FDA workshop on emerging infectious diseases: evaluating emerging infectious diseases (EIDs) for transfusion safety
Chintamani Atreya,
Hira Nakhasi,
Paul Mied,
Jay Epstein,
James Hughes,
Marta Gwinn,
Steven Kleinman,
Roger Dodd,
Susan Stramer,
Mark Walderhaug,
Peter Ganz,
Raymond Goodrich,
Clark Tibbetts,
David Asher,
Corresponding Author
Chintamani Atreya
Chintamani Atreya, PhD, US Food and Drug Administration, 1401 Rockville Pike, Suite 400N, HFM-300, Rockville, MD 20852; e-mail: [email protected].Search for more papers by this authorHira Nakhasi
From the US Food and Drug Administration, Rockville, MD.
Search for more papers by this authorPaul Mied
From the US Food and Drug Administration, Rockville, MD.
Search for more papers by this authorJay Epstein
From the US Food and Drug Administration, Rockville, MD.
Search for more papers by this authorJames Hughes
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorMarta Gwinn
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorSteven Kleinman
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorRoger Dodd
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorSusan Stramer
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorMark Walderhaug
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorPeter Ganz
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorRaymond Goodrich
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorClark Tibbetts
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorDavid Asher
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorChintamani Atreya,
Hira Nakhasi,
Paul Mied,
Jay Epstein,
James Hughes,
Marta Gwinn,
Steven Kleinman,
Roger Dodd,
Susan Stramer,
Mark Walderhaug,
Peter Ganz,
Raymond Goodrich,
Clark Tibbetts,
David Asher,
Corresponding Author
Chintamani Atreya
Chintamani Atreya, PhD, US Food and Drug Administration, 1401 Rockville Pike, Suite 400N, HFM-300, Rockville, MD 20852; e-mail: [email protected].Search for more papers by this authorHira Nakhasi
From the US Food and Drug Administration, Rockville, MD.
Search for more papers by this authorPaul Mied
From the US Food and Drug Administration, Rockville, MD.
Search for more papers by this authorJay Epstein
From the US Food and Drug Administration, Rockville, MD.
Search for more papers by this authorJames Hughes
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorMarta Gwinn
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorSteven Kleinman
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorRoger Dodd
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorSusan Stramer
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorMark Walderhaug
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorPeter Ganz
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorRaymond Goodrich
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorClark Tibbetts
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this authorDavid Asher
Speakers at the workshop and their affiliations are embedded in the text as appropriate.
Search for more papers by this author
REFERENCES
- 1 Armstrong GL, Conn LA, Pinner RW. Trends in infectious disease mortality in the United States during the 20th century. JAMA 1999; 281: 61-6.
- 2 Lederberg J, Shope RE, Oaks SC Jr, editors. Emerging infections: microbial threats to health in the United States. Washington, DC: National Academies Press; 1992.
- 3 Smolinski MS, Hamburg MA, Lederberg L, editors. Microbial threats to health: emergence, detection, and response. Washington, DC: National Academies Press; 2003.
- 4 Asnis D, Conetta R, Teixeria A, Waldman G, Sampson B. The West Nile virus outbreak of 1999 in New York; the Flushing Hospital experience. Clin Infect Dis 2000; 30: 413-18.
- 5 Pealer LN, Marfin AA, Petersen LR. Transmission of West Nile virus through blood transfusion in the United States in 2002. N Engl J Med 2003; 349: 1236-45.
- 6 Iwamoto M, Jernigan DB, Guasch A, Trepka MJ, Blackmore CG, Hellinger WC, Pham SM, Zaki S, Lanciotti RS, Lance-Parker SE, DiazGranados CA, Winquist AG, Perlino CA, Wiersma S, Hillyer KL, Goodman JL, Marfin AA, Chamberland ME, Petersen LR. Transmission of West Nile virus from an organ donor to four transplant recipients. N Engl J Med 2003; 348: 2196-203.
