Reasons for HSV-2 testing included diagnostic workup as well as asymptomatic screening, according to California guidelines. Eligible patients included those ⩾18 years of age who were able to provide verbal consent in English, Spanish, or Russian and who were receiving a serologic test for HSV-2 infection as part of their routine clinical care. Patients were recruited from San Francisco's municipal sexually transmitted disease clinic during October 2007. To gain additional information on point-of-care test performance when the test is performed by clinic staff in an urban sexually transmitted disease clinic, we compared the results of HerpeSelect Express with our current standard HSV-2 serologic assay, the HerpeSelect HSV-2 ELISA (Focus Diagnostics), with select confirmatory Western blot testing. The test requires only 2 steps but does not yet have a Clinical Laboratory Improvement Amendments waiver. Third, capillary blood tests are preferable to standard venipuncture because of decreased discomfort and lower risk of occupational bloodborne infection, and performance of the tests does not require a trained phlebotomist.Ī new point-of-care rapid assay for the detection of HSV-2 (HerpeSelect Express Focus Diagnostics) has recently been approved by the United States Food and Drug Administration, and preliminary studies have estimated the test to have high sensitivity (86%–100%) and specificity (97%–100%), compared with HSV-2 immunoblot and Western blot testing. Second, they do not require additional expensive equipment, which is particularly important in areas with limited resources or infrastructure. First, they allow for same-visit diagnosis and immediate counseling and treatment, if indicated. Rapid HSV-2 serologic assays that can be performed on-site with use of blood specimens obtained by fingerstick provide several potential advantages over standard laboratory-based assays. Western blot is considered the gold standard for HSV-2 serologic testing, but because of its cost and limited availability, commercially available type-specific HSV-2 serologic assays are more commonly used for screening. Because most HSV-2 infections are subclinical or unrecognized, serologic testing is often necessary to make a diagnosis after a diagnosis is made, infected patients can be counseled that symptom awareness, condom use, and suppressive treatment may all decrease the risk of transmission to uninfected partners. Appropriate counseling and treatment are predicated on an accurate diagnosis of genital herpes. Genital herpes due to herpes simplex virus type 2 (HSV-2) infection is common and remains underdiagnosed in the United States.
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