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FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

  • 1.  FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

    Posted 12 days ago

    On Tuesday, September 15, 2020, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA.

    The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test's performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA).

    The data published today gives laboratories, health care providers, and patients a new resource on the relative performance of available tests to better inform which tests they choose to use. The FDA will continue to update the table as it receives additional results.

    https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data?utm_medium=email&utm_source=govdelivery



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    Jim Flanigan, CAE
    Executive Vice President
    American Society for Clinical Laboratory Science (ASCLS)
    1861 International Drive, #200 McLean, VA 22102
    o: 571-748-3746 | m: 708-359-5721
    jimf@ascls.org | @jimflanigancae
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