title: A nationwide multicenter study of the Cochlin tomo-protein detection test: clinical characteristics of perilymphatic fistula cases.
abstract: OBJECTIVE
  To investigate the positive rate for the Cochlin tomo-protein (CTP: an inner ear-specific protein) detection test among patients with inner ear-related clinical manifestations and evaluate the clinical characteristics of definite perilymphatic fistula (PLF).
  
  
  METHODS
  We have performed an ELISA-based CTP detection test using middle ear lavage (MEL) samples from 497 cases of suspected PLF enrolled from 70 clinical centers nationwide between 2014 and 2015. In addition to the CTP-positive rate, audio-vestibular symptoms were compared between CTP-positive and -negative cases.
  
  
  RESULTS
  8-50% of patients in category 1 (trauma, middle and inner ear disease cases), and about 20% of those in categories 2, 3 and 4 (external origin antecedent events, internal origin antecedent events, and without antecedent event, respectively) were positive for CTP. In category 1 cases, the earlier tested samples showed a higher CTP-positive rate, whereas no differences were observed in categories 2, 3 or 4. The characteristic clinical features in the earlier tested cases were nystagmus and fistula sign in CTP test-positive cases in category 1, and streaming water-like tinnitus in those in categories 2, 3 and 4.
  
  
  CONCLUSIONS
  The present study clarified that CTP detection test-positive patients exist at considerable rates among patients with inner ear-related manifestations.
authors.affiliation: a Department of Otorhinolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Han
authors.initials: H
authors.lastname: Matsuda
authors.affiliation: a Department of Otorhinolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Sakamoto
authors.affiliation: b Department of Biochemistry and Molecular Biology , Nippon Medical School , Tokyo , Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Matsumura
authors.affiliation: b Department of Biochemistry and Molecular Biology , Nippon Medical School , Tokyo , Japan.
authors.forename: Shiho
authors.initials: S
authors.lastname: Saito
authors.affiliation: a Department of Otorhinolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Shindo
authors.affiliation: c Shin Kurashiki ENT Clinic , Okayama , Japan.
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Fukushima
authors.affiliation: d Department of Otorhinolaryngology , Shinshu University School of Medicine , Matsumoto , Japan.
authors.forename: Shin-Ya
authors.initials: SY
authors.lastname: Nishio
authors.affiliation: d Department of Otorhinolaryngology , Shinshu University School of Medicine , Matsumoto , Japan.
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Kitoh
authors.affiliation: e Division of Neuro-Otology, Department of Otolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Shibasaki
authors.affiliation: e Division of Neuro-Otology, Department of Otolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Akinori
authors.initials: A
authors.lastname: Ito
authors.affiliation: f Community Health Science Center, Saitama Medical University , Moroyama , Japan.
authors.forename: Ryuichiro
authors.initials: R
authors.lastname: Araki
authors.affiliation: d Department of Otorhinolaryngology , Shinshu University School of Medicine , Matsumoto , Japan.
authors.forename: Shin-Ichi
authors.initials: SI
authors.lastname: Usami
authors.affiliation: g Department of Otolaryngology , Tokyo Medical University , Tokyo , Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Suzuki
authors.affiliation: h Department of Otorhinolaryngology Head and Neck Surgery , Keio University School of Medicine , Tokyo , Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Ogawa
authors.affiliation: i SRL, Inc. , Tokyo , Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hasegawa
authors.affiliation: j IBL Co., Ltd. (Immuno-Biological Laboratories, Co., Ltd.) , Fujioka , Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Hagiwara
authors.affiliation: a Department of Otorhinolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kase
authors.affiliation: a Department of Otorhinolaryngology , Saitama Medical University , Moroyama , Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Ikezono
mesh_terms: D004427:Ear Diseases / Q000175:diagnosis*; D016326:Extracellular Matrix Proteins / Q000032:analysis*; D005260:Female; D005402:Fistula / Q000175:diagnosis*; D006801:Humans; D008297:Male
chemical_list: C110668:COCH protein, human; D016326:Extracellular Matrix Proteins
keywords: Cochlin isoform; ELISA; Perilymphatic fistula; biomarker; hearing loss; perilymph; tinnitus; vertigo; vestibular symptom