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Journal Article > Research

Target product profiles: tests for tuberculosis treatment monitoring and optimization

Gupta-Wright A, den Boon S, MacLean E, Cirillo DM, Cobelens F, Gillespie S, Kohli M, Ruhwald M, Savic R, Brigden G, Gidado M, Goletti D, Hanna D, Hasan R, Hewison CCH, Koura K, Lienhardt C, Lungu PS, McHugh TD, McKenna L, Scott C, Scriba T, Sekaggya-Wiltshire C, Kasaeva T, Zignol M, Denkinger CM, Falzon D
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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.
Subject Area
tuberculosisdiagnostics
DOI
10.2471/BLT.23.290901
Published Date
01-Nov-2023
PubMed ID
37961060
Languages
English
Français (Abstract Only) - End of Article
Español (Abstract Only) - End of Article
عَرَبِيّ (Abstract Only) - End of Article
中文 (Abstract Only) - End of Article
Русский (Abstract Only) - End of Article
Journal
Bulletin of the World Health Organization
Volume / Issue / Pages
Volume 101, Issue 11, Pages 730-737
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