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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Herpes Simplex

Intervention / Treatment
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* Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vela Sentosa SA HSV1/2 PCR Test<br>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<br>* medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test<br>* Other names: Sentosa HSV Assay;|

What is the study measuring?
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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 | 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 |