Document Type

Article

Department

Population Health (East Africa)

Abstract

Objective: CD4þ T lymphocyte count remains the most common biomarker of immune status and disease progression in human immunodeficiency virus (HIV)-positive individuals. VISITECTVR CD4 is an instrument-free, low-cost point-of-care CD4 test with a cut-off of 350 CD4 cells/lL. This study aimed to evaluate VISITECTVR CD4 test’s diagnostic accuracy.

Methods: Two hundred HIV-positive patients attending a tertiary HIV centre in South India were recruited. Patients provided venous blood for reference and VISITECTVR CD4 tests. An additional finger-prick blood sample was obtained for VISITECTVR CD4. VISITECTVR CD4’s diagnostic performance in identifying individuals with CD4 counts 350 cells/lL was assessed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking flow cytometry as the reference.

Results: The overall agreement between VISITECTVR CD4 and flow cytometry was 89.5% using venous blood and 81.5% using finger-prick blood. VISITECTVR CD4 showed better performance using venous blood [sensitivity: 96.6% (95% confidence interval: 92.1%–98.9%), specificity: 70.9% (57.1%–82.4%), PPV: 89.7% (83.9%–94.0%) and NPV: 88.6% (75.4%–96.2%)] than using fingerprick blood [sensitivity: 84.8% (77.9%–90.2%), specificity: 72.7% (59.0%–83.9%), PPV: 89.1% (82.7%–93.8%) and NPV: 64.5% (51.3%–76.3%)].

Conclusion: VISITECTVR CD4 performed well using venous blood, demonstrating its potential utility in decentralization of CD4 testing services in resource-constrained settings.

Publication (Name of Journal)

Journal of International Medical Research

Creative Commons License

Creative Commons Attribution-NonCommercial 4.0 International License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

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