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Target product profiles: tests for tuberculosis treatment monitoring and optimization

Gupta-Wright, Ankur; den Boon, Saskia; MacLean, Emily L; Cirillo, Daniela; Cobelens, Frank; Gillespie, Stephen H; Kohli, Mikashmi; ... Falzon, Dennis; + view all (2023) Target product profiles: tests for tuberculosis treatment monitoring and optimization. Bulletin of the World Health Organization , 101 (11) pp. 730-737. 10.2471/BLT.23.290901. Green open access

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Abstract

The World Health Organization has developed target product profiles containing minimum and optimum targets for key characteristics for tests for tuberculosis treatment monitoring and optimization. Tuberculosis treatment optimization refers to initiating or switching to an effective tuberculosis treatment regimen that results in a high likelihood of a good treatment outcome. The target product profiles also cover tests of cure conducted at the end of treatment. The development of the target product profiles was informed by a stakeholder survey, a cost-effectiveness analysis and a patient-care pathway analysis. Additional feedback from stakeholders was obtained by means of a Delphi-like process, a technical consultation and a call for public comment on a draft document. A scientific development group agreed on the final targets in a consensus meeting. For characteristics rated of highest importance, the document lists: (i) high diagnostic accuracy (sensitivity and specificity); (ii) time to result of optimally ≤ 2 hours and no more than 1 day; (iii) required sample type to be minimally invasive, easily obtainable, such as urine, breath, or capillary blood, or a respiratory sample that goes beyond sputum; (iv) ideally the test could be placed at a peripheral-level health facility without a laboratory; and (v) the test should be affordable to low- and middle-income countries, and allow wide and equitable access and scale-up. Use of these target product profiles should facilitate the development of new tuberculosis treatment monitoring and optimization tests that are accurate and accessible for all people being treated for tuberculosis.

Type: Article
Title: Target product profiles: tests for tuberculosis treatment monitoring and optimization
Location: Switzerland
Open access status: An open access version is available from UCL Discovery
DOI: 10.2471/BLT.23.290901
Publisher version: https://doi.org/10.2471/BLT.23.290901
Language: English
Additional information: © 2023 The authors; licensee World Health Organization. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/legalcode).
Keywords: Humans, Tuberculosis, Sensitivity and Specificity, World Health Organization, Sputum, Body Fluids
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity
URI: https://discovery.ucl.ac.uk/id/eprint/10182270
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