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.
NODIA's choice
Recommended product for your FVIII testing
Update
Emicizumab can be monitored 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.
Reaction principle
Major Features
- CE-IVD applications on all major analyzers
- 3Special buffer results in a better recovery of all variants of the FVIII-molecule.
- Based on purified human factors
- Stability of the reagents makes routine application feasible:
- 72h at 2-8
- 24h at room temperature
- 2 months at -20oC or lower
- Chromogenic FVIII assay with bovine FX-
Introduction
In exceptional cases, there may be a need for a test that is not sensitive to the bispecific antibodies so that a distinction can be made between the artificial and real Factor VIII. By replacing human Factor X in the original BIOPHEN™ FVIII:C kit with a bovine Factor X, it no longer reacts with the humanised bispecific antibodies.
The new BIOPHEN™ FVIII Variant with bovine FX kit is now available for these applications.
The bovine factor X in the BIOPHEN™ FVIII variant kit seems to be more sensitive for activation at low FVIII levels than human Factor X. The variant kit may therefore also have an application for the for diagnosis of severe haemophilia A.
CE marked applications are available for all common coagulation analyzers
Recommended product for testing without interference of bispecific antibody such as Emicizumab
Reaction principle
Major Features
- CE-IVD applications on all major analyzers
- Based on the original BIOPHEN FVIII:C but using a Bovin Factor X
- Recommended product for testing without interference of bispecific antibody such as Emicizumab
- Stability of the reagents makes routine application feasible:
- 72h at 2-8
- 24h at room temperature
- 2 months at -20oC or lower
Applicability of the BIOPHEN FVIII kits
| BIOPHEN™ Factor VIII | |||
|---|---|---|---|
| 1. | Screening | ||
| Routine | |||
| Severe haemophilia A | |||
| Tests for FVIII-autoantibodies | |||
| 2. | Replacement therapy | ||
| Purified FVIII | |||
| Recombinant proteins | |||
| Extended Half-life products | |||
| 3. | Treatment with Bispecific antibodies (AB) such as Emicizumab | ||
| Follow-up on AB-activity | |||
| Patients native FVIII | |||
| Tests for FVIII-autoantibodies | |||
| Not applicable | |
| Routine Application | |
| Best choice | |
| Uncertain |
Factor VIII Inhibitor and Deficient plasma
Factor VIII inhibitor plasma products
All Factor FVIII Inhibitor Plasmas are produced from normal human plasmas from which specific factors have been removed by selective affinity immuno-adsorption.
- Human Factor VIII Inhibitor Plasma, Mild, Frozen
- Human Factor VIII Inhibitor Plasma, Mild, Lyophilised
- Human Factor VIII Inhibitor Plasma, Moderate, Frozen
- Human Factor VIII Inhibitor Plasma, Moderate, Lyophilised
- Human Factor VIII Inhibitor Plasma, Severe, Frozen
- Human Factor VIII Inhibitor Plasma, Severe, Lyophilised
An antibody inhibitory to the specific factor is added to provide neutralizing activity.
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.
Factor VIII antibodies
DIY
Antibodies for immunoblotting, immunostaining of cells and several types of immunoassays where a higher signal-to-noise is required:
- Anti-human Factor VIII:C, Sheep, Affinity Purified Biotinylated IgG
- Anti-human Factor VIII:C, Sheep, Affinity Purified FITC IgG
- Anti-human Factor VIII:C, Sheep, HRP conjugated IgG
- Anti-canine Factor VIII:C, Sheep, HRP conjugated IgG
- Anti-human Factor VIII:C, Sheep, Purified IgG
- Anti-human Factor VIII:C, Sheep, Affinity Purified IgG
- Anti-canine Factor VIII:C, Sheep, Purified IgG
Matched pair of antibodies:
- Detection of Human Anti-Factor VIII antibodies -
(Available on request)
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
Product overview
