Babesia Testing in Blood Donors

Study Overview
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Brief Summary
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Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. Two laboratory methodologies will be utilized: - PCR, to look for the presence of B.microti in whole blood - IFA, to look for significant titers of B.microti antibody

Detailed Description
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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

Official Title
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Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays

Conditions
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Transfusion Transmitted Babesiosis

Intervention / Treatment
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* Biological: B.microti diagnostic blood tests
* Biological: B.microti diagnostic blood tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: same as for donating blood Exclusion Criteria: donor refusual to sign informed consent for this investigational babesia testing

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: retrospective<br>archived specimens from blood donors whose units have already been released and transfused into recipients will be tested. Attempts will be made to contact and obtain follow up specimens from both the donor and recipient of units initially testing positive for B.microti. the interventions are investigational diagnostic tests for B.microti (PCR and IFA). | Biological: B.microti diagnostic blood tests<br>* the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).<br>* Other names: proprietary in-house developed PCR and IFA Babesia doagnostic tests;|
| Experimental: prospective, real time<br>specimens from current blood donors will be tested and those testing positive for B.microti will not be released and the units will be disgarded, and the donors notified and deferred from future blood donation. the interventions are investigational diagnostic tests for B.microti (PCR and IFA). | Biological: B.microti diagnostic blood tests<br>* the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of cases of transfusion transmitted babesia infection identified |  | goal is up to one year (all specimens by end 2012) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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babesia, blood donation, transfusion transmitted babesiosis