HPV16 L1 in PLWH

Evidence before the study With anal cancer incidence rising, professional societies have issued guidelines recommending regular anal screening across high-risk populations, most notably people living with HIV (PLWH). Current screening methods include sampling cells using anal swabs, eliciting ‘shame’ (consent is sub-optimal) and error (results depend on sampling a region). Recently, we demonstrated that a novel blood-based rapid test for antibodies against HPV16-L1 enables detection of HPV16-induced cancers with high specificity and sensitivity. However, performance in detecting pre-cancerous lesions has not been evaluated to date. Added value of this study This study describes the first investigation of a serological marker in anal cancer screening, and demonstrates for the first time a relationship between serum HPV16-L1 antibody levels and anal dysplasia in PLWH. Our results demonstrate concordance between serology and anal cytology, with serological assay sensitivity particularly high for high grade anal dysplasia. Implications of all the available evidence Blood-based testing for antibodies against HPV16-L1 potentially offers a non-invasive, cost-effective, easy-to-use additional tool for anal dysplasia screening. Serum testing could be easily integrated into current routine visits of PLWH without requiring additional equipment, invasive procedures or specialist training. In settings where regular proctologic assessments are non-feasible or refused by the patients, blood-based testing may enhance compliance with current recommendations for regular screening

研究前置证据
随着肛门癌发病率持续攀升，各专业学会已发布指南，推荐在高危人群中开展常规肛门筛查，尤以人类免疫缺陷病毒感染者（people living with HIV, 简称PLWH）为重点。当前主流筛查方法为肛拭子采集细胞样本，该方式易引发受试者"羞耻感"（知情同意率欠佳）且存在采样误差（检测结果依赖采样区域）。近期本团队已证实，一款新型基于血液的HPV16-L1抗体快速检测试剂，可实现高特异性、高灵敏度的HPV16相关癌症检出，但截至目前，其在癌前病变检测中的性能尚未得到评估。

本研究的新增价值
本研究首次针对肛门癌筛查中的血清学标志物开展系统性探索，并首次证实了HIV感染者血清HPV16-L1抗体水平与肛门异型增生之间的显著关联。研究结果显示，血清学检测与肛门细胞学检测具有良好一致性，且该血清学检测对高级别肛门异型增生的灵敏度尤为突出。

综合现有全部证据的实践启示
针对HPV16-L1抗体的血液检测，有望为肛门异型增生筛查提供一种无创、高性价比且操作简便的辅助工具。该血清检测可轻松融入HIV感染者的常规就诊流程，无需额外设备、侵入性操作或专业培训。在常规肛门直肠专科检查不可行或患者拒绝接受的场景中，血液检测或可大幅提升患者对现有常规筛查指南的依从性。