Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT02092233
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
Sponsor:
Luminex Corporation
Organization:
Study Overview
Official Title:
A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ARIES HSV 1\&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA.
The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay.
The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay.
Detailed Description:
The ARIES HSV 1\&2 Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA in male external and internal anogenital, female external and internal anogenital (vaginal), oral and skin lesion specimens.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: