With a new $765,120 grant, Global Health professor Paul Drain will lead a study to develop an antigen-based COVID-19 test – as well as evaluate PCR-based tests and immunological assays – to be used at the point of care. This grant, sponsored by the Bill and Melinda Gates Foundation, is titled “Developing and Evaluating Point-of-Care Antigen and Immunoassays for COVID-19 and Cytokine Release Syndrome among people being screened for SARS-CoV-2 infection in Seattle”.
“Access to diagnostic testing for SARS-CoV-2, the virus that causes COVID-19, has been a major problem, not only for people in the United States, but also for people around the world,” said Drain. “With the generous support from the Gates Foundation, we will work to develop a novel antigen-based COVID-19 test that can be used in either community-based or resource-limited settings. In addition, we will evaluate several emerging point-of-care diagnostic tests that may also help to expand COVID-19 testing.”
In February, the World Health Organization (WHO) identified some pressing research priorities in studying COVID-19. One of the keys was to “mobilize research on rapid point of care diagnostics for use at the community level.” With this new grant, Drain and his team hope to do just that through antigen-based and rapid PCR testing, which would detect COVID-19 on a molecular level.
Currently, testing for COVID-19 involves a deep swab of the nasopharynx, the upper part of the throat behind the nose. However, the quality of these results is dependent on the person collecting the swab, as well as the avoidance of contamination and the condition of the person being tested. Something as simple as using an incorrect technique can lead to false results, thus hampering efforts to contain the virus’ transmission. While these samples are collected at the point-of-care, the test is processed in a centralized laboratory, and the person being tested often has to wait more than 24 hours to receive the results.
Drain and his team are also exploring an alternative immunoassay (a procedure for detecting or measuring specific proteins or other substances through their properties as antigens or antibodies) using nasal, mid-turbinate, or throat swabs—all of which may have several advantages over the current process. This test would be both inexpensive and quick, with results potentially coming within 15 minutes after collecting the sample. Another benefit of the proposed tests is the ability to detect COVID-19 in those who previously tested negative.
As stated in the grant’s abstract, this form of testing has the greatest potential for widespread community-based screening and home self-testing, particularly in resource-limited settings.
“Most of us living in and around Seattle have been fortunate to have a state-of-the-art Clinical Virology Lab at the University of Washington, which has conducted over 80,000 COVID-19 tests,” said Drain. "However, most people live in areas with minimal access to laboratory testing. There is a growing need to serve these people, as well as allow people to test in their own homes and to know the test results within minutes—not days.”
As part of the study, the laboratory team would evaluate antigen-based and rapid PCR-based assays and conduct a longitudinal component to distinguish the patterns of antigen and antibody detection. In other words, the study will help define how long people remain positive for antigen detection, and when an antibody-based test becomes positive and may be more useful. With the COVID-19 pandemic requiring health workers, scientists, researchers, and the public to engage in responsible methods of virus suppression, a new, convenient testing system could prove to be a valuable resource.
“Many public health leaders have continually said that increasing access to COVID-19 testing will be a critical component to returning to our normal, pre-pandemic lives,” said Drain. “We’ve partnered with our dedicated COVID-19 testing teams at Harborview Medical Center and Northwest Hospital to accelerate the development of these tests as quickly as possible. All the dedicated health care workers and affiliated staff who are working at the front lines and risking exposure to offer testing to others have been heroic and inspirational.”