Sicherheit der Blutprodukte – update 2024

Infektionssicherheit von potenziell durch Blut übertragbaren Infektionserregern ist ein zentrales Thema der Transfusionsmedizin. Die Sicherheit der Blutprodukte ist durch viele Innovationen in den letzten beiden Jahrzehnten auf einem so hohen Standard angekommen, dass transfusionsbedingte Übertragungen von Pathogenen heute sehr selten beobachtet werden. Der Beitrag erläutert den aktuellen Stand.

Abstract

Currently, donor screening consists of a combination of serological detection methods to detect antigens and antibodies from viral and bacterial infections (HBsAg, anti-HBc, anti-HCV, anti-HIV, p24Ag, anti-syphilis) and molecular detection methods (nucleic amplification technology (NAT) for HCV, HIV-1, HEV, WNV). Based on a mathematical model, the current residual infection risks for HBV, HCV and HIV are 1:300000, 1:11 million and 1:4.3 million, respectively. This means that the residual infection risks for blood products are significantly lower than residual risks of other widely used drugs such as the use of erythropoietin (1:×1000 for hyperkalemia, hypersensitivity, seizures and congestion of the respiratory tract) or iron preparations (1:10000 for anaphylactic reactions, syncope and bronchospasm). Despite the shortening of the shelf life of platelet concentrates from 5 days to 4 days, the residual infection risk for a fatal, serious bacterial transmission is stated to be 1:400000 (approx. one fatal transmission per year in Germany). Pathogen reduction methods (Intercept, Mirasol or Theraflex) can reduce the risk of bacterial infections on a product-specific basis. The NAT technology offers great potential to implement new, previously irrelevant or unknown pathogens in donor screening at short notice. By means of intensive research in recent decades and the further development of serological and molecular detection methods, the safety of blood products in Germany has been raised to the highest international level and contributes to the fact that autologous blood donations are currently no longer relevant in everyday clinical practice.

Schlüsselwörter

Hepatitis-B-Virus - Hepatitis-C-Virus - HIV - humanes Immundefizienzvirus - West-Nil-Virus - Restinfektionsrisiko

Key words

hepatitis B virus - hepatitis C virus - HIV - human immuno-deficiency virus - blood product safety - WNV - residual infection risk

