Diagnostic accuracy of the VISITECT CD4 lateral-flow assay for screening advanced HIV disease: a systematic review and meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the pooled performance of the VISITECT-CD4 Advanced Disease lateral-flow assay (VISITECT-CD4-LFA) for diagnosing advanced HIV disease (AHD). METHODS: A search was conducted in PubMed, EMBASE, Google Scholar, and Scopus up to February 2, 2026, to identify studies that evaluated VISITECT-CD4-LFA. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Meta-analysis was conducted using a bivariate random-effects model to estimate pooled sensitivity and specificity compared to flow cytometry. RESULTS: Ten studies were included, comprising 6962 people with HIV. Pooled sensitivity and specificity were 98% (95% CI: 94-99%) and 71% (95% CI: 56-85%), respectively, with an area under the curve (AUC) of 0.95. Subgroup analysis revealed that VISITECT-CD4-LFA from capillary blood had similar sensitivity (96%, 95% CI: 93-97%) to venous blood (99%, 95% CI: 93-100%). CONCLUSIONS: VISITECT-CD4-LFA meets the ≥90% sensitivity requirement specified in the target product profile (TPP) for point-of-care CD4 tests for AHD. With robust sensitivity using both venous and capillary blood, it has the potential to facilitate timely screening and prophylaxis for opportunistic infections in decentralized settings. The assay's pooled specificity fell slightly below the ≥80% TTP target. Further research is needed for South American and Asian populations, with strategies to boost specificity. PROSPERO REGISTRATION: CRD420251272180.