4 Topic Commentaries

Why Rapid Tests Fail to Gain Traction

Why Rapid Tests Fail to Gain Traction

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  Michael J. Mina, MD, PhD

  Epidemiology; Clinical microbiology

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  Harvard T.H. Chan School of Public Health

  Until the regulatory landscape changes, those companies have no reason to bring a product to market.

  Source
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  Jeff Shuren, MD, JD

  Medical devices regulation

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  U.S. Food and Drug Administration

  This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab.

  Source
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  Catharina Boehme, MD

  Global health diagnostics

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  Foundation for Innovative New Diagnostics (FIND)

  It’s the Wild West in diagnostics,

  Source
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  Gerald J. Kost, MD, PhD

  Point-of-care diagnostics; Clinical pathology

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  University of California, Davis

  Suboptimal sensitivity of rapid antigen tests limits performance.

  Source