cobas 4800 HPV检测在宫颈癌筛查中的应用价值

Application of cobas 4 800 human papilloma virus test in cervical cancer screening

目的:评价cobas 4800 HPV检测技术在宫颈癌及癌前病变筛查中的可行性及应用价值。方法:对河南省新密市856例年龄>21岁有性生活的妇女进行宫颈癌筛查。每位妇女均接受了cobas 4800 HPV检测、高危型HPV第二代杂交捕获试验(hy brid capture 2 technology,HC2)检测、ThinPrep液基细胞学和阴道镜检查。阴道镜下在可见病变处直接取活检;任意筛查结果阳性但无可见病变时,于宫颈外口鳞柱交界处行四象限随机活检和宫颈管搔刮术(endocervical curettage,ECC)。结果:cobas 4800HPV检测与HC2检测对宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)2级以上(CIN2、CIN3及宫颈癌)患者的灵敏度均为94.4%(34/36),特异度分别为63.2%(516/817)和63.9%(522/817);一致率为83.4%(711/853),两者具有高度一致性(Kappa=0.65)。cobas 4800 HPV检测对于液基细胞学检查漏诊的患者具有100%检出率。cobas 4800 HPV16及18分型检测对于CIN2以上患者的阳性预测值21.9%为HC2检测10.3%的2.13倍。妇女感染HPV16及18型患CIN2以上病变的年龄比感染其他类型平均小5.4岁。结论:cobas 4800 HPV检测与HC2检测具有相似的准确性和良好的一致性,比ThinPrep液基细胞学检查更为灵敏,并且能鉴别HPV16及18两种高风险类型HPV感染,利于医生更有针对性地随访宫颈病变中的高危病例。

Objective： This study aimed to evaluate the feasibility and utility ofcobas 4800 human papilloma virus （HPV） test as a primary screening test and a triage tool in cervical cancer screening. Methods： A total of 856 unscreened women subjects over 21 years of age and have engaged in sexual activities were recruited from Henan, China in 2011. All subjects were screened through cobas 4800 HPV, Hybrid Capture 2 （HC2） technology, ThinPrep liquid-based cytology, and colposcopy. Any visible lesion was directly biopsied through colposcopy. Random biopsies in four quadrants at the squamocolumnar junction and endocervical curettage were performed when apparent colposcopic abnormality was not observed, but at least one of the HPV tests was positive. Pathologic diagnosis was used as the golden standard to evaluate the performance of the screening tests. Results： Measured as a primary screening test, the sensitivity and specificity of the cobas 4 800 HPV test in detecting grade II cervical intraepithelial neoplasia （CIN2） and CIN2＋ in patients reached 94.4% and 63.2%, respectively, compared with 94.4% and 63.9% of the HC2 test. The concordance rate in detecting HPV DNA between cobas 4800 HPV and HC2 tests was 83.4% （k=0.65）. The cobas 4800 HPV test could detect all CIN2＋ cases that were undetected by the ThinPrep liquid-based cytologic test. The positive predictive value of the HPV 16/18 typing test in detecting CIN2＋ lesions was twice as high as that of the HC2 test （2.13x）. In the CIN2＋ cases, the women subjects infected with HPV16/18 were 5.4 years younger than those infected with other types of HPV. Conclusion： Satisfactory consistency and similar accuracy between the cobas 4800 HPV and HC2 tests were observed. However, cobas 4 800 HPV test is superior in detecting high-risk HPV types. This test could provide more sensitive and efficient strategies compared with the ThinPrep liquid-based cytology. Cobas 4 800 HPV can also identify the sub-genotypes of high-risk HPV16/18, which can effectively help the doctors follow up high-risk cases among women with high-grade cervical lesions. Cobas 4 800 HPV test is expected to be a new method for cervical cancer screening.