Diagnostic Accuracy and Practicability of the VISITECT® Advanced HIV Disease CD4 Test Compared to the Partec® CyFlow Counter II for CD4 Enumeration in Nigeria’s HIV Program
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We evaluated the diagnostic performance and practicability of the VISITECT® CD4 Lateral Flow Assay for identifying advanced HIV disease (AHD) across 334 facilities in Nigeria. In two phases, 468 participants were tested with VISITECT® CD4 and Partec® CyFlow. VISITECT® CD4 achieved a sensitivity of 100.0% and specificity of 89.8% for detecting CD4 ≤ 200 cells/mm³. The positive predictive value (PPV) was 91.3% (95% CI: 87.4–94.1), and the negative predictive value (NPV) was 100% (95% Cl: 98.1–100.0). Overall diagnostic accuracy was 95.1% (95% CI: 92.8–96.8). We recommend its use to enhance timely AHD detection and improve linkage to prophylactic interventions in resource-limited settings.
