Latex Agglutination Turbidimetric Immunoassay Versus Enzyme-Linked Immunosorbent Assay for Helicobacter pylori: An Observational Study.

Abstract

Background: Helicobacter pylori antibody levels in the blood are currently measured using an enzyme-linked immunosorbent assay (ELISA). In April 2016, FUJIFILM Wako Pure Chemical Corporation launched the “L-type Wako Helicobacter pylori antibody J” test, which is based on the latex agglutination turbidimetric immunoassay. In this study, we investigated the usefulness of the Wako test. Methods: We measured H. pylori antibody levels using both ELISA and Wako tests in 180 patients who underwent esophagogastroduodenoscopy at our hospital between September 2017 and February 2019. Ninety patients had H. pylori infections. We calculated the diagnostic accuracy, sensitivity, and specificity of each test and the concordance rate between the two tests. If the lower limits of 90% confidence intervals (CI) for each diagnostic validity exceeded the 85% threshold, the usefulness of the diagnostic test was confirmed. Results: Diagnostic accuracy, sensitivity, and specificity were 94.4% (90% CI; 90.8–97.0%), 94.4% (90% CI; 88.7–97.8%), and 94.4% (90% CI; 88.7–97.8%), respectively, using the Wako test, and 94.4% (90% CI; 90.8–97.0%), 88.9% (90% CI; 81.9–93.8%), and 100% (90% CI; 96.0–100%), respectively, using ELISA. The concordance rate between the two tests was high (κ = 0.8444). Conclusions: We confirmed the usefulness of the Wako test, especially when screening for H. pylori infection, due to its high sensitivity.Trial registration: We retrospectively registered the data of this study.