Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-29 @ 9:54 PM
Study NCT ID:
NCT01112956
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2009-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: