Evaluation of InnoLIA HTLV I/II Score

January 29, 2019 updated by: Creative Testing Solutions

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • Creative Testing Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Whole blood and HCT/P donor samples found repeatedly reactive for anti-HTLV-I/II using an FDA approved donor screening test

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
residual blood donor samples
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creative Testing Solutions

Investigators

  • Principal Investigator: Phillip C Williamson, PhD, Creative Testing Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

January 25, 2019

Study Completion (Actual)

January 25, 2019

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BB-IND 14309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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