{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T15:51:57Z","timestamp":1784562717177,"version":"3.55.0"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T00:00:00Z","timestamp":1764115200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Tuberculosis (TB) infection is a driver of the global TB epidemic. Accurate, affordable, and simpler diagnostics are crucial for identifying people for preventive therapy. We evaluated the diagnostic performance of the STANDARD F TB-Feron FIA (TB-Feron), a near-point-of-care (POC) assay for detecting TB infection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>From June to December 2024, we conducted a cross-sectional study at the Vietnam National Lung Hospital, enrolling 352 participants, including 345 eligible participants: 95 with microbiologically confirmed pulmonary TB (Group 1), 200 household contacts of people with pulmonary TB (Group 2), and 50 with a recent history of a negative QFT-Plus result and no known TB exposure (Group 3). Participants were tested with TB-Feron and the reference standard, QuantiFERON TB Gold Plus (QFT-Plus). Results were compared for sensitivity and specificity (primary endpoints), with inter-test agreement (Cohen's \u03ba) and reproducibility (Bland\u2013Altman analysis) as secondary outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 345 eligible participants, TB-Feron sensitivity was 88.4% (95% confidence interval [CI] 80.2\u201394.1) in Group 1, and specificity was 70.0% (55.4\u201382.1) in Group 3. In Group 2, positive and negative agreements with QFT-Plus were 89.2% (79.8\u201395.2%) and 75.4% (66.9\u201382.6), respectively, with inter-test agreement of 80.5% (Cohen's \u03ba=0.6069, P &amp;lt; .0001). Intra-test reproducibility showed no significant differences in IFN-\u03b3 levels (mean difference = 2.08\u2005IU\/mL, 95% CI \u22121.28 to 5.44, P = .206).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>With high sensitivity, the TB-Feron assay is a potential near-POC alternative to the QFT-Plus assay for diagnosing TB infection, but requires consideration of its suboptimal specificity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf561","type":"journal-article","created":{"date-parts":[[2025,10,5]],"date-time":"2025-10-05T11:44:54Z","timestamp":1759664694000},"page":"e996-e1004","source":"Crossref","is-referenced-by-count":2,"title":["Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study"],"prefix":"10.1093","volume":"82","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5541-8322","authenticated-orcid":false,"given":"Han Thi","family":"Nguyen","sequence":"first","affiliation":[{"name":"Research Department, FIT RD Social Enterprise Company Limited (FIT RD) , Hanoi ,","place":["Vietnam"]},{"name":"Division of Infectious Diseases, Department of Medicine, Karolinska Institutet , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5937-6286","authenticated-orcid":false,"given":"Luan Nguyen Quang","family":"Vo","sequence":"additional","affiliation":[{"name":"Management, Friends for International TB Relief , Hanoi ,","place":["Vietnam"]},{"name":"Department of Global Public Health, Karolinska Institutet , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew James","family":"Codlin","sequence":"additional","affiliation":[{"name":"Management, Friends for International TB Relief , Hanoi ,","place":["Vietnam"]},{"name":"Department of Global Public Health, Karolinska Institutet , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Forse","sequence":"additional","affiliation":[{"name":"Management, Friends for International TB Relief , Hanoi ,","place":["Vietnam"]},{"name":"Department of Global Public Health, Karolinska Institutet , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8433-6887","authenticated-orcid":false,"given":"Tom","family":"Wingfield","sequence":"additional","affiliation":[{"name":"Department of Global Public Health, Karolinska Institutet , Stockholm ,","place":["Sweden"]},{"name":"Centre for Tuberculosis Research, Departments of Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine , Liverpool ,","place":["United Kingdom"]},{"name":"Tropical and Infectious Diseases Unit, Liverpool University Hospitals NHS Foundation Trust , Liverpool ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristi Sidney","family":"Annerstedt","sequence":"additional","affiliation":[{"name":"Department of Global Public Health, Karolinska Institutet , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9272-0985","authenticated-orcid":false,"given":"Emily