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Evaluation of the performance of C. DIFF QUIK CHEK COMPLETE and its usefulness in a hospital setting with a high prevalence of Clostridium difficile infection
  1. Hae-Sun Chung,
  2. Miae Lee
  1. Department of Laboratory Medicine, Ewha Womans University School of Medicine, Seoul, Korea
  1. Correspondence to Professor Miae Lee, Department of Laboratory Medicine, Ewha Womans University School of Medicine, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Korea; miae{at}ewha.ac.kr

Abstract

Rapid and accurate diagnosis of Clostridium difficile infection (CDI) is crucial for patient care, infection control, and efficient surveillance. We evaluated C. DIFF QUIK CHEK COMPLETE (QCC; TechLab), which detects glutamate dehydrogenase (GDH) antigen (QCC-Ag) and toxin A/B (QCC-Tox) simultaneously, and compared it to the laboratory diagnostics for CDI currently in use in a tertiary hospital setting with a high prevalence of CDI. QCC, RIDASCREEN C. difficile toxin A/B assay (Toxin EIA; R-Biopharm AG), chromID C. difficile agar (bioMérieux) culture (ChromID culture), and Xpert C. difficile PCR assay (Xpert PCR; Cepheid) were performed according to the manufacturers' instructions. Performances of the assays were compared against that of Xpert PCR as a reference. Of the 231 loose stool specimens, 83 (35.9%) were positive by Xpert PCR. The sensitivity, specificity, and positive and negative predictive values were 97.6%, 93.9%, 90.0%, and 98.6%, respectively, for QCC-Ag and 55.4%, 100%, 100%, and 80.0%, respectively, for QCC-Tox. The median threshold cycle values of the QCC-Tox(+) specimens were lower than those of the QCC-Tox(−) specimens. Results of QCC as an initial screening test were confirmed in 81.0% (187/231) of samples; these specimens did not require further testing. QCC is a rapid, easy, and cost-effective method that would be a useful first-line screening assay for laboratory diagnosis of CDI in a tertiary hospital with a high prevalence of CDI. A two-step algorithm using QCC as an initial screening tool, followed by Xpert PCR as a confirmatory test, is a practical and cost-effective approach.

  • Clostridium difficile
  • Clostridium Infections

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Footnotes

  • This work was presented as the ePoster at ECCMID 2016 (26th European Congress of Clinical Microbiology and Infectious Diseases), Netherlands, Amsterdam, 9–12 April 2016 (poster board number EV0504).

  • Disclaimer Alere Healthcare Inc. was not involved either in the data collection or in the preparation of the manuscript.

  • Competing interests None declared.

  • Ethics approval Ewha Womans University Mokdong Hospital IRB.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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