Brief Communication

Ann Lab Med 2019; 39(3): 317-321

Published online May 1, 2019

Copyright © Korean Society for Laboratory Medicine.

Laboratory Diagnosis of Clostridium difficile Infection in Korea: The First National Survey

Hae-Sun Chung, M.D., Ph.D.1, Jeong Su Park, M.D., Ph.D.2, and Bo-Moon Shin , M.D., Ph.D.3

1Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea; 2Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea; 3Department of Laboratory Medicine, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, Korea

Correspondence to: Bo-Moon Shin, M.D.
Department of Laboratory Medicine, Sanggye Paik Hospital, School of Medicine, Inje University, 1342 Dongil-ro, Nowon-gu, Seoul 01757, Korea
Tel: +82-2-950-1227
Fax: +82-2-950-1244

Received: August 2, 2018; Revised: October 11, 2018; Accepted: December 11, 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

In May 2015, we conducted a voluntary online survey on laboratory diagnostic assays for Clostridium difficile infection (CDI) across clinical microbiology laboratories in Korea. Responses were obtained from 66 laboratories, including 61 hospitals and five commercial laboratories. Among them, nine laboratories reported having not conducted CDI assays. The toxin AB enzyme immunoassay (toxin AB EIA), nucleic acid amplification test (NAAT), and C. difficile culture, alone or in combination with other assays, were used in 51 (89.5%), 37 (64.9%), and 37 (64.9%) of the remaining 57 laboratories, respectively, and 23 (40.4%) of the laboratories performed all three assays. Only one laboratory used the glutamate dehydrogenase assay. Nine laboratories used the toxin AB EIA as a stand-alone assay. The median (range) of examined specimens in one month for the toxin AB EIA, NAAT, and C. difficile culture was 160 (50–2,060), 70 (7–720), and 130 (9–750), respectively. These findings serve as valuable basic data regarding the current status of laboratory diagnosis of CDI in Korea, offering guidance for improved implementation.

Keywords: Clostridium difficile infection, Laboratory diagnosis, Toxin AB enzyme immunoassay, Nucleic acid amplification test, Culture, Survey, Korea

Clostridium difficile assay methods and the numbers of laboratories that participated in the survey

Assay typeNameManufacturerTargetMethodLaboratories (N)
Toxin AB EIAVIDAS CD ABbioMérieux, Marcy-l'Étoile, FranceToxin A and BAutomated EIA36
RIDASCREEN Clostridium difficile Toxin A/BBioPharm, Darmstadt, GermanyToxin A and BWell-type EIA9
Clostridium difficile Tox A/B IITechLab, Blacksburg, VA, USAToxin A and BWell-type EIA6
NAATXpert C. difficileCepheid, Sunnyvale, CA, USAtcdB, cdt, tcdCReal-time PCR21
AdvanSure CDLG Life Sciences, Seoul, KoreatcdA, tcdBReal-time PCRTotal11
BD Max CdiffBecton Dickinson, Sparks, MD, USAtcdBReal-time PCR2
Illumigene C. difficileMeridian Bioscience, Cincinnati, OH, USAtcdALAMP1
Seeplex Diarrhea ACE DetectionSeegene, Seoul, KoreatcdBMultiplex PCR1
CultureChromeID C. difficilebioMérieux, Marcy-l'Étoile, FranceC. difficile24
CDSABecton Dickinson, Sparks, MD, USAC. difficile9
Blood agarC. difficile1
Home-madeC. difficile5
GDHVIDAS GDHbioMérieux, Marcy-l'Étoile, FranceGDHAutomated EIA1

Combinations of assays types for diagnosis of Clostridium difficile infection according to hospital size

Assay typeHospital beds (N)Total (%)
Toxin AB EIANAATCultureGDH< 300300–500> 500–1,000> 1,000CL*
+++1146223 (40.4)
++1719 (15.8)
++5229 (15.8)
+16119 (15.8)
++1214 (7.0)
++11 (1.8)
+11 (1.8)
+11 (1.8)
Total313711557 (100)

Numbers of specimens examined for CDI diagnosis according to assay types and hospital size per month in 2015

Size of hospital (N of beds)Toxin AB EIANAATCulture
Hospitals (N)Specimens, median (range)Hospitals (N)Specimens, median (range)Hospitals (N)Specimens, median (range)
< 3002140 (80–200)225 (10–40)242 (10–74)
< 500–1,00033155 (50–489)2370 (10–373)22100 (9–200)
> 1,00010200 (80–750)780 (35–300)9300 (80–750)
Subtotal46160 (50–750)3370 (7–370)33120 (9–750)
CL5568 (65–2,060)2365 (10–720)4140 (95–340)
Total51160 (50–2,060)35*70 (7–720)37130 (9–750)

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