{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T12:11:39Z","timestamp":1791288699053,"version":"4.3.0"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"Supplement_3","license":[{"start":{"date-parts":[[2019,10,8]],"date-time":"2019-10-08T00:00:00Z","timestamp":1570492800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["K24AI104830"],"award-info":[{"award-number":["K24AI104830"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Tests that can replace sputum smear microscopy have been identified as a top priority diagnostic need for tuberculosis by the World Health Organization. High-quality evidence on diagnostic accuracy for tests that may meet this need is an essential requirement to inform decisions about policy and scale-up. However, test accuracy studies are often of low and inconsistent quality and poorly reported, leading to uncertainty about true test performance. Here we provide guidance for the design of diagnostic test accuracy studies of sputum smear-replacement tests. Such studies should have a cross-sectional or cohort design, enrolling either a consecutive series or a random sample of patients who require evaluation for tuberculosis. Adults with respiratory symptoms are the target population. The reference standard should at a minimum be a single, automated, liquid culture, but additional cultures, follow-up, clinical case definition, and specific measures to understand discordant results should also be included. Inclusion of smear microscopy and Xpert MTB\/RIF (or MTB\/RIF Ultra) as comparators is critical to allow broader comparability and generalizability of results, because disease spectrum can vary between studies and affects relative test performance. Given the complex nature of sputum (the primary specimen type used for pulmonary TB), careful design and reporting of the specimen flow is essential. Test characteristics other than accuracy (such as feasibility, implementation considerations, and data on impact on patient, population and health systems outcomes) are also important aspects.<\/jats:p>","DOI":"10.1093\/infdis\/jiz258","type":"journal-article","created":{"date-parts":[[2019,7,4]],"date-time":"2019-07-04T15:09:05Z","timestamp":1562252945000},"page":"S99-S107","source":"Crossref","is-referenced-by-count":38,"title":["Guidance for Studies Evaluating the Accuracy of Sputum-Based Tests to Diagnose Tuberculosis"],"prefix":"10.1093","volume":"220","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6136-206X","authenticated-orcid":false,"given":"Samuel G","family":"Schumacher","sequence":"first","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William A","family":"Wells","sequence":"additional","affiliation":[{"name":"United States Agency for International Development, Washington, District of Columbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark P","family":"Nicol","sequence":"additional","affiliation":[{"name":"School of Biomedical Sciences, University of Western Australia, Perth, Australia, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen R","family":"Steingart","sequence":"additional","affiliation":[{"name":"Liverpool School of Tropical Medicine, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grant","family":"Theron","sequence":"additional","affiliation":[{"name":"DST\/NRF Centre of Excellence for Biomedical Tuberculosis Research, SA MRC Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan E","family":"Dorman","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina, Charleston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madhukar","family":"Pai","sequence":"additional","affiliation":[{"name":"McGill International TB Centre and Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin","family":"Churchyard","sequence":"additional","affiliation":[{"name":"Aurum Institute, Cape Town, South Africa"},{"name":"School of Public Health, University of the Witwatersrand, Johannesburg, South Africa"},{"name":"Advancing Care and Treatment for TB\/HIV, South African Medical Research Council, Parktown, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley","family":"Scott","sequence":"additional","affiliation":[{"name":"University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Stevens","sequence":"additional","affiliation":[{"name":"University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Nabeta","sequence":"additional","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Alland","sequence":"additional","affiliation":[{"name":"Rutgers University, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"Weyer","sequence":"additional","affiliation":[{"name":"World Health Organization, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia M","family":"Denkinger","sequence":"additional","affiliation":[{"name":"FIND, Geneva, Switzerland"},{"name":"University Hospital Heidelberg, Division of Tropical Medicine, Centre of Infectious Diseases, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Gilpin","sequence":"additional","affiliation":[{"name":"World Health Organization, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,10,8]]},"reference":[{"key":"2019100812184376900_CIT0001","doi-asserted-by":"crossref","first-page":"664","DOI":"10.1016\/S1473-3099(06)70602-8","article-title":"Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: a systematic review","volume":"6","author":"Steingart","year":"2006","journal-title":"Lancet Infect Dis"},{"key":"2019100812184376900_CIT0002","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1378\/chest.63.1.88","article-title":"Tuberculous 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