Aptima HPV E6/E7 mRNA检测在宫颈高级别病变临床筛查中的应用价值

APPLICATION VALUE OF APTIMA HPV E6/E7 MRNA TEST IN CLINICAL SCREENING OF CERVICAL LESIONS

目的 探讨Aptima HPV E6/E7 mRNA检测及分型检测在宫颈高级别鳞状上皮内病变(HSIL)及宫颈癌临床筛查中的应用价值。方法 选取2018年11月—2019年11月在唐山市妇幼保健院门诊及住院同时行Aptima HPV E6/E7 mRNA检测(Aptima HPV)、液基薄层细胞学检测(TCT)及阴道镜活检的825例患者为研究对象,以组织病理学结果为金标准,比较Aptima HPV和TCT单独或联合检测对宫颈高级别鳞状上皮内病变及宫颈癌的风险预测能力及诊断效能。结果 Aptima HPV分型检测对宫颈病变≥HSIL的检出率依次为16/18/45型(57.1%),16型(50.6%),18/45型(24.2%),其他11型(17.3%),差异有统计学意义(P<0.001)。16/18/45型同时阳性组、16型阳性组发生≥HSIL的相对危险度分别是其他11型阳性组患者的3.310倍、2.931倍,差异均有统计学意义(P<0.05)。Aptima HPV检测宫颈病变≥HSIL的灵敏度、阳性预测值和阴性预测值高于TCT检测,特异度低于TCT检测,两种方法联合检测的灵敏度最高(P<0.05)。结论 Aptima HPV 16/18/45型阳性对宫颈病变≥HSIL的风险预测能力优于其他分型阳性及TCT检测,联合检测可提高诊断的灵敏度,有效减少HSIL及宫颈癌的漏诊率,在宫颈病变临床筛查中具有重要意义。

Objective To explore the application value of Aptima HPV E6/E7 mRNA test and typing test in the clinical screening of cervical high-grade squamous intraepithelial lesion(HSIL) and cervical cancer.Methods A total of eight hundred and twenty-five patients who underwent Aptima HPV E6/E7 mRNA test(Aptima HPV),thinprep cytology test(TCT) and colposcopy biopsy in Tangshan Maternal and Child Health Care Hospital were selected from November 2018 to November 2019 were selected as subjects.Histopathological results were used as the gold standard to compare the risk prediction ability and diagnostic efficacy of Aptima HPV and TCT alone or in combination for high-grade squamous intraepithelial lesions and cervical cancer.Results The detection rate of cervical lesions ≥HSIL by Aptima HPV typing test was 16/18/45 type(57.1%),16 type(50.6%),18/45 type(24.2%),and other 11 types(17.3%),the difference was statistically significant(P<0.001).The relative risk of ≥HSIL in the 16/18/45 type positive group and the 16 types positive group was 3.310 times and 2.931 times than that of the other 11 types positive groups, respectively, and the differences were statistically significant(P<0.05).The sensitivity, positive predictive value, and negative predictive value of Aptima HPV for cervical lesions ≥HSIL are higher than TCT test(P<0.05),and the specificity is lower than TCT test(P=0.008).The combined test of the two methods has the highest sensitivity.Conclusion Aptima HPV 16/18/45 type positive has better risk prediction ability for ≥HSIL than other positive and TCT test.Combined detection can improve the sensitivity of diagnosis, effectively reduce the missed diagnosis rate of HSIL and cervical cancer, which is of great significance in clinical screening of cervical lesions.