NASH-FibroTest is a complete diagnostic test for the liver

It is pain-free, simple to use, and affordable, while offering high standards of performance.

NASH-FibroTest™ offers an end-to-end liver diagnostic service from a single blood sample.

BioPredictive's five main diagnostic tests are included in NASH-FibroTest, for a complete assessment of the condition of the liver and the five main causes of liver disease 1 .

NASH-FibroTest = FibroTest + SteatoTest 2 + NashTest 2 + ActiTest + AshTest

Metabolic diseases, steatosis

Hepatic steatosis, which is assessed by the SteatoTest 2, is a build-up of fat in the liver, which frequently causes elevated levels of Gamma-GT and transaminases.

Non-alcoholic steatohepatitis (NASH) is an inflammatory disease of the liver which is caused by metabolic conditions including excess weight, arterial hypertension (high blood pressure) and abnormal levels of triglycerides or cholesterol. The NashTest 2 evaluates the level of necroinflammatory activity caused by the metabolic condition.

Alcoholic steato-hepatitis (ASH) is an inflammatory disease of the liver caused by excessive alcohol consumption. The AshTest evaluates the level of this necroinflammatory activity due to alcohol.

Fibrosis and activity

FibroTest estimates the level of hepatic fibrosis and cirrhosis, while ActiTest estimates the level of activity.

Fibrosis and necroinflammatory activity are the two main causes of liver disease.

Fibrosis is a medical condition caused by the reaction of a diseased liver. Hepatic fibrosis is typically compared to a form of scar tissue that progresses throughout the liver. The most serious stage of fibrosis is known as cirrhosis.

Activity refers to the level of liver inflammation caused by disease. It is often compared to a burn.

Recommendations and validations

FibroTest

FibroTest is recommended by WHO 2 , the american Association for the Study of Liver Diseases (AASLD) 3 , the European Association for the Study of the Liver (EASL) 4 , and the Asia-Pacific Association for the Study of the Liver (APASL) 5 for testing for hepatic fibrosis in chronic hepatitis C patients, with or without HIV co-infections, as well as patients with metabolic conditions or who consume excess alcohol. 6 7 8

FibroTest is used to give access to non-interferon treatments for combating the hepatitis C virus and for patient monitoring 9 .

FibroTest, when combined with ActiTest, makes it possible to identify asymptomatic carriers of the hepatitis B virus as well as potential treatments 10 .

FibroTest is specifically designed for cirrhosis and approved for the purposes of classifying its severity into one of three classes 11 .

FibroTest is the only test that is capable of classifying the early stages of fibrosis 12 .

FibroTest can be used for longitudinal monitoring of patients with chronic liver disease 9 13 14 .

ActiTest

ActiTest is superior to ALT, which is the standard biomarker for necroinflammatory activity 15 .

ActiTest and FibroTest make it possible to identify asymptomatic carriers of hepatitis B 15 .

ActiTest and FibroTest make it possible to identify potential treatments and monitor the progression of chronic viral hepatitis 9 .

ActiTest is a quantitative biomarker which has been validated in subjects who are at high metabolic risk, whether or not this is accompanied by severe obesity 16 7 .

SteatoTest 2

SteatoTest 2 estimates the degree of steatosis in subjects at high metabolic risk, patients who consume excess alcohol or chronic carriers of the hepatitis B or C viruses. 17 1 18 19 11 20 7

As a quantitative biomarker for steatosis, SteatoTest 2 allows longitudinal monitoring to be performed on patients. 13 14

SteatoTest 2 is approved as a predictor of cardiovascular risk associated with steatosis 21 .

SteatoTest 2 is equivalent to SteatoTest (non-inferiority) but more convenient (no BMI, no bilirubin) 22 .

NashTest 2

NashTest 2 estimates the liver inflammation as a quantitative assessment 23 of steatohepatitis and the prediction of liver outcome 24 .

NashTest 2 is constructed using updated histological consensus on NASH definition and meets the requirements of the new SAF scoring system 25 7 .

It is a quantitative test, assessing the severity of the liver inflammation (NASH), without the need of BMI.

NashTest 2, when combined with FibroTest, has demonstrated its value in screening for NASH in patients with metabolic risk factors 26 27 28 .

AshTest

AshTest 29 is a fast alternative to transjugular hepatic biopsies, which therefore makes it possible to treat acute alcoholic steatohepatitis (ASH) in patients suffering from alcohol-related liver disease 30 18 29 19 .

10 components, 5 scores

NASH-FibroTest combines ten standard biomarkers:

  • Alpha-2-macroglobulin
  • Haptoglobin
  • Apolipoprotein A1
  • Total bilirubin
  • Gamma-GT
  • Alanine aminotransferase (ALT)
  • Aspartate aminotransférase (AST)
  • Fasting glucose
  • Cholesterol
  • Triglycerides

These markers are weighted depending on the patient's age, sex.

NASH-FibroTest tests must be done on an empty stomach in any local medical test laboratory that complies with BioPredictive's technical recommendations.

There is NO NEED for patient's BMI, nor its weight or height.

