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Questions Arise as FDA Assesses Serology Tests

Federal lab is studying COVID-19 serology tests for the FDA, but little is known about this process

CEO SUMMARY: On June 4, the FDA released results of an evaluation of some of the 20 tests offered for sale in this country to identify antibodies for SARS-CoV-2. A quality control expert in clinical labs called the antibody test analysis deeply flawed in part because of the study’s design. The FDA evaluated serology assays  using 110 samples from …

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