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

Tetsuo Ikezono, Tomohiro Matsumura, Han Matsuda, Satomi Shikaze, Shiho Saitoh, Susumu Shindo, Setsuo Hasegawa, Seung Ha Oh, Yoshiaki Hagiwara, Yasuo Ogawa, Hiroshi Ogawa, Hiroaki Sato, Tetsuya Tono, Ryuichiro Araki, Yukihide Maeda, Shin ichi Usami, Yasuhiro Kase

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article numbere0191498
JournalPLoS One
Volume13
Issue number1
DOIs
Publication statusPublished - Jan 1 2018

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Perilymph
fistula
Fistula
Enzyme-Linked Immunosorbent Assay
enzyme-linked immunosorbent assay
Blood
ears
Audition
Biomarkers
Middle Ear
testing
Dilution
Throughput
Tinnitus
Vertigo
Communication
blood
Testing
Dizziness
hearing

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

Ikezono, T., Matsumura, T., Matsuda, H., Shikaze, S., Saitoh, S., Shindo, S., ... Kase, Y. (2018). The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage. PLoS One, 13(1), [e0191498]. https://doi.org/10.1371/journal.pone.0191498

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.

In: PLoS One, Vol. 13, No. 1, e0191498, 01.01.2018.

Research output: Contribution to journalArticle

Ikezono, T, Matsumura, T, Matsuda, H, Shikaze, S, Saitoh, S, Shindo, S, Hasegawa, S, Oh, SH, Hagiwara, Y, Ogawa, Y, Ogawa, H, Sato, H, Tono, T, Araki, R, Maeda, Y, Usami, SI & Kase, Y 2018, 'The diagnostic performance of a novel ELISA for human CTP (Cochlin-tomoprotein) to detect perilymph leakage', PLoS One, vol. 13, no. 1, e0191498. https://doi.org/10.1371/journal.pone.0191498
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. In: PLoS One. 2018 ; Vol. 13, No. 1.
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