HPV E6/E7 mRNA检测在宫颈病变筛查中的临床效果

HPV E6/E7 mRNA detection in cervical disease screening clinical effect.

目的:评价HPV E6/E7 mRNA检测在宫颈病变筛查中的临床应用价值。方法:选取2021年3月至2022年12月就诊于云南省肿瘤医院的1409例患者,患者均行TCT、HPV DNA及HPV E6/E7 mRNA检测,活检结果为金标准,比较HPV E6/E7 mRNA检测与HPV DNA检测的一致性,分析不同筛查方式对宫颈高级别病变的检出率、阴道镜转诊率,计算其灵敏度、特异度、阳性预测值(PPV)、阴性预测值(NPV)、约登指数及AUC值。结果:HPV E6/E7 mRNA与HPV DNA两者检测一致性在HSIL组及宫颈癌组中Kappa系数分别为0.833、1,总体上两者Kappa系数为0.533;≤LSIL、≥HSIL病变中,HPV E6/E7 mRNA检测阳性率随宫颈病理级别升高而升高;5种初筛方式(mRNA检测、DNA检测、TCT检测、TCT+DNA、TCT+mRNA)在诊断≥HSIL病变的效能比较中,以HPV E6/E7 mRNA诊断效能最高,高于其它4种筛查方式,差异有统计学意义(P<0.05)。结论:HPV E6/E7 mRNA与HPV DNA检测宫颈高级别病变一致性较好;阳性率随着宫颈病理级别的升高而升高,同时HPV E6/E7 mRNA在筛查≥HSIL病变的效能最优,有望成为临床宫颈癌初筛工具的候选。

Objective:To evaluate the clinical application value of HPV E6/E7 mRNA detection in cervical lesion screening.Methods:A total of 1409 patients admitted to Yunnan Cancer Hospital from March 2021 to December 2022 were selected.All patients underwent TCT,HPV DNA and HPV E6/E7 mRNA detection,and biopsy results were the gold standard.The consistency of mRNA detection and DNA detection was compared.The detection rate and colposcopic referral rate of different screening methods for high-grade cervical lesions were analyzed,and their sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),Jorden index and AUC value were calculated.Results:The Kappa coefficients of HPV E6/E7 mRNA and HPV DNA were 0.833 and 1 in HSIL group and cervical cancer group,and the Kappa coefficients of both groups were 0.533 in general.In the cases of≤LSIL and≥HSIL,the positive rate of HPV E6/E7 mRNA detection increased with the increase of cervical pathological grade.In the comparison of the efficacy of the 5 primary screening methods(mRNA、DNA、TCT、TCT+DNA、TCT+mRNA)in the diagnosis of≥HSIL lesions,HPV E6/E7 mRNA diagnosis was the highest,which was higher than the other 4 screening methods,and the difference was statistically significant(P<0.05).Conclusion:There was good consistency between HPV E6/E7 mRNA and HPV DNA in detecting high-grade cervical lesions.The positive rate increases with the increase of cervical pathological grade,and mRNA has the best efficacy in screening≥HSIL lesions,which is expected to become a candidate for clinical cervical cancer screening tool.