Where to do the test   Technical Recommendations  

Find out more

NASH-FibroTest in metabolic conditions
NASH-FibroTest for excessive alcohol intake
FibroTest-ActiTest for carriers of the hepatitis C virus (HCV)
FibroTest-ActiTest for patients with the hepatitis B virus (HBV)
FibroTest-ActiTest for patients infected with both hepatitis C and HIV or hepatitis B and HIV
How is the result sheet read ?

You can also access all the scientific literature about NASH-FibroTest, and the latest news on non-invasive testing for the liver.

FibroTest-ActiTest

FibroTest and ActiTest are both available separately.

Find out more  

References

  1. Morra R, Munteanu M, Imbert-Bismut F, Messous D, Ratziu V, Poynard T. FibroMAX: towards a new universal biomarker of liver disease? Expert Rev. Mol. Diagn. 2007;7:5. abstract article
  2. . Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection book 2014;None:None. abstract
  3. . Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology 2015;62:3. abstract article
  4. . EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J. Hepatol. 2015;63:1. abstract article
  5. Shiha G, Sarin SK, Ibrahim AE, Omata M, Kumar A, Lesmana LA, Leung N, Tozun N, Hamid S, Jafri W, Maruyama H, Bedossa P, Pinzani M, Chawla Y, Esmat G, Doss W, Elzanaty T, Sakhuja P, Nasr AM, Omar A, Wai CT, Abdallah A, Salama M, Hamed A, Yousry A, Waked I, Elsahar M, Fateen A, Mogawer S, Hamdy H, Elwakil R. Liver fibrosis: consensus recommendations of the Asian Pacific Association for the Study of the Liver (APASL). Hepatol Int 2009;3:2. abstract article
  6. . EASL-EASD-EASO Clinical Practice Guidelines for the Management of Non-Alcoholic Fatty Liver Disease. Obes Facts 2016;9:2. abstract article
  7. Munteanu M, Tiniakos D, Anstee Q, Charlotte F, Marchesini G, Bugianesi E, Trauner M, Romero Gomez M, Oliveira C, Day C, Dufour JF, Bellentani S, Ngo Y, Traussnig S, Perazzo H, Deckmyn O, Bedossa P, Ratziu V, Poynard T. Diagnostic performance of FibroTest, SteatoTest and ActiTest in patients with NAFLD using the SAF score as histological reference. Aliment. Pharmacol. Ther. 2016;44:8. abstract article
  8. . EASL clinical practical guidelines: management of alcoholic liver disease. J. Hepatol. 2012;57:2. abstract article
  9. Poynard T, Ngo Y, Munteanu M, Thabut D, Massard J, Moussalli J, Varaud A, Benhamou Y, Ratziu V. Biomarkers of liver injury for hepatitis clinical trials: a meta-analysis of longitudinal studies. Antivir. Ther. (Lond.) 2010;15:4. abstract article
  10. Poynard T, Vergniol J, Ngo Y, Foucher J, Thibault V, Munteanu M, Merrouche W, Lebray P, Rudler M, Deckmyn O, Perazzo H, Thabut D, Ratziu V, De Lédinghen V. Staging chronic hepatitis B into seven categories, defining inactive carriers and assessing treatment impact using a fibrosis biomarker (FibroTest®) and elastography (FibroScan®). J. Hepatol. 2014;61:5. abstract article
  11. Poynard T, Vergniol J, Ngo Y, Foucher J, Munteanu M, Merrouche W, Colombo M, Thibault V, Schiff E, Brass CA, Albrecht JK, Rudler M, Deckmyn O, Lebray P, Thabut D, Ratziu V, De Lédinghen V. Staging chronic hepatitis C in seven categories using fibrosis biomarker (FibroTest™) and transient elastography (FibroScan®). J. Hepatol. 2014;60:4. abstract article
  12. Houot M, Ngo Y, Munteanu M, Marque S, Poynard T. Systematic review with meta-analysis: direct comparisons of biomarkers for the diagnosis of fibrosis in chronic hepatitis C and B. Aliment. Pharmacol. Ther. 2016;43:1. abstract article
  13. Ratziu V, De Lédinghen V, Oberti F, Mathurin P, Wartelle-Bladou C, Renou C, Sogni P, Maynard M, Larrey D, Serfaty L, Bonnefont-Rousselot D, Bastard JP, Rivière M, Spénard J. A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis. J. Hepatol. 2011;54:5. abstract article
  14. Lassailly G, Caiazzo R, Hollebecque A, Buob D, Leteurtre E, Arnalsteen L, Louvet A, Pigeyre M, Raverdy V, Verkindt H, Six MF, Eberle C, Patrice A, Dharancy S, Romon M, Pattou F, Mathurin P. Validation of noninvasive biomarkers (FibroTest, SteatoTest, and NashTest) for prediction of liver injury in patients with morbid obesity. Eur J Gastroenterol Hepatol 2011;23:6. abstract article
