Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
1 other identifier
observational
2,295
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2017
CompletedResults Posted
Study results publicly available
June 5, 2020
CompletedJune 5, 2020
May 1, 2020
1 year
February 10, 2016
May 22, 2018
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test
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
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
Study Arms (1)
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.
Interventions
medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test
Eligibility Criteria
Male and females with genital or oral lesions to be tested for HSV 1/2 infection.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vela Diagnosticslead
Study Sites (9)
Tampa General Hospital
Tampa, Florida, 33606, United States
Baystate Health
Springfield, Massachusetts, 01199, United States
Beaumont Health
Royal Oak, Michigan, 48073, United States
BioReference Labs
Elmwood Park, New Jersey, 07407, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Geisinger Health
Danville, Pennsylvania, 17822, United States
Quest Diagnostics
Horsham, Pennsylvania, 19044, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
MedFusion
Lewisville, Texas, 75067, United States
Related Links
Biospecimen
Samples collected from an oral or genital site, submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2. Samples collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Maas
- Organization
- Global BioClinical
Study Officials
- STUDY DIRECTOR
Shaw Chiat Hong
Vela Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 19, 2016
Study Start
April 1, 2016
Primary Completion
April 7, 2017
Study Completion
April 7, 2017
Last Updated
June 5, 2020
Results First Posted
June 5, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share