Objective: To evaluate the feasibility and effectiveness of isothermal human papillomavirus (HPV) DNA amplification test as a primary screening test in the early detection of cervical cancer. Methods: From June to August 2016, 2, 774 women aged 30-64 years old from Inner Mongolia were recruited for cervical cancer screening. HPV DNA was detected by Isomega and cobas4800. INNO-LiPA HPV Genotyping Extra was served as a reference method for the cases whose results were inconsistent by using these two methods. Histological diagnosis was considered as a gold standard to estimate the effectiveness and accuracy of Isomega and cobas4800 for detecting CIN2 or greater. Results: The concordance of Isomega and cobas4800 was 94.84% (Kappa=0.82) for high risk HPV (HR-HPV), 99.68% (Kappa=0.95) for HPV16, 99.78% (Kappa=0.91) for HPV18 and 94.34% (Kappa=0.76) for other HR-HPV types. The concordances of Isomega and the reference were 99.71% (Kappa=0.96), 99.86% (Kappa=0.94) and 96.76% (Kappa=0.87) for HPV16, 18 and other HR-HPV, respectively, while the concordances of cobas4800 and the reference were 99.82% (Kappa=0.97), 99.86% (Kappa=0.94) and 97.51% (Kappa=0.90), respectively. The sensitivity and specificity of Isomega for detecting CIN2+ (including CIN2, CIN3 and squamous cell carcinoma) were 87.76% and 82.94%, respectively, while those of cobas4800 were 89.80% and 85.06%, respectively. Conclusions: The concordances of Isomega and cobas4800 is confident. These two methods can accurately detect the HPV16 and 18 genotyping, and have good sensitivity and specificity for clinical diagnosis and population screening of cervical cancer.
目的： 评价人乳头状瘤病毒(HPV)DNA恒温扩增检测技术Isomega应用在高危型别HPV DNA检测及宫颈病变诊断中的可行性及有效性。 方法： 招募2 774名30～64岁来自内蒙古自治区健康妇女进行宫颈癌筛查。采用Isomega和cobas4800 HPV检测技术进行HPV DNA检测，应用线性探针法(INNO－LiPA)对两种检测方法结果不一致的标本进行分型检测。以病理诊断为金标准，评价Isomega和cobas4800方法检出宫颈上皮内瘤变(CIN)2级及以上病变的有效性和准确性。 结果： Isomega与cobas4800检出HPV DNA的总一致率为94.84%(Kappa＝0.82)，检出HPV16、HPV18型和其他型别HR－HPV的一致率分别为99.68%(Kappa＝0.95)、99.78%(Kappa＝0.91)和94.34%(Kappa＝0.76)。与INNO－LiPA校正结果比较，Isomega检出HPV16、HPV18和其他型别HR－HPV的一致率分别为99.71%(Kappa＝0.96)、99.86%(Kappa＝0.94)和96.76%(Kappa＝0.87)；cobas4800的一致率分别为99.82%(Kappa＝0.97)、99.86%(Kappa＝0.94)和97.51%(Kappa＝0.90)。Isomega检出CIN2＋(包括CIN2、CIN3和鳞癌)的敏感度和特异度分别为87.76%和82.94%，cobas4800分别为89.80%和85.06%。 结论： Isomega与cobas4800 HPV检测方法的一致性较好，检测HPV16和18型的准确性高，具有较高的敏感度和特异度，可用于临床检测和大规模人群的宫颈癌筛查。.
Keywords: Cervical neoplasms; Human papillomavirus; Screening.