Inside the Race to Provide Frontline Healthcare Workers With COVID-19 Testing Kits

In other words, they’re working to prevent the virus from degrading during its trip from testing site to lab. A degraded virus could lead to false negatives, or telling people that they’re healthy despite having COVID-19.

As testing demand has increased exponentially, VTM supply has dwindled. That’s why the team set out to create enough VTM and tubes for 10,000 tests. Without it, clinicians and researchers worry that, among other things, people who test positive but are asymptomatic could be missed and remain at risk of spreading the virus.

“This initiative, and the biotechnology students involved, are helping to make more testing possible in Philadelphia,” says Dr. Michael Dryer, dean of the Jefferson College of Health Professions. “I don’t want to overstate the importance and the impact that this could have. This new source of VTM allows us to keep up with the SARS-CoV-2 testing demand.”

Conceptually, the effort to ease the heavy demand for these devices during difficult times started three weeks ago.

That’s when Dr. Scott Gygax—department of medical laboratory sciences and biotechnology vice chair and biotechnology program director—took his supply-side concerns to Dr. Barbara Goldsmith, who’s the chair of the department and director of the clinical laboratories, point of care testing and quality at Thomas Jefferson University Hospital. Once complete, the VTM will be utilized across the Jefferson Health system.

“We are looking to provide resources for frontline healthcare workers to take samples from those suspected of testing positive for coronavirus,” explains Dr. Gygax, who lauded Dr. Matthew Pettengill, scientific director of clinical microbiology, for his transport-media ideas and coronavirus testing expertise. “We’re generating resources: the tube and the fluid inside it, which can be put together into test kits to provide to the hospital network.”

Dr. Goldsmith, who urges a similar push be undertaken to increase swab supply, quickly jumped behind the effort. Shortages of all supplies are a challenge for all clinical laboratories struggling to keep up with demand.

That urgency led teams from across the University—be they in supply chain, pathology administration, anatomy and cell biology, clinical microbiology, or molecular and genomic pathology—to turn an idea into a tangible reality.

Supplies and labels were ordered, “recipes” were gleaned from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, and standard operating procedures were established.

Then, the VTM creation process started on April 3, a day in which 1,250 testing kits were created “on a really short timeline with a skeleton crew,” Chadwick says.

Those batches have since passed sterility testing and, in ensuing days, validation. Upon clearing those hurdles, the team—which includes biotechnology student-volunteers and teaching assistants Ellen Robinson and Austin Pendergast—got back to work and have now produced 3,750 kits.

That process will repeat itself until the 10,000 goal is reached, at a time when VTM supplies dwindle from independent sources.

“We have a well-designed way of doing this. We can manufacture this in an alternative way, and the next step is creating it en masse,” Dr. Dryer says. “This will be done on a massive scale that will enable testing to move forward for large number of people.”

Dr. Dryer acknowledged the similarity in spirit between this and other initiatives, but noted that it’s profoundly different as “this is not quite a ‘MacGyver’ approach.” He also highlighted the unique nature of students being involved in the process.

“It’s bringing about a fairly complex thing that you can’t just go into a drugstore and buy,” he says. “This is taking people who have a skillset that they learned as students in the program and they’re now able to apply those special skills to this task.

“They’re not just creating something anybody could create. This is product development and real-world experience for them.”

Others participating in the production and validation of medical-collection devices for testing patients suspected of having the COVID-19 disease include Dr. Stephen C. Peiper (Chairman, Department of Pathology, Anatomy & Cell Biology), Steven Gudowski (Administrator, Pathology), Dr. Matthew Pettengill (Scientific Director of Clinical Microbiology) and Dr. Zi-Xuan Wang (Scientific Director of Molecular and Genomic Pathology).