MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2018-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Clinical Sites and the Reference Core-Lab will be masked of specimen disease state

Study Groups

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HTLV Infected (n=50)

Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)

Group Type EXPERIMENTAL

MP Diagnostics HTLV Blot 2.4

Intervention Type DIAGNOSTIC_TEST

HTLV I/II Confirmation and Differentiation

Neurological Disorders (n=100)

Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica

Group Type EXPERIMENTAL

MP Diagnostics HTLV Blot 2.4

Intervention Type DIAGNOSTIC_TEST

HTLV I/II Confirmation and Differentiation

Interventions

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MP Diagnostics HTLV Blot 2.4

HTLV I/II Confirmation and Differentiation

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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HTLV I/II Western Blot Assay

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No