A Paper-Based HPV E7 Oncoprotein Assay for Cervical Precancer Detection at the Point of Care

Authors

• Chelsey A Smith
• Sai Paul
• Karen E Haney
• Sonia G Parra
• Meaghan Bond
• Leticia López
• Mauricio Maza
• Juan Felix
• Preetha Ramalingam
• Pablo Escobar
• Philip E Castle
• Kathleen M Schmeler
• Rebecca R Richards-Kortum

Language

English

Publication Date

1-24-2025

Journal

Scientific Reports

DOI

10.1038/s41598-024-79472-2

PMID

39856147

PMCID

PMC11760965

PubMedCentral® Posted Date

1-24-2025

PubMedCentral® Full Text Version

Post-print

Abstract

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.

Keywords

Humans, Female, Uterine Cervical Neoplasms, Papillomavirus E7 Proteins, Papillomavirus Infections, Early Detection of Cancer, Precancerous Conditions, Point-of-Care Systems, Paper, Uterine Cervical Dysplasia, Sensitivity and Specificity, Oncogene proteins, Cancer screening, Cervical cancer

Published Open-Access

yes

Recommended Citation

Smith, Chelsey A; Paul, Sai; Haney, Karen E; et al., "A Paper-Based HPV E7 Oncoprotein Assay for Cervical Precancer Detection at the Point of Care" (2025). Faculty, Staff and Student Publications. 4376.
https://digitalcommons.library.tmc.edu/uthmed_docs/4376