Browsing by Author "Macé A"

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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.
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    Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability.
    (2024) Székely R; Sossen B; Mukoka M; Muyoyeta M; Nakabugo E; Hella J; Nguyen HV; Ubolyam S; Chikamatsu K; Macé A; Vermeulen M; Centner CM; Nyangu S; Sanjase N; Sasamalo M; Dinh HT; Ngo TA; Manosuthi W; Jirajariyavej S; Mitarai S; Nguyen NV; Avihingsanon A; Reither K; Nakiyingi L; Kerkhoff AD; MacPherson P; Meintjes G; Denkinger CM; Ruhwald M; Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom.; HIV-NAT, Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.; Viet Tiep Hospital, Hai Phong, Viet Nam.; Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand.; National Lung Hospital, Ha Noi, Viet Nam.; Taksin Hospital, Bangkok, Thailand.; Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.; University of Basel, Basel, Switzerland.; Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.; Public Health Group, Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi.; Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.; Ifakara Health Institute, Dar es Salaam, Tanzania.; FIND, The Global Alliance for Diagnostics, Geneva, Switzerland.; Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi.; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.; Division of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California San Francisco, San Francisco, CA, United States of America.; 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.; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; German Centre for Infection Research (DZIF), Partner site Heidelberg University Hospital, Heidelberg, Germany.; Division of Medical Microbiology, University of Cape Town and National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    There is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. This prospective trial in seven high tuberculosis burden countries evaluated the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpatients and outpatients living with HIV. Diagnostic performance of FujiLAM was assessed against a mycobacterial reference standard (sputum culture, blood culture, and Xpert Ultra from urine and sputum at enrollment, and additional sputum culture ≤7 days from enrollment), an extended mycobacterial reference standard (eMRS), and a composite reference standard including clinical evaluation. Of 1637 participants considered for the analysis, 296 (18%) were tuberculosis positive by eMRS. Median age was 40 years, median CD4 cell count was 369 cells/ul, and 52% were female. Overall FujiLAM sensitivity was 54·4% (95% CI: 48·7-60·0), overall specificity was 85·2% (83·2-87·0) against eMRS. Sensitivity and specificity estimates varied between sites, ranging from 26·5% (95% CI: 17·4%-38·0%) to 73·2% (60·4%-83·0%), and 75·0 (65·0%-82·9%) to 96·5 (92·1%-98·5%), respectively. Post-hoc exploratory analysis identified significant variability in the performance of the six FujiLAM lots used in this study. Lot variability limited interpretation of FujiLAM test performance. Although results with the current version of FujiLAM are too variable for clinical decision-making, the lipoarabinomannan biomarker still holds promise for tuberculosis diagnostics. The trial is registered at clinicaltrials.gov (NCT04089423).