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First Saliva Test Approved for At-Home Use for a COVID-19 Diagnostic Test

On May 8, 2020, the FDA announced that it had authorized the first COVID-19 diagnostic test that can be used to collect saliva in the home. Specifically, the FDA issued an emergency use authorization (EUA) to the Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory-developed test (LDT), to allow for a saliva sample to be taken at home (or in a healthcare setting) to be sent back to the Rutgers Laboratory for testing.

Rutgers already had authorization for numerous other types of collection, but not saliva.[1] The FDA’s Approval letter can be found here and the actual EUA here.  

While FDA has approved over 80 COVID-19 diagnostic tests, the Rutgers Clinical Genomics Laboratory test is currently the only test that can use saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19.  The test remains by prescription only so a physician (or other person authorized by state law to prescribe drugs and devices) must first authorize the test.

The FDA's authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using its molecular LDT COVID-19 authorized to test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.  The Rutgers Lab is a “high complexity” laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA).

This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which can use a sample collected from the patient’s nose with a nasal swab and saline. That EUA was approved for the Laboratory Corporation of America (LabCorp). The EUA for that test can be seen here

It is important to note – and FDA cautioned in its approval notice – that neither of these is “a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.”

[1] Previously, the Rutgers Laboratory had been approved for the collection of oropharyngeal (throat) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, and bronchoalveolar lavage.   

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