Factor VIII

Assay overview


Nodia offers a broad range of Factor VIII and anti-Factor VIII assays and research tools for both clinical and pharmaceutical applications. Find out more about our tests on this Factor VIII specific page. 

- Chromogenic FVIII assay -

Introduction

Chromogenic FVIII methods have been available for a very long time. For many applications they are the preferred method. The limited stability of the reagents was the main reason for not applying them in clinical routine. The chromogenic method did become the reference method for quality control of Factor VIII concentrates.

The Biophen Factor VIII makes, due to its excellent stability, the chromogenic technique now also applicable for clinical routine.
For the follow-up of the treatment of haemophiliacs with recombinant and modified factor VIII concentrates, Biophen Factor VIII even became first choice.

The use of purified human factors in the reagents of Biophen Factor VIII mimics the in vivo situation closely and makes the test sensitive for all new haemophilia treatments including the follow-up of patients treated with Emicizumab.

CE marked applications for normal and low range are available for all common coagulation analyzers.

Reaction principle

NODIA's choice

Recommended product for your FVIIII testing

 

Update

Emicizumab can be tested with the BIOPHEN Factor VIII:C kit. No modification of the instrument application is needed. Emicizumab can be tested under the same condition as FVIII in the plasma. A calibration curve covers a range from 0 to 100 µg/ml Emicizumab.

A method insensitive for Emicizumab can be obtained by exchanging of the human Factor X by an alternative bovine version. Ask Nodia for more info on this procedure!

Major Features

  • Stability of the reagents makes routine application feasible:
    • 24h at room temperature
      72h at 2-8oC
      2 months at -20oC or lower
  • Special buffer results in a better recovery of all variants of the FVIII-molecule.
  • Based on purified human factors 
  • Possibility to exchange Human, for Bovine Factor X reagent for applications insensitive to Emicizumab.

- Detection of Human Anti-Factor VIII antibodies -

Introduction

All products in the ZYMUTEST™ product line are enzyme immuno-assay (ELISA).

The ZYMUTEST™ Anti-FVIII IgG monostrip was developed as a diagnostic aid for the detection and quantification of antibodies to FVIII in plasma from haemophiliac A patients and patients who developed autoimmune FVIII inhibitors.

Major Features

  • High correlation between FVIII antibodies measured with Zymutest™ Anti-FVIII IgG monostrip and Bethesda Units.
  • No interference of Non Neutralizing anti-FVIII Antibodies.
  • Excellent reproducibility.
  • Elisa technique, no special training needed.
  • Can be used for the follow-up of Anti-FVIII IgG in patients treated with or without special caution.
  • Available in Monostrip format for individual patient testing.

Reaction principle

Factor VIII antigen

- FVIII antigen assay -

Factor VIII Inhibitor and Deficient plasma

Factor VIII inhibitor plasma products

Factor VIII deficient plasma products

Factor VIII:C Deficient Plasma can be used for the quantitative determination of Factor VIII:C (FVIII:C) activity in human citrated plasma using a clotting assay.

It can also be used to dilute FVIII in plasma to a desired concentration for e.g. the calibration of a low measuring range in the chromogen FVIII determination.


Product overview

ReferenceProduct namePackagingCategoriesManufacturer
221402BIOPHEN™ Chromogenic Factor VIII – small2 x 50 testsChromogenic AssayHYPHEN Biomed
221406BIOPHEN™ Chromogenic Factor VIII – large2 x 120 testsChromogenic AssayHYPHEN Biomed
RK039AZYMUTEST™ Anti-Factor VIII IgG monostrip4 x 8 testsELISAHYPHEN Biomed
223201BIOPHEN™ Normal Control Plasma12 x 1mlControlsHYPHEN Biomed
223301BIOPHEN™ Abnormal Control Plasma12 x 1mlControlsHYPHEN Biomed
222101BIOPHEN™ Plasma Calibrator 12 x 1mlCalibratorHYPHEN Biomed
DP040AFactor VIII Deficient Plasma – small1mlDeficient PlasmaHYPHEN Biomed
DP040KFactor VIII Deficient Plasma – large6 x 1mlDeficient PlasmaHYPHEN Biomed
5D-47119FHuman Factor VIII Inhibitor Plasma, Mild, Frozen1mLInhibitor Plasma5-Diagnostics
5D-47119LHuman Factor VIII Inhibitor Plasma, Mild, Lyophilized1mLInhibitor Plasma5-Diagnostics
5D-48119FHuman Factor VIII Inhibitor Plasma, Moderate, Frozen1mLInhibitor Plasma5-Diagnostics
5D-48119LHuman Factor VIII Inhibitor Plasma, Moderate, Lyophilized1mLInhibitor Plasma5-Diagnostics
5D-49119FHuman Factor VIII Inhibitor Plasma, Severe, Frozen1mLInhibitor Plasma5-Diagnostics
5D-49119LHuman Factor VIII Inhibitor Plasma, Severe, Lyophilized1mLInhibitor Plasma5-Diagnostics
5D-10119SAnti-human Factor VIII:C, Sheep, Purified IgG10mgAntibodies5-Diagnostics
5D-10120SAnti-canine Factor VIII:C, Sheep, Purified IgG5mgAntibodies5-Diagnostics
5D-11119SAnti-human Factor VIII:C, Sheep, Affinity Purified IgG0.5mgAntibodies5-Diagnostics
5D-12119SAnti-human Factor VIII:C, Sheep, HRP conjugated IgG0.2mgAntibodies5-Diagnostics
5D-12120SAnti-canine Factor VIII:C, Sheep, HRP conjugated IgG0.2mgAntibodies5-Diagnostics
5D-16119SAnti-human Factor VIII, Sheep, Affinity Purified FITC Conjugated IgG0.1mgAntibodies5-Diagnostics
5D-17119SAnti-human Factor VIII, Sheep, Affinity Purified Biotinylated IgG
0.1mgAntibodies5-Diagnostics
5D-181195-EIA Anti-human Factor VIII, Matched Pair Antibodies4 platesAntibodies5-Diagnostics
5D-181205-EIA Anti-canine Factor VIII, Matched Pair Antibodies4 platesAntibodies5-Diagnostics
5D-181285-EIA Anti-human Factor XIII, Matched Pair Antibodies5 platesAntibodies5-Diagnostics