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Pathogen inactivation of blood products

INTRODUCTION

A major public health concern regarding blood products in general and plasma derivatives in particular is the possibility that plasma used for further manufacture and eventual transfusion or administration may be contaminated with one or more viral agents (eg, HIV, HCV, parvovirus) or with other pathogens.

While some have argued that the pathogen inactivation procedures discussed below eliminate concerns about the presence of infectious agents in donor plasma, most authorities agree that adherence to strict standards of donor recruitment and donor screening are still necessary for ensuring the safety of these products. Blood donor screening and testing of blood for pathogens are discussed separately.

(See "Blood donor screening: Medical history".)

(See "Blood donor screening: Laboratory testing".)

(See "Blood donor screening: Procedures and processes to enhance safety for the blood recipient and the blood donor", section on 'Protection of the recipient'.)

                 

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Literature review current through: Nov 2014. | This topic last updated: Feb 4, 2014.
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References
Top
  1. Klein HG, Dodd RY, Dzik WH, et al. Current status of solvent/detergent-treated frozen plasma. Transfusion 1998; 38:102.
  2. Ludlam CA, Powderly WG, Bozzette S, et al. Clinical perspectives of emerging pathogens in bleeding disorders. Lancet 2006; 367:252.
  3. Pamphilon D. Viral inactivation of fresh frozen plasma. Br J Haematol 2000; 109:680.
  4. Schimpf K, Mannucci PM, Kreutz W, et al. Absence of hepatitis after treatment with a pasteurized factor VIII concentrate in patients with hemophilia and no previous transfusions. N Engl J Med 1987; 316:918.
  5. Lawrence JE. Affinity chromatography to remove viruses during preparation of plasma derivatives. In: Virological Safety of Plasma Derivatives, Brown F (Ed), Karger, Basel 1993. p.191.
  6. Horowitz MS, Rooks C, Horowitz B, Hilgartner MW. Virus safety of solvent/detergent-treated antihaemophilic factor concentrate. Lancet 1988; 2:186.
  7. Brown KE, Young NS, Alving BM, Barbosa LH. Parvovirus B19: implications for transfusion medicine. Summary of a workshop. Transfusion 2001; 41:130.
  8. Schneider B, Becker M, Brackmann HH, Eis-Hübinger AM. Contamination of coagulation factor concentrates with human parvovirus B19 genotype 1 and 2. Thromb Haemost 2004; 92:838.
  9. Kleinman SH, Glynn SA, Lee TH, et al. A linked donor-recipient study to evaluate parvovirus B19 transmission by blood component transfusion. Blood 2009; 114:3677.
  10. Prince AM, Horowitz B, Brotman B, et al. Inactivation of hepatitis B and Hutchinson strain non-A, non-B hepatitis viruses by exposure to Tween 80 and ether. Vox Sang 1984; 46:36.
  11. Pehta JC. Clinical studies with solvent detergent-treated products. Transfus Med Rev 1996; 10:303.
  12. Lerner RG, Nelson J, Sorcia E, et al. Evaluation of solvent/detergent-treated plasma in patients with a prolonged prothrombin time. Vox Sang 2000; 79:161.
  13. Snyder EL, Dodd RY. Reducing the risk of blood transfusion. Hematology Am Soc Hematol Educ Program 2001; :433.
  14. Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion 1999; 39:1160.
  15. Horowitz B, Busch M. Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin. Transfusion 2008; 48:1739.
  16. Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies. Transfusion 2009; 49:1931.
  17. Flamholz R, Jeon HR, Baron JM, Baron BW. Study of three patients with thrombotic thrombocytopenic purpura exchanged with solvent/detergent-treated plasma: is its decreased protein S activity clinically related to their development of deep venous thromboses? J Clin Apher 2000; 15:169.
  18. Mast AE, Stadanlick JE, Lockett JM, Dietzen DJ. Solvent/detergent-treated plasma has decreased antitrypsin activity and absent antiplasmin activity. Blood 1999; 94:3922.
  19. Nifong TP, Light J, Wenk RE. Coagulant stability and sterility of thawed S/D-treated plasma. Transfusion 2002; 42:1581.
  20. Williamson LM, Llewelyn CA, Fisher NC, et al. A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation. Transfusion 1999; 39:1227.
