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Journal of Clinical Microbiology, October 2001, p. 3603-3608, Vol. 39, No. 10
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.10.3603-3608.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Clinical Evaluation of Anti-Tuberculous Glycolipid Immunoglobulin G Antibody Assay for Rapid Serodiagnosis of Pulmonary Tuberculosis

Ryoji Maekura,1,* Yoshinari Okuda,1 Masaru Nakagawa,1 Touru Hiraga,1 Souichirou Yokota,1 Masami Ito,1 Ikuya Yano,2 Hiroaki Kohno,3 Masako Wada,4 Chiyoji Abe,4 Takeo Toyoda,5 Toshio Kishimoto,6 and Takeshi Ogura1

Toneyama National Hospital,1 and Department of Bacteriology, Osaka City University Medical School,2 Osaka, Fuji Research Laboratories, Kyowa Medex Co., Ltd., Shizuoka,3 Research Institution of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo,4 Higashi-Saitama National Hospital, Saitama,5 and Department of Health Care Medicine, Kawasaki Medical School, Okayama,6 Japan

Received 30 April 2001/Returned for modification 9 June 2001/Accepted 15 July 2001

Previously we reported the development of a highly sensitive enzyme-linked immunosorbent assay specific for anti-tuberculous glycolipid (anti-TBGL) for the rapid serodiagnosis of tuberculosis. In this study, the usefulness of an anti-TBGL antibody assay kit for rapid serodiagnosis was evaluated in a controlled multicenter study. Antibody titers in sera from 318 patients with active pulmonary tuberculosis (216 positive for Mycobacterium tuberculosis in smear and/or culture tests and 102 smear and culture negative and clinically diagnosed), 58 patients with old tuberculosis, 177 patients with other respiratory diseases, 156 patients with nonrespiratory diseases, and 454 healthy subjects were examined. Sera from 256 younger healthy subjects from among the 454 healthy subjects were examined as a control. When the cutoff point of anti-TBGL antibody titer was determined as 2.0 U/ml, the sensitivity for active tuberculosis patients was 81.1% and the specificity was 95.7%. Sensitivity in patients with smear-negative and culture-negative active pulmonary tuberculosis was 73.5%. Even in patients with noncavitary minimally advanced lesions, the positivity rate (60.0%) and the antibody titer (4.6 ± 9.4 U/ml) were significantly higher than those in the healthy group. These results indicate that this assay using anti-TBGL antibody is useful for the rapid serodiagnosis of active pulmonary tuberculosis.

* Corresponding author. Mailing address: Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka-City, Osaka 560-0045, Japan. Phone: 81-6-6853-2001. Fax: 81-6-6853-3127. E-mail: maekurar{at}med.osaka-cu.ac.jp.

Journal of Clinical Microbiology, October 2001, p. 3603-3608, Vol. 39, No. 10
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.10.3603-3608.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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