Robert Mercieri, assay development technologist, Molecular Lab, (left) and Christopher Cardona, section coordinator, Virology/Microbiology Lab, with a new Hamilton Vantage instrument – one of the pieces of equipment used to validate the COVID pooled testing process.
Throughout the COVID-19 pandemic, Yale New Haven Laboratory professionals have been on a mission to perform more COVID tests more quickly and efficiently – without sacrificing the quality of results.
In the coming weeks, Yale New Haven Hospital’s Virology Laboratory plans to launch “pooled testing” for certain patients. Put simply, the process involves taking samples from several people and performing one test on the combined samples. If the test is negative, no further testing is needed. If it’s positive, each sample is separated out and tested to determine which patient is infected. Pooled testing is designed to reduce the number of tests the Lab needs to perform and, in turn, conserve supplies such as reagents that are in demand worldwide.
Of course, the pooled testing process itself isn’t simple. Nor is getting it off the ground.
“This is an enormously complex endeavor,” said Maureen Owen, manager of YNHH’s Virology Laboratory. “It doesn’t happen overnight.”
Like many laboratory procedures, pooled testing requires highly trained staff, along with specific instruments, technology and supplies. Before the Lab can begin performing pooled (or any other type of) testing, Lab professionals must evaluate and validate the testing process. That means scrutinizing each of the many steps in the process to ensure they’re being performed correctly, and confirming that the testing process yields a high-quality result. If the Lab is not using a commercial test kit, or modified a kit testing process or instrumentation (as with pooled testing), the Lab must submit testing performance data to the FDA for approval.
YNHHS Laboratory physicians and staff have been through this arduous process before, for COVID and other types of testing. The process has become even more challenging now, with Laboratory staff throughout the health system busy performing more than 4,000 COVID tests daily. That number continues to grow.
Owen said YNHH’s Virology Laboratory has hired and is training numerous staff. Before COVID, Virology operated two shifts on weekdays, and, except for flu season, one shift on weekends. When COVID hit, staff had to cover three shifts a day, seven days a week. For over five months, a Virology staff member volunteered to work the third shift, but with newly hired staff, Virology now routinely operates 24-7.
Microbiology and Molecular Lab staff have provided essential help from the beginning; with increased testing over the past few months, Chemistry, Hematology and Saint Raphael Campus Lab staff are also assisting the COVID effort. At the same time, the various Labs continue to perform routine tests for non-COVID patients.
“It really is all hands on deck,” Owen said. “Everyone is committed to doing whatever they can to fight this pandemic and ensure that all our patients receive the care they need.”
