TY - JOUR
T1 - Performance of laboratory tests for detection for Clostridioides difficile
T2 - A multicenter prospective study in Japan
AU - Senoh, Mitsutoshi
AU - Kato, Haru
AU - Honda, Hitoshi
AU - Fukuda, Tadashi
AU - Tagashira, Yasuaki
AU - Horiuchi, Hiroko
AU - Chiba, Hiroshi
AU - Suzuki, Daisuke
AU - Hosokawa, Naoto
AU - Kitazono, Hidetaka
AU - Norisue, Yasuhiro
AU - Kume, Hisashi
AU - Mori, Nobuaki
AU - Morikawa, Hideo
AU - Kashiwagura, Saeko
AU - Higuchi, Akiko
AU - Kato, Hideaki
AU - Nakamura, Makoto
AU - Ishiguro, Saori
AU - Morita, Sayuri
AU - Ishikawa, Hideaki
AU - Watanabe, Takuya
AU - Kojima, Katsuyuki
AU - Yokomaku, Izumi
AU - Bando, Tatsuya
AU - Toimoto, Kayoko
AU - Moriya, Kei
AU - Kasahara, Kei
AU - Kitada, Seigo
AU - Ogawa, Junko
AU - Saito, Haruko
AU - Tominaga, Harumi
AU - Shimizu, Yousuke
AU - Masumoto, Fumi
AU - Tadera, Kayoko
AU - Yoshida, Junichi
AU - Kikuchi, Tetsuya
AU - Yoshikawa, Ichiro
AU - Watanabe, Tatsuyuki
AU - Honda, Masahisa
AU - Yokote, Kuniko
AU - Toyokawa, Takao
AU - Miyazato, Hiroko
AU - Nakama, Mika
AU - Mahe, Cedric
AU - Reske, Kimberly
AU - Olsen, Margaret A.
AU - Dubberke, Erik R.
N1 - Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/12
Y1 - 2019/12
N2 - 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.
AB - 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.
KW - Clostridioides difficile
KW - Enzyme immunoassay (EIA)
KW - Glutamate dehydrogenase (GDH)
KW - Japan
KW - Laboratory test
KW - Nucleic acid amplification test (NAAT)
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U2 - 10.1016/j.anaerobe.2019.102107
DO - 10.1016/j.anaerobe.2019.102107
M3 - Article
C2 - 31647977
AN - SCOPUS:85075367153
SN - 1075-9964
VL - 60
JO - Anaerobe
JF - Anaerobe
M1 - 102107
ER -
