Human Papillomavirus Oncogenic mRNA Testing for Cervical Cancer Screening: Baseline and Longitudinal Results From the CLEAR Study.

宫颈癌筛查中人乳头状瘤病毒致瘤性mRNA的检测： CLEAR研究中的基线和纵向结果

Reid JL,Wright TC,Stoler MH,Cuzick J,Castle PE,Dockter J,Getman D,Giachetti C

阅读：869 American Journal of Clinical Pathology； September; 144 (3) : 357 - 527:473-83

Abstract

This study determined the longitudinal clinical performance of a high-risk human papillomavirus (HR-HPV) E6/E7 RNA assay (Aptima HPV [AHPV]; Hologic, San Diego, CA) compared with an HR-HPV DNA assay (Hybrid Capture 2 [HC2]; Qiagen, Gaithersburg, MD) as an adjunctive method for cervical cancer screening.
Women 30 years or older with a negative result for intraepithelial lesions or malignancy cytology (n = 10,860) positive by AHPV and/or HC2 assays and randomly selected women negative by both assays were referred to colposcopy at baseline. Women without baseline cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+) continued into the 3-year follow-up.
The specificity of AHPV for CIN2 or lower was significantly greater at 96.3% compared with HC2 specificity of 94.8% (P < .001). Estimated sensitivities and risks for detection of CIN2+ were similar between the two assays. After 3 years of follow-up, women negative by either human papillomavirus test had a very low risk of CIN2+ (<0.3%) compared with CIN2+ risk in women with positive AHPV results (6.3%) or positive HC2 results (5.1%).
These results support the use of AHPV as a safe and effective adjunctive cervical cancer screening method.

摘要

目的本研究评估人类高危乳头状瘤病毒（HR-HPV）E6/E7 RNA分析（Aptima HPV [AHPV]；Hologic，San Diego，CA），与做为宫颈癌筛查一种辅助方法的HR-HPV DNA分析(Hybrid Capture 2 [HC2]；Qiagen，Gaithersburg，MD)比较，它的纵贯性临床表现。

方法 ≥30岁且无上皮内病变或恶性细胞学改变（n = 10,860）但AHPV和/或HC2检测阳性的妇女和从中随机挑选的AHPV及HC2检测均阴性的妇女行阴道镜检查作为基线研究。无CIN2或CIN2+的病例继续进行为期3年的临床随访。

结果对于CIN2或CIN2-，AHPV的特异性为96.3%，显著高于HC2的特异性（94.8%，P <0 .001）。而CIN2+的检测，AHPV和HC2两组间的敏感性及风险相似。经过3年随访，不论哪种HPV检测为阴性的妇女，进展为CIN2+的风险（<0.3%）低于AHPV检测阳性（6.3%）或HC2检测阳性（5.1%）的妇女。

结论研究结果支持AHPV检测是宫颈癌筛查中安全有效的辅助方法。