Burnet Institute developed a world first point-of-care CD4 test (VISITECT® CD4) based on a lateral flow principle which requires only a finger-prick specimen or venous blood specimen, giving visual results within 40 minutes.
The VISITECT® CD4 is more affordable than any other CD4 technology on the market and does not require cold chain storage or maintenance costs. VISITECT® CD4 tests do not require highly-skilled laboratory technicians and/or additional equipment to perform them.
A cross-sectional, diagnostic test accuracy study was designed for field evaluation of the VISITECT® CD4 test among 175 HIV-infected pregnant women attending the Coast Provincial General Hospital in Mombasa Kenya.
The VISITECT® CD4 test will be assessed against a standard flow cytometry assay (BD FACSCountTM/FACSCaliburTM, Becton Dickinson, Franklin Lakes, NJ, USA; current gold standard).
Performance of the VISITECT® CD4 will be assessed using finger-prick and venous blood. In addition, in-depth interviews with 8-12 selected women who had a CD4 cell test and focus groups discussions with health care workers will assess feasibility and acceptability of the test.
This study will provide first-hand data on the performance of the VISITECT® CD4 test in a real world setting and valuable information to inform the implementation of the test in low-resource settings.
October 2017 – October 2018
Saving Lives at Birth - Grand Challenges for Development, Round 2-Seed Grant, Funded jointly by USAID, Bill & Melinda Gates Foundation, Canada Grand Challenges, UKAID and the Norwegian Government.
For any general enquiries relating to this project, please contact:
Senior Research Officer