Dr. Maria E. Aguero-Rosenfeld peers inside the Roche cobas 6800, a diagnostic system that uses real-time polymerase chain reaction (PCR) technology to process up to 1,440 COVID-19 tests within 24 hours.
Photo: Elliot Goldstein
Coronavirus disease (COVID-19) testing in the United States is a tale of false starts that thwart the strongest medical tool we have for tracking the spread of the virus. With suspected cases on the rise during last spring’s surge, hospitals were forced to wait up to two weeks for test results, a delay that poses a dangerous roadblock for clinical care. But the tide turned quickly at ٺƵ Health. On Friday, March 13, when Roche Pharmaceuticals received emergency-use authorization from the U.S. Food and Drug Administration (FDA) for its new coronavirus test, ٺƵ became one of only two academic medical centers in New York City with the lab equipment and expertise required for processing it.
That evening, , director of clinical laboratories, assembled a team to validate the system, as well as a small army of PhDs, residents, and other volunteers trained to run the tests. By Monday morning, ٺƵ was ready to flip the switch on its own high-volume COVID-19 testing center—housed in a converted bike room adjacent to the Ronald O. Perelman Center for Emergency Services—and start testing hundreds of patient samples a day, returning results within 24 hours.
The new high-speed capability was a game changer. When Dean and CEO Robert I. Grossman, MD, toured the facility, he extended his gratitude to the volunteers and hailed the launch as “an extraordinary effort.” With the similar sites that opened days later at ٺƵ Hospital—Brooklyn and ٺƵ Hospital—Long Island, the enterprise soon conducted up to 2,400 tests a day—enough to meet the needs of patients, employees, and first responders. (By the end of July, the total tally exceeded 140,000 tests.)
As new testing systems have became available, ٺƵ has employed a rigorous validation process to weed out poor performers. “We refuse to compromise on accuracy,” says Joan F. Cangiarella, MD, vice chair of clinical operations for the . The two systems in play—the Roche cobas 6800 and the Cepheid GeneXpert—can detect even a few hundred viruses per milliliter of sample. That level of sensitivity means that even asymptomatic carriers who may have a low viral load won’t test negative. “Our tests are also very specific,” notes Dr. Aguero-Rosenfeld. “Patients won’t test positive when they’re actually negative.”
When shortages of testing reagents and nasal swabs threatened to stall the work flow, employees stepped up with ingenious workarounds and DIY solutions. ٺƵ procured swabs from non–COVID-19 test kits, while the followed a published “recipe” for the solution that protects the integrity of the samples. “We had hundreds of volunteers,” says Dr. Cangiarella, “and their enthusiasm, despite the presence of a contagious disease, was truly impressive.”
ٺƵ’s clinical laboratories continue to pursue more innovative testing capabilities. The team has rolled out a 3-in-1 test for respiratory syncytial virus (RSV), flu, and COVID-19. Also under consideration is a rapid saliva test for in patients with suspected COVID-19 infections. “It’s been nonstop learning since March,” says Dr. Aguero-Rosenfeld. “We are fortunate to have the support of leadership, and the resources to get the job done.”
