Authors
Mariana Andreani, Claudia E Frola, Liliana Guelfand, Fabiana C Chaile, José Barletta, María J Rolón, Mariana Erbin, Juan L Rodriguez-Tudela
Published in
Journal of clinical laboratory analysis. Pages e70340. Aug 19, 2026. Epub Aug 19, 2026.
Abstract
To 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.
We 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.
The 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.
The 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.
PMID:
42619277
Bibliographic data and abstract were imported from PubMed on 20 Aug 2026.
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