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

• Rita Székely,

  Roles Conceptualization, Supervision, Writing – original draft, Writing – review & editing

  Affiliation FIND, The Global Alliance for Diagnostics, Geneva, Switzerland

  ⨯
• Bianca Sossen,

  Roles Conceptualization, Investigation, Supervision, Writing – review & editing

  Affiliations Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa, Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa

  https://orcid.org/0000-0002-6028-3351

  ⨯
• Madalo Mukoka,

  Roles Investigation, Writing – review & editing

  Affiliations Public Health Group, Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi, Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi

  ⨯
• Monde Muyoyeta,

  Roles Conceptualization, Investigation, Supervision, Writing – review & editing

  Affiliation Centre for Infectious Disease Research in Zambia, Lusaka, Zambia

  ⨯
• Elizabeth Nakabugo,

  Roles Investigation, Writing – review & editing

  Affiliation Infectious Diseases Institute, Makerere University, Kampala, Uganda

  ⨯
• Jerry Hella,

  Roles Conceptualization, Investigation, Supervision, Writing – review & editing

  Affiliation Ifakara Health Institute, Dar es Salaam, Tanzania

  ⨯
• Hung Van Nguyen,

  Roles Conceptualization, Supervision, Writing – review & editing

  Affiliation National Lung Hospital, Ha Noi, Viet Nam

  ⨯
• Sasiwimol Ubolyam,

  Roles Investigation, Supervision, Writing – review & editing

  Affiliation HIV-NAT, Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  ⨯
• Kinuyo Chikamatsu,

  Roles Investigation, Writing – review & editing

  Affiliation Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan

  ⨯
• Aurélien Macé,

  Roles Formal analysis, Writing – review & editing

  Affiliation FIND, The Global Alliance for Diagnostics, Geneva, Switzerland

  ⨯
• Marcia Vermeulen,

  Roles Investigation, Writing – review & editing

  Affiliation Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa

  ⨯
• Chad M. Centner,

  Roles Conceptualization, Supervision, Writing – review & editing

  Affiliation Division of Medical Microbiology, University of Cape Town and National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa

  ⨯
• Sarah Nyangu,

  Roles Investigation, Writing – review & editing

  Affiliation Centre for Infectious Disease Research in Zambia, Lusaka, Zambia

  ⨯
• Nsala Sanjase,

  Roles Investigation, Writing – review & editing

  Affiliation Centre for Infectious Disease Research in Zambia, Lusaka, Zambia

  ⨯
• Mohamed Sasamalo,

  Roles Investigation, Writing – review & editing

  Affiliation Ifakara Health Institute, Dar es Salaam, Tanzania

  ⨯
• Huong Thi Dinh,

  Roles Investigation, Writing – review & editing

  Affiliation National Lung Hospital, Ha Noi, Viet Nam

  ⨯
• The Anh Ngo,

  Roles Supervision, Writing – review & editing

  Affiliation Viet Tiep Hospital, Hai Phong, Viet Nam

  ⨯
• Weerawat Manosuthi,

  Roles Supervision, Writing – review & editing

  Affiliation Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand

  ⨯
• Supunnee Jirajariyavej,

  Roles Supervision, Writing – review & editing

  Affiliation Taksin Hospital, Bangkok, Thailand

  ⨯
• Satoshi Mitarai,

  Roles Investigation, Writing – review & editing

  Affiliation Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan

  https://orcid.org/0000-0002-2288-077X

  ⨯
• Nhung Viet Nguyen,

  Roles Supervision, Writing – review & editing

  Affiliation National Lung Hospital, Ha Noi, Viet Nam

  ⨯
• Anchalee Avihingsanon,

  Roles Supervision, Writing – review & editing

  Affiliation HIV-NAT, Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  ⨯
• Klaus Reither,

  Roles Conceptualization, Supervision, Writing – review & editing

  Affiliations Swiss Tropical and Public Health Institute, Allschwil, Switzerland, University of Basel, Basel, Switzerland

  ⨯
• Lydia Nakiyingi,

  Roles Conceptualization, Investigation, Supervision, Writing – review & editing

  Affiliation Infectious Diseases Institute, Makerere University, Kampala, Uganda

  ⨯
• Andrew D. Kerkhoff,

  Roles Conceptualization, Supervision, Writing – review & editing

  Affiliation 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

  https://orcid.org/0000-0002-5023-6658

  ⨯
• Peter MacPherson,

  Roles Investigation, Supervision, Writing – review & editing

  Affiliations Public Health Group, Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom

  https://orcid.org/0000-0002-0329-9613

  ⨯
• Graeme Meintjes,

  Roles Conceptualization, Investigation, Supervision, Writing – review & editing

  Affiliations Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa, Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa

  ⨯
• Claudia M. Denkinger ,

  Contributed equally to this work with: Claudia M. Denkinger, Morten Ruhwald

  Roles Conceptualization, Supervision, Writing – original draft, Writing – review & editing

  Affiliations FIND, The Global Alliance for Diagnostics, Geneva, Switzerland, Division of Infectious Disease and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg, Germany, German Centre for Infection Research (DZIF), Partner site Heidelberg University Hospital, Heidelberg, Germany

  ⨯
• Morten Ruhwald ,

  Contributed equally to this work with: Claudia M. Denkinger, Morten Ruhwald

  Roles Supervision, Writing – original draft, Writing – review & editing

  * E-mail: morten.ruhwald@finddx.org

  Affiliation FIND, The Global Alliance for Diagnostics, Geneva, Switzerland

  https://orcid.org/0000-0002-1597-441X

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•  [ ... ],
• FujiLAM Study Consortium

  ¶Members of the FujiLAM study consortium are listed in a S8 File.

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