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

NCT02685956 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2295

Last updated 2020-06-05

Study results available
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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.

Conditions

  • Herpes Simplex

Interventions

DEVICE

Vela Sentosa SA HSV1/2 Qualitative PCR Test

medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test

Sponsors & Collaborators

  • Vela Diagnostics

    lead INDUSTRY

Principal Investigators

  • Shaw Chiat Hong · Vela Diagnostics

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-04-07
Completion
2017-04-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685956 on ClinicalTrials.gov