Clinical Trial: Evaluation of InnoLIA HTLV I/II Score

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: In Vitro Diagnostic Study for Supplemental Testing of Anti-HTLV-I/II Reactive Human Blood Specimens

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 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.

Detailed 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.
Sponsor: Creative Testing Solutions

Current Primary Outcome:

  • INNO-LIA HTLV I/II Score Testing [ Time Frame: September 2013 through December 2013, up to 3 months ]
    322 residual donor samples tested
  • INNO-LIA HTLV I/II Score Testing [ Time Frame: January 2014 through December 2014, up to one year ]
    896 residual donor samples tested
  • INNO-LIA HTLV I/II Score Testing [ Time Frame: January 2015 through December 2015, up to one year ]
    630 residual donor samples tested
  • INNO-LIA HTLV I/II Score Testing [ Time Frame: January 2016 through May 2016 ]
    315 residual donor samples tested


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Creative Testing Solutions

Dates:
Date Received: June 22, 2010
Date Started: July 2013
Date Completion: January 2018
Last Updated: February 8, 2017
Last Verified: February 2017