Performance of HerpeSelect ELISA for HSV-2 Diagnosis in Patients Attending a Clinic for Persons with HIV

Background:A growing body of evidence demonstrates potentially important interactions between HIV and HSV.   Because HSV/HIV coinfection is common, tests that accurately identify HSV in HIV-infected persons are needed.  Recent studies performed on other populations suggest that persons with positive type-specific ELISA tests for HSV-2 in the “low positive” range often have falsely positive tests.

Objectives:To determine the prevalence of HSV-2 in HIV positive patients receiving care in an HIV-dedicated clinic who were without a history of ano-genital herpes.  To evaluate the performance of the HerpeSelect™ HSV-2 serological test for HSV-2 diagnosis in a population of HIV positive patients.

Methods:As part of an ongoing study, sera from persons with HIV and no history of genital herpes were tested by ELISA for antibodies to HSV-2 (Focus Diagnostics HerpeSelect™ HSV-2 ELISA IgG).  The SureVue™ rapid HSV-2 test was used for confirmatory testing of all specimens yielding an index value above the recommended cut-off.

Results:To date, 71 HIV positive participants denying a history of genital herpes have been screened for antibodies to HSV-2.  Sixty-six percent (N = 47) of participants were positive by HerpeSelect™ HSV-2 ELISA.  The mean index value from positive sera was 12.05 (Range:  2.18 – 27.66).  Five specimens, positive by HerpeSelect™, yielded index values of ≤ 3.0.  The SureVue™ assay was positive in all but 3 (44 of 47) samples which were positive by HerpeSelect™.  All samples read as negative by SureVue™ had index values by HerpeSelect™ of <3.0.

Conclusions:HSV-2 seropositivity is common among HIV-infected patients attending our clinic who deny a history of ano-genital herpes.  In our population, few “low positive” results were observed using the HerpeSelect™ serological test.

Implications for Programs, Policy, and/or Research:More research is warranted to understand the affects of HIV/HSV coinfection.  Equivocal results defined as an index value of <3.0 by HerpeSelect™ are uncommon in this population but when present warrant confirmation using an alternative testing method.