University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece has announced the launch of a large-scale COVID-19 Testing Initiative that will significantly expand testing capability over the coming weeks, enabled by new funding of $2.5 million from the State of Maryland.
The new initiative will be launched with strong support and collaboration from the University of Maryland, Baltimore (UMB) and its President, Bruce Jarrell, who has been supportive of the program since its inception. This large-scale Testing Initiative will be progressively ramped up to eventually be able to run as many as 20,000 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.
The patient samples will be processed on robotic platforms with automated technologies housed in a laboratory in the UMSOM Institute for Genome Sciences (IGS). The new state funding would allow for the purchasing of additional platforms to facilitate an increase in testing capacity. Analysis of the samples will take place at the University of Maryland Pathology Associates (UMPA), CLIA/CAP accredited, which is operated by the UMSOM Department of Pathology.
While 18 laboratory staff are currently needed to process a maximum 3,000 samples per day in the IGS facility, increasing to 20,000 samples per day would involve 60 laboratory personnel working three 8-hour shifts over a 24-hour period. This ramp up in staffing and sample testing will occur over a few months. Most patients in the State have to wait for a week or more for commercial outfits to return their 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, dramatically increasing the turnaround time.
Analysing 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.
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 authorisation from the FDA and will then 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.
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