Spots Global Cancer Trial Database for MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study
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Trial Identification
Brief Title: MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study
Official Title: HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
Study ID: NCT03226119
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LABS, Inc., Philadelphia, Pennsylvania, United States
Qualtex Laboratories, San Antonio, Texas, United States
Eastern Virginia Medical School (EVMS), Norfolk, Virginia, United States
Contact Details
Name: Sara Dionne, PhD
Affiliation: LABS, Inc.
Role: PRINCIPAL_INVESTIGATOR
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