Human FDP (Fibrinogen Degradation Product) CLIA Kit (HUES01156)

Assay Genie supplies a chemiluminescence immunoassay (CLIA) kit for the quantitative determination of Human Fibrinogen Degradation Product (FDP) in serum, plasma and other biological fluids. The assay uses a sandwich-CLIA format in which standards or samples are added to a micro CLIA plate pre-coated with antibody specific to Human FDP, followed by a biotinylated detection antibody and an Avidin-HRP conjugate. Signal is generated with the substrate reagents and measured as Relative Light Units (RLU) on a chemiluminescence immunoassay analyzer, with the RLU value positively associated with the concentration of Human FDP.

Stated performance characteristics include a sensitivity of 0.38 ng/mL and a detection range of 0.63–40 ng/mL, with a required sample volume of 100 μL and a total assay time of 4.5h. Linearity has been evaluated in serum, EDTA plasma and cell culture media across dilutions of 1:2, 1:4, 1:8 and 1:16. Spike-recovery testing reports average recoveries of 98% in serum, 97% in EDTA plasma and 98% in cell culture media. Precision testing reports intra-assay CVs of 9.14%, 11.91% and 6.77% and inter-assay CVs of 10.65%, 9.23% and 8.86%, with the manufacturer noting that intra-CV and inter-CV are < 15%. The kit recognises Human FDP in samples, and no significant cross-reactivity or interference with analogues was observed.

Included components are a CLIA plate, reference standard, concentrated biotinylated detection antibody (100×), concentrated HRP conjugate (100×), reference standard and sample diluent, biotinylated detection antibody diluent, HRP conjugate diluent, concentrated wash buffer (25×), substrate reagents A and B, desiccant, plate sealer and a product description document. The product is intended for the in vitro quantitative determination of Human FDP concentrations and is positioned for research into coagulation and fibrinolysis processes, including conditions such as disseminated intravascular coagulation, thrombosis and liver diseases.