Intest Res  
Rapid and accurate diagnosis of Clostridium difficile infection by real-time polymerase chain reaction
Pil Hun Song1*, Jung Hwa Min1*, You Sun Kim1, Soo Yeon Jo1, Eun Jin Kim1, Kyung Jin Lee1, Jeonghun Lee1, Hyun Sung1, Jeong Seop Moon1, Dong Hee Whang2
Departments of 1Internal Medicine and 2Laboratory Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
*These authors contributed equally to this study.
Correspondence to: You Sun Kim, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, 9 Mareunnae-ro, Jung-gu, Seoul 04551, Korea. Tel: +82-2-2270-0012, Fax: +82-2-2270-0257, E-mail: yousun69@korea.com
Received: January 24, 2017; Revised: March 28, 2017; Accepted: April 1, 2017; Published online: August 2, 2017.
© Korean Association for the Study of Intestinal Diseases. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background/Aims: The incidence and severity of Clostridium difficile infection (CDI) have increased worldwide, resulting in a need for rapid and accurate diagnostic methods. Methods: A retrospective study was conducted to compare CDI diagnosis methods between January 2014 and December 2014. The stool samples, which were obtained in presumptive CDI patients, were compared for their diagnostic accuracy and rapidity, including real-time polymerase chain reaction (PCR) of toxin genes, C. difficile toxin assay, and culture for C. difficile. Results: A total of 207 cases from 116 patients were enrolled in this study and 117 cases (56.5%) were diagnosed as having CDI. Among the 117 cases, the sensitivities of real-time PCR, C. difficile toxin assay, and culture for C. difficile were 87.2% (102 cases; 95% CI, 80.7%−92.8%), 48.7% (57 cases; 95% CI, 41.0%−59.8%), and 65.0% (76 cases; 95% CI, 60.2%−78.5%), respectively (P<0.005). Notably, 34 cases (29.0%) were diagnosed with CDI by real-time PCR only. The time required to obtain results was 2.27 hours (136.62±82.51 minutes) for real-time PCR, 83.67 hours (5,020.66±3,816.38 minutes) for toxin assay, and 105.79 hours (6,347.68±3,331.46 minutes) for culture (P<0.005), respectively. Conclusions: We confirmed that real-time PCR of toxin genes is the most effective diagnostic method for accurate and early diagnosis of CDI. It also helps to diagnose hypervirulent CDI, such as ribotype 027 infection.
Keywords: Clostridium difficile infection; Polymerase chain reaction; Diagnostic method


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