Performance of an Innovative, Instrument-Free, Low-Cost, Rapid Point-of-Care CD4 Test for Accelerating Initiation of Antiretroviral Interventions for HIV 1-Infected Pregnant Women in Resource-Constrained Settings

A simple and accurate instrument-free, low-cost Point-of-Care CD4 test that is applicable in poor, hard-to-reach settings could sustainably increase uptake of antiretroviral intervention and reduce loss to follow-up associated with centralized laboratory-based testing. Four antenatal care clinics in Kenya and South Africa will enroll 275 HIV-infected pregnant women to prospectively assess the accuracy of the novel, rapid, inexpensive ($1.50) and instrument-free Burnet Point-of-Care CD4 test as performed by nurse-midwives in field settings, compared to a WHO pre-qualified POC CD4 instrument-based (PIMA) and a laboratory-based flow cytometric assay. If proven accurate in field settings, the Burnet Point-of-Care CD4 test could be rapidly scaled-up and markedly enhance care, particularly in rural areas of resource-constrained settings.