Lai-Ho","family":"MacLean","sequence":"additional","affiliation":[{"name":"NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney , Sydney, NSW ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4885-940X","authenticated-orcid":false,"given":"Jacob","family":"Creswell","sequence":"additional","affiliation":[{"name":"TB REACH, Stop TB Partnership , Geneva ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatrice","family":"Kirubi","sequence":"additional","affiliation":[{"name":"TB REACH, Stop TB Partnership , Geneva ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1543-4907","authenticated-orcid":false,"given":"Hoa Binh","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Research Centre, Vietnam National Lung Hospital , Hanoi ,","place":["Vietnam"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luong","family":"Van Dinh","sequence":"additional","affiliation":[{"name":"Research Centre, Vietnam National Lung Hospital , Hanoi ,","place":["Vietnam"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ha Thu","family":"Doan","sequence":"additional","affiliation":[{"name":"Research Centre, Vietnam National Lung Hospital , Hanoi ,","place":["Vietnam"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lina Davies","family":"Forsman","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Karolinska Institutet , Stockholm ,","place":["Sweden"]},{"name":"Department of Infectious Diseases, Karolinska University Hospital , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the TBI Testing Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinh","family":"Van Luong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nguyen Binh","family":"Hoa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ha Thi Tuyet","family":"Trinh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doan Thu","family":"Ha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinh Thi","family":"Huong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nguyen Trung","family":"Thanh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nguyen Thi","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nguyen Thi","family":"Cam Van","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ong Nguyen Huyen","family":"Trang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tran Thi Thu","family":"Thuy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luan Vo Nguyen","family":"Quang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew James","family":"Codlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bui Thi","family":"Huyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lina Davies","family":"Forsman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,11,26]]},"reference":[{"key":"2026052019263817800_ciaf561-B1","volume-title":"Global tuberculosis report 2024","year":"2024"},{"key":"2026052019263817800_ciaf561-B2","doi-asserted-by":"crossref","first-page":"k2738","DOI":"10.1136\/bmj.k2738","article-title":"Revisiting the timetable of tuberculosis","volume":"362","author":"Behr","year":"2018","journal-title":"BMJ"},{"key":"2026052019263817800_ciaf561-B3","doi-asserted-by":"crossref","first-page":"e1002152","DOI":"10.1371\/journal.pmed.1002152","article-title":"The global burden of latent tuberculosis infection: a re-estimation using mathematical modelling","volume":"13","author":"Houben","year":"2016","journal-title":"PLoS Medicine"},{"key":"2026052019263817800_ciaf561-B4","author":"WHO. Consolidated guidelines on tuberculosis"},{"key":"2026052019263817800_ciaf561-B5","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1186\/s12879-017-2301-4","article-title":"Comparing interferon-gamma release assays with tuberculin skin test for identifying latent tuberculosis infection that progresses to active tuberculosis: systematic review and meta-analysis","volume":"17","author":"Auguste","year":"2017","journal-title":"BMC Infect Dis"},{"key":"2026052019263817800_ciaf561-B6","doi-asserted-by":"crossref","first-page":"e204","DOI":"10.1017\/S0950268821001953","article-title":"Diagnostic value of interferon-\u03b3 release assay in HIV-infected individuals complicated with active tuberculosis: a systematic review and meta-analysis","volume":"149","author":"Ma","year":"2021","journal-title":"Epidemiol Infect"},{"key":"2026052019263817800_ciaf561-B7","first-page":"1192","article-title":"False-positive tuberculin skin tests: what is the absolute effect of BCG and non-tuberculous mycobacteria?","volume":"10","author":"Farhat","year":"2006","journal-title":"Int J Tuberc Lung