Pathogen reduction and blood transfusion safety in Africa: strengths, limitations and challenges of implementation in low-resource settings

Vox Sanguinis

Volumn 113, Issue 1, 2018, Pages 3-12

  Ware, A D ^a   Jacquot, C ^b   Tobian, A A R ^a   Gehrie, E A ^a   Ness, P M ^a   Bloch, E M ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

Author keywords

Africa; blood transfusion; pathogen reduction; transfusion transmitted infections

Indexed keywords

AMUSTALINE; DETERGENT; SOLVENT;

AFRICA; BLOOD TRANSFUSION; FILTRATION; HEALTH CARE UTILIZATION; HIGH INCOME COUNTRY; HUMAN; INFECTION CONTROL; INFECTION RISK; LOW INCOME COUNTRY; NONHUMAN; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW; RISK REDUCTION; SYSTEMATIC REVIEW; BLOOD; BLOOD DONOR; BLOOD SAFETY; COMMUNICABLE DISEASE; COMMUNICABLE DISEASE CONTROL; DEVELOPING COUNTRY; ECONOMICS; HEALTH CARE PLANNING; HEPATITIS C; PROCEDURES; STANDARDS; TRANSMISSION;

AFRICA; BLOOD DONORS; BLOOD SAFETY; BLOOD TRANSFUSION; COMMUNICABLE DISEASE CONTROL; COMMUNICABLE DISEASES; DEVELOPING COUNTRIES; HEALTH RESOURCES; HEPATITIS C; HUMANS; RISK REDUCTION BEHAVIOR;

EID: 85036564868     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/vox.12620     Document Type: Review

References (93)