  21. Zeiler T, Wittmann G, Zimmermann R, et al. The effect of virus inactivation on coagulation factors in therapeutic plasma. Br J Haematol 2000; 111:986.
  22. Haubelt H, Blome M, Kiessling AH, et al. Effects of solvent/detergent-treated plasma and fresh-frozen plasma on haemostasis and fibrinolysis in complex coagulopathy following open-heart surgery. Vox Sang 2002; 82:9.
  23. Freeman JW, Williamson LM, Llewelyn C, et al. A randomized trial of solvent/detergent and standard fresh frozen plasma in the treatment of the coagulopathy seen during Orthotopic Liver Transplantation. Vox Sang 1998; 74 Suppl 1:225.
  24. Lambrecht B, Mohr H, Knüver-Hopf J, Schmitt H. Photoinactivation of viruses in human fresh plasma by phenothiazine dyes in combination with visible light. Vox Sang 1991; 60:207.
  25. Zeiler T, Riess H, Wittmann G, et al. The effect of methylene blue phototreatment on plasma proteins and in vitro coagulation capability of single-donor fresh-frozen plasma. Transfusion 1994; 34:685.
  26. Atance R, Pereira A, Ramírez B. Transfusing methylene blue-photoinactivated plasma instead of FFP is associated with an increased demand for plasma and cryoprecipitate. Transfusion 2001; 41:1548.
  27. Suontaka AM, Blombäck M, Chapman J. Changes in functional activities of plasma fibrinogen after treatment with methylene blue and red light. Transfusion 2003; 43:568.
  28. Moog R, Reichenberg S, Hoburg A, Müller N. Quality of methylene-blue-treated fresh-frozen plasma stored up to 27 months. Transfusion 2010; 50:516.
  29. Sawyer L, Hanson D, Castro G, et al. Inactivation of parvovirus B19 in human platelet concentrates by treatment with amotosalen and ultraviolet A illumination. Transfusion 2007; 47:1062.
  30. Lin L, Cook DN, Wiesehahn GP, et al. Photochemical inactivation of viruses and bacteria in platelet concentrates by use of a novel psoralen and long-wavelength ultraviolet light. Transfusion 1997; 37:423.
  31. Wollowitz S. Fundamentals of the psoralen-based Helinx technology for inactivation of infectious pathogens and leukocytes in platelets and plasma. Semin Hematol 2001; 38:4.
  32. Ljungman P. Risk of cytomegalovirus transmission by blood products to immunocompromised patients and means for reduction. Br J Haematol 2004; 125:107.
  33. Singh Y, Sawyer LS, Pinkoski LS, et al. Photochemical treatment of plasma with amotosalen and long-wavelength ultraviolet light inactivates pathogens while retaining coagulation function. Transfusion 2006; 46:1168.
  34. Schlenke P, Hervig T, Isola H, et al. Photochemical treatment of plasma with amotosalen and UVA light: process validation in three European blood centers. Transfusion 2008; 48:697.
  35. Hambleton J, Wages D, Radu-Radulescu L, et al. Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin. Transfusion 2002; 42:1302.
  36. Ciaravino V. Preclinical safety of a nucleic acid-targeted Helinx compound: a clinical perspective. Semin Hematol 2001; 38:12.
  37. de Alarcon P, Benjamin R, Dugdale M, et al. Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies. Transfusion 2005; 45:1362.
  38. Mintz PD, Bass NM, Petz LD, et al. Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease. Blood 2006; 107:3753.
  39. Unger U, Poelsler G, Modrof J, Kreil TR. Virus inactivation during the freeze-drying processes as used for the manufacture of plasma-derived medicinal products. Transfusion 2009; 49:1924.
  40. Osselaer JC, Messe N, Hervig T, et al. A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment. Transfusion 2008; 48:1061.
  41. Wagner SJ, Skripchenko A, Myrup A, et al. Evaluation of in vitro storage properties of prestorage pooled whole blood-derived platelets suspended in 100 percent plasma and treated with amotosalen and long-wavelength ultraviolet light. Transfusion 2009; 49:704.
  42. Kerkhoffs JL, van Putten WL, Novotny VM, et al. Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction. Br J Haematol 2010; 150:209.
  43. Lozano M, Knutson F, Tardivel R, et al. A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion. Br J Haematol 2011; 153:393.
  44. Osselaer JC, Doyen C, Defoin L, et al. Universal adoption of pathogen inactivation of platelet components: impact on platelet and red blood cell component use. Transfusion 2009; 49:1412.
  45. Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology. Transfusion 2010; 50:2362.