Soren T. Hoff, Jonathan G. Peter, Grant Theron, Mellissa Pascoe,
Pernille N. Tingskov, Henrik Aggerbeck, Daniel Kolbus, Morten Ruhwald,
Peter Andersen and Keertan Dheda
ABSTRACT
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–Guerinvaccinated 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 QFTGIT 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.