A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients

Herpes Clinical Trial

Official title:

A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092233
• Other study ID #: LMA-HSV-01-CS-001
• 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. 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

• Herpes

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