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Published ahead of print on April 1, 2004, doi:10.1164/rccm.200402-179OC
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American Journal of Respiratory and Critical Care Medicine Vol 170. pp. 59-64, (2004)
© 2004 American Thoracic Society

Specific Detection of Tuberculosis Infection

An Interferon-{gamma}–based Assay Using New Antigens

Toru Mori, Mitsunori Sakatani, Fumio Yamagishi, Tetsuya Takashima, Yoshiko Kawabe, Keiji Nagao, Eriko Shigeto, Nobuyuki Harada, Satoshi Mitarai, Masaji Okada, Katsuhiro Suzuki, Yoshikazu Inoue, Kazunari Tsuyuguchi, Yuka Sasaki, Gerald H. Mazurek and Izuo Tsuyuguchi

Research Institute of Tuberculosis and National Tokyo Hospital, Tokyo; National Kinki Chuo Hospital for Chest Diseases and Osaka Prefectural Habikino Hospital, Osaka; National Chiba Higashi Hospital and Chiba University School of Medicine, Chiba; and National Hiroshima Hospital, Hiroshima, Japan; and Centers for Disease Control and Prevention and Emory University School of Medicine, Atlanta, Georgia

Correspondence and requests for reprints should be addressed to Toru Mori, M.D., Ph.D., Research Institute of Tuberculosis, 3-1-24 Matsuyama, Kiyose, Tokyo 204-8533, Japan. E-mail: tmori{at}jata.or.jp

The tuberculin skin test for immunologic diagnosis of Mycobacterium tuberculosis infection has many limitations, including being confounded by bacillus Calmette-Guérin (BCG) vaccination or exposure to nontuberculous mycobacteria. M. tuberculosis–specific antigens that are absent from BCG and most nontuberculous mycobacteria have been identified. We examined the use of two of these antigens, CFP-10 and ESAT-6, in a whole blood IFN-{gamma} assay as a diagnostic test for tuberculosis in BCG-vaccinated individuals. Because of the lack of an accurate standard with which to compare new tests for M. tuberculosis infection, specificity of the whole blood IFN-{gamma} assay was estimated on the basis of data from people with no identified risk for M. tuberculosis exposure (216 BCG-vaccinated Japanese adults) and sensitivity was estimated on the basis of data from 118 patients with culture-confirmed M. tuberculosis infection who had received less than 1 week of treatment. Using a combination of CFP-10 and ESAT-6 responses, the specificity of the test for the low-risk group was 98.1% and the sensitivity for patients with M. tuberculosis infection was 89.0%. The results demonstrate that the whole blood IFN-{gamma} assay using CFP-10 and ESAT-6 was highly specific and sensitive for M. tuberculosis infection and was unaffected by BCG vaccination status.

Key Words: bacillus Calmette-Guérin • diagnostics • infection • IFN-{gamma} • tuberculosis




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