Skip to main content
OpenTrials
Completed

NCT Number: NCT01149837

Evaluation of InnoLIA HTLV I/II Score

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Creative Testing Solutions

Tempe, Arizona, 85282, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InnoLIA HTLV I/II Score line immunoassay

Device

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

Primary outcomes

  1. INNO-LIA HTLV I/II Score Testing

    Time frame: September 2013 through December 2013, up to 3 months

    322 residual donor samples tested

  2. INNO-LIA HTLV I/II Score Testing

    Time frame: January 2014 through December 2014, up to one year

    896 residual donor samples tested

  3. INNO-LIA HTLV I/II Score Testing

    Time frame: January 2015 through December 2015, up to one year

    630 residual donor samples tested

  4. INNO-LIA HTLV I/II Score Testing

    Time frame: January 2016 through May 2016

    315 residual donor samples tested

Sponsors and collaborators

Lead sponsor

Creative Testing Solutions

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2010
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.