Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continues to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:
A new FDA Voices, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy [1], explains today’s update to a policy [2] from March 16th, 2020 on antibody tests for COVID-19 Coronavirus.
[3]Coronavirus.
The FDA will continue to take steps to appropriately balance assurances that an antibody test is accurate and reliable with timely access to such tests as the continually evolving circumstances and public health needs warrant.
FDA issued warning letters to operators of two websites, www.antroids.com [4] and www.foxroids.com [5], that market unapproved COVID-19 Coronavirus products, as part of the agency’s effort to protect consumers.
There are currently no FDA-approved drugs to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider. Consumers can visit BeSafeRx [6] to learn about how to safely buy medicine online.
The FDA authorized the first serology, or antibody, test [7] where the results of a new independent validation effort by the U.S. Government provided the scientific evidence used to support the authorization. The testing was performed at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Institutes of Health’s (NIH) National Cancer Institute (NCI).
The results are among the first to come from a collaborative effort by the FDA, NIH, U.S. Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA) to evaluate certain serological tests. Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases (NIAID), the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.
Diagnostics update to date:
- During the COVID-19 Coronavirus pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
- To date, the FDA has issued 58 individual EUAs [8] for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ [9] up to date.
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Additional Resources:
Consumer Inquiries: 888.INFO.FDA
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.