Babesia Species • Tick Species Vary with Babesia Species
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APPENDIX 2 Babesia Species • Tick species vary with Babesia species. • Transmission occurs after a period of tick attachment Disease Agent: that is generally at least 48 hours. • Blood transfusion • In the US: Babesia microti, Babesia duncani (formerly WA1), Babesia variant CA1, Babesia divergens-like Likelihood of Secondary Transmission: variant M01 • Moderate—transmissible by transfusion with over 70 • In Europe/Asia: Babesia microti, Babesia divergens, cases documented in the US Babesia variants: EU1, KO1, TW1 • Low—organ/tissue transplantation Disease Agent Characteristics: • Transplacental/perinatal transmissions documented for B. microti. • Protozoan, 1-2.5 mm (small Babesia species generally infect humans; large Babesia species of 2.5-5 mm At-Risk Populations: occur primarily in animals with the exception of the human variant KO1 that is classified as a large Babesia • Asplenic, elderly, immunocompromised adults and organism) infants at-risk for clinically manifest infection which • Order: Piroplasmidora might be severe. • Family: Babesiidae • People exposed to tick vectors during hiking, garden- • All are intraerythrocytic parasites with characteristic ing, and other outdoor activities; co-infection of B. microscopic appearance similar to Plasmodium microti with Borrelia burgdorferi (agent of Lyme species disease) can occur and can lead to more severe disease. Co-infection of B. microti with Anaplasma Disease Name: phagocytophilum (agent of human granulocytic ana- plasmosis) also is possible since all 3 agents are trans- • Babesiosis mitted by the same ticks. Priority Level Vector and Reservoir Involved: • Scientific/Epidemiologic evidence regarding blood safety: Moderate/High • Ixodes ticks for B. microti; I. scapularis (also referred • Public perception and/or regulatory concern regard- to as I. dammini) in the eastern US is the most ing blood safety: Very low, but moderate in endemic common; however, other tick species may be regions involved. • Public concern regarding disease agent: Very low, but • White-footed mice serve as amplifying hosts for B. moderate regionally microti. • Although white-tailed deer (Odocoileus virginianus) Background: are not infected with B. microti, they serve as the transport and reproduction hosts for adult ticks. • Approximately 100 species that infect mammals have • I. ricinus is one tick species identified as a vector for been described, some of which may be synonymous; B. divergens in Europe. traditionally, species have been defined based prima- • For some of the Babesia species, the tick vector and rily on morphology and host specificity. reservoir hosts have not been identified. • Emergent in the US, probably due in part to expand- ing range of ticks and their mammalian hosts, Blood Phase: increased intrusion of humans into tick-infested habitats and increased awareness and testing. • Intermittent parasitemia detectable for months to • B. divergens is primarily a bovine parasite but human years during asymptomatic infection infections have been documented in Europe. Survival/Persistence in Blood Products: • Worldwide, cases caused by various species are increasingly being recognized. • At least 35 days in red cells based on transfusion transmission data Common Human Exposure Routes: Transmission by Blood Transfusion: • Tick bites •ForB. microti, in the US, bite of an infected nymphal • B. microti documented in over 70 cases; all cases have stage of the tick Ixodes scapularis commonly known occurred in the US, except for one case in Canada as the black-legged or deer tick; other tick species (donor was exposed in the US) and one case in Japan; may also transmit B. microti. Adult ticks may also potentially one case in Europe. transmit. • B. duncani: 2 cases reported in the literature Volume 49, August 2009 Supplement TRANSFUSION 215S APPENDIX 2 • Travelers from non-endemic areas infected while Likelihood of Clinical Disease: visiting endemic areas, donors from babesiosis- • Generally produces mild and transient infection in endemic areas who donate elsewhere, and exporta- immunocompetent hosts; however, intermittent tion of blood products are increasingly implicated in parasitemia may be detected for months to years transfusion cases. • Higher likelihood of more severe clinical disease in • Since fiscal year 1998, an increasing number of fatali- at-risk populations ties and Blood Product Deviations (BPDs) have been reported to the FDA. A total of 272 BPDs related to Primary Disease Symptoms: possible Babesia infection in donors were reported • Clinical infection ranges from mild, flu-like illness to from FY 1998-2007 of which 52 were investigated as fulminant, malaria-like disease that can be fatal. possible transfusion-transmitted