Pathogen inactivation: The definitive safeguard for the blood supply

Archives of Pathology and Laboratory Medicine

Volumn 131, Issue 5, 2007, Pages 719-733

  Bryant, Barbara J ^a,b   Klein, Harvey C ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMOTOSALEN; METHYLENE BLUE; PHENOTHIAZINE; PHOTOSENSITIZING AGENT; PSORALEN; RIBOFLAVIN; SOLVENT; THIONINE; TRITON X 100;

BACTERIAL VIRULENCE; BLOOD COMPONENT; BLOOD DONOR; BLOOD TRANSFUSION; CROSS LINKING; CYTOMEGALOVIRUS; DEVELOPING COUNTRY; GENE INACTIVATION; HEPATITIS A VIRUS; HEPATITIS B VIRUS; HEPATITIS C VIRUS; HEPATITIS DELTA VIRUS; HEPATITIS E VIRUS; HEPATITIS G VIRUS; HUMAN; HUMAN HERPESVIRUS 8; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2; HUMAN T CELL LEUKEMIA VIRUS 1; HUMAN T CELL LEUKEMIA VIRUS 2; MEDICAL LITERATURE; NANOFILTRATION; NONHUMAN; PATHOGENESIS; REVIEW; SEROLOGY; ULTRAVIOLET A RADIATION; VASCULARIZATION; VIRAL CONTAMINATION; VIRUS INACTIVATION; VIRUS VIRULENCE; WEST NILE FLAVIVIRUS;

BLOOD BANKS; BLOOD DONORS; BLOOD TRANSFUSION; BLOOD-BORNE PATHOGENS; COMMUNICABLE DISEASE CONTROL; COMMUNICABLE DISEASES; HUMANS;

EID: 34248145455     PISSN: 00039985     EISSN: 15432165     Source Type: Journal    
DOI: None     Document Type: Review

References (113)

1. Beeson PB. Jaundice occurring one to four months after transfusion of blood or plasma - report of seven cases. JAMA. 1943;121:1332-1334.
2. Dodd RY, Notari EP, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood door population. Transfusion. 2002;42:975-979.
3. AuBuchon JP. Meeting transfusion safety expectations. Ann Intern Med. 2005;143:537-538.
4. Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine: first of two parts - blood transfusion. N Engl J Med. 1999;340:438-447.
5. Theodossiades G, Makris M. Transfusion-transmitted infections: epidemiology, risks and prevention. Haema. 2001;4:24-38.
6. Pillonel J, Laperche S. Trends in residual risk of transfusion transmitted viral infections (HIV, HCV, HBV) in France between 1992 and 2002 and impact of viral genome screening (nucleic acid testing). Transfus Clin Biol. 2004;11:81-86.
7. Centers for Disease Control and Prevention. Update: West Nile virus screening of blood donations and transfusion-associated transmission - United States, 2003. MMWR Weekly. April 9, 2004;53:281-284.
8. Chambers RW, Foley HT, Schmidt PJ. Transmission of syphilis by fresh blood components. Transfusion. 1969;9:32-34.
9. Silva MA, ed. Standards for Blood Banks and Transfusion Services. 23rd ed. Bethesda, Md: AABB; 2005:11.
10. Brecher ME, Hay SN. Improving platelet safety: bacterial contamination of platelets. Curr Hematol Rep. 2004;3:121-127.
11. Brecher ME, Hay SN, Rothenberg SJ. Monitoring of apheresis platelet bacterial contamination with an automated liquid culture system: a university experience. Transfusion. 2003;43:974-978.
12. Kuehnert MJ, Roth VR, Haley NR, et al. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion. 2001;41:1493-1499.
13. Perez P, Salmi LR, Follea G, et al. BACTHEM Group, French Haemovigilance Network. Determinants of transfusion-associated bacterial contamination: results of the French BACTHEM case-control study. Transfusion. 2001;41:862-871.
14. Serious Hazards of Transfusion (SHOT). SHOT report for 2000-2001. (Cumulative data 01/10/1995-30/09/2002). Available at: http://www.shot.demon. co.uk/toc.htm. Accessed November 25, 2006.
15. Brecher ME, Hay SN. Bacterial contamination of blood components. Clin Microbiol Rev. 2005;18:195-204.
16. Burnouf T, Radosevich M, Goubran HA, Willkommen A. Place of nanofiltration for assuring viral safety of biologicals. Curr Nanosci. 2005;1:189-201.
17. Allain JP, Bianco C, Blajchman MA, et al. Protecting the blood supply from emerging pathogens: the role of pathogen inactivation. Transfus Med Rev. 2005; 19:110-126.
