Fecal C. Difficile GDH CLIA Kit

The Fecal C. Difficile GDH CLIA Kit is a chemiluminescent immunoassay (CLIA) kit intended for the quantitative determination of Clostridium Difficile GDH (C. Difficile) 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.

Please contact us for a quote.

Test Principle of the Fecal C. Difficile GDH CLIA Kit

This CLIA is designed, developed, and produced for the quantitative measurement of C. Difficile GDH antigen in fecal samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of the GDH 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 vessel. The magnetic particles capture the biotin antibody and an immunocomplex in the form of “magnetic particles – biotinylated anti-GDH antibody –GDH antigen– acridinium ester conjugated anti-GDH antigen-antibody.”

The materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the trigger solution is added to the reaction vessel, and the light generated by the reaction is measured with the ECL100 Chemiluminescent Immunoassay Analyzer. The relative light units (RLU) are proportional to the concentration of GDH antigen in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in fecal C. Difficile antigen concentration.