Barriers and Enablers to the Development and Translation of Tuberculosis Biomarkers and Tests: a Scoping Review Protocol

Introduction Tuberculosis remains a major global health challenge, causing over a million deaths annually and affecting an estimated 10 million people worldwide each year. Diagnostic delays and the lack of accurate, deployable tests across TB disease states continue to hamper public health control efforts. Despite sustained investment in TB biomarker research, translation into clinical use has been limited, often because traditional approaches focus on technology development in isolation and overlook the scientific, regulatory, social, and market interdependencies that shape whether a test reaches the people who need it. This protocol describes a scoping review that will identify and map barriers and enablers for the development, validation, regulatory approval, commercialisation, and implementation of TB biomarkers and tests. Methods This scoping review follows Joanna Briggs Institute methodology and will be reported in accordance with PRISMA-ScR guidelines. Searches will be conducted in PubMed/MEDLINE, EMBASE, and EBSCOHOST (including CINAHL and Global Health), supplemented by grey literature from WHO, FIND, and regulatory bodies. Qualitative and mixed-methods studies published in English within the last 20 years will be the primary source type; opinion pieces, editorials, commentaries, and narrative reviews will be included conditionally if evidence is insufficient. Two independent reviewers will screen titles, abstracts, and full texts, and extract data using a standardised form capturing barriers and enablers across each stage of the development and translation pathway. Results Findings will be synthesised using descriptive content analysis and thematic synthesis, with data charted across the TB patient care pathway and the technology translation pathway, and evidence gaps identified and reported. Conclusions By systematically mapping barriers and enablers across the biomarker and test translation pathway, this review will provide researchers, funders, regulators, and implementers with a synthesised evidence base to support more effective investment and policy decisions, helping accelerate translation of TB biomarkers and tests into practice.