FDA Greenlights Second Pooled Sample COVID-19 Test As Crucial Tool To Reopen US Economy
US regulators have re-issued an EUA to LabCorp’s COVID-19 molecular diagnostic test for pooled sampling. While the method could speed up testing and use less resources, it also can result in false negatives.
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The US FDA’s diagnostics chief also addressed school screening and post-pandemic approval plans during a recent webinar.
US regulators gave the thumbs-up to the first COVID-19 test that pools patient samples to determine if any one of the individuals in the pool may be infected. Despite concerns such tests may be diluted and make it harder to detect the SARS-CoV-2 virus, the FDA says validation data shows it works.
US regulators have authorized the first COVID-19 test that lets people take a sample of mucus inside their nose at home to check for the novel coronavirus. The maker of the test, LabCorp, says the test will be available in most states within the next few weeks – but health care workers will be given the tests before the general public.