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Covid-19 Saliva Sample Collection Cleared by FDA

Saliva collection device

SDNA-1000 saliva collection kit (Spectrum Solutions)

14 Apr 2020. A Covid-19 test procedure using saliva samples rather than specimens from the nose and throat received emergency clearance from the Food and Drug Administration. The new testing method results from a collaboration between a Rutgers University genetics research center in Piscataway, New Jersey with the companies Accurate Diagnostic Labs in Plainfield, New Jersey and Spectrum Solutions in Draper, Utah.

Most current Covid-19 diagnostic tests use a nasopharyngeal swab that collects specimens of nasal secretions at the back of the throat. The swabs are inserted by a clinician through the patient’s nose to the region where the throat meets the roof of the mouth. The clinician gently rotates the swab around the throat to collect the specimen, then removes and sends the swab in a sterile container for analysis, either in a remote lab or at the point of care.

The technique developed by Rutgers’s RUCDR Infinite Biologics, a genetics bio-repository and diagnostics testing lab, and Accurate Diagnostic Labs replaces the nasopharyngeal swab with a saliva sample from the patient. The new technique still requires patients to collect samples at a clinic under the supervision of a clinician, with the samples sent to a lab for analysis. But the saliva method removes the need for medical technicians to be in close proximity to the patient, making it safer for the staff.

The new procedure uses a saliva collection kit developed by Spectrum Solutions. The SDNA-1000 device is a tube with a funnel replaced by a cap when enough saliva is captured. Placing the cap on the tube and turning it over, says the company, releases a preservative that stabilizes the RNA for analysis and deactivates the virus making it safer to handle.

Andrew Brooks, chief operating officer of RUCDR Infinite Biologics and professor of genetics says in an Accurate Diagnostic Labs statement that the Rutgers lab and company “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 percent concordance in detecting a patient that had the virus.” The university says it received word about FDA’s authorization of the technique on Saturday.

Rupen Patel, CEO of Accurate Diagnostic Labs adds, “you roll down your window, they give you the collection device, it takes seconds to spit into it. You put the cap on, which releases the preservation solution into the vial. You wipe it with a disposable alcohol pad, and you hand it back to the person at the window and you go off on your way. Twenty-four to 48 hours later, you get your test results.”

RUCDR Infinite Biologics is the university’s genetics sample collection and research center that collects, catalogues, and analyzes biological specimens for academic and industry studies. The center is also a licensed diagnostics testing lab conducting Covid-19 diagnostics testing for university-affiliated hospitals and health systems throughout the state. Using saliva samples rather than nose-and-throat swabs could increase the center’s capacity to tens of thousands Covid-19 tests per day.

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