US FDA grants emergency use authorisation for Covid-19 saliva test

14 April 2020 (Last Updated April 14th, 2020 11:48)

The US Food and Drug Administration (FDA) has issued emergency use authorisation (EUA) for a new collection approach that uses saliva as the primary test biomaterial for Covid-19.

US FDA grants emergency use authorisation for Covid-19 saliva test
Rutgers Professor Andrew Brooks, chief operating officer and director of technology development at RUCDR Infinite Biologics. Credit: Rutgers University.

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The US Food and Drug Administration (FDA) has issued emergency use authorisation (EUA) for a new collection approach that uses saliva as the primary test biomaterial for Covid-19.

The new saliva collection method has been developed by Accurate Diagnostic Labs and RUCDR Infinite Biologics at Rutgers University using Spectrum Solutions’ DNA 1000 Saliva Collection Kit.

When administered under the virtual supervision of a trained health professional, the method allows self-administered sample collection by individuals who are in quarantine or self-isolation. This is expected to reduce the exposure of healthcare professionals and patients to the virus.

RUCDR Infinite Biologics chief operating officer Dr Andrew Brooks said: “Working with Accurate Diagnostic Labs healthcare providers, we ran a study side-by-side, taking swabs, either nasal swabs or throat swabs, and we looked at those versus looking at saliva. We found 100% concordance in detecting a patient that had the virus.”

The Covid-19 test involves a proprietary preservative solution that overturns the risk to front-line laboratory professionals handling the samples. The preservative maintains ribonucleic acid (RNA) markers while inactivating coronavirus.

The new validation of the saliva testing method follows a comprehensive trial that confirms the reliability of the results. The trial was led by researchers at Accurate Diagnostic Labs and RUCDR.

Accurate Diagnostic Labs CEO Rupen Patel said: “Since February, we have been fighting global supply shortages of PPE, swabs and extraction kits. Our collaboration with Dr Brooks’ lab, which is just down the road from us, allowed our two labs to quickly scale a high-throughput option, allowing us to be one the largest Covid-19 testing options available.

“By partnering with Spectrum Solutions, a company based in Utah, we can continue to scale saliva collection device solutions made here in the United States.”