人乳头瘤病毒检测在非典型鳞状细胞意义不明确人群中检测宫颈癌：贝克顿·迪金森 Onclarity 试验的结果。
Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial.
机构信息
Department of Pathology, Columbia University, New York, NY.
University of Virginia Health System, Charlottesville.
出版信息
Am J Clin Pathol. 2019 Jan 1;151(1):53-62. doi: 10.1093/ajcp/aqy084.
OBJECTIVES
To determine clinical utility of Onclarity human papillomavirus (HPV) assay for atypical squamous cells-undetermined significance (ASC-US) triage, and the value of HPV genotyping within ASC-US.
METHODS
Women (n = 33,858; 21 years or older) had HPV testing using Onclarity and Hybrid Capture 2 (HC2). ASC-US individuals (n = 1,960, 5.8%) were referred to colposcopy.
RESULTS
Of ASC-US, 39.1% were HPV positive by Onclarity; HPV 16 was the most prevalent genotype (7.4%). Cervical intraepithelial neoplasia grade 2 (CIN 2) and CIN 3+ prevalences were 4.4% and 2.2%, respectively. Onclarity had sensitivity for CIN 2+ (85.7%) and CIN 3+ (91.4%), and specificities for CIN 2+ (64.1%) and CIN 3+ (62.0%), similar to HC2. Risks for CIN 3+ were 16.1%, 2.8%, 2.5%, and 2.7% with HPV 16, 18, 45, and 11 other genotypes, respectively.
CONCLUSIONS
Onclarity is clinically validated for ASC-US triage. Through risk stratification, genotyping could help identify women at highest risk for CIN 3+.
目的
确定 Onclarity 人乳头瘤病毒（HPV）检测在非典型鳞状细胞不明确意义（ASC-US）分流中的临床应用价值，以及 HPV 基因分型在 ASC-US 中的价值。
方法
共纳入 33858 名（年龄≥21 岁）女性，分别采用 Onclarity 和 Hybrid Capture 2（HC2）进行 HPV 检测。对 ASC-US 患者（n=1960，5.8%）行阴道镜检查。
结果
ASC-US 中，Onclarity 检测 HPV 阳性率为 39.1%；HPV16 是最常见的基因型（7.4%）。CIN2 和 CIN3+的患病率分别为 4.4%和 2.2%。Onclarity 检测对 CIN2+（85.7%）和 CIN3+（91.4%）的敏感度较高，对 CIN2+（64.1%）和 CIN3+（62.0%）的特异度较高，与 HC2 检测结果相似。HPV16、18、45 和 11 种其他基因型的患者中，CIN3+的风险分别为 16.1%、2.8%、2.5%和 2.7%。
结论
Onclarity 检测可用于 ASC-US 的分流，具有临床应用价值。通过风险分层，基因分型有助于识别 CIN3+风险最高的女性。
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