18. Heneine W, Switzer WM, Sandstrom P, et al. Identification of a human population infected with simian foamy viruses. Nat Med. 1998;4:403-407.
19. Switzer WM, Bhullar V, Shanmugam V, et al. Frequent simian foamy virus infection in persons occupationally exposed to nonhuman primates. J Virol. 2004; 78:2780-2789.
20. Cable RG, Leiby DA. Risk and prevention of transfusion transmitted babesiosis and other tick-borne diseases. Curr Opin Hematol. 2003;10:405-411.
21. Llewelyn CA, Hewitt PE, Knight RSG, et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet. 2004;363:417-421.
22. Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet. 2004; 264:527-529.
23. BBC News. Third vCJD "blood case" diagnosed. BBC News. February 9, 2006. Available at: http://news.bbc.co.uk/2/hi/health/4696522.stm. Accessed November 25, 2006.
24. Hollinger FB, Kleinman S. Transfusion transmission of West Nile virus: a merging of historical and contemporary perspectives. Transfusion. 2003;43:992-997.
25. Mostashari F, Bunning ML, Kitsutani PT, et al. Epidemic West Nile encephalitis, New York, 1999: results of a household-based seroepidemiological survey. Lancet. 2001;358:261-264.
26. Biggerstaff BJ, Petersen LR. Estimated risk of West Nile virus transmission through blood transfusion during an epidemic in Queens, New York City. Transfusion. 2002;42:1019-1026.
27. Centers for Disease Control and Prevention. Statistics, surveillance, and control. West Nile virus 2003 human cases as of August 12, 2003. Available at: http://www.cdc.gov/ncidod/dvbid/westnile/surv&controlCaseCount03.htm. Accessed November 25, 2006.
28. Public Health Agency of Canada. West Nile Virus Monitor, Human Surveillance (2002-2005). Available at: http://www.phac-aspc.gc.ca/wnv-vwn/ mon-hmnsurv-archive_e.html. Accessed November 27, 2006.
29. Centers for Disease Control and Prevention. Investigations of West Nile virus infections in recipients of blood transfusions. Available at: http://www.cdc.gov/ mmwr/preview/mmwrhtml/mm5139a5.htm. Accessed November 25, 2006.
30. Pealer LN, Marfin AA, Petersen LR, et al. West Nile Virus Transmission Investigation Team. Transmission of West Nile virus through blood transfusion in the United States in 2002. N Engl J Med. 2003;349:1236-1245.
31. World Health Organization. Fact sheets. Blood safety and volunteer donations. Available at: http://www.wpro.who.int/media_centre/fact_sheets/fs_ 20040610.htm. Accessed November 25, 2006.
32. Blood supply and demand. Lancet. 2005;365:2151.
33. Burdick MD, Pifat DY, Petteway SR Jr, Cai K. Clearance of prions during plasma protein manufacture. Transfus Med Rev. 2006;20:57-62.
34. World Health Organization. Guidelines on Viral Inactivation and Removal Procedures Intended to Assure the Viral Safety of Human Blood Plasma. Geneva, Switzerland: World Health Organization; 2004. WHO technical report, Series No. 924.
35. Klein HG. Pathogen inactivation technology: cleansing the blood supply. J Intern Med. 2005;257:224-237.
36. 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;39:1160-1168.
37. Kingdon HS, Lundblad RL. An adventure in biotechnology: the development of haemophilia A therapeutics - from whole blood transfusion to recombinant DNA to gene therapy. Biotechnol Appl Biochem. 2002;35:141-148.
38. Mannucci PM, Colombo M, Rodeghiero F. Non-A, non-B hepatitis after factor VIII concentrate treated by heating and chloroform. Lancet. 1985;2:1013.
39. Mariani G, Ghirardini A, Mandelli F, et al. Heated clotting factors and seroconversion for human immunodeficiency virus in three hemophilic patients. Ann Intern Med. 1987;107:113.
40. Skidmore SJ, Pasi KJ, Mawson SJ, Williams MD, Hill FG. Serological evidence that dry heating of clotting factor concentrates prevents transmission of non-A, non-B hepatitis. J Med Virol. 1990;30:50-52.
41. Azzi A, Ciappi S, Zakvrzewska K, Morfini M, Mariani G, Mannucci PM. Human parvovirus B19 infection in hemophiliacs first infused with two high-purity, virally attenuated factor VIII concentrates. Am J Hematol. 1992;39:228-230.
