BIOPHEN™ FVIII variant
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BIOPHEN™ FVIII variant

Code: A227102-RUO
Manufacturer’s Part Number: 227102
Product size: Kit
Clearance: RUO
Price: $461.00
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Product Description

In US and Canada: For Research Use Only. Not for Use in Diagnostic Procedures.

BIOPHEN™ FVIII Variant is a two-stage chromogenic FVIII:C assay using BOVINE Factor X, making it INSENSITIVE to emicizumab (HemlibraŽ). This is the only chromogenic method that measures true endogenous or infused FVIII:C activity in emicizumab-treated hemophilia A patients. Emicizumab is a bispecific antibody that mimics FVIII by activating human Factor X — but it cannot activate bovine Factor X, so this assay reports only true FVIII activity. Essential for: breakthrough bleed management in emicizumab patients, pre-surgical FVIII level assessment, monitoring FVIII replacement therapy given alongside emicizumab, and FVIII inhibitor titer measurement (modified Bethesda). Standard chromogenic FVIII:C assays (A221402/A221406) will report falsely elevated FVIII in emicizumab patients. RUO.

Product Characteristics

  • R1: Bovine Factor X at approximately 7.5 Âľg/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 Âľg/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)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents