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Developing a User-Friendly Oropharyngeal HPV-16 Point-of-Care Diagnostic: HPV-16 Virus Detection in Oral Rinse Sample Matrix With Colorimetric Loop-Mediated Isothermal Amplification

Halphen, J.; Wright, N. A.; Fisher, S.; Juarez, S. J. I.; Sanchez, L.; Riedel, T. E.

2024-05-16 infectious diseases
10.1101/2024.05.15.24307441 medRxiv
Show abstract

Human papillomavirus type 16 (HPV-16) is a highly carcinogenic variant that is responsible for the majority of human oropharyngeal cancers. HPV-16 is critically under-tested, and there are currently no commercially available HPV-16 diagnostics for oral infection sites. We developed an oral HPV-16 diagnostic system with the goal of being as user-friendly and non-invasive as possible. The system tests an oral rinse sample from the patient, is interpreted via a color change from pink to yellow, and can be incubated in a battery-powered coffee mug. The colorimetric loop-mediated isothermal amplification-based diagnostic is sensitive to synthetic HPV-16 E7/E1 DNA at levels as low as 103 copies after 20 minutes of incubation. This study supports the potential to develop an easy-to-assemble and easy-to-use diagnostic for oropharyngeal HPV-16 infections.

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