title: Performance of focus ELISA tests for herpes simplex virus type 1 (HSV-1) and HSV-2 antibodies among women in ten diverse geographical locations.
abstract: 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.
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, Washington 98105, USA. rhoda.morrow@seattlechildrens.org
authors.forename: R
authors.initials: R
authors.lastname: Ashley-Morrow
authors.forename: J
authors.initials: J
authors.lastname: Nollkamper
authors.forename: N J
authors.initials: NJ
authors.lastname: Robinson
authors.forename: N
authors.initials: N
authors.lastname: Bishop
authors.forename: J
authors.initials: J
authors.lastname: Smith
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis / Q000453:epidemiology; D006561:Herpes Simplex / Q000175:diagnosis / Q000453:epidemiology; D018259:Herpesvirus 1, Human / Q000276:immunology*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D038622:Internationality; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic