摘要
目的:分析Cobas 4800人乳头瘤病毒(Human papillomavirus,HPV)检测对宫颈癌筛查的效果,为宫颈癌的早期诊断和干预提供理论依据。方法:选取2010年7月至2013年7月来我院行宫颈癌筛查的1031例妇女,均采用Cobas 4800、第二代杂交捕获法(HC-2)对HPV进行检测,对比两种检查方法的确诊结果。结果:1031例受检者中共检出CINⅠ级271例,CINⅡ级17例,CINⅢ级31例,检出率30.94%;Cobas 4800 HPV检测阳性率为40.35%(416/1031),灵敏度为95.83%(46/48),特异度为44.2%(434/983),PPV为11.06%(46/416),NPV为70.6%(434/615);而HC-2检测阳性率为38.70%,灵敏度为97.92%,特异度为49.8%,PPV为11.78%,NPV为77.5%,两种方法的阳性率、灵敏度、特异度、PPV及NPV均无明显统计学差异(P>0.05)。CINⅡ、CINⅢ患者Cobas 4800 HPV和HC-2检测结果灵敏度均为97.92%(47/48),一致率为95.83%(46/48)(Kappa=0.45);全部受检者中,两种检测方法的一致率为93.11%(Kappa=0.73),其一致率存在统计学意义(P<0.05);两种方法在宫颈癌癌前病变和HPV感染的检测灵敏度、特异性均无明显统计学差异(P>0.05)。结论:Cobas 4800 HPV检测与常用HC-2检测方法敏感度、特异度均无明显差异,其一致性较高,而Cobas 4800具有更广的HPV基因型检测范围,能够有效指导进一步检查或治疗,是预防和控制宫颈癌的有效方式,值得广泛推广应用于宫颈癌的早期筛查。
Objectives： To analyze the application of Cobas 4800 human papillomavirus （HPV） detection on cervical cancer screening, and to provide a theoretical basis for the early diagnosis and treatment of cervical canc- er. Method： 1031 women presenting in our hospital for cervical cancer screening from July 2010 to July 2013 were selected. Cobas 4800 and the second generation of hybrid capture （HC -2） were used to detect the HPV on them to compare the results of the two methods. Results： Among the 1031 eases, 271 eases were detected as CIN I, 17 cases as CIN II, and 31 cases as CIN III, with the detection rate of 30.94%. The positive rate of Cobas 4800 HPV test was 40. 35% （ 416/1031 ） ; the sensitivity was 95.83% （46/48） ; the specificity was 44. 2% （ 434/983 ） ; PPV was 11.06% （46/416） and NPV was 70. 6% （434/615）. For the results of the HC -2 method, the positive rate was 38. 70%; the sensitivity was 97. 92%; the specificity was 49. 8%; PPV was 11.78% and NPV was 77.5%. There was no significant difference in the positive rate, sensitivity, specificity, PPV and NPV between the results of the two methods （P 〉 0. 05）. For CIN II and CIN III patients, both Cobas 4800 HPV and HC - 2 detec- tion sensitivity was 97. 92% （47/48） ; the coincidence rate was 95.83% （46/48） （ Kappa =0. 45 ） ; the consistent rate of the two methods was 93. 11% （ Kappa = 0. 73 ）, which had no statistical significance （ P 〈 0.05 ）. There was no statistical difference in the detection sensitivity, specificity of cervical precancerous lesions and HPV infection as well （P 〉 0.05）. Conclusion： Cobas 4800 HPV detection and HC - 2 detection showed no significant difference in sensitivity and specificity. Cobas 4800 possesses a wider detection range of HPV gene, which can be an effective guidance for the further examination or treatment, as well as an effective way to prevent and control the cervical cancer.
出处
《中国性科学》
2014年第1期25-27,共3页
Chinese Journal of Human Sexuality
基金
浙江省医药卫生科技计划项目(2013KYA230)
