FDA updates performance data for molecular tests to diagnose COVID-19 virus

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FDA updates performance data for molecular tests to diagnose COVID-19 virus
tjordan_drupal
Oct 1, 2020

The Food and Drug Administration yesterday posted updated comparative performance data for molecular tests to diagnose the COVID-19 virus.

Test developers, in order to receive emergency use authorization, are required to assess their test’s performance against a reference panel of viral samples.

In FDA’s data, a lower product LoD (limit of detection) indicates a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. FDA updates the data as it receives additional results to help inform laboratories, health care providers and patients about the relative performance of available tests.

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FDA updates performance data for molecular tests to diagnose COVID-19 virus
tjordan_drupal
Oct 1, 2020

The Food and Drug Administration yesterday posted updated comparative performance data for molecular tests to diagnose the COVID-19 virus.

Test developers, in order to receive emergency use authorization, are required to assess their test’s performance against a reference panel of viral samples.

In FDA’s data, a lower product LoD (limit of detection) indicates a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. FDA updates the data as it receives additional results to help inform laboratories, health care providers and patients about the relative performance of available tests.

Novel Coronavirus (COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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