CL0824R

Fecal C. Difficlie GDH CLIA Kit

Description

This Chemiluminescence Immunoassay (CLIA) kit is intended for the quantitative determination of Clostridium Difficile GDH (C. Difficile) antigen levels in feces using the ECL100 or ECL25 Immunoassay analyzer.
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For research use only. Not for use in diagnostics procedures.

Background


This CLIA is designed, developed, and produced for the quantitative measurement of GDH antigen in fecal samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of GDH antigen. Assay calibrators, controls, or extracted patient fecal samples are added directly to a reaction vessel. Simultaneously, a biotinylated antibody, a streptavidin coated magnetic particle and subsequentlyanacridinium ester conjugated antibodyare added to the vessel. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles – biotinylatedanti-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 light generated by the reaction is measured with the ECL100 or ECL25 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.

Specifications

Catalog no. CL0824R
Target Clostridium Difficile GDH Antigen
Species N/A
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 0.51 ng/mL
Dynamic Range 0 - 250 ng/mL
Total Incubation Time < 30 minutes
Sample Type Stool
Sample Volume 150-200 mg
Storage Temperature 2-8 °C

Selected Literature

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For research use only. Not for use in diagnostics procedures.