{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T04:28:16Z","timestamp":1787372896160,"version":"build-2736575974"},"reference-count":37,"publisher":"MDPI AG","issue":"16","license":[{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100018376","name":"Sapporo Medical University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100018376","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/01h7cca57","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Steatotic liver disease (SLD) is a global health priority, increasing the demand for accessible circulating biomarkers. Carboxylesterase 1 (CES1) plays a key role in hepatic lipid metabolism, but its clinical utility as a plasma biomarker remains unclear. This study aimed to validate an automated immunoassay for plasma CES1 and perform a preliminary evaluation of its diagnostic performance for hepatic steatosis quantified using advanced ultrasound. Methods: An automated ELISA for plasma CES1 was analytically validated. A preliminary clinical evaluation was performed in 95 consecutive outpatients structured to approximate a health-screening population, using ultrasound-derived attenuation coefficients (AC) to quantify steatosis. Results: The assay demonstrated robust analytical performance with intra- and inter-assay coefficients of variation &lt; 10% and excellent sample stability. Plasma CES1 significantly correlated with AC (r = 0.585, p &lt; 0.001), yielding an area under the receiver operating characteristic curve of 0.82 for diagnosing ultrasound-defined steatotic livers. In multivariable analysis, CES1 was independently associated with hepatic steatosis (adjusted odds ratio: 1.03 per 10 pg\/mL increase, p &lt; 0.001). Conclusions: Plasma CES1 shows strong diagnostic potential for ultrasound-defined hepatic steatosis. However, this preliminary evaluation is subject to a restricted cohort spectrum; further prospective validation in broader, unselected real-world populations is required before clinical implementation.<\/jats:p>","DOI":"10.3390\/diagnostics16162658","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T09:48:31Z","timestamp":1787219311000},"page":"2658","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical Validation and Preliminary Clinical Evaluation of Plasma Carboxylesterase 1 for Ultrasound-Defined Hepatic Steatosis"],"prefix":"10.3390","volume":"16","author":[{"given":"Makito","family":"Tanaka","sequence":"first","affiliation":[{"name":"Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan"},{"name":"Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine, Sapporo 060-8543, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9719-8161","authenticated-orcid":false,"given":"Shingo","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan"},{"name":"Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine, Sapporo 060-8543, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayoko","family":"Ochi","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5784-6427","authenticated-orcid":false,"given":"Ryo","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3310-2797","authenticated-orcid":false,"given":"Ryosei","family":"Murai","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan"},{"name":"Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine, Sapporo 060-8543, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1761","DOI":"10.1016\/S0140-6736(24)01811-7","article-title":"Steatotic Liver Disease","volume":"404","author":"Israelsen","year":"2024","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1542","DOI":"10.1016\/j.jhep.2023.06.003","article-title":"A Multisociety Delphi Consensus Statement on New Fatty Liver Disease Nomenclature","volume":"79","author":"Rinella","year":"2023","journal-title":"J. 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