호흡기세포융합바이러스 검출에 있어 Multiplex RT-PCR법과의 비교를 통한 Binax NOW RSV의 임상적 유용성 평가
Comparison of the Clinical Performance of Binax NOW RSV Versus Multiplex RT-PCR for Detection of Respiratory Syncytial Virus
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배경: 호흡기세포융합바이러스는 하기도감염의 주요 원인균이다. 신속항원검사는 검사방법이 간단하고 검사 소요시간이 짧으며 비용이 저렴한 장점이 있으나 상대적으로 민감도가 낮은 단점이 있다. 이번 연구에서는 다중 역전사중합효소연쇄반응과 비교하여 신속항원검사의 진단적 유용성을 평가하고자 하였다. 방법: RSV 신속항원검사(Binax; Alere Scarborough, Inc., USA)와 다중역전사중합효소연쇄반응(Seegene Inc., Korea)이 동시에 의뢰된 총 557개의 비인두 흡인액 혹은 비인두 면봉 채취 검체를 대상으로 두 검사 모두 제조사의 권고방법대로 검사하였다. 신속항원검사의 진단적 유용성은 다중역전사중합효소연쇄반응 결과를 기준으로 하여 민감도, 특이도, 양성예측도, 음성예측도를 평가하였다. 결과: 총 557개의 검체 중 신속항원검사와 다중역전사중합효소연쇄반응의 양성률은 각각 12.2% (N=68)와 25.1% (N=140)였다. 다중역전사 중합효소연쇄반응을 기준으로 하였을 때 신속항원검사의 민감도는 46.4%, 특이도는 99.3%였으며 양성예측도는 95.6%, 음성예측도는 84.7%였다. 나이군에 따라서는 36개월 이상의 환자군에서 민감도가 28.6%로 가장 낮았고 다른 호흡기 바이러스가 동반된 경우 민감도가 감소하는 양상을 보였다. 결론: Binax NOW RSV 키트는 사용이 간편하고 검사 소요시간이 15분으로 짧아 RSV의 조기 진단에 유용한 검사법이다. 그러나 민감도가 낮아 위음성률이 높기 때문에 임상에서 사용할 때에는 이 점에 유념하여 결과를 해석해야 할 것이다.
Abstract
Background: Respiratory syncytial virus (RSV) is one of the most important causes of lower respiratory tract infection. The rapid antigen test is a simple, cheap, and quick method for RSV detection, however, it has an acknowledged low sensitivity. The aim of this study is to evaluate the diagnostic performance of the rapid antigen test by comparing it with a multiplex reverse transcription-PCR (RT-PCR). Methods: A total of 557 nasopharyngeal aspirates or swabs that were submitted for both a rapid antigen test, Binax NOW RSV (Binax; Alere Scarborough, Inc., USA) and multiplex RT-PCR, Seeplex RV7 (Seegene Inc., Korea) were included in this study. We performed both tests according to the manufacturer’s recommendations and analyzed the diagnostic performances of a rapid antigen tests based on the results of multiplex RT-PCR. Results: Among the 557 specimens, the positive rates determined from the rapid antigen test and multiplex RT-PCR were 12.2% (N=68) and 25.1% (N=140), respectively. The relative sensitivity and specificity of the rapid antigen test were 46.4% and 99.3% based on the multiplex RT-PCR, respectively. Positive and negative predictive values were 95.6% and 84.7%, respectively. The diagnostic sensitivity was lower (28.6%) in children >36 months compared with children ≤36 months of age. Test sensitivity declined when RSV infection was accompanied by infection with other respiratory viruses. Conclusions: Binax NOW RSV exhibited good diagnostic performance, easy handling, and rapidity. However, it does have the possibility of false-negative results, and additional tests are needed when there is clinical suspicion of RSV infection.
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