Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China
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 enro...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2015-11-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971215002143 |
| _version_ | 1818545288896315392 |
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| author | Yan Qiu Yansen Wang Nan Lin Mingxiang Huang Yunhong Tan Qing Wang Yi Jiang Haican Liu Jiao Liu Jingrui Zhang Jue Wang Xinchan Chen Dongping Wang Guilian Li Zhongnan Chen Lishui Zhang Dixun Bao Lili Zhao Chaxiang Guan Kanlgin Wan |
| author_facet | Yan Qiu Yansen Wang Nan Lin Mingxiang Huang Yunhong Tan Qing Wang Yi Jiang Haican Liu Jiao Liu Jingrui Zhang Jue Wang Xinchan Chen Dongping Wang Guilian Li Zhongnan Chen Lishui Zhang Dixun Bao Lili Zhao Chaxiang Guan Kanlgin Wan |
| author_sort | Yan Qiu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T07:38:21Z |
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| issn | 1201-9712 1878-3511 |
| language | English |
| last_indexed | 2024-12-12T07:38:21Z |
| publishDate | 2015-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-1f9d78cad4c54e5a8b562810bf2d0a212022-12-22T00:32:52ZengElsevierInternational Journal of Infectious Diseases1201-97121878-35112015-11-0140C10811210.1016/j.ijid.2015.09.004Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in ChinaYan Qiu0Yansen Wang1Nan Lin2Mingxiang Huang3Yunhong Tan4Qing Wang5Yi Jiang6Haican Liu7Jiao Liu8Jingrui Zhang9Jue Wang10Xinchan Chen11Dongping Wang12Guilian Li13Zhongnan Chen14Lishui Zhang15Dixun Bao16Lili Zhao17Chaxiang Guan18Kanlgin Wan19State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaDepartment of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan 410078, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaAnhui Chest Hospital, Hefei, Anhui Province, ChinaHunan Chest Hospital, Changsha, Hunan Province, ChinaFuzhou Pulmonary Hospital, Fuzhou, Fujian Province, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaAnhui Chest Hospital, Hefei, Anhui Province, ChinaHunan Chest Hospital, Changsha, Hunan Province, ChinaFuzhou Pulmonary Hospital, Fuzhou, Fujian Province, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaAnhui Chest Hospital, Hefei, Anhui Province, ChinaHunan Chest Hospital, Changsha, Hunan Province, ChinaHunan Chest Hospital, Changsha, Hunan Province, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaDepartment of Physiology, Xiangya School of Medicine, Central South University, Changsha, Hunan 410078, ChinaState Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, PO Box 5, Changping, Beijing 102206, ChinaObjective: 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.http://www.sciencedirect.com/science/article/pii/S1201971215002143TuberculosisInterferon-gamma release assayDiagnosisEvaluationChina |
| spellingShingle | Yan Qiu Yansen Wang Nan Lin Mingxiang Huang Yunhong Tan Qing Wang Yi Jiang Haican Liu Jiao Liu Jingrui Zhang Jue Wang Xinchan Chen Dongping Wang Guilian Li Zhongnan Chen Lishui Zhang Dixun Bao Lili Zhao Chaxiang Guan Kanlgin Wan Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China International Journal of Infectious Diseases Tuberculosis Interferon-gamma release assay Diagnosis Evaluation China |
| title | Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China |
| title_full | Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China |
| title_fullStr | Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China |
| title_full_unstemmed | Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China |
| title_short | Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China |
| title_sort | multicenter clinical evaluation of three commercial reagent kits based on the interferon gamma release assay for the rapid diagnosis of tuberculosis in china |
| topic | Tuberculosis Interferon-gamma release assay Diagnosis Evaluation China |
| url | http://www.sciencedirect.com/science/article/pii/S1201971215002143 |
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