Evaluation of InnoLIA HTLV I/II Score

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01149837

Enrollment

3305

Registered

2010-06-24

Start date

2013-07-31

Completion date

2019-01-25

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HTLV, HTLV I, HTLV II, HTLV Type I and/or HTLV Type II antibody

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.

Interventions

DEVICEInnoLIA HTLV I/II Score line immunoassay

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
INNO-LIA HTLV I/II Score Testing	September 2013 through December 2013, up to 3 months	322 residual donor samples tested

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026