E. Albert Reece, MD, the academic dean of the University of Maryland School of Medicine, has announced a large-scale COVID-19 Testing Initiative. Enabled by funding of $2.5 million from the State of Maryland the new initiative will be ramped up to run as many as 20,000 tests per day.
Dean Reece, who is also the executive vice president for medical affairs, University of Maryland, said the state is in dire need of increased coronavirus testing, and the School of Medicine already has the early infrastructure in place, in terms of its technology and scientific expertise to help close the testing gap.
“This funding provided to us will enable us to better track the spread of the virus and provide swifter diagnoses and treatments to those in need,” he said in an April 10 statement.
The patient samples will be processed on robotic platforms with automated technologies housed in a laboratory in the University of Maryland School of Medicine Institute for Genome Sciences. Analysis of the samples will take place at the University of Maryland Pathology Associates, which is operated by the Department of Pathology.
Analyzing test samples from patients is a multi-step process that involves first transferring a portion of the sample to an inactivation solution and extracting its RNA, which contains the virus genetic code. The RNA is then converted to DNA and amplified using the CDC recommended assay.
The laboratory at the UMSOM faculty practice site ultimately determines whether the patient’s sample contains the novel coronavirus. Automation of these steps is critical to increasing the laboratory’s ability to test thousands of samples per day.
“Our state is continuing to marshal every tool in the arsenal of public health to combat the spread of this virus, including the expertise of our university system,” said Maryland Governor Larry Hogan in the statement. “Increasing our testing capability is critical moving forward, and I want to thank the Institute for Genome Sciences and the Department of Pathology at the University of Maryland School of Medicine for partnering with us in an effort to significantly expand COVID-19 testing here in Maryland.”
“A major impediment we face is not understanding the extent of asymptomatic disease in the Maryland population,” said one expert. “Having broad access to high-throughput testing will show us where the disease is and how it’s spreading. That’s the guidance we need to control this pandemic more effectively until a vaccine can be developed.”
Most patients in Maryland have to wait for a week or more for commercial outfits to return results due to a backlog of tests and limited capacity and throughput. The facility at UMSOM would be able to return the results to patients and doctors within 24 to 48 hours.
The testing facility at the University of Maryland Pathology Associates has been certified by the federal government to perform laboratory-developed tests. These tests, which are referred to as LDTs, consist of a type of diagnostic test that is designed to be performed and used in a single laboratory, often located in a hospital. For COVID-19 testing, the UMSOM Department of Pathology plans to seek emergency use authorization from the FDA and then will submit data to the agency to verify the test’s performance both in detecting true positive results for the virus and true negative results that indicate the virus is not present.