Evaluation of the MP Diagnostics HTLV Blot 2.4
Status unconfirmed
Conditions studied: HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1, Human T-lymphotropic Virus 2, HTLV I Associated T Cell Leukemia Lymphoma, HTLV I Associated Myelopathies
In brief
The purpose of this study is: 1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4. 2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.
Key facts
- Study ID
- NCT01467024
- Run by
- MP Biomedicals, LLC
- People needed
- 600
- Starts
- 2011-11-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2011-11-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- EIA Negative Population
- Male or female
- Completion of a health history evaluation for routine donor screening
- Willing and able to provide informed consent
- Negative screening assay results for all ARC screening assays
- EIA Repeat Reactive Population
- Male or female
- Completion of a health history evaluation for routine donor screening
- Willing and able to provide informed consent
- Previous RR result by bioMerieux ELISA, Abbott EIA, and / or Abbott ChLIA PRISM
- Known Positive Population
- Male or female
- Willing and able to provide informed consent
- Previous reactive screening test using either the bioMerieux ELISA, the Abbott EIA or the Abbott ChLIA PRISM, followed by supplemental testing
You may not qualify if…
- EIA Negative Population
- Inadequate sample volume for testing
- Unable to provide samples that meet the sample suitability requirements for testing
- Positive screening result for any infectious disease tested by ARC
- EIA Repeat Reactive Population
- Inadequate sample volume for testing
- Unable to provide samples that meet the sample suitability requirements for testing
- Positive result for HIV, HBV, HCV, or any other infectious disease
- Known Positive Population
- Unwilling or unable to provide informed consent
- Unable to provide adequate sample volume for testing
- Unable to provide samples that meet the sample suitability requirements for testing
- Positive result for HIV
Where it is running
- California Department of Public Health — Richmond, California, United States
- LABS, Inc — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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