ArticleJournal of clinical laboratory analysis2026
Performance Evaluation of the VISITECT CD4 Lateral Flow Point-Of-Care Assay for Identifying Advanced HIV Disease.
Article in Journal of clinical laboratory analysis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesTo evaluate the performance and reader-dependent variability of the VISITECT CD4 lateral flow assay (LFA) as a screening tool for identifying advanced HIV disease (AHD; CD4 ≤ 200 cells/μL) during routine programmatic implementation.
methodsWe conducted a two-phase diagnostic evaluation in Argentina, including a training phase (n = 100) and a validation phase (n = 249), for a total of 349 participants, comparing VISITECT CD4-LFA with flow cytometry. Diagnostic performance was assessed using the manufacturer-recommended cut-off. Sensitivity, specificity, and accuracy were calculated with 95% confidence intervals (CI). Receiver operating characteristic (ROC) analysis was used to estimate the implicit CD4 thresholds applied by readers.
resultsThe VISITECT CD4-LFA showed 100% sensitivity (95% CI 94-100) in both phases. Specificity improved from 19% (95% CI 8-35) to 40% (95% CI 31-49) after training, with accuracy increasing from 42% (95% CI 33-53) to 57% (95% CI 51-63). ROC analysis demonstrated a shift in the implicit reader threshold from 363 to 270 cells/μL, indicating improved interpretation with experience.
conclusionsThe VISITECT CD4-LFA is a highly sensitive point-of-care (POC) tool for AHD screening, though its visual design limits specificity, highlighting the need for reader-independent technologies.
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