{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T19:07:22Z","timestamp":1790536042933,"version":"4.1.0"},"reference-count":29,"publisher":"European Respiratory Society (ERS)","issue":"4","content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2018,7,12]]},"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:p>Novel accurate tests are needed that identify individuals infected with<jats:italic>Mycobacterium tuberculosis<\/jats:italic>who have incipient disease and are likely to develop clinical tuberculosis (TB) in the near future to allow for targeted preventive treatment beyond the current risk groups. Recently, a target product profile was developed that outlines the minimal and optimal characteristics for such an incipient TB test. We describe an evaluation framework for generating evidence to inform the development of policy guidance for the use of such a new test by the World Health Organization. Two research objectives are addressed. 1) The predictive ability of an incipient TB test should be assessed in clinical evaluation studies that include the intended target population and follow-up of sufficient duration to observe whether individuals do or do not progress to clinical TB disease. 2) Studies are needed to evaluate the test under routine programmatic conditions and measure its impact on patient- or health-system-important outcomes. For both research objectives, study designs, methods and analysis are described, with the intent to inform the clinical development plans of test manufacturers, researchers and funders.<\/jats:p>","DOI":"10.1183\/13993003.00946-2018","type":"journal-article","created":{"date-parts":[[2018,8,23]],"date-time":"2018-08-23T14:55:16Z","timestamp":1535036116000},"page":"1800946","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":32,"title":["An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease"],"prefix":"10.1183","volume":"52","author":[{"given":"Sandra V.","family":"Kik","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6136-206X","authenticated-orcid":false,"given":"Samuel","family":"Schumacher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela Maria","family":"Cirillo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin","family":"Churchyard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catharina","family":"Boehme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delia","family":"Goletti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molebogeng X.","family":"Rangaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia M.","family":"Denkinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Lienhardt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Gilpin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Matteelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Cobelens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2018,8,23]]},"reference":[{"key":"2024102100331685000_52.4.1800946.1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.0901720106"},{"key":"2024102100331685000_52.4.1800946.2","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00214014"},{"key":"2024102100331685000_52.4.1800946.3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002152"},{"key":"2024102100331685000_52.4.1800946.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1405427"},{"key":"2024102100331685000_52.4.1800946.5","doi-asserted-by":"publisher","DOI":"10.1378\/chest.11-3157"},{"key":"2024102100331685000_52.4.1800946.6","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(11)70210-9"},{"key":"2024102100331685000_52.4.1800946.7","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01245-2015"},{"key":"2024102100331685000_52.4.1800946.8","unstructured":"World Health Organization. Guideline on the Management of Latent Tuberculosis Infection. Geneva, WHO, 2015."},{"key":"2024102100331685000_52.4.1800946.9","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01012-2016"},{"key":"2024102100331685000_52.4.1800946.10","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1016\/j.ebiom.2014.12.001","article-title":"Biomarkers can identify pulmonary tuberculosis in HIV-infected drug users months prior to clinical diagnosis","volume":"2","author":"Sloot","year":"2015","journal-title":"EBioMedicine"},{"key":"2024102100331685000_52.4.1800946.11","doi-asserted-by":"crossref","first-page":"1198","DOI":"10.1164\/rccm.201711-2340OC","article-title":"Four-gene pan-African blood signature predicts progression to tuberculosis","volume":"197","author":"Suliman","year":"2018","journal-title":"Am J Respir Crit Care Med"},{"key":"2024102100331685000_52.4.1800946.12","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1016\/S2213-2600(16)30419-2","article-title":"From latent to patent: rethinking prediction of tuberculosis","volume":"5","author":"Cobelens","year":"2017","journal-title":"Lancet Respir Med"},{"key":"2024102100331685000_52.4.1800946.13","unstructured":"World Health Organization, FIND. Consensus Meeting Report. Development of a Target Product Profile (TPP) and a Framework for Evaluation for a Test for Predicting Progression from Tuberculosis Infection to Active Disease (WHO\/HTM\/TB\/2017.18). Geneva, WHO, 2017."