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
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.
更多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 trialⅣ(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.
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