Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2011-11-30
2012-06-30
Brief Summary
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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.
Detailed Description
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The validity of the MP Blot will be assessed by calculating the following:
1. Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
2. Percent positive agreement with CDPHL Algorithm on 200 EIA repeat reactive specimens
The sensitivity of the MP Blot will be evaluated by testing 200 known positive specimens. The study will be performed using three product lots at three clinical sites.
The reproducibility of the MP Blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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EIA Negative
Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.
CDPHL Algorithm
Supplemental testing algorithm performed by the CDPHL.
EIA Repeat Reactive
Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.
CDPHL Algorithm
Supplemental testing algorithm performed by the CDPHL.
Known Positive
Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.
CDPHL Algorithm
Supplemental testing algorithm performed by the CDPHL.
Interventions
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CDPHL Algorithm
Supplemental testing algorithm performed by the CDPHL.
Eligibility Criteria
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Inclusion Criteria
1. Male or female
2. Completion of a health history evaluation for routine donor screening
3. Willing and able to provide informed consent
4. Negative screening assay results for all ARC screening assays
* EIA Repeat Reactive Population
1. Male or female
2. Completion of a health history evaluation for routine donor screening
3. Willing and able to provide informed consent
4. Previous RR result by bioMerieux ELISA, Abbott EIA, and / or Abbott ChLIA PRISM
* Known Positive Population
1. Male or female
2. Willing and able to provide informed consent
3. Previous reactive screening test using either the bioMerieux ELISA, the Abbott EIA or the Abbott ChLIA PRISM, followed by supplemental testing
Exclusion Criteria
1. Inadequate sample volume for testing
2. Unable to provide samples that meet the sample suitability requirements for testing
3. Positive screening result for any infectious disease tested by ARC
* EIA Repeat Reactive Population
1. Inadequate sample volume for testing
2. Unable to provide samples that meet the sample suitability requirements for testing
3. Positive result for HIV, HBV, HCV, or any other infectious disease
* Known Positive Population
1. Unwilling or unable to provide informed consent
2. Unable to provide adequate sample volume for testing
3. Unable to provide samples that meet the sample suitability requirements for testing
4. Positive result for HIV
18 Years
ALL
No
Sponsors
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Vital Systems Inc.
OTHER
MP Biomedicals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Stramer, Ph.D
Role: PRINCIPAL_INVESTIGATOR
American National Red Cross
Locations
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California Department of Public Health
Richmond, California, United States
LABS, Inc
St Louis, Missouri, United States
Countries
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Other Identifiers
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MP-EIA-HTLV-001B
Identifier Type: -
Identifier Source: org_study_id