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Regulatory Focus™ > News Articles > 2020 > 9 > FDA shares comparative performance data for COVID-19 tests

FDA shares comparative performance data for COVID-19 tests

Posted 16 September 2020 | By Michael Mezher 

FDA shares comparative performance data for COVID-19 tests

The US Food and Drug Administration (FDA) on Tuesday released comparative performance data for 58 coronavirus disease (COVID-19) molecular diagnostics being used under emergency use authorizations (EUAs).
 
Specifically, FDA has published limit of detection (LoD) data for the tests against a standardized panel it developed and began distributing to test developers in May. FDA says it has so far contacted the developers of 176 authorized tests and has provided reference panels to the makers of 152 of the assays.
 
While FDA says it has asked test makers to conduct testing and return the results to the agency within two weeks, in many cases FDA says it has not received data or that the data received was uninterpretable.
 
“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 Center for Devices and Radiological Health (CDRH) Director Jeff Shuren.
 
On a new webpage presenting the reference panel comparative data, FDA lists all of the test developers it has contacted for distribution in Table 1, denoting their status with regard to responding to the agency’s outreach and returning the data.
 
In Tables 2A, 2B and 2C, FDA provides the LoD in terms of RNA nucleic acid-based amplification test (NAAT) detectable units/mL (NDU/mL) for tests based on the clinical matrix used: swab in transport media, direct swabs or saliva.
 
FDA explains that while a lower LoD “represents a test’s ability to detect a smaller amount of viral material in a given sample … the data does not indicate how sensitive a particular test is, and, therefore, cannot be used by itself to determine whether to authorize a test or other regulatory action.”
 
However, the agency says the data can be used to allow laboratories, health care providers and patients a means of comparing the tests’ performance relative to one another.
 
Statement, Comparative Data

Tags: coronavirus, FDA, US

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