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Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test
Antone R Opekun1,2, Claudia Zierold3, Ashli Rode3
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Baylor College of Medicine, Houston, TX 77030, USA.
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.
Insights
The LIAISON® Meridian assay offers reliable, noninvasive stool testing for Helicobacter pylori (H. pylori) infection. It demonstrates excellent agreement with invasive biopsy methods, improving H. pylori diagnosis.
Area of Science:
- Clinical diagnostics
- Microbiology
- Gastroenterology
Background:
- Helicobacter pylori (H. pylori) stool antigen tests are valuable diagnostic biomarkers.
- Existing H. pylori assays exhibit variable clinical performance.
- Need for reliable, noninvasive H. pylori diagnostic methods.
Purpose of the Study:
- To assess the clinical performance of the automated LIAISON® Meridian H. pylori SA assay.
- To compare the assay's accuracy against established invasive diagnostic methods.
Main Methods:
- Prospective, multisite study including adult patients undergoing esophagogastroduodenoscopy.
- Collection of biopsy and stool specimens for H. pylori testing.
- Composite Reference Method included histology, culture, and rapid urease test.
Main Results:
- Study included 277 patients; 24.2% prevalence of H. pylori infection.
- LIAISON® Meridian assay showed very good agreement with the Composite Reference Method (Cohen's kappa = 0.922).
- High sensitivity (95.5%) and specificity (97.6%) were observed.
Conclusions:
- The LIAISON® Meridian H. pylori SA assay provides reliable noninvasive H. pylori testing.
- Assay performance is in very good agreement with invasive, biopsy-based methods.
- Clinical trial identifiers: NCT03060746 (pretherapy) and NCT03060733 (posttherapy).
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