Babesia Testing in Blood Donors

Imugene

Status and phase: Completed; Phase 3

Conditions: Transfusion Transmitted Babesiosis

Treatments: Biological: B.microti diagnostic blood tests

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01528449

BNATIFA-10

Details and patient eligibility

About

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

Full 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

Enrollment: 90,116 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• same as for donating blood

Exclusion criteria

• donor refusual to sign informed consent for this investigational babesia testing

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90,116 participants in 2 patient groups

retrospective

Experimental group

Description:

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).

Treatment:

Biological: B.microti diagnostic blood tests

Biological: B.microti diagnostic blood tests

prospective, real time

Experimental group

Description:

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).

Treatment:

Biological: B.microti diagnostic blood tests

Biological: B.microti diagnostic blood tests