Department of Otolaryngology, National Taiwan University BioMedical Park Hospital, Hsin-Chu, Taiwan.
Department of Laboratory Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Ann Surg Oncol. 2024 Dec;31(13):9117-9124. doi: 10.1245/s10434-024-16058-2. Epub 2024 Aug 17.
Human papillomavirus (HPV) is a crucial prognostic factor in oropharyngeal cancer (OPC). p16 is a surrogate marker for diagnosing HPV+ OPC, however it is not direct evidence of HPV existence.
The purpose of our study was to evaluate an HPV DNA test-Cobas HPV assay-in diagnosing HPV+ OPC through neck lymph node aspiration.
Patients with suspected neck mass who received fine needle aspiration (FNA) or core needle biopsy (CNB) at the National Taiwan University Hospital between January 2018 and December 2022 were reviewed. Besides routine cytology and pathology study, needle rinse fluid was collected for the Cobas HPV assay to detect high-risk HPV.
We analyzed 137 patients with suspected lymph nodes, 32 (23.4%) of whom were HPV+ OPC patients and 105 (76.6%) of whom had non-HPV-related disease. FNA was performed in 31 patients and CNB was performed in 106 patients, according to the size and necrosis status of the lymph nodes. For diagnosing HPV+ OPC, CNB combined with p16 immunohistochemistry staining showed sensitivity of 93.3%, specificity of 97.8%, positive predictive value (PPV) of 87.5%, negative predictive value (NPV) of 98.9%, and accuracy of 97.2%. On the other hand, for the needle rinse Roche Cobas HPV assay, the test showed sensitivity of 96.9%, specificity of 100%, PPV of 100%, NPV of 99.1%, and accuracy of 99.3%. Compared with p16 IHC staining, the Cobas HPV test showed better PPV with statistical significance (p = 0.04).
The Cobas HPV assay is a US FDA-approved, highly automated, and readily used technique to directly detect the presence of high-risk HPV. We recommend utilizing the Cobas HPV assay in combination with routine cytology or histopathology examination in the work-up of neck lymphadenopathy.
人乳头瘤病毒（HPV）是口咽癌（OPC）的一个重要预后因素。p16 是诊断 HPV+OPC 的替代标志物，但它不是 HPV 存在的直接证据。
本研究旨在通过颈部淋巴结抽吸评估 HPV DNA 检测-Cobas HPV 检测-来诊断 HPV+OPC。
回顾性分析 2018 年 1 月至 2022 年 12 月期间在国立台湾大学医院接受细针抽吸（FNA）或核心针活检（CNB）的疑似颈部肿块患者。除了常规细胞学和病理学研究外，还收集了针冲洗液用于 Cobas HPV 检测以检测高危型 HPV。
我们分析了 137 例疑似淋巴结患者，其中 32 例（23.4%）为 HPV+OPC 患者，105 例（76.6%）为非 HPV 相关疾病患者。根据淋巴结的大小和坏死情况，对 31 例患者进行了 FNA 检查，对 106 例患者进行了 CNB 检查。对于诊断 HPV+OPC，CNB 结合 p16 免疫组化染色的敏感性为 93.3%，特异性为 97.8%，阳性预测值（PPV）为 87.5%，阴性预测值（NPV）为 98.9%，准确性为 97.2%。另一方面，对于罗氏 Cobas HPV 检测，该检测的敏感性为 96.9%，特异性为 100%，PPV 为 100%，NPV 为 99.1%，准确性为 99.3%。与 p16 IHC 染色相比，Cobas HPV 检测具有更好的 PPV，具有统计学意义（p=0.04）。
Cobas HPV 检测是一种获得美国食品和药物管理局（FDA）批准的、高度自动化的、易于使用的技术，可以直接检测高危型 HPV 的存在。我们建议在颈部淋巴结肿大的常规细胞学或组织病理学检查中联合使用 Cobas HPV 检测。
