title: Comparative performance of the Uni-Gold™ HSV-2 Rapid: a point-of-care HSV-2 diagnostic test in unselected sera from a reference laboratory.
abstract: BACKGROUND
  HSV-2 diagnosis is typically by viral culture, viral DNA amplification of lesion material or by serology in cases of subclinical presentation. These methods can be time consuming and expensive. The Uni-Gold™ HSV-2 Rapid is a fast, point-of-care diagnostic test that can be performed outside a full service laboratory.
  
  
  OBJECTIVE
  To evaluate the ability of the Uni-Gold™ HSV-2 Rapid to correctly diagnose the presence or absence of anti-HSV-2 antibodies in patient serum samples in comparison to the University of Washington HSV Western blot (UWWB).
  
  
  METHODS
  Sera from 100 adult patients in the USA were tested for HSV-2 specific antibodies by Uni-Gold™ HSV-2 Rapid and results were compared to those of the UWWB to determine the test's sensitivity and specificity.
  
  
  RESULTS
  Of 18 patients seropositive for HSV-2 by UWWB, 17 were correctly identified as such by the Uni-Gold™ HSV-2 Rapid. Of 76 patients who were seronegative for HSV-2 by UWWB, 75 were correctly identified by the rapid test. Six sera had indeterminate results by UWWB. Sensitivity for the Uni-Gold™ HSV-2 Rapid was 94% and specificity was 99%.
  
  
  CONCLUSIONS
  The Uni-Gold™ HSV-2 Rapid had high sensitivity and specificity in a small sample of unselected, adults seeking care in the Seattle, USA area. An accurate, near-person test allows immediate counseling directed toward symptom recognition, treatment, and practices that can limit the risk of HSV-2 transmission.
authors.affiliation: Institute of Immunology, Department of Biology, National University of Ireland Maynooth, Maynooth, Co. Kildare, Ireland.
authors.forename: Enda
authors.initials: E
authors.lastname: Shevlin
authors.affiliation: Department of Laboratory Medicine, University of Washington, Seattle, WA, USA; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: rmorrow@fhcrc.org.
authors.forename: Rhoda Ashley
authors.initials: RA
authors.lastname: Morrow
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D008297:Male; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D014861:Washington
chemical_list: D000914:Antibodies, Viral
keywords: HSV serology; Herpes simplex virus; Uni-Gold™ Rapid