COVID-19 Diagnostics: University Of California-Berkeley Starts Clinical Trials Of Saliva Test for COVID-19
: Researchers from the Innovative Genomics Institute (IGI), the same UC Berkeley group that rapidly popped up a state-of-the-art COVID-19 testing laboratory in March, are now trialing a quicker way to obtain patient samples: through saliva.
So far diagnostic tests for COVID-19 have relied on samples obtained by swabbing uncomfortably deep into a person’s nasal passages or in the mouth and nose, but those tests must be administered by trained medical staff wearing personal protective equipment (PPE).
Should the new study demonstrates that detecting the coronavirus in saliva is just as reliable as using nasal swabs, UC Berkeley will be able to ramp up the monitoring of students, faculty and staff as the campus gradually opens in preparation for the start of classes in late August.
COVID-19 infected individuals can spread the virus before symptoms appear, or even if symptoms never appear. Regular testing would, in theory, allow the campus to catch infected, but asymptomatic, people early, isolate them, trace and quarantine their close contacts and ideally tamp down inevitable flare-ups before they spread.
University campus volunteers began collecting saliva samples from a few hundred UC Berkeley employees on June 23 at kiosks set up in the breezeway of the Genetics and Plant Biology building, near Pat Brown’s Grill.
As opposed to swab testing, saliva testing is a lot simpler and allows people to literally spit into a tube. The researchers think it will take about five or six minutes as they pass through our testing center here, so the researchers hope to make this very painless, easy and simple for people to come by and get tested.
University of California graduate students, faculty and staff who are authorized to work on campus can sign up to participate in the Free Asymptomatic Saliva Testing (FAST) study on the IGI website.
The team of IGI researchers hopes to analyze the results of the saliva tests and submit an application for an Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA), which would allow them to employ the saliva test clinically.
The US FDA has already given EUAs to a handful of saliva-based tests for COVID-19. All are for at-home sample collection; the samples are then returned to labs for PCR (polymerase chain reaction)-based diagnostics. UC Berkeley will analyze its saliva samples at a pop-up lab in the IGI, with results returned within five days.
The COVID-19 testing lab currently employs PCR analysis to search for pieces of the virus in swab samples, now mostly obtained from symptomatic people or those who suspect exposure to the virus. After a robotic system came online this month, the capacity increased to 1,000 tests per day. While the initial focus was students and front-line responders on campus, the increased capacity allowed the lab to expand its outreach to other California communities.
One of the goals of setting up the testing lab at the IGI was to provide testing to a larger, broader community in the Bay Area and around California, people who do not have access to testing. The research team has been engaged for many weeks with health care providers that work with people in homeless encampments and nursing homes, as well as with first responders and utility workers who are keeping the lights on here in California.
Rapid and easier sample collection via saliva samples should expand the reach of COVID-19 testing to asymptomatic individuals more broadly, serving as a model for other universities and communities.
The researchers from University of California- Berkeley hope once the trial proves to be ok, to be able to take the diagnostic platform elsewhere.
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