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

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FDA Publishes Comparative Performance Data for Some SARS-CoV-2 Diagnostic Tests

FDA maze of regulations

New data from FDA shows comparative lower limit of detections for 55 SARS-CoV-2 diagnostic tests

In late May 2020, the US Food and Drug Administration (FDA) provided a SARS-CoV-2 reference panel for test developers that they could use while developing and validating tests (See: FDA Releases SARS-CoV-2 Reference Panel for Laboratory and Commercial Test Developers). The FDA also intended the panel to be used to assess the results of individual tests in a way that could be compared with the performance of other tests.

On Sept. 15, 2020, the FDA published comparative performance data for some authorized COVID-19 diagnostic tests, allowing clinical laboratory leaders a better understanding of how tests are performing. 

“By providing this panel to both commercial and laboratory test developers and evaluating the data we receive, we are able to gain valuable insight into the comparative performance of different authorized molecular diagnostic tests under the same conditions,” Jeff Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health, said in a statement. “Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust.”

The FDA data focused on the limit of detection of more than 55 authorized molecular diagnostic COVID-19 tests. The lowest limit of detection by far was found with the PerkinElmer New Coronavirus Nucleic Acid Detection Kit. 

Clinical laboratory leaders wanting to review the full data set can do so here.

Related Resources:

FDA: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

FDA: SARS-CoV-2 Reference Panel Comparative Data