Department of Pathology, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Mol Diagn. 2011 Mar;13(2):160-6. doi: 10.1016/j.jmoldx.2010.11.016.
Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. Herein is described our clinical experience using Cervista HPV HR, a testing platform recently approved by the US Food and Drug Administration for clinical use. Using data from a high-volume commercial laboratory, a retrospective analysis of cytologic and Cervista HPV HR test results from 56,501 samples was performed, and an indirect comparison was made with previous experience with 53,008 samples tested using the Hybrid Capture 2 platform. Of samples analyzed using Cervista HPV HR, 1.5% were of insufficient volume for testing and 1.1% yielded an insufficient signal from the internal control to be reported. In samples with a cytological interpretation of atypical squamous cells of undetermined significance, 48.5% (95% confidence interval [CI], 47.5 to 49.5) tested positive using Cervista HPV HR, compared with 59.4% (95% CI, 58.3 to 60.5) of samples using Hybrid Capture 2. Of samples from women aged 30 years or older with a negative cytological interpretation, 5.8% (95% CI, 5.6 to 6.1) tested positive using Cervista HPV HR, compared with 5.5% (95% CI, 5.3 to 5.7) of samples using Hybrid Capture 2. When stratified by five-year age groups between 30 and 65 years, positivity rates for high-risk human papillomavirus were similar in the Cervista HPV HR and Hybrid Capture 2 populations, and were consistent with expectations established by the literature.
检测高危型（HR）人乳头瘤病毒（HPV）是目前宫颈癌筛查建议的一个关键组成部分。本文介绍了我们使用 Cervista HPV HR 的临床经验，该检测平台最近获得美国食品和药物管理局批准用于临床使用。利用来自一个大容量商业实验室的数据，对 56501 例样本的细胞学和 Cervista HPV HR 检测结果进行了回顾性分析，并与之前使用 Hybrid Capture 2 平台检测的 53008 例样本的经验进行了间接比较。在使用 Cervista HPV HR 分析的样本中，有 1.5%的样本体积不足，有 1.1%的样本内部对照信号不足，无法报告。在细胞学检查结果为意义不明确的非典型鳞状细胞的样本中，使用 Cervista HPV HR 检测的阳性率为 48.5%（95%可信区间[CI]，47.5%至 49.5%），而使用 Hybrid Capture 2 的阳性率为 59.4%（95%CI，58.3%至 60.5%）。在细胞学检查结果为阴性的 30 岁及以上女性的样本中，使用 Cervista HPV HR 检测的阳性率为 5.8%（95%CI，5.6%至 6.1%），而使用 Hybrid Capture 2 的阳性率为 5.5%（95%CI，5.3%至 5.7%）。在 30 至 65 岁的五个年龄组中分层，Cervista HPV HR 和 Hybrid Capture 2 人群中的高危型 HPV 阳性率相似，与文献中建立的预期一致。
