TY - JOUR T1 - Diagnostic sensitivity of SILVAMP TB-LAM (FujiLAM) point-of-care urine assay for extra-pulmonary tuberculosis in people living with HIV JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.01259-2019 SP - 1901259 AU - Andrew D. Kerkhoff AU - Bianca Sossen AU - Charlotte Schutz AU - Elena Ivanova Reipold AU - Andre Trollip AU - Emmanuel Moreau AU - Samuel G. Schumacher AU - Rosie Burton AU - Amy Ward AU - Mark P. Nicol AU - Graeme Meintjes AU - Claudia M. Denkinger AU - Tobias Broger Y1 - 2019/01/01 UR - http://erj.ersjournals.com/content/early/2019/10/31/13993003.01259-2019.abstract N2 - Diagnosing tuberculosis (TB) in people living with HIV (PLHIV) remains challenging in part, because of its diversity of clinical manifestations, including high rates of extra-pulmonary and disseminated disease [1]. In particular, disseminated TB, involving multiple organ systems, is associated with high mortality but often presents non-specifically, which may hinder prompt diagnosis [2, 3]. Xpert MTB/RIF (Xpert, Cepheid, Sunnyvale, US), is currently recommended by the World Health Organization (WHO) as the first line assay for evaluating a subset of extra-pulmonary TB disease (EPTB) manifestations [4]. To detect specific forms of EPTB such as pleural TB, TB meningitis or TB lymphadenitis, Xpert may require an invasive sample to be collected, which often limits its use for EPTB detection to hospitals where appropriate equipment is available and invasive sampling can be safely performed. Furthermore, even when concomitant pulmonary disease is present, it can be very difficult to obtain sputum in the sickest HIV patients to submit for Xpert testing [5, 6]. Therefore, an urgent priority for improving TB detection among PLHIV remains the development of rapid, point-of-care (POC) assays that use an easily obtainable clinical specimen, such as urine, and that have good diagnostic accuracy for both pulmonary and extra-pulmonary TB (EPTB), including disseminated disease [7].FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: D. KerkhoffConflict of interest: Bianca SossenConflict of interest: Charlotte SchutzConflict of interest: Dr. Reipold has nothing to disclose.Conflict of interest: Andre TrollipConflict of interest: Emmanuel MoreauConflict of interest: G. SchumacherConflict of interest: Rosie BurtonConflict of interest: Amy WardConflict of interest: P. NicolConflict of interest: Graeme MeintjesConflict of interest: Dr. Denkinger reports and CMD is a former employee of FIND. FIND is a non-for-profit foundation, whose mission is to find diagnostic solutions to overcome diseases of poverty in LMICs. It works closely with the private and public sectors and receives funding from some of its industry partners. It has organisational firewalls to protect it against any undue influences in its work or the publication of its findings. All industry partnerships are subject to review by an independent Scientific Advisory Committee or another independent review body, based on due diligence, TTPs and public sector requirements. FIND catalyses product development, leads evaluations, takes positions, and accelerates access to tools identified as serving its mission. It provides indirect support to industry (e.g., access to open specimen banks, a clinical trial platform, technical support, expertise, laboratory capacity strengthening in LMICs, etc.) to facilitate the development and use of products in these areas. FIND alsoConflict of interest: Tobias Broger ER -