Evidence map›Paper›PMID 34521905›Full record

ArticleScientific reports2021

Development of a highly sensitive chemiluminescent enzyme immunoassay for fragmented cytokeratin 18 using new antibodies.

Minori Yamada, Akiko Eguchi, Koji Okuno, Koji Sakaguchi, Tetsuji Yamaguchi

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% of its field
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
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 at 2 institutions in 1 country.

Minori YamadaBio-Reagent Material Development, Bio-Diagnostic Reagent Technology Center, Sysmex Corporation, 4-3-2 Takatsukadai, Nishi-Ku, Kobe, Hyogo, 651-2271, Japan.
Akiko EguchiDepartment of Gastroenterology and Hepatology, School of Medicine, Mie University, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Koji OkunoScientific Affairs, Sysmex Corporation, 1-3-2 Murotani, Nishi-Ku, Kobe, Hyogo, 651-2241, Japan.
Koji SakaguchiBio-Reagent Material Development, Bio-Diagnostic Reagent Technology Center, Sysmex Corporation, 4-3-2 Takatsukadai, Nishi-Ku, Kobe, Hyogo, 651-2271, Japan.
Tetsuji YamaguchiManufacturing Technology Development 2, Reagent Production, Sysmex Corporation, 4-3-2 Takatsukadai, Nishi-Ku, Kobe, Hyogo, 651-2271, Japan. Yamaguchi.Tetsuji@sysmex.co.jp.
Sysmex (Japan) · JPJapan Science and Technology Agency · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Fragmented cytokeratin 18 (fCK18) released from epithelial cells undergoing apoptosis is widely studied in various diseases. However, fCK18 measurement is not utilized in clinical practice due to imprecise disease-state cutoff values. Therefore, we set out to generate new monoclonal antibodies (mAbs) and a recombinant fCK18 (rfCK18) calibrator in an effort to develop a highly sensitive chemiluminescent enzyme immunoassay (CLEIA). New capture mAb (K18-624) had a high binding ability compared to the current commercial antibody. New detection mAb (K18-328) recognized 323S-340G of CK18. A rfCK18 was expressed in the soluble fraction of E. coli when the N-terminal region (260 amino acid residues) of CK18 was truncated. Analysis of performance and measurement of human fCK18 were evaluated using K18-624 and K18-328 in a highly sensitive CLEIA. The coefficients of variation (CV) for within-run and between-day repeatability were below 10% and the recoveries were in the range of 15%. The detection sensitivity was 0.056 ng/mL. Serum fCK18 levels were significantly increased in non-alcoholic steatohepatitis (NASH) patients when compared to healthy individuals. Our new fCK18 mAbs showed high affinity and sensitivity. CLEIA using our new antibodies will be useful in measuring fCK18 in human blood thereby generating accurate clinical diagnoses of human liver diseases.

Indexed as

Antibodies, MonoclonalBiomarkersHumansImmunoenzyme TechniquesKeratin-18Molecular Diagnostic TechniquesNon-alcoholic Fatty Liver DiseaseSensitivity and SpecificityAntibodies, MonoclonalBiomarkersKeratin-18

Identifiers

PMID34521905
PMCPMC8440549
OpenAlexW3200037646

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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.