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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: To evaluate the feasibility and value of cobas 4800 HPV detection in cervical cancer screening and precancerous lesions screening. Methods: A total of 856 women with sexual life> 21 years old in Xinmi City of Henan Province were screened for cervical cancer. Each woman received the cobas 4800 HPV test, the high-risk HPV second-generation hybrid capture test (HC2) test, ThinPrep liquid-based cytology and colposcopy. Colposcopy directly in the visible lesions biopsy; any screening results were positive but no visible lesions at the junction of the cervical squamous column four quadrant random biopsy and endocervical curettage (ECC). Results: The sensitivity of cobas 4800 HPV detection and HC2 detection to cervical intraepithelial neoplasia (CIN) grade 2 and above (CIN2, CIN3 and cervical cancer) were 94.4% (34/36) and 63.2% % (516/817) and 63.9% (522/817), respectively. The concordance rate was 83.4% (711/853), which was highly consistent (Kappa = 0.65). The cobas 4800 HPV test has a 100% detection rate for patients missed by liquid-based cytology. The positive predictive value of cobas 4800 HPV16 and 18 genotyping for patients with CIN2 or above was 21.9%, which was 2.13 times higher than that of HC2 assay 10.3%. Women infected with HPV16 and 18 have a CIN2-over age 5.4 years younger than other types of infection. CONCLUSIONS: The cobas 4800 HPV test has similar accuracy and good agreement with the HC2 test and is more sensitive than the ThinPrep liquid-based cytology test and is capable of identifying HPV 16 and 18 two high-risk HPV types, which will help physicians target more Sexually followed high-risk cases of cervical lesions.