Department of Obstetrics and Gynaecology, Queen Mary Hospital, The University of Hong Kong, Hong Kong.
J Clin Microbiol. 2010 Mar;48(3):758-64. doi: 10.1128/JCM.00989-09. Epub 2009 Dec 30.
Persistent infection with high-risk types of human papillomavirus (HPV) is a necessary step in the development of cervical cancer. The incorporation of HPV detection into cervical screening programs may improve the ability to identify women at risk of cervical cancer. We recently evaluated the performance characteristics of a newly developed HPV detection assay, the GenoArray (GA) genotyping assay, for the detection of HPV infections by comparing it with the commercial Roche Linear Array (LA) HPV genotyping assay. The GA assay has an analytical sensitivity for the detection of HPV types 16 (HPV-16) and HPV-18 of as few as 10 to 50 copies, and its reproducibility is adequate. The GA and LA assays showed no significant difference in the rates of detection of genotypes detected by both HPV genotyping assays and oncogenic genotypes, and the interassay agreement was excellent. The GA and LA assays revealed either concordant or compatible genotyping results for 97.5% of the samples and discordant results for only eight (2.5%) samples. Compatible results were also observed for the detection of single or multiple HPV infections and the detection of most of the genotypes. The GA assay also demonstrated good clinical performance characteristics when the comparisons were carried out with clinical subgroups of samples from patients with normal cytologies, low-grade or high-grade squamous intraepithelial lesions, and cancers. Therefore, the GA assay appears to be highly sensitive and specific for the genotyping of HPV. It has the advantage that it specifically detects HPV-52, which overcomes a limitation of the LA assay, and hence, it has potential value for use for genotyping, especially in regions where HPV-52 has a high prevalence.
高危型人乳头瘤病毒（HPV）的持续感染是宫颈癌发展的必要步骤。将 HPV 检测纳入宫颈筛查计划可能会提高识别宫颈癌高危女性的能力。我们最近通过将新开发的 HPV 检测方法，即 GenoArray（GA）基因分型检测与商业 Roche Linear Array（LA）HPV 基因分型检测进行比较，评估了该方法的性能特征。GA 检测方法对 HPV 16（HPV-16）和 HPV-18 的分析灵敏度低至 10 到 50 拷贝，其重现性良好。GA 和 LA 检测方法在两种 HPV 基因分型检测方法和致癌基因类型检测的基因型检出率方面没有显著差异，并且检测间的一致性非常好。GA 和 LA 检测方法对 97.5%的样本显示出一致或兼容的基因分型结果，只有 8 份（2.5%）样本显示出不一致的结果。对于单一或多种 HPV 感染的检测以及大多数基因型的检测，也观察到了兼容的结果。GA 检测方法在与细胞学正常、低级别或高级别鳞状上皮内病变以及癌症患者的样本临床亚组进行比较时，也表现出良好的临床性能特征。因此，GA 检测方法似乎对 HPV 的基因分型具有高度的敏感性和特异性。它具有特异性检测 HPV-52 的优势，克服了 LA 检测方法的局限性，因此，它具有用于基因分型的潜在价值，特别是在 HPV-52 流行率较高的地区。
