HC2法在宫颈疾病类型辅助诊断中的应用研究

Study on the Application of HC2 Method in Auxiliary Diagnosis of Cervical Disorders

目的通过大样本研究报告HPV流行率,并对完成筛查患者开展长时程、大规模的随访研究,确定筛查结果同主要的宫颈疾病类型的发病情况的关系。方法使用实验室信息系统进行数据搜索,得到从2012年1月到2018年12月时间跨度为7年的年龄在18~85岁之间的4799名女性患者样本数据。所有样本均采用第二代杂交捕获法(hybrid capture 2,HC2)进行高危HPV DNA定量检测。分析不同年龄阶段同相对光单位/截断值的比值(relative light unit/cut-off value,RLU/CO)值的分级和分布人数和频率并计算阳性率。而后对已检测为HPV阳性的患者,经过平均随访时间24.6个月的追踪,根据患者随后的组织学、细胞学诊断结果,研究RLU/CO值与宫颈病变风险关系。结果在所有接受检查的患者当中,HPV阳性患者检出率为19.05%。RLU/CO值的分布显示除去HPV阴性患者外,全部年龄区间患者的检测值在1~500的患者分布基数较大(14.46%)。随着RLU/CO值的增加组织学和细胞学报道子宫颈上皮不典型增生(cervical intraepithelial neoplasia,CIN)II级及以上病变的比例和相对风险度增加。结论HC2检测方法稳定性得到了验证,纳入研究的患者当中HPV负荷级别较大的诊断为高度宫颈病变的风险更高。

Objective To evaluate the association between screening outcomes and the incidence of substantial cervical disease types by conducting a large sample survey of HPV prevalence,as well as a long-term,large-scale follow-up study of individuals who have undergone HPV screening.Methods Data were browsed utilizing a laboratory information system to obtain data from a sample of 4,799 female patients aged 18 to 85 years from January 2012 to December 2018.All samples were quantified for high-risk HPV DNA using a second-generation hybridization capture procedure(hybrid capture 2,HC2).The positive rate was determined after evaluating the distribution of the relative light unit/cut off value(RLU/CO)at varying generations.Then,for patients who had tested positive for HPV,the relationship between RLU/CO values and the risk of cervical lesions was investigated after a mean follow-up period of 24.6 months,based on the patients′subsequent histological and cytological diagnostic results.Results The prevalence of HPV-positive patients was 19.05%among all patients examined,and the distribution of RLU/CO values showed a larger base(14.46%)of patients in all age groups with test values between 1 and 500,excluding those who tested negative.The proportion and relative risk of histologically and cytologically reported CIN II and higher grade lesions increased with increasing RLU/CO values.Conclusion The stability of the HC2 assay was validated,and individuals with higher HPV load levels among the patients included in the study were at greater risk of developing high cervical lesions in the future.