Institut für Transfusionsmedizin, Laboratoriumsmedizin und Medizinische Mikrobiologie, Klinikum Dortmund gGmbH, 44137 Dortmund, Germany
Bernd Seese
Fachklinik für Pneumologie, Thoraxchirurgie, Rehabilitation, Schlaf- und Beatmungsmedizin, 97702 Münnerstadt, Germany
Daniel Teschner
Department of Haematology and Medical Oncology, University Medical Centre of the Johannes Gutenberg University, 55131 Mainz, Germany
Sabin Handzhiev
Karl Landsteiner Privatuniversität für Gesundheitswissenschaften, Universitätsklinikum Krems, 3500 Krems an der Donau, Austria
Uwe Graf
Innere Medizin IV, Klinikum Chemnitz gGmbH, 09116 Chemnitz, Germany
Christoph Lübbert
Department of Infectious Diseases and Tropical Medicine, Klinikum St. Georg gGmbH, 04129 Leipzig, Germany
Monika Steinmaurer
Klinikum Wels-Grieskirchen GmbH, 4600 Wels, Austria
Konstantina Kontogianni
Department for Pneumology and Critical Care Medicine, Thoraxklinik at University of Heidelberg, 69126 Heidelberg, Germany
Christoph Berg
Department of Internal Medicine I, Tübingen University Clinical Centre, 72016 Tübingen, Germany
Andreas Maieron
Internal Medicine 2, Gastroenterology and Hepatology and Rheumatology, Karl Landsteiner University of Health Sciences, University Hospital of St. Pölten, 3100 Sankt Pölten, Austria
Stefan H. Blaas
Center for Pneumology, Donaustauf Hospital, 93093 Donaustauf, Germany
Ralf Wagner
Institute for Medical Microbiology and Hygiene, University of Regensburg, 93053 Regensburg, Germany
Tuberculosis (TB) is one of the leading causes of death by an infectious disease. It remains a major health burden worldwide, in part due to misdiagnosis. Therefore, improved diagnostic tests allowing the faster and more reliable diagnosis of patients with active TB are urgently needed. This prospective study examined the performance of the new molecular whole-blood test T-Track® TB, which relies on the combined evaluation of IFNG and CXCL10 mRNA levels, and compared it to that of the QuantiFERON®-TB Gold Plus (QFT-Plus) enzyme-linked immunosorbent assay (ELISA). Diagnostic accuracy and agreement analyses were conducted on the whole blood of 181 active TB patients and 163 non-TB controls. T-Track® TB presented sensitivity of 94.9% and specificity of 93.8% for the detection of active TB vs. non-TB controls. In comparison, the QFT-Plus ELISA showed sensitivity of 84.3%. The sensitivity of T-Track® TB was significantly higher (p ® TB with QFT-Plus to diagnose active TB was 87.9%. Out of 21 samples with discordant results, 19 were correctly classified by T-Track® TB while misclassified by QFT-Plus (T-Track® TB-positive/QFT-Plus-negative), and two samples were misclassified by T-Track® TB while correctly classified by QFT-Plus (T-Track® TB-negative/QFT-Plus-positive). Our results demonstrate the excellent performance of the T-Track® TB molecular assay and its suitability to accurately detect TB infection and discriminate active TB patients from non-infected controls.
