Performance of focus ELISA tests for herpes simplex virus type 1 (HSV-1) and HSV-2 antibodies among women in ten diverse geographical locations

Clin Microbiol Infect. 2004 Jun;10(6):530-6. doi: 10.1111/j.1469-0691.2004.00836.x.


To determine the sensitivity and specificity of Focus HerpeSelect ELISAs, sera or plasma samples from women aged 18-55 years were collected in ten cities from eight countries and tested by HerpeSelect HSV-1 ELISA (Focus-HSV-1) and by HerpeSelect HSV-2 ELISA (Focus-HSV-2). Sera with Focus-HSV-2-positive results were retested; 94% of the 3617 samples retested were positive. A subset of sera from each site was then selected, based on the HSV-2 results, and tested by Western blot (WB). The sensitivity and specificity were determined with samples from ten sites (n = 967) for Focus-HSV-1 and from seven sites (n = 675) for Focus-HSV-2. Focus-HSV-1 and WB results were concordant (both negative or both positive) for 97% of samples, with 99% sensitivity and 77% specificity. Specimens from Songkla, Thailand had 84% concordance with WB results for HSV-1, while three other sites had 100% concordance. Concordance of Focus-HSV-2 and WB was 92%, with 97% sensitivity and 89% specificity. Ibadan, Nigeria had 78% concordance. Focus-HSV-2 sensitivity and specificity in sites other than Ibadan were 97% and 93%, respectively. Raising the positive cut-off index value for HSV-2 from 1.1 to 3.5 yielded a sensitivity of 90% and a specificity of 96%. A sensitivity of 90% and a specificity of 98% were achieved for sites other than Nigeria with the higher cut-off. In summary, the sensitivity and specificity of the Focus-HSV-1 and Focus-HSV-2 tests varied by site. Performance data generated in one area may not be applicable to other populations.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood*
  • Blotting, Western
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Herpes Genitalis / diagnosis
  • Herpes Genitalis / epidemiology
  • Herpes Simplex / diagnosis
  • Herpes Simplex / epidemiology
  • Herpesvirus 1, Human / immunology*
  • Herpesvirus 2, Human / immunology*
  • Humans
  • Internationality
  • Middle Aged
  • Reagent Kits, Diagnostic*
  • Reproducibility of Results
  • Sensitivity and Specificity


  • Antibodies, Viral
  • Reagent Kits, Diagnostic