  15. Poynard T, Munteanu M, Ngo Y, Castéra L, Halfon P, Ratziu V, Imbert-Bismut F, Thabut D, Bourliere M, Cacoub P, Messous D, De Lédinghen V. ActiTest accuracy for the assessment of histological activity grades in patients with chronic hepatitis C, an overview using Obuchowski measure. Gastroenterol. Clin. Biol. 2010;34:6-7. abstract article
  16. Poynard T, Lassailly G, Diaz E, Clement K, Caiazzo R, Tordjman J, Munteanu M, Perazzo H, Demol B, Callafe R, Pattou F, Charlotte F, Bedossa P, Mathurin P, Ratziu V. Performance of biomarkers FibroTest, ActiTest, SteatoTest, and NashTest in patients with severe obesity: meta analysis of individual patient data. PLoS ONE 2012;7:3. abstract article
  17. Poynard T, Ratziu V, Naveau S, Thabut D, Charlotte F, Messous D, Capron D, Abella A, Massard J, Ngo Y, Munteanu M, Mercadier A, Manns M, Albrecht J. The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis. Comp Hepatol 2005;4:None. abstract article
  18. Supronowicz Ł, Wójtowicz E, Cylwik B, Gruszewska E, Chrostek L. [The diagnostic value of non-invasive biochemical biomarkers in alcohol abuse]. Pol. Merkur. Lekarski 2013;35:207. abstract
  19. Gudowska M, Wójtowicz E, Cylwik B, Gruszewska E, Chrostek L. The Distribution of Liver Steatosis, Fibrosis, Steatohepatitis and Inflammation Activity in Alcoholics According to FibroMax Test. Adv Clin Exp Med 2015;24:5. abstract article
  20. Munteanu M, Houot M, Ngo Y, Poynard T. Biopsy as well as FibroTest/Fibrosure is suboptimal for discriminating intermediate fibrosis stages in patients with chronic hepatitis B. Am. J. Gastroenterol. 2014;109:8. abstract article
  21. Perazzo H, Munteanu M, Ngo Y, Lebray P, Seurat N, Rutka F, Couteau M, Jacqueminet S, Giral P, Monneret D, Imbert-Bismut F, Ratziu V, Hartemann-Huertier A, Housset C, Poynard T. Prognostic value of liver fibrosis and steatosis biomarkers in type-2 diabetes and dyslipidaemia. Aliment. Pharmacol. Ther. 2014;40:9. abstract article
  22. abstract
  23. Poynard T, Munteanu M, Charlotte F, Perazzo H, Ngo Y, Deckmyn O, Pais R, Merrouche W, De Lédinghen V, Mathurin P, Ratziu V. Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference. Eur J Gastroenterol Hepatol 2018;30:5. abstract article
  24. Munteanu M, Pais R, Peta V, Deckmyn O, Moussalli J, Ngo Y, Rudler M, Lebray P, Charlotte F, Thibault V, Lucidarme O, Ngo A, Imbert-Bismut F, Housset C, Thabut D, Ratziu V, Poynard T. 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. Aliment. Pharmacol. Ther. 2018;48:10. abstract article
  25. abstract
  26. Ratziu V, Giral P, Munteanu M, Messous D, Mercadier A, Bernard M, Morra R, Imbert-Bismut F, Bruckert E, Poynard T. Screening for liver disease using non-invasive biomarkers (FibroTest, SteatoTest and NashTest) in patients with hyperlipidaemia. Aliment. Pharmacol. Ther. 2007;25:2. abstract article
  27. Zelber-Sagi S, Nitzan-Kaluski D, Goldsmith R, Webb M, Zvibel I, Goldiner I, Blendis L, Halpern Z, Oren R. Role of leisure-time physical activity in nonalcoholic fatty liver disease: a population-based study. Hepatology 2008;48:6. abstract article
  28. Zelber-Sagi S, Salomone F, Webb M, Lotan R, Yeshua H, Halpern Z, Santo E, Oren R, Shibolet O. Coffee consumption and nonalcoholic fatty liver onset: a prospective study in the general population. Transl Res 2015;165:3. abstract article
  29. Rudler M, Mouri S, Charlotte F, Cluzel P, Ngo Y, Munteanu M, Lebray P, Ratziu V, Thabut D, Poynard T. Validation of AshTest as a Non-Invasive Alternative to Transjugular Liver Biopsy in Patients with Suspected Severe Acute Alcoholic Hepatitis. PLoS ONE 2015;10:8. abstract article
  30. Thabut D, Naveau S, Charlotte F, Massard J, Ratziu V, Imbert-Bismut F, Cazals-Hatem D, Abella A, Messous D, Beuzen F, Munteanu M, Taieb J, Moreau R, Lebrec D, Poynard T. The diagnostic value of biomarkers (AshTest) for the prediction of alcoholic steato-hepatitis in patients with chronic alcoholic liver disease. J. Hepatol. 2006;44:6. abstract article
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About BioPredictive

BioPredictive is an independent bio-pharmaceutical company, based in France, which designs and markets diagnostic tests for liver diseases, in particular FibroTest and NASH-FibroTest.

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