As the demand for COVID-19 diagnostic tests continues to soar, scientists have developed a blueprint to covert academic laboratories into facilities for testing patient samples for the novel coronavirus.
“As with other basic biology labs across the country, we were forced to shutter operations due to the pandemic,” said study senior author George Murphy from Boston University School of Medicine in the US.
Murphy and his team said they had extensive experience developing and running the type of quantitative, real-time reverse transcriptase polymerase chain reaction (qRT-PCR) tests that is used to detect the presence of viral genetic material, RNA, in patient samples.
They then adapted their lab to the strict policies required to run a certified, College of American Pathologists (CAP) accredited diagnostic lab. The scientists requested and received emergency permission from the US Food and Drug Administration (FDA) to re-purpose their lab, and they began operating in less than a week. As of April 20, 2020, the researchers said they have tested more than 3,000 samples, with a sample turnaround time that’s under 24 hours. Nearly 45 per cent of those tests were positive, a large number due in part to the high-risk population served by Boston Medical Centre (BMC) in the US, they said.
“Results from samples that were sent out to large commercial labs were taking up to a week,” Murphy said. “But even a wait-time of 24 hours delays the ability to make decisions about whether or not someone needs to be isolated and whether precious PPE (personal protective equipment) should be used,” he added.
The test developed by the researchers could be done with technologies and reagents that are likely to remain available, they said, adding that there is also flexibility to use different reagents at each step of the process. “Our ‘home-brew’ assay is extremely flexible, allowing us to slot in various reagents at multiple points and eliminating potential supply-chain issues,” Murphy said.
The scientists cautioned that the need for testing may not decline any time soon. “Although we have gotten through the early stages of this pandemic, which involved the testing of critically ill and symptomatic patients during a time of acute need, everyone is going to soon need to transition into asymptomatic and surveillance testing,” Murphy said. “It may be extremely difficult for large commercial labs to contend with the enormous number of samples this will entail,” he added.