point-of-care-antibody-test-for-covid-19-301137144.html. Accessed September 24, 2020.