{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T21:12:08Z","timestamp":1782940328823,"version":"3.54.5"},"reference-count":26,"publisher":"MDPI AG","issue":"22","license":[{"start":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T00:00:00Z","timestamp":1731283200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"FUJIREBIO Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background: Glial fibrillary acidic protein (GFAP) is an important biomarker for neuroinflammatory conditions. Recently, advancements in the treatment of neurological diseases have highlighted the increasing importance of biomarkers, creating a demand for accurate and simple measurement systems for GFAP levels, which are essential for both research and clinical applications. This study presents the development and validation of a novel fully automated immunoassay for the quantitative determination of GFAP levels in biological samples. Methods: We examined the analytical performance of the GFAP assay on the LUMIPULSE platform. The assay\u2019s parameters, including antibody concentrations, incubation times, and detection methods, were optimized to enhance sensitivity and specificity. GFAP levels were measured in 396 serum or plasma samples, comprising both healthy controls and patients with neurodegenerative diseases. Results: In the analytical performance studies, intra- and inter-assay coefficients of variation (CV) were below 5%, indicating high reproducibility. Additionally, the assay demonstrated good linearity over the measurement range. The limit of quantification (LoQ) for this assay was 6.0 pg\/mL, which is sufficient for measuring specimens from healthy controls. In clinical validation studies, GFAP levels were significantly elevated in patients with neurodegenerative diseases compared to healthy controls. Conclusions: This automated GFAP assay provides a robust and reliable tool for GFAP measurement, facilitating further research into GFAP\u2019s role in neurological disorders and potentially aiding in the diagnosis and monitoring of these conditions.<\/jats:p>","DOI":"10.3390\/diagnostics14222520","type":"journal-article","created":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T08:46:54Z","timestamp":1731314814000},"page":"2520","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Glial Fibrillary Acidic Protein\u2019s Usefulness as an Astrocyte Biomarker Using the Fully Automated LUMIPULSE\u00ae System"],"prefix":"10.3390","volume":"14","author":[{"given":"Jo","family":"Kamada","sequence":"first","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Hamanaka","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aya","family":"Oshimo","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideo","family":"Sato","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomonori","family":"Nishii","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marika","family":"Fujita","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiharu","family":"Makiguchi","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Tanaka","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsumi","family":"Aoyagi","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8907-5767","authenticated-orcid":false,"given":"Hisashi","family":"Nojima","sequence":"additional","affiliation":[{"name":"FUJIREBIO Inc., 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,11,11]]},"reference":[{"key":"ref_1","unstructured":"Bear, M.F., Connors, B.W., and Paradiso, M.A. (2020). Neuroscience: Exploring the Brain, Jones & Bartlett Learning. [4th ed.]."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1126\/science.aat0473","article-title":"Glia as architects of central nervous system formation and function","volume":"362","author":"Allen","year":"2018","journal-title":"Science"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1439","DOI":"10.1023\/A:1007677003387","article-title":"Glial fibrillary acidic protein: GFAP-thirty-one years (1969\u20132000)","volume":"25","author":"Eng","year":"2000","journal-title":"Neurochem. Res."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1038\/s41582-021-00616-3","article-title":"Blood GFAP as an emerging biomarker in brain and spinal cord disorders","volume":"18","author":"Abdelhak","year":"2022","journal-title":"Nat. Rev. Neurol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2398212818817495","DOI":"10.1177\/2398212818817495","article-title":"Neuroglia: Realising their true potential","volume":"2","author":"Butt","year":"2018","journal-title":"Brain Neurosci. Adv."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Escalada, P., Ezkurdia, A., Ramirez, M.J., and Solas, M. (2024). Essential Role of Astrocytes in Learning and Memory. Int. J. Mol. Sci., 25.","DOI":"10.3390\/ijms25031899"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"782","DOI":"10.1016\/S1474-4422(18)30231-X","article-title":"Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): A multicentre observational study","volume":"17","author":"Bazarian","year":"2018","journal-title":"Lancet Neurol."