CVI Accepts, published online ahead of print on 4 March 2009

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Clin. Vaccine Immunol. doi:10.1128/CVI.00308-08
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Evaluation of a rapid immunochromatographic ODK0501 assay for detecting Streptococcus pneumoniae antigen in sputum from patients with lower respiratory tract infection

Koichi Izumikawa^*, Suguru Akamatsu, Akiko Kageyama, Kiyomi Okada, Yukumasa Kazuyama, Noboru Takayanagi, Shigeki Nakamura, Yuichi Inoue, Yasuhito Higashiyama, Kiyoyasu Fukushima, Tadashi Ishida, Toyomitsu Sawai, Kunihiko Yoshimura, Chikara Nakahama, Mitsuhide Ohmichi, Tomoyuki Kakugawa, Yasuhiko Nishioka, Nobuki Aoki, Masafumi Seki, Hiroshi Kakeya, Yoshihiro Yamamoto, Katsunori Yanagihara, and Shigeru Kohno

Second Department of Internal Medicine, Nagasaki University School of Medicine; Otsuka Pharmaceutical Co., Ltd.; Kitasato-Otsuka Biomedical Assay Laboratories Co., Ltd.; Department of Respiratory Medicine, Saitama Cardiovascular and Respiratory Center; Department of Respiratory Medicine, National Hospital Organization Ureshino Medical Center; Department of Internal Medicine, Isahaya Health Insurance General Hospital; Department of Respiratory Medicine, Hokusho Central Hospital; Department of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital; Department of Respiratory Medicine, Kurashiki Central Hospital; Department of Internal Medicine, Sasebo City General Hospital; Department of Respiratory Medicine, Respiratory Center, Toranomon Hospital; Nakahama Clinic, Ohmichi Internal Medicine and Respiratory Clinic; Department of Internal Medicine, Kitakyushu Municipal Yahata Hospital; Department of Internal Medicine and Molecular Therapeutics, Institute of Health Biosciences, University of Tokushima Graduate School; Department of Internal Medicine, Shinrakuen Hospital; Department of Laboratory Medicine, Nagasaki University School of Medicine, Japan

^* To whom correspondence should be addressed. Email: koizumik{at}nagasaki-u.ac.jp.

A novel, rapid and noninvasive test (ODK0501) to detect Streptococcus pneumoniae antigen was evaluated in a Japanese multicenter study. ODK0501 uses polyclonal antibodies to detect C-polysaccharide of S. pneumoniae from sputum by an immunochromatographic assay. The utility of ODK0501 was evaluated in 161 adult patients with lower respiratory tract infection between March 2006 and March 2007. Bacterial culture and identification, real-time PCR, and ODK0501 assays were performed on sputum samples, and Binax NOW Streptococcus pneumoniae antigen test was performed in urine samples obtained from the same patients. The performance of all tests was compared based on the results of bacterial culture and identification. The sensitivity and specificity of ODK0501 were 89.1% (49/55) and 95.3% (101/106), respectively. We then compared the Binax NOW Streptococcus pneumoniae antigen test with ODK0501 in samples from 142 patients. The sensitivity of ODK0501 and the Binax NOW S. pneumoniae antigen test was 90.0% (45/50) and 62.0% (31/50), respectively (P = 0.002). The relative quantity of S. pneumoniae in expectorated sputum was calculated using real-time PCR and indicated that the possibility of false-positive results of ODK0501 due to indigenous S. pneumoniae was low. The positive and negative concordance rates of ODK0501 and Binax NOW were 96.8% (30/31) and 21.1% (4/19), respectively. Binax NOW was less capable of detecting S. pneumoniae antigen among patients with underlying COPD. In conclusion, ODK0501 is non-invasive, rapid and accurate tool for diagnosing respiratory infection caused by S. pneumoniae.