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Yale School of Public Health Nabs FDA EUA for COVID-19 At-Home Saliva Collection Kit, Test

NEW YORK – The US Food and Drug Administration announced on Tuesday that the Yale School of Public Health received Emergency Use Authorization for an at-home saliva-based collection kit and associated SARS-CoV-2 test.

The direct-to-consumer SalivaDirect DTC Saliva Collection Kit and SalivaDirect test are authorized for use by people without symptoms, the FDA said in its authorization letter. Yale's extraction-free SalivaDirect test first received EUA last year.

The collection kit is intended for self-collection of saliva at home, or in community-based settings, by people older than 18.

The RT-qPCR test has been newly authorized for use with specimens collected using the kit and is limited to labs designated by the Yale School of Public Health. The assay allows for testing of low volumes of saliva by treating the sample with proteinase K, followed by a heat inactivation step.

Negative test results are delivered via text, phone, or email, while people with positive and invalid results are contacted by a healthcare provider.

The system is intended to help users determine if they need to self-isolate or quarantine, the agency said.

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