NCT02685956

Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,295 (actual)
• Sponsor: Vela Diagnostics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.

Detailed description

This study will utilize residual samples from male and female patients with signs and symptoms of oral or genital HSV infections. Genital samples will include internal and external genital lesions such as those collected from lesions of the anus, buttocks, vagina, labia, or penis. Oral samples will include those collected from lip, gum, and mouth lesions. For concordance testing, the sample size is based on historical study design and estimates of the expected prevalence of HSV1 and/or HSV2 in the population enrolled.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DEVICE	Vela Sentosa SA HSV1/2 Qualitative PCR Test	medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-07
• Completion: 2017-04-07
• First posted: 2016-02-19
• Last updated: 2020-06-05
• Results posted: 2020-06-05

Locations

9 sites across 1 country: United States