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Abdelhak, A., Hottenrott, T., Morenas-Rodr\u00edguez, E., Su\u00e1rez-Calvet, M., Zettl, U.K., Haass, C., Meuth, S.G., Rauer, S., Otto, M., and Tumani, H. (2019). Glial Activation Markers in CSF and Serum from Patients With Primary Progressive Multiple Sclerosis: Potential of Serum GFAP as Disease Severity Marker?. Front. Neurol., 10.","DOI":"10.3389\/fneur.2019.00280"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1001\/jamaneurol.2016.0039","article-title":"Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients with and Without Mild Traumatic Brain Injury","volume":"73","author":"Papa","year":"2016","journal-title":"JAMA Neurol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1016\/S1474-4422(21)00361-6","article-title":"Blood-based biomarkers for Alzheimer\u2019s disease: Towards clinical implementation","volume":"21","author":"Teunissen","year":"2022","journal-title":"Lancet Neurol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1016\/j.jim.2004.01.015","article-title":"An ELISA for glial fibrillary acidic protein","volume":"287","author":"Petzold","year":"2004","journal-title":"J. Immunol. Methods"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"118","DOI":"10.1186\/s13195-020-00682-7","article-title":"Combination of plasma amyloid beta(1-42\/1-40) and glial fibrillary acidic protein strongly associates with cerebral amyloid pathology","volume":"12","author":"Verberk","year":"2020","journal-title":"Alzheimer\u2019s Res. Ther."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1016\/S1474-4422(22)00256-3","article-title":"Prognostic value of day-of-injury plasma GFAP and UCH-L1 concentrations for predicting functional recovery after traumatic brain injury in patients from the US TRACK-TBI cohort: An observational cohort study","volume":"21","author":"Korley","year":"2022","journal-title":"Lancet Neurol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1898","DOI":"10.1002\/acn3.51681","article-title":"Clinical utility of cerebrospinal fluid biomarkers measured by LUMIPULSE((R)) system","volume":"9","author":"Nojima","year":"2022","journal-title":"Ann. Clin. Transl. Neurol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1592","DOI":"10.1093\/brain\/awac333","article-title":"Head-to-head comparison of 10 plasma phospho-tau assays in prodromal Alzheimer\u2019s disease","volume":"146","author":"Janelidze","year":"2023","journal-title":"Brain"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"e53","DOI":"10.1515\/cclm-2022-0770","article-title":"Pre-analytical variability of the Lumipulse immunoassay for plasma biomarkers of Alzheimer\u2019s disease","volume":"61","author":"Musso","year":"2023","journal-title":"Clin. Chem. Lab. Med."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"238","DOI":"10.37349\/en.2023.00024","article-title":"Estimation of the allelic status of apolipoprotein E4 isoforms with fully automated LUMIPULSE\u00ae assays","volume":"2","author":"Yuri","year":"2023","journal-title":"Explor. Neurosci."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1002\/1098-2825(20001212)14:6<260::AID-JCLA2>3.0.CO;2-I","article-title":"Sandwich ELISA for the measurement of Apo-E4 levels in serum and the estimation of the allelic status of Apo-E4 isoforms","volume":"14","author":"Uchida","year":"2000","journal-title":"J. Clin. Lab. Anal."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1089\/neur.2020.0037","article-title":"Comparison of GFAP and UCH-L1 Measurements from Two Prototype Assays: The Abbott i-STAT and ARCHITECT Assays","volume":"2","author":"Korley","year":"2021","journal-title":"Neurotrauma Rep."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"236","DOI":"10.1016\/j.clinbiochem.2008.09.098","article-title":"Traceability as a unique tool to improve standardization in laboratory medicine","volume":"42","author":"Panteghini","year":"2009","journal-title":"Clin. Biochem."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1471","DOI":"10.1001\/jamaneurol.2021.3671","article-title":"Differences Between Plasma and Cerebrospinal Fluid Glial Fibrillary Acidic Protein Levels Across the Alzheimer Disease Continuum","volume":"78","author":"Benedet","year":"2021","journal-title":"JAMA Neurol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1016\/0197-4580(93)90100-P","article-title":"GFAP mRNA increases with age in rat and human brain","volume":"14","author":"Nichols","year":"1993","journal-title":"Neurobiol. Aging"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1001\/jamaneurol.2021.5216","article-title":"Prevalence Estimates of Amyloid Abnormality Across the Alzheimer Disease Clinical Spectrum","volume":"79","author":"Jansen","year":"2022","journal-title":"JAMA Neurol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1016\/j.exer.2014.06.005","article-title":"Insulin treatment normalizes retinal neuroinflammation but not markers of synapse loss in diabetic rats","volume":"125","author":"Masser","year":"2014","journal-title":"Exp. Eye Res."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1111\/cns.14077","article-title":"The gut microbiota-astrocyte axis: Implications for type 2 diabetic cognitive dysfunction","volume":"29","author":"Li","year":"2023","journal-title":"CNS Neurosci. Ther."},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Mayer, M.G., and Fischer, T. (2024). Microglia at the blood brain barrier in health and disease. Front. Cell. Neurosci., 18.","DOI":"10.3389\/fncel.2024.1360195"}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/14\/22\/2520\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:30:13Z","timestamp":1760113813000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/14\/22\/2520"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,11]]},"references-count":26,"journal-issue":{"issue":"22","published-online":{"date-parts":[[2024,11]]}},"alternative-id":["diagnostics14222520"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics14222520","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,11]]}}}