University of Virginia Health System, Charlottesville, USA.
Am J Clin Pathol. 2011 Mar;135(3):468-75. doi: 10.1309/AJCPZ5JY6FCVNMOT.
This study evaluated the clinical performance of the cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA) for high-risk human papillomavirus (HR-HPV) testing with individual HPV-16/HPV-18 genotyping in women 21 years or older with atypical squamous cells of undetermined significance (ASC-US). Women (N = 47,208) were recruited in the United States during routine screening, and liquid-based cytology and HPV testing were performed. The ASC-US prevalence was 4.1% (1,923/47,208), and 1,578 women underwent colposcopy with valid results. The cobas 4800 HPV Test demonstrated performance comparable to the Hybrid Capture 2 test (QIAGEN, Gaithersburg, MD) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse and grade 3 or worse. HPV-16/HPV-18+ women had a greater absolute risk of CIN 2 or worse compared with pooled HR-HPV+ and HR-HPV- women (24.4%, 14.0%, and 0.8%, respectively). The cobas 4800 HPV Test is clinically validated for ASC-US triage. HPV-16/HPV-18 genotyping can identify women at highest risk for high-grade cervical disease, and this additional risk stratification may be used in formulating patient management decisions.
本研究评估了 cobas 4800 HPV Test（罗氏分子系统公司，普莱森顿，加利福尼亚州）在 21 岁及以上的非典型鳞状细胞不能明确意义（ASC-US）女性中进行高危型人乳头瘤病毒（HR-HPV）检测和 HPV-16/HPV-18 基因分型的临床性能。该研究在美国进行了常规筛查，招募了 47208 名女性，进行了液基细胞学和 HPV 检测。ASC-US 的患病率为 4.1%（1923/47208），其中 1578 名女性接受了有效的阴道镜检查。cobas 4800 HPV Test 与 Hybrid Capture 2 检测（QIAGEN，盖瑟斯堡，马里兰州）相比，在检测宫颈上皮内瘤变（CIN）2 级或更高级别和 3 级或更高级别方面具有相当的性能。HPV-16/HPV-18+女性的 CIN 2 级或更高级别绝对风险高于 HPV 阳性和 HR-HPV-女性（分别为 24.4%、14.0%和 0.8%）。cobas 4800 HPV Test 经临床验证可用于 ASC-US 分流。HPV-16/HPV-18 基因分型可以识别出患有高级别宫颈疾病风险最高的女性，这种额外的风险分层可能用于制定患者管理决策。
