Abstract
Background Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian Methods This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian Results 277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen′s kappa = 0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV. Conclusion The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy).H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian
Highlights
The accurate diagnosis of Helicobacter pylori (H. pylori) remains clinically important due to its association with several gastroduodenal diseases including peptic ulcer disease, gastric lymphoma, and gastric cancer [1]
Clinical assessment of the new LIAISON® Meridian H. pylori SA stool assay was performed in a multicenter clinical trial
We have shown that the new automated LIAISON® Meridian H. pylori SA assay provides reliable noninvasive testing for active H. pylori infection that is in remarkable agreement with the current, more invasive biopsy-based methods such as histology, culture, or urease
Summary
The accurate diagnosis of Helicobacter pylori (H. pylori) remains clinically important due to its association with several gastroduodenal diseases including peptic (duodenal and gastric) ulcer disease, gastric lymphoma, and gastric cancer [1]. The Japanese healthcare system recently approved the insurance coverage of H. pylori infection diagnosis and eradication in all patients [6]. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the “gold standard” (Composite Reference Method). The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
