Performance of laboratory tests for detection for Clostridioides difficile: A multicenter prospective study in Japan

Autor: Takuya Watanabe, Hisashi Kume, Hideaki Kato, Kimberly A. Reske, Sayuri Morita, Hitoshi Honda, Cedric Mahé, Kei Moriya, Daisuke Suzuki, Kei Kasahara, Katsuyuki Kojima, Seigo Kitada, Tatsuya Bando, Erik R. Dubberke, Hideo Morikawa, Yasuaki Tagashira, Naoto Hosokawa, Haruko Saito, Kayoko Tadera, Masahisa Honda, Haru Kato, Harumi Tominaga, Makoto Nakamura, Kuniko Yokote, Akiko Higuchi, Tatsuyuki Watanabe, Kayoko Toimoto, Saeko Kashiwagura, Yasuhiro Norisue, Tadashi Fukuda, Ichiro Yoshikawa, Hideaki Ishikawa, Mika Nakama, Yousuke Shimizu, Tetsuya Kikuchi, Saori Ishiguro, Junko Ogawa, Hiroshi Chiba, Hiroko Miyazato, Hiroko Horiuchi, Jun-ichi Yoshida, Hidetaka Kitazono, Nobuaki Mori, Takao Toyokawa, Fumi Masumoto, Izumi Yokomaku, Mitsutoshi Senoh, Margaret A. Olsen
Rok vydání: 2019
Předmět:
Zdroj: Anaerobe. 60:102107
ISSN: 1075-9964
DOI: 10.1016/j.anaerobe.2019.102107
Popis: Background The optimal and practical laboratory diagnostic approach for detection of Clostridioides difficile to aid in the diagnosis of C. difficile infection (CDI) is controversial. A two-step algorithm with initial detection of glutamate dehydrogenase (GDH) or nucleic acid amplification test (NAAT) alone are recommended as a predominant method for C. difficile detection in developed countries. The aim of this study was to compare the performance of enzyme immunoassays (EIA) detecting toxins A and B, NAAT detecting the toxin B gene, and GDH compared to toxigenic culture (TC) for C. difficile as the gold standard, in patients prospectively and actively assessed with clinically significant diarrhea in 12 medical facilities in Japan. Methods A total of 650 stool specimens were collected from 566 patients with at least three diarrheal bowel movements (Bristol stool grade 6–7) in the preceding 24 h. EIA and GDH were performed at each hospital, and NAAT and toxigenic C. difficile culture with enriched media were performed at the National Institute of Infectious Diseases. All C. difficile isolates recovered were analyzed by PCR-ribotyping. Results Compared to TC, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of EIA were 41%, 96%, 75% and 84%, respectively, and for NAAT were 74%, 98%, 91%, and 92%, respectively. In 439 specimens tested with GDH, the sensitivity, specificity, PPV, and NPV were 73%, 87%, 65%, and 91%, and for an algorithm (GDH plus toxin EIA, arbitrated by NAAT) were 71%, 96%, 85%, and 91%, respectively. Among 157 isolates recovered, 75% of isolates corresponded to one of PCR-ribotypes (RTs) 002, 014, 018/018”, and 369; RT027 was not isolated. No clear differences in the sensitivities of any of EIA, NAAT and GDH for four predominant RTs were found. Conclusion The analytical sensitivities of NAAT and GDH-algorithm to detect toxigenic C. difficile in this study were lower than most previous reports. This study also found low PPV of EIAs. The optimal method to detect C. difficile or its toxins to assist in the diagnosis of CDI needs further investigation.
Databáze: OpenAIRE
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