Status:
UNKNOWN
Evaluation of the MP Diagnostics HTLV Blot 2.4
Lead Sponsor:
MP Biomedicals, LLC
Collaborating Sponsors:
Vital Systems Inc.
Conditions:
HTLV-I Infections
HTLV-II Infections
Eligibility:
All Genders
18+ years
Brief 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 popul...
Detailed Description
This is a retrospective study designed to assess the validity and reproducibility of the MP Diagnostics IVD device, the HTLV Blot 2.4 (MP Blot), in various populations. The study will be conducted at ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01467024
Start Date
November 1 2011
End Date
June 1 2012
Last Update
November 8 2011
Active Locations (2)
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1
California Department of Public Health
Richmond, California, United States, 94804
2
LABS, Inc
St Louis, Missouri, United States, 38611