UK Continues to Use Innova’s SARS-CoV-2 Antigen Rapid Test Despite Recall and FDA Warning Letter

FDA cites ‘risk of false results’ and concerns about labeling and ‘performance claims’ in its official warning letter to Innova, a company with connections to Chinese firms By many standards, the US government’s response to the COVID-19 pandemic has been phenomenal. However, the many emergency use authorizations (EUAs) awarded by the US federal Food and Drug Administration (FDA) to bring as many COVID-19 tests to market as quickly as possible means some of those tests in use today at clinical...

Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself. “Diagnostic tests, typically involving a...
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