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

May 18, 2020 updated by: Vela Diagnostics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health
    • New Jersey
      • Elmwood Park, New Jersey, United States, 07407
        • BioReference Labs
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Health
      • Horsham, Pennsylvania, United States, 19044
        • Quest Diagnostics
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
    • Texas
      • Lewisville, Texas, United States, 75067
        • MedFusion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and females with genital or oral lesions to be tested for HSV 1/2 infection.

Description

Inclusion Criteria:

  • Sample was taken from a lesion from an internal or external oral or genital site.
  • Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.
  • The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.
  • Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.
  • There is sufficient residual sample to perform both test and reference assays.

Exclusion Criteria:

  • Sample leaked during shipment or storage prior to assay.
  • Sample has undergone more than 1 freeze-thaw cycle before testing;
  • Sample eluent is not clear after centrifugation (refer to section 6.3.1).
  • Sample ID is missing or ambiguous.
  • Sample is collected using alginate calcium swab.
  • Sample handling and storage requirement in section 5.4 not followed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vela Sentosa SA HSV1/2 PCR Test
Male and female subjects of any age with sample collected from a lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.
Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test
medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test
Other Names:
  • Sentosa HSV Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
Time Frame: within 60 days of last sample enrollment
Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).
within 60 days of last sample enrollment
Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test
Time Frame: within 60 days of last sample enrollment
Study asses Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).
within 60 days of last sample enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vela Diagnostics

Investigators

  • Study Director: Shaw Chiat Hong, Vela Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 7, 2017

Study Completion (Actual)

April 7, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vela Sentosa HSV Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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