Evidence map›Paper›PMID 26462489›Full record

ArticleDigestive diseases and sciences2016

Poor Inter-test Reliability Between CK18 Kits as a Biomarker of NASH.

Carolina F M G Pimentel, Zhenghui G Jiang, Takeshi Otsubo, Linda Feldbrügge, Tracy L Challies, Imad Nasser, Simon Robson, Nezam Afdhal, Michelle Lai

Abstract read
In one paragraph

Article in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
–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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Racial and Ethnic Disparities in Nonalcoholic Fatty Liver Disease Prevalence, Severity, and Outcomes in the United States: A Systematic Review and Meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    Pooled it
  4. [Current research progress status in identifying hepatocellular ballooning degeneration in nonalcoholic steatohepatitis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
  5. Serum miR‑29 is increased in mice with early liver fibrosis.Experimental and therapeutic medicine · 2024
    Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Steatohepatitis and liver fibrosis are predicted by the characteristics of very low density lipoprotein in nonalcoholic fatty liver disease.Liver international : official journal of the International Association for the Study of the Liver · 2016
    Article
  13. Fibrosis Assessment in Nonalcoholic Fatty Liver Disease (NAFLD) in 2016.Digestive diseases and sciences · 2016 · on this map
    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

9 authors.

Carolina F M G PimentelDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA. carolinapimentel.gastro@gmail.com.ORCID http://orcid.org/0000-0001-8092-1106
Zhenghui G JiangDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA.
Takeshi OtsuboDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA.
Linda FeldbrüggeDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA.
Tracy L ChalliesDivision of Pathology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Imad NasserDivision of Pathology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Simon RobsonDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA.
Nezam AfdhalDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA.
Michelle LaiDivision of Gastroenterology/Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 110 Francis Street, Suite 4 A, Boston, MA, 02215, USA.

Funding

Non-invasive evaluation of Non-alcoholic SteatohepatitisK23DK083439 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI LAI, MICHELLE · 2010 to 2014
$887k
NIDDK NIH HHS 1K23DK083439NIDDK NIH HHS K23 DK083439
6 · The paper itself

Abstract

BACKGROUND AND

aimNonalcoholic fatty liver disease (NAFLD) affects 15-40% of the general population; 10-20% of those patients have a more severe form of the disease known as nonalcoholic steatohepatitis (NASH). Cytokeratin-18 (CK18), released during apoptosis and one of the most studied biomarkers in NASH, can be measured by a number of commercially available kits. We compared serum measurements of the CK18 M30 from two different kits using the same cohort to evaluate the reliability between two test kits.

methodsWe measured serum levels of CK18 M30 from 185 patients with biopsy-proven NAFLD from a single center from 2009 to 2015, using two different ELISA kits, Test 1 (T1) and Test 2 (T2). Advanced fibrosis was defined as fibrosis stages 3-4 and NASH defined by NAS score ≥ 5.

resultsMean age was 50.2 years (SD 12.6), 61.1% male and 87% White; 49.6% had NASH and 32.2% advanced fibrosis. There was no significant correlation between measurements from the two kits (p = 0.86, r = 0.01). While T2 predicted NASH and advanced fibrosis, T1 did not. The area under ROC curve for the prediction of NASH was 0.631 for T2 versus 0.500 for T1.

conclusionsMeasurements from two different CK18 M30 test kits did not correlate with each other. One kit showed statistically significantly higher levels of CK18 M30 in patients with advanced fibrosis and NASH, while the other kit did not. With the increasing use of CK18 as a biomarker in NASH, it is important to standardize the different kits as it could greatly bias the results.

Indexed as

AdultArea Under CurveBiomarkersEnzyme-Linked Immunosorbent AssayFemaleHumansImage-Guided BiopsyKeratin-18LiverLiver CirrhosisMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseProportional Hazards ModelsReagent Kits, DiagnosticReproducibility of ResultsBiomarkersKeratin-18KRT18 protein, humanReagent Kits, DiagnosticApoptosisBiomarkerCytokeratin 18Liver fibrosisNonalcoholic liver diseaseTest reliability

Identifiers

PMID26462489
PMCPMC4761280

What OpenQuestion holds

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Registered trials

None linked

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.