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Volumn 48, Issue 7, 2008, Pages 1459-1468

Quality control of recovered plasma for fractionation: An extensive Italian study

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 8 ANTIBODY; BLOOD DERIVATIVE;

EID: 52049111879     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2008.01709.x     Document Type: Article
Times cited : (8)

References (44)
  • 1
    • 4043103391 scopus 로고    scopus 로고
    • Plasma for fractionation: Safety and quality issues
    • Farrugia A. Plasma for fractionation: safety and quality issues. Haemophilia 2004;10:334-40.
    • (2004) Haemophilia , vol.10 , pp. 334-340
    • Farrugia, A.1
  • 3
    • 0020564362 scopus 로고
    • Improvement of plasma quality as raw material for factor VIII:C concentrates
    • Carlebjörk G, Blombäck M, Akerblom O. Improvement of plasma quality as raw material for factor VIII:C concentrates. Vox Sang 1983;45:233-42.
    • (1983) Vox Sang , vol.45 , pp. 233-242
    • Carlebjörk, G.1    Blombäck, M.2    Akerblom, O.3
  • 4
    • 0021362372 scopus 로고
    • Labile coagulation factors in thawed fresh frozen plasma prepared by two methods
    • Kakaiya RM, Morse EE, Panek S. Labile coagulation factors in thawed fresh frozen plasma prepared by two methods. Vox Sang 1984;46:44-6.
    • (1984) Vox Sang , vol.46 , pp. 44-46
    • Kakaiya, R.M.1    Morse, E.E.2    Panek, S.3
  • 5
    • 63849205874 scopus 로고    scopus 로고
    • Monograph of human plasma for fractionation (plasma humanum ad separationem) 01/2005:0853, corrected. Strasbourg: European Pharmacopeia; 2005.
    • Monograph of human plasma for fractionation (plasma humanum ad separationem) 01/2005:0853, corrected. Strasbourg: European Pharmacopeia; 2005.
  • 6
    • 0026662570 scopus 로고
    • Factor VIII/von Willebrand factor levels in plasma frozen to -30°C in air or halogenated hydrocarbons
    • Farrugia A, Hill R, Douglas S, Karabagias K, Kleinig A. Factor VIII/von Willebrand factor levels in plasma frozen to -30°C in air or halogenated hydrocarbons. Thromb Res 1992;68:97-102.
    • (1992) Thromb Res , vol.68 , pp. 97-102
    • Farrugia, A.1    Hill, R.2    Douglas, S.3    Karabagias, K.4    Kleinig, A.5
  • 8
    • 0031854059 scopus 로고    scopus 로고
    • Factors determining quality of plasma
    • Myllyla G. Factors determining quality of plasma. Vox Sang 1998;74(Suppl 2):507-11.
    • (1998) Vox Sang , vol.74 , Issue.SUPPL. 2 , pp. 507-511
    • Myllyla, G.1
  • 9
    • 0035689216 scopus 로고    scopus 로고
    • The impact of the intensity of serial automated plasmapheresis and the speed of deep-freezing on the quality of plasma
    • Hellstern P, Bach J, Haubelt H, Hitzler WE, Mathis S, Vogt A. The impact of the intensity of serial automated plasmapheresis and the speed of deep-freezing on the quality of plasma. Transfusion 2001;41:1601-5.
    • (2001) Transfusion , vol.41 , pp. 1601-1605
    • Hellstern, P.1    Bach, J.2    Haubelt, H.3    Hitzler, W.E.4    Mathis, S.5    Vogt, A.6
  • 10
    • 0037206603 scopus 로고    scopus 로고
    • Manufacture and composition of fresh frozen plasma and virus-inactivated therapeutic plasma preparations: Correlation between composition and therapeutic efficacy
    • Hellstern P, Haubert H. Manufacture and composition of fresh frozen plasma and virus-inactivated therapeutic plasma preparations: correlation between composition and therapeutic efficacy. Thromb Res 2002;107(Suppl 1):S3-8.
    • (2002) Thromb Res , vol.107 , Issue.SUPPL. 1
    • Hellstern, P.1    Haubert, H.2
  • 11
    • 0038307226 scopus 로고    scopus 로고
    • Vitamin K-dependent coagulation factors and fibrinogen levels in FFP remain stable upon repeated freezing and thawing
    • Ben-Tal O, Zwang E, Eichel R, Badalbev T, Hareuveni M. Vitamin K-dependent coagulation factors and fibrinogen levels in FFP remain stable upon repeated freezing and thawing. Transfusion 2003;43:873-7.
