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Univ. Lab to Offer Large-Scale Covid-19 Testing

Nurse at a Covid-19 drive-in testing site in New Jersey (Master Sgt. Matt Hecht,

12 Apr. 2020. A University of Maryland lab will seek FDA authorization for its plan to provide high-volume detection testing for Covid-19 infections among state citizens. The Covid-19 testing program, based at the university’s medical school in Baltimore, is funded in part by a $2.5 million grant from the Maryland state government.

Widespread testing for Covid-19 can not only determine the infection status of more people, it can also better inform public health authorities on the spread of the disease and effectiveness of mitigation steps. While faster Covid-19 testing systems are being developed and cleared, including those designed for point-of-care testing, most tests still require processing and analysis in a remote lab. As noted by Science & Enterprise at the end of March, tests are usually reserved for people with Covid-19 symptoms, and backlogs in returning tests are growing with the increased number of tested individuals, now often taking one week or longer.

The Maryland plan calls for the medical school’s Institute for Genomic Sciences to provide the lab space and technology for processing and analyzing a large volume of Covid-19 tests. Test specimen samples from patients will be chemically treated to extract their RNA, then reverse-transcribed to DNA and amplified for genetic analysis to determine if the sample contains SARS-CoV-2 viruses responsible for Covid-19 infections. The lab is re-engineering its automated robotic sample-handling system to accommodate a higher volume of Covid-19 tests.

The testing lab will be supervised by University of Maryland Pathology Associates, whose facilities provide pathology testing services for medical school faculty and are already certified for performing laboratory developed tests. Lab developed tests are diagnostics designed for use in a single laboratory, according to FDA. The school’s pathology department plans to seek an emergency use authorization from FDA for expanded testing, and provide the agency with validation data to verify the testing lab’s ability to generate true positive and negative results.

The medical school says its lab can now process up to 3,000 Covid-19 tests a day, mainly patients admitted to the university’s medical center, with its current staff of 18 technicians. When fully operational, the scaled-up lab expects to process 20,000 tests a day, running 24 hours a day with 60 technicians working in three shifts, returning results within 48 hours. The capacity expansion is planned to take a few months.

“Initially we will call in extra technicians who are currently working from home,” says Clare Fraser, Institute for Genomic Sciences director in a university statement. “Ramping up to a full staff will be done over time. I am sure many of our laboratory staff would be eager to return onsite to work for such a worthwhile endeavor.”

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