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Interpretation and Validation


measures the hepatic fibrosis stage. LiverFACt retains the same diagnostic value regardless of ethnicity, gender, transaminases level1. LiverFACt has the same diagnostic value for the intermediate and extreme stages.

FIBROSIS

Validation
There are many serum biomarkers measuring the level of liver fibrosis, however the most well validated is the LiverFACt. LiverFACt has been well validated in a large general population2, obese patients3, patients over the age of 65,4 and even children5.

Evaluation of the LiverFACt has been done in relation to liver biopsy (n = 2472)1 and proved to be a powerful analysis tool of fibrosis progression.


Interpretation

The LiverFACt result is provided as a score of 0 to 1, proportional to the severity of the fibrosis, with a conversion to the METAVIR system (from F0 to F4). To facilitate the visual interpretation, the result must be accompanied by a colored graph with three classes of severity:

Red ( significant )

Orange ( moderate )

Green ( mininmal or absent )

Fibrosis score METAVIR Stage of estimated fibrosis Interpretation
0.75 - 1.00 F4 Severe Fibrosis
0.59 - 0.74 F3 Significant Fibrosis
0.49 - 0.58 F2 Moderate fibrosis
0.28 - 0.48 F1 Minimal Fibrosis
0.00 - 0.27 F0 No fibrosis

Validation

There are many serum biomarkers measuring the level of liver fibrosis, however the most well validated is the LiverFACt. LiverFACt has been well validated in a large general population2, obese patients3, patients over the age of 654 and even children5.

Evaluation of the LiverFACt has been done in relation to liver biopsy (n = 2472)1 and proved to be a powerful analysis tool of fibrosis progression.


measures the degree of necroinflammatory activity of viral
origin (HBV and HCV). Activity score retains the same diagnostic
value independent of ethnic origin, sex or HBeAg.
The diagnostic value of Activity is the same for the
intermediate grades and the extreme grades.

ACTIVITY

Validation
ActiTest has been validated for initial diagnosis of necroinflammatory activity for Hep B and C, and also for monitoring of treated and untreated patients.
Inflammatory activities are key factors for treatment indication and ActiTest has been well validated in relation to liver biopsy for HBV patients (n = 924)6 and HCV patients (n = 519)7.
ActiTest is more accurate for the diagnosis of necroinflammatory activity than ALT transaminases8.


Interpretation

The Activity score result is provided as a score of 0 to 1, proportional
to the significance of the activity, with a conversion to the
METAVIR system (from A0 to A3). To facilitate the visual
interpretation, the result must be accompanied by a colored
graph with three classes of severity:

Red ( significant )

Orange ( moderate )

Green ( mininmal or absent )

 

Activity score Metavir Estimated activity grade Interpretation
0.73 - 1.00 A4 Severe activity
0.63 - 0.72 A3 Significant activity
0.53-0.62 A2 moderate activity
0.30-0.52 A1 Minimal activity
0.00 - 0.29 A0 No activity

Validation

Activity has been validated for initial diagnosis of necroinflammatory activity for Hep B and C, and also for monitoring of treated and
untreated patients.
Inflammatory activities are key factors for treatment indication and Activity has been well validated in relation to liver biopsy for HBV patients
(n = 924)6 and HCV patients (n = 519)7.
Activity score is more accurate for the diagnosis of necroinflammatory activity than ALT transaminases8.



gives a quantitative estimation of steatosis of different
origins NAFLD (overweight, diabetes, hyperlipidemia,
insulin resistance…) and ALD.

STEATOSIS

Validation
SteatoTest is used to measure hepatic steatosis and is more predictive and has significantly higher accuracy than the usual biomarkers like GGT, ALT and ultrasonography9.
Significant diagnostic performance for SteatoTest has been observed in patients with chronic hepatitis B, C, alcoholic liver disease and non alcoholic liver disease, according to a meta analysis10.


Interpretation

The SteatoTest result is provided as a score in 4 classes: No
Steatosis, minimal steatosis, moderate steatosis and severe
steatosis. To facilitate the visual interpretation, the result must be
accompanied by a colored graph with three classes of severity:

Red ( significant )

Orange ( moderate )

Green ( mininmal or absent )

 

Steatosis score Estimated activity grade Interpretation
0.69 - 1.00 S3 S3: severe steatosis, between 33 to 100% of hepatocytes with no steatosis
0.57-0.68 S2 S2: moderate steatosis, between 6 to 32% of hepatocytes with no steatosis
0.38-0.56 S1 S1: minimal steatosis, less that 5% of hepatocytes with no steatosis
0.00-0.37 S0 S0: no steatosis

Validation

SteatoTest is used to measure hepatic steatosis and is more predictive and has significantly higher accuracy than the usual biomarkers like
GGT, ALT and ultrasonography1.
Significant diagnostic performance for SteatoTest has been observed in patients with chronic hepatitis B, C, alcoholic liver disease and non
alcoholic liver disease, according to a meta analysis2.

References
  1. Ngo et al. An accurate definition of the status of inactive hepatitis B virus carrier by a combination of biomarkers (LiverFACt) and viral load. PlosOne 2008;3:e2573
  2. Poynard T et al. Validation of liver fibrosis biomarker (LiverFACt) for assessing liver fibrosis progression: proof of concept and first application in a large population. J Hepatol 2012;57:541-8
  3. Lassailly et al. Validation of noninvasive biomarkers (LiverFACt, SteatoTest, and NashTest) for prediction of liver injury in patients with morbid obesity. Eur J Gastroenterol Hepatol 2011;23:499-506
  4. Thabut D et al. Hepatitis C in 6,865 patients 65 yr or older: a severe and neglected curable disease? Am J Gastroenterol 2006;101:1260-7
  5. Flores-Calderón et al. Non-invasive markers of liver fibrosis in chronic liver disease in a group of Mexican children. A multicenter study Ann Hepatol 2012;11:364-8
  6. Poynard T et al. ActiTest accuracy for the assessment of histological activity grades in patients with chronic hepatitis C, an overview using Obuchowski measure. Gastroenterol Clin Biol 2010;34:388-396
  7. Poynard T et al. Impact of adefovir dipivoxil on liver fibrosis and activity assessed with biochemical markers (LiverFACt) in patients infected by Hepatitis B Virus. J Viral Hepatol 2009;16:203-13
  8. Halfon P et al. Independent Prospective Multicenter Validation of Biochemical Markers (LiverFACt) for the Prediction of Liver Fibrosis and Activity in Patients with Chronic Hepatitis C: The Fibropaca Study. Am J Gastroenterol 2006;101:547-55
  9. Thabut D et al. The diagnostic value of biomarkers (AshTest) for the prediction of alcoholic steato-hepatitis in patients with chronic alcoholic liver disease. J Hepatology 2006;44:1175-85
  10. Rudler M et al. Validation of AshTest as a Non-Invasive Alternative to Transjugular Liver Biopsy in Patients with Suspected Severe Acute Alcoholic Hepatitis. PlosOne 2015;10:e0134302