Helicobacter pylori is a spiral shaped bacterium, living in the mucus of the human digestive tract and is present in half of the world population. Strongly associated with peptic ulcer disease and chronic active gastritis, H.pylori is a major risk factor for gastric adenocarcinoma.Diagnosis of infection can be achieved by non-invasive methods, such as detection of H.pylori antigens in stool sample. The H.pylori stool antigen assay provides a simple alternative to the urea breath test and is appropriate for diagnosis and follow-up of infection.


Key Assay features Number of tests 100


Method


Solid Phase Conjugate


Label / Tracer Sandwich Qualitative


Monoclonal Antibodies to H.pylori Fla A Monoclonal Antibodies to H.pylori Fla A ABEI


Sample volume 200 µl Performance Characteristics


Method Comparison: A total of 324 stool samples collected from subjects were tested by the LIAISON®


H. pylori Stool Antigen ELISA assay. Commercial EIA assay


LIAISON® H. pylori Ag


LIAISON® Equivocal LIAISON® Total


+


ELISA + ELISA - Total 107


0 -0 107


3 1


1 2 3 217


110 1


213 324


A total of 105 stool samples collected from symptomatic patients were tested by the LIAISON®


assay and a H. pylori Stool Antigen ELISA assay Commercial EIA assay


LIAISON® H. pylori Ag


LIAISON® Equivocal LIAISON® Total


+54 0


-0 54


ELISA + ELISA - Total 0


1


50 51


54 1


50 105 Helicobacter Antigen Helicobacter Antigen assay and a


Sample type


Throughput LIAISON® Time to fi rst result


Integral on board stability


Stool


90 results / hour on LIAISON® 170 results / hr on LIAISON® XL


35 minutes 8 weeks


Calibrators availability 2 lyophilized – to be prepared Calibration stability 4 weeks


LIAISON® Helicobacter Antigen assay (code 318200)


LIAISON® Helicobacter Antigen Control set (code 318201)


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