This study is currently not recruiting participants.

Clinical Evaluation of the Aptima? Herpes Simplex Viruses 1 & 2 Assay on the Panther? System in Swab Specimens From Symptomatic Subjects Presenting With a Suspected Herpes Lesion(s)

Evaluation of an Investigational Test for Detecting HSV in Various Body Regions

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to evaluate the performance of the Aptima HSV assay for detection of HSV-1 and HSV-2 in swab samples prospectively collected from suspected HSV lesions in the male anogenital region, the female anogenital region, the oral cavity and other areas of the face, and the skin.

Detailed description of study

The purpose of this study is to evaluate the performance of the Aptima HSV assay for detection of HSV-1 and HSV-2 in swab samples prospectively collected from suspected HSV lesions in the male anogenital region, the female anogenital region, the oral cavity and other areas of the face, and the skin.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: herpes simplex virus
  • Age: 100 years or below
  • Gender: All

This study investigates the performance of an investigational test for detecting the herpes simplex virus (HSV) types 1 and 2. HSV is a virus that can cause sores on different parts of the body, including the mouth and genitals. The purpose of this study is to see how well this test works with samples taken from suspected sores.

Participants in the study will have swabs taken from areas that may have HSV sores. These areas include the male and female anogenital regions, the mouth, other facial areas, and the skin. The swab samples will be used to test the investigational method for detecting HSV.

  • Who can participate: Include age criteria and key eligibility factors if available.
  • Study details: Participants will have swabs taken from suspected HSV lesions in various body regions for testing with the investigational assay.
Updated on 19 Feb 2024. Study ID: 1503141446

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