Trial record 4 of 4 for:    "Human T-cell leukemia virus type 2"

Evaluation of InnoLIA HTLV I/II Score

This study is not yet open for participant recruitment.
Verified December 2012 by Creative Testing Solutions
Sponsor:
Information provided by (Responsible Party):
Creative Testing Solutions
ClinicalTrials.gov Identifier:
NCT01149837
First received: June 22, 2010
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Human T-cell Lymphotropic Virus
Device: InnoLIA HTLV I/II Score line immunoassay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Vitro Diagnostic Study for Supplemental Testing of Anti-HTLV-I/II Reactive Human Blood Specimens

Resource links provided by NLM:


Further study details as provided by Creative Testing Solutions:

Biospecimen Retention:   Samples With DNA

human serum and/or human plasma


Estimated Enrollment: 4500
Study Start Date: July 2013
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149837

Contacts
Contact: Eugene F Robertson, PhD 1-866-342-4275 grobertson@mycts.org
Contact: Sheryl J Cyrus, BS 1-866-342-4275 scyrus@mycts.org

Locations
United States, Arizona
Creative Testing Solutions Not yet recruiting
Tempe, Arizona, United States, 85282
Sponsors and Collaborators
Creative Testing Solutions
Investigators
Principal Investigator: Eugene F Robertson, PhD Creative Testing Solutions
  More Information

No publications provided

Responsible Party: Creative Testing Solutions
ClinicalTrials.gov Identifier: NCT01149837     History of Changes
Other Study ID Numbers: BB-IND 14309
Study First Received: June 22, 2010
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Creative Testing Solutions:
HTLV
HTLV I
HTLV II
HTLV Type I and/or HTLV Type II antibody

ClinicalTrials.gov processed this record on April 15, 2014