- 7 Srinivasan A, Burton EC, Kuehnert MJ, Rupprecht C, Sutker WL, Ksiazek TG, Paddock CD, Guarner J, Shieh W-J, Goldsmith C, Hanlon CA, Zoretic J, Fischbach B, Niezgoda M, El-Feky WH, Orciari L, Sanchez EQ, Likos A, Klintmalm GB, Cardo D, LeDuc J, Chamberland ME, Jernigan DB, Zaki SR. Transmission of rabies virus from an organ donor to four transplant recipients. N Engl J Med 2005; 352: 1103-11.
- 8 CDC. Lymphocytic choriomeningitis virus infection in organ transplant recipients—Massachusetts, Rhode Island, 2005. MMWR 2005; 54(Dispatch): 1-2.
- 9 Palacios G, Druce J, Du L, Tran T, Birch C, Briese T, Conlan S, Quan P-L, Hui J, Marshall J, Simons JF, Egholm M, Paddock CD, Shieh W-J, Goldsmith CS, Zaki SR, Catton M, Lipkin WI. A new arenavirus in a cluster of fatal transplant-associated diseases. N Engl J Med 2008; 358: 991-8.
- 10 Visvesvara GS, Martinez AJ, Schuster FL, Leitch GJ, Wallace SV, Sawyer TK, Anderson M. Leptomyxid ameba, a new agent of amebic meningoencephalitis in humans and animals. J Clin Microbiol 1990; 28: 2750-6.
- 11 Jones KE, Patel NG, Levy MA, Storeygard A, Balk D, Gittleman JL, Daszak P. Global trends in emerging infectious diseases. Nature 2008; 451: 990-4.
- 12 One Health Commission. One health: improving health in an interconnected world, people—animals—environment. Nov 17, 2009. [cited 2011 Feb 15]. Available from: URL: http://www.onehealthcommission.org
- 13 Davis JR, Lederberg J, editors. Emerging infectious diseases from the global to the local perspective. Institute of Medicine. Washington, DC: National Academy Press; 2001.
- 14 King DA, Peckham C, Waage JK, Brownlie J, Woolhouse ME. Epidemiology. Infectious diseases: preparing for the future. Science 2006; 313: 1392-3.
- 15 Brownstein JS, Freifeld CC, Madoff LC. Digital disease detection—harnessing the Web for public health surveillance. N Engl J Med 2009; 360: 2153-5. 2157.
- 16 Yu W, Gwinn M, Clyne M, Yesupriya A, Khoury MJ. A navigator for human genome epidemiology. Nat Genet 2008; 40: 124-5.
- 17 Weld ED, Eimer KM, Saharia K, Orenstein A, Hess JR. Transfusion medicine illustrated. The expanding range and severity of babesiosis. Transfusion 2010; 50: 290-1.
- 18 Madoff LC. ProMED-mail: an early warning system for emerging diseases. Clin Infect Dis 2004; 39: 227-32.
- 19 Ginsberg J, Mohebbi MH, Patel RS, Brammer L, Smolinski MS, Brilliant L. Detecting influenza epidemics using search engine query data. Nature 2009; 457: 1012-4.
- 20 Carneiro HA, Mylonakis E. Google trends: a web-based tool for real-time surveillance of disease outbreaks. Clin Infect Dis 2009; 49: 1557-64.
- 21 Brownstein JS, Freifeld CC, Reis BY, Mandl KD. Surveillance Sans Frontières: internet-based emerging infectious disease intelligence and the HealthMap project. PLoS Med 2008; 5: e151.
- 22 Allain JP, Busch MP. Donation archives and prospective donor-recipient repositories: indispensable tools for monitoring blood safety. Transfusion 2007; 47: 1110-4.
- 23 Aach RD, Stevens CE, Hollinger FB, Mosley JW, Peterson DA, Taylor PE, Johnson RG, Barbosa LH, Nemo GJ. Hepatitis C virus infection in post-transfusion hepatitis: an analysis of the Transfusion-Transmitted Viruses Study with first and second generation assays. N Engl J Med 1991; 325: 1325-9.
