PRODUCT DESCRIPTION

The BIOPHEN™ Factor VIII variant method involves the chromogenic assay of FVIII cofactor. In the presence of phospholipids (PLPs) and calcium, FVIII, activated by thrombin, forms an enzyme complex with Factor IXa, which activates Factor X. The resulting Factor Xa hydrolyzes the chromogenic substrate, leading to the release of paranitroaniline (pNa). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of FVIII in the specimen (Factor IXa, Thrombin and Factor X are in constant excess amount). The BIOPHEN™ FVIII variant kit is a variant method of BIOPHEN™ FVIII (A221402 / A221406) where FX is from bovine origin and which is insensitive to Emicizumab.

Chromogenic method for the in vitro quantitative determination of Factor VIII (FVIII) activity, in human citrated plasma or FVIII concentrates, using an automated method.

PRODUCT CHARACTERISTICS

R1: Bovine Factor X at approximately 7.5 µg/mL, lyophilized. Contains a fibrin polymerization inhibitor, BSA and stabilizers.

R2: Activation Reagent, human Factor IIa at approximately 1 NIH/mL, human Factor IXa at approximately 2 µg/mL and synthetic Phospholipids (1:40 dilution), lyophilized. Contains BSA, Calcium Chloride Dihydrate and stabilizers.

R3: SXa-11, chromogenic substrate specific to Factor Xa (CS-11(32)) at approximately 6 mg/mL, lyophilized. Contains stabilizers and EDTA disodium salt.H373: May cause damage to organs through prolonged or repeated exposure.

R4: Tris-BSA Buffer, liquid. Contains BSA, human acid glycoprotein (AGP), stabilizers and preservatives.

PRODUCT COMPONENTS

PRODUCT APPLICATION