CD4 QTest: a CD4 enumeration screening test . CD4 enumeration screening test: The CD4 QTest is the first truly non-invasive point of care test in development to date with the potential to significantly reduce the high cost of monitoring HIV patients globally by utilizing a safe, pain free saliva collection in preference to blood sampling, a test that is urgently needed for infants and children. All other potential competitor CD4 point of care tests in development require a blood draw, and this can be a safety issue in resource-limited regions due to exposure to blood-borne pathogens. In some Sub-Saharan cultures, blood collection is taboo, and in this situation, the CD4 QTest provides the only access to testing.
As of 2010, 34 million people have HIV globally, over 23 million in sub-Saharan Africa. Most live in remote areas, lack access to care, and thousands die every year, untreated by anti-retroviral drug therapy antiretroviral therapy (ART). ART would improve their quality and duration of life while slowing the spread of HIV. The internationally established standard of care in resource-limited areas dictates ART should be initiated when an individual’s CD4 count drops below 350 cells/µl. The challenge? Today CD4 counts require expensive, complex equipment operated by skilled technicians. In resource-limited regions, including sub-Saharan Africa, affordable access to CD4 counts is nearly impossible.
Unlike current CD4 enumeration methods, the CD4 QTest is intended to be used as a screening test. Major changes in CD4 counts detected using the CD4 QTest should be validated by using the traditional, cell-based, flow cytometric method. As a screening test, the CD4 QTest synergizes with current methods for patient evaluation and at the same time offers a radical improvement with an initial cost at least 5 times lower than the current options.