Text Size

Evaluation of the MP Diagnostics HTLV Blot 2.4

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Vital Systems Inc.
Information provided by (Responsible Party):
MP Biomedicals, LLC
ClinicalTrials.gov Identifier:
NCT01467024
First received: October 31, 2011
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the MP Diagnostics HTLV Blot 2.4

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MP Biomedicals, LLC:

Estimated Enrollment: 600
Study Start Date: November 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Red Cross
  More Information

No publications provided

Responsible Party: MP Biomedicals, LLC
ClinicalTrials.gov Identifier: NCT01467024     History of Changes
Other Study ID Numbers: MP-EIA-HTLV-001B
Study First Received: October 31, 2011
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013