Factor IX

Assay overview

Nodia has a broad range of Factor IX, anti-Factor IX and activated Factor IX (FIXa) assays for both clinical and pharmaceutical applications. Find out more about our tests on this Factor IX specific page.

- Chromogenic assay -

Introduction

In routine laboratories FVIII and FIX are generally measured with a one-stage clotting assay using factor deficient plasma’s. For clotting factor assays in human plasma this approach has been reliable so far. Since the introdcution of recombinant and modified factor concentrates, the follow-up of haemophilia patients with clotting assays is no longer recommended. The chromogenic factor assays are the first choice for this application.

The Biophen Factor IX kit offers a stable method for routine applications.The use of human factors in the reagents mimics the in vivo situation and makes the test sensitive for all new haemophilia B treatments.

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

About Factor IX

Coagulation Factor IX  is a vitamin K dependent glycoprotein which participates in the intrinsic pathway of the coagulation cascade.  When activated by Factor XIa, Factor IXa  forms an active complex with its cofactor Factor VIII in the presence of calcium and phospholipids. This complex will then activate Factor X in Factor Xa.

Deficiency of Factor IX causes Haemophilia B.

Reaction principle

Major Features

  • Special buffer results in a better recovery of al variants of the FIX-molecule.
  • Comprehensive CE validation files for the applications on the most common coagulation analysers.
  • High (5-200%) and Low (0-20 %) range.
  • Small (1ml), Medium (2.5ml) and Large (6 ml) kit available.
  • Stability of the reagents makes routine application feasible:
    • 24h at room temperature
    • 72h at 2-8oC
    • 2 months at -20oC or lower

Factor IX antigen

BIOPHEN™ Factor IXa

- Activated Factor IX -

Reaction principle​

Biophen Factor IXa

Intended use

BIOPHEN™ Factor IXa kit is a chromogenic method for in vitro quantitative determination of activated Factor IX (FIXa) activity in purified medium using an automated or manual method.

Calibrator and Controls

The calibrator is included in the kit. A set of specific Factor IXa controls is made available separately. 

Factor IX Inhibitor and Deficient plasma

Factor IX deficient plasma products

The Factor IX Deficient Plasma can be used for the quantitative determination of Factor IX activity in human citrated plasma using a clotting method via a manual or automated method.

The Factor IX deficient plasma can also be used to dilute factor IX or factor IX containing plasma to the desired FIX-concentration e.g. to obtain a low calibrator for the low range application of Biophen Factor IX.

Frozen Deficient plasma is available from 5-Diagnostics: Human Factor IX Deficient Plasma, Frozen.

Factor IX inhibitor plasma products

All Factor IX Inhibitor Plasmas are produced from normal human plasmas from which specific factors have been removed by selective affinity immuno-adsorption and an antibody inhibitory to the specific factor is added to provide neutralizing activity.


USE: These products can be used as a substitute for plasmas from patients that have developed neutralizing antibodies to coagulation factors and can be used as positive controls in factor inhibitor assays. The inhibitor potency is measured by standard Bethesda activity assay.

Product overview

ReferenceProduct namePackagingCategoriesManufacturer
5D-10113GAnti-human Factor IX, Goat, Purified IgG10 mgAntibodies5-Diagnostics
5D-10113SAnti-human Factor IX, Sheep, Purified IgG10 mgAntibodies5-Diagnostics
5D-11113GAnti-human Factor IX, Goat, Affinity Purified IgG0.5 mgAntibodies5-Diagnostics
5D-11113SAnti-human Factor IX, Sheep, Affinity Purified IgG0.5 mgAntibodies5-Diagnostics
5D-12113GAnti-human Factor IX, Goat, HRP conjugated IgG0.2 mgAntibodies5-Diagnostics
5D-15113GAnti-human Factor IX, Goat, Affinity Purified HRP Conjugated IgG0.1 mgAntibodies5-Diagnostics
5D-15113SAnti-human Factor IX, Sheep, Affinity Purified HRP Conjugated IgG0.1 mgAntibodies5-Diagnostics
5D-16113GAnti-human Factor IX, Goat, Affinity Purified FITC Conjugated IgG0.1 mgAntibodies5-Diagnostics
5D-17113GAnti-human Factor IX, Goat, Affinity Purified Biotinylated IgG0.1 mgAntibodies5-Diagnostics
5D-181135-EIA Anti-human Factor IX, Matched Pair Antibodies5 platesAntibodies5-Diagnostics
5D-181145-EIA Anti-canine Factor IX, Matched Pair Antibodies4 platesAntibodies5-Diagnostics