Multicentre accuracy trial of FUJIFILM SILVAMP TB LAM test in people with HIV reveals lot variability
Multicentre accuracy trial of FUJIFILM SILVAMP TB LAM test in people with HIV reveals lot variability
Abstract RationaleThere is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. ObjectivesThis prospective trial in seven high tuberculosis burden countries set out to evaluate the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpatient and outpatient people living with HIV. MethodsDiagnostic performance of FujiLAM at point of care was assessed among adult people with HIV 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 including available non-study test results, and a composite reference standard including clinical evaluation. Measurements and Main ResultsOf 1624 participants enrolled, 294 (18·0%) were classified as TB positive by eMRS. Median age was 40 years, median CD4 cell count was 372 cells/ul, 52% were female and 78% were taking antiretroviral therapy at enrollment. Overall FujiLAM sensitivity was 54·8% (95% CI: 49·1–60·4), and overall specificity was 85·1% (83·1–86·9), against the extended mycobacterial reference standard. Sensitivity and specificity estimates varied between sites, ranging from 26·5% (95% CI: 17·4%–38·0%) to 83·3% (43·6%–97·0%), 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. ConclusionsLot variability limited interpretation of FujiLAM test performance. Although the results with the current version of FujiLAM are too variable for clinical decision-making, the lipoarabinomannan biomarker still holds promise for tuberculosis diagnostics.
Kerkhoff Andrew D.、Sz¨|kely Rita、Hella Jerry、Ubolyam Sasiwimol、Chikamatsu Kinuyo、Mac¨| Aur¨|lien、Nyangu Sarah、MacPherson Peter、FujiLAM Study Consortium、Manosuthi Weerawat、Jirajariyavej Supunnee、Mitarai Satoshi、Reither Klaus、Nakiyingi Lydia、Dinh Huong Thi、Van Nguyen Hung、Ngo The Anh、Muyoyeta Monde、Vermeulen Marcia、Nakabugo Elizabeth、Sasamalo Mohamed、Meintjes Graeme、Mukoka Madalo、Denkinger Claudia M、Centner Chad M、Ruhwald Morten、Sossen Bianca、Nguyen Nhung Viet、Sanjase Nsala、Avihingsanon Anchalee
Division of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California San FranciscoFIND, the global alliance for diagnosticsIfakara Health Institute, Dar es SalaamHIV-NAT, Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn UniversityDepartment of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis AssociationFIND, the global alliance for diagnosticsCentre for Infectious Disease Research in ZambiaPublic Health Group, Malawi-Liverpool-Wellcome Programme||Department of Clinical Sciences, Liverpool School of Tropical Medicine||Clinical Research Department, London School of Hygiene & Tropical MedicineBamrasnaradura Infectious Diseases InstituteTaksin HospitalDepartment of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis AssociationSwiss Tropical and Public Health Institute||University of BaselInfectious Diseases Institute, Makerere UniversityNational Lung HospitalNational Lung HospitalViet Tiep HospitalCentre for Infectious Disease Research in ZambiaWellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape TownInfectious Diseases Institute, Makerere UniversityIfakara Health Institute, Dar es SalaamDepartment of Medicine, Faculty of Health Sciences, University of Cape Town||Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape TownPublic Health Group, Malawi-Liverpool-Wellcome Programme||Department of Pathology, Kamuzu University of Health SciencesFIND, the global alliance for diagnostics||Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University||German Centre for Infection Research (DZIF), Partner site Heidelberg University HospitalDivision of Medical Microbiology, University of Cape Town and National Health Laboratory Service, Groote Schuur HospitalFIND, the global alliance for diagnosticsDepartment of Medicine, Faculty of Health Sciences, University of Cape Town||Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape TownNational Lung HospitalCentre for Infectious Disease Research in ZambiaHIV-NAT, Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University
医学研究方法临床医学基础医学
Communicable Diseasesdiagnosticsdiagnostic accuracy
Kerkhoff Andrew D.,Sz¨|kely Rita,Hella Jerry,Ubolyam Sasiwimol,Chikamatsu Kinuyo,Mac¨| Aur¨|lien,Nyangu Sarah,MacPherson Peter,FujiLAM Study Consortium,Manosuthi Weerawat,Jirajariyavej Supunnee,Mitarai Satoshi,Reither Klaus,Nakiyingi Lydia,Dinh Huong Thi,Van Nguyen Hung,Ngo The Anh,Muyoyeta Monde,Vermeulen Marcia,Nakabugo Elizabeth,Sasamalo Mohamed,Meintjes Graeme,Mukoka Madalo,Denkinger Claudia M,Centner Chad M,Ruhwald Morten,Sossen Bianca,Nguyen Nhung Viet,Sanjase Nsala,Avihingsanon Anchalee.Multicentre accuracy trial of FUJIFILM SILVAMP TB LAM test in people with HIV reveals lot variability[EB/OL].(2025-03-28)[2025-06-21].https://www.medrxiv.org/content/10.1101/2022.09.07.22278961.点此复制
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