로타바이러스 검출을 위한 두 가지 면역크로마토그래피법 신속검사의 평가 = Performance Evaluation of Two Immunochromatographic Assays for Rotavirus Detection in Stool Specimens

국문 초록 (Abstract)

배경

로타바이러스는 전 세계적으로 5세 이하의 소아에서 장염을 일으키는 주요 병원균이다. 최근에는 로타바이러스 검출을 위한 검사방법으로 면역크로마토그래피법(ICA)이 널리 사용되고 있다. 이 연구의 목적은 두 제조사의 로타바이러스 신속 검사 키트의 성능을 비교 평가하고자 하였다.


방법

2017년 11월부터 2018년 1월까지 수집된 총 130개의 소아 급성 장염환자의 잔여 분변 검체를 사용했다. 기존에 시행되어 온 효소면역측정법과 면역크로마토그래피법에 기반한 두 개의 로타바이러스 신속 검사 키트(SD BIOLINE Rotavirus kit와 GENEDIA Rotavirus Ag Rapid Test) 간의 검사 결과를 비교하였다.


결과

SD BIOLINE Rotavirus kit와 효소면역측정법의 양성일치율, 음성일치율, 총 일치율은 각각 98.0%, 100%, 99.2%로 나타났다. GENEDIA Rotavirus Ag Rapid Test와 효소면역측정법의 양성일치율, 음성일치율, 총 일치율은 각각 96.0%, 100%, 98.4%로 나타났다.


결론

두 제조사의 로타바이러스 신속 검사 키트 모두 기존의 효소면역측정법과 매우 좋은 일치율을 보였다. 따라서 짧은 검사 시간 내에 간편하게 분변 검체에서 직접 로타 바이러스 검출이 가능한 유용한 검사로 생각된다.

다국어 초록 (Multilingual Abstract)

Background

Rotavirus is a major pathogen causing enteritis worldwide in children under five years of age. In recent years, immunochromatographic assay (ICA) has been widely used as a diagnostic test for rotavirus detection. This study aimed to compare and evaluate the performance of ICA-based rotavirus rapid test kits from two manufacturers.


Methods

Residual stool samples from a total of 130 children with acute enterocolitis from November 2017 to January 2018 were used. We compared the results of the two immunochromatographic methods (SD BIOLINE Rotavirus kit and GENEDIA Rotavirus Ag Rapid Test) with those of the currently used enzyme immunoassay method.


Results

Positive agreement, negative agreement, and total agreement rates between the SD BIOLINE rotavirus kit and the enzyme immunoassay were 98.0%, 100%, and 99.2%, respectively. Positive agreement, negative agreement, and total agreement rates between the GENEDIA Rotavirus Ag Rapid Test and the enzyme immunoassay were 96.0%, 100%, and 98.4%, respectively.


Conclusions

Both rotavirus rapid test kits showed very good agreement with the conventional enzyme immunoassay. Therefore, it could be a useful test to detect rotavirus directly from stool samples in a short time.

참고문헌 (Reference)

1 이숙영, "로타바이러스 항원 검출을 위한 라텍스응집법, 면역크로마토그래피법 및 효소면역법의 비교" 대한진단검사의학회 27 (27): 437-441, 2007

2 Pereira LA, "Rotavirus infection in a tertiary hospital : laboratory diagnosis and impact of immunization on pediatric hospitalization" 15 : 215-219, 2011

3 Estes MK, "Rotavirus gene structure and function" 53 : 410-449, 1989

4 Parashar UD, "Rotavirus" 4 : 561-570, 1998

5 Wolffs PF, "Replacing traditional diagnostics of fecal viral pathogens by a comprehensive panel of real-time PCRs" 49 : 1926-1931, 2011

6 Altman DG, "Practical statistics for medical research" CRC press 461-471, 1990

7 De Grazia S, "Performance analysis of two immunochromatographic assays for the diagnosis of rotavirus infection" 243 : 50-54, 2017

8 World Health Organization, "Manual of rotavirus detection and characterization methods"

9 Chieochansin T, "Evaluation of the rapid test for human rotavirus A in Thai children with acute gastroenteritis" 60 : 511-514, 2014

10 Kim HS, "Evaluation of an immunochromatographic assay for the detection of rotavirus" 35 : 107-114, 2013

11 김자영, "Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples" 대한진단검사의학회 34 (34): 216-222, 2014

12 Kim HS, "Discrepancies between antigen and polymerase chain reaction tests for the detection of rotavirus and norovirus" 46 : 282-285, 2016

13 Kaplon J, "Diagnostic accuracy of seven commercial assays for rapid detection of group A rotavirus antigens" 53 : 3670-3673, 2015

14 Corcoran MS, "Diagnosis of viral gastroenteritis in children : interpretation of real-time PCR results and relation to clinical symptoms" 33 : 1663-1673, 2014

15 Khamrin P, "Comparison of the rapid methods for screening of group A rotavirus in stool samples" 57 : 375-377, 2011

16 Gautam R, "Comparison of Premier™ Rotaclone®, ProSpecT™, and RIDASCREEN® rotavirus enzyme immunoassay kits for detection of rotavirus antigen in stool specimens" 58 : 292-294, 2013

17 Tate JE, "2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes : a systematic review and meta-analysis" 12 : 136-141, 2012