Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Study Overview
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Brief Summary
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The purposes of this study are: To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2); To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the gold standard in a diverse patient population; To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.

Detailed Description
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The purposes of this study are: To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2); To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the gold standard in a diverse patient population; To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2. We will evaluate the assays in diverse populations: STD clinic population Men who have sex with men, with high prevalence of HIV infection Pregnant women The study will inform the development of testing strategies: Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV) Increase cutoff values to increase PPV Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.

Official Title
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Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies

Conditions
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Genital Herpes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 16-55 years of age Exclusion Criteria: Those who refuse to get tested for HIV

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STD clinic patients<br>Patients attending sexually transmitted Disease clinics. If the initial testing result reported to the patient is confirmed by the Western Blot test, no follow-up specimens will be collected. If the initial testing result reported to the patient is different from the result by the Western Blot test, patients will be asked to provide a follow-up specimen 3-4 months after initial testing. | |
| Pregnant women<br>Women recruited from prenatal clinic. A follow-up visit may or may not needed depending on results from the initial test and Western blot test. | |
| Men who have Sex with men (MSM)<br>Men recruited from a clinic for MSM with high risk for HIV infection. A follow-up visit may or may not needed depending on results from the initial test and Western blot test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity using Western Blot as the Gold Standard test |  | Up to 4 months after initial testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In population with relative low prevalence of HSV-2 infection (e.g. persons <=25 years), whether a combination of tests (i.e. testing algorithm(s)) can increase the positive predictive value to the level of >= 95% |  | Up to 4 months after initial testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSV-2, HSV-1, Sensitivity, Specificity, Testing algorithm, Test evaluation