title: Comparative clinical evaluation of the IsoAmp(®) HSV Assay with ELVIS(®) HSV culture/ID/typing test system for the detection of herpes simplex virus in genital and oral lesions.
abstract: BACKGROUND
  The novel IsoAmp(®) HSV Assay employs isothermal helicase-dependent nucleic acid amplification and a user-friendly disposable test device to achieve rapid (<1.5h), on-demand qualitative detection of herpes simplex virus (HSV) types 1 and 2 in oral and genital lesions.
  
  
  OBJECTIVE
  To compare performance of the IsoAmp(®) HSV Assay with the ELVIS(®) HSV ID/typing (shell-vial culture and DFA) test system for clinical specimens collected from oral and genital lesions in symptomatic patients.
  
  
  METHODS
  A total of 994 specimens from male and female genital and oral lesions were obtained and evaluated at five study sites in the United States. Results from the IsoAmp(®) HSV Assay were compared to those from the ELVIS(®) system. Separate reproducibility studies were performed at 3 sites using a blinded and randomized study panel. Discrepant specimens were resolved by bidirectional sequencing analysis.
  
  
  RESULTS
  After discrepant analysis, overall agreement of IsoAmp(®) with ELVIS(®) was 98.8% with 37.0% overall prevalence (all study sites). Reproducibility rates were well within expectations.
  
  
  CONCLUSIONS
  The IsoAmp(®) HSV Assay showed excellent performance for clinical use for detection of HSV in genital and oral specimens. In contrast to ELVIS(®), IsoAmp(®) HSV offers excellent sensitivity plus rapid on-demand testing and simpler specimen preparation.
authors.affiliation: Boston Medical Center, Boston, MA 02118, United States. nancy.miller@bmc.org
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Miller
authors.forename: Belinda
authors.initials: B
authors.lastname: Yen-Lieberman
authors.forename: Melinda D
authors.initials: MD
authors.lastname: Poulter
authors.forename: Yi-Wei
authors.initials: YW
authors.lastname: Tang
authors.forename: Paul A
authors.initials: PA
authors.lastname: Granato
mesh_terms: D004265:DNA Helicases / Q000378:metabolism; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis* / Q000821:virology; D006561:Herpes Simplex / Q000175:diagnosis* / Q000821:virology; D018259:Herpesvirus 1, Human / Q000235:genetics* / Q000302:isolation & purification; D018258:Herpesvirus 2, Human / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D009059:Mouth Diseases / Q000175:diagnosis* / Q000821:virology; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D014776:Virus Cultivation / Q000379:methods
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic; D004265:DNA Helicases