- 24 Kleinman SH, Glynn SA, Higgins M, Triulzi D, Smith J, Nass CC, Garratty G, Murphy EL, LeParc GF, Schreiber G, King M, Chamberland M, Nemo G. The RADAR repository: a resource for studies of infectious agents and their transmissibility by transfusion. Transfusion 2005; 45: 1073-83.
- 25 Dollard SC, Nelson KE, Ness PM, Stambolis V, Kuenhert MJ, Pellett PE, Cannon MJ. Possible transmission of human herpesvirus-8 by blood transfusion in a historical US cohort. Transfusion 2005; 45: 500-3.
- 26 Donegan E, Stuart M, Niland JC, Sacks HS, Azen SP, Dietrich SL, Hagerty C, Kleinman SH, Operskalski EA, Perkins H, Pindyck J, Schiff ER, Stites D, Tomasulo PA, Mosley JW. Clinical outcome and laboratory findings among recipients of blood components from donors positive for antibody to human immunodeficiency virus type 1 at the time of blood donation. Ann Intern Med 1990; 113: 733-9.
- 27 Kleinman S, Kuhns M, Todd D, Glynn S, McNamara A, Demarco A, Busch MP. Frequency of HBV DNA detection in US blood donors positive for anti-HBc: implications for transfusion transmission and donor screening. Transfusion 2003; 43: 696-704.
- 28 Alter HJ, Nakatsuji Y, Melpolder J, Wages J, Wesley R, Shih WK, Kim J. The incidence of transfusion-associated hepatitis G virus infection and its relation to liver disease. N Engl J Med 2001; 336: 747-54.
- 29 Kleinman SH, Glynn SA, Lee TH, Tobler LH, Schlumpf KS, Todd DS, Qiao H, Yu MW; Busch MP for the NHLBI Retrovirus Epidemiology Donor Study–II (REDS-II). A linked donor-recipient study to evaluate parvovirus B19 transmission by blood component transfusion. Blood 2009; 114: 3677-83.
- 30 Cannon MJ, Operskalski EA, Mosley JW, Radford K, Dollard SC. Lack of evidence for human herpesvirus-8 transmission via blood transfusion in a historical US cohort. J Infect Dis 2009; 199: 1592-8.
- 31 Busch MP, Glynn SA. Use of blood-donor and transfusion-recipient biospecimen repositories to address emerging blood-safety concerns and advance infectious disease research: the National Heart, Lung, and Blood Institute biologic specimen repository. J Infect Dis 2009; 199: 1564-6.
- 32 Stramer SL, Hollinger FB, Katz LM, Kleinman S, Metzel PS, Gregory KR, Dodd RY. Emerging infectious disease agents and their potential threat to transfusion safety. Transfusion 2009; 49(Suppl): 1S-235S.
- 33 Leiby D. Babesiosis and blood transfusion: flying under the radar. Vox Sang 2006; 90: 157-65.
- 34 Urisman A, Molinaro RJ, Fischer N, Plummer SJ, Casey G, Klein EA, Malathi K, Magi-Galluzzi C, Tubbs RR, Ganem D, Silverman RH, De Risi JL. Idenification of a novel gammaretrovirus in prostate tumors of patients homozygous for R462Q RNASEL variant. PLoS Pathog 2006; 2: e25.
- 35 Lombadi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrwo-Sadowski C, Gold B, Dean M, Silverman RH, Mikovits JA. Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome. Science 2009; 326: 585-9.
- 36 Zou S, Dorsey KA, Notari EP, Foster GA, Krysztof DE, Musaveh F, Dodd RY, Stramer SL. Prevalence, incidence, and residual risk of human immunodeficiency and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing. Transfusion 2010; 50: 1495-504.
- 37 Zou S, Stramer SL, Notari EP, Kuhns MC, Krysztof DE, Musaveh F, Fang CT, Dodd RY. Current incidence and residual risk of hepatitis B infection among blood donors in the United States. Transfusion 2009; 49: 1609-20.
