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P190 Performance of HerpeSelect® ELISA for HSV-2 Screening in Patients Attending a U.S. Clinic for Persons with HIV

Wednesday, March 14, 2012
Hyatt Exhibit Hall
Nicholas Van Wagoner, MD, PhD1, Rhoda Morrow, PhD2, Jeannette Lee, PhD3, Paula Dixon1 and Edward W. Hook III, MD1, 1Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, 2Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, 3College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR

Background:  Experts suggest screening for HSV-2 in HIV-infected populations.  Optimal strategies for HSV-2 screening in the context of HIV are hampered by concerns about reduced accuracy of serologic HSV-2 assays.   

Objectives: To evaluate the performance of the HerpeSelect® HSV-2 ELISA compared to the Sure-Vue® Rapid HSV-2 test for HSV-2 screening in a population of HIV-infected patients attending a U.S. HIV clinic.

Methods:  Sera from HIV-infected volunteers were screened for HSV-2 using the Focus Diagnostics HerpeSelect® HSV-2 ELISA IgG and Sure-Vue® Rapid HSV-2 tests.  The distribution of index value by HerpeSelect® HSV-2 ELISA was determined.  Overall, negative, and positive test agreement between the HerpeSelect® HSV-2 ELISA and Sure-Vue® rapid HSV-2 test were calculated. 

Results:  HerpeSelect® index values fell into a bimodal distribution with the majority <0.9 or >3.5 and with only 7% of sera falling into a range of ≥0.9 to ≤3.5.  Overall test agreement between the HerpeSelect® HSV-2 assay and the Sure-Vue® HSV-2 rapid test was 96%.  Negative percent agreement was best at a HerpeSelect® index value <0.90 and positive percent agreement was best at a HerpeSelect® index value >3.0 (97% and 100%, respectively).  Discordant results between tests occurred in 4% of cases and the majority (9 of 14) occurred in a narrow range of HerpeSelect® index values (0.9 to 2.9).

Conclusions:  These data suggest appropriate performance of HerpeSelect® in a U.S. HIV-infected population with the expected distribution of index values.  Because of the high rate of test agreement between Sure-Vue® and HerpeSelect® at index values <0.9 and >3.0, confirmatory testing may not increase accuracy for most cases.

Implications for Programs, Policy, and Research:  In U.S. HIV-infected populations, HerpeSelect® ELISA remains a viable option of HSV-2 screening.

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