Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries

Sex Transm Infect. 2011 Apr;87(3):238-41. doi: 10.1136/sti.2010.047415. Epub 2011 Feb 9.


Objective: To compare the performance of the Focus HerpeSelect-2 enzyme immunoassay (EIA) with the gold standard herpes simplex virus (HSV) type 2 western blot, among HIV-1-uninfected men and women in east and southern Africa.

Methods: 3399 HIV-1-uninfected women and men from seven countries in east and southern Africa were tested for HSV-2 antibody using the Focus HerpeSelect-2 EIA. The performance of the HerpesSelect-2 EIA was compared with the gold standard HSV-2-specific western blot.

Results: Two-thirds (2294/3399) of participants were male and two-thirds (2242/3399) were from east Africa. By western blot testing, HSV-2 prevalence was 68%; 59% in men and 85% in women. At the manufacturer's recommended cut-off value of greater than 1.1, the HerpeSelect-2 EIA had a sensitivity of 98.3% and specificity of 80.3%. Receiver operating characteristic plot analysis indicated that the optimum cut-off was 2.1 or greater, with sensitivity 93.9% and specificity 90.5%. Diagnostic accuracy was modestly higher for southern Africa (area under the curve (AUC) 0.979, 95% CI 0.970 to 0.988) compared with east Africa (AUC 0.954, 95% CI 0.942 to 0.965; p<0.001 for southern vs east Africa).

Conclusions: The Focus HerpeSelect-2 EIA has acceptable diagnostic accuracy for the determination of HSV-2 serostatus in African HIV-1-uninfected adults. An assay cut-off value of 2.1 or greater results in approximately 90% sensitivity and specificity, against a gold standard HSV-2 western blot. Diagnostic accuracy differed slightly by geographical region.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Africa South of the Sahara
  • Aged
  • Antibodies, Viral / blood*
  • Blotting, Western
  • Feasibility Studies
  • Female
  • HIV Infections / complications
  • Herpes Genitalis / complications
  • Herpes Genitalis / diagnosis*
  • Herpesvirus 2, Human / immunology*
  • Humans
  • Immunoenzyme Techniques / methods*
  • Immunoenzyme Techniques / standards
  • Male
  • Middle Aged
  • Sensitivity and Specificity
  • Young Adult


  • Antibodies, Viral