- 38 Agapova M, Busch MP, Custer B. Cost-effectiveness of screening the US blood supply for Trypanosoma cruzi. Transfusion 2010; 50: 2220-32.
- 39 Stramer SL, Custer B, Busch MP, Dodd RY. Strategies for testing blood donors for West Nile virus. Transfusion 2006; 46: 2036-7.
- 40 Bern C, Montgomery SP, Katz L, Caglioti S, Stramer SL. Chagas disease and the US blood supply. Curr Opin Infect Dis 2008; 21: 476-82.
- 41 Tonnetti L, Eder AF, Dy B, Kennedy J, Pisciotto P, Benjamin RJ, Leiby DA. Transfusion-transmitted Babesia microti identified through hemovigilance. Transfusion 2009; 49: 2557-63.
- 42 Mohammed H, Linnen JM, Muñoz-Jordán JL, Tomashek J, Foster G, Broulik AS, Petersen L, Stramer SL. Dengue virus in blood donations, Puerto Rico, 2005. Transfusion 2008; 48: 1348-54.
- 43 Linnen JM, Vinelli E, Sabino EC, Tobler LH, Hyland C, Lee TH, Kolk DP, Broulik AS, Collins CS, Lanciotti RS, Busch MP. Dengue viremia in blood donors from Honduras, Brazil and Australia. Transfusion 2008; 48: 1355-62.
- 44 Hewitt PE, Llewlyn 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.
- 45 Baram M. Risk assessment in the federal government— managing the process. Environment 1983; 25: 25-7.
- 46 AABB. Xenotropic murine leukemia virus-related virus (XMRV). Factsheet. [cited 2011 Feb 15]. Available from: URL: http://www.aabb.org/resources/bct/eid/Documents/xmrvfactsheet.pdf
- 47 Eberhard ML, Walker EM, Steurer FJ. Survival and infectivity of babesia in blood maintained at 25°C and 2-4°C. J Parasitol 1995; 81: 790-2.
- 48 Hayes EB, Komar N, Nasci RS, Montgomery SP, O'Leary DR, Campbell GL. Epidemiology and transmission dynamics of West Nile virus disease. Emerg Infect Dis 2005; 11: 1167-73.
- 49 Wilcox BA, Gubler DJ. Disease ecology and the global emergence of zoonotic pathogens. Environ Health Prev Med 2005; 10: 263-72.
- 50 Slingenbergh J, Gilbert M, de Balogh K, Wint W. Ecological sources of zoonotic diseases. Rev Sci Tech 2004; 23: 467-84.
- 51 WHO. Report on the WHO/FAO/OIE joint consultation on emerging zoonotic diseases. Geneva, Switzerland, 3-5 May, 2004.
- 52 Health Canada. Decision making framework. 2005. [cited 2009 Sep 24]. Available from: URL: http://www.hc-sc.gc.ca/sr-sr/advice-avis/decision/index-eng.php
- 53 Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, Joiner S, Linehan JM, Brandner S, Wadsworth JD, Hewitt P, Collinge J. Clinical presentation and pre-mortem diagnosis of variant Creutzfeldt-Jakob disease associated with blood transfusion: a case report. Lancet 2006; 368: 2061-7.
- 54 Brooks JI, Merks HW, Fournier J, Boneva RS, Sandstrom PA. Characterization of blood-borne transmission of simian foamy virus. Transfusion 2007; 47: 162-70.
- 55 Public Health Agency of Canada. Available from: URL: http://www.phac-aspc.gc.ca/index-eng.php
- 56 Epstein JS. Alternative strategies in assuring blood safety: an overview. Biologicals 2010; 38: 31-5.
- 57 Klein HG. How safe is blood, really? Biologicals 2010; 38: 100-4.
- 58 Vamvakas EC, Blajchman MA. Blood still kills: six strategies to further reduce allogeneic blood transfusion-related mortality. Transfus Med Rev 2010; 24: 77-124.
