PLoS ONE (Jan 2020)

Clinical evaluation of a non-purified direct molecular assay for the detection of Clostridioides difficile toxin genes in stool specimens.

  • Toshinori Hara,
  • Hiromichi Suzuki,
  • Tadatomo Oyanagi,
  • Norito Koyanagi,
  • Akihito Ushiki,
  • Naoki Kawabata,
  • Miki Goto,
  • Yukio Hida,
  • Yuji Yaguchi,
  • Kiyoko Tamai,
  • Shigeyuki Notake,
  • Yosuke Kawashima,
  • Akio Sugiyama,
  • Keiichi Uemura,
  • Seiya Kashiyama,
  • Toru Nanmoku,
  • Satoshi Suzuki,
  • Hiroshi Yamazaki,
  • Hideki Kimura,
  • Hiroyuki Kunishima,
  • Hiroki Ohge

DOI
https://doi.org/10.1371/journal.pone.0234119
Journal volume & issue
Vol. 15, no. 6
p. e0234119

Abstract

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Recently, a new rapid assay for the detection of tcdB gene of Clostridioides difficile was developed using the GENECUBE. The assay can directly detect the tcdB gene from stool samples without a purification in approximately 35 minutes with a few minutes of preparation process. We performed a prospective comparative study of the performance of the assay at eight institutions in Japan. Fresh residual stool samples (Bristol stool scale ≥5) were used and comparisons were performed with the BD MAX Cdiff assay and toxigenic cultures. For the evaluation of 383 stool samples compared with the BD MAX Cdiff assay, the sensitivity, and specificity of the two assays was 99.0% (379/383), 98.1% (52/53), 99.1% (327/330), respectively. In the comparison with toxigenic culture, the total, sensitivity, and specificity were 96.6% (370/383), 85.0% (51/60), and 98.8% (319/323), respectively. The current investigation indicated the GENECUBE Clostridioides difficile assay has equivalent performance with the BD MAX Cdiff assay for the detection of tcdB gene of C. difficile.