MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03226119

Enrollment

150

Registered

2017-07-21

Start date

2018-01-15

Completion date

2018-08-31

Last updated

2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, HTLV-II Infections, HTLV-I Infections, Human T-lymphotropic Virus 1, Human T-lymphotropic Virus 2

Keywords

HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTMP Diagnostics HTLV Blot 2.4

HTLV I/II Confirmation and Differentiation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026