title: Quality control of recovered plasma for fractionation: an extensive Italian study.
abstract: BACKGROUND
  This study was aimed at obtaining significant information on the quality of whole-blood plasma (WBP) delivered to a private pharmaceutical company by the blood transfusion centers (BTCs) of 10 Italian regions.
  
  
  METHODS
  A statistical sampling plan of plasma units took into account the contribution each selected blood transfusion center, belonging to the 10 regions, made to the plasma pool annually delivered to the pharmaceutical company. A total of 1787 plasma units were selected for coagulation Factor VIII (FVIII:C) and Factor VIII antigen (FVIII:Ag) analysis.
  
  
  RESULTS
  The FVIII:C mean value was 0.99 IU per mL; it was significantly lower in O units (0.86 IU/mL) than in non-O units (1.08 IU/mL). The mean value of FVIII:Ag was 0.90 IU per mL; it was significantly lower in O units (0.78 IU/mL) than in non-O units (0.99 IU/mL). In units with a FVIII:C level of less than 0.70 IU per mL, the FVIII:Ag mean value (0.62 IU/mL) was higher in comparison to the FVIII:C mean value (0.57 IU/mL). Instead, in the units with a FVIII:C level of at least 0.70 IU per mL, the mean level of FVIII:C (1.08 IU/mL) was higher than that of FVIII:Ag (0.96 IU/mL).
  
  
  CONCLUSIONS
  The mean value of FVIII:C (0.99 IU/mL) in whole-blood plasma produced by the 10 Italian regions is higher than that reported in other studies. A total of 83.1 percent of units have a FVIII:C level of at least 0.70 IU per mL. The mean level of FVIII:Ag is lower than that of FVIII:C. FVIII:Ag is higher in those units with a FVIII:C level of less than 0.70 IU per mL, while it gradually decreases as FVIII:C exceeds 0.70 IU per mL, thus showing a greater resistance to handling of plasma in the production steps mostly affecting FVIII:C stability.
authors.affiliation: The Italian National Blood Center, Rome, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Grazzini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rossi
authors.forename: Daniela
authors.initials: D
authors.lastname: Rafanelli
authors.forename: Davide
authors.initials: D
authors.lastname: Gambelli
authors.forename: Claudio
authors.initials: C
authors.lastname: Farina
authors.forename: Filippo
authors.initials: F
authors.lastname: Mori
authors.forename: Paolo
authors.initials: P
authors.lastname: Zucchelli
authors.forename: Giorgio
authors.initials: G
authors.lastname: Marchiori
authors.forename: Antonio
authors.initials: A
authors.lastname: Breda
authors.forename: Giancarlo Maria
authors.initials: GM
authors.lastname: Liumbruno
mesh_terms: D001793:Blood Preservation / Q000009:adverse effects / Q000379:methods; D001803:Blood Transfusion / Q000379:methods / Q000592:standards; D005169:Factor VIII / Q000032:analysis*; D007558:Italy; D010949:Plasma / Q000737:chemistry*; D011786:Quality Control; D013048:Specimen Handling / Q000009:adverse effects / Q000379:methods
chemical_list: D005169:Factor VIII