MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

MP Biomedicals, LLC150 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

150

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

MP Diagnostics HTLV Blot 2.4DIAGNOSTIC_TEST

HTLV I/II Confirmation and Differentiation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

LABS, Inc.

Philadelphia, Pennsylvania, United States

Qualtex Laboratories

San Antonio, Texas, United States

Eastern Virginia Medical School (EVMS)

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

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

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

Time frame: 3 months

Data from ClinicalTrials.gov

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