{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T06:51:58Z","timestamp":1787986318588,"version":"build-2784847793"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,5,18]],"date-time":"2021-05-18T00:00:00Z","timestamp":1621296000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,5,18]],"date-time":"2021-05-18T00:00:00Z","timestamp":1621296000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R01AI113725;R01AI122932;R21Al126361"],"award-info":[{"award-number":["R01AI113725;R01AI122932;R21Al126361"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["K23AI120793;R21AI143341"],"award-info":[{"award-number":["K23AI120793;R21AI143341"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD090927"],"award-info":[{"award-number":["R01HD090927"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["UM1AI068632 (IMPAACT LOC);UM1AI068616 (IMPAACT SDMC);UM1AI106716 (IMPAACT LC);HHSN275201800001I"],"award-info":[{"award-number":["UM1AI068632 (IMPAACT LOC);UM1AI068616 (IMPAACT SDMC);UM1AI106716 (IMPAACT LC);HHSN275201800001I"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000005","name":"U.S. Department of Defense","doi-asserted-by":"publisher","award":["W8IXWH1910926"],"award-info":[{"award-number":["W8IXWH1910926"]}],"id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Non-sputum methods are urgently needed to improve tuberculosis diagnosis and treatment monitoring in children. This study evaluated the ability of a serum assay quantifying a species-specific peptide of the <jats:italic>Mycobacterium tuberculosis<\/jats:italic> CFP-10 virulence factor via nanotechnology and matrix-assisted laser desorption ionization time-of-flight mass spectrometry to diagnose tuberculosis in HIV-infected and HIV-uninfected infants.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Serum CFP-10 peptide signal was blinded evaluated in cryopreserved sera of 519 BCG-immunized, HIV-exposed infants (284 HIV-infected, 235 HIV-uninfected) from a multi-center randomized placebo-controlled isoniazid prophylaxis trial conducted in southern Africa between 2004 and 2008, who were followed up to 192\u2009weeks for <jats:italic>Mtb<\/jats:italic> infection and TB. Children were classified as confirmed, unconfirmed, or unlikely tuberculosis cases using 2015 NIH diagnostic criteria for pediatric TB.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>In HIV-infected infants, CFP-10 signal had 100% sensitivity for confirmed TB (5\/5, 95% CI, 47.8\u2013100) and 83.7% sensitivity for unconfirmed TB (36\/43, 95% CI 69.3\u201393.2), with 93.1% specificity (203\/218, 95% CI 88.9\u201396.1). In HIV-uninfected infants, CFP-10 signal detected the single confirmed TB case and 75.0% of unconfirmed TB cases (15\/20; 95% CI 50.9\u201391.3), with 96.2% specificity (177\/184, 95% CI, 92.3\u201398.5). Serum CFP-10 achieved 77% diagnostic sensitivity for confirmed and unconfirmed TB (13\/17, 95% CI, 50\u201393%) at \u2264\u200924\u2009weeks pre-diagnosis, and both CFP-10-positivity and concentration declined following anti-TB therapy initiation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Serum CFP-10 signal exhibited high diagnostic sensitivity and specificity for tuberculosis in HIV-infected and HIV-uninfected infants and potential utility for early TB detection and monitoring of anti-TB treatment responses.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12916-021-01983-w","type":"journal-article","created":{"date-parts":[[2021,5,18]],"date-time":"2021-05-18T01:02:16Z","timestamp":1621299736000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Evaluation of a serum-based antigen test for tuberculosis in HIV-exposed infants: a diagnostic accuracy study"],"prefix":"10.1186","volume":"19","author":[{"given":"Liyan","family":"Mao","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvia M.","family":"LaCourse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soyeon","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Ning","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Duran","family":"Bao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Fan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J.","family":"Lyon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziyong","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"Nachman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles D.","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony Y.","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,5,18]]},"reference":[{"key":"1983_CR1","volume-title":"Global tuberculosis report","author":"World Health Organization","year":"2019","unstructured":"World Health Organization. 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Written informed consent was obtained from the legal guardians of the children in parent study (IMPAACT P1041 study,  number, NCT0008119).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Y. H, C.L. and C.J.L. report other support from NanoPin Technologies, Inc., outside the submitted work; In addition, Y. H. has a patent \u201cCompositions and methods of determining a level of active <i>Mycobacterium tuberculosis<\/i> infectious in a subject\u201d licensed to NanoPin Technologies, Inc. Dr. Liu has patents PCT\/US18\/15742 and PCT\/US18\/16115 with royalties paid to NanoPin Technologies Inc.. All other authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"113"}}