Access to CD4 (VISITECT® CD4) testing among HIV-infected women in Kenya

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


  • International Centre for Reproductive Heath, Mombasa, Kenya
  • University of the Witwatersrand, Centre for Health Policy, School of Public Health, Johannesburg, South Africa
  • Omega Diagnostics Group PLC, Omega House Scotland, United Kingdom


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.

Contact Details

For any general enquiries relating to this project, please contact:

Doctor Minh Duc Pham

Senior Research Officer