Value of the BioPerfectus multiplex real time HPV assay for self-collected samples cervical cancer screening
10.3760/cma.j.issn.0529-567x.2019.05.004
- VernacularTitle:核酸分型定量法HPV检测用于自取样子宫颈癌筛查的价值
- Author:
Qing CHEN
1
;
Hui DU
;
Chun WANG
;
Qicai HU
;
Ruifang WU
Author Information
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
- Keywords:
Uterine cervical neoplasms;
Papillomaviridae;
Self-examination;
Vaginal smears;
Viral load
- From:
Chinese Journal of Obstetrics and Gynecology
2019;54(5):307-311
- CountryChina
- Language:Chinese
-
Abstract:
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.