- 59 Ruane P, Edrich R, Gampp D, Keil S, Leonard L, Goodrich R. Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion 2004; 44: 877-85.
- 60 Marschner S, Fast LD, Baldwin III, WM, Slichter SJ, Goodrich RP. White blood cell inactivation after treatment with riboflavin and ultraviolet light. Transfusion 2010; 50: 2489-98.
- 61 Goodrich RP, Custer B, Keil S, Busch M. Defining adequate pathogen reduction performance for transfused blood components. Transfusion 2010; 50: 1827-37.
- 62 Reddy H, Dayan AD, Cavagnaro J, Gad S, Li J, Goodrich R. Toxicity testing of the Mirasol PRT™ process for platelets and plasma: a novel riboflavin-based pathogen reduction technology for blood transfusion safety. Transfus Med Rev 2008; 22: 133-53.
- 63 Mirasol Clinical Evaluation Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with Mirasol pathogen reduction technology. Transfusion 2010; 50: 2362-75.
- 64 Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science 1981; 211: 453-8.
- 65 Kahneman D, Tversky A. Prospect theory: an analysis of decisions under risk. Econometrica 1979; 47: 313-27.
- 66 Public Health Service (PHS) Biovigilance Task Group. Biovigilance in the United States: efforts to bridge a critical gap in patient safety and donor health (White Paper), 2009.
- 67 Roberts SS. Blood safety in the age of AIDS. FASEB J 1996; 10: 391-402. Breakthroughs in Science Series. [cited 2011 Feb 15]. Available from: URL: http://www.fasebj.org/cgi/reprint/10/4/391.pdf
- 68 Friedman MA. Blood and plasma safety. 1998 Statement before the Subcommittee on Human Resources, House Committee on Government Reform and Oversight, September 9, 1998. [cited 2011 Feb 15]. Available from: URL: http://www.fda.gov/NewsEvents/Testimony/ucm115104.htm
- 69 Roche Molecular Diagnostics. Applications of PCR. 2010. [cited 2011 Feb 15]. Available from: URL: http://molecular.roche.com/roche_pcr/applications_of_pcr.html
- 70 CSL Behring. Plasma testing. 2010. [cited 2011 Feb 15]. Available from: URL: http://www.cslbehring.com/quality-safety/integrated-safety-system/plasma-testing.htm
- 71 U. S. Food and Drug Administration. Complete list of donor screening assays for infectious agents and HIV diagnostic assays. 2010. [cited 2011 Feb 15]. Available from: URL: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/UCM080466
- 72 Hanson E, Rowley R, Agan B, Tibbetts C, Niemeyer D. Chapter 3—Microarray incorporation for pathogen identification. In: J Kocik, MK Janiak, M Negut, editors. Preparedness against bioterrorism and re-emerging infectious diseases. Amsterdam, The Netherlands: IOS Press; 2004. p. 12-6. (Published in cooperation with NATO Scientific Affairs Division; Supported under the NATO Science Programme as a NATO Advanced Research Workshop).
- 73 Lin B, Vora GJ, Thach D, Walter E, Metzgar D, Tibbetts C, Stenger D. Rapid detection and serotyping of acute respiratory disease-associated adenoviruses with oligonucleotide microarrays. J Clin Microbiol 2004; 42: 3232-9.
- 74 Davignon L, Walter EA, Mueller KM, Barrozo CP, Stenger DA, Lin B. Use of resequencing oligonucleotide microarrays for identification of Streptococcus pyogenes and associated antibiotic resistance determinants. J Clin Microbiol 2005; 43: 5690-5.
- 75 Lin B, Wang Z, Vora GJ, Thorton JA, Schnur JM, Thach DC, Santiago J, Walter EA, Agan BK, Metzgar D, Mueller KM, Seto D, Daum LT, Kruzelock R, Rowley RK, Hanson EH, Tibbetts C, Stenger DA. Broad-spectrum respiratory tract pathogen identification using re-sequencing DNA microarrays. Genome Res 2006; 16: 527-35.
