Serologic herpes testing in the real world: validation of new type-specific serologic herpes simplex virus tests in a public health laboratory.
BACKGROUND
Serologic testing for herpes simplex virus type-2 (HSV-2) is being implemented in sexually transmitted disease (STD) clinics.


OBJECTIVE
To determine the performance characteristics of two HSV-2 type-specific serologic assays in a public health laboratory.


METHODS
Sera stored from a cross-sectional study were tested with the Meridian Diagnostics and Focus Technologies HSV-2 ELISA tests and a type-specific strip immunoblot assay (Chiron Corp.) was used as the reference standard.


RESULTS
Prevalence of HSV-2 infection in this sample was 44%. Compared to the reference standard, the sensitivity of the Meridian Diagnostics HSV-2 test was 95.5% (95% CI 83.3, 99.2) and specificity was 98.2% (95% CI 89.0, 99.9). The Focus Technologies test yielded 97.7% (95% CI 86.5, 99.9) sensitivity and 94.5% (95% CI 83.9, 98.6) specificity.


CONCLUSIONS
The performance of these HSV-2 type-specific serologic assays was adequate to support their use in high prevalence populations, such as STD clinic patients.
Turner
Katherine R
KR
San Francisco Department of Public Health, Sexually Transmitted Diseases Prevention and Control Services and Public Health Laboratory, San Francisco, California 94103, USA.
Wong
Ernest H
EH
Kent
Charlotte K
CK
Klausner
Jeffrey D
JD
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay; D006558:Herpes Genitalis / Q000175:diagnosis*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D015151:Immunoblotting; D007753:Laboratories; D011237:Predictive Value of Tests; D011634:Public Health; D011933:Reagent Kits, Diagnostic; D012495:San Francisco; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D013045:Species Specificity
D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic