This project aims to evaluate and document the feasibility and effectiveness of the VISITECT® CD4 in routine clinical settings in low- and middle-income countries.
Two cross-sectional, diagnostic accuracy and filed evaluation studies were conducted in South Africa (156 HIV-infected pregnant women) and India (200 HIV patients: 123 men, 77 women). The VISITECT® CD4 tests were performed by clinical staff (nurse, counselor) and trained laboratory technician with finger-prick and venous blood samples. Reference testing were standard laboratory-based flow-cytometry tests.
Results of these studies showed that the VISITECT® CD4 test achieved >80% sensitivity and >70 specificity in identifying patients with CD4 less than 350 cells/µl (late diagnosis and delayed in ART/treatment initiation) when performed by clinical staff, enabling decentralization of CD4 testing. A product profile of the VISITECT® CD4 and VISITECT® CD4 Advanced Disease (CD4 less than 200 cells/µl – advanced HIV disease) was developed to document the diagnostic performance, feasibility/acceptability of the test, and guide field implementation/scale-up of the VISITECT® CD4 in real-world settings.
This project has led to the adoption and implementation of the VISITECT® CD4 point-of-care tests at global scale. Following the successful commercialisation/licensing of the tests to Omega Diagnostics (UK), CE marking and WHO prequalification in 2020, the VISITECT® CD4 Advanced Disease has become a diagnostics of choice in global initiative to improve patients’ access to CD4 testing and reduce HIV-related deaths in over 130 low- and middle-income countries.
Links to publication websites
- Saving Lives at Birth
- Omega Diagnostics
- University of the Witwatersrand, Centre for Health Policy, School of Public Health, Johannesburg, South Africa
- International Centre for Reproductive Heath, Mombasa, Kenya
- YRG Centre for AIDS Research Education (YRG CARE), Chennai, India
- Omega Diagnostics, UK
Meet the project team. Together, we are translating research into better health, for all.