Scientific publications for BioPredictive non-invasive diagnostics
Peer-reviewed studies validating BioPredictive blood-test diagnostics for liver disease — from first-in-class development cohorts to long-term meta-analyses.
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“SteatoTest-2”
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The diagnostic performance of a simplified blood test (SteatoTest-2) for the prediction of liver steatosis. Key publication
…The performance of the SteatoTest-2 was compared with the reference test…
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Comparison of fatty liver index with noninvasive methods for steatosis detection and quantification.
…the SteatoTest; the fatty liver index (FLI); regular abdominal ultrasound (AUS); and…
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Diagnostic performance of FibroTest, SteatoTest and ActiTest in patients with NAFLD using the SAF score as histological reference.
…patients, FibroTest for fibrosis staging, SteatoTest for steatosis grading and ActiTest for…
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Noninvasive biomarkers for the screening of fibrosis, steatosis and steatohepatitis in patients with metabolic risk factors: FibroTest-FibroMax experience. Key publication Review
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Prediction for steatosis in type-2 diabetes: clinico-biological markers versus 1H-MR spectroscopy.
### Objectives The SteatoTest, fatty liver index (FLI) and hepatic steatosis index (HSI…
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The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis. Key publication
…For the diagnosis of grade 2-4 steatosis, the sensitivity of SteatoTest…
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Performance of biomarkers FibroTest, ActiTest, SteatoTest, and NashTest in patients with severe obesity: meta analysis of individual patient data. Meta Analysis
…FibroTest = 0.72 (0.63-0.79; P<0.0001); SteatoTest = 0…
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Comparative diagnostic study of biomarkers using FibroMax™ and pathology for prediction of liver steatosis in patients with chronic hepatitis C virus infection: an Egyptian study.
### Background Steatosis is common in patients with hepatitis C virus (HCV) infection…
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Prognostic value of liver fibrosis and steatosis biomarkers in type-2 diabetes and dyslipidaemia.
…FibroTest) and steatosis (SteatoTest) in patients with type-2 diabetes and/or…
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Non-invasive diagnosis of liver steatosis using controlled attenuation parameter (CAP) and transient elastography.
…CAP was significantly correlated with SteatoTest, Fatty Liver Index (FLI), percentage of…
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Prospective external validation of a new non-invasive test for the diagnosis of non-alcoholic steatohepatitis in patients with type 2 diabetes.
…The performances of the FibroTest, NashTest-2 and SteatoTest-2 were assessed…
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Nonalcoholic fatty liver disease in chronic obstructive pulmonary disease.
…In multivariate analysis, SteatoTest and FibroTest were significantly associated with sex, body…
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European Association for the Study of the Liver (EASL), European Association for the Study of Diabetes (EASD) and European Association for the Study of Obesity (EASO) clinical practice recommendations for the management of non-alcoholic fatty liver disease: evaluation of their application in people with Type 2 diabetes.
…2 diabetes. ### Methods A total of 179 people with Type 2 diabetes…
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Validation of noninvasive biomarkers (FibroTest, SteatoTest, and NashTest) for prediction of liver injury in patients with morbid obesity.
…0.85, 0.83-0.87, P<0.0001; SteatoTest for advanced…
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Non-invasive diagnosis of steatosis, inflammatory changes and liver fibrosis in patients with non-alcoholic fatty liver diseases. Pilot study.
…examination), using non-invasive tests: SteatoTest, ActiTest and FibroTest. We compared the…
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Performance of liver biomarkers, in patients at risk of nonalcoholic steato-hepatitis, according to presence of type-2 diabetes.
…SteatoTest-2 and NashTest-2 were all equivalent in 136 type-2…
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Utility of noninvasive methods for the characterization of nonalcoholic liver steatosis in the family practice. The "VARES" Italian multicenter study.
…Patients had mild (16.2%), moderate (69.9%), or severe (13.9…
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Clinical and genetic definition of serum bilirubin levels for the diagnosis of Gilbert syndrome and hypobilirubinemia.
