The factor VIII mimetic Emicizumab (Hemlibra®, Roche), approved in the EU since 2018, poses a new challenge for laboratories: A FVIII chromogenic assay, designed with human FIXa/FX, is available for measuring Emicizumab “FVIII like activity” in plasma. However, it cannot be used for titrating FVIII inhibitors in Emicizumab treated patients, as presence of FVIII residual activity is measured and interferes in the method.
Remedy is provided by our chromogenic BIOPHEN™ Factor VIII kits: The original BIOPHEN™ Factor VIII is designed with human FIXa and FX and can quantitatively measure Emicizumab concentrations in plasma, with high sensitivity and specificity. In case a test kit insensitive to Emicizumab is required, we offer a solution with our BIOPHEN™ Factor VIII (bovine reagent R1).
| CHARACTERISTICS / FEATURES | BIOPHEN™ Factor VIII, ref. 221402 / 221406 | BIOPHEN™ Factor VIII (bovine reagent 1), ref. 227102 |
|---|---|---|
| FX reagent | Human | Bovine |
| Emicizumab-sensitive | Yes | No |
| Determination of Emicizumab levels | Yes | No |
FVIII inhibitor assay in presence of Emicizumab | No | Yes |
| Emicizumab inhibitor assay | Yes | No |
| Determination of native FVIII levels | Yes | Yes |
| Level determination for plasmatic and recombinant FVIII preparations | Yes | Yes |
| FVIII determination independent of Emicizumab | No | Yes |
The assays are fully automatable on all coagulation instruments.
Further information on the modified BIOPHEN™ Factor VIII Kit is available here:
Download (HYPHEN BioMed ISTH Publikation)
The following BIOPHEN™ Factor VIII Kit are available from us:
