Assay for measuring Factor VII in plasma with a chromogenic method

INTENDED USE:

BIOPHEN FVII kit is a chromogenic assay proposed for measuring the Factor VII activity in human plasma or in biological fluids, using a chromogenic method, manual or automated.

This kit is for research use only and should not be used for patient diagnosis or treatment. ASSAY PRINCIPLE:

Factor VII is the serine esterase of the extrinsic coagulation pathway. When complexed to Tissue Factor (TF), in presence of phospholipids and Calcium, it activates Factor X to Factor Xa.

Biophen Factor VII is a chromogenic assay for testing Factor VII activity.

Factor VII forms an enzymatic complex with Tissue Factor, provided by rabbit Thromboplastin. It then activates Factor X, present in the assay at a constant concentration and in excess, to Factor Xa, which concentration is exactly measured by its activity on a specific Factor Xa chromogenic substrate (SXa-11). Factor Xa cleaves the substrate and generates pNA. The amount of pNA generated is directly proportional to the Factor Xa activity.

Finally, there is a direct relationship between the amount of Factor VII in the assayed sample and the Factor Xa activity generated, measured by the amount of pNA released, determined by color development at 405 nm.