Evaluation of InnoLIA HTLV I/II Score

Study Overview
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Brief Summary
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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 Description
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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.

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

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

Intervention / Treatment
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* Device: InnoLIA HTLV I/II Score line immunoassay


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| residual blood donor samples<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HTLV, HTLV I, HTLV II, HTLV Type I and/or HTLV Type II antibody