},{"key":"2024102100331685000_52.4.1800946.14","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1093\/oxfordjournals.aje.a121593","article-title":"The prognosis of a positive tuberculin reaction in childhood and adolescence","volume":"99","author":"Comstock","year":"1974","journal-title":"Am J Epidemiol"},{"key":"2024102100331685000_52.4.1800946.15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01316-1"},{"key":"2024102100331685000_52.4.1800946.16","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00157212"},{"key":"2024102100331685000_52.4.1800946.17","unstructured":"World Health Organization. Handbook for Guideline Development. Geneva, WHO, 2012."},{"key":"2024102100331685000_52.4.1800946.18","unstructured":"European Commission. Regulatory Framework on Medical Devices. 2017. https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/regulatory-framework_en Date last accessed: May 21, 2018."},{"key":"2024102100331685000_52.4.1800946.19","first-page":"7366","article-title":"Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final Rule","volume":"83","author":"Food and Drug Administration","year":"2018","journal-title":"Fed Regist"},{"key":"2024102100331685000_52.4.1800946.20","unstructured":"US food and Drug Administration. Acceptance of Clinical Data to Support Medical Device Applications and Submissions, Frequently Asked Questions, Guidance for Industry and Food and Drug Administration Staff. 2018. www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM597273.pdf Date last accessed: July 17, 2018."},{"key":"2024102100331685000_52.4.1800946.21","doi-asserted-by":"crossref","first-page":"661","DOI":"10.3389\/fimmu.2018.00661","volume":"9","author":"Duffy","year":"2018","journal-title":"Front Immunol"},{"key":"2024102100331685000_52.4.1800946.22","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1016\/j.tube.2017.11.009","article-title":"Considerations for biomarker-targeted intervention strategies for tuberculosis disease prevention","volume":"109","author":"Fiore-Gartland","year":"2018","journal-title":"Tuberculosis"},{"key":"2024102100331685000_52.4.1800946.23","doi-asserted-by":"crossref","first-page":"1421","DOI":"10.1164\/rccm.201508-1595OC","article-title":"Quantitative IFN-gamma and IL-2 response associated with latent tuberculosis test discordance in HIV-infected pregnant women","volume":"193","author":"Mathad","year":"2016","journal-title":"Am J Respir Crit Care Med"},{"key":"2024102100331685000_52.4.1800946.24","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60162-8"},{"key":"2024102100331685000_52.4.1800946.25","doi-asserted-by":"crossref","first-page":"e0169539","DOI":"10.1371\/journal.pone.0169539","article-title":"Comparison of TST and IGRA in diagnosis of latent tuberculosis infection in a high TB-burden setting","volume":"12","author":"Sharma","year":"2017","journal-title":"PLoS One"},{"key":"2024102100331685000_52.4.1800946.26","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62073-5"},{"key":"2024102100331685000_52.4.1800946.27","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h391"},{"key":"2024102100331685000_52.4.1800946.28","doi-asserted-by":"crossref","first-page":"1190","DOI":"10.1016\/S1473-3099(17)30447-4","article-title":"A score to predict and stratify risk of tuberculosis in adult contacts of tuberculosis index cases: a prospective derivation and external validation cohort study","volume":"17","author":"Saunders","year":"2017","journal-title":"Lancet Infect Dis"},{"key":"2024102100331685000_52.4.1800946.29","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0017984"}],"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.00946-2018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T06:59:22Z","timestamp":1740380362000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.00946-2018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8,23]]},"references-count":29,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2018,10,25]]},"published-print":{"date-parts":[[2018,10]]}},"alternative-id":["10.1183\/13993003.00946-2018"],"URL":"https:\/\/doi.org\/10.1183\/13993003.00946-2018","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8,23]]}}}