{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T23:35:16Z","timestamp":1791329716884,"version":"4.3.1"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:00:00Z","timestamp":1769472000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Evidence on the accuracy and safety of the ESAT-6\/CFP-10\u2013based Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      in BCG-vaccinated populations outside Eastern Europe remains limited. In Brazil, recurrent shortages of purified protein derivative (PPD) have challenged the implementation of tuberculin skin testing, underscoring the need to evaluate alternative tools for tuberculosis infection (TBI) screening. This trial compared the diagnostic performance and safety of Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      with the tuberculin skin test (TST) using PPD Rt-23 in Brazilian adults, a predominantly BCG-vaccinated population.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>\n                      A double-blind randomized clinical trial was conducted at eight centers in Brazil between July 2023 and September 2024. Participants were allocated to the TB group (microbiologically confirmed pulmonary TB), in whom sensitivity was estimated, and the control group (healthy, unexposed adults), in whom specificity was estimated using the QuantiFERON-TB Plus\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (QFT-Plus) as the reference standard. All participants first underwent QFT-Plus testing, followed by intradermal application of Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      and TST in opposite arms, with randomized right\u2013left allocation. Induration was measured at 48\u201396\u202fh using a prespecified 5\u202fmm cutoff. Secondary outcomes included safety, assessed through active monitoring of adverse events (AEs), included injection site reactions.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 337 controls and 136\u202fTB participants were enrolled. TST showed higher sensitivity than both Diaskintest and QFT-plus (0.84 [95% CI 0.76\u20130.90] vs. 0.68 [95% CI 0.59\u20130.76], and 0.63 [95% CI 0.54\u20130.72], respectively). Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      demonstrated higher specificity than TST (0.93 [95% CI 0.90\u20130.96] vs. 0.75 [95% CI 0.70\u20130.80]). Injection-site reactions occurred less frequently with Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      than with TST (1.7% vs. 4.9%. RR\u202f=\u202f0.35 [0.15\u20130.79]). The most common reactions were phlyctenular reactions and itching. No serious AEs were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      TST had greater sensitivity than Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , whereas Diaskintest\n                      <jats:sup>\u00ae<\/jats:sup>\n                      demonstrated higher specificity and fewer local adverse reactions. In this study, specificity was estimated using QFT-Plus as a surrogate reference standard, acknowledging the absence of a true gold standard for tuberculosis infection. These complementary performance profiles highlight a trade-off between false-positive reduction and case detection, suggesting that the choice of test should consider programmatic priorities and local epidemiological context.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:uri>https:\/\/ensaiosclinicos.gov.br\/<\/jats:uri>\n                      , identifier RBR-7tn2ysw.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1736211","type":"journal-article","created":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T05:25:35Z","timestamp":1769491535000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Diagnostic accuracy and safety of Diaskintest\u00ae compared with the tuberculin skin test for detecting tuberculosis infection in BCG-vaccinated Brazilian adults"],"prefix":"10.3389","volume":"13","author":[{"given":"Afr\u00e2nio","family":"Kritski","sequence":"first","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Concei\u00e7\u00e3o","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha","family":"Oliveira","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]},{"name":"Laborat\u00f3rio de Micobacteriologia Molecular, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Paula Razal","family":"Dalvi","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelo","family":"Cordeiro-Santos","sequence":"additional","affiliation":[{"name":"Funda\u00e7\u00e3o de Medicina Tropical Dr. Heitor Vieira Dourado","place":["Manaus, Brazil"]},{"name":"School of Medicine, Universidade do Estado do Amazonas","place":["Manaus, Brazil"]},{"name":"School of Medicine, Universidade Nilton Lins","place":["Manaus, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana Rezende","family":"Moreira","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]},{"name":"Centro Municipal de Sa\u00fade de Duque de Caxias, Municipal Health Secretariat","place":["Duque de Caxias, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aline","family":"Lopes","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rogerio","family":"Ruffino","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Pedro Ernesto, Universidade do Estado do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luciana","family":"Rodrigues","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Pedro Ernesto, Universidade do Estado do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eliene","family":"Mesquita","sequence":"additional","affiliation":[{"name":"Instituto Ary Parreiras State, State Health Secretariat of Rio de Janeiro","place":["Niter\u00f3i, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergian Vianna","family":"Cardozo","sequence":"additional","affiliation":[{"name":"School of Medicine, Universidade do Grande Rio Professor Jos\u00e9 de Souza Herdy","place":["Duque de Caxias, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Jose Fernandes","family":"Pereira","sequence":"additional","affiliation":[{"name":"Servi\u00e7o de Aten\u00e7\u00e3o Especializada em Tuberculose, Municipal Health Secretariat of Itabora\u00ed","place":["Itabora\u00ed, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumire","family":"Sakabe","sequence":"additional","affiliation":[{"name":"Centro de Refer\u00eancia e Treinamento DST-AIDS-SP","place":["S\u00e3o Paulo, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anete","family":"Trajman","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do T\u00f3rax, Escola de Medicina, Universidade Federal do Rio de Janeiro","place":["Rio de Janeiro, Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcela","family":"Bhering","sequence":"additional","affiliation":[{"name":"Hospital Universit\u00e1rio Clementino Fraga Filho\/Instituto de Doen\u00e7as do 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