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Evaluation of InnoLIA HTLV I/II Score

2014-08-27 03:12:42 | BioPortfolio

Summary

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Human T-cell Lymphotropic Virus

Location

Creative Testing Solutions
Tempe
Arizona
United States
85282

Status

Not yet recruiting

Source

Creative Testing Solutions

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:42-0400

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Medical and Biotech [MESH] Definitions

A strain of PRIMATE T-LYMPHOTROPIC VIRUS 2, closely related to the human HTLV-1 virus. The clinical, hematological, and histopathological characteristics of the disease in STLV-infected monkeys are very similar to those of human adult T-cell leukemia. Subgroups include the African green monkey subtype (STLV-I-AGM), for which the nucleotide sequence is 95% homologous with that of HUMAN T-LYMPHOTROPIC VIRUS 1, and the Asian rhesus macaque subtype (STLV-I-MM), for which the nucleotide sequence is 90% homologous with that of HUMAN T-LYMPHOTROPIC VIRUS 1.

A strain of PRIMATE T-LYMPHOTROPIC VIRUS 2 that can transform normal T-lymphocytes and can replicate in both T- and B-cell lines. The virus is related to but distinct from HTLV-1.

A species in the family DELTARETROVIRUS, comprising strains from different host species but arising from the same geographic origin. They include HUMAN T-LYMPHOTROPIC VIRUS 2; SIMIAN T-LYMPHOTROPIC VIRUS 2; and Simian T-lymphotropic virus - PP.

A species of DELTARETROVIRUS that includes the strains SIMIAN T-LYMPHOTROPIC VIRUS 3 and HUMAN T-LYMPHOTROPIC VIRUS 3.

A species in the family DELTARETROVIRUS comprising strains of different host species but arising from the same geographic origin. They include HUMAN T-LYMPHOTROPIC VIRUS 1 and SIMIAN T-LYMPHOTROPIC VIRUS 1.

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