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FDA Issues First EUA for Pooled SARS-CoV-2 Diagnostic Testing

FDA maze of regulations

Pooled SARS-CoV-2 diagnostic testing is now available after FDA issues first EUA for this testing method.

The US Food and Drug Administration (FDA) announced July 18, 2020, that an EUA has been granted that allows pooled testing for SARS-CoV-2 diagnostic testing. This EUA is a reissued EUA for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, allowing it to be used for pooled specimens containing up to four samples. The EUA for the Quest test makes it the first COVID-19 diagnostic test to be authorized for use with pooled samples.

According to the FDA press release, “Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Sample pooling does this by allowing multiple people—in this case four individuals—to be tested at once.”

“This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”

The FDA further noted, “While there is a concern that combining samples may make it more difficult to detect positives, since pooling in the laboratory dilutes any viral material present in the samples, Quest’s validation data demonstrates that its test correctly identified all of the pooled samples that contained a positive sample.”

The FDA also noted that the Quest test “remains authorized to test individual samples collected by their health care provider from people with suspected COVID-19 infection. The test is also still authorized for use with individual nasal swab specimens that are self-collected at home or in a health care setting using an authorized home-collection kit when determined to be appropriate by a health care provider.”

Related Resources:

FDA Press Release: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

Quest Diagnostics: Package Insert