Race against COVID-19 | UCSB current
COVID-19 is fast. To beat him, you have to be faster. That’s why UC Santa Barbara has created its own CLIA-certified lab, enabling rapid clinical testing and medical diagnostics needed to help stem the pandemic tide.
“Clinically, the weather makes a huge difference,” said UCSB biologist Stuart Feinstein, who is one of the leaders behind the university’s COVID-19 testing efforts targeting the asymptomatic campus community. The lab, which has become fully operational in recent weeks, can perform tests in hours to a day – a critical time saver in detecting the SARS-CoV-2 virus.
Dr. Laura Polito of the COVID-19 Response Team at UC Santa Barbara couldn’t agree more.
“In our population, this virus is mainly transmitted by asymptomatic people – people who don’t know they have it,” she said. “And they can spread it for days before they even develop symptoms.” The faster the turnaround time, the sooner the necessary isolation measures can be taken and contact tracing initiated if a test gives a positive result, she added.
Located in the BioEngineering building, the facility looks like any other lab, with approximately 700 square feet of scientific lab equipment: fume hoods, refrigerators, freezers, centrifuges. What sets it apart, however, are the clinical standards by which the equipment is calibrated and maintained, and the people who work on it are trained. Short for Clinical Laboratory Improvement Amendments, a CLIA laboratory meets the requirements set out by the Food and Drug Administration, the Center for Medicaid Services, and the Centers for Disease Control for the handling and analysis of human samples.
“In a lab where you make clinical decisions about people’s health, it’s very heavily regulated to be sure you’re accurate,” Feinstein said. In the case of COVID-19, only tests performed in CLIA-certified laboratories meet the rigor required for a medical diagnosis.
The lab serves as a hub for samples collected at the Loma Pelona Center test sites and in the Linda Vista room at the Santa Catalina Residence. The tests are available to students, faculty, and staff who live in housing on campus or who work or conduct research on campus, as part of a surveillance screening program. Students are required to undergo asymptomatic testing on a weekly basis. At its peak, the lab should process up to a thousand samples per day; any excess will be sent off campus to partner labs of UCLA and private sector company Fulgent. These typically have turnaround times of 1 to 2 days.
With the new CLIA certified lab and off-campus partner labs, the COVID monitoring team performs approximately 4,000 tests per week. Most are done in the CLIA lab on campus.
“We expect this to increase to a few thousand tests per week in the next quarter,” Feinstein said.
UC Santa Barbara is the result of true inter-campus collaboration: in a state-of-the-art space generously donated by the College of Engineering, clinical staff members of Student Health Services perform tests for the novel coronavirus along with ‘an asymptomatic testing framework developed with biologists from UCSB, all with the support of the Chancellor. And that doesn’t even cover the myriad of other contributions from other departments that helped make the lab a reality, Feinstein said.
“Everyone has been extremely cooperative,” he said. “The lab was not set up by three or four people; it really took dozens of people to spend a lot of time on Zoom. “
The establishment of the CLIA lab at UCSB is even more impressive considering it was accomplished in a fraction of the time it normally takes labs to achieve CLIA certification (a process that can take up to a few years). ), and that it is brand new. The campus is also grateful for the generous private donations in support of this effort.
“We are a non-medical school campus,” Polito said. “So it wasn’t something we could use certified hospital space for. It was literally built from the ground up.
The campus benefited from the assistance of a group of local pathologists from Mission Pathology Consultants (a subsidiary of Cottage Health Systems) who brought their expertise to the laboratory setup and accreditation. “Clinical Pathologists – Drs. Emily Waterhouse and David Martin-Reay, as well as Drs. Matthew DeNicola and Stewart Comer – all helped get the project across the finish line in record time, ”said Feinstein.
“We set up a lab from scratch in four months,” said Dr Martin-Reay, who, along with his colleagues, advised on setting up the lab and endorsed its creation. “I think this is something the university and mission pathology consultants should be proud of.”
Additional essential contributions came from biology professor Carolina Arias, student health lab manager Lisa Foley, Associate Chancellor Chuck Haines and many others, Feinstein noted. The COVID testing lab is technically covered by an extension of the existing CLIA certification that covers the Student Health Services clinical lab.
In addition to collecting samples and running tests, building this lab also meant building a system to manage a mountain of information. “You have to keep meticulous documentation of how many tests you performed, how many were positive, how many were negative, how many were inconclusive,” Polito said. Not only is this data stored as an official electronic medical record for each person tested, it is reported to the State of California via CalREDIE, an electronic disease notification and surveillance program operated by the California Department of Public Health.
The current campus population is kept low in order to prevent and limit the spread of infection as much as possible; therefore, the lab sees up to 700 samples per day. Surveillance will be a useful tool in capturing and controlling potential infections as people come and go for the holidays.
“We are particularly concerned about the holidays,” Polito said. “We are 10 months away in this pandemic and people are tired. It’s the holidays and everyone wants to go see their family. I fully understand that.
“But, unfortunately, those two things – travel and gatherings – are two of the best ways to spread this virus,” she continued, adding that health officials had seen a dramatic increase in cases since Thanksgiving involving students residing in Isla Vista who participate in the surveillance. project, but who do not attend classes on campus. “This should also happen during the winter holidays.”