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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Herpes Simplex

Clinical Trial Details

NCT number	NCT02685956
Study type	Observational
Source	Vela Diagnostics
Contact
Status	Completed
Phase
Start date	April 2016
Completion date	April 7, 2017

View Details

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