Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 4 of 4 for:    "Human T-cell leukemia virus type 2"

Evaluation of InnoLIA HTLV I/II Score

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Creative Testing Solutions
ClinicalTrials.gov Identifier:
NCT01149837
First received: June 22, 2010
Last updated: March 3, 2016
Last verified: March 2016
  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-Lymphotrophic Virus Type I and/or Type II
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:

Primary Outcome Measures:
  • INNO-LIA HTLV I/II Score Testing [ Time Frame: September 2013 through December 2013, up to 3 months ] [ Designated as safety issue: No ]
    322 residual donor samples tested

  • INNO-LIA HTLV I/II Score Testing [ Time Frame: January 2014 through December 2014, up to one year ] [ Designated as safety issue: No ]
    896 residual donor samples tested

  • INNO-LIA HTLV I/II Score Testing [ Time Frame: January 2015 through December 2015, up to one year ] [ Designated as safety issue: No ]
    630 residual donor samples tested


Biospecimen Retention:   Samples With DNA
human serum and/or human plasma

Estimated Enrollment: 4500
Study Start Date: July 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Creative Testing Solutions
Tempe, Arizona, United States, 85282
Sponsors and Collaborators
Creative Testing Solutions
Investigators
Principal Investigator: Phillip C Williamson, PhD Creative Testing Solutions
  More Information

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: March 3, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

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 September 28, 2016