Publication History

Article published online:
19 February 2024

• Literatur

• 1 Bertsch T, Lüdecke J, Antl W. et al. Karl Landsteiner: The discovery of the AB0 blood group system and its value for teaching medical students. Clin Lab 2019; 65: 1-6
• 2 Landsteiner K, Wiener AS. Studies on an agglutinogen (rh) in human blood reacting with anti-rhesus sera and with human isoantibodies. J Exp Med 1941; 74: 309-320
• 3 Blumberg BS, Sutnick AI, London WT. et al. Australia antigen and hepatitis. N Engl J Med 1970; 283: 349-354
• 4 Olaf Henseler. Meldung Transfusionsgesetz §21: Jahre 2013 bis 2022, 26.06.2023
• 5 Norder H, Couroucé A-M, Coursaget P. et al. Genetic diversity of hepatitis B virus strains derived worldwide: genotypes, subgenotypes, and HBsAg subtypes. Intervirology 2004; 47: 289-309
• 6 Biswas R, Tabor E, Hsia CC. et al. Comparative sensitivity of HBV NATs and HBsAg assays for detection of acute HBV infection. Transfusion 2003; 43: 788-798
• 7 Reinhard Burger RO. Erhöhung der Sicherheit von zellulären Blutkomponenten und quaran tänegelagertem Frischplasma durch Untersuchung der Blut- und Plasmaspenden auf Antikörper gegen das Hepatitis-BCore-Antigen (Anti-HBc). In: Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz. 698-699
• 8 Hourfar MK, Jork C, Schottstedt V. et al. Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus. Transfusion 2008; 48: 1558-1566
• 9 Schiller JT, Lowy DR. An introduction to virus infections and human cancer. Recent Results Cancer Res 2021; 217: 1-11
• 10 Roth WK, Weber M, Seifried E. Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in a blood-bank setting. Lancet 1999; 353: 359-363
• 11 Glynn SA, Wright DJ, Kleinman SH. et al. Dynamics of viremia in early hepatitis C virus infection. Transfusion 2005; 45: 994-1002
• 12 Winnie Byanyima. Global HIV & AIDS statistics — Fact sheet. Im Internet: https://www.unaids.org/en/resources/fact-sheet (Stand: 08.12.2023)
• 13 Chudy M, Kress J, Halbauer J. et al. Risk Minimization measures for blood screening hiv-1 nucleic acid amplification technique assays in Germany. Transfus Med Hemother 2014; 41: 45-51
• 14 Schmidt M, Korn K, Nübling CM. et al. First transmission of human immunodeficiency virus Type 1 by a cellular blood product after mandatory nucleic acid screening in Germany. Transfusion 2009; 49: 1836-1844
• 15 Matsubayashi K, Nagaoka Y, Sakata H. et al. Transfusion-transmitted hepatitis E caused by apparently indigenous hepatitis E virus strain in Hokkaido, Japan. Transfusion 2004; 44: 934-940
• 16 Kleinman S, Glynn SA, Busch M. et al. The 2003 West Nile virus United States epidemic: the America’s Blood Centers experience. Transfusion 2005; 45: 469-479
• 17 Pisani G, Cristiano K, Pupella S. et al. West Nile virus in Europe and safety of blood transfusion. Transfus Med Hemother 2016; 43: 158-167
• 18 Frank C, Schmidt-Chanasit J, Ziegler U. et al. West Nile virus in Germany: An emerging infection and its relevance for transfusion safety. Transfus Med Hemother 2022; 49: 192-204
• 19 Klaus Drescher. West-Nil-Virus: Erster Nachweis in Schleswig-Holstein, 06.10.2023
• 20 McCluskie JA. Transmission of syphilis by blood transfusion. Br Med J 1939; 1: 264-266
• 21 van der Sluis JJ, Onvlee PC, Kothe FC. et al. Transfusion syphilis, survival of Treponema pallidum in donor blood. I. Report of an orientating study. Vox Sang 1984; 47: 197-204
• 22 O’Brien SF, Drews SJ, Yi Q-L. et al. Monitoring syphilis serology in blood donors: Is there utility as a surrogate marker of early transfusion transmissible infection behavioral risk?. Transfusion 2023; 63: 1195-1203
• 23 Jayawardena T, Hoad V, Styles C. et al. Modelling the risk of transfusion-transmitted syphilis: a reconsideration of blood donation testing strategies. Vox Sang 2019; 114: 107-116
• 24 Deutsches Ärzteblatt, Jg. 117, Heft 40, 2. Oktober 2020
• 25 Ziemann M, Hennig H. Prevention of transfusion-transmitted cytomegalovirus infections: Which is the optimal strategy?. Transfus Med Hemother 2014; 41: 40-44
• 26 Lefeuvre C, Lefort C, Boyer F. et al. Transfusion-transmitted hepatitis A virus, France, 2018. Emerg Infect Dis 2022; 28: 219-223
• 27 Robertson BH, Friedberg D, Normann A. et al. Sequence variability of hepatitis A virus and factor VIII associated hepatitis A infections in hemophilia patients in Europe. An update. Vox Sang 1994; 67: 39-45 discussion 46
• 28 Cossart YE, Field AM, Cant B. et al. Parvovirus-like particles in human sera. Lancet 1975; 1: 72-73
• 29 Levi JE. Dengue virus and blood transfusion. J Infect Dis 2016; 213: 689-690
• 30 Jimenez A, Shaz BH, Bloch EM. Zika virus and the blood supply: what do we know?. Transfus Med Rev 2017; 31: 1-10
• 31 de Korte D, Curvers J, de Kort WL. et al. Effects of skin disinfection method, deviation bag, and bacterial screening on clinical safety of platelet transfusions in the Netherlands. Transfusion 2006; 46: 476-485
• 32 Irsch J, Lin L. Pathogen inactivation of platelet and plasma blood components for transfusion using the INTERCEPT Blood System™. Transfus Med Hemother 2011; 38: 19-31
• 33 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
• 34 Seghatchian J, Tolksdorf F. Characteristics of the THERAFLEX UV-platelets pathogen inactivation system an update. Transfus Apher Sci 2012; 46: 221-229
• 35 Janssen-Cilag GmbH. Fachinformation Erypo. Im Internet: www.rote-liste.de (Stand: 07.12.2023)
• 36 Vifor Pharma GmbH. Ferinject. Im Internet: www.rote-liste.de (Stand: 07.12.2023)