1. Perkins HA, Busch MP: Transfusion-associated infections: 50 years of relentless challenges and remarkable progress. Transfusion 2010; 50:2080–2099
2. Musso D, Richard V, Broult J, et al.: Inactivation of dengue virus in plasma with amotosalen and ultraviolet A illumination. Transfusion 2014; 54:2924–2930
3. Bloch EM, Vermeulen M, Murphy E: Blood transfusion safety in Africa: a literature review of infectious disease and organizational challenges. Transfus Med Rev 2012; 26:164–180
4. Tagny CT, Mbanya D, Tapko JB, et al.: Blood safety in Sub-Saharan Africa: a multi-factorial problem. Transfusion 2008; 48:1256–1261
5. Jayaraman S, Chalabi Z, Perel P, et al.: The risk of transfusion-transmitted infections in sub-Saharan Africa. Transfusion 2010; 50:433–442
6. Ifland L, Bloch EM, Pitman JP: Funding blood safety in the 21st century. Transfusion 2017 doi: 10.1111/trf.14374. [Epub ahead of print]
7. Marshall DA, Kleinman SH, Wong JB, et al.: Cost-effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States. Vox Sang 2004; 86:28–40
8. Davidson T, Ekermo B, Gaines H, et al.: The cost-effectiveness of introducing nucleic acid testing to test for hepatitis B, hepatitis C, and human immunodeficiency virus among blood donors in Sweden. Transfusion 2011; 51:421–429
9. Busch MP, Caglioti S, Robertson EF, et al.: Screening the blood supply for West Nile virus RNA by nucleic acid amplification testing. N Engl J Med 2005; 353:460–467
10. Kuehnert MJ, Basavaraju SV, Moseley RR, et al.: Screening of blood donations for Zika Virus Infection – Puerto Rico, April 3-June 11, 2016. MMWR Morb Mortal Wkly Rep 2016; 65:627–628
11. Webert KE, Cserti CM, Hannon J, et al.: Proceedings of a Consensus Conference: pathogen inactivation-making decisions about new technologies. Transfus Med Rev 2008; 22:1–34
12. Li J, de Korte D, Woolum MD, et al.: Pathogen reduction of buffy coat platelet concentrates using riboflavin and light: comparisons with pathogen-reduction technology-treated apheresis platelet products. Vox Sang 2004; 87:82–90
13. Cardo LJ, Salata J, Mendez J, et al.: Pathogen inactivation of Trypanosoma cruzi in plasma and platelet concentrates using riboflavin and ultraviolet light. Transfus Apher Sci 2007; 37:131–137
14. Rentas F, Harman R, Gomez C, et al.: Inactivation of Orientia tsutsugamushi in red blood cells, plasma, and platelets with riboflavin and light, as demonstrated in an animal model. Transfusion 2007; 47:240–247
15. Goodrich RP, Edrich RA, Li J, et al.: The Mirasol PRT system for pathogen reduction of platelets and plasma: an overview of current status and future trends. Transfus Apher Sci 2006; 35:5–17
16. Tonnetti L, Proctor MC, Reddy HL, et al.: Evaluation of the Mirasol pathogen [corrected] reduction technology system against Babesia microti in apheresis platelets and plasma. Transfusion 2010; 50:1019–1027
17. Herwaldt BL, Linden JV, Bosserman E, et al.: Transfusion-associated babesiosis in the United States: a description of cases. Ann Intern Med 2011; 155:509–519
18. Prowse CV: Component pathogen inactivation: a critical review. Vox Sang 2013; 104:183–199
19. Aubry M, Richard V, Green J, et al.: Inactivation of Zika virus in plasma with amotosalen and ultraviolet A illumination. Transfusion 2016; 56:33–40
20. Allain JP, Owusu-Ofori AK, Assennato SM, et al.: Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial. Lancet 2016; 387:1753–1761
21. BCT T. Mirasol pathogen reduction technology system: a simple, proven system with built-in flexibility. [monograph on the internet]. 2012. Available from: https://www.terumobct.com/Public/306690275.pdf
22. Perez-Pujol S, Tonda R, Lozano M, et al.: Effects of a new pathogen-reduction technology (Mirasol PRT) on functional aspects of platelet concentrates. Transfusion 2005; 45:911–919
23. Butler C, Doree C, Estcourt LJ, et al.: Pathogen-reduced platelets for the prevention of bleeding. Cochrane Database Syst Rev 2013:CD009072.
24. Drawz SM, Marschner S, Yanez M, et al.: Observational study of corrected count increments after transfusion of platelets treated with riboflavin pathogen reduction technology in additive solutions. Transfusion 2015; 55:1745–1751
25. Group MCES: A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology. Transfusion 2010; 50:2362–2375
26. Trakhtman P, Karpova O, Balashov D, et al.: Efficacy and safety of pathogen-reduced platelet concentrates in children with cancer: a retrospective cohort study. Transfusion 2016; 56(Suppl. 1):S24–S28
27. Cancelas JA, Slichter SJ, Rugg N, et al.: Red blood cells derived from whole blood treated with riboflavin and ultraviolet light maintain adequate survival in vivo after 21 days of storage. Transfusion 2017; 57:1218–1225
28. Hubbard T, Backholer L, Wiltshire M, et al.: Effects of riboflavin and amotosalen photoactivation systems for pathogen inactivation of fresh-frozen plasma on fibrin clot structure. Transfusion 2016; 56:41–48
29. Kaiser-Guignard J, Canellini G, Lion N, et al.: The clinical and biological impact of new pathogen inactivation technologies on platelet concentrates. Blood Rev 2014; 28:235–241
30. Ciaravino V, McCullough T, Cimino G: The role of toxicology assessment in transfusion medicine. Transfusion 2003; 43:1481–1492
