Rapid detection of Helicobacter pylori and its virulence genes by fluorescence-chromogenic double-indicator LAMP (FC-LAMP)

Helicobacter pylori ( H. pylori ) is a risk factor of gastrointestinal diseases. Vacuolating cytotoxin A (VacA) is a key component of the pathogenicity of H. pylori for gastric diseases , and detection for virulence genotypes facilitates precise clinical diagnosis and individual treatment. Hence, a more accurate, convenient, and highly sensitive detection method is urgently needed. In this study, we developed a method based on fluorescence-colorimetric dual-indicator loop-mediated isothermal amplification (FC-LAMP), allowing for naked-eye readout, using a constant temperature water bath within 40 min in clinical settings. Such an excellent sensitivity and specificity, and user-friendly operation approach achieved a limit of 10 −6  ng/μl for 16 s rRNA detection of H. pylori , and 100 % specificity for 55 clinical gastric fluid samples compared with the immunofluorescence staining (IFS) and quantitative polymerase chain reaction (qPCR) as reference methods. In short, this study offers a new strategy for detection of H. pylori and its virulence genotype in primary hospitals and in limited resources settings, facilitating individualized precision eradication of H. pylori .