Chromogenic assay for measuring Factor IX activity in plasma or concentrates.

规格2x2.5ml  对应货号：221802

规格2x6ml    对应货号：221806

INTENDED USE:

BIOPHEN Factor IX kit is a chromogenic assay for measuring Factor IX activity in human citrated plasma or in Factor IX concentrates, using a chromogenic method, manual or automated. CLINICAL APPLICATIONS:

Assay of Factor IX activity in any biological fluid or therapeutic concentrate, where Factor IX activity must be measured. ASSAY PRINCIPLE:

In presence of thrombin, phospholipids and calcium, first Factor XIa, supplied in the assay at a constant concentration and in excess, activates FIX, present in the tested sample, into FIXa, which forms an enzymatic complex with thrombin activated factor VIII:C, also supplied in the assay at a constant concentration and in excess, phospholipids (PLPs) and Calcium, that activates Factor X, present in the assay system, into Factor Xa.

This activity is directly related to the amount of Factor IX, which is the limiting factor. Generated Factor Xa is then exactly measured by its specific activity on 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 IXa activity.

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

Nota : FVIII:C*: Thrombin activated FVIII:C REAGENTS:

R1: Reagent 1: Human Factor X and FVIII:C

Human Factor X, and FVIII:C, lyophilized in presence of a fibrin polymerization inhibitor and stabilizers.

2 vials (to be reconstituted with 2.5 mL of distilled water).

R2: Reagent 2: Activation Reagent (XIa-Thrombin-Calcium-phospholipids)

Factor XIa (human), at a constant and optimized concentration, containing human thrombin, calcium and synthetic phospholipids, lyophilized, in presence of stabilizers.

2 vials (to be reconstituted with 2.5 mL of distilled water).

R3: Reagent 3: SXa-11

Chromogenic substrate, specific for Factor Xa (SXa-11), lyophilized.

2 vials of SXa-11 with a FXIa inhibitor (to be reconstituted with 2.5 mL of distilled water).

R4: Reagent 4: Tris-BSA Buffer

Tris-BSA Buffer, ready to use. Contains 1% BSA, PEG, FVIII:C Stabilizer and sodium azide (0.9g/L). (2 vials of 25 mL).