Language

English

Publication Date

5-1-2024

Journal

Analytical Biochemistry

DOI

10.1016/j.ab.2024.115480

PMID

38331373

PMCID

PMC11899860

PubMedCentral® Posted Date

5-1-2025

PubMedCentral® Full Text Version

Author MSS

Abstract

Isothermal nucleic acid amplification methods have many advantages for use at the point of care. However, there is a lack of multiplexed isothermal amplification tests to detect multiple targets in a single reaction, which would be valuable for many diseases, such as infection with high-risk human papillomavirus (hrHPV). In this study, we developed a multiplexed loop-mediated isothermal amplification (LAMP) reaction to detect the three most common hrHPV types that cause cervical cancer (HPV16, HPV18, and HPV45) and a cellular control for sample adequacy. First, we characterized the assay limit of detection (LOD) in a real-time reaction with fluorescence readout; after 30 min of amplification the LOD was 100, 10, and 10 copies/reaction of HPV16, HPV18, and HPV45, respectively, and 0.1 ng/reaction of human genomic DNA (gDNA). Next, we implemented the assay on lateral flow strips, and the LOD was maintained for HPV16 and HPV18, but increased to 100 copies/reaction for HPV45 and to 1 ng/reaction for gDNA. Lastly, we used the LAMP test to evaluate total nucleic acid extracted from 38 clinical samples; compared to qPCR, the LAMP test had 89% sensitivity and 95% specificity. When integrated with sample preparation, this multiplexed LAMP assay could be useful for point-of-care testing.

Keywords

Female, Humans, Uterine Cervical Neoplasms, Human Papillomavirus Viruses, Sensitivity and Specificity, Papillomavirus Infections, Nucleic Acid Amplification Techniques, Human papillomavirus 16, Papillomaviridae, DNA, Viral, Human papillomavirus 18, loop-mediated isothermal amplification, HPV, lateral flow assay, multiplex

Published Open-Access

yes

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