Evaluation of InnoLIA HTLV I/II Score

Completed

Conditions studied: Human T-Lymphotrophic Virus Type I and/or Type II

In brief

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.

Key facts

Study ID

NCT01149837

Run by

Creative Testing Solutions

People needed

3305

Starts

2013-07-01

Expected to finish

2019-01-25

Last updated by the study team

2019-01-30

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Creative Testing Solutions — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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