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Multicentre clinical study of the herpes simplex virus immunochromatographic assay kit for the diagnosis of herpetic epithelial keratitis
  1. Yoshitsugu Inoue1,
  2. Yoshikazu Shimomura2,
  3. Masahiko Fukuda2,
  4. Dai Miyazaki1,
  5. Yuichi Ohashi3,
  6. Hiroshi Sasaki4,
  7. Yoshitsugu Tagawa5,
  8. Hiroshi Shiota6,
  9. Noriko Inada7,
  10. Shigeki Okamoto8,
  11. Kaoru Araki-Sasaki9,
  12. Tairo Kimura10,
  13. Hiroshi Hatano11,
  14. Hisashi Nakagawa12,
  15. Satoshi Nakamura13,
  16. Atsuko Hirahara14,
  17. Kazumi Tanaka15,
  18. Hirofumi Sakuma16
  1. 1Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University, Yonago, Tottori, Japan
  2. 2Department of Ophthalmology, Faculty of Medicine, Kinki University, Osaka-Sayama, Osaka, Japan
  3. 3Department of Ophthalmology and Regenerative Medicine, Ehime University Graduate School of Medicine, Shitsukawa, Ehime, Japan
  4. 4Department of Ophthalmology, Kanazawa Medical University, Uchinada, Ishikawa, Japan
  5. 5Department of Ophthalmology, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan
  6. 6Department of Ophthalmology, Institute of Health Biosciences, The University of Tokushima Graduate School, Tokushima, Japan
  7. 7Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine, Tokyo, Japan
  8. 8Okamoto Eye Clinic, Matsuyama, Ehime, Japan
  9. 9Ideta Eye Hospital, Kumamoto, Japan
  10. 10Ueno Eye Clinic, Tokyo, Japan
  11. 11Hatano Eye Clinic, Fujisawa, Kanagawa, Japan
  12. 12Tokushima Eye Clinic, Tokyo, Japan
  13. 13Yoshinocho Eye Clinic, Yokohama, Kanagawa, Japan
  14. 14Hirahara Eye Clinic, Odawara, Kanagawa, Japan
  15. 15Nagatsuta Eye Clinic, Yokohama, Kanagawa, Japan
  16. 16Totsuka Hiro Eye Clinic, Yokohama, Kanagawa, Japan
  1. Correspondence to Dr Yoshitsugu Inoue, Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University, 36-1 Nishi-cho, Yonago Tottori 683-8504, Japan; yoinoue{at}grape.med.tottori-u.ac.jp

Abstract

Background/aims 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.

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