Department of Laboratory Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea.
Biomed Res Int. 2016;2016:5170419. doi: 10.1155/2016/5170419. Epub 2016 Dec 21.
Human papillomavirus (HPV) infection is an important etiologic factor in cervical carcinogenesis. Various HPV DNA detection methods have been evaluated for clinicopathological level. For the specimens with normal cytological finding, discrepancies among the detection methods were frequently found and adequate interpretation can be difficult. 6,322 clinical specimens were submitted and evaluated for real-time PCR and Hybrid Capture 2 (HC2). 573 positive or "Not Detected but Amplified" (NDBA) specimens by real-time PCR were additionally tested using genetic analyzer. For the reliability of real-time PCR, 325 retests were performed. Optimal cut-off cycle threshold ( ) value was evaluated also. 78.7% of submitted specimens showed normal or nonspecific cytological finding. The distributions of HPV types by real-time PCR were not different between positive and NDBA cases. For positive cases by fragment analysis, concordance rates with real-time PCR and HC2 were 94.2% and 84.2%. In NDBA cases, fragment analysis and real-time PCR showed identical results in 77.0% and HC2 revealed 27.6% of concordance with fragment analysis. Optimal cut-off value was different for HPV types. NDBA results in real-time PCR should be regarded as equivocal, not negative. The adjustment of cut-off value for HPV types will be helpful for the appropriate result interpretation.
人乳头瘤病毒（HPV）感染是宫颈癌发生的重要病因。已经评估了各种 HPV DNA 检测方法在临床病理水平上的应用。对于细胞学正常的标本，检测方法之间经常存在差异，难以进行充分的解释。提交并评估了 6322 例临床标本，进行实时 PCR 和杂交捕获 2（HC2）检测。对实时 PCR 阳性或“未检出但扩增”（NDBA）的 573 例标本，使用基因分析仪进一步检测。为了验证实时 PCR 的可靠性，进行了 325 次重复检测。还评估了最佳循环阈值（）值。78.7%的送检标本显示正常或非特异性细胞学发现。实时 PCR 检测的 HPV 类型分布在阳性和 NDBA 病例之间没有差异。对于片段分析阳性病例，与实时 PCR 和 HC2 的符合率分别为 94.2%和 84.2%。在 NDBA 病例中，片段分析和实时 PCR 显示 77.0%的结果一致，HC2 与片段分析的符合率为 27.6%。最佳截止值因 HPV 类型而异。实时 PCR 的 NDBA 结果应视为不确定，而不是阴性。调整 HPV 类型的截止值将有助于对结果进行适当的解释。
