Target product profiles: tests for tuberculosis treatment monitoring and optimization

Ankur Gupta-Wright, Saskia den Boon, Emily L MacLean, Daniela Cirillo, Frank Cobelens, Stephen H Gillespie, Mikashmi Kohli, Morten Ruhwald, Rada Savic, Grania Brigden, Mustapha Gidado, Delia Goletti, Debra Hanna, Rumina Hasan, Cathy Hewison, Kobto G Koura, Christian Lienhardt, Patrick Lungu, Timothy D McHugh, Lindsay McKennaCherise Scott, Thomas Scriba, Christine Sekaggya-Wiltshire, Tereza Kasaeva, Matteo Zignol, Claudia M Denkinger, Dennis Falzon

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)730-737
Number of pages8
JournalBulletin of the World Health Organization
Volume101
Issue number11
DOIs
Publication statusPublished - 1 Nov 2023

Keywords

  • Humans
  • Tuberculosis/diagnosis
  • Sensitivity and specificity
  • World Health Organization
  • Sputum
  • Body fluids

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