COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail

CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from the market. Also, the FDA says 45 …

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COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail

Only three of the COVID-19 serology tests with EUAs met the FDA’s published requirements when evaluated

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