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

Luminex

Status: Completed

Conditions: Herpes

Study type: Observational

Funder types: Industry

Identifiers

NCT02092233

LMA-HSV-01-CS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,963 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,963 participants in 2 patient groups

Blinded, Prospective Arm

Description:

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.

Blinded, Pre-selected Arm

Description:

For specimen types that are less common, banked, pre-selected, positive clinical specimens will be tested.