PT - JOURNAL ARTICLE AU - Soren T. Hoff AU - Jonathan G. Peter AU - Grant Theron AU - Mellissa Pascoe AU - Pernille N. Tingskov AU - Henrik Aggerbeck AU - Daniel Kolbus AU - Morten Ruhwald AU - Peter Andersen AU - Keertan Dheda TI - Sensitivity of C-Tb: a novel RD-1-specific skin test for the diagnosis of tuberculosis infection AID - 10.1183/13993003.01464-2015 DP - 2016 Mar 01 TA - European Respiratory Journal PG - 919--928 VI - 47 IP - 3 4099 - http://erj.ersjournals.com/content/47/3/919.short 4100 - http://erj.ersjournals.com/content/47/3/919.full SO - Eur Respir J2016 Mar 01; 47 AB - C-Tb, a novel Mycobacterium tuberculosis 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–Guerin-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).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.Using a receiver operating characteristic curve-derived cut-point of 5 mm, C-Tb sensitivity was similar to QFT-GIT (73.9 (95% CI 67.8–79.3) versus 75.1 (95% CI 69.3–80.2)), and similar in HIV-infected and HIV-uninfected patients (76.7 (95% CI 69.0–83.3) versus 69.5 (95% CI 59.2–78.5)). However, sensitivity was significantly diminished in HIV-infected patients with CD4 counts <100 cells·mm–3. C-Tb and QFT-GIT combined had significantly higher sensitivity than C-Tb alone (p<0.0001). C-Tb was safe with no significant adverse events. The 5 mm cut-point corresponded to that found in the previously published specificity study (TESEC-04).C-Tb has similar sensitivity compared with QFT-GIT for the diagnosis of M. tuberculosis infection. Sensitivity was reduced only in HIV-infected patients with severe immunosuppression. Further studies in different settings are required to validate the proposed 5 mm cut-point.C-Tb has similar sensitivity compared with QFT-GIT for the diagnosis of M. tuberculosis infection http://ow.ly/TtFf6