    • (2003) Transfusion , vol.43 , pp. 873-877
    • Ben-Tal, O.1    Zwang, E.2    Eichel, R.3    Badalbev, T.4    Hareuveni, M.5
  • 12
    • 0042835813 scopus 로고    scopus 로고
    • Protein composition and activation markers in plasma collected by three apheresis procedure
    • Burnouf T, Kappelsberger C, Frank K, Burkhardt T. Protein composition and activation markers in plasma collected by three apheresis procedure. Transfusion 2003; 43:1223-9.
    • (2003) Transfusion , vol.43 , pp. 1223-1229
    • Burnouf, T.1    Kappelsberger, C.2    Frank, K.3    Burkhardt, T.4
  • 13
    • 7944220700 scopus 로고    scopus 로고
    • Effects of extended storage of whole blood before leukocyte depletion on coagulation factors in plasma
    • Kretzschmar E, Kruse F, Greiss O, Paunovic D, Kallweit T, Trobisch H. Effects of extended storage of whole blood before leukocyte depletion on coagulation factors in plasma. Vox Sang 2004;87:156-64.
    • (2004) Vox Sang , vol.87 , pp. 156-164
    • Kretzschmar, E.1    Kruse, F.2    Greiss, O.3    Paunovic, D.4    Kallweit, T.5    Trobisch, H.6
  • 14
    • 15244343858 scopus 로고    scopus 로고
    • The quality of plasma collected by automated apheresis and of recovered plasma from leukodepleted whole blood
    • Runkel S, Haubelt H, Hitzler W, Hellstern P. The quality of plasma collected by automated apheresis and of recovered plasma from leukodepleted whole blood. Transfusion 2005; 45:427-32.
    • (2005) Transfusion , vol.45 , pp. 427-432
    • Runkel, S.1    Haubelt, H.2    Hitzler, W.3    Hellstern, P.4
  • 16
    • 0000429094 scopus 로고
    • The plasma concentration of factor VIII in the normal population. The effect of age, sex and blood group
    • Preston AE, Barr A. The plasma concentration of factor VIII in the normal population. The effect of age, sex and blood group. Br J Haematol 1964;10:238-45.
    • (1964) Br J Haematol , vol.10 , pp. 238-245
    • Preston, A.E.1    Barr, A.2
  • 19
    • 0021951144 scopus 로고
    • Factor VIII and factor IX in a twin population. Evidence for a major effect of ABO locus on factor VIII level
    • Ørstavik KH, Magnus P, Reisner H, Berg K, Graham JB, Nance W. Factor VIII and factor IX in a twin population. Evidence for a major effect of ABO locus on factor VIII level. Am J Hum Genet 1985;37:89-101.
    • (1985) Am J Hum Genet , vol.37 , pp. 89-101
    • Ørstavik, K.H.1    Magnus, P.2    Reisner, H.3    Berg, K.4    Graham, J.B.5    Nance, W.6
  • 22
    • 0034892732 scopus 로고    scopus 로고
    • The relationship between ABO histo-blood group, factor VIII and von Willebrand factor
    • O'Donnell J, Laffan MA. The relationship between ABO histo-blood group, factor VIII and von Willebrand factor. Transfus Med 2001;11:343-51.
    • (2001) Transfus Med , vol.11 , pp. 343-351
    • O'Donnell, J.1    Laffan, M.A.2
  • 23
    • 0036159559 scopus 로고    scopus 로고
    • Amount of H antigen expressed on circulating von Willebrand factor is modified by ABO blood group genotype and is a major determinant of plasma von Willebrand factor antigen levels
    • O'Donnell J, Boulton FE, Manning RA, Laffan MA. Amount of H antigen expressed on circulating von Willebrand factor is modified by ABO blood group genotype and is a major determinant of plasma von Willebrand factor antigen levels. Arterioscler Thromb Vasc Biol 2002;22: 335-41.
    • (2002) Arterioscler Thromb Vasc Biol , vol.22 , pp. 335-341
    • O'Donnell, J.1    Boulton, F.E.2    Manning, R.A.3    Laffan, M.A.4
  • 24
    • 27844489519 scopus 로고    scopus 로고
    • Cross-laboratory audit of normal reference ranges and assessment of ABO blood group, gender and age on detected levels of plasma coagulation factors
    • Favaloro EJ, Soltani S, McDonald J, Grezchnik E, Easton L. Cross-laboratory audit of normal reference ranges and assessment of ABO blood group, gender and age on detected levels of plasma coagulation factors. Blood Coagul Fibrinolysis 2005;16:597-605.
