Steatotic liver disease is a global health challenge that requires reliable and noninvasive diagnostic biomarkers. This research aimed to validate the analytical and clinical performance of a fibroblast growth factor 21 (FGF21) enzyme-linked immunosorbent assay (ELISA) kit using an automated immunoassay analyzer. Plasma FGF21 levels were measured using a commercial ELISA kit on an automated immunoassay analyzer. Validation included intra- and inter-assay precision, dilution linearity, spike recovery, lower limit of quantification (LLOQ), interference testing, and sample stability analysis. Clinical evaluation involved 97 patients who underwent abdominal ultrasound-based attenuation imaging for the diagnosis of hepatic steatosis. The assay demonstrated high analytical precision, with intra- and inter-assay coefficients of variation <15% and an LLOQ of 3.260 pg/mL. Dilution linearity, spike recovery, and interference tests confirmed the reliability of the assay, whereas stability tests highlighted the minimal effect of freeze-thaw cycles and storage conditions. Clinically, FGF21 levels correlated with attenuation coefficient (r = 0.44). Diagnostic performance indicated 84% sensitivity and 81% specificity at defined FGF21 thresholds for the diagnosis of hepatic steatosis. This research confirmed the reliable analytical and clinical performance of the FGF21 ELISA kit, reinforcing its potential as a diagnostic biomarker of hepatic steatosis.

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 < 10% and excellent sample stability. Plasma CES1 significantly correlated with AC (r = 0.585, p < 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 < 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.

2023年3月から赤血球液の有効期間が採血後21日から28日へ延長された．本検討は有効期間の延長が当院の輸血医療にどのような影響を与えているか解析することを目的とした．有効期間延長に伴い廃棄率は0.39％から0.16％へ減少した．その原因として，有効期間延長前には廃棄原因の80％を占めていた有効期限切れによる廃棄が，有効期間延長に伴い認められなくなったことに起因すると考えられた．なお，本検討期間において，当院への赤血球液納品時における残り有効期間の中央値は，延長前は全血液型で12日（0～19日）であったのに対し，延長後は17日（0～17日）と5日長くなっていた．一方，有害事象の発生率については，有効期間延長の前後で0.49％から0.73％へとわずかに増加を認めたが，採血後の経過日数によって発生率が上昇する傾向や有効期間延長に起因して生じたと考えられる副反応は認めなかった．以上より，赤血球液の有効期間延長は血液製剤の廃棄率減少につながること，すなわち血液製剤の有効利用に貢献していると考えられた．