Evaluation of the diagnostic validity of the HIV VISITECT CD4 point-of-care rapid diagnostic test in Uganda.
6 affiliations
- 1Department of Immunology and Molecular Biology, Makerere University, Kampala, Uganda. [email protected].
- 2Department of Immunology and Molecular Biology, Makerere University, Kampala, Uganda.
- 3Department of Medical Microbiology, Makerere University, Kampala, Uganda.
- 4Makerere University Biomedical Research Center (MAKBRC), Kampala, Uganda.
- 5Infectious Diseases Institute (IDI), Kampala, Uganda.
- 6Uganda Protestant Medical Bureau, Kampala, Uganda.
Abstract
Background
HIV remains highly prevalent in Uganda, where CD4 T-cell counts are central to identifying and managing Advanced HIV Disease (AHD). Instrument-based point-of-care (POC) CD4 platforms face cost and operational constraints in resource-limited settings. The VISITECT CD4 lateral flow immunoassay (LFA) offers a non-instrument-based alternative, but its diagnostic validity against the Pima Analyzer had not been evaluated in Uganda.Objectives
To compare diagnostic validity of the VISITECT CD4 LFA against the Pima Analyzer at the 200 cells/µL AHD threshold and explore factors influencing performance.Methods
A comparative cross-sectional study was conducted between June and August 2023 at three Kampala health centres. Venous blood from 351 HIV-positive adults was tested simultaneously on both platforms. Sensitivity, specificity, PPV, NPV, and likelihood ratios were calculated with 95% CIs using the Pima Analyzer-a point-of-care, not gold-standard, platform-as reference; estimates reflect relative, not absolute, performance.Results
Most participants were female (68.11%), median age 31 years; mean CD4 count was 482 cells/µL (± 283.9) and AHD prevalence 22.79%. VISITECT CD4 LFA showed sensitivity of 86.25% (95% CI: 76.73-92.93), specificity of 90.41% (95% CI: 86.26-93.64), PPV of 72.63% (95% CI: 64.57-79.44), NPV of 95.70% (95% CI: 92.78-97.48), and inter-rater agreement κ = 0.957. No assessed factor significantly modified performance.Conclusions
The VISITECT CD4 LFA performed reliably as an AHD screening tool relative to the Pima Analyzer in resource-limited settings, particularly where instrument-based platforms are unavailable. It should complement, not replace, confirmatory testing; improvements in sensitivity and PPV remain warranted.
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BibTeX
@article{nakamaanya2026evaluation,
title = {{Evaluation of the diagnostic validity of the HIV VISITECT CD4 point-of-care rapid diagnostic test in Uganda.}},
author = {Oliver Nakamaanya and Bernard Bagaya and Willy Ssengooba and Erick Thokerunga and Henry Zamarano},
journal = {BMC infectious diseases},
year = {2026},
month = jul,
doi = {10.1186/s12879-026-14021-y},
url = {https://europepmc.org/article/MED/42902167},
note = {CC BY},
}
RIS
TY - JOUR
TI - Evaluation of the diagnostic validity of the HIV VISITECT CD4 point-of-care rapid diagnostic test in Uganda.
AU - Oliver Nakamaanya
AU - Bernard Bagaya
AU - Willy Ssengooba
AU - Erick Thokerunga
AU - Henry Zamarano
PY - 2026
DA - 2026/07/01
JO - BMC infectious diseases
DO - 10.1186/s12879-026-14021-y
UR - https://europepmc.org/article/MED/42902167
AB - Background HIV remains highly prevalent in Uganda, where CD4 T-cell counts are central to identifying and managing Advanced HIV Disease (AHD). Instrument-based point-of-care (POC) CD4 platforms face cost and operational constraints in resource-limited settings. The VISITECT CD4 lateral flow immunoassay (LFA) offers a non-instrument-based alternative, but its diagnostic validity against the Pima Analyzer had not been evaluated in Uganda.Objectives To compare diagnostic validity of the VISITECT CD4 LFA against the Pima Analyzer at the 200 cells/µL AHD threshold and explore factors influencing performance.Methods A comparative cross-sectional study was conducted between June and August 2023 at three Kampala health centres. Venous blood from 351 HIV-positive adults was tested simultaneously on both platforms. Sensitivity, specificity, PPV, NPV, and likelihood ratios were calculated with 95% CIs using the Pima Analyzer-a point-of-care, not gold-standard, platform-as reference; estimates reflect relative, not absolute, performance.Results Most participants were female (68.11%), median age 31 years; mean CD4 count was 482 cells/µL (± 283.9) and AHD prevalence 22.79%. VISITECT CD4 LFA showed sensitivity of 86.25% (95% CI: 76.73-92.93), specificity of 90.41% (95% CI: 86.26-93.64), PPV of 72.63% (95% CI: 64.57-79.44), NPV of 95.70% (95% CI: 92.78-97.48), and inter-rater agreement κ = 0.957. No assessed factor significantly modified performance.Conclusions The VISITECT CD4 LFA performed reliably as an AHD screening tool relative to the Pima Analyzer in resource-limited settings, particularly where instrument-based platforms are unavailable. It should complement, not replace, confirmatory testing; improvements in sensitivity and PPV remain warranted.
SN - 1471-2334
ER -