    • (2005) Blood Coagul Fibrinolysis , vol.16 , pp. 597-605
    • Favaloro, E.J.1    Soltani, S.2    McDonald, J.3    Grezchnik, E.4    Easton, L.5
  • 25
    • 0004106491 scopus 로고    scopus 로고
    • Select Committee on Quality Assurance in Blood Transfusion Services, 13th ed. Strasbourg, France: Council of Europe Publishing;
    • Select Committee on Quality Assurance in Blood Transfusion Services. Guide to the preparation, use and quality assurance of blood components. 13th ed. Strasbourg, France: Council of Europe Publishing; 2007.
    • (2007) Guide to the preparation, use and quality assurance of blood components
  • 26
    • 47749143732 scopus 로고    scopus 로고
    • Decree of March 3rd, 2005. Characteristics and modalities for blood and blood components donation
    • Italian Ministry of Health, April 13th
    • Italian Ministry of Health. Decree of March 3rd, 2005. Characteristics and modalities for blood and blood components donation. Gazzetta Ufficiale della Repubblica Italiana n. 85, April 13th, 2005.
    • (2005) Gazzetta Ufficiale della Repubblica Italiana , Issue.85
  • 28
    • 0002624219 scopus 로고    scopus 로고
    • Assay of factor VIII antigen (VIII:Ag) in 294 haemophilia A patients by a new commercial ELISA using monoclonal antibodies
    • Girma JP, Fressinaud E, Houllier A, Laurian Y, Amiral J, Meyer D. Assay of factor VIII antigen (VIII:Ag) in 294 haemophilia A patients by a new commercial ELISA using monoclonal antibodies. Haemophilia 1998;4:98-103.
    • (1998) Haemophilia , vol.4 , pp. 98-103
    • Girma, J.P.1    Fressinaud, E.2    Houllier, A.3    Laurian, Y.4    Amiral, J.5    Meyer, D.6
  • 29
    • 63849276358 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group. Guideline for industry. Text on validation of analytical procedures. ICH- Q2A. March 1995. Available from: URL
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group. Guideline for industry. Text on validation of analytical procedures. ICH- Q2A. March 1995. Available from: URL: http://www.fda.gov/cder/Guidance/ichq2a.pdf
  • 30
    • 63849155270 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group. Guidance for industry. Validation of analytical procedures: methodology. ICH-Q2B. November 1996. Available from: URL
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group. Guidance for industry. Validation of analytical procedures: methodology. ICH-Q2B. November 1996. Available from: URL: http://www.fda.gov/cder/Guidance/ 1320fnl.pdf
  • 31
    • 63849190343 scopus 로고    scopus 로고
    • Law n. 219 of October 21st, 2005. New discipline of transfusion medicine activities and national production of blood derivatives
    • Italian Republic, October 27th
    • Italian Republic. Law n. 219 of October 21st, 2005. New discipline of transfusion medicine activities and national production of blood derivatives. Gazzetta Ufficiale della Repubblica Italiana n. 251, October 27th, 2005.
    • (2005) Gazzetta Ufficiale della Repubblica Italiana , Issue.251
  • 32
    • 63849280087 scopus 로고    scopus 로고
    • Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003: setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Directive 2001/83/EC. Official Journal of the European Union 2003;8/2/2003:L 33/30-40.
    • Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003: setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Directive 2001/83/EC. Official Journal of the European Union 2003;8/2/2003:L 33/30-40.
  • 33
    • 34547741075 scopus 로고    scopus 로고
    • The European Union Blood Safety Directive and its implications for blood services
    • Robinson EAE. The European Union Blood Safety Directive and its implications for blood services. Vox Sang 2007;93: 122-30.
    • (2007) Vox Sang , vol.93 , pp. 122-130
    • Robinson, E.A.E.1
  • 34
    • 63849089212 scopus 로고    scopus 로고
    • Commission Directive 2004/33/EC of 2 March 2004: implementing certain technical requirements for blood and blood components. Off J Eur Union 2004;30/3/2004:L 91/25-39.
    • Commission Directive 2004/33/EC of 2 March 2004: implementing certain technical requirements for blood and blood components. Off J Eur Union 2004;30/3/2004:L 91/25-39.
  • 35
    • 0034097236 scopus 로고    scopus 로고
    • Retention of coagulation factors in plasma frozen after extended holding at 1-6°C
    • Smith JF, Ness PM, Moroff G, Luban NLC. Retention of coagulation factors in plasma frozen after extended holding at 1-6°C. Vox Sang 2000;78:28-30.
    • (2000) Vox Sang , vol.78 , pp. 28-30
    • Smith, J.F.1    Ness, P.M.2    Moroff, G.3    Luban, N.L.C.4
  • 36
    • 0024549869 scopus 로고
    • Importance of a quality assurance scheme for factor VIII assays in quality monitoring of human plasma destined for fractionation into factor VIII concentrate
    • Gabra GS, Prowse CV, Boulton FE. Importance of a quality assurance scheme for factor VIII assays in quality monitoring of human plasma destined for fractionation into factor VIII concentrate. Vox Sang 1989;56:65-70.
