HTLV-I InfectionsNCT01467024
Evaluation of the MP Diagnostics HTLV Blot 2.4
An observational study of HTLV-I Infections and HTLV-II Infections, run by MP Biomedicals, LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1
- What is being tested?
- CDPHL Algorithm
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All populations are from whole blood donors.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
California Department of Public Health
Richmond, California, 94804
LABS, Inc
St Louis, Missouri, 38611
About this study
The purpose of this study is:
- To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
- To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.
Read the 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 three geographical distinct locations.
The validity of the MP Blot will be assessed by calculating the following:
- Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
- 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
- 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
- Being tested
- CDPHL Algorithm
- Keywords
- HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II
- Medical subject headings
- HTLV-I Infections, HTLV-II Infections, Leukemia-Lymphoma, Adult T-Cell, Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDPHL AlgorithmOther
Supplemental testing algorithm performed by the CDPHL.
| Study group | Role | What they receive |
|---|---|---|
| EIA Negative | Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay. Receives: Other: CDPHL Algorithm | |
| EIA Repeat Reactive | Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed. Receives: Other: CDPHL Algorithm | |
| Known Positive | Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing. Receives: Other: CDPHL Algorithm |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HTLV-I InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MP Biomedicals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vital Systems Inc.
- Responsible party
- Sponsor
- Investigators
- Susan Stramer, Ph.D, Principal investigator, American National Red Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467024
- Sponsor's protocol ID
- MP-EIA-HTLV-001B
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the MP Diagnostics HTLV Blot 2.4
- ClinicalTrials.gov ID
- NCT01467024
- Acronym / sponsor ID
- MP-EIA-HTLV-001B
- Conditions
- 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
- Keywords
- HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- MP Biomedicals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Vital Systems Inc.
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
- To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.
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 three geographical distinct locations.
The validity of the MP Blot will be assessed by calculating the following:
- Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EIA Negative | – | Other: CDPHL AlgorithmBlood donor specimens that tested non-reactive by previously licensed HTLV screening assay. |
| EIA Repeat Reactive | – | Other: CDPHL AlgorithmBlood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed. |
| Known Positive | – | Other: CDPHL AlgorithmBlood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All populations are from whole blood donors.
Key inclusion criteria (14 listed)
- EIA Negative Population
- EIA Repeat Reactive Population
- Known Positive Population
Key exclusion criteria (13 listed)
- EIA Negative Population
- EIA Repeat Reactive Population
- Known Positive Population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDPHL AlgorithmSupplemental testing algorithm performed by the CDPHL. | Other | EIA Negative, EIA Repeat Reactive, Known Positive |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Stramer, Ph.D principal investigator
American National Red Cross
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HTLV-I Infections and HTLV-II Infections, run by MP Biomedicals, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.