Yale’s rapid COVID-19 saliva test receives FDA authorization

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In a new study, a saliva-based laboratory diagnostic test developed to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA).

The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA).

SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing.

Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.

The research was conducted by a team at the Yale School of Public Health.

With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation—and, perhaps, beyond—in the coming weeks.

A key component of SalivaDirect is that the method has been validated with reagents and instruments from multiple vendors.

This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.

The team says this is a huge step forward to make testing more accessible. They found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health.

Testing for SARS-CoV-2 has been a major stumbling block in the fight against the pandemic, with long delays and shortages of testing.

Some experts have said that up to 4 million tests are needed per day; SalivaDirect provides one pathway toward that goal.

One author of the study is Chantal Vogels, a Yale postdoctoral fellow.

The study is published in medRxiv.

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