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US Company Launches Early Infant HIV Diagnosis

FILE - HIV tests show negative and positive results.

Zimbabwe is among 15 countries in Africa that will soon be able to test infants for HIV in just 60-minutes.

The test, called Alere q HIV ½ Detect assay, which has proved effective in Maputo, Mozambique, where it was tested in five clinics, was developed by Alere, a leading provider of point-of-care rapid diagnostic and health information solutions, in the world.

In a study published by Alere, the five clinics in Maputo effectively used Alere q to detect the presence of HIV in infants as young as one month old, in order to allow the immediate start of anti-retroviral therapy.

UNAIDS studies show that 90 percent of HIV-infected children currently live in Sub-Saharan Africa and an estimated 90% of infections in children are acquired through mother-to-child transmission, also known as MTCT.

The study conducted under the support of the National Institute of Health together with the Clinton Health Access Initiative and the University of Eduardo Mondlane in Maputo, trained nurses in local clinics to administer the test.


Alere president for commercial operations in Africa, Tom Lindsay, said the company decided to develop the technology, so as to simplify HIV testing in infants, by making the nucleic acid test available at clinic level.

“The standard diagnostic technologies essentially are not reliable because you are not sure if you are picking up maternal anti-bodies or picking anti-bodies in the child; so molecular technologies which actually identify the viral nucleic acid are needed,” said Lindsay.

According to the Alere study, of the 827 samples tested on both the Alere q and laboratory platform, 825 results were consistent, among the infants, the majority of whom were aged between one and two months.

Lindsay, who said the process of testing the infants was simple and yielded results within an hour, added that immediate testing, reduced the follow up time, and eliminated instances where results back to the patient or mother of the child, were lost in clinical systems.


During the study the nurses would collect blood from the infants using a heel prick or a heel stick, said Lindsay.

He noted that they do a small heel prick on the child, collect blood, then apply it to a diagnostic cartridge called Alere Detect, where it is then inserted into the Alere q analyzer to be processed giving a result within 60 minutes.

Zimbabwe, like many other countries, has worked to curb MTCT and in 2013, launched a program - Families and Communities for the Elimination of Pediatric HIV in Zimbabwe (FACE).

The effort by the ministry of health and a consortium of non-governmental health organizations and a grant of $60 million from the US government, is designed to reduce the rate of MTCT from 14% to less than five percent by 2015.

Lindsay said in cases where mother to child transmission persisted, Alere q technologies could improve the outcome of infant patients.

“By using this point-to-care technologies we can deploy these at the actual clinical site, our clinicians are seeing both mothers and infants and can then use those technologies to diagnose the infants while they are there with their mothers,” added Lindsay.


The Alere q is currently awaiting World Health Organization approval, but Lindsay said the company is hoping to expand from infant testing to other forms of detection for not only HIV, but other illnesses found throughout Africa.

“We will also use the molecular platform in future for the diagnosis of other infections such as Hepatitis. We are very excited for the technology it is a molecular platform and it has many applications,” said Lindsay

Alere q is set to start operating in Zimbabwe, South Africa, Malawi, Zambia and 11 other African countries in the next six months.

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