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

Herpes Simplex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685956
• Other study ID #: Vela Sentosa HSV Study
• Status: Completed
• Start date: April 2016
• Est. completion date: April 7, 2017

Study information

• Verified date: May 2020
• Source: Vela Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2295
• Est. completion date: April 7, 2017
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Geisinger Health	Danville	Pennsylvania
United States	BioReference Labs	Elmwood Park	New Jersey
United States	Quest Diagnostics	Horsham	Pennsylvania
United States	MedFusion	Lewisville	Texas
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Beaumont Health	Royal Oak	Michigan
United States	Baystate Health	Springfield	Massachusetts
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vela Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Vela Diagnostics Website