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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)

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Table 3

Overview of lessons learned as shared during the TB Union World Lung Health Conference Workshop, 2023

Laboratory Clinical Programmatic
Repeat all Xpert tests resulting in “invalid,” “no result,” and “error” results as 2nd attempt usually result in valid result.
Prioritize installation of upgrades needed for Xpert Ultra at scale-up sites, given importance of trace results for children.
Provide a space suitable for the GeneXpert instrument (e.g., air conditioned, backup power supply) to reduce maintenance issues.
Ensure regular maintenance of all GeneXpert instruments.
Include stool Xpert testing in the routine GeneXpert Quality Assurance program.
Ensure that only laboratory technicians trained on the SOS stool-processing method perform tests.
Explore with manufacturers whether the current software can be adapted to provide the possibility to enter stool as sample type along with sputum in the Xpert database instead as a note under “other sample," which will facilitate monitoring by disaggregating data by sample type including stool.
Videos can be used to guide laboratory staff in the new methods (i.e,.Stoolbox, or customized by country).
Stool as a sample is accepted for use by laboratory staff.
•Stool should be transported in cold chain if possible.
Stool samples are easy to collect, child-friendly, and fast to test for TB in children.
Guardians are willing to provide stool samples for their children for a TB diagnosis.
Stool testing must be included in diagnostic algorithms as a routine test (i.e., in national guidelines), and should be prioritized for children and adolescents who cannot provide sputum spontaneously.
Need to integrate stool testing results into the medical information system to facilitate uptake and monitoring (i.e., recording of stool as sample type).
Train healthcare providers (doctors, nurses, laboratory staff) in the new WHO childhood TB guidelines to help promote the uptake of stool-based testing at health facilities.
Intensive and ongoing awareness raising among healthcare providers and the general population using different platforms (e.g., webinars, meetings, campaigns) is critical to generate high demand for stool-based testing.
Screening of all children arriving for care using a stamp on the individual health record as a screening tool to help increase identification of presumptive TB in children (e.g., the “STAMP” strategy used in Zimbabwe).
Strengthen contact investigation to increase TB case finding among children.
Emphasize that stool is a recommended new specimen for TB and should be included in referral mechanisms to facilitate its use.
SOS is the preferred method for stool processing: no additional equipment is required, and the test is simple to perform. Requirements are similar to sputum testing by Xpert.
Introduction of stool-based diagnosis for pediatric TB into routine healthcare services is feasible, acceptable, and can increase childhood TB notification, as well as bacteriological confirmation of TB among children.
Implementation of stool testing in practice is possible in remote healthcare settings.
Ensuring local ownership from inception and throughout implementation is important.
Weekly supervision and analysis of key indicators during the pilot is important to identify bottlenecks to implementation and immediate challenges that need to be addressed.
Development of a phased implementation plan and targeted capacity building strategy facilitates routine introduction, including pilot implementation at selected sites to gain experience; analysis of the pilot data and development of recommendations for expanding/further scale-up; site-level support and identification of specific “champions” for the approach who can support scale-up; and digital tracking of sample referral.
Regular supervision, mentorship, and follow-up are essential to sustain the gains in stool-based testing.
Review of recording and reporting tools and ongoing analysis of testing indicators is a key priority to ensure proper program monitoring and reporting.
Strengthening monitoring by including stool on the request form and all the other report and recording tools.
Communication and advocacy for stool-based testing is critical. One best practice is implementation of a National Childhood TB Testing week to bring attention to the need for improved diagnosis of TB among children and the use of stool-based testing as a key innovation to improve case finding.
Further research is needed to determine if stool samples can be used with other TB diagnostic techniques such as culture, 10-color module/XDR cartridge, and Truenat.

*SOS=Simple One Step (method for stool processing); WHO, World Health Organization; Xpert, Xpert MTB/RIF and Xpert MTB/RIF Ultra (Cefeid, https://www.cepheid.com).

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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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