核酸分型定量法HPV检测用于自取样子宫颈癌筛查的价值  

Value of the BioPerfectus multiplex real time HPV assay for self-collected samples cervical cancer screening

作　　者：陈晴[1] 杜辉[1] 王纯[1] 胡启彩 吴瑞芳[1] Chen Qing;Du Hui;Wang Chun;Hu Qicai;Wu Ruifang(Department of Obstetrics and Gynecology, Shenzhen Key Laboratory of Gynecological Diagnostic Technology Research, Peking University Shenzhen Hospital, Shenzhen 518036, China)

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

出　　处：《中华妇产科杂志》2019年第5期307-311,共5页Chinese Journal of Obstetrics and Gynecology

基　　金：深圳市科技计划(GCZX2015043016200372,JCYJ20150403091443285).

摘　　要：目的探讨核酸分型定量法(BMRT)HPV检测用于自取样子宫颈癌筛查的价值。方法选取2013年7月—2014年9月深圳市子宫颈癌筛查项目Ⅳ(SHENCCAST-Ⅳ)研究中保存的839例妇女的DNA标本[每例妇女均同时有自取样标本(是指参加筛查的妇女自己获取阴道子宫颈脱落细胞)和医生取样标本],采用BMRT HPV检测两种标本中14种高危型HPV亚型(HPV 16、18、31、33、35、39、45、51、52、53、56、58、59、66型)的感染情况和病毒载量,并评价BMRT HPV检测方法的筛查效能。结果839例筛查妇女中,有完整BMRT HPV检测数据者804例,将其纳入本研究,其年龄为(46±7)岁。(1)804例妇女中,自取样、医生取样标本的14种高危型HPV亚型的阳性率分别为12.2%(98/804)、12.8%(103/804),两者比较,差异无统计学意义(χ2=0.14,P=0.71)。85例HPV感染亚型完全一致的妇女中,自取样标本的取样细胞数(中位数为19 901.0个)明显多于医生取样标本(中位数为1 778.4个),两者比较,差异有统计学意义(Z=-7.61,P<0.01);自取样标本的HPV单一亚型感染、总HPV感染的中位病毒载量分别为2 642.8、3 246.0拷贝数/标本,医生取样标本分别为2 015.4、2 015.4拷贝数/标本,两者分别比较,差异均无统计学意义(P>0.05)。(2)HPV 16、18型和其他12种高危型HPV亚型在自取样与医生取样标本中的总符合率分别为99.8%、100.0%和96.1%,Kappa值分别为0.95、1.00和0.81,自取样、医生取样标本检出的高危型HPV感染型别具有高度一致性。804例妇女中,组织学诊断为子宫颈上皮内瘤变(CIN)Ⅱ及以上病变者6例,BMRT HPV检测此6例患者的自取样和医生取样标本中HPV均为阳性,无一例漏诊。结论BMRT HPV检测用于自取样标本HPV检测的子宫颈癌筛查是可行的。Objective To evaluate the feasibility of the BioPerfectus multiplex real time (BMRT) HPV assay for self-sample cervical cancer screening. Methods Eight hundreds and thirty-nine self-collected and physician-obtained DNA samples from the Shenzhen cervical cancer screening trial Ⅳ(SHENCCAST-Ⅳ) study collected samples for cervical cancer screening during June 2013 to September 2014 were detected by BMRT HPV assay to evaluate the screening efficacy. Results A total of the 839 women who were screened, 804 with complete BMRT HPV data was included in the study, and average age was (46±7) years. Of the 804 women, the positive rates of 14 high-risk HPV genotypes (including HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 subtype) of self-sample and physician-obtained samples were 12.2%(98/804) and 12.8%(103/804), respectively (χ2=0.14, P=0.71). Self-collected samples with HPV-positive had significantly more cells (median 19 901.0) than physician-obtained samples (median 1 778.4), and there was statistically significant difference (Z=-7.61, P<0.01). The degree of agreement between self-sample and physician-obtained samples of HPV 16, HPV 18 and other 12 high risk HPV genotype was 99.8%, 100.0% and 96.1%, respectively. And the consistent Kappa value was 0.95, 1.00 and 0.81, respectively. Of 804 samples, there were 6 cervical intraepithelial neoplasia (CIN)Ⅱ+ cases. There were no missed CINⅡ+ cases by BMRT HPV assay. Conclusion BMRT HPV assay is feasible for self-sample cervical cancer screening.

关 键 词：宫颈肿瘤 乳头状瘤病毒科 自我检查 阴道涂片 病毒载量 

分 类 号：R737.33[医药卫生—肿瘤]