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

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ClinicalTrials.gov Identifier: NCT02685956
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Vela Diagnostics

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.

Condition or disease Intervention/treatment
Herpes Simplex Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test

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.

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Study Type : Observational
Actual Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

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 Name: Sentosa HSV Assay




Primary Outcome Measures :
  1. Clinical sensitivity and specificity of quantitative HSV DNA detection using the Vela Sentosa assay compared to traditional microbiology culture-based HSV DNA detection using ELVIS assay (reference method). [ Time Frame: within 60 days of last sample enrollment ]
    Study will assess clinical sensitivity and specificity of Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). Clinical sensitivity and specificity for HSV DNA detection will be determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion). Clinical sensitivity will be the ratio of test assay to reference assay positives. Clinical specificity will be the ratio of test assay negatives to reference assay negatives. Ratios will be presented with 95% confidence intervals.


Biospecimen Retention:   Samples With DNA

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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and females with genital or oral lesions to be tested for HSV 1/2 infection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685956


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Massachusetts
Baystate Health
Springfield, Massachusetts, United States, 01199
United States, Michigan
Beaumont Health
Royal Oak, Michigan, United States, 48073
United States, New Jersey
BioReference Labs
Elmwood Park, New Jersey, United States, 07407
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Geisinger Health
Danville, Pennsylvania, United States, 17822
Quest Diagnostics
Horsham, Pennsylvania, United States, 19044
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
MedFusion
Lewisville, Texas, United States, 75067
Sponsors and Collaborators
Vela Diagnostics
Investigators
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Study Director: Shaw Chiat Hong Vela Diagnostics

Additional Information:
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Responsible Party: Vela Diagnostics
ClinicalTrials.gov Identifier: NCT02685956     History of Changes
Other Study ID Numbers: Vela Sentosa HSV Study
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases