Any Questions?
Call us: 0043 1 236 222 1
Free call in Germany: 0800 24 66 330
Email: info@coachrom.com
DE EN

Modified Nijmegen-Bethesda-Assay

Our new CE marked CRYOcheckTM factor VIII inhibitor kit contains the components required for performing a modified Nijmegen-Bethesda assay.


Factor VIII inhibitors reduce the effectiveness of hemophilia A therapy. Therefore, it is crucial to use testing systems that can precisely quantify inhibitors such as a modified Nijmegen-Bethesda assay (MNBA). The new CE marked CRYOcheckTM factor VIII inhibitor kit contains the components required for performing a modified Nijmegen-Bethesda assay.

CRYOcheckTM factor VIII inhibitor kit - key advantages at a glance:

  • Standardized components and a validated procedure for performing a modified Nijmegen-Bethesda assay (MNBA) as per the U.S. Centers for Disease Control and Prevention (CDC) recommendation
     
  • Excellent repeatability and reproducibility, for a better lab-to-lab comparability
     
  • Outstanding linearity across a broad reportable range
     
  • Convenient frozen format – ready to use within minutes, no reconstitution errors
     
  • Each kit contains 5 vial sets including positive and negative FVIII inhibitor controls - the amount required to prepare 5 to approx. 25 patient samples.  

Download IFU CRYOcheckTM factor VIII inhibitor kit, Ref.No. CCIK08 (pdf)

Download product sheet CRYOcheckTM factor VIII inhibitor kit (pdf)

Literatur:

- Miller et al., Haemophilia 2018, Reagent substitutions in the Centers for Disease Control and Prevention Nijmegen‐Bethesda assay for factor VIII inhibitors.

- Miller et al., J Thromb Haemost 2012, Validation of Nijmegen–Bethesda assay modifications to allow inhibitor measurement during replacement therapy and facilitate inhibitor surveillance.

- Kershaw et al., Thromb Res 2013, Validation of 4% albumin as a diluent in the Bethesda assay for FVIII inhibitors.

- Verbruggen et al., Thromb Haemost 2002, A 4% solution of bovine serum albumin may be used in place of factor VIII:C deficient plasma in the control sample in the Nijmegen Modification of the Bethesda factor VIII:C inhibitor assay.