고위험군 인유두종바이러스 검출에 있어 AMPLICOR HPV Test와 Hybrid Capture 2 Assay의 비교 = Comparison of the AMPLICOR human papillomavirus (HPV) Test and the Hybrid Capture 2 Assay for detection of high-risk HPV

국문 초록 (Abstract)

목적: 본 연구에서는 최근에 소개된 중합효소연쇄반응(polymerase chain reaction, PCR)법으로 target DNA를 증폭하여 고위험군 HPV를 검출하는 AMPLICOR HPV test와 기존에 시행되어 왔던 Hybrid Capture 2 (이하 HC2으로 기술함) assay를 비교하여 임상적 유용성을 평가하고자 하였다. 방법: 질확대경 클리닉에서 자궁경부암 검사를 시행하였던 153명의 환자를 대상으로 하였다. 결과: 고위험군 HPV 검사에서 AMPLICOR HPV test에서 양성이었던 경우는 53/153 (34.6%)이었으며 HC2 assay에서 양성이었던 경우는 52/153 (34.0%)이었다. 두 검사 간에 결과가 일치했던 경우는 128예 (83.7%)로 통계학적으로 의미있는 일치도를 보였다(Cohen`s kappa=0.63, p<0.001). 두 검사 간에 결과가 다른 경우 HPV genotyping을 확인한 결과 AMPLICOR HPV test에서 음성, HC2 assay에서 양성인 군에서 고위험군 HPV는 검출되지 않았으며 AMPLICOR HPV test에서 양성, HC2 assay에서 음성인 13예 중 3예 (23.1%)에서 고위험군 HPV가 발견되었다. 자궁경부질세포진 검사에 따른 HPV 양성률은 고등급병변으로 진행됨에 따라 두 가지 검사 모두에서 고위험군 HPV 양성 비율이 증가되는 경향을 보였다 (p<0.001). 조직학적으로 진단된 110예에서 고위험군 HPV 양성 비율은 CIN 1에서 AMPLICOR HPV test 결과 38.7%, HC2 assay 결과 48.4%에서 양성으로 나타났으며 CIN3/cancer에서는 AMPLICOR HPV test에서 95.0%, HC2 assay에서 100%의 양성률을 보여 고등급병변으로 진행됨에 따라 두 가지 검사 모두에서 고위험군 HPV 양성 비율이 증가되는 경향을 보였다 (p<0.001). 조직학적 검사로 진단된 CIN 2 이상의 고등급병변을 기준으로 민감도와 특이도를 구한 결과 AMPLICOR HPV test에서 민감도는 90.9% (신뢰구간 75.9~97.0%), 특이도는 72.7% (신뢰구간 64.3~79.8%)였고 HC2 assay에서 민감도는 95.5% (신뢰구간 81.9~99.0%), 특이도는 69.3% (신뢰구간 60.7~76.7%)였다. AMPLICOR HPV test와 HC2 assay간에 민감도와 특이도는 의의있는 차이는 없었다. 결론: 고위험군 HPV를 진단하는 데는 AMPLICOR HPV test와 HC2 assay는 의미있게 일치하였으며 고등급병변을 진단하는데 있어서 민감도와 특이도는 두 가지 검사간에 차이가 없었다. AMPLICOR HPV test는 고위험군 HPV 검출에 유용한 검사법으로 사료된다. AMPLICOR HPV test가 선별검사로서의 유용성을 판단하기 위해서는 더 많은 자료에 대한 연구가 필요하리라 사료된다.

다국어 초록 (Multilingual Abstract)

Objective: The purpose of this study was to determine the efficacy of the AMPLICOR HPV test in comparison with the Hybrid Capture 2 (HC2) test in detecting HR HPV. Methods: One hundred and fifty-three consecutive women attending the Colposcopy Clinic were included and cervical scrape specimens were tested for the presence of 13 HR HPV genotypes by both AMPLICOR HPV test and HC2 assay. Results: The prevalence of HR HPV was 53/153 (34.6%) and 52/153 (34.0%) by AMPLICOR HPV test and HC2 assay, respectively. When discordant results were observed between AMPLICOR HPV test and HC2 assay, we used the HPV genotyping DNA chip and DNA sequence analysis, as reference standards. Concordant results were obtained for 128 (83.7%) of the 153 samples (Cohen`s kappa=0.63, p<0.001). The genotyping showed that no HR HPV was detected in the 10 AMPLICOR negative HC2 positive samples, while HR HPV genotype was found in 3/13 (23.1%) AMPLICOR positive HC2 negative samples. The detection rates of HR HPV with AMPLICOR HPV test and HC2 assay were 38.7% and 48.4%, respectively, in CIN1; 95.0% and 100%, respectively, in CIN3/cancer. HPV positivity of AMPLICOR HPV test and HC2 assay increased linearly with the increasing grade of cytology or histology (p<0.001). In detecting high grade (CIN2+) lesions, sensitivities were 90.9% (CI, 75.9~97.0%), 95.5% (CI, 81.9~99.0%), respectively, for AMPLICOR HPV test and HC2 assay (p=1.00). The specificities of AMPLICOR HPV test and HC2 assay were 72.7% (CI, 64.3~79.8%) and 69.3% (CI, 60.7~76.7%), respectively (p=0.75). Conclusions: AMPLICOR HPV test is comparable to HC2 assay for detection of HR HPV, with similar sensitivity and specificity in detecting CIN2+ lesions. AMPLICOR HPV test can be considered clinically useful for detection of HR HPV. However, more data are clearly needed on the performance of AMPLICOR HPV test as a screening tool.

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