BIDMC’s Novel, Homegrown COVID-19 Test

A Test of Willpower

How one dedicated team developed a COVID-19 test—right here at BIDMC

Dr. James Kirby in the pathology labOn March 17, 2020, BIDMC launched its own COVID-19 test, becoming the first hospital in New England to offer high capacity, in-house testing—which remains key to the medical center’s pandemic response.

It sounds impressive—and it is—but the journey to get to where we are today was anything but easy. “It was a race against time, and the challenge of a lifetime. Innovation and cooperation were pivotal,” says Clinical Microbiology Laboratory Director James Kirby, MD. “It was a team effort all around. Support from our Chair of Pathology, Dr. Jeff Saffitz, and our Vice Chair for Laboratory and Transfusion Medicine, Dr. Lynne Uhl, enabled us to overcome many obstacles.” Also essential was the exceptional effort and dedication of BIDMC staff. “Our success happened because dozens of staff turned their lives upside down to help,” says Annie Cheng, Clinical Supervisor of Molecular Diagnostics in the Department of Pathology.

We had to ramp up to perform 1,500 COVID tests a day.
James Kirby, MD
Clinical Microbiology Laboratory Director

In the pandemic's early days, testing was absolutely crucial to identify who was infectious and to keep the hospital running safely. “We were originally sending tests to outside labs, but the turnaround time was several days,” says Kirby. “Our medical staff didn't have that time to spare.” So he gathered a team from the Department of Pathology, the Clinical Microbiology Laboratory, and the Division of Infectious Diseases. In a process that typically takes months, Kirby led the team in identifying, testing, and validating a polymerase chain reaction (PCR) test to genetically detect the SARS-CoV-2 virus, which causes COVID-19—all within a stunning three days. Ryan Pena, MD, CLIA Director of Molecular Diagnostics, spearheaded the effort to submit the test, also known as an assay, to the FDA for review, allowing for immediate deployment of our testing.

The group’s lab space was soon transformed into a small factory, operating 24/7. “Our team of two typically processes 1,500 influenza tests over the course of an entire flu season,” says Kirby. “We had to ramp up to perform 1,500 COVID tests a day.” Twenty-six research staff whose own labs had been shut down were recruited and trained by Cheng and lab manager Tammy Galloway, but challenges continued. Beyond the actual PCR platform, a COVID-19 test requires a number of essential components—all of which were on backorder due to international manufacturing delays. The team needed viral transport medium, the liquid that keeps samples stable until they reach the laboratory, as well as test tubes and nasal swabs to collect specimen samples, but everything was in dangerously short supply.

Through a combination of inspired ingenuity and dogged outreach, the team addressed these challenges one by one. An assembly line was created to develop viral transport medium, led by postdoctoral fellow KP Smith. Members of the team rounded up thousands upon thousands of existing test tubes from throughout BIDMC and across the city. And pathologist Ramy Arnaout, MD, PhD, spearheaded an effort to design and mass-produce nasal swabs using 3D printing in a mere 22 days. This not only carried BIDMC and the Beth Israel Lahey Health (BILH) system through the crisis, but continues to supply nasal swabs throughout the world.

In addition, Stefan Riedel, MD, PhD, Associate Director of the Clinical Microbiology Laboratory, and his team brought on new rapid tests that can diagnose COVID-19 in an hour. “Dr. Riedel worked many late nights on rapid testing,” says Kirby. “This was an important step forward in our fight against COVID-19 and made a great impact on BIDMC’s ability to provide the safest possible emergency care.”

Since March 17, more than 475,000 COVID tests have been administered throughout BILH—thanks in large part to the dedication of this incredible team. “Without our team’s efforts, BIDMC and all of BILH would have had no ability to provide accurate, high-throughput, rapid-turnaround testing,” says Jeff Saffitz, MD, PhD, Chair of the Department of Pathology. “Just imagine what would have happened if we had to send samples to an outside lab and wait weeks for the answer.” According to Sam Skura, MBA, Chief Operating Officer, testing was indispensable to the medical center’s pandemic response. “At the beginning when there was not a lot of available testing, BIDMC solved for a unique need,” says Skura, explaining that the medical center provided testing for the BILH system and our greater Boston community.

BIDMC also extended testing at its three sites: BIDMC’s main campus, BID–Chelsea HealthCare, and Bowdoin Street Health Center, to all individuals, including non-patients, regardless of their insurance status. “We did a tremendous public health service to our community to diagnose patients and help them quarantine appropriately,” says Skura, commending the many groups who worked on this effort. “From the facilities team, who stood up weatherproof testing tents to the swabbers, who worked outdoors in the freezing cold to the IS team, who wired the tents to the HR talent acquisition team, who helped to staff the testing sites, teamwork made this incredible effort possible.”

The faculty and staff in the pathology group could not agree more, and all feel gratified that their work helped people across Eastern Massachusetts and beyond. “For months, so many bottlenecks stood in the way of efficient testing, but we were able to overcome each one,” says Arnaout. Adds Cheng: “If you have willpower, nothing can stop you. We came together, and we found a way.”

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