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.