Evaluation of a Newly Developed GenoArray Human Papillomavirus (HPV) Genotyping Assay and Comparison with the Roche Linear Array HPV Genotyping Assay
Evaluation of a Newly Developed GenoArray Human Papillomavirus (HPV) Genotyping Assay and Comparison with the Roche Linear Array HPV Genotyping Assay
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DOI：
10.1128/jcm.00989-09
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发表时间：
2010-03-01
影响因子：
9.4
通讯作者：
Ngan, Hextan Y. S.
中科院分区：
文献类型：
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作者：
Liu, Stephanie S.;Leung, Rebecca C. Y.;Ngan, Hextan Y. S.
宫颈癌的早期症状有哪些？宫颈癌的早期症状有哪些？将HPV检测纳入宫颈筛查计划可能会提高识别宫颈癌风险妇女的能力。我们最近通过将其与市售罗氏线性阵列（LA）HPV基因分型检测试剂盒进行比较，评价了新开发的HPV检测试剂盒（GenoArray（GA）基因分型检测试剂盒）用于检测HPV感染的性能特征。GA检测试剂盒检测HPV 16型（HPV-16）和HPV-18的分析灵敏度仅为10 - 50拷贝，且其重现性足够。GA和LA检测显示HPV基因分型检测和致癌基因型检测的基因型检出率无显著差异，且检测间一致性极佳。GA和LA检测显示97.5%的样本的基因分型结果一致或相容，仅8份（2.5%）样本的结果不一致。对于单个或多个HPV感染的检测以及大多数基因型的检测也观察到相容的结果。当与来自正常细胞学、低度或高度鳞状上皮内病变和癌症患者的样本的临床亚组进行比较时，GA测定也表现出良好的临床性能特征。因此，GA检测似乎对HPV基因分型具有高度敏感性和特异性。它的优点是特异性检测HPV-52，这克服了LA测定的局限性，因此，它具有用于基因分型的潜在价值，特别是在HPV-52具有高流行率的地区。
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.