The CRYOcheck Factor VIII Inhibitor Kit contains standardized components and a validated procedure to prepare patient samples for performing a modified Nijmegen-Bethesda assay (MNBA) as per the U.S. Centers for Disease Control and Prevention (CDC) recommendation.*
It is ideal for laboratories seeking to standardize sample preparation to limit variability in their MNBA.
CE Marked and Health Canada approved. Included on the Australian Register of Therapeutic Goods (ARTG). FDA clearance pending. Not for sale in the U.S.
- Each kit contains five vial sets—enough to prepare five patient samples—including positive and negative FVIII inhibitor controls
- Excellent repeatability and reproducibility; suitable for multi-center clinical studies
- Excellent linearity across a broad reportable range
- Convenient frozen format—ready to use within minutes, no reconstitution errors
* Miller CH, Platt SJ, Rice AS, Kelly F, Soucie JM, the Hemophilia Inhibitor Research Study Investigators. Validation of Nijmegen-Bethesda assay modifications to allow inhibitor measurement during replacement therapy and facilitate inhibitor surveillance. J Thromb Haemost 2012; 10: 1055–1061.