High-risk human papilloma virus DNA detection Kit(cervista HPV HR)should be highly validated clinically in cervical cancer screening programs
10.3760/cma.j.issn.1003-9279.2011.02.023
- VernacularTitle:高危型人乳头状瘤病毒DNA检测方法在宫颈疾病中的临床意义
- Author:
Jian ZHAO
1
;
Xiao-Guang ZHANG
;
Rui CHEN
;
Hui BI
;
Xu WANG
;
Gui-Wen LIU
;
Dian-Xin YAO
;
Yi ZONG
;
Qin-Ping LIAO
Author Information
1. 北京大学第一医院
- Keywords:
Papillonmavirus,human;
DAN;
Gene expression;
Cervix diseases
- From:
Chinese Journal of Experimental and Clinical Virology
2011;25(2):149-151
- CountryChina
- Language:Chinese
-
Abstract:
Objective The aim of this study is to evaluate the clinical significance of High-risk Human Papilloma virus DNA Detection Kit(Cervista HPV HR) designed to the utilized in cervical cancer screening programs. Methods The investigation for Cervista HPV HR test is designed to detect 437 residual liquid-based cytology specimens collected during routine liquid-based Pap tests at standard care vistis and to identify the presence of HR HPV. We compared Cervista HPV HR Test against standard PCR,in order to examine the performance of Cervista HPV HR Test in populations with cervical intraepithelial neoplasia grade 2 + ( CIN 2, CIN 3 and Cancer, CIN 2 + ), and the capabilities of A5/A6, A7, A9 oligonucleotides of Cervista for predicting CIN2 +. Results The accuracy of Cervista compared to PCR with bi-directional sequencing was 88.26%. The positive percent of Cervista HPV HR Test and PCR were 38.96% and 29.08%, respectively. The sensitivity, specificity, negative predictive value (NPV) and positive predictive value ( PPV ) of Cervista HPV HR Test for the detection of CIN2 + were 98.46%,58.49% ,99. 54% and 29. 68%, respectively. The A9 oligonucleotides positivity percent was significantly higher in CIN2 + (odds ratio:24. 037,95% CI:10. 086 -57. 283). Conclusion The Cervista HPV HR test can be clinically used for detecting HR HPV types during routine cervical cancer screening. A9 oligonucleotides were also strongly associated with CIN2 + diagnosis, which is improtant in cervical cancer screening for triage to colposcopy.
