Evaluation of the MP Diagnostics HTLV Blot 2.4

November 7, 2011 updated by: MP Biomedicals, LLC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Richmond, California, United States, 94804
        • California Department of Public Health
    • Missouri
      • St. Louis, Missouri, United States, 38611
        • LABS, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All populations are from whole blood donors.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MP Biomedicals, LLC

Collaborators

Vital Systems Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (ESTIMATE)

November 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-EIA-HTLV-001B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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