HPV DNA 基因芯片分析在 BS GP5+/6+ MPG Luminex 检测的宫颈样本检测 CIN2+病变中的临床性能。

Clinical performance of the HPV DNA Array genotyping assay in detection of CIN2+ lesions with BS GP5+/6+ MPG Luminex tested cervical samples.

机构信息

Gynaecology Clinic, Charité Universitätsmedizin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.

AID/GenID Diagnostika, Strassberg, Germany.

出版信息

J Med Virol. 2020 Jan;92(1):113-118. doi: 10.1002/jmv.25583. Epub 2019 Sep 8.

DOI:10.1002/jmv.25583

PMID:31471920

Abstract

Human papillomavirus (HPV) detection is used for screening of cervical cancer and genotype-specific persistence has shown to be mandatory for dysplasia development. Aim of this study was to evaluate the clinical performance of HPV DNA Array for cervical intraepithelial neoplasia 2+ (CIN2+) lesion detection. HPV DNA Array is a polymerase chain reaction-based assay that targets E1 sequences 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). The clinical evaluation was performed against the reference assay, BS-GP5+/6+ multiplex genotyping (MPG)-Luminex, with 600 cervical smear samples of a referral population. HPV DNA Array detected CIN2+ lesions with a sensitivity of 90.2%, identical to that of MPG-Luminex. Detection of CIN3+ lesions was with a sensitivity of 90.3%, as compared with 88.7% of MPG-Luminex. It demonstrated very good agreement for HPV detection, irrespective of type, of 91.5% (κ = 0.832). HPV DNA Array is a simple and robust assay, with a short protocol of 4 hours hands-on time and automated readout by ELISpot AiDot software. It permits testing of up to 96 samples in one run and may be considered for use in organized screening programs and low resource settings.

摘要

人乳头瘤病毒（HPV）检测用于宫颈癌筛查，特定基因型的持续性已被证明对发育不良的发展是强制性的。本研究旨在评估 HPV DNA 微阵列在宫颈上皮内瘤变 2+（CIN2+）病变检测中的临床性能。HPV DNA 微阵列是一种基于聚合酶链反应的检测方法，针对 29 种 HPV 类型的 E1 序列（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 和 97）。临床评估是针对参考检测方法 BS-GP5+/6+多重基因分型（MPG）-Luminex 进行的，使用了 600 个转诊人群的宫颈涂片样本。HPV DNA 微阵列检测 CIN2+病变的敏感性为 90.2%，与 MPG-Luminex 相同。检测 CIN3+病变的敏感性为 90.3%，而 MPG-Luminex 为 88.7%。无论 HPV 类型如何，HPV 检测的一致性非常好，为 91.5%（κ=0.832）。HPV DNA 微阵列是一种简单而强大的检测方法，其协议简单，耗时 4 小时，通过 ELISpot AiDot 软件进行自动化读取。它可以在一个运行中测试多达 96 个样本，可考虑用于有组织的筛查计划和资源有限的环境。