Perhaps as early as this weekend, people getting their noses swabbed to test for COVID-19 at Queen’s Medical Center and Island Urgent Care may also be asked to provide a little saliva, said Dr. Todd B. Seto, the center’s director of academic affairs and research.
The standard swab test will, as always, be used to determine whether the person has been infected by the novel coronavirus; but the saliva will be collected in a clinical trial of a new, spit-in-cup test, ASSURE-19, developed by Honolulu’s Oceanit Laboratories in partnership with Queen’s Medical Center and the University of Hawai‘i at Manoa John A. Burns School of Medicine, Seto said.
ASSURE-19, which can be self-administered like a home pregnancy test, gives results within 3-10 minutes and will cost an estimated $20 per test, Patrick Sullivan, Oceanit CEO and founder, told the Honolulu Star-Advertiser.
The results of the saliva tests will be compared with those of the swab tests in the human clinical trials.
“We’re going to time (the trials) out with our routine testing in the hospital already and at Island Urgent Care,” Seto said, “so whenever people get the nasal swab testing done routinely as their doctor wants them to, we’ll ask them to provide some saliva also,” Seto said.
That way, he added, “there won’t be any extra nasal swab testing” conducted for the trials.
ASSURE-19 has been selected for support by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative, whose goal is “to fill the nation’s critical need for rapid, simple, and affordable COVID-19 testing,” Oceanit announced Thursday, adding that the launch of the clinical trials will also begin the process of gathering data to provide the U.S. Food and Drug Administration in applying for approval to bring the test to market.
“This phase will help with regulatory compliance and approval, as well as support for accelerating a ‘go to market’ timeline and scale manufacturing,” the announcement said, noting that the goal is to bring ASSURE-19-10 to market quickly, with the initial aim of providing schools and airports with the simple, quick saliva test.
After collecting data in two trials, Oceanit will apply for FDA Emergency Use Authorization.
“With daily PCR test counts actually dropping in the state, we feel it’s absolutely critical to push forward with ASSURE-19 as a viable, equipment-free, lab-free testing regime,” James Andrews, Oceanit head of marketing, wrote in an email.
For more information about the test kit and the Aloha Protocol in which Oceanit proposes it be used, visit assure19.com .