A clinical trial of a new HIV drug test could improve the lives of both mothers and children in developing nations. The test delivers results in under one hour – far faster than conventional tests – and researchers hope it will increase the rate at which HIV positive infants are diagnosed and treated.
The pending trial was announced this week by Northwestern University, where the research on the test took place. The trial will take place “soon” in Maputo, Mozambique, with nine other countries slated to begin trials after the results of the Mozambique trial are analyzed.
“Our test provides while-you-wait results, and if a child is infected, he or she will begin treatment immediately, which is critical to survival,” said David Kelso, professor of biomedical engineering at the McCormick School of Engineering and Applied Science at Northwestern. “One and a half million infants in Africa and Asia are born to HIV-positive mothers each year, but only a fraction of the HIV-positive infants are identified in time to start treatment. While adults can manage the disease for decades, an infant who isn’t treated likely will die within a year or two.”
The new test is a miniaturized version of the p24 HIV test. It was specifically designed for use in developing nations, is “easy-to-use,” and has a 95% accuracy rate, according to Northwestern. The test detects low levels of core protein 24, which is made by the virus.
To perform the test, medical personnel take a drop of an infant’s blood and place it on a blood-separation membrane, which is then inserted into a small processor. Results come in just 30 minutes, with two black lines indicating the presence of HIV. The cost of the test is currently $15, though that price is expected to drop by as much as half as production volume increases.
The technology behind the test was developed with funding from the Bill & Melinda Gates Foundation. It is the first product to come out of the Northwestern Global Health Foundation, which Kelso helped found in 2010.
“The Northwestern Global Health Foundation is a new sort of business: a nonprofit biotech company that helps manufacture and deliver health care products that wouldn’t turn enough profit to be attractive to traditional companies,” Kelso said. “If the foundation works, I think it’s an entirely new way to do business.”
(Photo courtesy Northwestern University)