Native Human Factor VIII and Von Willebrand Factor Reference Standard

• Cat.No.: FVIII/VWF-17HRS

Specification

• Species: Human
• Source: Human Plasma
• Tag: Non
• Tag: Non
• Form: Solid
• Stability: Accelerated degradation studies have indicated that this material is suitably stable, when stored at -20 °C or below, for the assigned values to remain valid until the material is withdrawn or replaced. These studies have also shown that the material is suitably stable for shipment at ambient temperature without any effect on the assigned values.
• Usage: The standard is intended to be used for the estimation of these analytes in human plasma. For the estimation of FVIII:C in therapeutic concentrates; For the estimation of VWF:Ag, VWF:CB and VWF:RCo in therapeutic concentrates.
• Storage: Unopened ampoules should be stored in the dark at -20 °C or below.
• Shipping: Because of the inherent stability of lyophilized material, may ship these materials at ambient temperature
• UNITAGE: The overall mean values assigned to each ampoule as follows:
  FVIII:C 0.68 IU per ampoule
  FVIII:Ag 1.04 IU per ampoule
  VWF:Ag 1.00 IU per ampoule
  VWF:RCo 0.87 IU per ampoule
  VWF:GPIbR 0.87 units per ampoule
  VWF:GPIbM 0.87 units per ampoule
  VWF:CB 1.03 IU per ampoule
  VWFpp 1.03 IU per ampoule
• USE OF MATERIAL: No attempt should be made to weigh out any portion of the freeze-dried material prior to reconstitution.
  Dissolve the total contents of the ampoule by adding 1.0 ml of distilled water, using gentle shaking, then transfer the contents to a plastic tube. Although studies have shown the reconstituted standard to be stable for up to 3 hours when kept on melting ice it is recommended that assays of FVIII:C and VWF:RCo be carried out as soon as possible after reconstitution. The use of frozen aliquots for FVIII:Ag, VWF:Ag and VWFpp estimation should be validated locally. It is not recommended that frozen aliquots are used for FVIII:C, VWF:RCo or VWF:CB estimation.