    • (1989) Vox Sang , vol.56 , pp. 65-70
    • Gabra, G.S.1    Prowse, C.V.2    Boulton, F.E.3
  • 37
    • 2442456960 scopus 로고    scopus 로고
    • Variability in factor VIII concentrate measurement: Results from SSC field collaborative studies
    • Raut S, Sands D, Heat AB, Barrowcliffe TW. Variability in factor VIII concentrate measurement: results from SSC field collaborative studies. J Thromb Haemost 2003;1:1927- 34.
    • (2003) J Thromb Haemost , vol.1 , pp. 1927-1934
    • Raut, S.1    Sands, D.2    Heat, A.B.3    Barrowcliffe, T.W.4
  • 38
    • 0034768365 scopus 로고    scopus 로고
    • A rebuttal: Issues with the assay of factor VIII activity in plasma and factor VIII concentrates
    • Rosen S. A rebuttal: issues with the assay of factor VIII activity in plasma and factor VIII concentrates. Thromb Haemost 2001;86:1132-3.
    • (2001) Thromb Haemost , vol.86 , pp. 1132-1133
    • Rosen, S.1
  • 39
    • 0035018552 scopus 로고    scopus 로고
    • Potency estimation of recombinant factor VIII: Effect of assay method and standard
    • Hubbard AR, Bevan SA, Weller LJ. Potency estimation of recombinant factor VIII: effect of assay method and standard. Br J Haematol 2001;113:533-6.
    • (2001) Br J Haematol , vol.113 , pp. 533-536
    • Hubbard, A.R.1    Bevan, S.A.2    Weller, L.J.3
  • 40
    • 33644799923 scopus 로고    scopus 로고
    • van den Besselaar AM, Haas FJ, Kuypers AW. Harmonisation of factor VIII:C assay results: study within the framework of the Dutch project Calibration 2000. Br J Haematol 2006;132:75-9.
    • van den Besselaar AM, Haas FJ, Kuypers AW. Harmonisation of factor VIII:C assay results: study within the framework of the Dutch project "Calibration 2000." Br J Haematol 2006;132:75-9.
  • 41
    • 33644989357 scopus 로고    scopus 로고
    • Accuracy of FVIII:C assay by one-stage method can be improved using hemophilic plasma as diluent
    • Cinotti S, Paladino E, Morfini M. Accuracy of FVIII:C assay by one-stage method can be improved using hemophilic plasma as diluent. J Thromb Haemost 2006;4:828-33.
    • (2006) J Thromb Haemost , vol.4 , pp. 828-833
    • Cinotti, S.1    Paladino, E.2    Morfini, M.3
  • 42
    • 0036017368 scopus 로고    scopus 로고
    • Coagulation and chromogenic assays of factor VIII activity: General aspects, standardization, and recommendations
    • Barrowcliffe TW, Raut S, Sands D, Hubbard AR. Coagulation and chromogenic assays of factor VIII activity: general aspects, standardization, and recommendations. Semin Thromb Hemost 2002;28:247-56.
    • (2002) Semin Thromb Hemost , vol.28 , pp. 247-256
    • Barrowcliffe, T.W.1    Raut, S.2    Sands, D.3    Hubbard, A.R.4
  • 43
    • 0025052323 scopus 로고
    • Validation of a procedure for potency assessing of a high purity factor VIII concentrate: Comparison of different factor VIII coagulant assays and effect of prediluent
    • Mazurier C, Parquet-Gernez A, Goudemand M. Validation of a procedure for potency assessing of a high purity factor VIII concentrate: comparison of different factor VIII coagulant assays and effect of prediluent. Thromb Haemost 1990;64:251-5.
    • (1990) Thromb Haemost , vol.64 , pp. 251-255
    • Mazurier, C.1    Parquet-Gernez, A.2    Goudemand, M.3
  • 44
    • 4844227035 scopus 로고    scopus 로고
    • Relationships between factor VIII:Ag and factorVIII in recombinant and plasma-derived factor VIII concentrates
    • Lin Y, Yang X, Chevrier MC, Craven S, Barrowcliffw TW, Lemieux R, Ofosu FA. Relationships between factor VIII:Ag and factorVIII in recombinant and plasma-derived factor VIII concentrates. Haemophilia 2004;10:459-69.
    • (2004) Haemophilia , vol.10 , pp. 459-469
    • Lin, Y.1    Yang, X.2    Chevrier, M.C.3    Craven, S.4    Barrowcliffw, T.W.5    Lemieux, R.6    Ofosu, F.A.7


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