FDA releases performance data for COVID-19 molecular diagnostic tests

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FDA releases performance data for COVID-19 molecular diagnostic tests
tjordan_drupal
Sep 16, 2020

The Food and Drug Administration yesterday released comparative performance data for 55 COVID-19 molecular diagnostic tests.

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

In the 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 plans to update the data as it receives additional results to help inform laboratories, health care providers and patients about the relative performance of available tests.

In other news this week, FDA awarded a research contract to the University of Liverpool and global partners to sequence and analyze SARS-CoV-2 and other coronavirus samples to help inform the real-time performance of molecular-based diagnostics.

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FDA releases performance data for COVID-19 molecular diagnostic tests
tjordan_drupal
Sep 16, 2020

The Food and Drug Administration yesterday released comparative performance data for 55 COVID-19 molecular diagnostic tests.

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

In the 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 plans to update the data as it receives additional results to help inform laboratories, health care providers and patients about the relative performance of available tests.

In other news this week, FDA awarded a research contract to the University of Liverpool and global partners to sequence and analyze SARS-CoV-2 and other coronavirus samples to help inform the real-time performance of molecular-based diagnostics.

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

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