Factor VIII Testing

CRYOcheck™ Factor VIII Kits - Helping to Support the Management of Haemophilia

Testing for Factor VIII, a blood-clotting protein can determine whether a patient has haemophilia A or another clotting disorder. Under normal circumstances, certain proteins, including factor VIII, come together to form blood clots and quickly stop bleeding.

If factor VIII protein levels are low blood doesn't clot properly putting a person at risk of uncontrolled bleeding. Almost all people with hemophilia A are male. Women are generally only carriers of the gene and have a 50% chance of passing it on to each of their children. (Boys who receive the gene would be affected and girls would be carriers). But it's possible for females to develop mild symptoms of this disorder.

Because blood-clotting proteins work together to stop bleeding, the test may be done as part of an overall screening for the proteins involved in clotting.

Two products are available from Precision BioLogic to support the diagnosis and management of haemophilia.

CRYOcheck™ Chromogenic Factor VIII Assay

For laboratories wishing to accurately quantify Factor VIII activity, there is a ready-to-use chromogenic Factor VIII assay.

The CRYOcheck Chromogenic Factor VIII assay is designed for ease of use and to minimise reagent waste. The assay is intended to identify Factor VIII deficiency and aid in the management of haemophilia A.


The CRYOcheck Chromogenic Factor VIII assay comes packaged as four vial sets, making it suitable for both high and low volumes of testing. Laboratories can scale up for high volume testing, and the ability to store unused reagents refrigerated for up to 5 days or frozen for up to 1 month, makes the kit perfect for low volume testing too. The kit offers labs flexibility in how they plan their Factor VIII activity testing.


  • Ready to use components, simply thaw in water bath for a few minutes

  • Designed to minimise reagent wastage, the kit saves you money

  • The kit can accurately quantify FVIII activity in patients being treated with extended half-life therapies and Emicizumab

  • The CRYOcheck Chromogenic FVIII assay uses a bovine based FX protein insensitive to Emicizumab in the patient sample, making it suitable for measuring FVIII activity levels in the presence of Emicizumab

  • Chromogenic assays are less susceptible to interferences from pre-activation of FVIII, the presence of anti-phospholipid antibodies, lipaemic samples, or samples with heparin, than clot-based assays

  • Suitable for both high and low volumes of testing

  • The assay has a Limit of Quantitation of 0.5%, ensuring accurate testing of samples at the low end

  • The assay uses a single calibration curve for all measurements, and reflex testing for any samples under 5%

  • Validated protocols are available for most coagulation analysers

CRYOcheck™ Factor VIII Inhibitor Kit

For laboratories wishing to determine and quantify the presence of functional FVIII inhibitors, there is now a ready-to-use sample preparation kit to facilitate the performance of a modified Nijmegen-Bethesda assay.

With standardised components and a validated protocol, it brings you excellent repeatability and reproducibility.


The CRYOcheck™ Factor VIII Inhibitor kit is suitable for use in conjunction with a one-stage clot-based assay or a chromogenic assay, to determine the Factor VIII activity of the sample on any coagulation analyser - making it easy to introduce into your laboratory.


  • Standardised components with a validated method, working to reduce inter laboratory variation

  • Excellent repeatability and reproducibility

  • Platform independent - FVIII activity can be measured using a 1-stage clot based assay or a chromogenic assay on any coagulation analyser

  • Ready to use components, simply thaw in a water bath in a few minutes - saving time, improving workflow and eliminating reconstitution errors

  • Includes a pre-analytical heat treatment step to inactivate endogenous FVIII

  • Bovine Serum Albumin (BSA) has been validated as a practical alternative to FVIII deficient plasma, improving stability and reducing inter laboratory variation from different sources of FVIII deficient plasma

  • Includes an additional inhibitor positive and negative control, to increase confidence in your results