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.
Study Type
OBSERVATIONAL
Enrollment
2,500
John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York University School of Medicine
New York, New York, United States
Sensitivity and Specificity using Western Blot as the Gold Standard test
Time frame: Up to 4 months after initial testing
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%
Time frame: Up to 4 months after initial testing
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