Background
This CLIA is designed, developed, and produced for the quantitative measurement of Cryptosporidium parvum in fecal samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of Cryptosporidium parvum. Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. An acridinium ester conjugated antibody and a biotin conjugated antibody are added. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles – biotin anti-C. parvum antibody –C. parvum – acridinium ester anti-C. parvum 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 ECL-25 analyzer. The relative light units (RLU) are proportional to the concentration of C. parvum in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve and reported in Units per mL concentration.
