The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Azure Biotech Inc. for the Assure COVID-19 IgG/IgM Rapid Test Device. This is the first serology (antibody) point-of-care (POC) test for coronavirus disease 2019 (COVID-19) using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings such as outpatient physician offices, hospitals, urgent care centers, and emergency rooms rather than having to be sent to a central lab for testing.
The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test. 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 COVID-19, indicating recent or prior COVID-19 infection.
The FDA noted that a positive Assure test does not mean that individuals are immune from COVID-19, only that they have the antibodies to the virus in their system. Nor should the test be used to diagnose an active infection. Individuals should continue taking steps to protect themselves and others, such as social distancing, wearing masks, and working from home when possible. The FDA continues to work with test developers to expand access to COVID-19 testing.
Azure Biotech Inc. is a global biotechnology company that specializes in research and development, as well as the production and sales of diagnostic reagents, POCT analyzers and biological materials. Its product line includes more than 100 products in nine series that have been successfully developed and are currently marketed, including but not limited to: pregnancy test, DOA tests, infectious disease tests, tumor marker tests, cardiac marker tests, food safety tests, biochemical reagent series, allergy tests, integrated instruments, and reagents.
This was reported by the FDA on September 23, 2020.
Contact Information: U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993; 301-348-1956; Website: https://www.fda.gov/