ArticleThe Journal of infectious diseases2025
A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries.
Article in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV
Start4All - Start Taking Action for TB Diagnosis SCREEN-TB
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Diagnostic accuracy of the WHO clinical staging system for detection of immunologically defined advanced HIV disease: A systematic review and meta-analysis.HIV medicine · 2026Pooled it
- Performance Evaluation of the VISITECT CD4 Lateral Flow Point-Of-Care Assay for Identifying Advanced HIV Disease.Journal of clinical laboratory analysis · 2026Article
- Accuracy and Acceptability of the VISITECT CD4 Advanced Disease Test Compared With the PIMA CD4 Test at the Point of Care as Part of the Advanced HIV Disease Care Package: A Mixed-Methods Study.Open forum infectious diseases · 2026Article
- Diagnostic accuracy and practicability of the VISITECTAIDS research and therapy · 2026Article
- Article
- VISITECT® CD4 advanced disease assay in routine use: Diagnostic accuracy and usability, Ethiopia and Indonesia.Tropical medicine & international health : TM & IH · 2025Article
- Microfluidic Assays for CD4 T Lymphocyte Counting: A Review.Biosensors · 2025Review
Corrections and comments
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Authors and funding
28 authors.
Funding
Abstract
backgroundCD4 measurement is pivotal in the management of advanced human immunodeficiency virus (HIV) disease. VISITECT CD4 Advanced Disease (VISITECT; AccuBio, Ltd) is an instrument-free, point-of-care, semiquantitative test allowing visual identification of CD4 ≤ 200 cells/µL or >200 cells/ µL from finger-prick or venous blood.
methodsAs part of a diagnostic accuracy study of FUJIFILM SILVAMP TB LAM, people with HIV ≥18 years old were prospectively recruited in 7 countries from outpatient departments if a tuberculosis symptom was present, and from inpatient departments. Participants provided venous blood for CD4 measurement using flow cytometry (reference standard) and finger-prick blood for VISITECT (index text), performed at point-of-care. Sensitivity, specificity, and positive and negative predictive values of VISITECT to determine CD4 ≤ 200 cells/ µL were evaluated.
resultsAmong 1604 participants, the median flow cytometry CD4 was 367 cells/µL (interquartile range, 128-626 cells/µL) and 521 (32.5%) had CD4 ≤ 200 cells/µL. VISITECT sensitivity was 92.7% (483/521; 95% confidence interval [CI], 90.1%-94.7%) and specificity was 61.4% (665/1083; 95% CI, 58.4%-64.3%). For participants with CD4 0-100, 101-200, 201-300, 301-500, and >500 cells/µL, VISITECT misclassified 4.5% (95% CI, 2.5%-7.2%), 12.5 (95% CI, 8.0%-18.2%), 74.1% (95% CI, 67.0%-80.5%), 48.0% (95% CI, 42.5%-53.6%), and 22.6% (95% CI, 19.3%-26.3%), respectively.
conclusionsVISITECT's sensitivity, but not specificity, met the World Health Organization's minimal sensitivity and specificity threshold of 80% for point-of-care CD4 tests. VISITECT's quality needs to be assessed and its accuracy optimized. VISITECT's utility as CD4 triage test should be investigated. Clinical Trials Registration. NCT04089423.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.