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PLoS One. 2018 Jan 29;13(1):e0191498. doi: 10.1371/journal.pone.0191498. eCollection 2018.

The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage.

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Department of Otorhinolaryngology, Saitama Medical University, Saitama, Japan.
Department of Biochemistry and Molecular Biology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.
R&D and Business Development Segment, Mitsubishi Chemical Medience Corporation, Tokyo, Japan.
Sekino Clinical Pharmacology Clinic, Hoeikai Med.Corp., Tokyo, Japan.
Department of Otorhinolaryngology, Seoul National University Hospital, Seoul, Korea.
IBL Co., Ltd. (Immuno-Biological Laboratories Co., Ltd.), Fujioka-shi, Gunma, Japan.
Department of Otolaryngology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.
Department of Otorhinolaryngology, Fukushima Medical University Medical Center, Aizuwakamatsu, Japan.
Department of Otolaryngology-Head and Neck Surgery, Iwate Medical University, Morioka, Japan.
Department of Otolaryngology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Community Health Science Center, Saitama Medical University, Saitama, Japan.
Department of Otolaryngology-Head and Neck Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.


Perilymphatic fistula is defined as an abnormal communication between the perilymph-filled space and the middle ear, or cranial spaces. The manifestations include a broad spectrum of neuro-otological symptoms such as hearing loss, vertigo/dizziness, disequilibrium, aural fullness, tinnitus, and cognitive dysfunction. By sealing the fistula, perilymphatic fistula is a surgically correctable disease. Also, appropriate recognition and treatment of perilymphatic fistula can improve a patient's condition and hence the quality of life. However, the difficulty in making a definitive diagnosis due to the lack of an appropriate biomarker to detect perilymph leakage has caused a long-standing debate regarding its management. We have reported a clinical test for the diagnosis of perilymphatic fistula by detecting a perilymph specific protein, Cochlin-tomoprotein, as a diagnostic marker using a western blot. The aim of this study is to establish an ELISA-based human Cochlin-tomoprotein detection test and to evaluate its diagnostic accuracy in clinical subjects. The results of ELISA showed good dilution reproducibility. The mean concentration was 49.7±9.4 of 10 perilymph samples. The ROC curve in differentiating the perilymph leakage condition from the normal middle ear was significant (P < 0.001) with an area under the curve (AUC) of 0.918 (95% CI 0.824-0.100). We defined the diagnostic criteria as follows: CTP<0.4 negative; 0.4≦CTP<0.8 intermediate; 0.8≦CTP(ng/ml) positive in the clinical usage of the hCTP ELISA, and sensitivity and specificity were 86.4% and 100%, respectively. We further tested the expression specificity of the Cochlin-tomoprotein by testing blood and CSF samples. The concentration was below the detection limit (0.2 ng/ml) in 38 of the 40 blood, and 14 of the 19 CSF samples. We report the accuracy of this test for the diagnosis of perilymphatic fistula. Using ELISA, we can improve the throughput of the test. Furthermore, it is useful for a large-scale study to characterize the clinical picture and delineate the management of this medical condition.

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