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| Name | Class |
|---|---|
| American National Red Cross | OTHER |
| Memorial Blood Centers, Minnesota | OTHER |
| Rhode Island Blood Center | UNKNOWN |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| retrospective | Experimental | 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). |
|
| prospective, real time | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B.microti diagnostic blood tests | Biological | the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA). |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip J Molloy, MD | Imugen Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imugen | Norwood | Massachusetts | 02062 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27959685 | Derived | Moritz ED, Winton CS, Tonnetti L, Townsend RL, Berardi VP, Hewins ME, Weeks KE, Dodd RY, Stramer SL. Screening for Babesia microti in the U.S. Blood Supply. N Engl J Med. 2016 Dec 8;375(23):2236-2245. doi: 10.1056/NEJMoa1600897. |
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| B.microti diagnostic blood tests | Biological | the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA). |
|