OHSU’s research arm has been ramping down for weeks so more resources can be directed to our local response against the global coronavirus pandemic. But that doesn’t mean those not involved in direct patient care have stopped working.
One prime example is an in-house COVID-19 testing lab that OHSU staff built from scratch and opened for business on March 24. Today, the lab is enabling OHSU to identify coronavirus patients within 36 hours. But back in March, there was no clinical microbiology laboratory at OHSU’s Marquam Hill campus. It was constructed, stocked, staffed and operational in just 14 days.
The effort started with a flurry of phone calls and emails between OHSU research and pathology staff determined to contribute to OHSU’s clinical fight against the virus descending on the world – and Oregon.
“When Oregon’s first presumptive case of COVID-19 was announced in Lake Oswego on Feb. 28, I picked up the phone,” said Donna Hansel, M.D., Ph.D., chair of OHSU’s Department of Pathology. Hansel called Guang Fan, M.D., Ph.D., associate medical director for OHSU laboratory medicine.
“I began checking the CDC and FDA websites, calling my microbiology colleagues, assessing commercially available tests or tests in development,” Fan said. “It looked like no commercial test kits would be ready before April, and we were afraid that April might be too late.”
Meanwhile, OHSU Vaccine & Gene Therapy Institute Director Jay Nelson, Ph.D., and Dan Streblow, Ph.D., an associate professor at the institute, were meeting to discuss establishing COVID-19 testing and potential vaccine strategies against the virus. At that point, Streblow was setting up COVID-19 testing for nonhuman primates at OHSU’s Oregon National Primate Research Center in Beaverton.
“The conversation flipped to the important role testing plays in being able to effectively limit transmission,” said Streblow. After that, Nelson emailed OHSU Chief Research Officer Peter Barr-Gillespie, Ph.D., about establishing an OHSU clinical testing facility – for humans.
Two hours later, Nelson and Streblow were exchanging excited emails with Hansel and her colleagues about creating a testing facility together.
“The lab started getting off the ground when Jay Nelson and Dan Streblow offered to help,” said Hansel. “Here we had two world-class infectious disease experts stepping up to help make this happen — it made all the difference.”
Building a Biosafety Level 2+ lab in two weeks
The lab is a BSL-2+ lab, or a Biosafety Level 2 laboratory with BSL-3 practices and procedures in place. This hybrid model means that PPE — including gloves, lab coats and gloves, eye protection and face shields — and procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet. An Occupational Health Program exists for medical surveillance of laboratory workers and access to the laboratory is restricted and controlled at all times.
The Healthcare Facilities and Construction and Design teams rebuilt a former lab located in a building on the south side of OHSU’s Marquam Hill campus in Portland. In one week, they had the space ready for facilities to begin building lab benches and cabinets, tables for computers, wash stations, and all that the lab would require.
The Vaccine & Gene Therapy Institute team brought extensive experience establishing workflows and detection systems for emerging viruses. This experience was key at this point in construction. The team from Marquam Hill toured the Biosafety Level 3 lab on West Campus to get a sense of the kind of space required for appropriate biosafety. Before the laboratory workbenches and tables were placed and constructed in the new laboratory, the VGTI team visited the new lab to help organize the logistics of workflow that contribute to biosafety. Following that, the lab space was ready to be completed.
The focus turned to establishing and validating the detection assay.
Following CDC and FDA guidelines, the lab currently uses laboratory-developed tests that rely on the molecular biology method (PCR) polymerase chain reaction, which rapidly makes millions to billions of copies of a specific DNA sample to create a large enough amount to study in detail. The workflow of the PCR test includes sample collection, extraction, thermal cycling — and logging the findings. They began with small batches and have slowly increased the number of tests they run each day. Currently, they test 210 samples daily while maintaining the highest levels of safety and accuracy.
“Researchers have been amazingly eager to contribute to the coronavirus fight,” said Barr-Gillespie. “Scientists have contributed time and expertise, equipment and reagents — anything that is asked of them, they are ready to give.”
Susan Hayflick, M.D., chair of the OHSU Department of Molecular and Medical Genetics, formed a workgroup to amplify the call for materials and volunteers, and helped rally the research community behind their clinical colleagues. OHSU researchers were asked to share the reagents going unused in their now-shuttered labs. Generous offers poured in as a result.
On one of the last days all staff were allowed on campus, Hayflick sent out a general call for labs to donate any extra TRIzol reagent, a chemical solution commonly used to extract RNA, DNA and proteins from cells that can be used in COVID-19 testing. The response was overwhelming. So, too, was the response for scientists and teams to volunteer their skills. The morning after the call for volunteers went out, 800 people had responded.
Three of the scientists who responded to that call for volunteers were trained the first week of operations, and four are being trained this week. Right now, all testing is done by hand. The goal is to test seven days a week. But in the future, a robot that’s currently on backorder will significantly speed up their process.
Bringing it all together
The lab initially focused on providing testing for critically ill patients at OHSU. As capacity expands, it will serve a broader group of people. They are now conducting presurgical screenings.
The lab was supported by the gift from Nike leaders to accelerate statewide efforts to contain, diagnose and treat COVID-19. The $7 million Nike gift will support expanding diagnostic testing capacity.
In-house testing is one component of OHSU’s complex of strategies contributing to statewide efforts to flatten the curve. Another new piece of that complex is the drive-through testing sites at the Gordon Farber Recreation Center in Hillsboro and the Expo Center in Portland for first responders and OHSU Health patients (OHSU, Adventist Health Portland and Tuality Healthcare) with COVID-19 symptoms. OHSU plans to expand testing when more supplies become available.