MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Study Overview
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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).

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.

Official Title
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HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV 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

Intervention / Treatment
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* Diagnostic Test: MP Diagnostics HTLV Blot 2.4


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HTLV Infected (n=50)<br>Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP) | Diagnostic Test: MP Diagnostics HTLV Blot 2.4<br>* HTLV I/II Confirmation and Differentiation<br>* Other names: HTLV I/II Western Blot Assay;|
| Experimental: Neurological Disorders (n=100)<br>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 | Diagnostic Test: MP Diagnostics HTLV Blot 2.4<br>* HTLV I/II Confirmation and Differentiation<br>* Other names: HTLV I/II Western Blot Assay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens |  | 3 months | 
| To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blot, HTLV, Confirmatory, Supplemental, HTLV-I, HTLV-II