신종인플루엔자 검사에 사용되는 신속항원검사와 실시간 역전사 중합효소연쇄반응검사의 비교
Comparison of Rapid Antigen Test and Real-Time Reverse Transcriptase PCR for Diagnosing Novel Swine Influenza A (H1N1)
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배경: 2009년 4월 멕시코에서 새로운 인플루엔자 A (H1N1) 바이러스가 분리되어 신종인플루엔자로 명명되었다. 신종인플루엔자는 전파속도가 빠르고 감염성이 높아 빠른 진단을 위해 신속한 선별검사가 필요하다. 이 연구는 신종인플루엔자 진단을 위해 현재 사용하고 있는 신속항원검사와 실시간 역전사 중합효소연쇄반응(real-time RT-PCR, rRT-PCR) 검사를 비교하여 선별검사로서 신속항원검사의 유용성을 평가해보고자 하였다. 방법: 2009년 8월 14일부터 2009년 9월 30일까지 한림대학교 강동성심병원에 내원한 신종인플루엔자 의심환자 중, 선별검사인 신속항원검사와 확진검사인 rRT-PCR 검사를 모두 실시한 총 1,228명의 환자를 대상으로 하였다. 결과: 신속항원검사의 민감도, 특이도, 양성검사 예측률(predictive value of a positive test), 음성검사 예측률(predictive value of a negative test)은 각각 30.5%, 99.2%, 86.4%, 90.1%였다. 신속항원검사와 rRT-PCR 검사에 모두 양성인 환자는 51명(4.2%)이었고 모두 음성인 환자는 1,053명(85.7%)이었다. 총 124명(10.1%)이 두 검사 간의 결과 불일치를 보였다. rRT-PCR 검사에서 양성을 보였으나 신속항원검사에서 음성을 보인 환자는 116명(9.4%)이었으며, 8명(0.7%)은 신속항원검사에서만 양성반응을 보였다. 신속항원검사에서만 양성반응을 보였던 환자 8명 모두 rRT-PCR 검사에서 H1/M2 음성이었다. rRT-PCR 검사의 H1 Ct 값(threshold cycle) 및 환자의 연령대에 따라 신속항원검사의 양성률에 차이를 보였으며이는 통계적으로 유의하였다(P＜0.05). 결론: 신속항원검사는 검사방법이 간편하고 빠른 시간 내에 검사결과를 알 수 있는 장점이 있지만 rRT-PCR 검사에 비해민감도가 낮으므로, 신종인플루엔자의 선별검사로는 한계가 있을 것으로 생각된다. [대한임상미생물학회지 2010;13:109-113]
Abstract
Background: Novel swine influenza (H1N1) was first identified in Mexico in April 2009. Because of its high infectivity and worldwide distribution, a rapid and efficient screening test is necessary. Here we evaluated the usefulness of a rapid antigen test currently in use, compared to real-time RT-PCR (rRT-PCR) as a screening test for detection of novel swine influenza (H1N1). Methods: A total of 1,228 patients who visited Hallym University Kangdong Sacred Heart Hospital with influenza-like illness between 14 August 2009 and 30September 2009, and were tested by both rapid antigen and rRT-PCR tests, were enrolled in this study. Results: Sensitivity, specificity, predictive value of a positive test, and predictive value of a negative test for the rapid antigen test were 30.5%, 99.2%, 86.4%and 90.1%, respectively. Fifty-one (4.2%) patients were positive for both rapid antigen test and rRTPCR,and 1,053 (85.7%) were negative for both rapid antigen test and rRT-PCR. A total of 124 (10.1%)patients showed a discrepancy between the two tests. Among them, 116 (9.4%) were only positive for rRT-PCR and 8 (0.7%) were only positive for the rapid antigen test. The latter 8 patients all showed negative H1/M2 results in rRT-PCR. There were significant differences in detection rates of the rapid antigen test between different H1 Ct (threshold cycle)interval groups and for different age groups (P ＜0.05). Conclusion: Although the rapid antigen test is easy to perform and provides fast results, its limits as a screening test for detection of novel swine influenza (H1N1) due to its low sensitivity compared to rRTPCR need to be considered in practical situations. (Korean J Clin Microbiol 2010;13:109-113)
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