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APPENDIX 2

Trypanosoma brucei by : • Single, poorly documented case of transmission by Disease Agent: blood transfusion • brucei gambiense Cases/Frequency in Population: • rhodesiense

Disease Agent Characteristics: • WHO estimates that nearly half a million people carry this , albeit underreported. • Protozoan, 14-33 mm • Order: Incubation Period: • Family: Trypanosomatidae • Local signs present 2-3 days to weeks following bite of • Hemoflagellates that do not invade cells but inhabit infected tsetse fly. connective tissue space • CNS signs can present a few months (T.b. rhodesiense) • Found in humans as pleomorphic trypomastigotes to several years (T.b. gambiense) after infection. present in peripheral blood, lymph nodes, spleen, and cerebrospinal fluid Likelihood of Clinical Disease:

Disease Name: • High

• African sleeping sickness Primary Disease Symptoms: • Human African • Chancre at the inoculation site, which persists for up Priority Level: to 2 weeks. Thereafter, generalized • Scientific/Epidemiologic evidence regarding blood followed by fever, headache, pruritus, skin rash, safety: Theoretical hepatosplenomegaly, anemia, edema, cardiovascular, • Public perception and/or regulatory concern regard- endocrinological, and renal disorders. ing blood safety: Absent • Second stage includes neurological effects (sleeping • Public concern regarding disease agent: Very low disturbances, alteration of mental state, abnormal reflexes, tone, coordination, and sensory disorders). Background: Progressive, untreated disease leads into deteriora- tion of consciousness and death in 100% of cases. • Stable, limited to African continent Severity of Clinical Disease: Common Human Exposure Routes: • Severe • Bite of infected tsetse fly

Likelihood of Secondary Transmission: Mortality:

•Low • Approaches 100% in untreated cases • 2-8% in treated cases At-Risk Populations: Chronic Carriage: • Residents of endemic areas of Africa ᭺ T. b. gambiense—West and Central Africa • Months to years ᭺ T. b. rhodesiense—East and Southeast Africa Treatment Available/Efficacious: • Over 60 million people at risk, with 150,000 new cases/year and nearly 100,000 deaths/year • isothionate, , , and eflornithine are used for , depending on the and Reservoir Involved: stage of disease (hemolymphatic or CNS) and the • Tsetse flies of the Glossina subspecies of T. brucei. • Primarily infects humans • Treatments primarily effective during early stages of disease but less effective once central nervous system Blood Phase: involved. Drugs can have serious side effects. • is present during the symptomatic phase Agent-Specific Questions(s): and can be present for years. • No specific question is in use. Survival/Persistence in Blood Products: • Not indicated in the US • Unknown • No sensitive or specific question is feasible.

Volume 49, August 2009 Supplement TRANSFUSION 229S APPENDIX 2

Laboratory Test(s) Available: Suggested Reading:

• No FDA-licensed blood donor screening test exists. 1. Barbara JAJ. Transfusion-transmitted : • Options for laboratory testing include blood smear epidemiology relevant to blood safety. In Rock G, Seg- microscopy, culture of blood or tissue biopsies, IHA, hatchian MG, editors. Quality assurance in Transfu- IFA, EIA, and NAT. sion Medicine, Vol. I. Boca Raton: CRC Press; 1992. p. 419-44. Currently Recommended Donor Deferral Period: 2. Barrett MP, Burchmore RJ, Stich A, Lazzari JO, Frasch AC, Cazzulo JJ, Krishna S. The trypanosomiases. • No FDA Guidance or AABB Standard exists. Lancet 2003;362:1469-80. • Prudent practice, given the possibility of chronic car- 3. Hira PR, Husein SF. Some transfusion-induced para- riage, would be a lifetime deferral for history of sitic infections in Zambia. J Hyg Epidemiol Microbiol infection. Immunol 1979;23:436-44. 4. McCulloch R. in African Impact on Blood Availability: trypanosomes: monitoring progress. Trends Parasitol 2004;20:117-21. • Agent-specific screening question(s): Not applicable 5. Papadoupolos MC, Abel PM, Agranoff D, Stich A, • Laboratory test(s) available: Not applicable Tarelli E, Bell BA, Planche T, Loosemore A, Saadoun S, Impact on Blood Safety: Wilkins P, Krishna S. A novel and accurate diagnostic test for human . Lancet 2004; • Agent-specific screening question(s): Not applicable 363:1358-63. • Laboratory test(s) available: Not applicable 6. Stich AH, Abel P, Krishna S. Human African trypano- somiasis. BMJ 2002;325:203-6. Leukoreduction Efficacy: 7. Welburn SC, Odit M. Recent developments in human African trypanosomiasis. Curr Opin Infect Dis 2002; • Unknown, though probably unlikely, given that only a 15:477-84. partial reduction effect in parasite load is observed for 8. Wendel S. The protozoal parasites— and T. cruzi Chagas’ disease. In: Linden JV, Bianco C, editors. Blood safety and surveillance, New York: Marcel Reduction Efficacy for Plasma Derivatives: Dekker, Inc.; 2001. p. 355-98. 9. World Health Organization (WHO). Human African • No specific data are available but it is presumed that trypanosomiasis. [cited 2009 May]. Available the agent would be sensitive to many measures used from: http://apps.who.int/tdr/svc/diseases/african- in the fractionation process. trypanosomiasis Other Prevention Measures: 10. Zavizion B, Pereira M, de Melo Jorge M, Serebryanik D, Mather TN, Chapman J, Miller NJ, Alford B, Bzik DJ, • Based on studies with T. cruzi, pathogen reduction Purmal A. Inactivation of protozoan parasites in red technology for cellular components may be effective. blood cells using INACTINE PEN110 chemistry. • Personal protective measures in endemic areas Transfusion 2004;44:731-8.

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