Management of notifications of donors with Creutzfeldt-Jakob disease (post-donation information)

Blood Transfusion

Volumn 12, Issue 1, 2014, Pages 22-27

  Calizzani, Gabriele ^a   Vaglio, Stefania ^a   Vetrugno, Vito ^b   Delbò, Marisa ^c   Pani, Luca ^c   Grazzini, Giuliano ^a  

^a Italian National Blood Centre   (Italy)

^b ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^c ITALIAN MEDICINES AGENCY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD DONORS; CREUTZFELDT-JAKOB SYNDROME; DISEASE NOTIFICATION; FEMALE; HUMANS; ITALY; MALE;

EID: 84885607044     PISSN: 17232007     EISSN: None     Source Type: Journal    
DOI: 10.2450/2013.0035-13     Document Type: Article

References (26)

1. Official Journal of the European Union L91, March 30th, 2004. Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components. Available at: http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ :L:2004:091:0025:0039:EN:PDF. Accessed on 28/02/2013.
2. Official Journal of Italian Republic no. 85, April 13th, 2005. Decreto del Ministro della Salute 3 marzo 2005: "Protocolli per l'accertamento della idoneità del donatore di sangue e di emocomponenti". Available at: http://www.centronazionalesangue.it/content/decreto-3-marzo-2005-0. Accessed on 10/03/2013.
3. CHMP Position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. EMA/CHMP/BWP/303353/2010. European Medicines Agency (EMA). London, 23 June 2011. Available at: http://www.ema. europa.eu/docs/en-GB/document-library/Position-statement/2011/06/WC500108071. pdf. Accessed on 18/02/2011.
4. Guidance for Industry. Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products, May 2010. Food and Drug Administration (FDA). Available at: http://www.fda. gov/downloads/ biologicsbloodvaccines/guidancecomplianc eregulatoryinformation/guidances/ ucm213415.pdf. Accessed on 10/03/2013.
5. Vetrugno V, Cardinale A, Filesi I, et al. KDEL-tagged antiprion intrabodies impair PrP lysosomal degradation and inhibit scrapie infectivity. Biochem Biophys Res Commun 2005; 338: 1791-7.
6. Head MW, Ironside JW. Creutzfeldt-Jakob disease: prion protein type, disease phenotype and agent strain. Neuropathol Appl Neurobiol 2012; 38: 296-310.
7. Pocchiari M, Puopolo M, Croes EA, et al. Predictors of survival in sporadic Creutzfeldt-Jakob disease and other human transmissible spongiform encephalopathies. Brain 2004; 127: 2348-59.
8. Parchi P, Giese A, Capellari S, et al. Classification of sporadic Creutzfeldt-Jakob disease based on molecular and phenotypic analysis of 300 subjects. Ann Neurol 1999; 46: 224-33.
9. Ladogana A, Puopolo M, Poleggi A, et al. High incidence of genetic human transmissible spongiform encephalopathies in Italy. Neurology 2005; 64: 1592-7.
10. Kovacs GG, Puopolo M, Ladogana A, et al. Genetic prion disease: the EUROCJD experience. Human Genet 2005; 118: 166-174.
11. Brown P, Brandel JP, Sato T, et al. Iatrogenic Creutzfeldt-Jakob disease, final assessment. Emerg Infect Dis 2012; 18: 901-7.
12. Heath CA, Cooper SA, Murray K, et al. Validation of diagnostic criteria for variant Creutzfeldt-Jakob disease. Ann Neurol 2010; 67: 761-70.
13. Brown P. Can Creutzfeldt-Jakob disease be transmitted by transfusion? Curr Opin Hematol. 1995; 2: 472-7.
14. Vetrugno V, Puopolo M, Giampaolo A, et al. Risk analysis of Creutzfeldt-Jakob disease transmission through plasmaderived medicinal products in humans (Italian). Roma: Istituto Superiore di Sanità (2011). (Rapporti ISTISAN 11/8). Available at: http://www.iss.it/binary/publ/cont/undici8web. pdf. Accessed on 28/02/2013.
15. Brown P, Gibbs CJ, Johnson PR, et al. Human spongiform encephalopathy: the National Institutes of Health series of 300 cases of experimentally transmitted disease. Ann Neurol 1994; 35: 513-29.
16. Peden A, McCardle L, Head MW, et al. Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia. Haemophilia 2010; 16: 296-304.
17. Hewitt PE, Llewelyn CA, Mackenzie J, Will RG. Creutzfeldt- Jakob disease and blood transfusion: results of the UK Transfusion Medicine Epidemiological Review study. Vox Sang 2006; 91: 221-30.
18. Dorsey K, Zou S, Schonberger LB, et al. Lack of evidence of transfusion transmission of Creutzfeldt-Jakob disease in a US surveillance study. Transfusion 2009; 49: 977-84.
19. Puopolo M, Ladogana A, Vetrugno V, Pocchiari M. Transmission of sporadic Creutzfeldt-Jakob disease by blood transfusion: risk factor or possible bias. Transfusion 2011; 51: 1556-66.
20. Molesworth AM, Mackenzie J, Everington D, et al. Sporadic Creutzfeldt-Jakob disease and risk of blood transfusion in the United Kingdom. Transfusion 2011; 51: 1872-3.
21. Puopolo M, Ladogana A, Vetrugno V, Pocchiari M. (Author reply to: Molesworth et al., (2011). Sporadic Creutzfeldt-Jakob disease and risk of blood transfusion in the United Kingdom). Transfusion 2011; 51: 1873-4.
22. Cardone F, Simoneau S, Arzel A, et al. Comparison of nanofiltration efficacy in reducing infectivity of centrifuged versus ultracentrifuged 263K scrapie-infected brain homogenates in "spiked" albumin solutions. Transfusion 2012; 52: 953-62.
23. Official Journal of Italian Republic no. 82 April 9th, 2011. Decreto del Ministero della Salute 20 gennaio 2011: "Programma di autosufficienza nazionale del sangue e dei suoi prodotti per l'anno 2010". Available at: http://www.centronazionalesangue. it/sites/default/files/dm-20.01.2011- programma-nazionale-autosufficienza-2010.pdf. Accessed on 28/02/2013.
24. Official Journal of Italian Republic no. 271 November 21st, 2011. Decreto del Ministero della Salute 7 ottobre 2011: "Programma di autosufficienza nazionale del sangue e dei suoi prodotti, per l'anno 2011". Available at: http://www.centronazionalesangue.it/sites/default/files/d.m.-7.10. 11-programma-nazionale-autosufficienza-2011-gu-22.11.11. pdf. Accessed on 28/02/2013.
25. Official Journal of Italian Republic no. 241 October 15th, 2012. Decreto del Ministero della Salute 4 settembre 2012: "Programma di autosufficienza nazionale del sangue e dei suoi prodotti per l'anno 2012". Available at: http://www.centronazionalesangue.it/sites/default/files/programmazione-autosuff- 2012-0.pdf. Accessed on 28/02/2013.
26. 17th WHO Essential Medicines List and the 3rd WHO Essential Medicines List for Children updated in March 2011. World Health Organization (WHO). Available at: http://www.who. int/medicines/publications/essentialmedicines/en/. Accessed on 24/01/2013.