FibroTest® is the combination of FibroTest® & ActiTest® for the fibrosis staging and activity grading

• FibroTest® : diagnoses hepatic fibrosis
• ActiTest® : assesses viral necro-infl ammatory activity

FibroTest® (FT) is a biomarker of liver fibrosis which was initially validated in patients with chronic hepatitis C (HCV) and then in the three other common fibrotic liver diseases:  chronic hepatitis B (HBV), alcoholic liver disease  (ALD) and  non-alcoholic fatty liver disease (NAFLD).

FT  is widely  used  as  a  non  invasive  alternative  to  liver  biopsy, with  190,000  tests ordered  between  September  2002  and  April  2007¹ .

FT has been mainly studied in chronic hepatitis C, and the FT diagnostic value is lower for intermediate fibrosis stages  (bridging  vs.  non  bridging  fibrosis)  than  for  extreme  stages  (no fibrosis or cirrhosis). In this latter critic, which is also true for liver biopsy, there is a risk of confusion between adjacent stages and intermediate stages or an absence of taking into account  the  prevalence  of  fibrosis  stages  defining  advanced  and  non-advanced  fibrosis.

The FibroTest® biomarkers are alpha-2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and ALT (for ActiTest).
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What is FibroMax?

FibroMax® is the combination of up to five non-invasive liver tests to assess liver injuries in HBV, HCV, Alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD)

• FibroTest® : diagnoses hepatic fibrosis
• SteatoTest® : diagnoses hepatic steatosis (otherwise known as ‘fatty liver’) the most common cause of ALT and GGT abnormalities
• ActiTest® : assesses viral necro-inflammatory activity
• AshTest® : diagnoses severe alcoholic steatohepatitis (ASH) in excessive drinkers
• NashTest®: diagnoses non-alcoholic steatohepatitis (NASH) in patients who are overweight, insulin resistant, have diabetes or hyperlipidemia.

The FibroMax® biomarkers are alpha-2 macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, ALT, AST, GGT, fasting glucose, triglycerides, and total cholesterol.
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Who is at risk of liver steatosis?

Fatty liver or hepatic steatosis is defined as an excessive accumulation of fat in hepatocytes. On worldwide grounds, the prevalence of steatosis is very high, and is associated with several factors such as alcohol, diabetes, overweight, hyperlipidemia, insulin resistance, hepatitis C genotype 3, abetalipoproteinemia and administration of some drugs.

Current guidelines recommend liver biopsy as part of the management of chronic liver disease. As a result of the biopsy’s limitations (risks) as well as patient reluctance to undergo liver biopsy, the estimate of liver injury using non-invasive biomarkers has gained a growing importance.

For the diagnosis of steatosis, there is no standard recommendation. The usual recommendation is to measure γ- glutamyl-transpeptidase (GGT) and alanine aminotransferase (ALT) and, in addition, to perform liver biopsy for grading and staging . The evaluation of liver steatosis using ultrasonography is subjective as based on echo intensity (echogenicity) and special patterns of echoes (texture) and is inaccurate in patients with advanced fibrosis.

SteatoTest was constructed using a combination of the 6 components of FibroTest-ActiTest plus body mass index, serum cholesterol, triglycerides, and glucose adjusted for age and gender. SteatoTest is a simple and non-invasive quantitative estimate of liver steatosis  and may reduce the need for liver biopsy, particularly in patients with metabolic risk factor.
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Why obesity and diabetes are linked to liver disease?

Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of conditions characterized histologically by an excessive accumulation of hepatic fat in the absence of alcohol consumption. Two main histological patterns of NAFLD have been described: bland steatosis and steatohepatitis (NASH). NAFLD is an increasingly recognized cause of liver-related morbidity and mortality [1-3]. Although the majority of patients do not develop complications, 28% may develop serious liver sequelae, including end-stage liver disease and hepatocellular carcinoma. Those at highest risk include patients with significant hepatic necro-inflammation and fibrosis [1-6]. Liver biopsy, therefore, has been recommended for confirming its diagnosis and for providing prognostic information.

Because liver biopsy is impossible to perform in such large cohorts of individuals, some investigators have tried to identify simple non-invasive markers of liver injury in patients with NAFLD. In the last five years, we have developed several panels of simple biochemical markers known as FibroTest®, ActiTest®, SteatoTest® and AshTest® (Biopredictive Paris, France)

Until the validation study of NashTest® in 2006, NASH was the only important histological feature for which no biomarkers were available NashTest® was developed using patented algorithms combining 13 parameters: age, sex, height, weight, and serum levels of triglycerides, cholesterol, alpha2macroglobulin, apolipoprotein A1, haptoglobin, gamma-glutamyltranspeptidase, transaminases ALT, AST, and total bilirubin.

In patients with non-alcoholic fatty liver disease, NashTest®, a simple and non-invasive biomarker reliably predicts the presence or absence of NASH (3 class score: No Nash, Borderline Nash, Nash).
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Can chronic alcohol use cause liver disease?

Chronic alcoholic liver disease (ALD) affects millions of individuals worldwide and is a major cause of liver transplantation and death. Although the majority will not develop complications, 15–40% may develop end-stage liver disease, digestive hemorrhage and hepatocellular carcinoma. Those at the highest risk include patients with cirrhosis and alcoholic steato-hepatitis (ASH). ASH is a necrotizing inflammatory lesion that in its severe form (Maddrey-DFO32) is associated with high mortality despite corticosteroid treatment.

Current guidelines often recommend liver biopsy to be included as part of the management of ALD. Unfortunately, liver biopsy has a potential sampling error, and is invasive, costly, and prone to complications. In patients with severe liver disease, coagulation disorders are frequent and justify the need for a transjugular liver biopsy.

As a result of these limitations and patient reluctance to undergo liver biopsy, the prediction of hepatic histology using non-invasive means has gained importance. For the diagnosis of fibrosis, FibroTest® (FT) has been validated as a surrogate marker in chronic hepatitis C and B and recently in ALD.

In heavy drinkers, AshTest® is a simple and non-invasive quantitative estimate of alcoholic hepatitis. The use of AshTest® may reduce the need for liver biopsy, and therefore allow an earlier treatment of alcoholic hepatitis.
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