Evaluation of InnoLIA HTLV I/II Score

Creative Testing Solutions

Status

Completed

Conditions

Human T-Lymphotrophic Virus Type I and/or Type II

Treatments

Device: InnoLIA HTLV I/II Score line immunoassay

Study type

Observational

Funder types

Other

Identifiers

NCT01149837

BB-IND 14309

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,305 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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