42. Rubinstein AI, Rubinstein DB. Inability of solvent-detergent (S-D) treated factor VIII concentrate to inactivate parvoviruses and non-lipid enveloped non-A, non-B hepatitis virus in factor VIII concentrate: advantages to using sterilizing 100 degrees C dry heat treatment. Am J Hematol. 1990;35:142.
43. Burnouf T, Griffiths E, Padilla A, Seddik S, Stephano MA, Gutierrez JM. Assessment of the viral safety of antivenoms fractionated from equine plasma. Biologicals. 2004;32:115-128.
44. Burnouf-Radosevich M. Viral safety of intravenous immunoglobulins G for therapeutic use. Transfus Clin Biol. 1995;2:167-179.
45. Omar A, Kempf C, Immelmann A, Rentsch M, Morgenthaler JJ. Virus inactivation by pepsin treatment at pH 4 of IgG solutions: factors affecting the rate of virus inactivation. Transfusion. 1996;36:866-872.
46. Bos OJ, Sunye DG, Nieuweboer CE, van Engelenburg FA, Schuitemaker H, Over J. Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process. Biologicals. 1998;26:267-276.
47. Reid KG, Cuthbertson B, Jones AD, McIntosh RV. Potential contribution of mild pepsin treatment at pH4 to the viral safety of human immunoglobulin products. Vox Sang. 1988;55:75-80.
48. Prince AM, Horowitz B, Brotman B. Sterilization of hepatitis and HTLV-III viruses by exposure to tri(n-butyl)phosphate and sodium cholate. Lancet. 1986; 1:706-710.
49. Klein HG, Dodd RY, Dzik WH, et al. Current status of solvent/detergent- treated frozen plasma. Transfusion. 1998;38:102-107.
50. Yarranton H, Cohen H, Pavord SR, Benjamin S, Hagger D, Machin SJ. Venous thromboembolism associated with the management of acute thrombotic thrombocytopenic purpura. Br J Haematol. 2003;121:778-785.
51. 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;39:1227-1234.
52. Burnouf T, Goubran HA, Radosevich M, Sayed MA, Gorgy G, El-Ekiaby M. A process for solvent/detergent treatment of plasma for transfusion at blood centers using a disposable-bag system. Transfusion. 2006;46:2100-2108.
53. Burnouf T, Radosevich M. Nanofiltration of plasma-derived biopharmaceutical products. Haemophilia. 2003;9:24-37.
54. Yokoyama T, Murai K, Murozuka T, et al. Removal of small non-enveloped viruses by nanofiltration. Vox Sang. 2004;86:225-229.
55. Wagner SJ. Virus inactivation in blood components by photoactive phenothiazine dyes. Transfus Med Rev. 2002;16:61-66.
56. Mohr H, Lambrecht B, Selz A. Photodynamic virus inactivation of blood components. Immunol Invest. 1995;24:73-85.
57. Williamson LM, Cardigan R, Prowse CV. Methylene blue treated fresh-frozen plasma: what is its contribution to blood safety? Transfusion. 2003;43: 1322-1329.
58. Mohr H. Methylene blue and thionine in pathogen inactivation of plasma and platelet concentrates. Transfus Apher Sci. 2001;25:183-184.
59. Hanson CV. Photochemical inactivation of viruses with psoralens: an overview. Blood Cells. 1992;18:7-25.
60. 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;37:423-435.
61. Corash L, Lin L, Wiesehahn G. Use of 8-methoxypsoralen and long wavelength ultraviolet radiation for decontamination of platelet concentrates. Blood Cells. 1992;18:57-73.
62. Moroff G, Wagner S, Benade L, Dodd RY. Factors influencing virus inactivation and retention of platelet properties following treatment with aminomethyltrimethylpsoralen and ultraviolet A light. Blood Cells. 1992;18:43-54.
63. van Rhenen DJ, Vermeij J, Mayaudon V, Hind C, Lin L, Corash L. Functional characteristics of S-59 photochemically treated platelet concentrates derived from buffy coats. Vox Sang. 2000;79:206-214.
64. Ciaravino V, McCullough T, Dayan AD. Pharmacokinetic and toxicology assessment of INTERCEPT (S-59 and UVA treated) platelets. Hum Exp Toxicol. 2001;20:533-550.
65. McCullough J, Vesole DH, Benjamin RJ, et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood. 2004;104:1534-1541.
66. Janetzko K, Cazenave JP, Kluter H, et al. Therapeutic efficacy and safety of photochemically treated apheresis platelets processed with an optimized integrated set. Transfusion. 2005;45:1443-1452.
67. Snyder E, McCullough J, Slichter SJ, et al. Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion. 2005;45:1864-1875.
