UMass Lowell to test COVID-19 diagnostic methods

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UMass Lowell researchers and students will help evaluate the effectiveness of new, rapid methods to diagnose COVID-19 through a program overseen by the National Institutes of Health.

The NIH awarded $935,000 to UMass Lowell's Solomont School of Nursing for the project as part of the federal agency's Rapid Acceleration of Diagnostics (RADx) initiative. The initiative was created last year to help private industry develop affordable and accurate COVID-19 screening tests that can be administered and analyzed within minutes at home and at doctors' offices, clinics, pharmacies, hospitals and community testing sites.

At UMass Lowell, nursing faculty and students will oversee RADx clinical trials that assess the viability of new COVID-19 diagnostic products that are being developed by established and startup medical-device and biotech companies. 

Products to be evaluated could be anything from more comfortable nasal swabs to the machines that analyze samples. The initiative will also involve community partners that can offer COVID-19 testing sites for the study.

RADx draws on the expertise of five academic centers across the country, including the Center for Advancing Point of Care Technologies (CAPCaT), a partnership between UMass Lowell and UMass Medical School that is a product of the institutions' joint venture, the Massachusetts Medical Device Development Center (M2D2).

WHAT'S THE IMPACT?

Polymerase chain reaction (PCR) laboratory tests are the gold standard for detecting the SARS-CoV-2 virus, according to the U.S. Centers for Disease Control and Prevention. But results from this type of test are often not returned quickly. 

Fast-acting tests to diagnose COVID-19 are currently available under emergency use authorization from the U.S. Food and Drug Administration. Test developers have manufactured rapid PCR and rapid antigen test platforms, some with excellent sensitivity. For example, some rapid PCR tests have greater than 95% positive agreement with the gold standard PCR lab test, and some new rapid antigen tests have achieved more than 91% positive agreement, with improved results when the test is repeated. 

Companies with emerging technologies selected for the clinical trials completed a rigorous review process. The trials will be conducted in partnership with a medical group that offers drive-through testing, UMass Lowell's own testing clinic and possibly mass testing events. It's possible there may also be a partnership with a local hospital.

At each site, nurses and nursing students will ask patients who come in for a COVID-19 screening if they are willing to take another test with an experimental device to aid in the research. Patients who consent will then answer a few questions and get the second test. Results from the tests using the experimental devices or methods will be compared to results on the same samples using the established gold-standard devices or methods.

The project was enabled by federal funding from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and National Heart, Lung and Blood Institute (NHLBI), the NIH and the Department of Health and Human Services.

THE LARGER TREND

As of Monday, there were 212,251,510 confirmed cases of COVID-19 across the world, including more than 37.8 million in the U.S., which leads the world. The U.S. also leads the world in virus-related deaths, with 628,984, according to the Johns Hopkins coronavirus tracker. 

India is second in the world in terms of cases, with more than 32.4 million, while Brazil comes in third at roughly 20 million. Brazil has recorded the second-highest number of deaths, at more than 574,000, while India has the third-highest death rate, with more than 434,000.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com