Evidence map›Paper›PMID 40563517›Full record

ArticleBiomolecules2025

Analytical and Clinical Validation of a Plasma Fibroblast Growth Factor 21 ELISA Kit Using an Automated Platform in Steatotic Liver Disease.

Makito Tanaka, Shingo Tanaka, Ryo Kobayashi, Ryosei Murai, Satoshi Takahashi

Abstract readValidation Study
In one paragraph

Article in Biomolecules, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Makito TanakaDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan.
Shingo TanakaDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan.
Ryo KobayashiDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan.ORCID 0000-0001-5784-6427
Ryosei MuraiDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan.ORCID 0000-0002-3310-2797
Satoshi TakahashiDivision of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo 060-8543, Japan.

Funding

Sapporo Medical University
6 · The paper itself

Abstract

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 (

Indexed as

Fatty LiverFibroblast Growth FactorsAdultAgedBiomarkersEnzyme-Linked Immunosorbent AssayFemaleHumansMaleMiddle AgedReproducibility of ResultsBiomarkersFGF21 protein, humanfibroblast growth factor 21Fibroblast Growth Factorsattenuation imagingenzyme-linked immunosorbent assayfibroblast growth factor 21noninvasive diagnostic biomarkersample stabilitysteatotic liver disease

Identifiers

PMID40563517
PMCPMC12190780

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.