{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T19:07:19Z","timestamp":1790536039804,"version":"4.1.0"},"reference-count":29,"publisher":"European Respiratory Society (ERS)","issue":"3","funder":[{"name":"Statens Serum Institut"}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2015,10,9]]},"published-print":{"date-parts":[[2016,3]]},"abstract":"<jats:p>C-Tb, a novel<jats:italic>Mycobacterium tuberculosis<\/jats:italic>and 6-kDa early secretory antigenic target\/10-kDa culture filtrate protein (ESAT-6\/CFP-10)-specific skin test, has high specificity in bacille Calmette\u2013Guerin-vaccinated healthy controls. However, the sensitivity of C-Tb has hitherto not been determined. The objective was to determine the sensitivity of C-Tb in patients with active tuberculosis (TB) in comparison with the tuberculin skin test (TST) and QuantiFERON-TB Gold In-Tube (QFT-GIT).<\/jats:p><jats:p>C-Tb and TST were randomly administered in a double-blinded fashion to one or the other forearm in 253 patients with active TB with or without HIV co-infection. QFT-GIT testing was performed prior to skin testing.<\/jats:p><jats:p>Using a receiver operating characteristic curve-derived cut-point of 5\u2005mm, C-Tb sensitivity was similar to QFT-GIT (73.9 (95% CI 67.8\u201379.3)<jats:italic>versus<\/jats:italic>75.1 (95% CI 69.3\u201380.2)), and similar in HIV-infected and HIV-uninfected patients (76.7 (95% CI 69.0\u201383.3)<jats:italic>versus<\/jats:italic>69.5 (95% CI 59.2\u201378.5)). However, sensitivity was significantly diminished in HIV-infected patients with CD4 counts &lt;100\u2005cells\u00b7mm<jats:sup>\u20133<\/jats:sup>. C-Tb and QFT-GIT combined had significantly higher sensitivity than C-Tb alone (p&lt;0.0001). C-Tb was safe with no significant adverse events. The 5\u2005mm cut-point corresponded to that found in the previously published specificity study (TESEC-04).<\/jats:p><jats:p>C-Tb has similar sensitivity compared with QFT-GIT for the diagnosis of<jats:italic>M. tuberculosis<\/jats:italic>infection. Sensitivity was reduced only in HIV-infected patients with severe immunosuppression. Further studies in different settings are required to validate the proposed 5\u2005mm cut-point.<\/jats:p>","DOI":"10.1183\/13993003.01464-2015","type":"journal-article","created":{"date-parts":[[2015,12,18]],"date-time":"2015-12-18T05:11:57Z","timestamp":1450415517000},"page":"919-928","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":63,"title":["Sensitivity of C-Tb: a novel RD-1-specific skin test for the diagnosis of tuberculosis infection"],"prefix":"10.1183","volume":"47","author":[{"given":"Soren T.","family":"Hoff","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan G.","family":"Peter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grant","family":"Theron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mellissa","family":"Pascoe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pernille N.","family":"Tingskov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"Aggerbeck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Kolbus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Ruhwald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Andersen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keertan","family":"Dheda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2015,12,17]]},"reference":[{"key":"2024102023494939000_47.3.919.1","doi-asserted-by":"crossref","unstructured":"Dheda K , Barry C III , Maartens G . 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