BMC infectious diseases · 2026
Evaluation of the diagnostic validity of the HIV VISITECT CD4 point-of-care rapid diagnostic test in Uganda.
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Nakamaanya Oliver, Bagaya Bernard, Ssengooba Willy, Thokerunga Erick, Zamarano Henry
Аннотация
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.
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.