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

Digestive Diseases and Sciences

Volumn 61, Issue 3, 2016, Pages 905-912

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

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Apoptosis; Biomarker; Cytokeratin 18; Liver fibrosis; Nonalcoholic liver disease; Test reliability

Indexed keywords

BIOLOGICAL MARKER; CYTOKERATIN 18; DIAGNOSTIC KIT; KRT18 PROTEIN, HUMAN;

ADULT; ANIMAL CELL; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DIABETES MELLITUS; ELISA KIT; FEMALE; HUMAN; HUMAN TISSUE; HYPERTENSION; INTER TEST RELIABILITY; LIVER BIOPSY; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; MOLECULAR DIAGNOSIS; MOUSE; NONALCOHOLIC FATTY LIVER; NONALCOHOLIC FATTY LIVER DISEASE ACTIVITY SCORE; NONHUMAN; POST HOC ANALYSIS; PREDICTIVE VALUE; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RECEIVER OPERATING CHARACTERISTIC; RELIABILITY; YOUDEN INDEX; AREA UNDER THE CURVE; BLOOD; DIAGNOSTIC IMAGING; DIAGNOSTIC KIT; ECHOGRAPHY; ENZYME LINKED IMMUNOSORBENT ASSAY; IMAGE GUIDED BIOPSY; LIVER; LIVER CIRRHOSIS; MIDDLE AGED; NON-ALCOHOLIC FATTY LIVER DISEASE; PATHOLOGY; PROPORTIONAL HAZARDS MODEL; REPRODUCIBILITY;

ADULT; AREA UNDER CURVE; BIOMARKERS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; IMAGE-GUIDED BIOPSY; KERATIN-18; LIVER; LIVER CIRRHOSIS; MALE; MIDDLE AGED; NON-ALCOHOLIC FATTY LIVER DISEASE; PROPORTIONAL HAZARDS MODELS; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; ROC CURVE; ULTRASONOGRAPHY;

EID: 84958844478     PISSN: 01632116     EISSN: 15732568     Source Type: Journal    
DOI: 10.1007/s10620-015-3916-1     Document Type: Article

References (27)

1. Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011;34:274–285.
2. Browning JD, Szczepaniak LS, Dobbins R, et al. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004;40:1387–1395.
3. Williams CD, Stengel J, Asike MI, et al. Prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among a largely middle-aged population utilizing ultrasound and liver biopsy: a prospective study. Gastroenterology. 2011;140:124–131.
4. Younossi ZM, Stepanova M, Afendy M, et al. Changes in the prevalence of the most common causes of chronic liver diseases in the United States From 1988 to 2008. Clin Gastroenterol Hepatol. 2011;9:524–530.
5. Adams LA, Sanderson S, Lindor KD, Angulo P. The histological course of nonalcoholic fatty liver disease: a longitudinal study of 103 patients with sequential liver biopsies. J Hepatol. 2005;42:132–138.
6. Teli MR, James OF, Burt AD, Bennett MK, Day CP. The natural history of nonalcoholic fatty liver: a follow-up study. Hepatology. 1995;22:1714–1719.
7. Starley BQ, Calcagno CJ, Harrison SA. Nonalcoholic fatty liver disease and hepatocellular carcinoma: a weighty connection. Hepatology. 2010;51:1820–1832.
8. Bugianesi E, Leone N, Vanni E, et al. Expanding the natural history of nonalcoholic steatohepatitis: from cryptogenic cirrhosis to hepatocellular carcinoma. Gastroenterology. 2002;123:134–140.
9. Chalasani N, Younossi Z, Lavine JE, et al. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012;142:1592–1609.
10. Ong JP, Younossi ZM. Epidemiology and natural history of NAFLD and NASH. Clin Liver Dis. 2007;11:1–16.
11. Singh S, Allen AM, Wang Z, Prokop LJ, Murad MH, Loomba R. Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: a systematic review and meta-analysis of paired-biopsy studies. Clin Gastroenterol Hepatol. 2015;13:643.e9–654.e9.
12. McPherson S, Hardy T, Henderson E, Burt AD, Day CP, Anstee QM. Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management. J Hepatol. 2014;62:1148–1155.
13. Pais R, Charlotte F, Fedchuk L, et al. A systematic review of follow-up biopsies reveals disease progression in patients with non-alcoholic fatty liver. J Hepatol. 2013;59:550–556.
14. Ekstedt M, Hagström H, Nasr P, et al. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology. 2015;61:1547–1554.
15. Kramer G, Erdal H, Mertens HJMM, et al. Differentiation between cell death modes using measurements of different soluble forms of extracellular cytokeratin 18. Cancer Res. 2004;64:1751–1756.
16. Wieckowska A, Zein NN, Yerian LM, Lopez AR, McCullough AJ, Feldstein AE. In vivo assessment of liver cell apoptosis as a novel biomarker of disease severity in nonalcoholic fatty liver disease. Hepatology. 2006;44:27–33.
17. Yilmaz Y. Systematic review: caspase-cleaved fragments of cytokeratin 18—the promises and challenges of a biomarker for chronic liver disease. Aliment Pharmacol Ther. 2009;30:1103–1109.
18. Aida Y, Abe H, Tomita Y, et al. Serum cytokeratin 18 fragment level as a noninvasive biomarker for non-alcoholic fatty liver disease. Int J Clin Exp Med. 2014;7:4191–4198.
19. Younossi ZM, Jarrar M, Nugent C, et al. A novel diagnostic biomarker panel for obesity-related nonalcoholic steatohepatitis (NASH). Obes Surg. 2008;18:1430–1437.
20. Cao W, Zhao C, Shen C, Wang Y. Cytokeratin 18, alanine aminotransferase, platelets and triglycerides predict the presence of nonalcoholic steatohepatitis. PLoS One. 2013;8:1–8.
21. Anty R, Iannelli A, Patouraux S, Bonnafous S, Lavallard VJ, Amor IB. A new composite model including metabolic syndrome, alanine aminotransferase and cytokeratin-18 for the diagnosis of non-alcoholic steatohepatitis in morbidly obese patients. Aliment Pharmacol Ther. 2010;32:1315–1322.
22. Feldstein AE, Wieckowska A, Lopez AR, Liu YC, Zein NN, McCullough AJ. Cytokeratin-18 fragment levels as noninvasive biomarkers for nonalcoholic steatohepatitis: a multicenter validation study. Hepatology. 2009;50:1072–1078.
23. Chan W-K, Sthaneshwar P, Mustapha NRN, Mahadeva S. Limited utility of plasma M30 in discriminating non-alcoholic steatohepatitis from steatosis—a comparison with routine biochemical markers. PLoS One. 2014;9:e105903.
24. Cusi K, Chang Z, Harrison S, et al. Limited value of plasma cytokeratin-18 as a biomarker for NASH and fibrosis in patients with non-alcoholic fatty liver disease. J Hepatol. 2014;60:167–174.
25. Kleiner DE, Brunt EM, Van Natta M, et al. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005;41:1313–1321.
26. Yilmaz Y, Dolar E, Ulukaya E, et al. Soluble forms of extracellular cytokeratin 18 may differentiate simple steatosis from nonalcoholic steatohepatitis. World J Gastroenterol. 2007;13:837–844.
27. Shen J, Chan HL-Y, Wong GL-H, et al. Assessment of non-alcoholic fatty liver disease using serum total cell death and apoptosis markers. Aliment Pharmacol Ther. 2012;36:1057–1066.