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MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

NCT03226119 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-09-13

No results posted yet for this study

Summary

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

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

Interventions

DIAGNOSTIC_TEST

MP Diagnostics HTLV Blot 2.4

HTLV I/II Confirmation and Differentiation

Sponsors & Collaborators

  • MP Biomedicals Asia Pacific Pte. Ltd.

    collaborator UNKNOWN

  • MP Biomedicals, LLC

    lead INDUSTRY

Principal Investigators

  • Sara Dionne, PhD · LABS, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2018-07-10
Completion
2018-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226119 on ClinicalTrials.gov