Evaluating the Utility and Prevalence of HPV Biomarkers in Oral Rinses and Serology for HPV-related Oropharyngeal Cancer
Evaluating the Utility and Prevalence of HPV Biomarkers in Oral Rinses and Serology for HPV-related Oropharyngeal Cancer
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DOI：
10.1158/1940-6207.capr-19-0185
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发表时间：
2019-10-01
影响因子：
3.3
通讯作者：
Fakhry, Carole
中科院分区：
文献类型：
--
作者：
D'Souza, Gypsyamber;Clemens, Gwendolyn;Fakhry, Carole
市售的人乳头瘤病毒（HPV）测定法（批准用于宫颈HPV检测）用于检测HPV相关口咽癌（HPV- opc）的性能尚不清楚。采用ELISA （DEIA）和Cobas法检测口腔冲洗液中HPV DNA、RNA （Aptima）及血清HPV癌基因抗体。探讨各检测方法在HPV-OPC病例和对照组中的敏感性和特异性。在294名“高危”人群（筛查）和133名“高危”人群（已知先前检测到口服致癌HPV (oncHPV) DNA和/或HPV16 E6/E7抗体）中评估了生物标志物的患病率。HPV16 E6抗体的整体检测性能最佳，灵敏度为88%，而DEIA和Cobas的口服HPV16 DNA灵敏度分别为51%和43% （P均< 0.001）。这些试验的特异性具有可比性（>= 98%）。当任何一种oncHPV类型的阳性与HPV16进行相同测试时，敏感性是相当的（DEIA， Cobas和E6抗体分别为60%对51%，40%对43%，92%对88%），但特异性降低了（93%-97%）。Aptima的敏感性较差（23%）。当同时检测HPV16口腔冲洗液DNA和E6抗体（37% - 48%）或多种E抗体（69%-72%）时，敏感性下降。DEIA或Cobas在大约2%的高危人群和高达15%的高危人群中检测到HPV16 DNA。hpv16e6血清阳性率在高危人群和高危人群中分别为2.3%和2.4%。口腔冲洗HPV检测对HPV- opc的敏感性中等至较差，这表明在潜在的筛查方案中会遗漏许多真正的阳性结果。hpv16e6血清抗体是最有希望的生物标志物。
Performance of commercially available human papillomavirus (HPV) assays (approved for cervical HPV detection) is unknown for detecting HPV-related oropharyngeal cancer (HPV-OPC). Assays for detection of HPV DNA [ELISA (DEIA) and Cobas], and RNA (Aptima) in oral rinse samples, and serum HPV oncogene antibodies were evaluated. Sensitivity and specificity of each test was explored among HPV-OPC cases and controls. Biomarker prevalence was evaluated among 294 "at-risk" people (screening) and 133 "high-risk" people 'known to previously have oral oncogenic HPV (oncHPV) DNA and/or HPV16 E6/E7 antibodies detected]. HPV16 E6 antibodies had the best overall test performance with sensitivity of 88%, compared with oral HPV16 DNA sensitivity of 51% by DEIA and 43% by Cobas (each P < 0.001). Specificity was comparable in each of these tests (>= 98%). When positivity for any oncHPV type was compared with HPV16 for the same test, sensitivity was comparable (60% vs. 51%, 40% vs. 43%, and 92% vs. 88% for DEIA, Cobas, and E6 antibodies, respectively), but specificity was reduced (93%-97%). Aptima had poor sensitivity (23%). Sensitivity decreased when cotesting HPV16 oral rinse DNA and E6 antibodies (37%48%), or multiple E antibodies (69%-72%). HPV16 DNA were detected in similar to 2% of the at-risk by either DEIA or Cobas and up to 15% of the high-risk population. HPV16 E6 seroprevalence was 2.3% and 2.4% in the at-risk and high-risk populations, respectively. Oral rinse HPV testing had moderate-to-poor sensitivity for HPV-OPC, suggesting many true positives would be missed in a potential screening scenario. HPV16 E6 serum antibody was the most promising biomarker evaluated.