Michigan researchers say academic labs should be allowed to help with coronavirus testing
Michigan researchers say they’ve created a new test for COVID-19 that’s 500 times more sensitive than the standard coronavirus test.
Researchers say the standard tests can have between 20% to 30% false negatives - particularly in patients who have not yet exhibited symptoms.
Jack Lipton is the chair of translational neuroscience at Michigan State University. He said one patient they’ve been working with has continued shedding virus over a four week period - much longer than 14 days.
“So you have to make sure there is a process in place where people are being tested and then retested. We can’t just test people once.”
It is not yet clear whether the shedded virus is still infectious.
Lipton’s new testing method requires a machine called the Droplet Digital PCR. The company that produces the machines, Bio-Rad laboratories, is currently seeking emergency FDA approval for Lipton’s test.
One roadblock to ramping up testing, according to Lipton, is that academic labs often don’t have the necessary federal certification.
Lipton and his colleague, Caryl Sortwell, recently wrote a Wall Street Journal op-ed calling on the FDA and Centers for Medicare and Medicaid Services, which oversee accreditation, to temporarily allow academic labs to do testing.
“Provide 90 day certifications during this pandemic that can be renewed as needed and when we’re no longer needed we’ll stand down and no longer be part of the testing process. I think that’s really critical if we want to do this quickly. We could probably get labs running in two to three weeks.”
Lipton estimates if just one tenth of academic labs across the country were allowed to help with testing it could mean an additional 500-thousand to one-million tests would be processed each day.
A spokesperson for the Centers for Medicare and Medicaid Services did not immediately respond to our request for comment.