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
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90,116
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Imugen
Norwood, Massachusetts, United States
number of blood donors testing positive for evidence of Babesia infection
Time frame: goal is up to one year (all specimens by end 2012)
the number of cases of transfusion transmitted babesia infection identified
Time frame: goal is up to one year (all specimens by end 2012)
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