NCT01112956

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 16 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Genital Herpes

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2010-04-29
• Last updated: 2011-03-23

Locations

3 sites across 1 country: United States