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The US Food and Drug Administration (FDA) revealed comparative performance data for 55 molecular diagnostic COVID-19 tests that the agency approved under an Emergency Use Authorization protocol.
Patients, physicians, and laboratories can use the online data to get a better understanding of how each authorized commercial assay compares with a reference panel the FDA developed.
Test manufacturers are expected to compare their products in development with the benchmark data. But there is more to the story.
“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,” Jeff Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health, said in a news release.
The SARS-CoV-2 Reference Panel Comparative Data features companies that provided the required data alphabetically, from Abbott Diagnostics to Zymo Research Corporation. Physicians and patients can also search by keyword.
Some manufacturers have not yet provided data, or their submission remains under review. The agency plans to continue evaluating COVID-19 test performance on an ongoing basis.
“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,” Shuren added in the release.
The FDA compares each test’s “limit of detection.” This threshold reflects the minimum amount of virus that must be present in a sample for the test to yield a positive result, reflecting the sensitivity of the assay.
The agency stated, “the data gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use.”
In a recent commentary for Medscape Medical News, William P. Hanage, PhD, of Harvard T.H. Chan School of Public Health in Boston, Massachusetts, points out that a perfect COVID-19 test — one with 100% sensitivity and specificity — should not be the only goal. The speed of assay results matters as well, and in some cases highly specific but less sensitive testing could prove invaluable in reducing transmission of SARS-CoV-2.
US Food and Drug Administration: SARS-CoV-2 Reference Panel Comparative Data
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and dermatology. Follow Damian on Twitter: @MedReporter.