title: Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries.
abstract: 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.
authors.affiliation: Department of Global Health, University of Washington, Seattle, Washington, USA. mujugira@uw.edu
authors.forename: Andrew
authors.initials: A
authors.lastname: Mujugira
authors.forename: Rhoda Ashley
authors.initials: RA
authors.lastname: Morrow
authors.forename: Connie
authors.initials: C
authors.lastname: Celum
authors.forename: Jairam
authors.initials: J
authors.lastname: Lingappa
authors.forename: Sinead
authors.initials: S
authors.lastname: Delany-Moretlwe
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Fife
authors.forename: Renee
authors.initials: R
authors.lastname: Heffron
authors.forename: Guy
authors.initials: G
authors.lastname: De Bruyn
authors.forename: Brigitte
authors.initials: B
authors.lastname: Homawoo
authors.forename: Etienne
authors.initials: E
authors.lastname: Karita
authors.forename: Nelly
authors.initials: N
authors.lastname: Mugo
authors.forename: Bellington
authors.initials: B
authors.lastname: Vwalika
authors.forename: Jared M
authors.initials: JM
authors.lastname: Baeten
mesh_terms: D000328:Adult; D017954:Africa South of the Sahara; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D015153:Blotting, Western; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000150:complications; D006558:Herpes Genitalis / Q000150:complications / Q000175:diagnosis*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods* / Q000592:standards; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral