Dual Algorithm Post Market Clinical Study

June 9, 2017 updated by: MP Biomedicals, LLC

Evaluation of the MP Diagnostics HTLV Blot 2.4

The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Study Type

Observational

Enrollment (Actual)

100

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
    • North Carolina
      • Charlotte, North Carolina, United States, 28273
        • American Red Cross - National Testing Laboratory

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

16 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:

  1. Male or female
  2. Completion of a health history evaluation for routine donor screening
  3. Provided a routine blood donation
  4. Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay

Exclusion Criteria:

  1. Unwilling or unable to provide informed consent to blood donation
  2. Inadequate sample volume for testing
  3. Unable to provide samples that meet the suitability requirements for testing

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HTLV Repeat Reactive (RR) / Non Reactive (NR)
Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay
Diagnostic test: MP Diagnostics HTLV Blot 2.4
HTLV I/II Confirmation and Differentiation
Other Names:
  • HTLV I/II Western Blot Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the HTLV dual algorithm testing in blood donor facilities
Time Frame: 3 months
HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.
3 months

Collaborators and Investigators

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

Sponsor

MP Biomedicals, LLC

Collaborators

MP Biomedicals Asia Pacific Pte. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2017

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP EIA-HTLV-001B Amendment 6.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual patient data (IPD) was deidentified prior to sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

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.

Clinical Trials on HTLV-I Infections

Clinical Trials on MP Diagnostics HTLV Blot 2.4

  • MP Biomedicals, LLC
    MP Biomedicals Asia Pacific Pte. Ltd.
    Completed
    MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study
    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
    United States

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