Dis"},{"key":"2026052019263817800_ciaf561-B8","doi-asserted-by":"crossref","first-page":"1028","DOI":"10.2105\/AJPH.2019.305069","article-title":"QuantiFERON-TB Gold versus tuberculin screening and care retention among persons experiencing homelessness: Georgia, 2015\u20132017","volume":"109","author":"Collins","year":"2019","journal-title":"Am J Public Health"},{"key":"2026052019263817800_ciaf561-B9","doi-asserted-by":"crossref","first-page":"e158","DOI":"10.1002\/hsr2.158","article-title":"How are high burden countries implementing policies and tools for latent tuberculosis infection? A survey of current practices and barriers","volume":"3","author":"Faust","year":"2020","journal-title":"Health Sci Rep"},{"key":"2026052019263817800_ciaf561-B10","doi-asserted-by":"crossref","first-page":"388","DOI":"10.1016\/S0140-6736(13)62003-6","article-title":"Point-of-care diagnostics for tuberculosis elimination?","volume":"383","author":"Wejse","year":"2014","journal-title":"Lancet"},{"key":"2026052019263817800_ciaf561-B11","author":"SD Biosensor"},{"key":"2026052019263817800_ciaf561-B12","doi-asserted-by":"crossref","first-page":"e085614","DOI":"10.1136\/bmjopen-2024-085614","article-title":"Study protocol: diagnostic accuracy study comparing Cy-Tb and STANDARD F TB-Feron FIA tests for tuberculosis infection diagnosis in Vietnam","volume":"14","author":"Nguyen","year":"2024","journal-title":"BMJ Open"},{"key":"2026052019263817800_ciaf561-B13","author":"WHO"},{"key":"2026052019263817800_ciaf561-B14","author":"WHO"},{"key":"2026052019263817800_ciaf561-B15","doi-asserted-by":"crossref","first-page":"2004078","DOI":"10.1183\/13993003.04078-2020","article-title":"Framework for the evaluation of new tests for tuberculosis infection","volume":"58","author":"Hamada","year":"2021","journal-title":"Eur Respir J"},{"key":"2026052019263817800_ciaf561-B16","author":"QIAGEN"},{"key":"2026052019263817800_ciaf561-B17","doi-asserted-by":"crossref","first-page":"1162","DOI":"10.3390\/diagnostics13061162","article-title":"Comparison of two tuberculosis infection tests in a South American tertiary hospital: STANDARD F TB-Feron FIA vs. QIAreachTM QuantiFERON-TB","volume":"13","author":"Saint-Pierre","year":"2023","journal-title":"Diagnostics (Basel)"},{"key":"2026052019263817800_ciaf561-B18","doi-asserted-by":"crossref","first-page":"100518","DOI":"10.1016\/j.jctube.2025.100518","article-title":"Diagnostic accuracy study of STANDARD TB-Feron FIA and STANDARD TB-Feron ELISA tests for tuberculosis infection diagnosis in Eastern European setting","volume":"39","author":"Crudu","year":"2025","journal-title":"J Clin Tuberc Other Mycobact Dis"},{"key":"2026052019263817800_ciaf561-B19","doi-asserted-by":"crossref","first-page":"910","DOI":"10.1148\/radiol.12120509","article-title":"Methods for calculating sensitivity and specificity of clustered data: a tutorial","volume":"265","author":"Genders","year":"2012","journal-title":"Radiology"},{"key":"2026052019263817800_ciaf561-B20","doi-asserted-by":"crossref","first-page":"159","DOI":"10.2307\/2529310","article-title":"The measurement of observer agreement for categorical data","volume":"33","author":"Landis","year":"1977","journal-title":"Biometrics"},{"key":"2026052019263817800_ciaf561-B21","author":"MedCalc Software Ltd"},{"key":"2026052019263817800_ciaf561-B22","author":"National Health Service (NHS)"},{"key":"2026052019263817800_ciaf561-B23","first-page":"e50976","article-title":"Utility of a clinical scoring cystem (Bandim TB Score and Karnofsky Performance Score) to assess mycobacterial burden in terms of Cartridge-Based Nucleic Acid Amplification Test (CBNAAT) cycle threshold values among pulmonary TB patients","volume":"15","author":"Sarkar","year":"2023","journal-title":"Cureus"},{"key":"2026052019263817800_ciaf561-B24","doi-asserted-by":"crossref","first-page":"e0004612","DOI":"10.1371\/journal.pgph.0004612","article-title":"WHO target product profile for TB detection at peripheral settings: 2024 update","volume":"5","author":"Kohli","year":"2025","journal-title":"PLoS Glob Public Health"},{"key":"2026052019263817800_ciaf561-B25","doi-asserted-by":"crossref","first-page":"e0232142","DOI":"10.1371\/journal.pone.0232142","article-title":"The second national tuberculosis prevalence survey in Vietnam","volume":"15","author":"Nguyen","year":"2020","journal-title":"PLoS One"},{"key":"2026052019263817800_ciaf561-B26","doi-asserted-by":"crossref","first-page":"1607","DOI":"10.1038\/s41598-020-58459-9","article-title":"Factors associated with false negative