Evaluation of InnoLIA HTLV I/II Score
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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 |
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 |
Whole blood and HCT/P donor samples found repeatedly reactive for anti-HTLV-I/II using an FDA approved donor screening test
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| Contact: Eugene F Robertson, PhD | 1-866-342-4275 | grobertson@mycts.org |
| Contact: Sheryl J Cyrus, BS | 1-866-342-4275 | scyrus@mycts.org |
| United States, Arizona | |
| Creative Testing Solutions | Not yet recruiting |
| Tempe, Arizona, United States, 85282 | |
| 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 May 19, 2013