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Evaluation of the MP Diagnostics HTLV Blot 2.4

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ClinicalTrials.gov Identifier: NCT01467024
Recruitment Status : Unknown
Verified November 2011 by MP Biomedicals, LLC.
Recruitment status was:  Enrolling by invitation
First Posted : November 8, 2011
Last Update Posted : November 8, 2011
Sponsor:
Collaborator:
Vital Systems Inc.
Information provided by (Responsible Party):
MP Biomedicals, LLC

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
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 Other: CDPHL Algorithm

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:

  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.


Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the MP Diagnostics HTLV Blot 2.4
Study Start Date : November 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
EIA Negative
Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.
 Other: 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.
 Other: 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.
 Other: CDPHL Algorithm
Supplemental testing algorithm performed by the CDPHL.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All populations are from whole blood donors.
Criteria

Inclusion Criteria:

  • EIA Negative 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. 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:

  • EIA Negative Population

    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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467024


Locations
United States, California
California Department of Public Health
Richmond, California, United States, 94804
United States, Missouri
LABS, Inc
St. Louis, Missouri, United States, 38611
Sponsors and Collaborators
MP Biomedicals, LLC
Vital Systems Inc.
Investigators
Principal Investigator: Susan Stramer, Ph.D American National Red Cross
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: MP Biomedicals, LLC
ClinicalTrials.gov Identifier: NCT01467024     History of Changes
Other Study ID Numbers: MP-EIA-HTLV-001B
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by MP Biomedicals, LLC:
HTLV
Confirmatory
Supplemental
 Blot
HTLV-I
HTLV-II

Additional relevant MeSH terms:
Paraparesis, Tropical Spastic
Infection
Communicable Diseases
Leukemia, T-Cell
Spinal Cord Diseases
HTLV-I Infections
Leukemia-Lymphoma, Adult T-Cell
HTLV-II Infections
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Immunologic Deficiency Syndromes