{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T13:42:44Z","timestamp":1774618964399,"version":"3.50.1"},"reference-count":12,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2022,10,4]],"date-time":"2022-10-04T00:00:00Z","timestamp":1664841600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Private funder"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The Xpert MTB\/RIF Ultra (Xpert-Ultra) assay provides timely results with good sensitivity and acceptable specificity with stool specimens in children for bacteriological confirmation of tuberculosis (TB). This study aims to optimize the Simple One-Step (SOS) stool processing method for testing stool specimens using the Xpert-Ultra in children and adults in selected health facilities in Addis Ababa, Ethiopia. The study is designed to assess the robustness of the SOS stool method, to help fine-tune the practical aspects of performing the test and to provide insights in stool storage conditions and sampling strategies before the method can be implemented and scaled in routine settings in Ethiopia as well as globally.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods and design<\/jats:title>\n                    <jats:p>\n                      The project \u201cpainless optimized diagnosis of TB in Ethiopian children\u201d (PODTEC) will be a cross sectional study where three key experiments will be carried out focusing on 1) sampling strategy to investigate if the Xpert-Ultra\n                      <jats:italic>M<\/jats:italic>\n                      .\n                      <jats:italic>tuberculosis<\/jats:italic>\n                      (MTB) -positivity rate depends on stool consistency, and if sensitivity can be increased by taking more than one stool specimen from the same participant, or doing multiple tests from the same stool specimen, 2) storage conditions to determine how long and at what temperature stool can be stored without losing sensitivity, and 3) optimization of sensitivity and robustness of the SOS stool processing method by varying stool processing steps, stool volume, and storage time and conditions of the stool-sample reagent mixture. Stool specimens will be collected from participants (children and adults) who are either sputum or naso-gastric aspiration (NGA) and\/or stool Xpert-Ultra MTB positive depending on the experiment. Stool specimens from these participants, recruited from 22 sites for an ongoing related study, will be utilized for the PODTEC experiments. The sample size is estimated to be 50 participants. We will use EpiData for data entry and Stata for data analysis purposes. The main analyses will include computing the loss or gain in the Xpert-Ultra MTB positivity rate and rates of non-determinate Xpert-Ultra test results per experiment compared to the Xpert-Ultra MTB result of stool processed according to the published standard operating procedures for SOS stool processing. The differences in the MTB positivity rate by regarding testing more than one sample per child, and using different storage, and processing conditions, will be also compared to the baseline (on-site) Xpert-Ultra result.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0264103","type":"journal-article","created":{"date-parts":[[2022,10,4]],"date-time":"2022-10-04T13:30:34Z","timestamp":1664890234000},"page":"e0264103","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":6,"title":["The Simple One-step stool processing method for detection of Pulmonary tuberculosis: A study protocol to assess the robustness, stool storage conditions and sampling strategy for global implementation and scale-up"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3024-0198","authenticated-orcid":true,"given":"Petra","family":"de Haas","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8505-7000","authenticated-orcid":true,"given":"Bazezew","family":"Yenew","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0166-682X","authenticated-orcid":true,"given":"Getu","family":"Diriba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Misikir","family":"Amare","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrii","family":"Slyzkyi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yohannes","family":"Demissie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bihil","family":"Sherefdin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmed","family":"Bedru","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Endale","family":"Mengesha","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zewdu Gashu","family":"Dememew","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abebaw","family":"Kebede","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muluwork","family":"Getahun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edine","family":"Tiemersma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Degu","family":"Jerene","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2022,10,4]]},"reference":[{"key":"pone.0264103.ref001","author":"WHO global tuberculosis report 2021","year":"2021","journal-title":"World Health Organisation"},{"key":"pone.0264103.ref002","year":"2018","journal-title":"Roadmap towards ending TB in children and adolescents"},{"key":"pone.0264103.ref003","volume-title":"Module 3: Diagnosis","author":"WHO operational handbook on tuberculosis","year":"2021"},{"key":"pone.0264103.ref004","year":"2022","journal-title":"WHO consolidated guideline on tuberculosis: module 5: management of tuberculosis in children and adolescents: web annex 4: summaries of unpublished studies, World Health Organisation"},{"key":"pone.0264103.ref005","volume-title":"Module 5: management of tuberculosis in children and adolescents","author":"WHO consolidated guidelines on tuberculosis","year":"2022"},{"key":"pone.0264103.ref006","year":"2022","journal-title":"Practical manual of processing stool samples for the diagnosis of childhood TB, Global laboratory initiative"},{"issue":"8","key":"pone.0264103.ref007","doi-asserted-by":"crossref","first-page":"e0040621","DOI":"10.1128\/JCM.00406-21","article-title":"Stool Processing Method for Use with the Xpert MTB\/RIF Assay for a Child-Friendly Diagnosis of Tuberculosis Closer to the Point of Care","volume":"59","author":"P de Haas","year":"2021","journal-title":"J Clin Microbiol"},{"key":"pone.0264103.ref008","author":"KNCV","year":"2021","journal-title":"SOS stool toolbox, implementation package of the SOS stool methode"},{"key":"pone.0264103.ref009","author":"P de Haas","year":"2022","journal-title":"IJTLD"},{"issue":"1","key":"pone.0264103.ref010","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1002\/sim.4780040112","article-title":"A Wilcoxon-type test for trend","volume":"4","author":"J. Cuzick","year":"1985","journal-title":"Stat Med"},{"issue":"2","key":"pone.0264103.ref011","doi-asserted-by":"crossref","first-page":"55","DOI":"10.5588\/pha.20.0079","article-title":"Laboratory comparison of stool processing methods for Xpert Ultra","volume":"11","author":"CL Jasumback","year":"2021","journal-title":"Public Health Action"},{"key":"pone.0264103.ref012","doi-asserted-by":"crossref","first-page":"102002","DOI":"10.1016\/j.tube.2020.102002","article-title":"Laboratory development of a simple stool sample processing method diagnosis of pediatric tuberculosis using Xpert Ultra","volume":"125","author":"M Lounnas","year":"2020","journal-title":"Tuberculosis (Edinb)"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0264103","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,4]],"date-time":"2022-10-04T13:30:52Z","timestamp":1664890252000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0264103"}},"subtitle":[],"editor":[{"given":"Padmapriya P.","family":"Banada","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2022,10,4]]},"references-count":12,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2022,10,4]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0264103","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2022.02.04.22270430","asserted-by":"object"}]},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,4]]}}}