Recently, the U.S. Food and Drug Administration (FDA) released a guidance that accelerated the ability for certain laboratories to use coronavirus tests they are developing in order to increase testing capacity across the US. The guidance follows criticisms that the US was not doing enough to increase its ability to test more people, and as coronavirus cases begin to increase rapidly nationwide.
Guidance
FDA says in the guidance that for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments, for a period of 15 days after validating their tests and while they are preparing their emergency use authorizations (EUA) requests, FDA does not intend to object to the use of these tests for specimen testing.
“In the absence of known positive samples for testing, FDA recommends that laboratories confirm performance of their assay with a series of contrived clinical specimens by testing a minimum of 30 contrived reactive specimens and 30 non-reactive specimens,” the guidance adds, explaining further what labs can do.
According to the FDA, it released the guidance to provide a policy for coronavirus molecular diagnostics tests developed and used in laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments prior to issuance of EUA for such tests. The agency further notes that the Secretary of Health and Human Services determined there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the coronavirus.
FDA notes, “Rapid detection cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes an accelerated policy enabling laboratories to use tests they develop faster in order to achieve more rapid testing capacity in the United States.”
FDA also explains that because of the public health emergency, the guidance is being implemented without prior public comment. FDA has determined that prior public participation for this guidance is not feasible or appropriate.