One of the biggest challenges with the COVID-19 outbreak in the United States has been a shortage of testing kits.
As of mid-March, there were no FDA-approved, commercially available kits for COVID-19, and none was expected until at least May.
“We had hoped that COVID-19 would not arrive in Connecticut until after commercial tests were available; however, it became clear that the virus had been circulating in the U.S. undetected for weeks, and tests were urgently needed,” said Marie-Louise Landry, MD, Yale New Haven Hospital Clinical Virology Laboratory director.
Prompt testing helps ensure those infected receive appropriate treatment; it also shows where and how extensive outbreaks are.
When the FDA in late February changed its rules to make it easier for laboratories to implement their own tests, YNHH’s Virology Laboratory sprang into action. Developing the Centers for Disease Control and Prevention (CDC) test on site wasn’t easy.
Testing components from various suppliers were back ordered and lab instruments used for other tests had to be modified.
Virology leaders Maureen Owen, Robin Garner and Jody Criscuolo worked overtime to develop the test and meet extensive FDA requirements to validate that it worked. Former Virology Manager David Ferguson, now a senior manager at Yale Medicine’s Center for Outcomes Research and Evaluation, volunteered to help. On March 13, the Virology Lab began testing inpatient specimens, with plans to increase testing to up to 400 specimens per day for YNHH and other health system hospitals.
“Virology found itself in a unique position to make a difference and provide needed help to our patients, healthcare workers and our community during this public health emergency,” Dr. Landry said. “We are grateful to be able to contribute our skills to the effort.”
We had hoped that COVID-19 would not arrive in Connecticut until after commercial tests were available; however, it became clear that the virus had been circulating in the U.S. undetected for weeks, and tests were urgently needed,
Marie-Louise Landry, MD, Yale New Haven Hospital Clinical Virology Laboratory director.