BIOPHEN™ FVIII variant
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BIOPHEN™ FVIII variant

Code: A227102-RUO
Manufacturer’s Part Number: 227102
Product size: Kit
Clearance: RUO
Price: $420.00
Qty
 

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.

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 Applications

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

This method is for the detection of FVIII deficiency states and monitoring of replacement therapy (except Emicizumab) on patients who are suspected of congenital or acquired deficiency and potency estimation of FVIII concentrates.

This device of in vitro diagnostic use is intended for professional use in the laboratory.

Instructions For Use

Material Safety Data Sheet (MSDS)

Technical Data

Certificate of Analysis (COA)

Other Documents