Evaluation of InnoLIA HTLV I/II Score
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/1/2019 |
| Start Date: | July 2013 |
| End Date: | January 25, 2019 |
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.
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.
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.
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.
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
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