Browsing by Author "Jacobs BKM"

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    A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries.
    (2025-Feb-04) Gils T; Hella J; Jacobs BKM; Sossen B; Mukoka M; Muyoyeta M; Nakabugo E; Van Nguyen H; Ubolyam S; Macé A; Vermeulen M; Nyangu S; Sanjase N; Sasamalo M; Dinh HT; Ngo TA; Manosuthi W; Jirajariyavej S; Denkinger CM; Nguyen NV; Avihingsanon A; Nakiyingi L; Székely R; Kerkhoff AD; MacPherson P; Meintjes G; Reither K; Ruhwald M; School of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.; German Centre for Infection Research, Heidelberg University Hospital, Heidelberg, Germany.; Viet Tiep Hospital, Hai Phong, Viet Nam.; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand.; National Lung Hospital, Ha Noi, Viet Nam.; Taksin Hospital, Bangkok, Thailand.; Global Health Institute, University of Antwerp, Wilrijk, Belgium.; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.; Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.; University of Basel, Basel, Switzerland.; Public Health Group, Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi.; Ifakara Health Institute, Dar es Salaam, Tanzania.; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.; Division of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, California, USA.; Clinical Research Unit, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi.; HIV Netherlands Australia Thailand Research Collaboration, Thai Red Cross AIDS Research Centre and Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.; Foundation for Innovative New Diagnostics, the Global Alliance for Diagnostics, Geneva, Switzerland.; Clinical Research Department, London School of Hygiene and Tropical Medicine, London, United Kingdom.; Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg, Germany.; Infectious Diseases Institute, Makerere University, Kampala, Uganda.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: CD4 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. METHODS: As 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. RESULTS: Among 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. CONCLUSIONS: VISITECT'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.