BACKGROUND Cervical cancer is caused by a persistent infection of human papillomavirus (HPV). Therefore, tests which detect the carcinogenic virus can be used for cervical cancer screening. OBJECTIVE This is the first evaluation of the HPV DNA Array (AID Diagnostika, Strassberg, Germany), an E1-based genotyping polymerase chain reaction (PCR) test for identification of 29 HPV types (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 44, 45, 51, 52, 53, 54, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 85, and 97). METHODS Analytical performance of the assay was assessed with cervical cancer cell lines with known HPV status, and preselected clinical cervical scrapings genotyped by multiplexed genotyping (MPG) with a Luminex readout (validated in-house assay). Intra- and inter-laboratory reproducibility experiments were performed to ensure the reliability of the assay. RESULTS HPV DNA Array identified the intrinsic HPV genotype in all cervical cancer cell lines and demonstrated a high sensitivity for HPV16 probe (1 cell per PCR reaction), as well as HPV18 and 45 probes (100 cells per PCR reaction). When compared with MPG, HPV DNA Array showed a good agreement of 92.2% for HPV detection irrespective of type (κ = 0.601), and demonstrated high agreement for HPV16 (80.7%, κ = 0.836) and HPV18 (86.7%, κ = 0.925). Furthermore, high intra-/inter-laboratory reproducibility was observed (90.9-100%). CONCLUSION HPV DNA Array showed high sensitivity for correct HPV genotype detection in experimental and clinical samples with a good correlation to the reference test. Since HPV DNA Array is based on a simple multiplexed PCR followed by reverse hybridization in a 96-well format and automated visual readout by AID ELISpot reader, it is capable of high throughput in a time-effective manner. HPV DNA Array could be considered for extended HPV genotyping of cervical smears.

中文翻译：

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基于人乳头瘤病毒HPV DNA阵列E1的基因分型分析的分析评估。

背景技术宫颈癌是由人乳头瘤病毒（HPV）的持续感染引起的。因此，检测致癌病毒的测试可用于宫颈癌筛查。目的这是对HPV DNA阵列（AID Diagnostika，斯特拉斯堡，德国）的首次评估，这是一种基于E1的基因分型聚合酶链反应（PCR）测试，用于鉴定29种HPV类型（6、11、16、16、18、26、31 ，33、35、39、40、42、44、45、51、52、53、54、56、58、59、66、67、68、69、70、73、82、85和97）。方法用具有已知HPV状况的宫颈癌细胞系评估测定的分析性能，并通过Luminex读数（经过验证的内部测定）通过多重基因分型（MPG）对预选的临床宫颈刮clinical进行基因分型。进行了实验室内和实验室间的重现性实验，以确保测定的可靠性。结果HPV DNA Array鉴定了所有宫颈癌细胞系中固有的HPV基因型，并显示出对HPV16探针（每个PCR反应1个细胞）以及HPV18和45个探针（每个PCR反应100个细胞）的高敏感性。与MPG相比，HPV DNA Array不论类型（κ= 0.601），对HPV检测均显示92.2％的良好一致性，对HPV16（80.7％，κ= 0.836）和HPV18（86.7％，κ= 0.925）表现出较高的一致性）。此外，观察到较高的实验室内/实验室间重现性（90.9-100％）。结论HPV DNA阵列对实验和临床样品中正确的HPV基因型检测显示出高灵敏度，与参考测试有很好的相关性。由于HPV DNA阵列基于简单的多重PCR，然后以96孔格式进行反向杂交，并由AID ELISpot阅读器进行自动视觉读取，因此它能够以高效的方式实现高通量。HPV DNA Array可考虑用于宫颈涂片的扩展HPV基因分型。