Babesia infections. • Severe babesiosis can manifest with hemolysis, dis- Twelve fatalities were reported since 1998, with 9 of 12 seminated intravascular coagulation (DIC), hemody- reported in the last 3-year period. Five of these namic instability and multiorgan dysfunction (e.g., patients received their transfusions in states where renal failure, respiratory distress). Babesia was not endemic. All recipients who died were infected with B. microti. Red blood cells were Severity of Clinical Disease: implicated in each case, including one frozen deglyc- erolized product. Each infection was diagnosed by • Absent/Low: Healthy, immunocompetent persons thin peripheral blood smear; associated donors had • High: Asplenic, elderly, immunocompromised adults antibody titers Ն1:128 by IFA. or infants • The American Red Cross reported 18 definite or pro- Mortality: bable cases of transfusion-transmitted B. microti from 2005-2007, including five fatalities. Seventeen • For clinical B. microti infections, estimated at 5% in antibody-positive donors were implicated including population-based study the donor of one split red cell unit that infected a • Rates may be higher among splenectomized patients 1-day old infant and a 32-year old sickle cell patient. Chronic Carriage: Of the 17 antibody-positive donors, 11 were residents of Babesia-endemic areas, while 4 residents of non- • Months to years in some people endemic areas had a history of travel to endemic • Self-limiting infection in most people areas. Treatment Available/Efficacious: Cases/Frequency in Population: • Effective treatment with clindamycin and quinine, • B. microti is endemic in Northeast as far south as New but side effects are very frequent. Clindamycin and Jersey and the Upper Midwest. Seroprevalence in quinine remain the standard of care for severe healthy blood donors in endemic areas ranges up to babesiosis. 2%, but the only seroprevalence study carried out • The combination of atovaquone and azithromycin, outside of New England was in Wisconsin. Areas of recently introduced, is equally efficacious with sig- hyperendemicity (up to 9%) in the general population nificantly fewer side effects have been reported. • Exchange transfusion may be indicated in severe • B. duncani and the variant CA1 are found in several cases (i.e., high-level parasitemia). western states. MO1 and other B. divergens—like Agent-Specific Screening Question(s): organisms have been identified in Missouri and several other states. • Currently in use as part of Donor History • B. divergens, EU1, and B. microti found in Europe; B. Questionnaire: “Have you ever had babesiosis?” microti reported in Japan where it was implicated in a • In endemic areas, a question on exposure to tick bites transfusion case; KO1 in Korea; TW1 in Taiwan has been shown to be ineffective in distinguishing Babesia-infected from uninfected donors. The ques- Incubation Period: tion lacks sensitivity and specificity. • 1-6 weeks following tick bite Laboratory Test(s) Available: • 1-9 weeks following transfusion but may be longer depending in part on the immune status of the • No FDA-licensed blood donor screening test exists. individual • Options for diagnostic testing include blood smear • The 9 fatalities reported above had an approximate microscopy, indirect IFA (cut-off titers vary with interval from transfusion to symptom onset of 2.5 to 7 assay and lab), EIA, western blot, NAT, and animal weeks. inoculations. 216S TRANSFUSION Volume 49, August 2009 Supplement APPENDIX 2 • Limited donor screening is being conducted or con- Other Comments: sidered using research tests (i.e., IFA, PCR) in some endemic areas. This may enable the application of a • Clinical recognition and early treatment important selective algorithm for screening of blood compo- • Because of the parasite’s regional distribution, trans- nents for transfusion to high-risk patients in endemic fusion cases outside the endemic area may not be areas (i.e., the CMV model). recognized or accurately diagnosed; however, under- recognition is a problem even in areas where babesio- Currently Recommended Donor Deferral Period: sis is endemic. • Indefinite deferral for history of babesiosis per AABB Suggested Reading: Standard. No FDA Guidance exists. 1. Conrad PA, Kjemtrup AM, Carreno RA, Thomford J, • Consideration of deferral for donors implicated in Wainwright K, Eberhard M, Quick R, Telford SR 3rd, investigations of transfusion-transmitted babesiosis Herwaldt BL. Description of Babesia duncani n.sp. or those testing positive by research/investigational (Apicomplexa: Babesiidae) from humans and its tests differentiation from other piroplasms. Int J Parasitol 2006;36:779-89. Impact on Blood Availability: 2. Eberhard ML, Walker EM, Steuer FJ. Survival and infectivity of Babesia in blood maintained at 25C and