Department of Epidemiology, School of Public Health, The George Washington University, Washington, DC.
Department of Biostatistics and Bioinformatics, School of Public Health, The George Washington University, Washington, DC.
J Low Genit Tract Dis. 2023 Jul 1;27(3):248-251. doi: 10.1097/LGT.0000000000000750. Epub 2023 May 17.
The aim of the study is to determine whether a positive OncoE6 Anal Test result has statistically significant higher odds of being associated with high-grade squamous intraepithelial lesion (HSIL) and to calculate sensitivity and specificity of this test for predicting HSIL in adult men who have sex with men and are living with HIV (MSMLWH).
Men living with HIV 18 years or older having ≥atypical squamous cells of undetermined significance-grade anal cytology results were eligible to enroll in this cross-sectional study. Anal samples were collected just before the high-resolution anoscopy procedure. OncoE6 Anal Test results were compared with histology, the reference standard. Sensitivity, specificity, and odds ratio were calculated using HSIL as the threshold.
Two hundred seventy-seven consented MSMLWH were enrolled between June 2017 and January 2022. Of these, 219 (79.1%) had biopsies obtained and histology performed; 81 of 219 participants (37%) had 1 or more biopsies with HSIL results while the remaining 138 of 219 (63%) had only low-grade squamous intraepithelial lesion or were negative for dysplasia. Anal samples from 7 participants (8.6%, 7/81) with HSIL and 3 (2.2%, 3/138) with low-grade squamous intraepithelial lesion had positive OncoE6 Anal Test results. Odds of having HSIL were 4.26 times higher among participants testing positive for HPV16/HPV18 E6 oncoprotein(s) (OR = 4.26, 95% CI = 1.07-16.95, p = .04). The OncoE6 Anal Test demonstrated excellent specificity, 97.83% (93.78-99.55), but poor sensitivity, 8.64% (3.55-17.0).
In this highest-risk population for anal cancer, one could combine the OncoE6 Anal Test, having excellent specificity, with the anal Pap test, having higher sensitivity. Patients found having both an abnormal anal Pap and positive OncoE6 Anal Test result could be triaged for rapid scheduling of their high-resolution anoscopy.
本研究旨在确定 OncoE6 Anal Test 阳性结果是否与高级别鳞状上皮内病变（HSIL）具有统计学显著关联，并计算该检测方法在患有 HIV 的男男性行为者（MSMLWH）中预测 HSIL 的敏感性和特异性。
18 岁或以上、≥非典型鳞状细胞意义不明确-肛门细胞学结果的 HIV 感染者有资格参加这项横断面研究。在进行高分辨率肛门镜检查之前采集肛门样本。OncoE6 Anal Test 结果与组织学（参考标准）进行比较。使用 HSIL 作为阈值计算敏感性、特异性和优势比。
2017 年 6 月至 2022 年 1 月期间，共纳入 277 名同意参加的 MSMLWH。其中，219 名（79.1%）进行了活检和组织学检查；219 名参与者中有 81 名（37%）有 1 个或多个活检结果为 HSIL，而其余 138 名（63%）仅有低度鳞状上皮内病变或无发育不良。81 名 HSIL 患者中有 7 名（8.6%，7/81）和 138 名低度鳞状上皮内病变患者中有 3 名（2.2%，3/138）的肛门样本的 OncoE6 Anal Test 结果为阳性。HPV16/HPV18 E6 癌蛋白（OR = 4.26，95%CI = 1.07-16.95，p =.04）检测阳性的参与者发生 HSIL 的可能性是检测阴性的参与者的 4.26 倍。OncoE6 Anal Test 显示出极好的特异性，为 97.83%（93.78-99.55），但敏感性较差，为 8.64%（3.55-17.0）。
在这个肛门癌风险最高的人群中，人们可以将特异性极佳的 OncoE6 Anal Test 与敏感性更高的肛门巴氏试验相结合。发现肛门巴氏试验异常和 OncoE6 Anal Test 阳性的患者可以进行快速高分辨率肛门镜检查。