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Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials.
…test (comprising components including the SteatoTest, NashTest and FibroTest) through three randomized…
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The diagnostic value of combining carbohydrate-deficient transferrin, fibrosis, and steatosis biomarkers for the prediction of excessive alcohol consumption.
…AST/ALT was higher in ALD patients with steatosis versus without (2…
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Prospective direct comparison of non-invasive liver tests in outpatients with type 2 diabetes using intention-to-diagnose analysis.
…T2D, SteatoTest-T2D and MashTest-T2D was optimised for type 2 diabetes…
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The impact of bariatric surgery on nonalcoholic fatty liver disease as measured using non-invasive tests.
…Data collected included anthropometrics, biochemistry, adiponectin, SteatoTest™, NashTest™, FibroTest™, OWLiver® test and…
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Noninvasive Markers of Improvement of Liver Steatosis Achieved by Weight Reduction in Patients with Nonalcoholic Fatty Liver Disease.
…Blood samples (biochemistry, HOMA-IR, cytokine levels, steatotest) were collected at entry…
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Real-Time Shear Wave versus Transient Elastography for Predicting Fibrosis: Applicability, and Impact of Inflammation and Steatosis. A Non-Invasive Comparison.
…We validated the predetermined 0.2 kPa cut-off as a too…
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Coffee consumption and nonalcoholic fatty liver onset: a prospective study in the general population.
…by hepatorenal index (HRI) and SteatoTest, whereas FibroTest was used to assess…
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Prevalence of steatosis and insulin resistance in patients with chronic hepatitis B compared with chronic hepatitis C and non-alcoholic fatty liver disease.
…2.3±1.8; 3±2.6 and 3.8±2.7…
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Nonalcoholic fatty liver disease, nocturnal hypoxia, and endothelial function in patients with sleep apnea.
…subjects. ### Methods Noninvasive blood tests (SteatoTest, NashTest, and FibroTest) were used to…
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FibroMAX: towards a new universal biomarker of liver disease? Review
…FibroTest (BioPredictive) for the quantitative assessment of fibrosis; SteatoTest (BioPredictive) for the…
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Role of leisure-time physical activity in nonalcoholic fatty liver disease: a population-based study.
…The SteatoTest was significantly lower among subjects engaging in any PA or…
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Evolution of Non-alcoholic Fatty Liver Disease (NAFLD) Biomarkers in Response to Weight Loss 1 Year After Bariatric Surgery-a Post Hoc Analysis of the FibroTest Prospective Study.
…NAFLD's prevalence was 84% with a PPV for SteatoTest® of 85…
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Non-alcoholic fatty liver disease biomarkers estimate cardiovascular risk based on coronary artery calcium score in type 2 diabetes: a cross-sectional study with two independent cohorts.
…FibroMax® panels (i.e., SteatoTest®, FibroTest®, NashTest®, and ActiTest®) were determined from…
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Performance of the SteatoTest, ActiTest, NashTest and FibroTest in a multiethnic cohort of patients with type 2 diabetes mellitus.
…of steatosis (SteatoTest), necrosis and inflammation (ActiTest and NashTest-2) and fibrosis…
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Impact of steatosis and inflammation definitions on the performance of NASH tests.
### Background And Aim One of the unmet needs in subjects with metabolic…
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Assessment of liver fibrosis and steatosis in PBC with FibroScan, MRI, MR-spectroscopy, and serum markers.
…index (r=0.46), the SteatoTest (r=0.39), homeostasis model assessment…
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The Distribution of Liver Steatosis, Fibrosis, Steatohepatitis and Inflammation Activity in Alcoholics According to FibroMax Test.
…The insignificant fibrosis (F<2) is present in 37.2%, advanced (F…
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Metabolic dysfunction-associated steatotic liver disease (MASLD) biomarkers and progression of lower limb arterial calcification in patients with type 2 diabetes: a prospective cohort study.
