FDA issues EUA for nasal specimen self-collection kits

June 1, 2020

The U.S. Food and Drug Administration (FDA) issued emergency-use authorizations (EUA) for two nasal self-collection kits to test patients for infections from SARS-CoV-2.

In the first case, Quest Diagnostics said it has received an EUA from the FDA for its nasal self-collection kit, which patients can use to collect their nasal specimen either at home or at a healthcare setting, according to a press release.

Specimens are shipped overnight via FedEx at room temperature (without a frozen cold pack). Quest said it has already tested specimens using a similar collection method in real-world settings in drive-thru and other onsite COVID-19 testing sites across the United States.

Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an Emergency Use Authorization in March.

The company expects to have more than a half-million kits available by the end of June, with plans to make additional kits available on an ongoing basis.

Separately, the FDA issued an EUA to PrivaPath Diagnostics for its nasal self-collection kit, Let’sGetChecked COVID-19 test. The FDA authorized the use of the home-collection kit when “determined by a healthcare provider to be appropriate based on the results of a COVID-19 questionnaire,” according to the FDA’s EUA authorization letter to the company.

PrivaPath, doing business as LGC Labs, a CLIA-certified high-complexity lab, will analyze the specimens using an RT-PCR assay.

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