Evaluation of the MP Diagnostics HTLV Blot 2.4
1 other identifier
observational
600
1 country
2
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 population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 8, 2011
November 1, 2011
2 months
October 31, 2011
November 7, 2011
Conditions
Keywords
Study Arms (3)
EIA Negative
Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.
EIA Repeat Reactive
Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.
Known Positive
Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.
Interventions
Supplemental testing algorithm performed by the CDPHL.
Eligibility Criteria
All populations are from whole blood donors.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MP Biomedicals, LLClead
- Vital Systems Inc.collaborator
Study Sites (2)
California Department of Public Health
Richmond, California, 94804, United States
LABS, Inc
St Louis, Missouri, 38611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Stramer, Ph.D
American National Red Cross
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 8, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2012
Study Completion
June 1, 2012
Last Updated
November 8, 2011
Record last verified: 2011-11