CD4 tests measure immune cell levels and can determine when patients need to start or adjust treatment. They are a crucial diagnostic component in HIV/AIDS treatment.
The innovation from Zyomyx, a US diagnostics company, is a portable, durable kit with tests that are as easy to read as a thermometer. This ease makes the tests suitable for health workers at all levels and in a range of clinical settings. Each test costs around US$10.
Joanna Sickler, director of global product strategy at Zyomyx, tells SciDev.Net: The test provides results in under ten minutes, so health workers can start or adjust treatment in the same visit, if needed.
The product will be launched in Africa soon, but the exact date will depend on a couple of factors, including the speed of regulatory approval.
Currently, CD4 tests require expensive machines often located only in central laboratories.So tests may need to be sent away, taking weeks. Many patients never return for their results or to start treatment. According to recent Ugandan data, laboratory CD4 testing takes 59 days on average.
Stella Kentutsi, the executive director at Ugandas National Forum of People Living with HIV/AIDS Networks, says the new kit means that people living with HIV/AIDS can regularly access CD4 test results.
She says the cost for ordinary people is high, but that she believes faster, more accessible service is the way to go.
The new test is a small, disposable cartridge about eight centimetres tall. A simple, battery-operated spinner comes in a durable and portable box that fits in a backpack.
The technique uses a patented cell capture and stacking technology. A finger-prick blood sample is put in a test cartridge, and a reagent binds to the CD4 cells, making them heavier than other cells.
Spinning the sample separates out the heavy CD4 cells and pulls them into a narrow tube within the cartridge, where the result can be easily read much like reading a thermometer.
Arthur Sekiziyivu, a researcher at the Makerere University-Walter Reed Project, in Uganda, says the kit should be compared against existing technology for cost, accuracy and reliability.
The new test comes shortly after the World Health Organization (WHO) released new guidelines last month (30 June) that expand the number of people eligible for HIV/AIDS treatment to nearly 26 million.
Zyomyx has entered into partnership with US-based pharmaceuticals company Mylan, a leading provider of antiretrovirals in developing countries, to distribute the test kit.
Mylan has signed a global access commitment with the Bill and Melinda Gates Foundation, a Zyomyx investor, to ensure the new test is available and accessible at a reasonable price in countries with high HIV/AIDS burdens.
This is a revolutionary technology that couldnt have come at a better time, says Rajiv Malik, Mylans president.
The more quickly patients can receive CD4 testing, the more quickly they can access life-saving medicine.
This article has been produced by SciDev.Nets Sub-Saharan Africa desk.