宫颈癌是全球关注的问题，每年报告有604,000例新病例和342,000例死亡病例，其中绝大多数在低收入国家被诊断出。尽管高危人乳头瘤病毒(HR HPV)引发的宫颈癌已通过预防性疫苗变得高度可预防，但筛查计划对于接种疫苗机会有限及已曾暴露于HR HPV感染的老年妇女群体的宫颈癌发生控制至关重要。HPV分子检测的涌现提供了一种比细胞学筛查更敏感准确的诊断选择。鉴于HPV DNA检测呈现出低阳性预测值，导致不必要的治疗，高危HPV型别的E6致癌蛋白因其在转化的HPV阳性癌细胞中过表达而成为一种有前途的诊断标志物。基于此，本研究旨在获得针对全球最常见的高危HPV型别之一HPV18的E6致癌蛋白的单克隆抗体（mAbs），以开发一种高度特异性和敏感性的间接竞争性酶联免疫吸附测定法(icELISA)。通过结合耐受和免疫化策略来产生分泌HPV18 E6 mAbs的杂交瘤细胞，以避免与低危HPV型别6和11的E6蛋白发生交叉反应。我们选择了7D2杂交瘤克隆，该克隆能识别HPV18 E6，并对高危HPV45的E6致癌蛋白显示一定的交叉反应。 7D2抗体使得开发一种敏感、可靠和重复性好的icELISA成为可能，该方法可以检测和定量宫颈癌进展的少量HPV18 E6生物标志物。本研究建立了一种有效的基于7D2的icELISA方法，可用于早期检测和定量宫颈拭子样本中的HPV18 E6致癌蛋白，以实现癌症预防。 版权：© 2023 Contreras et al. 这是一篇遵循创作共用许可(CC BY)协议的开放获取文章，允许任何媒体在署名原作者和出处的前提下进行自由使用、传播和复制。

Cervical cancer represents a global concern with 604,000 new cases and 342,000 deaths reported annually, with the vast majority diagnosed in low income countries. Despite high-risk Human Papillomavirus (HR HPV)-induced cervical cancer has become highly preventable through prophylactic vaccines, screening programs are critical in the control of cervical carcinogenesis in populations with limited access to vaccination and in older generations of women who have already been exposed to HR HPV infection. The surge of HPV molecular tests has provided a more sensitive and accurate diagnostic alternative to cytology screening. Given that HPV DNA testing presents a low positive predicted value, leading to unnecessary treatment, the E6 oncoprotein from HR HPV types arises as a promising diagnostic marker for its overexpression in transformed HPV-positive cancer cells. For these reasons, this study aimed at obtaining monoclonal antibodies (mAbs) against the E6 oncoprotein of one of the most prevalent HR HPV types worldwide, HPV18, in order to develop a highly specific and sensitive indirect competitive ELISA (icELISA). The production of hybridomas secreting HPV18 E6 mAbs was carried out through a combined tolerization and immunization strategy, in order to avoid cross-reactivity with the E6 protein from low-risk HPV types 6 and 11. We selected the 7D2 hybridoma clone, which recognized HPV18 E6 and showed some cross-reactivity against the HR HPV45 E6 oncoprotein. The 7D2 mAb enabled the development of a sensitive, reliable and reproducible icELISA to detect and quantify small amounts of HPV18 E6 biomarker for cervical cancer progression. The present study establishes a valid 7D2-based icELISA that constitutes a promising bioanalytical method for the early detection and quantification of HPV18 E6 oncoprotein in cervical swab samples and cancer prevention.Copyright: © 2023 Contreras et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.