Department of Pathology, Seoul National University Hospital, Seoul National University College of Medicine, 28 Yongon-dong, Chongno-gu, Seoul, 110-744, South Korea.
Division of Clinical Bioinformatics, Biomedical Research Institute, Seoul National University Hospital, Seoul, South Korea.
Arch Virol. 2019 Nov;164(11):2699-2706. doi: 10.1007/s00705-019-04379-7. Epub 2019 Aug 21.
Recently, a clinical need for an improved human papilloma virus (HPV) test that covers a broad range of genotypes has emerged as a valuable primary screening tool for cervical lesions. The liquid bead microarray (LBMA) assay is a recently developed high-throughput platform covering a broad range of genotypes. Here, we compared the clinical performance of two recently developed LBMA assays, GeneFinder HPV Liquid Bead Microarray (GeneFinder) and CareGENE HPV genotyping kit-O (CareGENE), in the Korean general population. A total of 3,148 cervical swabs were tested by the GeneFinder and CareGENE assays. Cases with discrepant results between the two assays were subjected to direct sequencing as a reference method for evaluating the performance of the two LBMA assays. Among all swabs tested, 12.6% showed HPV positivity, and the prevalent HPV genotypes were HPV53, 70, 16, 39, and 51, in that order. The concordance rates between the two assays for the detection of HPV and for genotyping were 96.6% (kappa = 0.836) and 94.5% (kappa = 0.779), respectively. The two LBMA assays showed comparable sensitivity and specificity for HPV detection (GeneFinder: sensitivity 94.4% and specificity 98.7%, CareGENE: sensitivity 89.8% and specificity 99.6%) and for genotyping (GeneFinder: sensitivity 91.0% and specificity 96.6%, CareGENE: sensitivity 90.2% and specificity 99.1%). This is the first demonstration that CareGENE has comparable clinical performance to GeneFinder, which has been established to show excellent performance for screening HPV in previous studies. Both LBMA platforms are thus considered to be valuable tools for HPV detection and genotyping to improve cervical screening in the general population.
最近，一种能够广泛覆盖基因型的改良型人乳头瘤病毒（HPV）检测作为宫颈病变的有价值的初筛工具，在临床上的需求日益增长。液芯芯片（LBMA）检测是一种新开发的高通量平台，能够广泛覆盖基因型。在这里，我们比较了两种新开发的 LBMA 检测方法，即 GeneFinder HPV 液芯芯片（GeneFinder）和 CareGENE HPV 基因分型试剂盒-O（CareGENE）在韩国普通人群中的临床性能。对 3148 例宫颈拭子进行了 GeneFinder 和 CareGENE 检测。对两种检测方法结果不一致的病例进行直接测序，作为评估两种 LBMA 检测方法性能的参考方法。在所有测试的拭子中，12.6%显示 HPV 阳性，最常见的 HPV 基因型依次为 HPV53、70、16、39 和 51。两种检测方法检测 HPV 和基因分型的一致性率分别为 96.6%（kappa = 0.836）和 94.5%（kappa = 0.779）。两种 LBMA 检测方法在 HPV 检测（GeneFinder：敏感性 94.4%，特异性 98.7%，CareGENE：敏感性 89.8%，特异性 99.6%）和基因分型（GeneFinder：敏感性 91.0%，特异性 96.6%，CareGENE：敏感性 90.2%，特异性 99.1%）方面具有相似的敏感性和特异性。这是首次证明 CareGENE 的临床性能与 GeneFinder 相当，后者在之前的研究中已被证明在 HPV 筛查方面具有优异的性能。这两种 LBMA 平台都被认为是 HPV 检测和基因分型的有价值的工具，可用于提高普通人群的宫颈筛查效果。
