Department of Obstetrics and Gynecology, University of Tsukuba, Japan.
J Virol Methods. 2013 Mar;188(1-2):83-93. doi: 10.1016/j.jviromet.2012.10.014. Epub 2012 Dec 5.
This study was designed to evaluate the Clinichip HPV test, a new DNA test that detects carcinogenic human papillomavirus (HPV) rapidly by loop-mediated isothermal amplification and performs genotyping of all 13 carcinogenic types using automated DNA chip technology with an assay time 2.5h. Using this test, 247 Japanese women (109 with normal cytology, 43 with cervical intraepithelial neoplasia grade 1, 60 with cervical intraepithelial neoplasia grade 2/3 and 35 with invasive cervical cancer) were tested for carcinogenic HPV genotypes. The results were compared to those obtained by the polymerase chain reaction-amplified DNA sequencing using 13 type-specific primers. Overall, there was very good agreement for the detection of carcinogenic HPV between the Clinichip test and direct sequencing, with 95.5% total agreement and a kappa value of 0.91. Comparison of the detection of individual HPV types shows that the overall agreement was also high (range: 96.8-100%). In women with cervical intraepithelial neoplasia grade 2 or worse, the detection rate of carcinogenic HPV was 95.7% by both the Clinichip test and the direct-sequencing method, indicating complete agreement between the two methods. In conclusion, it was found that the Clinichip test is a promising new laboratory method for genotyping of carcinogenic HPV.
本研究旨在评估 Clinichip HPV 检测,这是一种新的 DNA 检测方法,通过环介导等温扩增快速检测致癌型人乳头瘤病毒(HPV),并使用自动化 DNA 芯片技术对所有 13 种致癌型进行基因分型,检测时间为 2.5 小时。使用该检测方法,对 247 名日本女性(109 名细胞学正常、43 名宫颈上皮内瘤变 1 级、60 名宫颈上皮内瘤变 2/3 级和 35 名浸润性宫颈癌)进行了致癌 HPV 基因型检测。将结果与使用 13 种型特异性引物进行聚合酶链反应扩增 DNA 测序的结果进行比较。总体而言,Clinichip 检测与直接测序在致癌 HPV 的检测方面具有非常好的一致性,总符合率为 95.5%,kappa 值为 0.91。对个别 HPV 类型的检测比较表明,总体一致性也很高(范围:96.8-100%)。在宫颈上皮内瘤变 2 级或更高级别女性中,Clinichip 检测和直接测序方法检测致癌 HPV 的检出率均为 95.7%,两种方法完全一致。总之,研究结果表明 Clinichip 检测是一种有前途的新型致癌 HPV 基因分型实验室方法。
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