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One-hour extraction-free loop-mediated isothermal amplification HPV DNA assay for point-of-care testing in Maputo,
Maria J Barra1, Alexis F Wilkinson1, Ariel E Ma1
1Department of Bioengineering, Rice University, Houston, TX, USA.
Nature Communications
|August 7, 2025
Summary
A new loop-mediated isothermal amplification (LAMP) HPV DNA test offers affordable, rapid cervical cancer screening. This point-of-care test is suitable for low-resource settings, detecting high-risk human papillomavirus (HPV) types.
Area of Science:
- Molecular diagnostics
- Global health
- Oncology
Background:
- Cervical cancer, primarily caused by human papillomavirus (HPV), disproportionately affects low- and middle-income countries.
- Current HPV DNA testing methods often require extensive laboratory infrastructure and trained personnel, limiting accessibility in resource-limited settings.
- There is a critical need for affordable, point-of-care diagnostic tools for effective cervical cancer screening.
Purpose of the Study:
- To develop and analytically evaluate a novel loop-mediated isothermal amplification (LAMP)-based HPV DNA test.
- To assess the test's performance, including sensitivity and specificity, for detecting high-risk HPV types (16, 18, 45).
- To establish the feasibility of an extraction-free, rapid, and low-cost HPV testing solution for resource-limited settings.
Main Methods:
- Development of a four-step, extraction-free HPV DNA assay utilizing loop-mediated isothermal amplification (LAMP).
- Targeting of oncogenic HPV types 16, 18, and 45, along with a cellular control.
- Analytical evaluation of the assay using clinical samples in Houston, Texas, and Maputo, Mozambique, with results obtained in under one hour using a low-cost benchtop instrument.
Main Results:
- The developed HPV DNA test demonstrated analytical sensitivity comparable to gold standard methods.
- Evaluation with clinical samples showed high concordance: 100% in Houston (n=38) and 93% in Maputo (n=191) compared to a reference test.
- The assay provides results in less than one hour, utilizing a simplified sample preparation and low-cost instrumentation.
Conclusions:
- The developed LAMP-based HPV DNA test is a sensitive, specific, and rapid diagnostic tool.
- The extraction-free, point-of-care nature of this assay makes it highly suitable for cervical cancer screening in resource-limited settings.
- This technology has the potential to significantly expand access to cervical cancer screening and reduce the global burden of the disease.
