Fecal Pancreatic Elastase-1 CLIA Kit

The Fecal Pancreatic Elastase-1 CLIA Kit is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of human pancreatic elastase-1 antigen levels in stool.

Compatible with the ECL100 Chemiluminescent Immunoassay Analyzer.

FDA Class 1 Exempt. For In Vitro Diagnostic Use.

For Laboratory Professional Use Only.

Manufactured by Epitope Diagnostics, Inc.

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Test Principle of the Fecal Pancreatic Elastase-1 CLIA Kit

This CLIA Kit is designed, developed, and produced for the quantitative measurement of pancreatic elastase-1 antigen in stool samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of the PE-1 antigen.

Assay calibrators, controls, or extracted stool samples are added directly to a reaction vessel. Simultaneously, a biotinylated antibody, a streptavidin-coated magnetic particle, and subsequently an acridinium ester-conjugated antibody are added to the reaction vessel. The magnetic particles capture the biotin antibody and an immunocomplex in the form of “magnetic particles – biotinylated anti-PE-1 antibody–PE-1 antigen–acridinium ester conjugated anti-PE-1 antigen-antibody”. Materials bound to the solid phase are held in a magnetic field while unbound materials are washed away.

Then, trigger solutions are added to the reaction vessel, and the light generated by the reaction is measured using the ECL100 Chemiluminescent Immunoassay Analyzer. The relative light units (RLU) are proportional to the concentration of PE-1 antigen in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in fecal PE-1 antigen concentration.