Journal
INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Volume 40, Issue -, Pages 108-112Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ijid.2015.09.004
Keywords
Tuberculosis; Interferon-gamma release assay; Diagnosis; Evaluation; China
Categories
Funding
- National Key Program of Mega Infectious Disease [2013ZX10003002-001]
Ask authors/readers for more resources
Objective: To evaluate the performance of three interferon-gamma release assay (IGRA) kits in detecting Mycobacterium tuberculosis infection in China. Methods: A multicenter clinical trial was used to compare the effectiveness and application of the three kits. A total of 1026 participants were enrolled at three hospitals, including 597 tuberculosis (TB) patients diagnosed clinically (517 patients with pulmonary TB and 80 patients with extrapulmonary TB) and 429 negative controls (244 patients with pulmonary disease but not TB, or with non-tuberculosis mycobacterial lung diseases, and 185 healthy people). Detection performance indicators including sensitivity, specificity, and the Youden index (YI) were used to evaluate performance. Results: Through bacterial culture evaluation, 224 of the 517 pulmonary TB patients were positive and all 429 negative controls were negative. When the gold standard bacterial methods were used, the sensitivity, specificity, and YI were 89.7% (201/224), 91.1% (391/429), and 0.81 for T-SPOT. TB, 86.2% (193/224), 87.2% (374/429), and 0.73 for QB-SPOT, and 83.9% (188/224), 88.6% (380/429), and 0.73 for TB-IGRA, respectively. There were no significant differences in the sensitivity and specificity of the three kits. Conclusions: The results showed that the three kits had very high sensitivity and specificity and exhibited a good performance for the detection of M. tuberculosis infection. (C) 2015 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available