Developing Paper-Based Enzyme-Linked Immunoassays for Highly Sensitive Diagnosis at the Point-of-Care
| dc.contributor.advisor | Richards-Kortum, Rebecca | |
| dc.creator | Smith, Chelsey Anne | |
| dc.date.accessioned | 2022-10-11T19:24:38Z | |
| dc.date.available | 2023-08-01T05:01:12Z | |
| dc.date.created | 2021-08 | |
| dc.date.issued | 2021-06-25 | |
| dc.date.submitted | August 2021 | |
| dc.date.updated | 2022-10-11T19:24:38Z | |
| dc.description.abstract | Cervical cancer is a leading cause of cancer death among women in low-resource settings, largely due to disparities in the availability and affordability of cancer screening and early detection programs. Access to screening and diagnostic tests are often limited by high per-test costs, infrastructure requirements, and the need for highly trained personnel. Because of this, over 85% of cervical cancer deaths occur in resource-limited areas. This thesis describes the development of a highly sensitive paper-based enzyme-linked immunoassay (ELISA) platform that is low-cost and easy-to-use. The platform is then applied towards developing two point-of-care assays for cervical cancer: a human papillomavirus (HPV) DNA assay and an HPV E7 oncoprotein assay for cervical cancer screening and diagnosis respectively, as HPV is the etiologic agent for most cervical cancers. First, this work presents the development of an HPV DNA paper assay. The assay is low-cost, does not require expensive equipment or infrastructure, and runs within an hour. Moreover, the assay is easy-to-use, with seven user steps and acceptable System Usability Scale (SUS) scores from usability assessments in El Salvador and Mozambique. Furthermore, the assay has equivalent sensitivity to the gold standard digene Hybrid Capture 2 assay. In a set of 16 clinical samples, the point-of-care assay was able to determine HPV status with 93.75% accuracy. Next, this work describes an HPV E7 paper oncoprotein assay for higher specificity in diagnosis of precancerous lesions. Similar to the HPV DNA paper assay, the HPV E7 paper assay has a low per-test cost, no infrastructure requirements, and can be completed in five simple user steps. In a set of 10 clinical samples, the sample-to-answer assay was able to detect CIN2+ samples with 90% accuracy. In combination, the paper-based HPV DNA and oncoprotein tests demonstrate comparable performance to gold standard technologies in a point-of-care format appropriate for use in resource-limited settings. After additional clinical validation, these assays have the ability to improve access to cervical cancer screening and diagnosis in resource-limited settings. | |
| dc.embargo.terms | 2023-08-01 | |
| dc.format.mimetype | application/pdf | |
| dc.identifier.citation | Smith, Chelsey Anne. "Developing Paper-Based Enzyme-Linked Immunoassays for Highly Sensitive Diagnosis at the Point-of-Care." (2021) Diss., Rice University. <a href="https://hdl.handle.net/1911/113693">https://hdl.handle.net/1911/113693</a>. | |
| dc.identifier.uri | https://hdl.handle.net/1911/113693 | |
| dc.language.iso | eng | |
| dc.rights | Copyright is held by the author, unless otherwise indicated. Permission to reuse, publish, or reproduce the work beyond the bounds of fair use or other exemptions to copyright law must be obtained from the copyright holder. | |
| dc.subject | point-of-care | |
| dc.subject | cervical cancer | |
| dc.subject | ELISA | |
| dc.subject | paper-based | |
| dc.subject | diagnostics | |
| dc.subject | HPV | |
| dc.title | Developing Paper-Based Enzyme-Linked Immunoassays for Highly Sensitive Diagnosis at the Point-of-Care | |
| dc.type | Thesis | |
| dc.type.material | Text | |
| thesis.degree.department | Bioengineering | |
| thesis.degree.discipline | Engineering | |
| thesis.degree.grantor | Rice University | |
| thesis.degree.level | Doctoral | |
| thesis.degree.name | Doctor of Philosophy |
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