Background
This CLIA is designed, developed, and produced for the quantitative measurement of Lactoferrin in fecal samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of Lactoferrin.
Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Acridinium ester antibody and a biotin antibody are added. The magnetic particles capture the biotin antibody as well as an immune-complex in the form of “magnetic particles – biotin Lactoferrin antibody –Lactoferrin– acridinium ester Lactoferrin 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 Lactoferrin in the sample. The amount of analyte in the sample is determined from a stored, multi point calibration curve and reported in FecalLactoferrin concentration.