Title: Georgetown Created Its Own COVID-19 Testing Lab – With Rapid Results

The Race for Faster Test Results

Like many universities around the country, Georgetown switched to all virtual learning in spring 2020 as the COVID-19 pandemic began. It also dramatically reduced density in laboratory and research spaces, and transitioned to teleworking where possible. Public health, medical and administrative leaders at Georgetown recognized the importance of establishing rapid COVID-19 testing if the university community was to restore in-person operations safely.

From June 2020 to mid-November 2020, outside labs exclusively performed testing of university samples. The turnaround time for results varied from three to seven days, with the longer wait times occurring earlier in the pandemic. This timing was problematic: Georgetown needed faster results to protect the safety of its community members. Its leadership found a solution at Georgetown’s Medical Center.

A Maryland Lab’s Nimble Pivot

To have more control over the testing process and turnaround times, Georgetown leaders leveraged the only high-complexity, CLIA-certified lab at the university, a federal designation that allows for diagnostic testing of human samples — and asked them to devote time and lab space to COVID-19 testing. The lab, the C.W. Bill Young Cell Transplantation Program (CWBYP) in Rockville, is a high complexity clinical lab that performs sophisticated blood type and genetic testing for bone marrow transplants. COVID-19 testing required similar skills and expertise.

The Medical Center’s Elliott Crooke, senior associate dean of faculty and academic affairs, initiated and coordinated with the lab’s leadership to stand up the testing site. Then, complex logistical work involving university-wide teams and community health experts was executed by Marc Fournier, vice president of auxiliary services and real estate.

“The changing landscape kept us on our toes, but fortunately, we had experts in just about every field at Georgetown,” Fournier says. “It was like building an airplane as you are flying it to a destination that keeps moving. The science changes, the behavior changes and the needs change. During all that, the entire team has been relentlessly pivoting, aligning and responding.”

Planning for testing at the bone marrow transplant lab (known as BMT) began in earnest in July. In November 2020, under the direction of Peter Luger in the office of the senior vice president for research, the BMT COVID-19 lab was up and running, using a testing kit authorized for emergency use by the U.S. Food and Drug Administration. After several weeks of validation testing, the university began processing COVID-19 samples from students, staff and faculty on Nov. 18, 2020.

“Many things had to come together for this to happen,” Luger says. “We hired additional laboratory staff, acquired additional testing equipment and refurbished separate space dedicated to this testing. We also partnered with [primary health care provider] One Medical to arrange logistics such as testing supplies and appointments, specimen couriers, and results delivery.”

Georgetown’s University Information Services also worked with the BMT lab and One Medical to enable data sharing with the public health team.

By April 2021, the Georgetown University COVID-19 testing lab had completely separated from the BMT lab to become an unique entity with its own high complexity CLIA-certification. Since October 2021, the lab has performed 100% of the university’s PCR testing of samples collected on its main, Georgetown Law and School of Continuing Studies campuses, and now has 15 dedicated staff.

Detecting COVID-19 and the Omicron Wave

Since the inception of in-house testing, Georgetown’s lab has used the ThermoFisher Scientific TaqPath™ COVID-19 Combo Kit for RT-PCR tests. When the lab was scaling up to do the PCR testing, which experts call the “gold standard” for testing, validation studies were performed on de-identified COVID-19 samples from patients treated at MedStar Health, the university’s academic health system partner.  

The PCR test amplifies three viral genes that code for critical structural proteins. The test is robust enough to detect presumed variants based on the presence or absence of key genes. 

“At the end of November 2021, we suspected that we were already seeing the Omicron variant in our community,” Luger says. “We worked with NIH [National Institutes of Health] and DC Health to further analyze the samples, and by early December, NIH confirmed through full genome sequencing that Omicron was here.”

Rapid Results in Hours – Not Days

The combination of accurate PCR testing and a rapid turnaround time for results has “made it so people can, with some level of confidence, continue their lives as normally as possible when they receive a negative test result,” Luger says.

In 2022, the average turnaround time for results – calculated from the time the tester checks in at a testing center to when they receive their result – is 10 hours. If a sample was brought to the lab immediately after it was taken and processed immediately upon receipt, results could be as quick as 5 hours.

Luger adds that the lab can “turn on a dime and accommodate a higher volume of samples during a surge.” He says, “We are able to rapidly collect and share data with the public health team on campus, One Medical and the public health departments in DC, Maryland and Virginia. This type of reporting could not happen nearly as fast if we were relying on an outside lab. The IT team at the bone marrow transplant lab was instrumental in setting up the infrastructure necessary to receive, send and analyze all of the data.”

Supply Chain Speed Bumps 

The testing process has not always been seamless. Supply chain and other logistical challenges have required the lab staff to employ creative strategies to maintain the flow of testing.

For example, Luger and his team dealt with issues involving pipetting – the process used to draw up samples to carry from one vial to another – including severe shortages of pipette tips. While they managed to keep up their supply through several suppliers, they still have outstanding orders from May 2021. In December 2021, there was another shortage of the swabs and the liquid in the sample tubes required for collecting the samples on campus, but thanks to a reserve of supplies, testing continued uninterrupted.

“Throughout the last 20 months, we’ve worked collaboratively with departments and colleagues university-wide,” Luger says. “We engaged the Tissue Culture Shared Resource Lab at the Medical Center, the Office of Environmental Health & Safety and even used a cold room and lab storage in the Reiss Science Building courtesy of  the physics and biology departments. It was all hands on deck. All departments pitched in.”

A Robust Public Health Strategy

Ranit Mishori, MD, MHS, FAAFP, vice president, chief public health officer and professor of family medicine, says that in-house testing has been integral to Georgetown’s public health strategy.

“The ability to do on-campus testing and use our own lab has been crucial to the success of our public health response,” she says. “The short turnaround time and the ability to call the lab directly to review the potential genetic makeup of variants has enabled us to anticipate surges.”

Mishori adds, “We’ve been able to rapidly identify, isolate and track cases of infection in members of our campus community in our efforts to cut the chain of transmission. You cannot ask for more, especially when community-based testing doesn’t deliver, as we’ve seen during the Omicron surge.”  

In January of 2022, Georgetown extended PCR testing to children under the age of five of full-time, benefits eligible employees. The university released this offering to support parents and guardians of children under the age of five who currently have no option for vaccination to increase their access to testing.

Fournier says that the team continues to monitor progress on testing, researching different collection methods and testing types.

“While testing cannot be 100% accurate, it is part of our layered approach to health safety,” he says. “I’m a trained chef, and I equate it to the Swiss cheese model. While there are holes in individual pieces, when you stack those pieces up, the holes get smaller and smaller. We will keep working on the layers and making them as tight as they can be.” 

Special acknowledgment goes to the CWBYP lab and Carolyn Hurley, Ph.D., emeritus professor of oncology and microbiology & immunology and the former CLIA-certified lab director, Jennifer Ng, Ph.D., professor of pediatrics and technical director, and Daniel Behm, senior software architect, who were instrumental in planning for and setting up the dedicated COVID-19 testing facility. All statistics in this story were compiled as of March 17, 2022.

Beth N. Peshkin
GUMC Communications