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

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.

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