Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
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ClinicalTrials.gov Identifier: NCT01112956 |
Recruitment Status
:
Completed
First Posted
: April 29, 2010
Last Update Posted
: March 23, 2011
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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.
Condition or disease |
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Genital Herpes |
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:
- STD clinic population
- Men who have sex with men, with high prevalence of HIV infection
- Pregnant women
The study will inform the development of testing strategies:
- Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)
- Increase cutoff values to increase PPV
- Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.
Study Type : | Observational |
Actual Enrollment : | 2500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | February 2011 |

Group/Cohort |
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STD clinic patients
Patients attending sexually transmitted Disease clinics. If the initial testing result reported to the patient is confirmed by the Western Blot test, no follow-up specimens will be collected. If the initial testing result reported to the patient is different from the result by the Western Blot test, patients will be asked to provide a follow-up specimen 3-4 months after initial testing.
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Pregnant women
Women recruited from prenatal clinic. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.
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Men who have Sex with men (MSM)
Men recruited from a clinic for MSM with high risk for HIV infection. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.
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- 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 ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 16 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Men and women 16-55 years of age
Exclusion Criteria:
- Those who refuse to get tested for HIV

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112956
United States, Maryland | |
John Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 |
Principal Investigator: | Donna Felsenstein, MD | Massachusetts General Hospital |
Responsible Party: | Fujie Xu/Epidemiologist, CDC |
ClinicalTrials.gov Identifier: | NCT01112956 History of Changes |
Other Study ID Numbers: |
CDC-NCHHSTP-1127 |
First Posted: | April 29, 2010 Key Record Dates |
Last Update Posted: | March 23, 2011 |
Last Verified: | March 2011 |
Keywords provided by Centers for Disease Control and Prevention:
HSV-2 HSV-1 Sensitivity |
Specificity Testing algorithm Test evaluation |
Additional relevant MeSH terms:
Herpes Simplex Herpes Genitalis Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral |
Skin Diseases, Infectious Skin Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male Genital Diseases, Female |