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

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.

Completed

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Key information

Conditions

Herpes DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Baystate Medical Center, Springfield, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Time frame: Within the first year of sample collection

Sponsors and collaborators

Lead sponsor

Luminex Corporation

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
First posted: Mar 20, 2014
Registry last updated: Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed