The VisuLizeÃ¢â€žÂ¢ FVIII Antigen Kit is intended to quantitatively measure factor VIII (F8) in human plasma and factor concentrates. The biological importance of factor VIII (F8) is demonstrated in Hemophilia A and those patients suspected of thrombophilia. The laboratory diagnosis of factor VIII (F8) deficiency in Hemophilia A typically involves quantitative determination of factor VIII’s functional activity. The use of this kit in conjunction with functional assays in the area of gene therapy, assessment of factor VIII (F8) concentrates, as well as distinguishing those patients with cross-reactive material will prove useful in the area of Hemophilia A. Additionally as documented in numerous studies, elevated levels of factor VIII (F8) is being recognized as a common risk of venous thrombosisÃ‚Â¹, an area where Affinity’s VisuLizeÃ¢â€žÂ¢ FVIII (F8) Antigen Kit has utility.
The VisuLizeÃ¢â€žÂ¢ FVIII (F8) Antigen Kit is FDA cleared, Health Canada approved, CE marked for in vitro diagnostic use.References:
1.O’Donnell J, Tuddenham EG, Manning R, Kemball-Cook G, Johnson D, Laffan M. High prevalence of elevated factor VIII levels in patients referred for thrombophilia screening: role of increased synthesis and relationship to the acute phase reaction. Thromb Haemost. 1997;77:825Ã¢â‚¬â€œ828.
Rapid sandwich ELISA to measure FVIII (F8) antigen (FVIII:Ag)
1 hour 55 minutes total incubation time!
FVIII:Ag reported as International Units/ml traceable to WHO standard for FVIII antigen
Detection limit to 0.008 IU/ml FVIII:Ag (0.8%)
Includes normal and low controls
Shelf-life: 18 months
Quantification of FVIII (F8) in plasma and therapeutic concentrates