Diagnosis & Testing

In the United States, more people are infected with HSV-2 than all other STDs combined^*1-3

As many as 1 in 5 adults may have the infection, with an estimated 1 million new cases each year^1,3
Almost 90% of those who tested positive for HSV-2 were unaware they were infected³

Your patients may attribute their genital herpes symptoms to other medical conditions

Up to 60% of HSV-2 seropositive adults have undiagnosed signs or symptoms that are not recognized as genital herpes^4-6

Gential herpes and other conditions can display the same symptoms^4,6
Possible overlapping symptoms	Patient-reported conditions			Actual diagnosis
	UTI	Vaginitis	Yeast infection	Genital herpes
Itching
Burning
Redness
Discharge
Pain with urination
Urinary frequency and urgency

CDC Guidelines on Serologic Testing

The 2006 CDC Guidelines for Diagnosis of Genital Herpes state³:

“The clinical diagnosis of HSV is both insensitive and nonspecific… and should be confirmed by laboratory testing. Both virologic tests and type-specific serologic tests for HSV should be available in clinical settings that provide care for patients with STDs or those at risk for STDs.”
“Some specialists believe that HSV serologic testing should be included in a comprehensive evaluation for STDs among persons with multiple sex partners, HIV infection, and among MSM at increased risk for HIV acquisition.”
“The serologic type-specific glycoprotein G (gG)-based assays should be specifically requested when serology is performed.”

The CDC states that type-specific HSV serologic testing may be useful in the following patients^†:

Patients with recurrent genital herpes symptoms or with atypical symptoms and negative HSV cultures
Patients with a clinical diagnosis of genital herpes without laboratory confirmation
Patients with a partner with genital herpes

FDA-approved type-specific serologic tests include^‡
Test	Test order codes	Sensitivity/Specificity for HSV-2^*
Herpe Select^® 2 ELISA (HSV-2 only)	Quest Diagnostics: 3640X LabCorp: 163147	96% - 100% 96% - 98%
Herpe Select^® 1 and 2 ELISA^‡ (HSV-1 & HSV-2)	Quest Diagnostics: 6447X LabCorp: 164905	96% - 100% 96% - 98%
biokitHSV-2 Rapid Test	In-office test^§	91% - 97% 81% - 98%

^*Test results should be correlated to clinical history and epidemiologic data, as the likelihood of a false-positive result increases with decreasing underlying prevalence of HSV-2.

^†HSV testing in the general population is not indicated.

^‡HerpeSelect® 1 ELISA for HSV-1 is also available as an individual test, with sensitivity and specificity ranges of 75%–96% and 91%–98%, respectively.

^§For offices that are CLIA certified to conduct moderately complex tests.

A variety of test kits for HSV are available.

An example of an office-based kit is the “biokit HSV-2 Rapid Assay”
An example of a lab-based kit is the “Focus HerpeSelect HSV-2 ELISA”

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The biokit HSV-2 Rapid Assay and Focus HerpeSelect HSV-2 ELISA are not GSK-manufactured products nor is GSK recommending their use over other products.

biokit HSV-2 Rapid Assay is a registered trademark of biokit USA. HerpeSelect is a registered trademark of Quest Diagnostics.