Transfusion Transmitted Babesiosis
Conditions
Keywords
babesia, blood donation, transfusion transmitted babesiosis
Brief summary
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. Two laboratory methodologies will be utilized: 1. \- PCR, to look for the presence of B.microti in whole blood 2. \- IFA, to look for significant titers of B.microti antibody
Detailed description
Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients. Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation
Interventions
BIOLOGICALB.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Sponsors
American National Red Cross
Memorial Blood Centers, Minnesota
Rhode Island Blood Center
Imugen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* same as for donating blood
Exclusion criteria
* donor refusual to sign informed consent for this investigational babesia testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of blood donors testing positive for evidence of Babesia infection | goal is up to one year (all specimens by end 2012) |
Secondary
| Measure | Time frame |
|---|---|
| the number of cases of transfusion transmitted babesia infection identified | goal is up to one year (all specimens by end 2012) |
Countries
United States
Outcome results
None listed