Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

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

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.

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:

1. STD clinic population
2. Men who have sex with men, with high prevalence of HIV infection
3. Pregnant women

The study will inform the development of testing strategies:

1. Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)
2. Increase cutoff values to increase PPV
3. Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.

Inclusion Criteria:

• Men and women 16-55 years of age

Exclusion Criteria:

• Those who refuse to get tested for HIV