title: Performance of commercial herpes simplex virus type-2 antibody tests using serum samples from Sub-Saharan Africa: a systematic review and meta-analysis.
abstract: 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.
authors: Medical Research Council/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe, Uganda. samuel.biraro@lshtm.ac.uk
authors: Samuel
authors: S
authors: Biraro
authors: Philippe
authors: P
authors: Mayaud
authors: Rhoda Ashley
authors: RA
authors: Morrow
authors: Heiner
authors: H
authors: Grosskurth
authors: Helen A
authors: HA
authors: Weiss
mesh_terms: D017954:Africa South of the Sahara / Q000453:epidemiology; D000914:Antibodies, Viral / Q000097:blood*; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005060:Europe / Q000453:epidemiology; D006558:Herpes Genitalis / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D014481:United States / Q000453:epidemiology
chemical_list: D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic