Revisiting blood safety practices given emerging data about Zika Virus

New England Journal of Medicine

Volumn 378, Issue 19, 2018, Pages 1837-1841

  Bloch, Evan M ^a   Ness, Paul M ^a   Tobian, Aaron A R ^a   Sugarman, Jeremy ^b  

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

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN P24; VIRUS RNA;

AEDES AEGYPTI; AEDES ALBOPICTUS; ALANINE AMINOTRANSFERASE LEVEL; ANAMNESIS; ARTICLE; BLOOD DONOR; BLOOD SAFETY; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; DEMOGRAPHY; EVIDENCE BASED PRACTICE; FETOMATERNAL TRANSFUSION; FLAVIVIRUS INFECTION; FOOD AND DRUG ADMINISTRATION; GEOGRAPHIC DISTRIBUTION; HEALTH CARE QUALITY; HEALTH HAZARD; HUMAN; PANDEMIC; POSITIVE-STRAND RNA VIRUS; PRIORITY JOURNAL; PUBLIC HEALTH; RISK ASSESSMENT; RISK MANAGEMENT; SCREENING TEST; SEXUAL TRANSMISSION; SOCIAL RESPONSIBILITY; SPERM; TRUST; TRYPANOSOMA CRUZI; UNITED STATES; VIRAL CLEARANCE; VIRUS TRANSMISSION; ZIKA FEVER; ZIKA VIRUS; COMMUNICABLE DISEASE; HEALTH CARE POLICY; LEGISLATION AND JURISPRUDENCE; MASS SCREENING;

BLOOD DONORS; BLOOD SAFETY; COMMUNICABLE DISEASES, EMERGING; HEALTH POLICY; HUMANS; MASS SCREENING; PANDEMICS; UNITED STATES; ZIKA VIRUS; ZIKA VIRUS INFECTION;

EID: 85046966482     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsb1704752     Document Type: Article

References (37)

1. Zika virus classification table: 24 November 2017. Geneva: World health Organization (http://www.who.int/emergencies/zika-virus/classification-tables/en/).
2. Brasil P, Pereira JP Jr, Moreira ME, et al. Zika virus infection in pregnant women in Rio de Janeiro. N Engl J Med 2016;375: 2321-34.
3. Lustig Y, Mendelson E, Paran N, Melamed S, Schwartz E. Detection of Zika virus RNA in whole blood of imported Zika virus disease cases up to 2 months after symptom onset, Israel, December 2015 to April 2016. Euro Surveill 2016;21(26):30269.
4. Herriman R. Transfusion-associated Zika virus reported in Brazil. Outbreak News Today. December 18, 2015 (http://outbreaknewstoday.com/transfusion-associated-zika-virus-reported -in-brazil-76935/).
5. Barjas-Castro ML, Angerami RN, Cunha MS, et al. Probable transfusion-transmitted Zika virus in Brazil. Transfusion 2016; 56:1684-8.
6. Motta IJ, Spencer BR, Cordeiro da Silva SG, et al. Evidence for transmission of Zika virus by platelet transfusion. N Engl J Med 2016;375:1101-3.
7. Recommendations for donor screening, deferral, and product management to reduce the risk of transfusion-transmission of Zika virus: guidance for industry. Silver Spring, MD: Food and Drug Administration, February 2016 (http://www.chinacdc.cn/jkzt/crb/ablcxr_8561/zstd_8600/201602/W020160227450427915217.pdf).
8. Saá P, Proctor M, Foster G, et al. Investigational testing for Zika virus among U.S. blood donors. N Engl J Med 2018;378: 1778-88.
9. Stramer SL, Hollinger FB, Katz LM, et al. Emerging infectious disease agents and their potential threat to transfusion safety. Transfusion 2009;49:Suppl 2:1S-29S.
10. Jimenez A, Shaz BH, Bloch EM. Zika virus and the blood supply: what do we know? Transfus Med Rev 2017;31:1-10.
11. Joguet G, Mansuy JM, Matusali G, et al. Effect of acute Zika virus infection on sperm and virus clearance in body fluids: a prospective observational study. Lancet Infect Dis 2017;17: 1200-8.
12. Paz-Bailey G, Rosenberg ES, Doyle K, et al. Persistence of Zika virus in body fluids — preliminary report. N Engl J Med 2017 February 14 (Epub ahead of print).
13. Musso D, Richard V, Teissier A, et al. Detection of Zika virus RNA in semen of asymptomatic blood donors. Clin Microbiol Infect 2017;23(12):1001.e1-1001.e3.
14. Cumulative Zika virus disease case counts in the United States, 2015-2018. Atlanta: Centers for Disease Control and Prevention (https://www.cdc.gov/zika/reporting/case-counts.html).
15. 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(14):20761.
16. 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;65:627-8.
17. Stone M, Lanteri MC, Bakkour S, et al. Relative analytical sensitivity of donor nucleic acid amplification technology screening and diagnostic real-time polymerase chain reaction assays for detection of Zika virus RNA. Transfusion 2017;57:734-47.
18. Leach Bennett J, Blajchman MA, Delage G, Fearon M, Devine D. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety. Transfus Med Rev 2011;25:267-92.
19. Custer B, Hoch JS. Cost-effectiveness analysis: what it really means for transfusion medicine decision making. Transfus Med Rev 2009;23:1-12.
20. Wingspread Conference on the Precautionary Principle. Racine, WI: The Johnson Foundation at Wingspread, January 26, 1998.
21. EUR-Lex. Communication from the Commission on the precautionary principle. Brussels: Commission of the European Communities, 2000.
22. Paules CI, Fauci AS. Emerging and reemerging infectious diseases: the dichotomy between acute outbreaks and chronic endemicity. JAMA 2017;317:691-2.
23. 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.
24. Kuklina EV, Meikle SF, Jamieson DJ, et al. Severe obstetric morbidity in the United States: 1998-2005. Obstet Gynecol 2009; 113:293-9.
25. Galel SA, Williamson PC, Busch MP, et al. First Zika-positive donations in the continental United States. Transfusion 2017;57: 762-9.
26. Pate LL, Williamson PC, Busch MP, et al. Detection of Zika virus RNA in United States blood donations using cobas Zika on the cobas 6800/8800 Systems. Transfusion 2017;57:Suppl S3:26A. abstract.
27. Saá PP, Nguyen ML, Proctor MC, et al. Investigational detection of Zika virus RNA in U.S. blood donors. Transfusion 2017; 57:Suppl S3:25A. abstract.
28. Ellingson KD, Sapiano MRP, Haass KA, et al. Cost projections for implementation of safety interventions to prevent transfusion-transmitted Zika virus infection in the United States. Transfusion 2017;57:Suppl 2:1625-33.
29. Herwaldt BL, Linden JV, Bosserman E, Young C, Olkowska D, Wilson M. Transfusion-associated babesiosis in the United States: a description of cases. Ann Intern Med 2011;155:509-19.
30. Fatalities reported to FDA following blood collection and transfusion: annual summary for Fiscal Year 2015 (http://transfusion.ru/2016/12-05-2.pdf).
31. Dodd RY, Notari EP, Nelson D, et al. Development of a multi-system surveillance database for transfusion-transmitted infections among blood donors in the United States. Transfusion 2016; 56:2781-9.
32. Gallian P, Cabié A, Richard P, et al. Zika virus in asymptomatic blood donors in Martinique. Blood 2017;129:263-6.
33. REDS-III Zika virus research. Bethesda, MD: National Heart, Lung, and Blood Institute, 2016 (https://reds-iii.rti.org/ResearchStudies/ZIKAStudies.aspx).
34. Pan American Health Organization, World Health Organization. Regional Zika virus epidemiological update (Americas). August 25, 2017 (http://www.paho.org/hq/index.php?option=com_content&view=article&id=11599%3Aregional-zika-epidemiological-update -americas).
35. 2017 Meeting materials, Blood Products Advisory Committee. Silver Spring, MD: Food and Drug Administration, 2017 (https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisory Committee/ucm543914.htm).
36. Kramer K, Verweij MF, Zaaijer HL. Are there ethical differences between stopping and not starting blood safety measures? Vox Sang 2017;112:417-24.
37. Alliance of Blood Operators. Risk-based decision-making framework for blood safety. April 2, 2015 (https://allianceofbloodoperators.org/media/115522/rbdm-framework-2-april-2015 -v11-for-website.pdf).