…We also measured the serum biomarkers included in the FibroMax® panels (SteatoTest…
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Noninvasive procedures to evaluate liver involvement in HIV-1 vertically infected children.
…Liver function was assessed with standard serum biochemical markers, FibroTest, ActiTest, SteatoTest…
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Intestinal failure-associated liver disease in patients with short bowel syndrome: Evaluation by transient elastography.
…12 mo (5.2 kPa [2.8-16.2 kPa]; 223dB/m…
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Review article: the diagnosis of non-alcoholic fatty liver disease -- availability and accuracy of non-invasive methods. Review
…by the complex biochemical score SteatoTest. Serum cytokeratin-18 is a promising…
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Long-term prognostic value of the FibroTest in patients with non-alcoholic fatty liver disease, compared to chronic hepatitis C, B, and alcoholic liver disease.
### Background Although the FibroTest has been validated as a biomarker to determine…
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An Invisible Early Steatosis Phenotype Defined for a Large Population-Based Cohort.
…databases (_N_ = 149,212) using SteatoTest-2 or a proxy. We performed…
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Hepatoprotective Effect of Antrodia cinnamomea Mycelium in Patients with Nonalcoholic Steatohepatitis: A Randomized, Double-Blind, Placebo-Controlled Trial.
…NASH patients who received ACM showed a significant decrease in the SteatoTest…
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The product of triglycerides and glucose as biomarker for screening simple steatosis and NASH in asymptomatic women.
…2.80 and 0.18 for NASH. As compared versus SteatoTest, NashTest…
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Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference.
### Background One of the unmet needs in patients with metabolic risks is…
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Fibromax-based nonalcoholic fatty liver disease in chronic obstructive pulmonary disease patients with obstructive sleep apnea: Methodological considerations.
…the FibroTest, SteatoTest and NashTest, from the Fibromax® panel. Among the main…
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Prevalence of liver fibrosis and risk factors in a general population using non-invasive biomarkers (FibroTest).
…The prevalence of presumed fibrosis was 2.8%, (209/7,463), including…
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Diagnostic value of biochemical markers (NashTest) for the prediction of non alcoholo steato hepatitis in patients with non-alcoholic fatty liver disease. Key publication
### Background Liver biopsy is considered the gold standard for assessing histologic lesions…
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Concordance in a world without a gold standard: a new non-invasive methodology for improving accuracy of fibrosis markers.
…Results Applying manufacturers' recommendations in 2,004 patients increased the strength of…
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Diagnostic Accuracy of Noninvasive Markers of Steatosis, NASH, and Liver Fibrosis in HIV-Monoinfected Individuals at Risk of Nonalcoholic Fatty Liver Disease (NAFLD): Results From the ECHAM Study.
…All had hepatic MRI-PDFF, FibroScan/CAP, FibroTest/NashTest/SteatoTest, APRI, FIB…
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Three Neglected STARD Criteria Reduce the Uncertainty of the Liver Fibrosis Biomarker FibroTest-T2D in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
**Background/Objectives:** Bariatric surgery (BS), drugs approved for type-2-diabetes (T2D…
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Letter: FibroTest for staging fibrosis in non-alcoholic fatty liver disease.
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Interferon-γ-inducible protein-10 in chronic hepatitis C: Correlations with insulin resistance, histological features & sustained virological response.
…noninvasively using FibroTest, ActiTest and SteatoTest. Predictive factors for SVR and their…
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Biomarkers of liver fibrosis. Review
Liver biopsy, due to its limitations and risks, is an imperfect gold…
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Letter: FibroTest for staging fibrosis in non-alcoholic fatty liver disease - authors' reply.
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Novel Biomarkers of Grade I Left Ventricular Diastolic Dysfunction in Type 2 Diabetes Patients with Metabolic-Dysfunction-Associated Steatotic Liver Disease.
