A profile of the Visitect® CD4 and Visitect® CD4 Advanced Disease for Management of People Living with HIV

Abstract

ABSTRACT 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 decentralisation 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 healthcare workers, feasible to implement in primary healthcare settings and can provide reliable results for clinical decision-making. Hand-on training with pictorial instructions for use are 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 cut-off 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.