Performance of commercial herpes simplex virus type-2 antibody tests using serum samples from Sub-Saharan Africa: a systematic review and meta-analysis

Sex Transm Dis. 2011 Feb;38(2):140-7. doi: 10.1097/OLQ.0b013e3181f0bafb.


Background: Several commercial type-specific serologic tests are available for herpes simplex virus type 2 (HSV-2). Poor specificity of some tests has been reported on samples from sub-Saharan Africa.

Methods: To summarize the performance of the tests using samples from sub-Saharan Africa, we conducted a systematic review of publications reporting performance of commercially available HSV-2 tests against a gold standard (Western Blot or monoclonal antibody-blocking EIA). We used random-effects meta-analyses to summarize sensitivity and specificity of the 2 most commonly evaluated tests, Kalon gG2 enzyme-linked immunosorbent assay (ELISA), and Focus HerpeSelect HSV-2 ELISA.

Results: We identified 10 eligible articles that included 21 studies of the performance of Focus, and 12 of Kalon. The primary analyses included studies using the manufacturers' cut-offs (index value = 1.1). Focus had high sensitivity (random effects summary estimate 99%, 95% confidence interval [CI]: 99%-100%) but low specificity (69%, 95% CI: 59%-80%). Kalon had sensitivity of 95% (95% CI: 93%-97%) and specificity of 91% (95% CI: 86%-95%). Specificity of Focus was significantly lower (P = 0.002) among HIV-positive (54%, 95% CI: 40%-68%) than HIV-negative individuals (69%, 95% CI: 56%-82%). When the cut-off optical density index was increased above the recommended value of 1.1 to between 2.2 and 3.5, the specificity of Focus increased to 85% (95% CI: 77%-92%).

Conclusions: Sensitivity and specificity of HSV-2 tests used in sub-Saharan Africa vary by setting, and are lower than reported from studies in the United States and Europe. Increasing the cut-off optical density index may improve test performance. Evaluation of test performance in a given setting may help deciding which test is most appropriate.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Africa South of the Sahara / epidemiology
  • Antibodies, Viral / blood*
  • Blotting, Western
  • Enzyme-Linked Immunosorbent Assay
  • Europe / epidemiology
  • Herpes Genitalis / diagnosis*
  • Herpes Genitalis / epidemiology
  • Herpes Genitalis / virology
  • Herpesvirus 2, Human / immunology*
  • Humans
  • Immunoenzyme Techniques
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Serologic Tests
  • United States / epidemiology


  • Antibodies, Viral
  • Reagent Kits, Diagnostic