…LVDD) in patients with type 2 diabetes mellitus (T2DM). **Methods**: This single…
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First-line assessment of patients with chronic liver disease with non-invasive techniques and without recourse to liver biopsy.
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Impact of Non-alcoholic Fatty Liver Disease on long-term cardiovascular events and death in Chronic Obstructive Pulmonary Disease.
…mortality (Hazard ratio [95% CI]: 2.75 [1.26; 6.03]) than…
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Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis.
### Background & Aims There is controversy about the performance of noninvasive tests such…
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Assessment of liver fibrosis: noninvasive means.
…Among a total of 2,237 references, a total of 14 validated…
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Applicability and variability of liver stiffness measurements according to probe position.
### Aim To investigate the liver stiffness measurement (LSM) applicability and variability with…
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Screening for liver disease using non-invasive biomarkers (FibroTest, SteatoTest and NashTest) in patients with hyperlipidaemia.
…Advanced fibrosis was identified by FT in 53/1909 (2.8%) hyperlipidaemic…
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Screening for liver fibrosis by using a noninvasive biomarker in patients with diabetes.
…In the population with type 2 diabetes who were 45 years or…
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Liver fibrosis evaluation using real-time shear wave elastography: applicability and diagnostic performance using methods without a gold standard.
### Background & Aims Real-time shear wave elastography (SWE) is a new two…
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Validation of AshTest as a Non-Invasive Alternative to Transjugular Liver Biopsy in Patients with Suspected Severe Acute Alcoholic Hepatitis.
…95% of patients received prednisolone; and the 2-year mortality was 63…
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Validation of liver fibrosis biomarker (FibroTest) for assessing liver fibrosis progression: proof of concept and first application in a large population.
…male gender (Relative Risk=3.29), HIV co-infection (2.33), and…
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Noninvasive, Blood-Based Biomarkers as Screening Tools for Hepatic Fibrosis in People With Type 2 Diabetes.
…Finally, the authors assessed the diagnostic role of ActiTest and NashTest 2…
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Finasteride and methadone use and risk of advanced hepatitis C related liver disease.
…White male methadone-users had 2.1-fold excess advanced inflammation risk…
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Awareness of the severity of liver disease re-examined using software-combined biomarkers of liver fibrosis and necroinflammatory activity.
…This resulted in twice as many cases of cirrhosis being detected, 2…
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Screening studies of transient elastography and FibroTest in the general population.
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Noninvasive evaluation of NAFLD. Review
A common clinical concern in patients with NAFLD is whether they have…
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Editorial: FibroTest to predict liver-related mortality in NAFLD. Should this change the diagnostic algorithm in NAFLD?
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Impact of quality control accepted inter-laboratory variations on calculated Fibrotest/Actitest scores for the non-invasive biochemical assessment of liver fibrosis.
…Haptoglobin, ALT, gamma GT, alpha-2-macroglobulin, apolipoprotein A1 and bilirubin, required…
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Screening studies of transient elastography and FibroTest in the general population - Authors' reply.
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Relative performances of FibroTest, Fibroscan, and biopsy for the assessment of the stage of liver fibrosis in patients with chronic hepatitis C: a step toward the truth in the absence of a gold standard.
### Background & Aims Liver fibrosis stage is traditionally assessed with biopsy, an imperfect…
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Non-invasive measurement of liver and pancreas fibrosis in patients with cystic fibrosis.
### Background Patients with cystic fibrosis (CF) have a relevant morbidity and mortality…
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HCV-GenoFibrotest: a combination of viral, liver and genomic (IL28b, ITPA, UGT1A1) biomarkers for predicting treatment response in patients with chronic hepatitis C.
