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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of Seegene Anyplex II HPV28 with the PGMY-CHUV Assay for Human Papillomavirus Genotyping
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Comparison of Seegene Anyplex II HPV28 with the PGMY-CHUV Assay for Human Papillomavirus Genotyping

机译:Seegene Anyplex II HPV28与人乳头瘤病毒基因分型的PGMY-CHUV分析的比较

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The Anyplex II HPV28 (H28; Seegene) is a new semiquantitative real-time multiplex PCR assay for screening and genotyping 28 human papillomaviruses (HPV) in only 2 reaction wells. H28 was compared to the PGMY-CHUV assay (PG) with 309 archival DNA samples from cervical smears collected over 8 years in our laboratory. H28 and PG were fully concordant at the genotypic level on 228 (73.8%) out of 309 samples: 27 HPV negative and 201 HPV positive. The 201 fully concordant positive samples corresponded to single infections (n = 145) and to multiple infections (2 genotypes, n = 38; 3 to 5 genotypes, n = 18). The remaining 81 samples (26.2%) were either partially concordant (n = 64, 20.7%) or fully discordant (n = 17, 5.5%). While genotype-specific agreement was nearly perfect (κ = 0.877), HPV51 was significantly less well detected by H28 and the converse was observed for HPV40, -42, -54, and -68. Sequencing of PG amplicons confirmed HPV51 discordants and suggested the involvement of a possibly local HPV51 subtype. Mismatches in the PGMY09 primers to HPV68a explained most of the HPV68 discordants, confirming the specificity of H28 toward HPV68. With PG as a reference, the sensitivity and specificity of H28 were 93.4% and 99.0%, respectively. Considering H28 as a reference, the sensitivity and specificity of PG were 83.8% and 99.6%, respectively. H28 is a very sensitive and specific HPV genotyping assay suitable for research and clinical use as an adjunct to a clinically validated test. H28 semiquantitative readout ought to be evaluated for primary cervical cancer screening.
机译:Anyplex II HPV28(H28; Seegene)是一种新型的半定量实时多重PCR检测方法,仅在2个反应孔中即可筛查和基因分型28种人乳头瘤病毒(HPV)。将H28与PGMY-CHUV分析法(PG)进行了比较,从我们的实验室中收集了309份宫颈涂片中8年以上的存档DNA样本。 H309和PG在309个样本中的228个(73.8%)的基因型水平上完全一致:27个HPV阴性和201个HPV阳性。 201个完全一致的阳性样本分别对应于单次感染( n = 145)和多重感染(2个基因型, n = 38; 3至5个基因型, n = 18)。其余的81个样本(占26.2%)部分一致( n = 64,20.7%)或完全不一致( n = 17,5.5%)。尽管基因型特异性一致性接近完美(κ= 0.877),但是H28不能很好地检测HPV51,而HPV40,-42,-54和-68则相反。 PG扩增子的测序证实了HPV51不一致,并暗示可能是局部HPV51亚型的参与。 HPV68a的PGMY09引物中的错配解释了大多数HPV68不一致症,证实了H28对HPV68的特异性。以PG为参照,H28的敏感性和特异性分别为93.4%和99.0%。以H28为参考,PG的敏感性和特异性分别为83.8%和99.6%。 H28是一种非常敏感和特异的HPV基因分型测定法,适合作为临床验证测试的辅助手段进行研究和临床使用。 H28半定量读数应用于原发性宫颈癌筛查。

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