68. Murphy S, Snyder E, Cable R, et al. Platelet dose consistency and its effect on the number of platelet transfusions for support of thrombocytopenia: an analysis of the SPRINT trial of platelets photochemically treated with amotosalen HCl and ultraviolet A light. Transfusion. 2006;46:24-33.
69. Ciaravino V, McCullough T, Cimino G., Sullivan T. Preclinical safety profile of plasma prepared using the INTERCEPT Blood System. Vox Sang. 2003;85:171-182.
70. Sing 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;46:1168-1177.
71. 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: 1302-1307.
72. 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: 1362-1372.
73. 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;107:3753-3760.
74. Conlan MG, Corash L, Lin J, et al. vWF cleaving protease activity and inhibitors in patients with thrombotic thrombocytopenic purpura (TTP) treated with INTERCEPT FFP vs. conventional FFP: results of a phase III trial. Transfusion. 2005;45:30A.
75. Mintz PD, Neff A, MacKenzie M, et al. A randomized, controlled phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura. Transfusion. 2006;46:1693-1704.
76. Mintz PD, Avery NL, Monlaison SL, et al. Preparation of cryoprecipitate from photochemically treated fresh frozen plasma. Transfusion. 2000;40:63s.
77. Yarranton H, Lawrie AS, Mackie IJ, Pinkoski L, Corash L, Machin SJ. Coagulation factor levels in cryosupernatant prepared from plasma treated with amotosalen hydrochloride (S-59) and ultraviolet A light. Transfusion. 2005;45: 1453-1458.
78. Dardare N, Platz MS. Binding affinities of commonly employed sensitizers of viral inactivation. Photochem Photobiol. 2002;75:561-564.
79. Hardwick CC, Herivel TR, Hernandez SC, Ruane PH, Goodrich RP. Separation, identification and quantification of riboflavin and its photoproducts in blood products using HPLC with fluorescence detection: a method to support pathogen reduction technology. Photochem Photobiol. 2004;80:609-615.
80. US Food and Drug Administration. Vitamin B, 21 CFR 582.5695 (1998).
81. Ruane PH, Edrich R, Gampp D, Keil SD, Leonard RL, Goodrich RP. Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion. 2004;44:877-885.
82. Goodrich RP. The use of riboflavin for the inactivation of pathogens in blood products. Vox Sang. 2000;78(S2):211-215.
83. Schuyler R. Use of riboflavin for photoinactivation of pathogens in blood components. Transfus Apher Sci. 2001;25:189-190.
84. Cardo LJ, Rentas FJ, Ketchum L, et al. Pathogen inactivation of Leishmania donovani infantum in plasma and platelet concentrates using riboflavin and ultraviolet light. Vox Sang. 2006;90:85-91.
85. Li J, Goodrich L, Hansen E, Edrich R, Gampp D, Goodrich RP. Platelet glycolytic flux increases stimulated by ultraviolet-induced stress is not the direct cause of platelet morphology and activation changes: possible implications for the role of glucose in platelet storage. Transfusion. 2005;45:1750-1758.
86. Buytaert-Hoefen KA, Gampp D, Edrich R, Goodrich R. Mirasol pathogen reduction treated fresh frozen plasma maintains protein quality. Vox Sang. 2006; 91:183s.
87. Corash L. Helinx technology for inactivation of infectious pathogens and leukocytes in labile blood components: from theory to clinical application. Transfus Apher Sci. 2001;25:179-181.
88. Corash L. Inactivation of infectious pathogens in labile blood components: meeting the challenge. Transfus Clin Biol. 2001;8:138-145.
89. Benjamin RJ, McCullough J, Mintz PD, et al. Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a phase III clinical trial in cardiac surgery patients. Transfusion. 2005; 45:1739-1749.
90. Conlan MG, Garrity G, Castro G, et al. Antibodies to S-303 treated red blood cells prepared with the original treatment process for pathogen inactivation do not react with red blood cells prepared with a modified S-303 treatment process. Blood. 2005;106:130a.
91. Ohagen A, Gibaja V, Aytay S, Horrigan J, Lunderfille D, Lazo A. Inactivation of HIV in blood. Transfusion. 2002;42:1308-1317.
92. Mather T, Takeda T, Tassello J, et al. West Nile virus in blood: stability, distribution, and susceptibility to PEN110 inactivation. Transfusion. 2003;43: 1029-1037.
93. Purmal A, Valeri CR, Dzik W, et al. Process for the preparation of pathogen-inactivated RBC concentrates by using PEN110 chemistry: preclinical studies. Transfusion. 2002;42:139-145.