…FibroTest remained significant [OR=4.20 (2.59-12.50); P=0…
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Methodological aspects of the interpretation of non-invasive biomarkers of liver fibrosis: a 2008 update. Key publication Review
This review summarizes the methodological aspects of the interpretation of non-invasive…
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Non-invasive assessment of non-alcoholic fatty liver disease: Clinical prediction rules and blood-based biomarkers. Review
The correct identification of patients at increased risk of non-alcoholic steatohepatitis…
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Fibrotest-Actitest: the biochemical marker of liver fibrosis--the Israeli experience.
…total bilirubin, gamma-glutamyltransferase, alpha-2 macroglobulin, haptoglobin, alanine aminotransferase, and apolipoprotein…
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Systematic review with meta-analysis: direct comparisons of biomarkers for the diagnosis of fibrosis in chronic hepatitis C and B. Meta Analysis
### Background Blood tests and transient elastography (TE), proposed as alternatives to biopsy…
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Accuracy of prognostic serological biomarkers in predicting liver fibrosis severity in people with metabolic dysfunction-associated steatotic liver disease: a meta-analysis of over 40,000 participants.
…Assessment of Diagnostic Accuracy Studies-2. ### Results In total, 138 articles were…
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Clinical Interest of Serum Alpha-2 Macroglobulin, Apolipoprotein A1, and Haptoglobin in Patients with Non-Alcoholic Fatty Liver Disease, with and without Type 2 Diabetes, before or during COVID-19.
…or without type 2 diabetes mellitus (T2DM), alpha-2 macroglobulin (A2M), apolipoprotein…
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A brief review on molecular, genetic and imaging techniques for HCV fibrosis evaluation. Review
### Background Chronic HCV is one of the major causes of morbidity and…
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EASL-EASD-EASO Clinical Practice Guidelines for the Management of Non-Alcoholic Fatty Liver Disease.
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Acoustic radiation force imaging sonoelastography for noninvasive staging of liver fibrosis.
…had a validity of 90.2% (95% CI AUROC = 0.831-0…
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Variability in definitions of transaminase upper limit of the normal impacts the APRI performance as a biomarker of fibrosis in patients with chronic hepatitis C: "APRI c'est fini ?".
…assessment of AST-ULN in 2 control populations 7521 healthy volunteers and…
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Real-time tissue elastography versus FibroScan for noninvasive assessment of liver fibrosis in chronic liver disease.
…of significant fibrosis (F > or = 2), and 0.97, 0.65, and…
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Real-world efficacy and safety of ombitasvir, paritaprevir/r+dasabuvir+ribavirin in genotype 1b patients with hepatitis C virus cirrhosis.
…Serious adverse events related to therapy were reported in 61/2070(2…
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Performances of Elasto-FibroTest(®), a combination between FibroTest(®) and liver stiffness measurements for assessing the stage of liver fibrosis in patients with chronic hepatitis C.
### Background FibroTest(®) (FT), and liver stiffness measurement (LSM) are the most validated…
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LCR1 and LCR2, two multi-analyte blood tests to assess liver cancer risk in patients without or with cirrhosis. Key publication
### Background No blood test has been shown to be effective in the…
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Serum apolipoprotein A1 and haptoglobin, in patients with suspected drug-induced liver injury (DILI) as biomarkers of recovery.
…apoliprotein-A1, haptoglobin and alpha-2-macroglobulin, in patients with DILI. ### Methods…
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[Biomarkers for liver fibrosis: advances, advantages and disadvantages]. Review
Liver cirrhosis in Mexico is one of the most important causes of…
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The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis.
…52.5% with F4 NASH, 40% male, 72% with type 2 diabetes…
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FibroTest/Fibrosure for significant liver fibrosis and cirrhosis in chronic hepatitis B: a meta-analysis. Meta Analysis
…80 (72-86%), and 6.2% (3.3-11.9), respectively. The…
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Silymarin in non alcoholic fatty liver disease.
### Aim This study was undertaken to evaluate the hepatic effects of silybum…
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Non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol-related liver disease: a systematic review and economic evaluation.
…pre-selected cut-off thresholds; (2) the influence of potential confounding variables…
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