VisuLize FIX Antigen Kit
The VisuLize FIX 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 pro-coagulant 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).
The VisuLize FIX Antigen Kit is FDA cleared, Health Canada approved and CE marked for use as in vitro Diagnostic use.
1. White GC, Roendaal, F. Aledort LM, Lusher JM, Rothschild C, Ingersley J. Definitions in Hemophilia, Recommendation of the Scientific Subcomittee on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Hemostasis, Thrombosis and Hemostasis, 2001, 85, p. 560.
- Rapid sandwich ELISA to measure FIX antigen (FIX:Ag)
- 70 minutes total incubation time!
- FIX:Ag reported as International Units/ml traceable to WHO standard for FIX activity
- Detection limit to 0.005 IU/ml FIX:Ag (0.5%)
- Includes normal and low controls
- Quantification of FIX in plasma and therapeutic concentrates
- Diagnosis and characterization of Hemophilia B
- Carrier testing for Hemophilia B
- Thrombophilia screening
|Product||Catalogue No.||Size||Product Insert|
|VisuLize FIX Antigen ELISA kit||FIX-AG||1 plate|
- GAFIX-IG – goat anti-human Factor IX, whole IgG from serum, 10 mg vial
- GAFIX-AP – goat anti-human Factor IX, affinity-purified IgG, 0.5 mg vial
- GAFIX-HRP – goat anti-human Factor IX, peroxidase labelled IgG, 0.2 mg vial
- GAFIX-APHRP – goat anti-human Factor IX, affinity-purified, peroxidase labelled IgG, 0.1 mg vial
- GAFIX-APFTC – goat anti-human Factor IX, affinity-purified, FITC conjugated IgG, 0.1 mg vial
- GAFIX-APBIO – goat anti-human Factor IX, biotinylated affinity-purified IgG, 0.1mg vial
- SAFIX-IG – sheep anti-human Factor IX, whole IgG from serum, 10 mg vial
- SAFIX-AP – sheep anti-human Factor IX, affinity-purified IgG, 0.5 mg vial
- SAFIX-APHRP – sheep anti-human Factor IX, affinity-purified, peroxidase labelled IgG, 0.1 mg vial
- FIX-DP – Factor IX deficient plasma – citrated plasma immune depleted of Factor IX, 1 ml vial to bulk quantitites available
- INH9-DP – Factor IX Inhibitor plasma, available in various activities (recorded as BU/mL), 1 ml vial to bulk quantities