CL0006

Fecal Human Pancreatic Elastase 1 CLIA Kit

Description

The EDI™ Fecal Pancreatic Elastase 1 CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative determination of human pancreatic elastase-1 antigen level in feces using the ECL100 or ECL-25 Immunoassay analyzer.

For in-vitro diagnostics purpose only

Background


The EDI™ Fecal Pancreatic Elastase 1 CLIA Kit is designed, developed, and produced for the quantitative measurement of pancreatic elastase-1antigeninfecalsamples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of PE-1antigen. Assay calibrators, controls, or extracted patient fecal samples are added directly to a reaction vessel. Simultaneously, a biotinylated antibody, a streptavidin coated magnetic particle andsubsequentlyacridinium ester conjugated antibodyare added to the reaction vessel. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles – biotinylatedanti-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 light generated by the reaction is measured with the ECL100 or ECL-25 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.

Specifications

Catalog no. CL0006
Target Pancreatic Elastase-1
Species N/A
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 1.59µg/g
Dynamic Range 0 - 2037.85 µg/g
Total Incubation Time <25 min
Sample Type Stool
Sample Volume 1-5 g (solid), 1-2 mL (liquid)
Storage Temperature 2-8 °C

Selected Literature

1. Brophy, Megan Brunjes; Nolan, Elizabeth M. (2015). "Manganese and Microbial Pathogenesis: Sequestration by the Mammalian Immune System and Utilization by Microorganisms". ACS Chemical Biology. 10: 150116125412006. -:10.1021/cb500792b. PMC 4372095
2. Costa, F., Mumolo, M. G., Ceccarelli, L., Bellini, M., Romano, M. R., Sterpi, C., Bottai, M. (2005). Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease. Gut, 54(3), 364–368. doi:10.1136/gut.2004.043406
​​​​​​​3. Gupta, Ramesh (2014). Biomarkers in toxicology. San Diego, CA: Academic Press. pp. 272–273. ISBN 9780124046498
For in-vitro diagnostic use.