- 76 Malanoski AP, Lin B, Wang Z, Schnur JM, Stenger DA. Automated identification of multiple micro-organisms from resequencing DNA microarrays. Nucleic Acids Res 2006; 34: 5300-11.
- 77 Wang Z, Daum LT, Vora GJ, Metzgar D, Walter EA, Canas LC, Malanoski AP, Lin B, Stenger DA. Identifying influenza viruses with resequencing microarrays. Emerg Infect Dis 2006; 12: 638-46.
- 78 Lin B, Blaney KM, Malanoski AP, Ligler AG, Schnur JM, Metzgar D, Russell KL, Stenger DA. Using resequencing microarray as a multiple respiratory pathogen detection assay. J Clin Microbiol 2007; 45: 443-52.
- 79 Lin B, Malanoski AP, Wang Z, Blaney KM, Ligler AG, Rowley RK, Hanson E, von Rosenvinge E, Ligler FS, Metzgar D, Barrozo CP, Russell KL, Tibbetts C, Schnur JM, Stenger DA. Application of broad-spectrum, sequence-based pathogen identification in an urban population. PLoS ONE 2007; 2: e419.
- 80 Wang Z, Malanoski AP, Lin B, Kidd C, Long NC, Blaney KM, Thach DC, Tibbetts C, Stenger DA. Resequencing microarray probe design for typing genetically diverse viruses: human rhinoviruses and enteroviruses. BMC Genomics 2008; 9: 577.
- 81 Malanoski AP, Lin B, Stenger DA. A model of base-call resolution on broad-spectrum pathogen detection resequencing microarrays. Nucleic Acids Res 2008; 36: 3194-201.
- 82 Lin B, Malanoski AP, Wang Z, Blaney KM, Long NC, Meador CE, Metzgar D, Myers CA, Yingst SL, Monteville MR, Saad MD, Schnur JM, Tibbetts C, Stenger DA. Universal detection and identification of avian influenza using resequencing microarrays. J Clin Microbiol 2009; 47: 988-93.
- 83 Leski TA, Lin B, Malanoski AP, Wang Z, Long NC, Meador CE, Barrows B, Ibrahim SM, Hardick JP, Aitichou M, Schnur JM, Tibbetts C, Stenger D. Testing and validation of high density resequencing microarray for broad range biothreat agents detection. PLoS ONE 2009; 4: e6569.
- 84 Metzgar D, Myers CA, Russell KL, Faix D, Brown J, Swayne DE, Thomas C, Stenger DA, Lin B, Malanoski AP, Wang Z, Blaney KM, Long NC, Schnur JM, Saad MD, Borsuk LA, Lichanska AM, Lorence MC, Weslowski B, Schafer KO, Tibbetts C. Simultaneous detection and identification of influenza virus types, subtypes and emergent variants in single microarray-based resequencing assays. PLoS ONE 2009; 5: e8995.
- 85 U. S. Food and Drug Administration. Medical devices and flu emergencies. In vitro diagnostics (IVD). Tessarray resequencing influenza A microarray detection panel. 2009. [cited 2011 Feb 15]. Available from: URL: http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm
- 86
Tibbetts C,
Lichanska AM,
Borsuk LA,
Weslowski B,
Morris LM,
Lorence MC,
Schafer KO,
Campos J,
Sene M,
Myers CA,
Faix D,
Blair PJ,
Brown J,
Metzgar D.
Resequencing Pathogen Microarray (RPM) for prospective detection and identification of emergent pathogen strains and variants. 2010. SPIE Proceedings—Defense, Security & Sensing, Orlando (FL).
10.1117/12.853469 Google Scholar
- 87 Tibbetts C. Highly multiplexed and simultaneous sequencing of targeted genes transforms detection and identification of pathogens for medical diagnostics and for public health surveillance. Chin J Lab Med (Invited review, Sept 2010) 2010. In press.