31. Irsch J, Seghatchian J: Update on pathogen inactivation treatment of plasma, with the INTERCEPT Blood System: current position on methodological, clinical and regulatory aspects. Transfus Apher Sci 2015; 52:240–244
32. Cerus Corporation. INTERCEPT blood system: resources [monograph on the internet]. 2016.
33. Hauser L, Roque-Afonso AM, Beylouné A, et al., : Hepatitis E transmission by transfusion of Intercept blood system-treated plasma. Blood 2014; 123:796–797
34. Schmidt M, Hourfar MK, Sireis W, et al.: Evaluation of the effectiveness of a pathogen inactivation technology against clinically relevant transfusion-transmitted bacterial strains. Transfusion 2015; 55:2104–2112
35. Pathogen inactivation savings [monograph on the internet]. Cerus Corporation; 2016. Available from: http://interceptbloodsystem.com/general-blood-safety/cost-effectiveness/pathogen-inactivation-savings
36. Vamvakas EC: Meta-analysis of the studies of bleeding complications of platelets pathogen-reduced with the Intercept system. Vox Sang 2012; 102:302–316
37. van Rhenen D, Gulliksson H, Cazenave JP, et al.: Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial. Blood 2003; 101:2426–2433
38. Slichter SJ, Kaufman RM, Assmann SF, et al.: Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med 2010; 362:600–613
39. 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
40. Snyder EL. A open label, post marketing surveillance study following transfusion of INTERCEPT platelet components (PIPER) [monograph on the internet]. ClinicalTrials.gov: Cerus Corporation; 2015. Available from: https://clinicaltrials.gov/ct2/show/NCT02549222
41. 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
42. Osman A, Hitzler WE, Meyer CU, et al.: Effects of pathogen reduction systems on platelet microRNAs, mRNAs, activation, and function. Platelets 2015; 26:154–163
43. Bruchmüller I, Lösel R, Bugert P, et al.: Effect of the psoralen-based photochemical pathogen inactivation on mitochondrial DNA in platelets. Platelets 2005; 16:441–445
44. Snyder E, Raife T, Lin L, et al.: Recovery and life span of 111indium-radiolabeled platelets treated with pathogen inactivation with amotosalen HCl (S-59) and ultraviolet A light. Transfusion 2004; 44:1732–1740
45. Apelseth T, Bruserud Ø, Wentzel-Larsen T, et al.: In vitro evaluation of metabolic changes and residual platelet responsiveness in photochemical treated and gamma-irradiated single-donor platelet concentrates during long-term storage. Transfusion 2007; 47:653–665
46. Irsch J, Pinkoski L, Corash L, et al.: INTERCEPT plasma: comparability with conventional fresh-frozen plasma based on coagulation function – an in vitro analysis. Vox Sang 2010; 98:47–55
47. 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
48. 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
49. Salunkhe V, van der Meer PF, de Korte D, et al.: Development of blood transfusion product pathogen reduction treatments: a review of methods, current applications and demands. Transfus Apher Sci 2015; 52:19–34
50. Macopharma. THERAFLEX MB-Plasma: Real Throughput [monograph on the internet]. Available from: http://blood-safety.macopharma.com/en/category/products/theraflex-mb-plasma-products/real-throughput/
51. Álvarez M, Luis-Hidalgo M, Bracho MA, et al.: Transmission of human immunodeficiency virus Type-1 by fresh-frozen plasma treated with methylene blue and light. Transfusion 2016; 56:831–836
52. Seghatchian J, Tolksdorf F: Characteristics of the THERAFLEX UV-platelets pathogen inactivation system – an update. Transfus Apher Sci 2012; 46:221–229
53. Klamroth R, Gröner A, Simon TL: Pathogen inactivation and removal methods for plasma-derived clotting factor concentrates. Transfusion 2014; 54:1406–1417
54. Liumbruno GM, Marano G, Grazzini G, et al.: Solvent/detergent-treated plasma: a tale of 30 years of experience. Expert Rev Hematol 2015; 8:367–374
55. Hellstern P, Solheim BG: The use of solvent/detergent treatment in pathogen reduction of plasma. Transfus Med Hemother 2011; 38:65–70
56. Chou ML, Wu YW, Su CY, et al.: Impact of solvent/detergent treatment of plasma on transfusion-relevant bacteria. Vox Sang 2012; 102:277–284
57. Molenaar-de Backer MW, de Waal M, Sjerps MC, et al.: Validation of new real-time polymerase chain reaction assays for detection of hepatitis A virus RNA and parvovirus B19 DNA. Transfusion 2016; 56:440–448
58. Andreu G: France: solvent/detergent plasma; in: AuBuchon J, Prowse C (eds): Pathogen Inactivation: the Penultimate Paradigm Shift. Bethesda, MD, AABB Press, 2010:137–151
59. Neisser-Svae A, Trawnicek L, Heger A, et al.: Five-day stability of thawed plasma: solvent/detergent-treated plasma comparable with fresh-frozen plasma and plasma frozen within 24 hours. Transfusion 2016; 56:404–409
60. Liumbruno GM, Franchini M: Solvent/detergent plasma: pharmaceutical characteristics and clinical experience. J Thromb Thrombolysis 2015; 39:118–128
61. Bolton-Maggs PH, Cohen H: Serious Hazards of Transfusion (SHOT) haemovigilance and progress is improving transfusion safety. Br J Haematol 2013; 163:303–314
