October 26, 2012
In Sub-Saharan Africa, it can take up to three months for mothers to know if they have passed HIV to their babies, as the tests have to be sent off to a lab. Meanwhile, infected infants are not receiving treatment. To address this problem, researchers at Northwestern University have created a new device targeted specifically for testing infants in rural Africa. It will provide results in less than an hour. The test was designed by David Kelso, a professor of biomedical engineering at Northwestern with the help of Abbott Laboratories, Quidel Corp., and others.
The device is the size of a single-slice toaster and is battery powered. It can be used by less experienced nurses and community health workers and should cost less than $500. The researchers aim for the cost of each test to be less than $10, and to distribute the equipment to as many rural public health clinics as possible. The intention is that mothers of HIV-infected infants should leave the clinic with a month's supply of antiretroviral drugs for the child.
To determine whether the new test will result in significantly more HIV-positive infants receiving treatment, the researchers plan a clinical trial to begin early next year in Mozambique. The device will be evaluated in five clinics in the capital Maputo, and later expand to rural settings, where researchers will measure accuracy of the test, how availability affects the number of infants tested, and how many of the tested HIV-positive infants receive treatment. Results from first round trials in South Africa were promising. Of 634 infants tested, the device was 99.4 percent specific, and 95 percent sensitive.
The research took 10 years and was funded through a $5 million grant from the Bill & Melinda Gates Foundation. Northwestern has created a nonprofit foundation to manufacture and distribute the test. The nonprofit will outsource manufacturing and set up distribution channels and manage sales and inventory.