To help labs, clinicians, and patients evaluate competing COVID-19 diagnostic screening products, the FDA has released performance data for more than 55 tests.
When diagnostic tests were in short supply during the early days of the pandemic, companies rushed to produce them. As a result, there are now more than 100 tests on the market, but consumers and medical professionals have not had access to information about their efficacy in detecting infection.
In May 2020, the FDA began shipping standardized reference panels with undisclosed amounts of viral material in them to COVID-19 test developers, who then assessed their products’ performance against the panels as a condition of its Emergency Use Authorization.
The first round of comparative data, published on September 15, provided tests’ level of detection, which represents a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. The test with the lowest level of detection was PerkinElmer’s New Coronavirus Nucleic Acid Detection Kit (LoD = 180 NDU/mL). However, the agency cautioned that these data provide information about the relative performance of available tests, and “cannot be used [alone] to determine whether to authorize a test or other regulatory action.”
“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,” said Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health.