透景HPV检测试剂在高危HPV DNA检测及宫颈上皮内瘤变筛查中的应用

发布时间：2019-02-16 05:23

【摘要】：目的评价国产透景试剂(透景HPV)用于HR-HPV DNA检测及宫颈病变诊断的有效性和可行性。方法 602例来自医院门诊健康体检的妇女或者宫颈上皮内瘤变(CIN)住院治疗的患者,经病理学明确诊断。采用透景试剂和Roche试剂(cobas HPV)平行检测子宫颈脱落细胞标本,比较两种方法的一致性。以病理诊断结果作为金标准,评估透景试剂和Roche试剂筛查子宫颈上皮内瘤变的敏感性和特异性。结果透景试剂与Roche试剂总一致率为94.62%(Kappa=0.881),阳性一致率为96.85%,阴性一致率为90.53%;透景试剂与Roche试剂HPV16、HPV18及其他12种高危型HPV的总一致率分别为95.92%(Kappa=0.906),98.70%(Kappa=0.885)和92.76%(Kappa=0.805)。校正后两种检测的总一致率为98.51%(Kappa=0.967),阳性一致率为98.87%,阴性一致率为97.81%;校正后HPV16,HPV18及其他12种高危型HPV的总一致率分别为97.40%(Kappa=0.940),100%(Kappa=1.00)和97.58%(Kappa=0.950)。透景试剂筛查CIN2+的敏感性和特异性分别为91.52%和52.06%,Roche试剂筛查CIN2+的敏感性和特异性分别为91.52%和54.29%,无统计学差异(P0.05)。结论国产透景试剂与进口Roche试剂检测HR-HPV的一致性高,是有效的HPV DNA检测方法,可用于人群中宫颈癌和癌前病变的筛查。
[Abstract]:Objective to evaluate the effectiveness and feasibility of domestic HPV for detection of HR-HPV DNA and diagnosis of cervical lesions. Methods 602 patients with cervical intraepithelial neoplasia (CIN) were diagnosed by pathology. Parallel detection of exfoliated cells of cervix with Roche reagent and Roche reagent was used to compare the consistency of the two methods. The sensitivity and specificity of screening cervical intraepithelial neoplasia were evaluated with the diagnostic results of pathology and Roche reagent. Results the total consistent rate of Roche reagent and transparent reagent was 94.62% (Kappa=0.881), the positive consistency rate was 96.85 and the negative consistency rate was 90.53%. The concordance rates of permeation reagent with Roche reagent, HPV16,HPV18 and other 12 high risk HPV were 95.92% (Kappa=0.906), 98.70% (Kappa=0.885) and 92.76% (Kappa=0.805), respectively. After correction, the total consistency rate of the two tests was 98.51% (Kappa=0.967), the positive consistency rate was 98.87%, and the negative consistency rate was 97.81%. The total consistent rates of HPV16,HPV18 and other high risk HPV were 97.40% (Kappa=0.940), 100% (Kappa=1.00) and 97.58% (Kappa=0.950), respectively. The sensitivity and specificity of roche reagent in screening CIN2 were 91.52% and 52.06%, respectively. The sensitivity and specificity of Roche reagent were 91.52% and 54.29%, respectively. There was no statistical difference (P0.05). Conclusion there is a high consistency between domestic and imported Roche reagent for detection of HR-HPV, which is an effective method for HPV DNA detection and can be used for screening cervical cancer and precancerous lesions in the population.
【作者单位】：北京协和医学院/中国医学科学院肿瘤医院流行病学研究室;大连医科大学公共卫生学院流行病与卫生统计学教研室;
【分类号】：R737.33

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