Dual Algorithm Post Market Clinical Study

NCT03146013 | Completed FDA Drug FDA Device

• 1 other identifier: MP EIA-HTLV-001B Amendment 6.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

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

Outcome Measures

Primary Outcomes (1)

• Assess the HTLV dual algorithm testing in blood donor facilities

  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

Study Arms (1)

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

Interventions

MP Diagnostics HTLV Blot 2.4 DIAGNOSTIC_TEST

HTLV I/II Confirmation and Differentiation

Also known as: HTLV I/II Western Blot Assay

HTLV Repeat Reactive (RR) / Non Reactive (NR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All populations are from whole blood donors.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MP Biomedicals, LLC: lead
• MP Biomedicals Asia Pacific Pte. Ltd.: collaborator

Study Sites (1)

American Red Cross - National Testing Laboratory

Charlotte, North Carolina, 28273, United States

Location

Related Publications (1)

• Miller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11.

  PMID: 26589659 BACKGROUND

MeSH Terms

Conditions

HTLV-I Infections; HTLV-II Infections; Leukemia-Lymphoma, Adult T-Cell; Paraparesis, Tropical Spastic

Condition Hierarchy (Ancestors)

Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Myelitis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases

Study Officials

• Susan Stramer, Ph.D

  American National Red Cross

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: March 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)