One-hour extraction-free loop-mediated isothermal amplification HPV DNA assay for point-of-care testing in Maputo, Mozambique

Abstract Human papillomavirus (HPV) is responsible for nearly all cases of cervical cancer. Affordable point-of-care DNA testing is needed for cervical cancer screening in low- and middle-income countries, where most cervical cancer cases occur. HPV DNA testing typically requires complex lab infrast...

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Main Authors: Maria J. Barra, Alexis F. Wilkinson, Ariel E. Ma, Karthik Goli, Hira Atif, Nafissa M.R.B. Osman, Cesaltina Lorenzoni, Guilhermina Tivir, Eva H. Lathrop, Philip E. Castle, Ming Guo, Jane R. Montealegre, Ellen S. Baker, Mila P. Salcedo, Kathleen M. Schmeler, Rebecca R. Richards-Kortum
Format: Article
Language:English
Published: Nature Portfolio 2025-08-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-025-62454-x
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Summary:Abstract Human papillomavirus (HPV) is responsible for nearly all cases of cervical cancer. Affordable point-of-care DNA testing is needed for cervical cancer screening in low- and middle-income countries, where most cervical cancer cases occur. HPV DNA testing typically requires complex lab infrastructure and trained personnel. In this work, we develop a loop-mediated isothermal amplification (LAMP)-based HPV DNA test, which targets three of the most oncogenic HPV types (HPV16, HPV18, HPV45) and a cellular control and achieves analytical sensitivity comparable to gold standard methods. Our extraction-free sample preparation strategy permits adding sample lysate directly to the LAMP reaction. We utilize a low-cost benchtop heater/fluorimeter, delivering results in less than one hour. We analytically evaluate our assay with clinical samples in Houston, Texas (n = 38) and Maputo, Mozambique (n = 191). Results show 100% and 93% concordance, respectively, with a reference test widely used in low-resource settings. This sensitive and specific four-step assay can potentially expand cervical cancer screening in resource-limited settings.
ISSN:2041-1723