用于检测和 HPV 基因分型的等温扩增 AmpFire 分析技术在福尔马林固定、石蜡包埋的口咽癌样本中的应用。
The Isothermal Amplification AmpFire Assay for Human Papillomavirus (HPV) Detection and Genotyping in Formalin-Fixed, Paraffin-Embedded Oropharyngeal Cancer Samples.
机构信息
Cancer Epidemiology Research Program, Catalan Institute of Oncology, IDIBELL, ONCOBELL, Barcelona, Spain.
Medical Oncology Department, Catalan Institute of Oncology, IDIBELL, ONCOBELL, Barcelona, Spain.
出版信息
J Mol Diagn. 2022 Jan;24(1):79-87. doi: 10.1016/j.jmoldx.2021.10.008. Epub 2021 Nov 18.
Human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) represent a distinct clinical entity compared with HPV-negative tumors with particular regard to treatment response and survival outcome. The aim of this study was to assess the AmpFire Multiplex HR-HPV tests, for the detection and genotyping of 15 high-risk (HR) HPV types in formalin-fixed, paraffin-embedded (FFPE) samples and identify HPV-driven OPSCC. DNA from 160 OPSCC FFPE specimens plus 23 samples from other head and neck primary sites was tested. Results were compared with those obtained using Linear Array HPV-DNA Genotyping Test. Linear Array and AmpFire Multiplex HR-HPV tests showed, for all samples and specifically for OPSCCs, an overall concordance agreement of 98.9% and 99.4% and a Cohen κ coefficient of 0.972 and 0.984, respectively. A concordance of 100% for HPV16 and HPV18 was observed. The overall agreement between p16 overexpression and HPV detection by the AmpFire Multiplex HR-HPV assay in 145 OPSCC samples was 93.8%, with a Cohen κ coefficient of 0.848. The AmpFire HPV Tests are simple assays for detection and genotyping of HPV-DNA in OPSCC FFPE samples and can be easily implemented in the clinical practice setting for HPV-DNA detection.
人乳头瘤病毒（HPV）相关的口咽鳞状细胞癌（OPSCC）与 HPV 阴性肿瘤相比具有明显不同的临床特征，特别是在治疗反应和生存结局方面。本研究旨在评估 AmpFire 多重 HR-HPV 检测，用于检测和 HPV 15 种高危型（HR）在福尔马林固定、石蜡包埋（FFPE）样本中的基因分型，并鉴定 HPV 驱动的 OPSCC。对 160 例 OPSCC FFPE 标本和 23 例其他头颈部原发性部位的样本进行了 DNA 检测。结果与线性阵列 HPV-DNA 基因分型检测的结果进行了比较。线性阵列和 AmpFire 多重 HR-HPV 检测显示，对于所有样本，特别是对于 OPSCC，总体一致性协议分别为 98.9%和 99.4%，Cohen κ 系数分别为 0.972 和 0.984。HPV16 和 HPV18 的一致性为 100%。在 145 例 OPSCC 样本中，p16 过表达和 AmpFire 多重 HR-HPV 检测 HPV 的总体一致性为 93.8%，Cohen κ 系数为 0.848。AmpFire HPV 检测是一种简单的检测方法，用于检测和 HPV-DNA 的 HPV 基因分型在 OPSCC FFPE 样本中，并且可以很容易地在临床实践中实施 HPV-DNA 的检测。
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