Determining a healthy reference range and factors potentially influencing PRO-C3 – A biomarker of liver fibrosis
| العنوان: | Determining a healthy reference range and factors potentially influencing PRO-C3 – A biomarker of liver fibrosis |
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| المؤلفون: | Daniel G.K. Rasmussen, Peder Frederiksen, Diana Julie Leeming, Lise Lotte Gluud, Elisabeth Erhardtsen, Jörn M. Schattenberg, Diane E. Shevell, M.A. Karsdal, Guruprasad P. Aithal |
| المصدر: | Erhardtsen, E, Rasmussen, D G K, Frederiksen, P, Leeming, D J, Shevell, D, Gluud, L L, Karsdal, M A, Aithal, G P & Schattenberg, J M 2021, ' Determining a healthy reference range and factors potentially influencing PRO-C3 – A biomarker of liver fibrosis ', JHEP Reports, vol. 3, no. 4, 100317 . https://doi.org/10.1016/j.jhepr.2021.100317Test JHEP Reports, Vol 3, Iss 4, Pp 100317-(2021) JHEP Reports |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | NASH-CRN, NASH Clinical Research Network, Biopsy, Disease, AST, aspartate aminotransferase, RC799-869, Ethnic groups, Gastroenterology, NIMBLE, Non-Invasive Biomarkers of Metabolic Liver Disease (consortium), Fibrosis, Immunology and Allergy, Body mass index, medicine.diagnostic_test, Fatty liver, NAS, NAFLD Activity Score, Diseases of the digestive system. Gastroenterology, Hospitals, NPV, negative predictive value, Liver biopsy, Biomarker (medicine), Research Article, medicine.medical_specialty, NAFLD, non-alcoholic fatty liver disease, ADAM, A Disintegrin and Metalloproteases, NASH, non-alcoholic steatohepatitis, Reference range, Reference values, AUROC, area under the receiver operating characteristics curve, Internal medicine, ALT, alanine aminotransferase, Internal Medicine, medicine, Humans, FIB-4, fibrosis-4, Healthy volunteers, Hepatology, ALP, alkaline phosphatase, business.industry, CLSI, Clinical and Laboratory Standards Institute, T2DM, type 2 diabetes mellitus, ELF™ test, Enhanced Liver Fibrosis test, medicine.disease, LITMUS, Liver Investigation: Testing Marker Utility in Steatohepatitis (consortium), Collagen type III, PPV, positive predictive value, Reference standards, business, Biomarkers, Non-alcoholic fatty liver disease |
| الوصف: | Background & Aims Progressive fibrosis has been identified as the major predictor of mortality in patients with non-alcoholic fatty liver disease (NAFLD). Several biomarkers are currently being evaluated for their ability to substitute the liver biopsy as the reference standard. Recent clinical studies in NAFLD/NASH patients support the utility of PRO-C3, a marker of type III collagen formation, as a marker for the degree of fibrosis, disease activity, and effect of treatment. Here we establish the healthy reference range, optimal sample handling conditions for both short- and long-term serum storage, and robustness for the PRO-C3 assay. Methods PRO-C3 was measured in 269 healthy volunteers and in 222 NAFLD patients. Robustness of the PRO-C3 assay was measured according to Clinical and Laboratory Standards Institute standards and included validation of interference, precision, and reagent stability, whilst sample stability was defined for storage at different temperatures and for 3 freeze-thaw cycles. Fibrosis scoring was based on histological assessments and used as a reference for the diagnostic ability of PRO-C3 to discriminate between patients with different levels of fibrosis. Results Robustness of the PRO-C3 analysis validated by interference, precision, and reagent stability was found to be within the predefined acceptance criteria. The healthy reference range was determined to be 6.1–14.7 ng/ml. Levels of PRO-C3 were not affected by sex, age, BMI, or ethnicity. Levels of PRO-C3 were able to identify patients with clinically significant fibrosis and advanced fibrosis (AUC = 0.83 (95% CI [0.77–0.88], p Graphical abstract Highlights • A normal reference range in healthy adult volunteers was established for PRO-C3. • PRO-C3 levels were not affected by age, sex, BMI, or ethnicity. • PRO-C3 levels increased with liver fibrosis stage. • PRO-C3 identified patients with significant and advanced liver fibrosis. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d4eefdc7b3714522d884aabf5fb9f2cTest https://curis.ku.dk/portal/da/publications/determining-a-healthy-reference-range-and-factors-potentially-influencing-proc3--a-biomarker-of-liver-fibrosisTest(c941fd32-bad0-4d92-b259-f5dc9c239ed9).html |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....8d4eefdc7b3714522d884aabf5fb9f2c |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |