COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Updates Comparative Performance Data to Include Most Available SARS-CoV-2 Diagnostic Tests

FDA maze of regulations

New FDA update to comparative COVID-19 test performance data now includes information about most available SARS-CoV-2 diagnostic molecular tests

The US Food and Drug Administration (FDA) provided a SARS-CoV-2 reference panel for test developers in late May 2020. The purpose of this panel was for test developers and manufacturers to use it while developing and validating tests. Another purpose of the panel was to allow for the comparison of the performance of each COVID-19 diagnostic test alongside others.

The FDA released partial data on various COVID-19 diagnostic tests’ relative performance using this panel in mid-September 2020, but several tests were not included at the time as the FDA was still compiling data. However, on Sept. 20, the FDA announced an update to this data, including information on approximately 165 diagnostic tests.

While some of the SARS-CoV-2 molecular diagnostic tests did not provide data, or provided data that is under review, the FDA has made public the relative limit of detection of approximately 83 tests and has divided the data into three categories:

  1. swabs in transport media,
  2. direct swabs (dry swabs), and
  3. saliva.

The FDA’s comparative update represents data or the status of this data on most of the SARS-CoV-2 diagnostic tests that are commercially available in the United States. The FDA has announced the intention to update comparative COVID-19 test performance data frequently (see the most current comparative data), allowing clinical laboratory leaders insights into how each test performs.

Related Resources:

FDA: SARS-CoV-2 Reference Panel Comparative Data

FDA: Coronavirus (COVID-19) Update: Daily Roundup September 30, 2020