Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Status Completed

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01112956
Study type	Observational
Source	Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	N/A
Start date	July 2009
Completion date	February 2011

View Details

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