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

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 cogn...

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Autores principales: Ikezono, Tetsuo, Matsumura, Tomohiro, Matsuda, Han, Shikaze, Satomi, Saitoh, Shiho, Shindo, Susumu, Hasegawa, Setsuo, Oh, Seung Ha, Hagiwara, Yoshiaki, Ogawa, Yasuo, Ogawa, Hiroshi, Sato, Hiroaki, Tono, Tetsuya, Araki, Ryuichiro, Maeda, Yukihide, Usami, Shin-ichi, Kase, Yasuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788340/
https://www.ncbi.nlm.nih.gov/pubmed/29377910
http://dx.doi.org/10.1371/journal.pone.0191498
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author Ikezono, Tetsuo
Matsumura, Tomohiro
Matsuda, Han
Shikaze, Satomi
Saitoh, Shiho
Shindo, Susumu
Hasegawa, Setsuo
Oh, Seung Ha
Hagiwara, Yoshiaki
Ogawa, Yasuo
Ogawa, Hiroshi
Sato, Hiroaki
Tono, Tetsuya
Araki, Ryuichiro
Maeda, Yukihide
Usami, Shin-ichi
Kase, Yasuhiro
author_facet Ikezono, Tetsuo
Matsumura, Tomohiro
Matsuda, Han
Shikaze, Satomi
Saitoh, Shiho
Shindo, Susumu
Hasegawa, Setsuo
Oh, Seung Ha
Hagiwara, Yoshiaki
Ogawa, Yasuo
Ogawa, Hiroshi
Sato, Hiroaki
Tono, Tetsuya
Araki, Ryuichiro
Maeda, Yukihide
Usami, Shin-ichi
Kase, Yasuhiro
author_sort Ikezono, Tetsuo
collection PubMed
description 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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spelling pubmed-57883402018-02-09 The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage Ikezono, Tetsuo Matsumura, Tomohiro Matsuda, Han Shikaze, Satomi Saitoh, Shiho Shindo, Susumu Hasegawa, Setsuo Oh, Seung Ha Hagiwara, Yoshiaki Ogawa, Yasuo Ogawa, Hiroshi Sato, Hiroaki Tono, Tetsuya Araki, Ryuichiro Maeda, Yukihide Usami, Shin-ichi Kase, Yasuhiro PLoS One Research Article 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. Public Library of Science 2018-01-29 /pmc/articles/PMC5788340/ /pubmed/29377910 http://dx.doi.org/10.1371/journal.pone.0191498 Text en © 2018 Ikezono et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Ikezono, Tetsuo
Matsumura, Tomohiro
Matsuda, Han
Shikaze, Satomi
Saitoh, Shiho
Shindo, Susumu
Hasegawa, Setsuo
Oh, Seung Ha
Hagiwara, Yoshiaki
Ogawa, Yasuo
Ogawa, Hiroshi
Sato, Hiroaki
Tono, Tetsuya
Araki, Ryuichiro
Maeda, Yukihide
Usami, Shin-ichi
Kase, Yasuhiro
The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage
title The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage
title_full The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage
title_fullStr The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage
title_full_unstemmed The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage
title_short The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage
title_sort diagnostic performance of a novel elisa for human ctp (cochlin-tomoprotein) to detect perilymph leakage
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788340/
https://www.ncbi.nlm.nih.gov/pubmed/29377910
http://dx.doi.org/10.1371/journal.pone.0191498
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