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FDA Publishes First Batch of SARS-CoV-2 MDx Limit of Detection Comparison Results

Sep 16, 2020
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Madeleine Johnson
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This story has been updated to include additional commentary from test developers.

NEW YORK – The US Food and Drug Administration on Tuesday published the first results of a limit of detection comparison of Emergency Use Authorized molecular diagnostic tests for SARS-CoV-2.

Reported as nucleic acid amplification test-detectable units (NDU) per milliliter, the limits of detection for the first batch of 55 tests reported differed by 10,000-fold.

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