Assessing the performance of a point-of-need diagnostic algorithm in rapid detection of peripheral lymph node tuberculosis (Mobile-TB-Lab): a diagnostic evaluation study protocol
The study protocol (PR-23031) has been approved by the research review committee (RRC) and the ethical review committee (ERC) under the institutional review board (IRB) of icddr,b in Bangladesh. In Uganda, the study protocol has been approved by the Research Ethics Committee of the Infectious Diseases Institute of Makerere University under reference number IDI-REC-2023-62 and approval from the Uganda National Council for Science and Technology (UNCST) under reference number HS3494ES. All the study materials and procedures to be used for the enrolment of the participants have been approved by the ethical review committee. The study will be performed according to the declaration of Helsinki and the International Council for Harmonisation-Good Clinical Practice to ensure the participants' rights, safety and well-being. The findings from this study will be submitted to peer-reviewed journals and presented at relevant national and international meetings.
Authors
- Shakib Morshed
- Elizabeth Ekirapa Kiracho (ORCID: https://orcid.org/0000-0001-6938-2068)
- Bishnu Pada Dey (ORCID: https://orcid.org/0000-0003-2379-3923)
- Sophie Schneitler (ORCID: https://orcid.org/0000-0002-5766-9894)
- Dinesh Mondal (ORCID: https://orcid.org/0000-0001-9154-8327)
- Ahmed Abu Saleh (ORCID: https://orcid.org/0000-0001-7552-0674)
- Bishwajit Bhowmik (ORCID: https://orcid.org/0000-0001-8292-0633)
- Rea Maja Kobialka
- Arianna Ceruti (ORCID: https://orcid.org/0009-0002-3219-8691)
- Kevin Cassar (ORCID: https://orcid.org/0000-0001-6220-7435)
- Ahmed Abd El Wahed (ORCID: https://orcid.org/0000-0003-3347-6075)
- Md. Arko Ayon Chowdhury (ORCID: https://orcid.org/0000-0002-7437-7287)
- Martin S. Siegel (ORCID: https://orcid.org/0000-0001-8219-8986)
- Manfred Weidmann (ORCID: https://orcid.org/0000-0002-7063-7491)
- Sophie Elisabeth Müller (ORCID: https://orcid.org/0000-0002-2280-534X)
- Shaheda Anwar (ORCID: https://orcid.org/0000-0002-2335-5352)
- Julius Boniface Okuni (ORCID: https://orcid.org/0000-0001-6361-7356)
- Lydia Nakiyingi (ORCID: https://orcid.org/0000-0001-7263-3198)
- Prakash Ghosh (ORCID: https://orcid.org/0000-0002-4300-8761)
- Nishad Tasnim Mithila
- Cemre Arpa
- Farhana Rahman Luba
Institutions
- University of Malta (MT)
- Bangladesh Medical University (BD)
- International Centre for Diarrhoeal Disease Research (BD)
- Heidelberg University (DE)
- University Hospital Heidelberg (DE)
- Institute of Medical Microbiology and Hygiene (DE)
- Technische Universität Berlin (DE)
- Makerere University (UG)
- Saarland University (DE)
- Leipzig University (DE)
- Dhaka Medical College and Hospital (BD)
Publication Details
- Journal
- BMJ Open
- Published
- 2025-05-01
- DOI
- https://doi.org/10.1136/bmjopen-2024-097001
- Primary Topic
- COVID-19 diagnosis using AI
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Bundesministerium für Bildung und Forschung
- Uganda National Council for Science and Technology