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Evaluation of a Newly Developed Campylobacter Antigen Detection Kit for Patients with Enteritis
1)Department of Infectious Diseases, Yokohama Municipal Citizen's Hospital, 2)Department of Infectious Diseases, Kyoto City Hospital, 3)Department of Infectious Diseases, Osaka City General Hospital, 4)Department of Infectious Diseases, Tokyo Metropolitan Health and Medical Treatment Corporation Ebara Hospital, 5)Department of Infectious Diseases, Tokyo Metropolitan Health and Medical Treatment Corporation Toshima Hospital, 6)Department of Infectious Diseases, Tokyo Metropolitan Bokutoh General Hospital, 7)Department of Infectious Diseases, Kawasaki Municipal Hospital, 8)Nakafukawa Pediatrics, 9)Clinical Laboratory, Municipal Tsuruga Hospital, 10)Clinical Laboratory, Public Central Hospital of Matto Ishikawa, 11)School of Public Health in the Graduate School of Medicine, Kyoto University
Natsuo TACHIKAWA1), Yukihiro YOSHIMURA1), Tsunehiro SHIMIZU2), Kentaro TOCHITANI2)11), Tetsushi GOTO3), Takahumi TSUNODA4), Takuya ADACHI5), Kenichiro KOBAYASHI6), Mitsuo SAKAMOTO7), Shigeru ONARI8), Naoki KAWABATA9), Yukiko SAKAGAMI10) & Hiroko SAGARA5)
(Received June 7, 2016)
(Accepted January 10, 2017)
Key words: Campylobacter, rapid diagnosis, immunochromatography

The newly developed rapid diagnostic test (RDT, DK14-CA1, Denka Seiken Co., Ltd.) to detect Campylobacter antigen was evaluated using fecal specimens of patients with enteritis. The RDT is an immunochromatographic assay using colored latex and can detect Campylobacter antigen (C. jejuni and C. coli) from patients' stool samples within 15 minutes.

A total of 227 stool samples obtained from patients with enteritis were examined and the results were compared with conventional culture methods. Overall sensitivity, specificity, accuracy and positive predictive value (PPV) were 75.6%, 98.6%, 89.9% and 97.0% respectively. Among 53 severe cases defined with their clinical findings, sensitivity, specificity, accuracy and PPV were 82.1%, 100%, 90.6% and 100% respectively. Mean time to obtain the result with the RDT was 7 minutes whereas the culture method took 2.2 days.

This study revealed the usefulness of the newly developed RDT as a rapid detection tool for Campylobacter antigen. Although the RDT has a little lower sensitivity compared with culture method, the simple and rapid test can contribute to treatment decisions for patients with enteritis and can be used at the patient's bedside and in outpatient clinics.

[ Kansenshogaku Zasshi 91: 145-150, 2017 ]

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