cobas 4800与careHPV用于人乳头瘤病毒检测的对比研究

A Comparative Study of careHPV and cobas 4800 for Detecting Human Papillomavirous

[目的]比较cobas 4800检测和careHPV人乳头瘤病毒（human papillomavirus,HPV）检测方法用于宫颈癌筛查的有效性和一致性。[方法]本研究纳入856名研究对象,采用cobas4800和careHPV检测方法对宫颈脱落细胞标本进行HPV DNA检测。以病理组织学为金标准,评估careHPV和cobas 4800检出宫颈上皮内瘤变2（cervical intraepithelial neoplasia grade 2,CIN2）及以上病人的有效性和准确性。采用McNemar检验对两种检测方法进行一致性检验。[结果]最终853例妇女的有效检测结果纳入统计分析。careHPV和cobas 4800检出HPV DNA阳性率分别是37.1%（316/853）和39.3%（335/853）。cobas 4800检测和careHPV检出HPV DNA一致率为83.2%（710/853）,Kappa=0.65（95%CI：0.59-0.70）。careHPV和cobas 4800检出CIN2＋的敏感度和特异性分别为94.4%（95%CI：81.3%-99.2%）和65.5%（95%CI：62.1%-68.7%）,94.4%（95%CI：81.3%-99.2%）和63.2%（95%CI：59.7%-66.5%）。在最后纳入统计分析的853名妇女中HPV16和HPV 18的感染率分别为13.1%和2.6%,而在36例CIN2＋的病人中,HPV16和HPV18的感染率分别为77.8%和2.8%。[结论]careHPV和cobas4800作为初筛方法检出CIN2＋的一致性较好,然而两种方法又有其不同的优势,应该根据当地的经济水平来选择用于筛查的HPV DNA检测方法。

[Purpose] To compare effectiveness and accuracy of careHPV test and cobas 4800 test for detecting human papillomavirous（HPV） DNA in the cervical cancer screening. [Methods] A total of856 women were enrolled in this study. HPV DNA of cervical cell specimens was detected by cobas4800 and careHPV. With the pathological results as golden standard,the effectiveness and accuracy of careHPV and cobas 4800 for detecting cervical intraepithelial neoplasia grade 2（CIN2） or greater were evaluated. McNemar test was used to evaluate the agreement of careHPV and cobas 4800 for detecting HPV DNA.[Results] A total of 853 women with valid testing results were included in the analysis. The positive rates of HPV detected by careHPV testing and cobas 4800 testing were 37.1%（316/853） and 39.3%（335/853）,respectively. The total agreement of these two methods was 83.2%（710/853） with Kappa value=0.65（95%CI：0.59~0.70）. The sensitivity and specificity of careHPV and cobas 4800 for detecting CIN2 ＋ were 94.4%（95% CI：81.3% ~99.2%） and 65.5%（95% CI：62.1% ~68.7%）,94.4%（95%CI：81.3%~99.2%） and 63.2%（95%CI：59.7%~66.5%）,respectively. The rate of HPV 16 and HPV 18 of 853 women were 13.1% and 2.6% respectively. Among the 36 women with CIN2＋,the rate of HPV 16 and HPV 18 were 77.8% and 2.8% respectively. [Conclusion] There is good agreement between careHPV and cobas 4800 for detecting CIN2＋. Due to different advantages of careHPV and cobas 4800,the tests used for detecting HPV DNA in cervical cancer screening should be chosen according to the levels of local economy.