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

目的 评价高危型人乳头状瘤病毒DNA(酶切信号放大法)(Cervista High-risk humanpapilloma vires,Cervista HR-HPV)检测方法在宫颈疾病中的临床意义.方法 利用Cerrista HR-HPV检测方法对437例人组标本进行高危型HPV检测,检测结果与基因测序结果进行对比,同时评价Cervista HR-HPV检测方法在检测CIN2以上的宫颈病变(CIN 2+CIN 3+Cancer,以下简称CIN2+)的能力,以及三组A5/A6,A7,A9与CIN2+的相关性.结果 Cervista HR-HPV检测方法与基因测序结果相比总体符合率为88.26%,基因测序阳性率为29.08%,本实验为38.96%(P<0.0001).该检测方法对CIN2+灵敏度98.46%.特异度58.49%.阳性预测值29.68%,阴性预测值99.54%.A9和CIN2+的95%OR值的可信区间为10.086～57.283(P<0.0001).结论 Cervista HR-HPV与基因测序的检测一致性较好.对于CIN2+灵敏度与特异性较好,可以应用于宫颈癌的防癌筛查,出现A阳性的患者建议进一步行阴道镜检测确诊是否有CIN2+.

High-risk human papilloma virus DNA detection Kit(cervista HPV HR)should be highly validated clinically in cervical cancer screening programs

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.