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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01112956

Enrollment

2500

Registered

2010-04-29

Start date

2009-07-31

Completion date

2011-02-28

Last updated

2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Herpes

Keywords

HSV-2, HSV-1, Sensitivity, Specificity, Testing algorithm, Test evaluation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Men and women 16-55 years of age

Exclusion criteria

* Those who refuse to get tested for HIV

Design outcomes

Primary

Measure	Time frame
Sensitivity and Specificity using Western Blot as the Gold Standard test	Up to 4 months after initial testing

Secondary

Measure	Time frame
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%	Up to 4 months after initial testing

Countries

United States

Outcome results