{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T18:30:23Z","timestamp":1784140223093,"version":"3.55.0"},"reference-count":22,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2025,1,27]],"date-time":"2025-01-27T00:00:00Z","timestamp":1737936000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune-related neurological disease that primarily affects the optic nerve and spinal cord. According to current international consensus guidelines for NMOSD, confirming the presence of aquaporin-4 immunoglobulin G antibody (AQP4-IgG) is one of the most important diagnostic criteria because AQP4-IgG is a significant diagnostic biomarker of NMOSD. Several assays are currently available for detecting AQP4-IgG, including cell-based assays (CBAs) and enzyme-linked immunosorbent assays (ELISAs). However, each assay has certain disadvantages, including insufficient sensitivity and specificity, the need for sophisticated techniques, and semi-quantitative results. Methods: We developed a fully automated chemiluminescent enzyme immunoassay (CLEIA) to detect AQP4-IgG (AQP4-CLEIA). This assay utilizes the recombinant antigen purified from the newly generated AQP4-M23 stably expressing Chinese hamster ovary cell line and an anti-AQP4 monoclonal antibody as a calibrator. Results: In analytical performance studies, the assay demonstrates good precision and linearity over the entire measurement range. Moreover, this assay showed no high-dose hook effect and interference from endogenous substances. In clinical validation studies, patients with AQP4-IgG positive NMOSD, multiple sclerosis, or myelin oligodendrocyte glycoprotein antibody-associated disorder and healthy individuals were tested. A cutoff value of 10.0 U\/mL was determined by receiver operating characteristic curves based on the results of a microscopic live CBA. The sensitivity and specificity for AQP4-IgG-positive NMOSD were 97.0% and 100.0%, respectively, at the cutoff value. Conclusions: The results suggest that AQP4-CLEIA is a convenient automated method for measuring AQP4-IgG titers in hospitals and clinical laboratories, offering an effective alternative to the gold-standard CBA.<\/jats:p>","DOI":"10.3390\/diagnostics15030298","type":"journal-article","created":{"date-parts":[[2025,1,27]],"date-time":"2025-01-27T09:42:23Z","timestamp":1737970943000},"page":"298","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Novel Automated Chemiluminescent Immunoassay for the Detection of Autoantibodies Against Aquaporin-4 in Neuromyelitis Optica Spectrum Disorders"],"prefix":"10.3390","volume":"15","author":[{"given":"Nozomi","family":"Yamazaki","sequence":"first","affiliation":[{"name":"Medical & Biological Laboratories Co., Ltd., Tokyo 105-0012, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tohoku University Graduate School of Medicine, Sendai 980-8574, Japan"},{"name":"Department of Neurology, National Hospital Organization Yonezawa National Hospital, Yonezawa 992-1202, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuro","family":"Misu","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tohoku University Graduate School of Medicine, Sendai 980-8574, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihiro","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Medical & Biological Laboratories Co., Ltd., Tokyo 105-0012, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1212\/WNL.0000000000001729","article-title":"International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorders","volume":"85","author":"Wingerchuk","year":"2015","journal-title":"Neurology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1212\/WNL.0000000000011153","article-title":"Worldwide Incidence and Prevalence of Neuromyelitis Optica: A Systematic Review","volume":"96","author":"Papp","year":"2021","journal-title":"Neurology"},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Hor, J.Y., Asgari, N., Nakashima, I., Broadley, S.A., Leite, M.I., Kissani, N., Jacob, A., Marignier, R., Weinshenker, B.G., and Paul, F. 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