Factor IX (F9, FIX) ELISA Kit

The VisuLize Factor IX Antigen Kit is intended to quantitatively measure factor IX antigen in human plasma and factor concentrates. The biological importance of Factor IX is demonstrated in Hemophilia B (Christmas disease), an X-linked congenital bleeding disease resulting from a quantitative (low activity and low antigen) or qualitative (low activity and normal antigen) defect in Factor IX function. The congenital deficiency of Factor IX may be classified as severe (1% Factor IX activity), moderate (between 1 and 5% Factor IX activity) or mild (between 5 and 40% Factor IX activity). The laboratory diagnosis of Factor IX deficiency typically involves quantitative determinations of procoagulant levels i.e., functional activity of Factor IX.¹ An ELISA for Factor IX antigen may be used in conjunction with functional assays in the area of gene therapy, assessment of Factor IX concentrates, determination of carrier status as well as distinguishing those patients with cross-reactive material (i.e., low functional activity but near normal antigen levels of Factor IX).

This product is cleared for in vitro Diagnostic use by FDA, Health Canada and CE marked.  Available for sale in the United States, Canada and select European countries.

Factor IX ELISA kit principles:

Strip wells are pre-coated with sheep polyclonal antibody to human Factor IX. Plasma samples are diluted and applied to the wells. The FIX antigen present binds to the coated antibody. After washing away unbound material, peroxidase labeled sheep detecting antibody is applied and allowed to bind to the captured FIX.  The wells are again washed and a solution of TMB (the peroxidase substrate tetramethylbenzidine) is applied and allowed to react for a fixed period of time. A blue color develops which changes to yellow upon quenching the reaction with acid. The color formed is measured spectrophotometrically in a microplate reader at 450nm. The absorbance at 450nm is directly proportional to the quantity of FIX antigen captured onto the well. The assay is calibrated using the calibrator plasma provided in the kit.