An observational study in Human T-Lymphotrophic Virus Type I and/or Type II, sponsored by Creative Testing Solutions. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Creative Testing Solutions · Observational
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.
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.
This is the only study on the registry with Creative Testing Solutions as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Whole blood and HCT/P donor samples found repeatedly reactive for anti-HTLV-I/II using an FDA approved donor screening test
Exclusion Criteria:
Protocol describes testing an HTLV-I/II antibody reactive population from this cohort using the InnoLIA HTLV I/II Score line immunoassay
Device: InnoLIA HTLV I/II Score line immunoassay
This intervention consists of testing a residual serum or plasma sample from a blood donation or donor follow-up sample using the InnoLIA HTLV I/II Score line immunoassay
INNO-LIA HTLV I/II Score Testing
322 residual donor samples tested
Time frame: September 2013 through December 2013, up to 3 months
INNO-LIA HTLV I/II Score Testing
896 residual donor samples tested
Time frame: January 2014 through December 2014, up to one year
INNO-LIA HTLV I/II Score Testing
630 residual donor samples tested
Time frame: January 2015 through December 2015, up to one year
INNO-LIA HTLV I/II Score Testing
315 residual donor samples tested
Time frame: January 2016 through May 2016
Plan to share: Undecided
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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