62. Nkohkwo A, Agbor G, Asongalem E, et al.: Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: a systematic review with regional discussion. Afr J Lab Med 2016; 5:a363
63. HIV/AIDS [monograph on the internet]. World Health Organization 2016. Available from: http://www.who.int/mediacentre/factsheets/fs360/en/
64. Karoney MJ, Siika AM: Hepatitis C virus (HCV) infection in Africa: a review. Pan Afr Med J 2013; 14:44
65. Hepatitis B [monograph on the internet]. World Health Organization; 2016.
66. Global incidence and prevalence of selected curable sexually transmitted infections – 2008. In: Research WHODoRHa, ed., 2012.
67. Bloch EM, Shah A, Kaidarova Z, et al.: A pilot external quality assurance study of transfusion screening for HIV, HCV and HBsAG in 12 African countries. Vox Sang 2014; 107:333–342
68. Laperche S, Francophone African Group for Research in Blood Transfusion: Multinational assessment of blood-borne virus testing and transfusion safety on the African continent. Transfusion 2013; 53:816–826
69. Laperche S, Boukatou G, Kouegnigan L, et al.: Transfusion safety on the African continent: an international quality control of virus testing in blood banks. Transfusion 2009; 49:1600–1608
70. Abdullah S, Karunamoorthi K: Malaria and blood transfusion: major issues of blood safety in malaria-endemic countries and strategies for mitigating the risk of Plasmodium parasites. Parasitol Res 2016; 115:35–47
71. Owusu-Ofori AK, Parry C, Bates I: Transfusion-transmitted malaria in countries where malaria is endemic: a review of the literature from sub-Saharan Africa. Clin Infect Dis 2010; 51:1192–1198
72. Chiodini PL: Malaria diagnostics: now and the future. Parasitology 2014; 141:1873–1879
73. Mbabazi P, Hopkins H, Osilo E, et al.: Accuracy of two malaria rapid diagnostic tests (RDTS) for initial diagnosis and treatment monitoring in a high transmission setting in Uganda. Am J Trop Med Hyg 2015; 92:530–536
74. Hassall O, Maitland K, Pole L, et al.: Bacterial contamination of pediatric whole blood transfusions in a Kenyan hospital. Transfusion 2009; 49:2594–2598
75. Hume HA, Ddungu H, Angom R, et al.: Platelet transfusion therapy in sub-Saharan Africa: bacterial contamination, recipient characteristics, and acute transfusion reactions. Transfusion 2016; 56:1951–1959
76. Musso D, Nhan T, Robin E, et al.: Potential for Zika virus transmission through blood transfusion demonstrated during an outbreak in French Polynesia, November 2013 to February 2014. Euro Surveill 2014; 19:20761
77. Petersen LR, Stramer SL, Powers AM: Chikungunya virus: possible impact on transfusion medicine. Transfus Med Rev 2010; 24:15–21
78. Sabino EC, Loureiro P, Lopes ME, et al.: Transfusion-transmitted dengue and associated clinical symptoms during the 2012 epidemic in Brazil. J Infect Dis 2016; 213:694–702
79. Gallian P, De Lamballerie X, De Micco P, et al.: [West Nile virus (WNV): generalities and implications for blood transfusion]. Transfus Clin Biol 2005; 12:11–17
80. (CDC) CfDCaP. Transfusion-related transmission of yellow fever vaccine virus–California, 2009. MMWR Morb Mortal Wkly Rep 2010; 59:34–37.
81. Pozzetto B, Garraud O: [New viral risks in blood transfusion by 2016]. Transfus Clin Biol 2016; 23:20–27
82. Brown JF, Rowe K, Zacharias P, et al.: Apheresis for collection of Ebola convalescent plasma in Liberia. J Clin Apher 2017; 32:175–181
83. Rasongles P, Angelini-Tibert MF, Simon P, et al.: Transfusion of platelet components prepared with photochemical pathogen inactivation treatment during a Chikungunya virus epidemic in Ile de La Reunion. Transfusion 2009; 49:1083–1091
84. Tsetsarkin KA, Sampson-Johannes A, Sawyer L, et al.: Photochemical inactivation of chikungunya virus in human apheresis platelet components by amotosalen and UVA light. Am J Trop Med Hyg 2013; 88:1163–1169
85. Cao-Lormeau VM, Roche C, Teissier A, et al.: Zika virus, French polynesia, South pacific, 2013. Emerg Infect Dis 2014; 20:1085–1086
86. Agapova M, Lachert E, Brojer E, et al.: Introducing pathogen reduction technology in Poland: a cost-utility analysis. Transfus Med Hemother 2015; 42:158–165
87. Faddy HM, Prow NA, Fryk JJ, et al.: The effect of riboflavin and ultraviolet light on the infectivity of arboviruses. Transfusion 2015; 55:824–831
88. Owada T, Kaneko M, Matsumoto C, et al.: Establishment of culture systems for Genotypes 3 and 4 hepatitis E virus (HEV) obtained from human blood and application of HEV inactivation using a pathogen reduction technology system. Transfusion 2014; 54:2820–2827
89. Vanlandingham DL, Keil SD, Horne KM, et al.: Photochemical inactivation of chikungunya virus in plasma and platelets using the Mirasol pathogen reduction technology system. Transfusion 2013; 53:284–290
90. Ruane PH, Edrich R, Gampp D, et al.: Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion 2004; 44:877–885
91. Tonnetti L, Thorp AM, Reddy HL, et al.: Evaluating pathogen reduction of Trypanosoma cruzi with riboflavin and ultraviolet light for whole blood. Transfusion 2012; 52:409–416
92. 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
93. Keil SD, Kiser P, Sullivan JJ, et al.: Inactivation of Plasmodium spp. in plasma and platelet concentrates using riboflavin and ultraviolet light. Transfusion 2013; 53:2278–2286