Status:
COMPLETED
Evaluation of InnoLIA HTLV I/II Score
Lead Sponsor:
Creative Testing Solutions
Conditions:
Human T-Lymphotrophic Virus Type I and/or Type II
Eligibility:
All Genders
Brief Summary
The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a suppl...
Detailed Description
The InnoLIA HTLV I/II Score study consists of three sub-studies. The first sub-study will determine the sensitivity, specificity and accuracy of HTLV type assignment using well-characterized samples f...
Eligibility Criteria
Inclusion
- Subjects completing a health history evaluation for routine donor screening
- Subjects willing and able to provide informed consent
- Subjects testing repeat reactive on a licensed screening test for HTLV antibodies
Exclusion
- Subjects not meeting health history criteria for routine donor screening
- Subjects unwilling and unable to provide informed consent
- Subjects testing negative on a licensed screening test for HTLV antibodies
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 25 2019
Estimated Enrollment :
3305 Patients enrolled
Trial Details
Trial ID
NCT01149837
Start Date
July 1 2013
End Date
January 25 2019
Last Update
January 30 2019
Active Locations (1)
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1
Creative Testing Solutions
Tempe, Arizona, United States, 85282