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目的评价杂交捕获二代(HC-Ⅱ)和实时荧光PCR(real-time PCR)两种人乳头瘤病毒(HPV)检测方法的一致性;探讨两法筛查宫颈癌及其癌前病变的敏感性和阴性预测值;为实时荧光PCR试剂盒的应用提供临床资料。方法对877名就诊的妇女用HC-Ⅱ和real-time PCR两种方法检测HPV,并进行宫颈液基细胞学检查(LCT),其中任一结果异常者再进行组织病理检查。结果877名妇女中有804名两种HPV检测法结果一致,总符合率达91.7%,一致性检验Kappa值为0.792。在对高级别宫颈上皮内瘤样病变(CIN)的检测中,HC-Ⅱ和real-time PCR的敏感性分别为96.7%和94.6%,阴性预测值分别为99.5%和99.2%。结论real-time PCR与HC-Ⅱ检测具有很好的一致性,可用于宫颈癌及其癌前病变的筛查。
OBJECTIVE: To evaluate the consistency of the detection methods of two human papillomavirus (HPV) hybridization capture second generation (HC-Ⅱ) and real-time PCR (real-time PCR); To explore the sensitivity of screening two methods for cervical cancer and precancerous lesions Sex and negative predictive value; provide clinical data for the application of real-time fluorescence PCR kit. Methods Eighty-eight women were examined by HC-Ⅱ and real-time PCR to detect HPV and LCT. Any abnormality was detected by histopathological examination. Results Among 877 women, there were 804 HPV test results of the two methods were consistent, with a total compliance rate of 91.7%, consistency test Kappa value of 0.792. The sensitivity of HC-Ⅱ and real-time PCR was 96.7% and 94.6% for the high-grade cervical intraepithelial neoplasia (CIN), and the negative predictive values were 99.5% and 99.2%, respectively. Conclusion The real-time PCR and HC-Ⅱ test have good consistency and can be used for screening of cervical cancer and precancerous lesions.