- 88 Bennett P, Ball J. vCJD Risk assessment calculations for a patient with multiple routes of exposure. United Kingdom Department of Health e-publication. 2009. [cited 2010 Aug]. Available from: URL: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_100357
- 89 Bowcott O. Blood filter to protect patients from vCJD—but only for the young. Health advisory committee recommends adoption of a newly developed blood filter for transfusion of a newly developed blood filter for transfusion patients aged under 13. Guardian November 26, 2009 [cited 2010 Aug]. Available from: URL: http://www.guardian.co.uk/society/2009/nov/26/blood-filter-vcjd-transfusion-prion-capture
- 90 Chesebro B. Introduction to the transmissible spongiform encephalopathies or prion diseases. Br Med Bull 2003; 66: 1-20.
- 91 Dorsey K, Zou S, Schonberger LB, Sullivan M, Kessler D, Notari E 4th, Fang CT, Dodd RY. Lack of evidence of transfusion transmission of Creutzfeldt-Jakob disease in a US surveillance study. Transfusion 2009; 49: 977-84.
- 92 Gibbs CJ Jr, Gajdusek DC, Asher DM, Alpers MP, Beck E, Daniel PM, Matthews WB. Creutzfeldt-Jakob disease (spongiform encephalopathy): transmission to the chimpanzee. Science 1968; 161: 388-9.
- 93 Gregori L, Gray BN, Rose E, Spinner DS, Kascsak RJ, Rohwer RG. A sensitive and quantitative assay for normal PrP in plasma. J Virol Methods 2008; 149: 251-9.
- 94 Gregori L, Gurgel PV, Lathrop JT, Edwardson P, Lambert BC, Carbonell RG, Burton SJ, Hammond DJ, Rohwer RG. Reduction in infectivity of endogenous transmissible spongiform encephalopathies present in blood by adsorption to selective affinity resins. Lancet 2006; 368: 2226-30.
- 95 Prusiner SB. Novel proteinaceous infectious particles cause scrapie. Science 1982; 216: 136-44.
- 96 Sowemimo-Coker SO, Demczyk CA, Andrade F, Baker CA. Evaluation of removal of prion infectivity from red blood cells with prion reduction filters using a new rapid and highly sensitive cell culture-based infectivity assay. Transfusion 2010; 50: 980-8.
- 97 United Kingdom Health Protection Agency. vCJD abnormal prion protein found in a patient with haemophilia at post mortem. Evidence of infection with the agent (abnormal prion protein) that causes variant Creutzfeldt-Jakob Disease (vCJD) has been found at post mortem in the spleen of a person with haemophilia. Press Release 16 Feb 2009 [cited 2010 Aug]. Available from: URL: http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1234859690542?p=1231252394302
- 98 United Kingdom Transfusion Medicine Epidemiological Review (TMER). Web site. 2010. [cited 2010 Aug]. Available from: URL: http://www.cjd.ed.ac.uk/TMER/TMER.htm
- 99 U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. 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. 2010. [cited 2010 Aug]. Available from: URL: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf
- 100 Wilesmith JW, Wells GA, Cranwell MP, Ryan JB. Bovine spongiform encephalopathy: epidemiological studies. Vet Rec 1988; 123: 638-44.
- 101 Will RG, Ironside JW, Zeidler M, Cousens SN, Estibeiro K, Alperovitch A, Poser S, Pocchiari M, Hofman A, Smith PG. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 1996; 347: 921-5.
- 102 World Health Organization. WHO guidelines on tissue infectivity distribution in transmissible spongiform encephalopathies. Geneva. 2006. [cited 2010 Aug]. AvailAvailable from: URL: http://www.who.int/bloodproducts/TSEREPORT-LoRes.pdf
- 103 U.S. Food and Drug Administration. Emerging infectious diseases: evaluation to implementation for transfusion and transplantation safety public workshop, May 11-12, 2010. Transcripts. [cited 2011 Feb 15]. Available from: URL: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm206773.htm
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