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.
Study Type
OBSERVATIONAL
Enrollment
3,305
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
Creative Testing Solutions
Tempe, Arizona, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.