Evaluation of InnoLIA HTLV I/II Score

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

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.

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