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Completed

NCT Number: NCT03226119

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

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).

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Key information

Conditions

HTLV-I Infections Central Nervous System Diseases Central Nervous System Infections Deltaretrovirus Infections HTLV I Associated Myelopathies HTLV I Associated T Cell Leukemia Lymphoma HTLV-II Infections Hematologic Diseases Hemic and Lymphatic Diseases Human T-lymphotropic Virus 1 Human T-lymphotropic Virus 2 Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphatic Diseases Lymphoproliferative Disorders Myelitis Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neuroinflammatory Diseases Paraparesis, Tropical Spastic RNA Virus Infections Retroviridae Infections Spinal Cord Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LABS, Inc., Philadelphia, Pennsylvania, United States

Loading trial locations.

About this study

The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Specimens:

  • Male or female
  • Biorepository specimen de-identified of PHI
  • Specimen meets HTLV Blot 2.4 labeling collection/handling criteria

HTLV Positive Specimens:

Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II

Neurological Disorders:

Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders:

  • Acute Disseminated Encephalitis
  • Amyotrophic Lateral Sclerosis (ALS)
  • Autonomic Dysfunction
  • Conus Medularis Syndrome
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Dermatomyositis
  • HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP)
  • Meningitis
  • Mild Cognitive Impairment
  • Multiple Sclerosis (MS)
  • Polymyositis
  • Spastic Paraparesis
  • Sciatica

Exclusion criteria

HTLV Infected:

  • specimens with a known infection or history of HIV, HCV or HBV
  • specimens not meeting specimen labeling collection / handling criteria

Neurological Disorders

  • specimens not meeting specimen labeling collection / handling criteria

Treatment and study plan

MP Diagnostics HTLV Blot 2.4

Diagnostic Test

HTLV I/II Confirmation and Differentiation

Other names: HTLV I/II Western Blot Assay

Primary outcomes

  1. To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens

    Time frame: 3 months

  2. To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

MP Biomedicals, LLC

Industry

Collaborators

  • MP Biomedicals Asia Pacific Pte. Ltd.

Registry information

Official study title

HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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