FDA authorizes first COVID-19 diagnostic test for pooled sampling
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The FDA approved the first COVID-19 diagnostic test for pooled sampling.
The agency reissued an emergency use authorization (EUA) for Quest Diagnostics’ SARS-CoV-2 rRT-PCR, allowing for the testing of up to four individual COVID-19 swab specimens at a time.
“This emergency use authorization for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” FDA Commissioner Stephen M. Hahn, MD, said in press release. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”
Sample pooling allows for more people to be tested quicker while using fewer resources. In this case, four individuals will be tested at one time in a batch, the FDA said. If the batch tests positive, each sample would then be tested individually.
Quest’s test, which was initially authorized for emergency use on March 17, is still authorized to test individual samples of suspected COVID-19 cases collected by health care providers, as well as for use with individual nasal swab specimens self-collected at home or in a health care setting using an authorized home-collection kit, according to the release.
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