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Volume 31, Number 3—March 2025
Online Report

Lessons Learned from Early Implementation and Scale-up of Stool-Based Xpert Testing to Diagnose Tuberculosis in Children

Eveline Klinkenberg1Comments to Author , Petra de Haas1, Charles Manyonge, Joanita Namutebi, Bibiche Mujangi, Hebert Mutunzi, Amri Kingalu, Nkiru Nwokoye, Kuzani Mbendera, Yohannes D. Babo, Gulmira Kalmambetova, Gunta Dravniece, Winnie Mwanza, Ahmed Bedru, Degu D. Jerene, Lisa V. Adams, Andwele Mwansasu, and Charlotte Colvin
Author affiliation: ConnectTB, the Hague, the Netherlands (E. Klinkenberg); Amsterdam University Medical Centers, Amsterdam, the Netherlands (E. Klinkenberg); KNCV Tuberculosis Foundation, the Hague (P. de Haas, D. D. Jerene); Supra National Reference Laboratory, Kampala, Uganda (C. Manyonge, J. Namutebi); National Reference Laboratory and National TB Program, Kinshasa, Democratic Republic of Congo (B. Mujangi); USAID, Infectious Disease Detection and Surveillance Project, Harare, Zimbabwe (H. Mutunzi); Central Tuberculosis Reference Laboratory, Dar es Salaam, Tanzania (A. Kingalu); KNCV Nigeria, Abuja, Nigeria (N. Nwokoye); National Tuberculosis Program, Lilongwe, Malawi (K. Mbendera); KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia (Y.D. Babo, A. Bedru); Ministry of Health, Bishek, Kyrgyzstan (G. Kalmambetova); PATH, Kiev, Ukraine (G. Dravniece); Ministry of Health, Lusaka, Zambia (W. Mwanza); Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA (L.V. Adams); USAID Infectious Disease Detection and Surveillance Project, Washington, DC, USA (A. Mwansasu); USAID Bureau for Global Health, Washington (C. Colvin); Credence Management Solutions, LLC, McLean, Virginia, USA (C. Colvin)

Main Article

Table 1

Phased implementation of stool-based Xpert TB testing from generic protocol for integrated training and technical assistance package*

Element Phase 1: rapid validation Phase 2: laboratory practices Phase 3: operational aspects
Purpose
 Provide data to support use of stool-based testing as an alternative to sputum testing
 Define laboratory procedures and build skills and confidence of laboratory staff to test stool
 Define operational needs for routine use of stool-based testing throughout the health system
Setting
 NTRL or other central laboratory with GeneXpert
 Hospitals and primary care facilities in defined subnational area(s)
 Variety of routine healthcare and geographic settings
Sample
 25–50 persons with bacteriologically confirmed TB
 300–500 children with presumptive TB
 >1,500 children with presumptive TB
Anticipated outcome
 Study results to confirm validity of the method in the setting, draft SOPs for routine laboratory procedures
 Revised SOPs for laboratory procedures and standardized training materials for phase 3
 Revised pediatric TB diagnosis algorithm and operational guidance on how to implement stool-based Xpert testing in routine healthcare settings
When to be performed Need for validation of stool-based Xpert testing in country context No need for in-country validation; NTP and stakeholders are ready to start introduction in selected sites Country is ready to implement stool-based testing in routine settings.

*Table taken from the generic protocol that Is part of the training and technical assistance packaged developed by KNCV TB Plus, the Supra National Reference Laboratory-Uganda, and the Infectious Disease Detection and Surveillance project with support from the US Agency for International Development. NTRL, national TB reference laboratory; NTP, national TB program; SOP, standard operating procedure; TB, tuberculosis; Xpert, Xpert MTB/RIF or Xpert MTB/RIF Ultra (Cefeid, https://www.cepheid.com).

Main Article

1These first authors contributed equally to this article.

Page created: February 07, 2025
Page updated: February 28, 2025
Page reviewed: February 28, 2025
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