interferon-\u03b3 release assay results in patients with tuberculosis: a systematic review with meta-analysis","volume":"10","author":"Yamasue","year":"2020","journal-title":"Sci Rep"},{"key":"2026052019263817800_ciaf561-B27","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1016\/j.jinf.2019.08.018","article-title":"QuantiFERON TB Gold Plus for the diagnosis of tuberculosis: a systematic review and meta-analysis","volume":"79","author":"Sotgiu","year":"2019","journal-title":"J Infect"},{"key":"2026052019263817800_ciaf561-B28","doi-asserted-by":"crossref","first-page":"109132","DOI":"10.1016\/j.clim.2022.109132","article-title":"Positive rates of interferon-\u03b3 release assay and tuberculin skin test in detection of latent tuberculosis infection: a systematic review and meta-analysis of 200,000 head-to-head comparative tests","volume":"245","author":"Zhou","year":"2022","journal-title":"Clin Immunol"},{"key":"2026052019263817800_ciaf561-B29","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1016\/S1473-3099(11)70210-9","article-title":"Predictive value of interferon-\u03b3 release assays for incident active tuberculosis: a systematic review and meta-analysis","volume":"12","author":"Rangaka","year":"2012","journal-title":"Lancet Infect Dis"},{"key":"2026052019263817800_ciaf561-B30","doi-asserted-by":"crossref","first-page":"20130437","DOI":"10.1098\/rstb.2013.0437","article-title":"The ongoing challenge of latent tuberculosis","volume":"369","author":"Esmail","year":"2014","journal-title":"Philos Trans R Soc B: Biol Sci"},{"key":"2026052019263817800_ciaf561-B31","doi-asserted-by":"crossref","first-page":"1659","DOI":"10.3390\/diagnostics11091659","article-title":"Comparative evaluation of standard E TB-Feron ELISA and QuantiFERON-TB Gold Plus assays in patients with tuberculosis and healthcare workers","volume":"11","author":"Yoo","year":"2021","journal-title":"Diagnostics"},{"key":"2026052019263817800_ciaf561-B32","doi-asserted-by":"crossref","first-page":"14455","DOI":"10.1038\/s41598-024-65663-4","article-title":"Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis","volume":"14","author":"Mahmoudi","year":"2024","journal-title":"Sci Rep"},{"key":"2026052019263817800_ciaf561-B33","doi-asserted-by":"crossref","first-page":"15209","DOI":"10.1038\/s41598-023-42515-1","article-title":"Comparative performance evaluation of QIAreach QuantiFERON-TB and tuberculin skin test for diagnosis of tuberculosis infection in Viet Nam","volume":"13","author":"Vo","year":"2023","journal-title":"Sci Rep"},{"key":"2026052019263817800_ciaf561-B34","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1093\/cid\/ciw778","article-title":"Official American Thoracic Society\/Infectious Diseases Society of America\/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children","volume":"64","author":"Lewinsohn","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2026052019263817800_ciaf561-B35","doi-asserted-by":"crossref","first-page":"19972","DOI":"10.1038\/srep19972","article-title":"Effects of acute critical illnesses on the performance of interferon-gamma release assay","volume":"6","author":"Huang","year":"2016","journal-title":"Sci Rep"},{"key":"2026052019263817800_ciaf561-B36","doi-asserted-by":"crossref","first-page":"101","DOI":"10.3390\/v12010101","article-title":"Hepatitis C virus affects tuberculosis-specific T cells in HIV-negative patients","volume":"12","author":"El-Mokhtar","year":"2020","journal-title":"Viruses"},{"key":"2026052019263817800_ciaf561-B37","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1056\/NEJMoa1700209","article-title":"Household-contact investigation for detection of tuberculosis in Vietnam","volume":"378","author":"Fox","year":"2018","journal-title":"N Engl J Med"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciaf561\/65493039\/ciaf561.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/82\/5\/e996\/65493039\/ciaf561.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/82\/5\/e996\/65493039\/ciaf561.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T23:26:44Z","timestamp":1779319604000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/82\/5\/e996\/8341627"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,26]]},"references-count":37,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,11,26]]},"published-print":{"date-parts":[[2026,5,20]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciaf561","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,5,15]]},"published":{"date-parts":[[2025,11,26]]}}}