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Human Trafficking Statement
Products: LIAISON® Meridian H. pylori SA
LIAISON® Meridian H. pylori SA
LIAISON<sup>®</sup> Meridian H. pylori SA

The LIAISON® Meridian H. pylori SA is a chemiluminescent assay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool.
The test is an aid in the diagnosis of patients suspected of
H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks.

Product Details
DiaSorin Catalog #: 318200
Kit Size 100 tests
Storage Requirements 2°-8° C
Specimen Type Stool
Assay Format Chemiluminescence (CLIA)
CE Marked No
FDA Yes
Sensitivity (Initial Diagnosis) 95.5%
Specificity (Initial Diagnosis) 98.6%
Sensitivity (Post Eradication) 100%
Hazardous No
Country of Origin USA
Available Within/Outside USA USA only
Suggested CPT Code 87338
Results Interpretation - Diagnostic Ranges
Index Results Interpretation
< 0.90 Negative Indicates the absence of H. pylori stool antigen (or the level of antigen is below that which can be detected by the assay)
≥ 0.90 and < 1.10 Equivocal Equivocal samples should be retested using a new extraction from the original sample to confirm the initial result. Samples that are positive (≥1.10) by the second test should be considered positive. Samples that are negative (<0.90) by the second test should be considered negative. For samples that are equivocal on retesting; a new specimen should be collected and retested.
≥ 1.10 Positive Indicates the presence of detectable H. pylori stool antigen.