노로바이러스 감염 진단을 위한 신속항원검사법의 평가: 효소면역검사법(ELISA) 및 실시간정량 역전사중합효소연쇄반응 검사법과의 비교
Evaluation of Rapid Antigen Test for the Detection of Norovirus Infection: Comparison with ELISA and Real Time Quantitative Reverse Transcription PCR Assays
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Background: Norovirus is a leading cause of epidemic and sporadic acute gastroenteritis worldwide. Because of the rapid transmission of the virus, early detection is important to prevent outbreak of norovirus infection. To evaluate the performance of a newly introduced rapid antigen test for detecting human norovirus in stool specimens, we compared it with the established ELISA test and real time quantitative reverse transcription PCR (qRT-PCR). Methods: One hundred and eighty-four stool samples were analyzed by rapid antigen test (Denka-Seiken, Japan), ELISA (R-Biopharm, Germany),and qRT-PCR (R-Biopharm, Germany). Overall percent agreement, percent positive agreement (PPA), and percent negative agreement (NPA) of the rapid antigen test in comparison with ELISA and qRT-PCR were obtained. Results: Positive rates of rapid antigen test, ELISA, and qRT-PCR were 44.0% (81/184), 51.6% (95/184), and 42.9% (79/184), respectively. Seventy samples (38.0%) showed all positive, and 86 samples (46.7%) showed all negative results by three methods. Overall percent agreement of three methods was 84.8% (156/184). Overall percent agreement, PPA, and NPA of the rapid antigen test in comparison with qRT-PCR were 89.1%,88.6%, and 89.5%, respectively, and those of the rapid antigen test in comparison with ELISA were 90.2%, 83.2%, and 97.8%, respectively. Total procedure of the rapid antigen test was finished within 20 min. Conclusions: Rapid antigen test was easier and quicker to perform, and showed high agreement rates with ELISA and qRT-PCR. This test may be useful for rapid screening of norovirus infection.
Abstract
Background: Norovirus is a leading cause of epidemic and sporadic acute gastroenteritis worldwide. Because of the rapid transmission of the virus, early detection is important to prevent outbreak of norovirus infection. To evaluate the performance of a newly introduced rapid antigen test for detecting human norovirus in stool specimens, we compared it with the established ELISA test and real time quantitative reverse transcription PCR (qRT-PCR). Methods: One hundred and eighty-four stool samples were analyzed by rapid antigen test (Denka-Seiken, Japan), ELISA (R-Biopharm, Germany),and qRT-PCR (R-Biopharm, Germany). Overall percent agreement, percent positive agreement (PPA), and percent negative agreement (NPA) of the rapid antigen test in comparison with ELISA and qRT-PCR were obtained. Results: Positive rates of rapid antigen test, ELISA, and qRT-PCR were 44.0% (81/184), 51.6% (95/184), and 42.9% (79/184), respectively. Seventy samples (38.0%) showed all positive, and 86 samples (46.7%) showed all negative results by three methods. Overall percent agreement of three methods was 84.8% (156/184). Overall percent agreement, PPA, and NPA of the rapid antigen test in comparison with qRT-PCR were 89.1%,88.6%, and 89.5%, respectively, and those of the rapid antigen test in comparison with ELISA were 90.2%, 83.2%, and 97.8%, respectively. Total procedure of the rapid antigen test was finished within 20 min. Conclusions: Rapid antigen test was easier and quicker to perform, and showed high agreement rates with ELISA and qRT-PCR. This test may be useful for rapid screening of norovirus infection.
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