title: Multicentre clinical study of the herpes simplex virus immunochromatographic assay kit for the diagnosis of herpetic epithelial keratitis.
abstract: OBJECTIVE
  The novel immunochromatographic assay (ICGA) kit was recently developed to diagnose herpes simplex virus (HSV) infection. This multicentre study aimed to evaluate the value of the ICGA kit for the diagnosis of herpetic epithelial keratitis by comparing it with immunofluorescence assay (IFA) and real-time PCR.
  
  
  METHODS
  Corneal scrapings were collected from 117 patients, including 77 with herpetic keratitis as their final clinical diagnosis as well as 40 others at 21 facilities. These samples were tested by the ICGA kit, IFA and real-time PCR.
  
  
  RESULTS
  The positive concordance between final clinical diagnosis and ICGA was 46.7% (35/75 cases) and the negative concordance was 100% (39/39). The positive and negative concordance between real-time PCR and ICGA were 57.4% (35/61 cases) and 100% (53/53), respectively. The positive and negative concordance between IFA and ICGA were 61.1% (22/36 cases) and 83.3% (55/66), respectively. In 92 cases where anti-HSV drugs were not prescribed prior to corneal scraping, the positive and negative concordance between final clinical diagnosis and ICGA were 55.0% (33/60 cases) and 100% (32/32), respectively.
  
  
  CONCLUSIONS
  The ICGA kit has moderate sensitivity and high specificity, indicating clinical utility in the diagnosis of herpetic epithelial keratitis.
authors.affiliation: Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University, Yonago, Japan. yoinoue@grape.med.tottori-u.ac.jp
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Inoue
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Shimomura
authors.forename: Masahiko
authors.initials: M
authors.lastname: Fukuda
authors.forename: Dai
authors.initials: D
authors.lastname: Miyazaki
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sasaki
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Tagawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Shiota
authors.forename: Noriko
authors.initials: N
authors.lastname: Inada
authors.forename: Shigeki
authors.initials: S
authors.lastname: Okamoto
authors.forename: Kaoru
authors.initials: K
authors.lastname: Araki-Sasaki
authors.forename: Tairo
authors.initials: T
authors.lastname: Kimura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hatano
authors.forename: Hisashi
authors.initials: H
authors.lastname: Nakagawa
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nakamura
authors.forename: Atsuko
authors.initials: A
authors.lastname: Hirahara
authors.forename: Kazumi
authors.initials: K
authors.lastname: Tanaka
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Sakuma
mesh_terms: D000368:Aged; D002846:Chromatography, Affinity / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D016849:Keratitis, Herpetic / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D018139:Simplexvirus / Q000302:isolation & purification*
chemical_list: D011933:Reagent Kits, Diagnostic