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Dual Algorithm Post Market Clinical Study

NCT03146013 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-06-12

No results posted yet for this study

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

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

  • Susan Stramer, Ph.D · American National Red Cross

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2017-05-31
Completion
2017-05-31
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 NCT03146013 on ClinicalTrials.gov