New kit to test HIV in infants launched in Kenya

An HIV adherence counsellor draws a woman's blood for an HIV test at the IOM treatment centre in Eastleigh, Nairobi, Kenya, November 29, 2018.
An HIV adherence counsellor draws a woman's blood for an HIV test at the IOM treatment centre in Eastleigh, Nairobi, Kenya, November 29, 2018.

A new kit to test HIV in small babies has been launched in Kenya.

The tool will also test dried blood spots to monitor viral load and disease progression in infected individuals, which will guide treatment methods.

Kenya Medical Research Institute said laboratories using the tool could make quicker and easier HIV diagnosis and monitoring.

The test kit, called Aptima HIV-1 Quant Dx assay, is made by US-based diagnostic equipment producer Hologic.

“Kenya through the Ministry of Health and partners has set an ambitious target to provide HIV viral load testing to 1.5 million people annually,” said Prof Matilu Mwau, the Director for Infectious Diseases Research at Kemri.

“We anticipate testing between 300-400,000 dried blood spot specimens in 2019 and as a service provider we look for the technologies that will have a maximum output with minimal input.”

Prof Mwau said such volumes require systems that work efficiently from specimen collection, storage, transportation, testing and results transmission.

“Fully automated systems such as Hologic’s Panther system and their recently acquired CE IVD marks are a welcome addition to the different platforms we will employ to provide these much needed services for both viral load monitoring and early infant diagnosis,” he said.

Testing HIV in babies is difficult and using standard tests, all babies born to HIV-positive mothers will test positive at birth.

This is because babies carry their biological mothers’ antibodies and it can take months for these antibodies to disappear.

A molecular HIV test like the new kit is extremely sensitive and can accurately confirm whether the HIV virus is present in a newborn baby.

This means that infected babies can receive ART while healthy babies won't have to undergo treatment.

Aptima will cost about Sh1,200 a piece.

The manufacturer said the price was subsidised through the recent Hologic Global Access Initiative, launched in partnership with the Clinton Health Alliance Initiative and MedAccess.

In Kenya there are estimated 110,000 children under the age of 14 living with HIV and an estimated 8,000 children were newly infected with HIV in 2017.

The new test can use plasma, serum or dried blood spots to get an accurate HIV diagnosis on the automated PantherTM system.

It was awarded World Health Organisation prequalification for in vitro diagnostics using plasma samples in 2017, which allows global health organisations to consider it for public sector procurement in developing countries.

“We designed the Aptima HIV-1 Quant Dx assay and the Panther system keeping in mind the specific needs of viral diagnosis laboratories in Africa,” said João Malagueira, Hologic’s vice president, Europe South and Indirect Markets, in a statement.

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