Clinical Performance of the Automated LIAISON® Meridian SA Stool Antigen Test.

BACKGROUND

Antigens derived from can be used as stool biomarkers to assist in the diagnosis of infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian 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. infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian 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 SA assay brings reliable noninvasive testing for 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). infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.