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Stool processing methods for Xpert Ultra testing in childhood tuberculosis: a prospective, multicountry accuracy study

Centrifuge-free processing methods support stool Xpert Ultra testing for childhood tuberculosis, but data on their accuracy, acceptability, and usability are limited.We conducted a prospective evaluation of stool Xpert Ultra in India, South Africa, and Uganda with 3 methods: the Stool Processing Kit...

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Hauptverfasser: Jaganath, Devan (VerfasserIn) , Nabeta, Pamela (VerfasserIn) , Nicol, Mark P (VerfasserIn) , Castro, Robert (VerfasserIn) , Wambi, Peter (VerfasserIn) , Zar, Heather J (VerfasserIn) , Workman, Lesley (VerfasserIn) , Lodha, Rakesh (VerfasserIn) , Singh, Urvashi B (VerfasserIn) , Bavdekar, Ashish (VerfasserIn) , Sanghavi, Sonali (VerfasserIn) , Trollip, André (VerfasserIn) , Mace, Aurélien (VerfasserIn) , Bonnet, Maryline (VerfasserIn) , Lounnas, Manon (VerfasserIn) , de Haas, Petra (VerfasserIn) , Tiemersma, Edine (VerfasserIn) , Alland, David (VerfasserIn) , Banada, Padmapriya (VerfasserIn) , Cattamanchi, Adithya (VerfasserIn) , Ruhwald, Morten (VerfasserIn) , Wobudeya, Eric (VerfasserIn) , Denkinger, Claudia M. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 3 June 2025
In: Clinical infectious diseases

ISSN:1537-6591
DOI:10.1093/cid/ciaf289
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.1093/cid/ciaf289
Verlag, kostenfrei, Volltext: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf289/8156021?login=true
Volltext
Verfasserangaben:Devan Jaganath, Pamela Nabeta, Mark P Nicol, Robert Castro, Peter Wambi, Heather J Zar, Lesley Workman, Rakesh Lodha, Urvashi B Singh, Ashish Bavdekar, Sonali Sanghavi, André Trollip, Aurélien Mace, Maryline Bonnet, Manon Lounnas, Petra de Haas, Edine Tiemersma, David Alland, Padmapriya Banada, Adithya Cattamanchi, Morten Ruhwald, Eric Wobudeya, Claudia M Denkinger, for the Stool H2H Study Team
Beschreibung
Zusammenfassung:Centrifuge-free processing methods support stool Xpert Ultra testing for childhood tuberculosis, but data on their accuracy, acceptability, and usability are limited.We conducted a prospective evaluation of stool Xpert Ultra in India, South Africa, and Uganda with 3 methods: the Stool Processing Kit (SPK), the Simple One-Step method (SOS), and the Optimized Sucrose Flotation method (OSF). Children <15 years old with presumptive tuberculosis underwent sputum testing with Xpert Ultra and culture. We compared the accuracy of each method against a microbiological reference standard (tuberculosis if Xpert Ultra or culture positive) and a composite reference standard (tuberculosis if confirmed or unconfirmed tuberculosis). We surveyed laboratory staff to assess the acceptability and usability of the methods.We included 607 children, with a median age of 3.5 years (interquartile range, 1.3-7 years); 15.5% were human immunodeficiency virus positive. Against the microbiological reference standard, the sensitivities of SPK, SOS, and OSF were 36.9% (95% confidence interval, 28.6%-45.8%), 38.6% (17.2%-51.0%), and 31.3% (20.2%-44.1%), respectively, and the specificities, 98.2% (96.4%-99.3%), 97.3% (93.7%-99.1%), and 97.1% (93.3%-99%). The methods were acceptable and usable, but SOS was reported as most feasible to implement in a peripheral facility. Across methods, sensitivities increased among children who were culture positive (range, 55.0%-77.3%) and were low (13%-16.7%) against the composite reference standard. Adding stool Xpert Ultra increased sensitivity from 0% (OSF) to 11.8% (SPK/SOS), compared with sputum alone.Stool processing methods for Xpert Ultra were acceptable and usable and performed similarly, with highest sensitivity among children with culture-positive tuberculosis.
Beschreibung:Gesehen am 16.12.2025
Beschreibung:Online Resource
ISSN:1537-6591
DOI:10.1093/cid/ciaf289

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