HIV testing on infants is set to be revolutionised, thanks to a diagnostic being piloted in the Western Cape which cuts the diagnosis time from weeks to less than an hour.
The Alere q HIV-1/2 Detect is the first molecular diagnostic to test for HIV in a clinic setting, not in a laboratory. It takes anywhere from a few days to a few weeks to test for HIV in infants because of logistics involved in laboratory testing.
It was invented by a US-based diagnostics company, Alere Inc, and was recently awarded World Health Organisation (WHO) pre-qualification, making it available for public sector procurement and use.
Point-of-care, or clinic-based HIVtesting, could have a significant effect in South Africa, which has the highest HIV incidence in the world.
HIV-testing in infants is complex because newborns keep their mother’s antibodies, making it difficult to detect HIV infection early on. Although HIV diagnosis in newborns is possible, using virologic assays, or DNA-testing, these can take weeks before final results are available.
The Alere q HIV-1/2 Detect assay, which was tested at Mowbray Maternity Hospital and Gugulethu Maternity and Obstetrics Unit, has the ability to detect and differentiate between HIV strains such as HIV-1 and HIV-2.
With the WHO pre-qualification, the testing device can be actively deployed by global health organisations in developing countries and used by health workers to rapidly diagnose HIV infection in infants, allowing for a speedier initiation of antiretroviral therapy.
Professor Landon Myer, from the school of Public Health at UCT, who also piloted the testing device in the province, said it would accelerate the HIV-testing process on infants.
Most newborns in developing countries are screened for HIV infection via dry blood spot testing, but because health workers have to wait three to six weeks for results, many potentially HIV-positive infants are lost to follow-up and remain untreated.
The point-of-care testing was a powerful tool to help meet WHO goals for timely viral HIV screening of newborns, he said.
Early infant diagnosis was especially critical in South Africa, where an estimated 410 000 children up to the age of 14 were living with HIV.
Unicef (The United Nations Children’s Fund) estimated that close to 50 000 babies and young children who died of HIV in South Africa every year could be saved through higher coverage of a few high-impact health interventions. It said the challenge was to ensure these interventions reached the children and women who need them most.
Alere global president of infectious disease, Avi Pelossof, said children with HIV were significantly less likely to receive antiretroviral therapy than adults.
Traditional methods of early infant diagnosis do not address this gap because they don’t allow for immediate linkage to care. Now, countries with the highest burden of HIV infection will have broader access to the Alere q HIV-1/2 Detect, which delivers lab-accurate results in 52 minutes.
“This will empower health workers to diagnose HIV while the mother and newborn are present and immediately initiate antiretroviral therapy, if needed.