Local biotechnology firm BioTech Africa has announced that it'll will soon launch an accurate, readily available HIV test that won't need to be refrigerated and can give immediate results, eliminating the need for samples to be sent to distant labs. This could revolutionise HIV care and treatment in South Africa – and Africa as a whole.
Why should babies be tested?
Not every baby born to an HIV-positive mother will get the virus.
There is a 30% risk of babies born to an HIV-positive moms being infected with the virus, reports the Discovery Centre for Health Journalism at Rhodes University. HIV can be transmitted to the baby in the womb, during labour and through breastmilk – but with intervention in the form of antiretroviral treatment (ART) for the pregnant mother and careful delivery of the baby, this risk can be significantly reduced.
The current procedure is for all babies of HIV-postive moms to be tested three times: at birth, after 6 weeks and again after 12 weeks. If all these tests are negative and the mother have not been breastfeeding, the baby has not been infected.
But of course, thousands are. With more than 6 million South Africans living with HIV, and a 3:1 female/male ratio, South Africa has a very high rate of pregnant mothers who test positive for HIV. And not all mothers know their status.
What are the challenges of testing babies?
Using standard tests, all babies born to HIV-positive mothers will test positive at birth.
Babies carry their biological mothers’ antibodies and it can take months for these antibodies to disappear. Using rapid HIV tests can make the accurate diagnosis of infants quite difficult.
So what to do in the interim?
Why ART treatment for all babies is not the answer:
"Not only do we constantly hear about shortages of antiretrovirals in South Africa, but the therapy is expensive, it is not accessible to everyone, and adverse reactions to the treatment can be life-threatening if it is not monitored properly," says Dr Leslie.
So what is the answer?
A molecular HIV test is an extremely sensitive test that can accurately confirm whether the HIV virus is present in a newborn baby.
With a molecular test, there is no need to wait until the mother’s antibodies disappear – every baby can receive an accurate diagnosis on day 1. This means that infected babies can receive ART while healthy babies won't have to undergo treatment.
But as far as molecular tests go, there is a massive shortage in South Africa right now.
"That’s why we’re creating our own," says BioTech Africa CEO Jason Lurie. "From the first protein right through to the final product, we’re producing it all, right here in South Africa."
The firm has already been internationally lauded for the quality of the test components. "What that means for us here in South Africa is that we can produce incredibly sensitive HIV tests, maintain a more constant supply, and keep the costs down."
They're packaging these tests in a user-friendly format. "One of the problems we’re dealing with in Africa is logistics, so we freeze-dry our proteins so you don’t have to keep them in the fridge," says Dr Leslie. And the tests are also being optimised to run on select battery-operated platforms. "If they need to, our tests could actually be performed in the back of a car – or even at a home birth," she continues.
BioTech Africa, who also develops tests for infectious diseases like typhoid, TB and syphilis, aims to launch South Africa’s first fully home-grown molecular HIV test kits during the first quarter of 2016.
Q&A: HIV meds & delivery options