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About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All Specimens:
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:
Exclusion criteria
HTLV Infected:
Neurological Disorders
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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