Smith Chelsey A, Paul Sai, Haney Karen E, Parra Sonia G, Bond Meaghan, López Leticia, Maza Mauricio, Felix Juan, Ramalingam Preetha, Escobar Pablo, Castle Philip E, Schmeler Kathleen M, Richards-Kortum Rebecca R
Department of Bioengineering, Rice University, Houston, TX, USA.
Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center, Houston, TX, USA.
Sci Rep. 2025 Jan 24;15(1):3041. doi: 10.1038/s41598-024-79472-2.
Cervical cancer, while preventable through screening and treatment of cervical precancer, remains a global challenge with a disproportionately high burden of disease in resource-limited settings, especially in low- and middle-income countries (LMICs). Lack of affordable, easy-to-use screening and diagnostic tests contributes to this disparity. Most commercially available tests are not appropriate for use in LMICs due to resource constraints. Specifically, HPV mRNA and oncoprotein tests that have high specificity for cervical precancer and cancer require complex sample preparation protocols and expensive instrumentation. To address these limitations, an HPV E7 oncoprotein assay for HPV16, 18, and 45 was developed that is appropriate for use at the point of care. The assay is paper-based, involves only five simple steps, and does not require instrumentation. A clinically relevant limit of detection was demonstrated with cellular samples. Additionally, clinical performance was demonstrated with a small pilot study (n = 19), in which the HPV E7 paper-based assay was found to have 95% accuracy when compared to histopathologic diagnosis of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). With further clinical validation, this assay could enable highly specific point-of-care testing for cervical precancer and cancer that is instrumentation-free, affordable, and ideal for use in resource-limited settings.
宫颈癌虽然可通过筛查和治疗宫颈上皮内瘤变来预防，但仍是一项全球性挑战，在资源有限的环境中，尤其是在低收入和中等收入国家（LMICs），疾病负担过高且分布不均。缺乏负担得起且易于使用的筛查和诊断测试加剧了这种差异。由于资源限制，大多数市售测试不适用于LMICs。具体而言，对宫颈上皮内瘤变和癌症具有高特异性的HPV mRNA和癌蛋白测试需要复杂的样本制备方案和昂贵的仪器设备。为了解决这些限制，开发了一种针对HPV16、18和45的HPV E7癌蛋白检测方法，适用于即时检测。该检测方法基于纸质，仅涉及五个简单步骤，且无需仪器设备。在细胞样本中证明了具有临床相关性的检测限。此外，通过一项小型试点研究（n = 19）证明了其临床性能，在该研究中，与宫颈上皮内瘤变2级或更严重（CIN2+）的组织病理学诊断相比，基于纸质的HPV E7检测方法的准确率为95%。通过进一步的临床验证，该检测方法可实现对宫颈上皮内瘤变和癌症的高特异性即时检测，无需仪器设备，价格低廉，非常适合在资源有限的环境中使用。
