University of Maryland School of Medicine Launches New Large Scale COVID-19 Testing Initiative Enhanced Testing Capability Could Help Ensure Sustained COVID-19 Surveillance Across the State of Maryland After Lifting of Restrictions

University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, launched a large-scale COVID-19 Testing Initiative that will significantly expand testing capability over the coming months, enabled by new funding of $2.5 million from the State of Maryland.

The initiative was launched with strong support and collaboration from the University of Maryland, Baltimore (UMB) and its President, Bruce Jarrell, MD, who has been supportive of the program since its inception.  At the UMSOM, this initiative is led by Claire Fraser, PhD, the Dean’s Endowed Professor and Director of the Institute for Genome Sciences (IGS) at UMSOM, and Sanford Stass, MD, Professor and Chair of both the UMSOM Department of Pathology and Department of Medical and Research Technology.  This large-scale Testing Initiative will be progressively ramped up to eventually run thousands of tests per day within the next few months.  This will allow for far wider access to testing in Maryland through coordination with the City of Baltimore and the State Health Department.

“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. “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.”   

The patient samples are being processed on robotic platforms with automated technologies housed in a laboratory in the UMSOM Institute for Genome Sciences (IGS). The new state funding has allowed for the purchasing of additional platforms to facilitate an increase in testing capacity. Analysis of the samples is taking place at the University of Maryland Pathology Associates (UMPA), CLIA/CAP accredited, which is operated by the UMSOM Department of Pathology.

“Ramping up to a full staff will be done over time,” said Dr. Fraser. “I am sure many of our laboratory staff would be eager to return onsite to work for such a worthwhile endeavor.”

Analyzing test samples from patients suspected of having COVID-19 is a complex 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 ability to test thousands of samples per day.

“We have now implemented a reconfiguration of the IGS laboratory to establish this high-throughput testing capability,” said Jacques Ravel, PhD, Professor of Microbiology and Immunology and Associate Director of the Institute for Genome Sciences at UMSOM. “Working closely with the oversight of the Department of Pathology, the UMPA laboratory was able to obtain regulatory approval to enable us to process samples to be tested under the supervision of UMPA, a member of the UMSOM faculty practice.”

Dr. Ravel noted that Mike Humphrys, Director of the Microbiome Service Laboratory (MSL) at IGS, has led this effort, and his past-experience as a CDC laboratory scientist and expertise were key to this effort. The MSL, working with his laboratory team, repurposed and reprogrammed the robotic platforms to handle specific tasks related to COVID-19 testing, a task that they started in late February after it became clear that the virus was spreading beyond China. The machines had previously been used for research studies to characterize the bacteria that compose the human microbiome.

The testing facility at the University of Maryland Pathology Associates has been certified by the federal government to perform laboratory developed tests. These tests, 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 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.