94. Lazo A, Tassello J, Jayarama V, et al. Broad-spectrum virus reduction in red cell concentrates using INACTINE PEN110 chemistry. Vox Sang. 2002;83:313-323.
95. Ohagen A, Gibaja V, Horrigan J, et al. Induction of latent human cytomegalovirus by conventional gamma irradiation and prevention by treatment with INACTINE PEN110. Vox Sang. 2004;87:1-9.
96. Zavizion B, Pereira M, de Melo JM, et al. Inactivation of protozoan parasites in red blood cells using INACTINE PEN110 chemistry. Transfusion. 2004; 44:731-738.
97. Zavizion B, Purmal A, Chapman J, Alford B. Inactivation of mycoplasma species in blood by INACTINE PEN110 process. Transfusion. 2004;44:286-293.
98. Zavizion B, Serebryanik D, Serebryanik I, Chapman J, Purmal A. Prevention of Yersinia enterocolitica, Pseudomonas fluorescens, and Pseudomonas putida outgrowth in deliberately inoculated blood by a novel pathogen-reduction process. Transfusion. 2003;43:135-142.
99. AuBuchon JP, Pickard CA, Herschel LH, et al. Production of pathogen-inactivated RBC concentrates using PEN110 chemistry: a phase I clinical study. Transfusion. 2002;42:146-152.
100. Wagner SJ. Virus inactivation in blood components by photoactive phenothiazine dyes. Transfus Med Rev. 2002;16:61-66.
101. Wagner SJ, Skripchenko A, Robinette D, et al. The use of dimethylmethylene blue for virus photoinactivation of red cell suspensions. Dev Biol Stand. 2000;102:125-129.
102. Skripchenko AA, Wagner SJ. Inactivation of WBCs in RBC suspensions by photoactive phenothiazine dyes: comparison of dimethylmethylene blue and MB. Transfusion. 2000;40:968-975.
103. Wagner SJ, Skripchenko A, Robinette D, Mallory DA, Cincotta L. Preservation of red cell properties after virucidal phototreatment with dimethylmethylene blue. Transfusion. 1998;38:729-737.
104. Besselink GAJ, Ebbing IG, Hilarius PM, de Korte D, Verhoeven AJ, Lagerberg JWM. Composition of the additive solution affects red blood cell integrity after photodynamic treatment. Vox Sang. 2003;85:183-189.
105. Wagner SJ, Skripchenko A, Cincotta L, Thompson-Montgomery D, Awatefe H. Use of a flexible thiopyrylium photosensitizer and competitive inhibitor for pathogen reduction of viruses and bacteria with retention of red cell storage properties. Transfusion. 2005;45:752-760.
106. Skripchenko A, Wagner SJ, Thompson-Montgomery D, Awatefe H. Thiazole orange, a DNA-binding photosensitizer with flexible structure, can inactivate pathogens in red blood cell suspensions while maintaining red cell storage properties. Transfusion. 2006;46:213-219.
107. Gregori L, McCombie N, Palmer D, et al. Effectiveness of leucoreduction for removal of infectivity of transmissible spongiform encephalopathies from blood. Lancet. 2004;364:529-531.
108. Sowemimo-Coker S, Kascsak R, Kim A, et al. Removal of exogenous (spiked) and endogenous prion infectivity from red cells with a new prototype of leukoreduction filter. Transfusion. 2005;45:1839-1844.
109. Lin L. Inactivation of cytomegalovirus in platelet concentrates using Helinx technology. Semin Hematol. 2001;38(4S11):27-33.
110. Lin L, Dikeman R, Molini B, et al. Photochemical treatment of platelet concentrates with amotosalen and long-wavelength ultraviolet light inactivates a broad spectrum of pathogenic bacteria. Transfusion. 2004;44:1496-1504.
111. Knutson F, Alfonso R, Dupuis K, et al. Photochemical inactivation of bacteria and HIV in buffy-coat-derived platelet concentrates under conditions that preserve in vitro platelet function. Vox Sang. 2000;78:209-216.
112. Roback JD, Conlan M, Drew WL, Ljungman P, Nichols WG, Preiksaitis JK. The role of photochemical treatment with amotosalen and UV-A light in the prevention of transfusion-transmitted cytomegalovirus infections. Transfus Med Rev. 2006;20:45-56.
113. Eastman RT, Barrett LK, Dupuis K, Buckner FS, Van Voorhis WC. Leishmania inactivation in human pheresis platelets by a psoralen (amotosalen HCl) and long-wavelength ultraviolet irradiation. Transfusion. 2005;45:1459-1463.