Comparison of Hybribio GenoArray and Roche Human Papillomavirus (HPV) Linear Array for HPV Genotyping in Anal Swab Samples

Comparison of Hybribio GenoArray and Roche Human Papillomavirus (HPV) Linear Array for HPV Genotyping in Anal Swab Samples
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DOI:
10.1128/jcm.02274-14
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发表时间:
2015-02-01
影响因子:
9.4
通讯作者:
Woo, Yin Ling
Woo, Yin Ling
中科院分区:
医学2区
文献类型:
--
作者:
Low, Huey Chi;Silver, Michelle I.;Woo, Yin Ling

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人乳头瘤病毒(HPV)与肛门癌有因果关系,因为在高达90%的肛门上皮内瘤变和肛门癌中检测到HPV DNA。随着肛门癌发病率的逐渐上升,越来越需要建立可靠的、临床相关的检测肛门癌前体的方法。在资源有限的情况下,HPV DNA检测是肛门癌筛查的潜在相关工具。在这里,我们评估了杂交生物基因阵列(GA)对肛门样本中HPV基因分型的性能,对比参考标准罗氏线性阵列(LA)。肛拭子样本取自与男性发生性关系的性活跃男性。提取DNA后,分别用GA和LA进行基因分型。通过kappa统计和McNemar's chi(2)检验来评估总体检测间一致性、型特异性以及单基因型和多基因型一致性。使用GA和LA, 68%和76%的样本分别为HPV DNA阳性。所有HPV基因型的检测结果在测定间具有一致性(kappa = 0.70,一致性为86%)。虽然LA能够在每个样本中检测到更多的基因型,但测定间的一致性是可以接受的(kappa = 0.53, 63%的一致性)。GA对HPV基因型35、42和51的特异性检测较差(kappa < 0.60)。总之,GA和LA对肛门样本中大多数HPV基因型的检测具有良好的检测间一致性。然而,在高达76%的肛门样本中检测到HPV DNA值得进一步评估其临床意义。
Human papillomavirus (HPV) is causally associated with anal cancer, as HPV DNA is detected in up to 90% of anal intraepithelial neoplasias and anal cancers. With the gradual increase of anal cancer rates, there is a growing need to establish reliable and clinically relevant methods to detect anal cancer precursors. In resource-limited settings, HPV DNA detection is a potentially relevant tool for anal cancer screening. Here, we evaluated the performance of the Hybribio GenoArray (GA) for genotyping HPV in anal samples, against the reference standard Roche Linear Array (LA). Anal swab samples were obtained from sexually active men who have sex with men. Following DNA extraction, each sample was genotyped using GA and LA. The overall interassay agreement, type-specific, and single and multiple genotype agreements were evaluated by kappa statistics and McNemar's chi(2) tests. Using GA and LA, 68% and 76% of samples were HPV DNA positive, respectively. There was substantial interassay agreements for the detection of all HPV genotypes (kappa = 0.70, 86% agreement). Although LA was able to detect more genotypes per sample, the interassay agreement was acceptable (kappa = 0.53, 63% agreement). GA had poorer specific detection of HPV genotypes 35, 42, and 51 (kappa < 0.60). In conclusion, GA and LA showed good interassay agreement for the detection of most HPV genotypes in anal samples. However, the detection of HPV DNA in up to 76% of anal samples warrants further evaluation of its clinical significance.