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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(P>0.05)。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。
Objective To evaluate the effectiveness and feasibility of domestic transfoming reagent (transmembrane HPV) for detecting HR-HPV DNA and diagnosing cervical lesions. Methods A total of 602 patients from hospital health examination or cervical intraepithelial neoplasia (CIN) hospitalized patients were diagnosed by pathology. The specimens of cervical exfoliated cells were detected in parallel with both toscarpi and Roche reagent (cobas HPV), and the consistency of the two methods was compared. With pathological diagnosis as the gold standard, we evaluated the sensitivity and specificity of TungKing Reagent and Roche Reagent in the screening of cervical intraepithelial neoplasia. Results The total agreement rate between Roche reagent and Roche reagent was 94.62% (Kappa = 0.881), the positive consistency rate was 96.85%, the negative consistency rate was 90.53% The overall agreement rates were 95.92% (Kappa = 0.906), 98.70% (Kappa = 0.885) and 92.76% (Kappa = 0.805), respectively. The total concordance rate of the two tests after calibration was 98.51% (Kappa = 0.967), the positive coincidence rate was 98.87% and the negative consistency rate was 97.81%. The total concordance rates of HPV16, HPV18 and other 12 high-risk HPV types were 97.40% (Kappa = 0.940), 100% (Kappa = 1.00) and 97.58% (Kappa = 0.950). The sensitivity and specificity of permethrin screening for CIN2 + were 91.52% and 52.06%, respectively. The sensitivity and specificity of Roche for screening CIN2 + were 91.52% and 54.29%, respectively. There was no significant difference (P> 0.05). CONCLUSION: The consistency between HRP and imported Roche reagent is high, and it is an effective HPV DNA detection method. It can be used in the screening of cervical cancer and precancerous lesions in the population.