TY - JOUR
T1 - WHO target product profile for TB detection at peripheral settings
T2 - 2024 update
AU - Kohli, Mikashmi
AU - Korobitsyn, Alexei
AU - Ismail, Nazir
AU - Zignol, Matteo
AU - Kasaeva, Tereza
AU - Dewan, Puneet
AU - Ruhwald, Morten
AU - Anyaike, Chukwuma
AU - Ayles, Helen
AU - Basilio, Ramon
AU - Branigan, David
AU - Cattamanchi, Adithya
AU - Cirillo, Daniela Maria
AU - Cobelens, Frank
AU - Denkinger, Claudia
AU - Dowdy, David
AU - de Haas, Petra
AU - Hall, Patricia
AU - Hasan, Rumina
AU - Hewison, Cathy
AU - Ismailova, Jamilya
AU - Jagdagsuren, Davaalkham
AU - Joshi, Rajendra Panduranga
AU - Kalmambetova, Gulmira
AU - Kisia, Jacqueline
AU - Kranzer, Katharina
AU - Scientific TPP Development group
AU - Lobo, Rhea
AU - MacPherson, Peter
AU - Meharwal, Sandeep
AU - Miotto, Paolo
AU - Murrell, Troy
AU - Nathavitharana, Ruvandhi
AU - Ndjeka, Norbert
AU - Nguyen, Van Hung
AU - Nicol, Mark
AU - Nurov, Rustam
AU - Omar, Shaheed Vally
AU - Pai, Madhukar
AU - Pakasi, Tiffany Tiara
AU - Redner, Paulo
AU - Rukmana, Andriansjah
AU - Samoilova, Anastasia
AU - Sarker, Mahafuzer Rahman
AU - Shanmugam, Siva Kumar
AU - Shinnick, Thomas
AU - de Souza, Nicole
AU - Ssengooba, Willy
AU - Tahseen, Sabira
AU - Vakhrusheva, Diana
AU - van Luong, Dinh
AU - Yanlin, Zhao
N1 - Publisher Copyright:
© 2025 Kohli et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2025/6/1
Y1 - 2025/6/1
N2 - In 2014, the World Health Organization (WHO) published target product profiles (TPPs) which detailed minimal and optimal criteria to address high-priority TB diagnostic needs. Since then, the TB community’s needs have evolved; there has been a surge in new and innovative platforms suggesting use of alternative non-invasive specimens for TB diagnosis. This updated TPP used evidence-based modelling to guide the decision-making process for specific characteristics which was a novel approach to this process. This document focusses on point of care, near point of care and low complexity assays using sputum and non-sputum-based specimens. The standard WHO protocol was followed for this TPP document including Delphi process, public comments and TPP development group consultations. Our modelling work suggests that lower accuracy estimates for point of care, easily accessible tests are acceptable to achieve comparable or better case detection than the current standard of care. In this document, we describe the process of updating the TPP for TB diagnostic tests at peripheral settings, highlight key updates, use of modelling to inform this update, and discuss guidance regarding technical and operational specifications.
AB - In 2014, the World Health Organization (WHO) published target product profiles (TPPs) which detailed minimal and optimal criteria to address high-priority TB diagnostic needs. Since then, the TB community’s needs have evolved; there has been a surge in new and innovative platforms suggesting use of alternative non-invasive specimens for TB diagnosis. This updated TPP used evidence-based modelling to guide the decision-making process for specific characteristics which was a novel approach to this process. This document focusses on point of care, near point of care and low complexity assays using sputum and non-sputum-based specimens. The standard WHO protocol was followed for this TPP document including Delphi process, public comments and TPP development group consultations. Our modelling work suggests that lower accuracy estimates for point of care, easily accessible tests are acceptable to achieve comparable or better case detection than the current standard of care. In this document, we describe the process of updating the TPP for TB diagnostic tests at peripheral settings, highlight key updates, use of modelling to inform this update, and discuss guidance regarding technical and operational specifications.
UR - https://www.scopus.com/pages/publications/105008031799
U2 - 10.1371/journal.pgph.0004612
DO - 10.1371/journal.pgph.0004612
M3 - Article
C2 - 40498791
SN - 2767-3375
VL - 5
JO - PLOS global public health
JF - PLOS global public health
IS - 6 June
M1 - e0004612
ER -