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FDA Regulations on Monkeypox Rapid Antigen Test Kits EUA Applications


In August 2022, the Secretary of the U.S. Department of Health and Human Services (HHS) declared an Emergency Use Authorization (EUA) for diagnostic tests for monkeypox. As of this past September, the Food and Drug Administration (FDA) has been allowed to expand testing options using the emergency use pathway. To support the HHS, the FDA also issued its policy on Monkeypox rapid Antigen test kits to guide laboratories and manufacturers in submitting documentation. 

As of October 13th, the FDA has invited test developers to notify them of the intent to submit a EUQ request, prioritizing rapid diagnostic tests and providing further insight into treatment. While the monkeypox national emergency doesn’t pose the same public health risks as Covid-19, the FDA and HHS can coordinate a national response to contain the outbreak before it becomes more widespread.

The Latest FDA Regulations on Monkeypox EUA ApplicationsĀ 

Since its announcement in October, the FDA established a new national protocol for clinical research centers seeking to submit rapid Antigen test devices to control the spread of Monkeypox. These protocols include: The FDA cleared tests for non-variola orthopoxviruses, including monkeypox, that are developed by the (CDC) Centers for Disease Control and Prevention. The Policy focuses on specific testing needs, including high-throughput tests (detection of monkeypox specifically or for non-variola orthopoxviruses), tests with home specimen collection, and rapid Antigen diagnostic tests. 

EUA applications are prioritized based on experienced developers with high manufacturing capacity, allowing developers to inform the FDA within 30 days of September 7, 2022

In EUA applications, the diagnostic test validation templates include: 

  • Summary template with recommendations for analytical and clinical validation testing
  • Comprehensive template with study design considerations and fill-in-the-blank responsive text
  • Molecular Only (FDA plans to provide additional templates)

For exceptions, the FDA notes that serology tests cannot be used to diagnose or aid in diagnosing an active monkeypox infection and are not tests of immunity. This also applied to the detection of antibodies, as with rapid Antigen tests. 

By providing these guidelines, the FDA provides a balanced view of the monkeypox public health risk by counteracting it with a strategic and responsible approach to the quality and numbers of EUA requests. As for test developers, those who intend on submitting a EUA should work with priority tests, rapid Antigen test kits, and be an experienced developer to engage with the output of high manufacturing capabilities. 

The Future of Monkeypox Rapid EUA Applications

Validation must be achieved prior to a test being used. The potential risk of negative impacts can have far-reaching implications for public health. As of the writing of this article, only lesion swabs have been approved for diagnosing monkeypox. The FDA will provide updates as other specimen types become validated for this purpose. Those involved in the development of tests should discuss alternate approaches to validating their tests, alternative specimen types, and diagnostic technologies with the FDA. For more information about submitting a EUA request, representatives and test developers should contact NAMSA as soon as possible for more information.