A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
NCT ID: NCT02092233
Last Updated: 2015-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1963 participants
OBSERVATIONAL
2014-01-31
Brief Summary
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The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay.
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Detailed Description
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The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay through a multi-site, method comparison on prospectively collected, left-over de-identified, clinical specimens (i.e. all-comers accrued at enrolled clinical sites between pre-determined dates) as an aid in the diagnosis of herpes infection.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Blinded, Prospective Arm
The diagnostic accuracy for lesions from individuals suspected of having a herpes infection will be evaluated in prospectively collected, left-over de-identified, clinical specimens accrued between pre-defined dates.
No interventions assigned to this group
Blinded, Pre-selected Arm
For specimen types that are less common, banked, pre-selected, positive clinical specimens will be tested.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Luminex Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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David Himsworth
Role: STUDY_DIRECTOR
Luminex Corporation
Locations
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Baystate Medical Center
Springfield, Massachusetts, United States
Tricore
Albuquerque, New Mexico, United States
Labcorp
Burlington, North Carolina, United States
Countries
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Other Identifiers
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LMA-HSV-01-CS-001
Identifier Type: -
Identifier Source: org_study_id
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