用于口咽鳞癌组织学标本中 HPV DNA 检测的 VisionArray® 芯片测定的验证

IF 3.2 Q2 PATHOLOGY

Head & Neck Pathology Pub Date : 2024-03-27 DOI:10.1007/s12105-024-01628-3

Hani Ibrahim Channir, Simone Kloch Bendtsen, Linea Cecilie Melchior, Pia Rovsing Sandholm, Christine Mordhorst, Amanda-Louise Fenger Carlander, Christian von Buchwald, Katalin Kiss

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引用次数: 0

摘要

背景：人类乳头状瘤病毒（HPV）的检测对口咽鳞状细胞癌（OPSCC）的诊断和治疗有多方面的影响。不同机构选择的 HPV 检测试剂和检测算法各不相同，在成本、检测目标、技术可行性和周转时间方面也不尽相同。在本研究中，我们旨在以之前应用的标准泛HPV DNA PCR检测方法为参考，验证VisionArray® HPV芯片在福尔马林固定和石蜡包埋（FFPE）OPSCC样本中的应用：验证队列包括先前诊断为HPV DNA阳性OPSCC（n = 80）、HPV DNA阴性OPSCC（n = 21）患者的FFPE组织样本，以及由Warthin's肿瘤（n = 20）和侧颈支裂囊肿（n = 14）组成的良性肿瘤样本组。所有样本均采用 p16 免疫组化、pan-HPV DNA PCR 和 VisionArray® HPV 芯片进行检测：结果：VisionArray® HPV 芯片检测的总体灵敏度和特异性分别为 100% [95% CI 95.5%; 100.0%] 和 96.3% [95% CI 87.3%; 99.6%]，阳性预测值和阴性预测值分别为 97.6% [95% CI 91.5%; 99.7%] 和 100% [95% CI 93.2%; 100%]：VisionArray®HPV芯片检测法可为OPSCC的FFPE组织样本的高危HPV检测提供快速、同步的41种临床相关HPV类型的基因分型。

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Validation of the VisionArray® Chip Assay for HPV DNA Testing in Histology Specimens of Oropharyngeal Squamous Cell Carcinoma.

Background: The detection of human papillomavirus (HPV) has several implications in the diagnostic work-up and management of oropharyngeal squamous cell carcinoma (OPSCC). The choice of HPV detection assay and testing algorithms differ across institutions and vary in cost, detection targets, technical feasibility, and turnaround time. In this study, we aimed to validate the VisionArray® HPV Chip for formalin-fixed and paraffin-embedded (FFPE) samples of OPSCC using the previously applied standard pan-HPV DNA PCR assay as a reference.

Methods: The validation cohort consisted of FFPE tissue samples from patients previously diagnosed with HPV DNA-positive OPSCC (n = 80), HPV DNA-negative OPSCC (n = 21), and a benign group of tumor samples consisting of Warthin's tumors (n = 20) and branchial cleft cysts of the lateral neck (n = 14). All samples were tested with p16 immunohistochemistry, pan-HPV DNA PCR, and the VisionArray® HPV Chip.

Results: The overall sensitivity and specificity of the VisionArray® HPV Chip assay were 100% [95% CI 95.5%; 100.0%] and 96.3% [95% CI 87.3%; 99.6%] and the positive predictive value and negative predictive value were 97.6% [95% CI 91.5%; 99.7%] and 100% [95% CI 93.2%; 100%], respectively.

Conclusions: The VisionArray® HPV Chip assay can be recommended for high-risk HPV testing in FFPE tissue samples from OPSCC, providing both a fast and simultaneous genotyping for 41 clinically relevant HPV types.

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来源期刊

Head & Neck Pathology PATHOLOGY-

CiteScore

5.70

自引率

9.50%

发文量

期刊介绍： Head & Neck Pathology presents scholarly papers, reviews and symposia that cover the spectrum of human surgical pathology within the anatomic zones of the oral cavity, sinonasal tract, larynx, hypopharynx, salivary gland, ear and temporal bone, and neck. The journal publishes rapid developments in new diagnostic criteria, intraoperative consultation, immunohistochemical studies, molecular techniques, genetic analyses, diagnostic aids, experimental pathology, cytology, radiographic imaging, and application of uniform terminology to allow practitioners to continue to maintain and expand their knowledge in the subspecialty of head and neck pathology. Coverage of practical application to daily clinical practice is supported with proceedings and symposia from international societies and academies devoted to this field. Single-blind peer review The journal follows a single-blind review procedure, where the reviewers are aware of the names and affiliations of the authors, but the reviewer reports provided to authors are anonymous. Single-blind peer review is the traditional model of peer review that many reviewers are comfortable with, and it facilitates a dispassionate critique of a manuscript.