Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives.

Abstract

Loop-mediated isothermal amplification (LAMP) has emerged as a rapid and accessible alternative to traditional polymerase chain reactions (PCR) for nucleic acid amplification in research, significantly enhancing pathogen detection in infectious disease diagnostics. This review aims to bridge the gap in the literature regarding the real-world applications of LAMP assays and their potential to improve infectious disease diagnostics across various healthcare settings. We evaluated the current landscape of United States Food and Drug Administration (FDA)-authorized LAMP-based microbial tests, categorizing 30 such tests and detailing their regulatory pathways, such as 510(k) clearance and Emergency Use Authorization (EUA), particularly in response to the COVID-19 pandemic. We comprehensively examine the technical characteristics of LAMP assays, including sample collection, nucleic acid extraction, amplification processes, signal detection, device automation, and their analytical and clinical performance. We highlight the versatility of LAMP assays in diagnostic applications and their growing role in rapid infectious disease. We discuss the advantages and limitations of LAMP technology and identify future directions for its development in infectious disease diagnostics. By analyzing FDA-authorized LAMP-based microbial tests, this review aims to guide healthcare professionals and support future research and product development, ultimately improving patient care.