Introduction: CD4 testing plays an important role in clinical management and epidemiological surveillance of HIV disease. Rapid, point-of-care (POC) CD4 tests can improve patients' access to CD4 testing, enabling decentralization of HIV services.
Areas covered: We conducted a profile review of the Visitect®CD4 and the Visitect®CD4 Advanced Disease (Omega Diagnostics, UK) - the two lateral flow, equipment-free POC CD4 tests, which can be used to identify people with HIV who have CD4 of less than 350 and 200 cells/μl, respectively. Using published data from independent studies, we discussed the performance and utility of these tests, highlighting the advantages as well as their limitations.
Expert opinion: The tests are user-friendly, acceptable to health care workers, and feasible to implement in primary health care settings and can provide reliable results for clinical decision-making. Hands-on training with pictorial instructions for use is needed to enhance test's operator confidence in interpretation of test results. Quality assurance program should be in place to ensure the quality of testing. Development of a next-generation test with a cutoff of 100 cells/μl is recommended to identify patients with advanced immunosuppression for initiation of prophylaxis to reduce HIV-related death. Operational research is also needed to identify cost-effective implementation strategies in real-world settings.
Keywords: CD4; HIV; lateral flow; low-resource setting; point-of-care.