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

Hae-Sun Chung; M.D.; Ph.D.; Jeong Su Park; M.D.; Ph.D.; and Bo-Moon Shin; M.D.; Ph.D.

doi:10.3343/alm.2019.39.3.317

Article

Brief Communication

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

Published online May 1, 2019 https://doi.org/10.3343/alm.2019.39.3.317

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. https://orcid.org/0000-0001-8432-9556
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
E-mail: ortensia5577@gmail.com

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 (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

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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

Tables

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CONFLICTS OF INTEREST
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Table 1

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

Assay type	Name	Manufacturer	Target	Method	Laboratories (N)
Toxin AB EIA	VIDAS CD AB	bioMérieux, Marcy-l'Étoile, France	Toxin A and B	Automated EIA		36
	RIDASCREEN Clostridium difficile Toxin A/B	BioPharm, Darmstadt, Germany	Toxin A and B	Well-type EIA		9
	Clostridium difficile Tox A/B II	TechLab, Blacksburg, VA, USA	Toxin A and B	Well-type EIA		6
					Total	51
NAAT	Xpert C. difficile	Cepheid, Sunnyvale, CA, USA	tcdB, cdt, tcdC	Real-time PCR		21
	AdvanSure CD	LG Life Sciences, Seoul, Korea	tcdA, tcdB	Real-time PCR	Total	11
	BD Max Cdiff	Becton Dickinson, Sparks, MD, USA	tcdB	Real-time PCR		2
	Illumigene C. difficile	Meridian Bioscience, Cincinnati, OH, USA	tcdA	LAMP		1
	Seeplex Diarrhea ACE Detection	Seegene, Seoul, Korea	tcdB	Multiplex PCR		1
	Home-made					2
						36^*
Culture	ChromeID C. difficile	bioMérieux, Marcy-l'Étoile, France	C. difficile			24
	CDSA	Becton Dickinson, Sparks, MD, USA	C. difficile			9
	Blood agar		C. difficile			1
	Home-made		C. difficile			5
					Total	37^†
GDH	VIDAS GDH	bioMérieux, Marcy-l'Étoile, France	GDH	Automated EIA		1
GDH					Total	1

Table 2

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

Assay type				Hospital beds (N)					Total (%)
Toxin AB EIA	NAAT	Culture	GDH	< 300	300–500	> 500–1,000	> 1,000	CL^*	Total (%)
+	+	+		1		14	6	2	23 (40.4)
+	+				1	7	1		9 (15.8)
+		+				5	2	2	9 (15.8)
+				1		6	1	1	9 (15.8)
	+	+		1		2	1		4 (7.0)
+			+			1			1 (1.8)
	+					1			1 (1.8)
		+				1			1 (1.8)
Total				3	1	37	11	5	57 (100)

Table 3

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 EIA		NAAT		Culture
Size of hospital (N of beds)	Hospitals (N)	Specimens, median (range)	Hospitals (N)	Specimens, median (range)	Hospitals (N)	Specimens, median (range)
< 300	2	140 (80–200)	2	25 (10–40)	2	42 (10–74)
300–500	1	90	1	7	0
< 500–1,000	33	155 (50–489)	23	70 (10–373)	22	100 (9–200)
> 1,000	10	200 (80–750)	7	80 (35–300)	9	300 (80–750)
Subtotal	46	160 (50–750)	33	70 (7–370)	33	120 (9–750)
CL	5	568 (65–2,060)	2	365 (10–720)	4	140 (95–340)
Total	51	160 (50–2,060)	35^*	70 (7–720)	37	130 (9–750)

References

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