Serologic herpes testing in the real world: validation of new type-specific serologic herpes simplex virus tests in a public health laboratory

Sex Transm Dis. 2002 Jul;29(7):422-5. doi: 10.1097/00007435-200207000-00011.


Background: Serologic testing for herpes simplex virus type-2 (HSV-2) is being implemented in sexually transmitted disease (STD) clinics.

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

Study design: 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.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood*
  • Enzyme-Linked Immunosorbent Assay
  • Herpes Genitalis / diagnosis*
  • Herpesvirus 2, Human / immunology*
  • Humans
  • Immunoblotting
  • Laboratories*
  • Predictive Value of Tests
  • Public Health*
  • Reagent Kits, Diagnostic*
  • San Francisco
  • Sensitivity and Specificity
  • Serologic Tests
  • Species Specificity


  • Antibodies, Viral
  • Reagent Kits, Diagnostic