title: Premarket evaluation of the POCkit HSV-2 type-specific serologic test in culture-documented cases of genital herpes simplex virus type 2 [see comment].
abstract: OBJECTIVE
  The genital herpes epidemic continues, in part, because patients with subclinical or atypical presentations cannot be identified by most herpes simplex virus (HSV) antibody tests. A new product, POCkit HSV-2, has been developed to rapidly and accurately detect antibodies to HSV type 2 (HSV-2) in capillary blood or serum.
  
  
  OBJECTIVE
  Sera from patients with culture-documented genital or oral herpes were tested to determine the sensitivity and specificity of the POCkit HSV-2 rapid point-of-care antibody test (Diagnology, Belfast, Northern Ireland).
  
  
  METHODS
  Sera from 50 patients with culture-documented HSV type 1 (9 oral, 41 genital) and from 253 patients with genital HSV-2 were tested by POCkit HSV-2 for HSV-2 antibodies. Each subject had a positive culture for HSV within 6 months of serum collection. Sera were preselected to include only those that were seropositive to the respective virus subtype by University of Washington Western blot.
  
  
  RESULTS
  Compared with viral culture and Western blot analysis, sensitivity of the POCkit HSV-2 test for HSV-2 antibody was 96%; specificity was 98%.
  
  
  CONCLUSIONS
  This test provides rapid, accurate identification of HSV-2 antibody in subjects with established HSV infections.
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Ashley
authors.forename: A
authors.initials: A
authors.lastname: Wald
authors.forename: M
authors.initials: M
authors.lastname: Eagleton
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis* / Q000821:virology; D018259:Herpesvirus 1, Human / Q000254:growth & development / Q000302:isolation & purification; D018258:Herpesvirus 2, Human / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014776:Virus Cultivation
chemical_list: D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic