Evaluation of the MP Diagnostics HTLV Blot 2.4 (NCT01467024) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the MP Diagnostics HTLV Blot 2.4
United States600 participantsStarted 2011-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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
✕. 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