Expired Study
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Tempe, Arizona 85282


Purpose:

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 supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. This study will determine if the test is useful for donor counseling purposes.


Study summary:

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 from the NIH-funded HTLV Outcomes Study (HOST). The second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. The third sub-study allows for use of the InnoLIA HTLV I/II Score as a supplemental test for whole blood and HCT/P donors testing repeatedly reactive with an FDA-approved donor screening test for anti-HTLV-I/II.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT01149837


Primary Contact:

Principal Investigator
Phillip C Williamson, PhD
Creative Testing Solutions


Backup Contact:

N/A


Location Contact:

Tempe, Arizona 85282
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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