Department of Laboratory Medicine, Seoul National University Hospital, Seoul, South Korea.
Diagn Microbiol Infect Dis. 2013 Aug;76(4):432-6. doi: 10.1016/j.diagmicrobio.2013.04.012. Epub 2013 Jun 18.
The detection of high-risk (HR) HPV in cervical cancer screening is important for early diagnosis of cervical cancer or pre-cancerous lesions. We evaluated the analytical and clinical performances of 3 HR HPV assays in Gynecology patients. A total of 991 specimens were included in this study: 787 specimens for use with a Hybrid Capture 2 (HC2) and 204 specimens for a HPV DNA microarray (DNA Chip). All specimens were tested using an Abbott RealTime High Risk HPV assay (Real-time HR), PGMY PCR, and sequence analysis. Clinical sensitivities for severe abnormal cytology (severe than high-grade squamous intraepithelial lesion) were 81.8% for Real-time HR, 77.3% for HC2, and 66.7% for DNA Chip, and clinical sensitivities for severe abnormal histology (cervical intraepithelial neoplasia grade 2+) were 91.7% for HC2, 87.5% for Real-time HR, and 73.3% for DNA Chip. As compared to results of the sequence analysis, HC2, Real-time HR, and DNA Chip showed concordance rates of 94.3% (115/122), 90.0% (117/130), and 61.5% (16/26), respectively. The HC2 assay and Real-time HR assay showed comparable results to each other in both clinical and analytical performances, while the DNA Chip assay showed poor clinical and analytical performances. The Real-time HR assay can be a good alternative option for HR HPV testing with advantages of allowing full automation and simultaneous genotyping of HR types 16 and 18.
在宫颈癌筛查中检测高危（HR）HPV 对于早期诊断宫颈癌或癌前病变非常重要。我们评估了 3 种 HR HPV 检测方法在妇科患者中的分析和临床性能。本研究共纳入 991 例标本：787 例标本用于 Hybrid Capture 2（HC2），204 例标本用于 HPV DNA 微阵列（DNA Chip）。所有标本均采用 Abbott RealTime High Risk HPV 检测（Real-time HR）、PGMY PCR 和序列分析进行检测。对于严重异常细胞学（高级别鳞状上皮内病变以上），Real-time HR 的临床敏感性为 81.8%，HC2 为 77.3%，DNA Chip 为 66.7%；对于严重异常组织学（宫颈上皮内瘤变 2+），HC2 的临床敏感性为 91.7%，Real-time HR 为 87.5%，DNA Chip 为 73.3%。与序列分析结果相比，HC2、Real-time HR 和 DNA Chip 的一致性率分别为 94.3%（115/122）、90.0%（117/130）和 61.5%（16/26）。HC2 检测和 Real-time HR 检测在临床和分析性能方面均具有可比性，而 DNA Chip 检测的临床和分析性能较差。Real-time HR 检测可以作为 HR HPV 检测的一种较好的替代选择，具有允许完全自动化和同时对 HR 型 16 和 18 进行基因分型的优势。
