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Review
. 2022 May 18;60(5):e0188421.
doi: 10.1128/JCM.01884-21. Epub 2021 Dec 15.

Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests

Tony Yang  1 , Larry G Kessler  2   3 , Matthew J Thompson  4   5 , Barry R Lutz  6   7
Affiliations
Review

Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests

Tony Yang et al. J Clin Microbiol. .

Abstract

Home testing for infectious disease has come to the forefront during the COVID-19 pandemic. There is now considerable commercial interest in developing complete home tests for a variety of viral and bacterial pathogens. However, the regulatory science around home infectious disease test approval and procedures that test manufacturers and laboratory professionals will need to follow have not yet been formalized by the U.S. Food and Drug Administration (FDA), with the exception of Emergency Use Authorization (EUA) guidance for COVID-19 tests. We describe the state of home-based testing for influenza with a focus on sample-to-result home tests, discuss the various regulatory pathways by which these products can reach populations, and provide recommendations for study designs, patient samples, and other important features necessary to gain market access. These recommendations have potential application for home use tests being developed for other viral respiratory infections, such as COVID-19, as guidance moves from EUA designation into 510(k) requirements.

Keywords: FDA; home test; influenza; regulation; study design.

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Conflict of interest statement

The authors declare a conflict of interest. B.R.L. is co-founder of and holds equity in a point-of-care diagnostics company (Anavasi Diagnostics). M.J.T. is employed part time as Senior Director of Clinical Science at Inflammatix Inc. He has also received in the past consulting fees from Roche Molecular Diagnostics and Visby Inc.

References

    1. Washington State Clinical Laboratory Advisory Council. 2017. Point-of-care testing guidelines. Washington State Department of Health, Olympia, WA. https://www.doh.wa.gov/portals/1/Documents/2700/POCT.pdf.
    1. Food and Drug Administration Center for Devices and Radiological Health. 2014. Guidance for industry: design considerations for devices intended for home use. https://www.fda.gov/media/84830/download.
    1. Food and Drug Administration. Home use tests. https://www.fda.gov/medical-devices/vitro-diagnostics/home-use-tests. Accessed January 2021.
    1. Conenello G. 2016. Microbiology devices panel meeting: over-the-counter diagnostic tests for the detection of pathogens causing infectious diseases. https://www.fda.gov/media/99903/download.
    1. Food and Drug Administration Center for Devices and Radiological Health. 2020. Guidance for industry: policy for Coronavirus disease-2019 tests during the public health emergency (revised). https://www.fda.gov/media/135659/download.

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