Performance of a rapid, visual fingerstick serology self-test for Helicobacter pylori detection and typing: A prospective multicenter diagnostic accuracy study.

Abstract

Objectives: Type I Helicobacter pylori (H. pylori) strains exhibit high levels of virulence. In this study, a rapid, visual self-testing kit for H. pylori typing using one drop of finger blood was developed based on the latex agglutination test (LAT). A prospective multicenter diagnostic accuracy study (ChiCTR2400082329) was conducted to evaluate its performance.

Methods: Each participant recruited from the Department of Gastroenterology or the Physical Examination Center of four centers performed the novel LAT and interpreted the results independently. The performance of the novel LAT for H. pylori typing in screening population (individuals voluntarily undergoing H. pylori infection screening, regardless of the presence of gastrointestinal symptoms) was evaluated using the consistent results of the ¹³C-urea breath test (¹³C-UBT), quantum dot-based immunofluorescence (QD) assay and immunoblotting (IB) assay conducted by professionals as the reference standard. This strict reference standard was adopted to ensure diagnostic accuracy for both active infection and strain typing.

Results: A total of 1,330 participants with consistent diagnostic data (¹³C-UBT, QD, and IB assays) were included in the final analysis. Compared with the reference standard, the novel LAT achieved a sensitivity, specificity, and accuracy of 93.67% [95% CI, 88.35%-96.75%], 97.86% [95% CI, 96.82%-98.59%], and 97.37% [95% CI, 96.44%-98.16%], respectively in identifying type I H. pylori infection.

Conclusions: The novel LAT developed in this study can potentially be used for the identification of type I H. pylori infection in home self-screening and large-scale population screening.