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