A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care
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 screeni...
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Nature Portfolio
2025-01-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-024-79472-2 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Chelsey A. Smith |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e6b665984f1c46778c3aaf5ae3c7e936 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-e6b665984f1c46778c3aaf5ae3c7e9362025-01-26T12:33:41ZengNature PortfolioScientific Reports2045-23222025-01-0115111110.1038/s41598-024-79472-2A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of careChelsey A. Smith0Sai Paul1Karen E. Haney2Sonia G. Parra3Meaghan Bond4Leticia López5Mauricio Maza6Juan Felix7Preetha Ramalingam8Pablo Escobar9Philip E. Castle10Kathleen M. Schmeler11Rebecca R. Richards-Kortum12Department of Bioengineering, Rice UniversityDepartment of Bioengineering, Rice UniversityDepartment of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science CenterDepartment of Bioengineering, Rice UniversityDepartment of Bioengineering, Rice UniversityBasic Health InternationalBasic Health InternationalBasic Health InternationalDepartment of Pathology, The University of Texas MD Anderson Cancer CenterLiga Contra el Cáncer de El SalvadorDivisions of Cancer Prevention and Cancer Epidemiology and Genetics, National Cancer InstituteDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer CenterDepartment of Bioengineering, Rice UniversityAbstract 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.https://doi.org/10.1038/s41598-024-79472-2 |
| spellingShingle | 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 A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care Scientific Reports |
| title | A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care |
| title_full | A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care |
| title_fullStr | A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care |
| title_full_unstemmed | A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care |
| title_short | A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care |
| title_sort | paper based hpv e7 oncoprotein assay for cervical precancer detection at the point of care |
| url | https://doi.org/10.1038/s41598-024-79472-2 |
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