Recruitment

Recruitment Status
Completed
Estimated Enrollment
1500

Summary

Conditions
Herpes
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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 specim...

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.

Locations

Springfield, Massachusetts, 01199
Burlington, North Carolina, 27215
Albuquerque, New Mexico, 87102
Springfield, Massachusetts, 01199
Burlington, North Carolina, 27215
Albuquerque, New Mexico, 87102

Tracking Information

NCT #
NCT02092233
Collaborators
Not Provided
Investigators
Study Director: David Himsworth Luminex Corporation