Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease
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 immunoa...
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MDPI AG
2025-06-01
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| Series: | Biomolecules |
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| Online Access: | https://www.mdpi.com/2218-273X/15/6/877 |
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| author | Makito Tanaka Shingo Tanaka Ryo Kobayashi Ryosei Murai Satoshi Takahashi |
| author_facet | Makito Tanaka Shingo Tanaka Ryo Kobayashi Ryosei Murai Satoshi Takahashi |
| author_sort | Makito Tanaka |
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| description | 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 (<i>r</i> = 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. |
| format | Article |
| id | doaj-art-f5da067e478b4d3b8568f74c8d21c81b |
| institution | Matheson Library |
| issn | 2218-273X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
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| series | Biomolecules |
| spelling | doaj-art-f5da067e478b4d3b8568f74c8d21c81b2025-06-25T13:33:38ZengMDPI AGBiomolecules2218-273X2025-06-0115687710.3390/biom15060877Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver DiseaseMakito Tanaka0Shingo Tanaka1Ryo Kobayashi2Ryosei Murai3Satoshi Takahashi4Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, JapanDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, JapanDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, JapanDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, JapanDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, JapanSteatotic 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 (<i>r</i> = 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.https://www.mdpi.com/2218-273X/15/6/877attenuation imagingenzyme-linked immunosorbent assayfibroblast growth factor 21noninvasive diagnostic biomarkersample stabilitysteatotic liver disease |
| spellingShingle | Makito Tanaka Shingo Tanaka Ryo Kobayashi Ryosei Murai Satoshi Takahashi Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease Biomolecules attenuation imaging enzyme-linked immunosorbent assay fibroblast growth factor 21 noninvasive diagnostic biomarker sample stability steatotic liver disease |
| title | Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease |
| title_full | Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease |
| title_fullStr | Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease |
| title_full_unstemmed | Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease |
| title_short | Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease |
| title_sort | analytical and clinical validation of a plasma fibroblast growth factor 21 elisa kit using an automated platform in steatotic liver disease |
| topic | attenuation imaging enzyme-linked immunosorbent assay fibroblast growth factor 21 noninvasive diagnostic biomarker sample stability steatotic liver disease |
| url | https://www.mdpi.com/2218-273X/15/6/877 |
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