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. 2020 Feb 6;55(2):1901259.
doi: 10.1183/13993003.01259-2019. Print 2020 Feb.

Diagnostic sensitivity of SILVAMP TB-LAM (FujiLAM) point-of-care urine assay for extra-pulmonary tuberculosis in people living with HIV

Andrew D Kerkhoff  1   2 , Bianca Sossen  3   4   2 , Charlotte Schutz  3   4 , Elena Ivanova Reipold  5 , Andre Trollip  5 , Emmanuel Moreau  5 , Samuel G Schumacher  5 , Rosie Burton  6 , Amy Ward  3   4 , Mark P Nicol  7   8 , Graeme Meintjes  3   4 , Claudia M Denkinger  5   9   2 , Tobias Broger  5   2
Affiliations

Diagnostic sensitivity of SILVAMP TB-LAM (FujiLAM) point-of-care urine assay for extra-pulmonary tuberculosis in people living with HIV

Andrew D Kerkhoff et al. Eur Respir J. .

Abstract

FujiLAM point-of-care rapid urine test for TB detects a large proportion of pulmonary and traditionally difficult-to-diagnose extra-pulmonary forms of TB in hospitalised patients with advanced HIV http://bit.ly/36Dl0Eo

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Conflict of interest statement

Conflict of interest: A.D. Kerkhoff has nothing to disclose. Conflict of interest: B. Sossen has nothing to disclose. Conflict of interest: C. Schutz has nothing to disclose. Conflict of interest: E.I. Reipold has nothing to disclose. Conflict of interest: A. Trollip has nothing to disclose. Conflict of interest: E. Moreau reports grants from GHIT and KfW, during the conduct of the study. Conflict of interest: S.G. Schumacher is an 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) to facilitate the development and use of products in these areas. FIND also supports the evaluation of prioritised assays and the early stages of implementation of WHO-approved (guidance and PQ) assays using donor grants. In order to carry out test validations and evaluations, has product evaluation agreements with several private sector companies for the diseases FIND works in which strictly define its independence and neutrality vis a vis the companies whose products get evaluated, and describes roles and responsibilities. Conflict of interest: R. Burton has nothing to disclose. Conflict of interest: A. Ward has nothing to disclose. Conflict of interest: M.P. Nicol reports grants from FIND, during the conduct of the study. Conflict of interest: G. Meintjes has nothing to disclose. Conflict of interest: C.M. Denkinger is a former employee of FIND. Conflict of interest: T. Broger reports grants from GHIT, personal fees from FIND, during the conduct of the study; and has a patent pending in the field of lipoarabinomannan detection for TB diagnosis.

Figures

FIGURE 1
FIGURE 1
The diagnostic sensitivity of FujiLAM and AlereLAM by (a) type of tuberculosis disease (pulmonary, extra pulmonary or both; n=553), (b) site of disease involvement in patients with confirmed extra-pulmonary tuberculosis (EPTB). Bars represent 95% confidence intervals. The numbers in parenthesis denote 95% confidence intervals. Of note, the same patient may have multiple sites of confirmed disease (e.g., pulmonary, blood, urine, etc). Sputum, blood and urine were obtained from all patients whenever possible and additional specimens were obtained at this discretion of routine medical team, however the ability to produce sputum was not a requirement for study entry. This analysis was limited to among those with both FujiLAM and AlereLAM results available. PTB: pulmonary tuberculosis.
See this image and copyright information in PMC

References

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