{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:16:55Z","timestamp":1787008615209,"version":"build-2736575974"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,5,22]],"date-time":"2021-05-22T00:00:00Z","timestamp":1621641600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100018537","name":"National Science and Technology Major Project","doi-asserted-by":"publisher","award":["2012ZX10004710"],"award-info":[{"award-number":["2012ZX10004710"]}],"id":[{"id":"10.13039\/501100018537","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Zhifei Longcom Biologic Pharmacy Company"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Diagnostics to identify tuberculosis infection are limited. We aimed to assess the diagnostic accuracy and safety of ESAT6-CFP10 (EC) skin test for tuberculosis infection in Chinese adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted 2 randomized, parallel-group clinical trials in healthy participants and tuberculosis patients. All participants were tested with the T-SPOT.TB test, then received an EC skin test and tuberculin skin test (TST). The diameter of skin indurations and\/or redness at injection sites were measured at different time periods. A bacillus Calmette Guerin (BCG) model was established to assess the diagnosis of tuberculosis infection using an EC skin test.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 777 healthy participants and 96 tuberculosis patients were allocated to receive EC skin test at 1.0 \u03bcg\/0.1 mL or 0.5 \u03bcg\/0.1 mL. The area under the curve was 0.95 (95% confidence interval [CI], .91\u2013.97) for the EC skin test at 1.0 \u03bcg\/0.1 mL at 24\u201372 hours. Compared with the T-SPOT.TB test, the EC skin test demonstrated similar sensitivity (87.5, 95% CI, 77.8\u201397.2 vs 86.5, 95% CI, 79.5\u201393.4) and specificity (98.9, 95% CI, 96.0\u201399.9 vs 96.1, 95% CI, 93.5\u201397.8). Among BCG vaccinated participants, the EC skin test had high consistency with the T-SPOT.TB test (96.3, 95% CI, 92.0\u2013100.0). No serious adverse events related to the EC skin test were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The EC skin test demonstrated both high specificity and sensitivity at a dose of 1.0 \u03bcg\/0.1 mL, comparable to the T-SPOT.TB test. The diagnostic accuracy of the EC skin test was not impacted by BCG vaccination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT02389322 and NCT02336542.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab472","type":"journal-article","created":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T07:13:24Z","timestamp":1621494804000},"page":"668-677","source":"Crossref","is-referenced-by-count":39,"title":["Sensitivity, Specificity, and Safety of a Novel ESAT6-CFP10 Skin Test for Tuberculosis Infection in China: 2 Randomized, Self-Controlled, Parallel-Group Phase 2b Trials"],"prefix":"10.1093","volume":"74","author":[{"given":"Miao","family":"Xu","sequence":"first","affiliation":[{"name":"National Institutes for Food and Drug Control , Beijing ,","place":["PR 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