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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02092233
Other study ID # LMA-HSV-01-CS-001
Secondary ID
Status Completed
Phase N/A
First received March 17, 2014
Last updated July 9, 2015
Start date January 2014

Study information

Verified date March 2014
Source Luminex Molecular Diagnostics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1963
Est. completion date
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

The specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium

Exclusion Criteria:

The specimen was not properly collected, transported or stored according to instructions provided by Sponsor

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Tricore Albuquerque New Mexico
United States Labcorp Burlington North Carolina
United States Baystate Medical Center Springfield Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). Within the first year of sample collection No
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