biophen FⅧ：C（6）试剂盒测定凝血因子Ⅷ：C活性的显色法测定人血浆中凝血因子Ⅷ：C或浓缩，用显色方法，手动或自动。临床应用：先天性或获得性因子Ⅷ：C诊断不足（血友病A）。因子Ⅷ：C的活性，测定人血浆中枸橼酸或治疗集中，在凝血因子Ⅷ：C的活性必须测量
INTENDED USE:
BIOPHEN FVIII:C (6) kit is a chromogenic assay for measuring the Factor VIII:C activity in human plasma or in Factor VIII:C concentrates, using a chromogenic method, manual or automated. CLINICAL APPLICATIONS:
Diagnosis of congenital or acquired Factor VIII:C deficiencies (Haemophilia A).
Assay of Factor VIII:C activity, in citrated human plasma or in therapeutic concentrates, where Factor VIII:C activity must be measured.
Follow-up of Factor VIII:C recovery in treated patients. ASSAY PRINCIPLE:
When activated by thrombin, Factor VIII:C forms an enzymatic complex with Factor IXa, phospholipids and Calcium, which activates Factor X to Factor Xa.
BIOPHEN Factor VIII:C is a chromogenic assay for testing the cofactor activity of Factor VIII:C.
In presence of a constant amount of Factor IXa, Phospholipids (PLPs) and Calcium, thrombin activated Factor VIII:C forms an enzymatic complex, which activates Factor X, supplied in the assay at a constant concentration and in excess, to Factor Xa. This activity is directly related to the amount of Factor VIII:C, which is the limiting factor in presence of a constant and in excess amount of Factor IXa. Generated Factor Xa is then exactly measured by its activity on a specific Factor Xa chromogenic substrate (SXa-11). Factor Xa cleaves the substrate and releases 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 VIII:C in the assayed sample and the Factor Xa activity generated, measured by the amount of pNA released, determined by color development at 405nm.
