새로운 인플루엔자 신속항원검사 BD Veritor System의 평가
Evaluation of the Performance of a New Chromatographic Assay BD Veritor System for Rapid Detection of Influenza A & B
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배경: 신속항원검사는 인플루엔자의 빠른 진단과 치료를 위해 흔히 사용되고 있다. 저자들은 새로이 소개된 BD VeritorSystem for Rapid Detection of Flu A＋B (BD Veritor System; BD Diagnostics, USA)의 성능을 다중 실시간 역전사 PCR검사법과 비교하여 평가하고자 하였다. 방법: 2013년 12월부터 2014년 4월까지 독감유사증상을 주소로 내원한 3,213명 환자에서 비인두 면봉이나 비강 면봉으로채취한 검체를 대상으로 BD Veritor System 검사를 시행하였다. 이중에서 AdvanSure RV real-time PCR (AdvanSure PCR;LG Life Sciences, Korea)을 이용하여 다중 실시간 역전사 PCR 검사를 동시에 시행한 127 검체를 대상으로 민감도와 특이도를 구하였다. 결과: BD Veritor System 검사 결과 41.3% (1,327/3,213)에서 인플루엔자 바이러스가 검출되었다. 127 검체 중 AdvanSurePCR 검사 결과 인플루엔자 A가 27 검체, 인플루엔자 B가 17 검체에서 확인되었다. AdvanSure PCR 검사와 비교하였을때 BD Veritor System의 민감도와 특이도는, 인플루엔자 A는 85.2%, 99.0%였고, 인플루엔자 B는 58.8%, 99.1%였다. BDVeritor System에서 음성이었던 190 검체 중 AdvanSure PCR 검사로 인플루엔자 A와 인플루엔자 B가 각각 19 검체와 13검체에서 검출되었다. 신속항원검사에서 양성 검체의 평균 Ct값은 음성 검체보다 낮았다. 결론: BD Veritor System은 우수한 특이도와 인플루엔자 A에 대해 좋은 민감도를 보였다. 인플루엔자 B에 대한 민감도는다중 실시간 역전사 PCR에 비해 낮았다. 위음성의 정확한 진단을 위해서는 분자유전학적 방법이 필요할 것으로 생각된다. BD Veritor System은 인플루엔자 선별 및 신속한 진단에 있어 유용한 검사가 될 것이다. [Ann Clin Microbiol2015;18:27-32]
Abstract
Background: For early diagnosis and treatment of influenza,rapid influenza diagnostic tests are commonlyused. We evaluated the performance of theBD Veritor System for Rapid Detection of Flu A＋B(BD Veritor System; BD Diagnostics, USA) comparedto multiplex real-time RT-PCR. Methods: A total of 3,213 nasal and nasopharyngealswab specimens in transport media from patients withinfluenza-like symptoms were tested with the BDVeritor System from December 2013 to April 2014. The sensitivity and specificity of 127 specimens weredetermined simultaneously using multiplex real-timeRT- PCR with the AdvanSure RV real-time PCR(AdvanSure PCR; LG Life Sciences, Korea). Results: Influenza viruses were detected in 41.3%(1,327/3,213) of all specimens tested using the BDVeritor System. Of the 127 specimens, 27 influenza Aand 17 influenza B viruses were identified by theAvanSure PCR. The sensitivity and specificity of theBD Veritor System relative to the AdvanSure PCRwas 85.2% and 99.0% for influenza A, and 58.8%and 99.1% for influenza B. Of the 190 specimensthat tested negative using the BD Veritor System, theAdvanSure PCR detected influenza A and influenzaB in 19 and 13 specimens, respectively. The meanthreshold cycle (Ct) values of the antigen positivespecimens were lower than those of the antigen negativespecimens. Conclusion: The BD Veritor System showed excellentspecificity for both influenza types and good sensitivityfor influenza A. However, the system was lesssensitive for influenza B compared to multiplex real-time RT-PCR. For accurate diagnosis of false negativespecimens, a molecular diagnostic test shouldbe performed. The BD Veritor system could be a usefultool for screening and early diagnosis of influenza. (Ann Clin Microbiol 2015;18:27-32)
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