Evaluation of InnoLIA HTLV I/II Score

Completed

• Conditions: Human T-Lymphotrophic Virus Type I and/or Type II
• Interventions: Device: InnoLIA HTLV I/II Score line immunoassay

• Registration Number: NCT01149837
• Lead Sponsor: Creative Testing Solutions

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 Description

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 Timeline

• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Study Start: 2013-07
• Status Verified: 2019-01
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3305

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
residual blood donor samples	InnoLIA HTLV I/II Score line immunoassay	Protocol describes testing an HTLV-I/II antibody reactive population from this cohort using the InnoLIA HTLV I/II Score line immunoassay

Primary Outcome Measures

Name	Time	Method
INNO-LIA HTLV I/II Score Testing	January 2016 through May 2016	315 residual donor samples tested

Trial Locations

Locations (1)

Creative Testing Solutions; 🇺🇸 Tempe, Arizona, United States