Montefiore Medical Center and Albert Einstein College of Medicine, 1695 Eastchester Road, Bronx, NY 10461, USA.
Gynecol Oncol. 2010 Aug 1;118(2):116-22. doi: 10.1016/j.ygyno.2010.04.013. Epub 2010 May 21.
High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens.
The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel.
There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8% (95% confidence interval [CI]: 84.1-96.9) and the negative predictive value (NPV) was 99.1% (95% CI: 98.1-99.6). Sensitivity for detection of > or =CIN 3 in women with ASC-US was 100% (95% CI: 85.1-100) and the NPV was 100% (95% CI: 99.4-100). The specificity of the test for detection of > or =CIN 2 and > or =CIN 3 was 44.2% (95% CI: 41.5-46.9) and 43% (95% CI: 40.3-45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV.
The Cervista HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.
高危型（HR）人乳头瘤病毒（HPV）检测在宫颈癌筛查中对阴道镜检查进行分流很重要。本研究评估了 Cervista HPV HR 和 16/18 基因分型检测用于检测宫颈细胞学标本中 HPV 的临床性能。
该检测在一项多中心临床研究中进行了前瞻性评估。从大约 4000 例常规液基巴氏涂片检查时采集的剩余液基细胞学标本中提取 DNA，并评估 HR HPV 和/或 HPV 16 和 18 型的存在情况。所有细胞学结果为非典型鳞状细胞意义不明确（ASC-US）或更高级别的女性均接受阴道镜检查，并采集活检。将检测结果与局部阴道镜和中央病理审查小组的组织学结果进行比较。
共有 1347 例完成细胞学、HR HPV、阴道镜和组织学完整数据集的受试者纳入 HPV HR 检测分析。在 ASC-US 细胞学的女性中，HPV HR 检测对检测宫颈上皮内瘤变（CIN）2+的敏感性为 92.8%（95%置信区间[CI]：84.1-96.9），阴性预测值（NPV）为 99.1%（95%CI：98.1-99.6）。在 ASC-US 女性中，检测 >或=CIN 3 的敏感性为 100%（95%CI：85.1-100），NPV 为 100%（95%CI：99.4-100）。该检测对检测 >或=CIN 2 和 >或=CIN 3 的特异性分别为 44.2%（95%CI：41.5-46.9）和 43%（95%CI：40.3-45.7）。HPV 16/18 基因分型检测在 HR HPV 阳性的 ASC-US 细胞学女性中也表现出预期的效果。
Cervista HPV HR 检测可与宫颈细胞学联合用于检测 HR HPV 型，用于常规宫颈癌筛查中 ASC-US 细胞学的女性分流。
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