Provincial Laboratory for Public Health (Microbiology), Calgary, Alberta, Canada.
J Clin Microbiol. 2012 Jan;50(1):25-9. doi: 10.1128/JCM.05400-11. Epub 2011 Nov 16.
Clinical cervical cytology specimens (n = 466) collected in PreservCyt (Hologic Inc.) were used to evaluate the agreement between Hybrid Capture 2 (hc2; Qiagen) and cobas 4800 (c4800; Roche Molecular Diagnostics) for the detection of high-risk human papillomavirus (HR HPV) genotype infections. The agreement between the two assays was 93.8% (kappa = 0.87; 95% confidence interval, 0.828 to 0.918), with 186 and 251 concordant positive and negative results, respectively. All 186 concordant positives were confirmed using the Linear Array (LA; Roche Molecular Diagnostics) genotyping test. Of the 29 samples with discordant results (6.2%), 18 were hc2 positive and LA verified 17 as positive for HR HPV. Eleven discordant specimens were c4800 positive, and LA confirmed 5 as positive for HR HPV. As of October 2009, practice guidelines in Alberta, Canada, recommend reflex HPV testing for women over 30 years old with atypical squamous cells of undetermined significance (ASCUS) and for women over 50 years old with low-grade squamous intraepithelial lesions (LSIL) to help prioritize those who should undergo further evaluation. In this study, agreement between hc2 and c4800 results for samples from women over 30 years old with ASCUS cytology was 92.3% (n = 13), while no samples from women over 50 years old with LSIL cytology were identified for analysis.
对保存在 PreservCyt（豪洛捷公司）中的 466 例临床宫颈细胞学标本进行了检测，以评估 Hybrid Capture 2（hc2；凯杰）和 cobas 4800（罗氏分子诊断）在检测高危型人乳头瘤病毒（HR HPV）基因型感染方面的一致性。两种检测方法的一致性为 93.8%（kappa=0.87；95%置信区间，0.828 至 0.918），分别有 186 例和 251 例阳性和阴性结果一致。所有 186 例一致阳性结果均通过 Linear Array（LA；罗氏分子诊断）基因分型试验得到确认。在 29 例不一致的样本中（6.2%），hc2 阳性的有 18 例，LA 验证 17 例为 HR HPV 阳性。11 例不一致的标本 c4800 阳性，LA 确认 5 例为 HR HPV 阳性。截至 2009 年 10 月，加拿大艾伯塔省的实践指南建议对细胞学结果为非典型鳞状细胞不能明确意义（ASCUS）的 30 岁以上女性和细胞学结果为低度鳞状上皮内病变（LSIL）的 50 岁以上女性进行 HPV 检测作为补充，以帮助确定需要进一步评估的人群。在本研究中，hc2 和 c4800 对细胞学结果为 ASCUS 的 30 岁以上女性的检测结果的一致性为 92.3%（n=13），而没有对细胞学结果为 LSIL 的 50 岁以上女性的样本进行分析。
