基质辅助激光解吸电离飞行时间质谱和HPV基因测序分型检测阴道自取样本用于子宫颈癌筛查的有效性研究  

Evaluation of vaginal self-sampling in combination with MALDI-TOF and SEQ HPV test for cervical cancer screening

作　　者：罗红学 卞苏环[1] 杜辉[1] 刘志红[1] 王桂香[1] 王纯[1] 周艳秋[1] 吴瑞芳[1] L UO Hongxue BIAN Suhuan DU Hui LIU Zhihong WANG Guixiang WANG Chun ZHOU Yanqiu WU Ruifang(Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen 518036, China)

机构地区：[1]北京大学深圳医院妇产科深圳市女性重大疾病早期诊断技术重点实验室,518036

出　　处：《中国妇产科临床杂志》2017年第2期120-123,共4页Chinese Journal of Clinical Obstetrics and Gynecology

基　　金：深圳市科创委(GCZX2015043016200372;JCYJ20140415162338808;JCYJ20140415162338821)

摘　　要：目的评价不同保存形式的阴道自取样本联合激光辅助解析/飞行时间质谱技术(MALDI-TOF)和HPV基因测序分型检测技术(SEQ HPV)用于宫颈癌筛查的有效性。方法 319例研究对象来自北京大学深圳医院门诊和子宫颈癌筛查项目中因异常宫颈细胞学和(或)高危型HPV阳性者需行阴道镜检查的妇女。采集液体载体、FTA固体卡和POI固体卡三种形式的阴道自取样本三份和医取样本一份。四种样本分别行PCR法(Cobas 4800)、MALDI-TOF和SEQ HPV法高危型HPV检测。结果 (1)MALDI-TOF检测阴道自取样本与Cobas4800检测医取样本比较,高危型HPV的一致率:液体载体88.58%,FTA卡83.04%,POI卡87.89%;对应的HPV16/18的一致率为97.58%、93.77%和97.23%;检测CIN2及以上病变(CIN2+)的敏感度为93.44%、88.52%和95.08%。(2)SEQ HPV检测阴道自取样本与Cobas 4800检测医取样本比较,高危型HPV的一致性:液体载体89.62%,FTA卡86.85%,POI卡89.97%,对应的HPV16/18的一致为97.23%、95.50%和97.23%;检测CIN2+的敏感度为96.72%、93.44%和96.72%,两者比较,差异无统计学意义(P>0.05)。结论与Cobas 4800检测医生取宫颈细胞样本比较,MALDI-TOF和SEQ HPV两种方法用于自取阴道宫颈脱落细胞样本高危型HPV的检测一致性较高;对于高级别宫颈病变,其筛查灵敏度无显著差别。Objective To evaluate the efficacy of vaginal self-sampling in different media in combination with MALDITOF（matrix-assisted laser desorption/ionization time-of-flight） and SEQ HPV（HPV genotyping based on sequencing） test for cervical cancer screening.Methods 319 women who suppose to undergo colposcope referral due to abnormal results of cytology or HPV positive were enrolled this study.Three self-sampling specimens were stored in liquid media,FTA card and POI card,respectively,followed by a regular cervical specimen collected by physician.MALDI-TOF and SEQ HPV test were used to detect the three self-sampling in different media,and the results were compared to the cervical specimen tested by Cobas 4800 HPV test.Meanwhile,histological diagnosis was considered as a golden standard to estimate the sensitivity and specificity of the different combinations of MALDI-TOF and SEQ HPV test with self-sampling for CIN2＋ detection.Results Self-sampling（Liquid meida,FTA cards,POI cards） detected by MALDI-TOF had a good agreement（88.58%,83.04%,87.89%） for high-risk HPV 14 and a good agreement（97.58%,93.77%,97.23%） for HPV16/18 compared with physician-sampling detected by Cobas 4800 HPV test.The corresponding sensitivity of detecting CIN2＋ were 93.44%,88.52%,and 95.08%.Self-sampling（Liquid meida,FTA cards,POI cards） detected by SEQ had a good agreement（89.62%,86.85%,89.97%） for 14 high-risk HPV and a very good agreement（97.23%,95.50%,97.23%） for HPV16/18 compared with physician-sampling detected by Cobas 4800 HPV test.The corresponding sensitivity of detecting CIN2＋ were 96.72%,93.44% and 96.72%,respectively.Conclusions Compared with the results of Cobas 4800 HPV test detecting physician-sampling for high-risk HPV,MALDI-TOF and SEQ HPV test detecting self-sampling have a good agreement.With regard to high-grade cervical lesions,they also have comparable sensitivity.

关 键 词：阴道自取样本 激光辅助解析/飞行时间质谱技术 HPV基因测序分型检测技术 子宫颈癌筛查 

分 类 号：R737.33[医药卫生—肿瘤]