A novel tailed primer nucleic acid test for detection of HPV 16, 18 and 45 DNA at the point of care

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dc.citation.articleNumber20397
dc.citation.journalTitleScientific Reports
dc.citation.volumeNumber13
dc.contributor.authorChang, Megan M.
dc.contributor.authorMa, Ariel
dc.contributor.authorNovak, Emilie Newsham
dc.contributor.authorBarra, Maria
dc.contributor.authorKundrod, Kathryn A.
dc.contributor.authorMontealegre, Jane Richards
dc.contributor.authorScheurer, Michael E.
dc.contributor.authorCastle, Philip E.
dc.contributor.authorSchmeler, Kathleen
dc.contributor.authorRichards-Kortum, Rebecca
dc.date.accessioned2024-05-03T15:51:20Z
dc.date.available2024-05-03T15:51:20Z
dc.date.issued2023
dc.description.abstractCervical cancer is a leading cause of death for women in low-resource settings despite being preventable through human papillomavirus (HPV) vaccination, early detection, and treatment of precancerous lesions. The World Health Organization recommends high-risk HPV (hrHPV) as the preferred cervical cancer screening strategy, which is difficult to implement in low-resource settings due to high costs, reliance on centralized laboratory infrastructure, and long sample-to-answer times. To help meet the need for rapid, low-cost, and decentralized cervical cancer screening, we developed tailed primer isothermal amplification and lateral flow detection assays for HPV16, HPV18, and HPV45 DNA. We translated these assays into a self-contained cartridge to achieve multiplexed detection of three hrHPV genotypes in a disposable cartridge. The developed test achieves clinically relevant limits of detection of 50–500 copies per reaction with extracted genomic DNA from HPV-positive cells. Finally, we performed sample-to-answer testing with direct lysates of HPV-negative and HPV-positive cell lines and demonstrated consistent detection of HPV16, HPV18, and HPV45 with 5000–50,000 cells/mL in < 35 min. With additional optimization to improve cartridge reliability, incorporation of additional hrHPV types, and validation with clinical samples, the assay could serve as a point-of-care HPV DNA test that improves access to cervical cancer screening in low-resource settings.
dc.identifier.citationChang, M. M., Ma, A., Novak, E. N., Barra, M., Kundrod, K. A., Montealegre, J. R., Scheurer, M. E., Castle, P. E., Schmeler, K., & Richards-Kortum, R. (2023). A novel tailed primer nucleic acid test for detection of HPV 16, 18 and 45 DNA at the point of care. Scientific Reports, 13(1), 20397. https://doi.org/10.1038/s41598-023-47582-y
dc.identifier.digitals41598-023-47582-y
dc.identifier.doihttps://doi.org/10.1038/s41598-023-47582-y
dc.identifier.urihttps://hdl.handle.net/1911/115626
dc.language.isoeng
dc.publisherSpringer Nature
dc.rightsExcept where otherwise noted, this work is licensed under a Creative Commons Attribution (CC BY) license. Permission to reuse, publish, or reproduce the work beyond the terms of the license or beyond the bounds of fair use or other exemptions to copyright law must be obtained from the copyright holder.
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.titleA novel tailed primer nucleic acid test for detection of HPV 16, 18 and 45 DNA at the point of care
dc.typeJournal article
dc.type.dcmiText
dc.type.publicationpublisher version
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