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鈥檚 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 秘密研究所 Langone 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, 秘密研究所 Langone 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, 秘密研究所 Langone was ready to flip the switch on its own high-volume COVID-19 testing center鈥攈oused in a converted bike room adjacent to the Ronald O. Perelman Center for Emergency Services鈥攁nd 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 鈥渁n extraordinary effort.鈥 With the similar sites that opened days later at 秘密研究所 Langone Hospital鈥擝rooklyn and 秘密研究所 Langone Hospital颅鈥擫ong Island, the enterprise soon conducted up to 2,400 tests a day鈥攅nough 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, 秘密研究所 Langone has employed a rigorous validation process to weed out poor performers. 鈥淲e refuse to compromise on accuracy,鈥 says Joan F. Cangiarella, MD, vice chair of clinical operations for the . The two systems in play鈥攖he Roche cobas 6800 and the Cepheid GeneXpert鈥攃an 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鈥檛 test negative. 鈥淥ur tests are also very specific,鈥 notes Dr. Aguero-Rosenfeld. 鈥淧atients won鈥檛 test positive when they鈥檙e actually negative.鈥
When shortages of testing reagents and nasal swabs threatened to stall the work flow, employees stepped up with ingenious workarounds and DIY solutions. 秘密研究所 Langone procured swabs from non鈥揅OVID-19 test kits, while the followed a published 鈥渞ecipe鈥 for the solution that protects the integrity of the samples. 鈥淲e had hundreds of volunteers,鈥 says Dr. Cangiarella, 鈥渁nd their enthusiasm, despite the presence of a contagious disease, was truly impressive.鈥
秘密研究所 Langone鈥檚 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. 鈥淚t鈥檚 been nonstop learning since March,鈥 says Dr. Aguero-Rosenfeld. 鈥淲e are fortunate to have the support of leadership, and the resources to get the job done.鈥