FibroScan® – Modern, Non-Invasive Liver and Spleen Diagnostics

FibroScan® examination is a non-invasive, fast, and safe method for assessing liver fibrosis and steatosis. Take care of your patients' health today.

Introduction to FibroScan®

Discover innovative diagnostic technology

FibroScan® is a non-invasive method of liver examination, introduced to the market in 2003. It is an alternative to biopsy in cases where the goal of the procedure is to assess the advancement of structural changes in the liver during chronic inflammation of various etiologies. FibroScan® enables immediate diagnostics.

The FibroScan® method is based on Vibration Controlled Transient Elastography (VCTE™) technology. The device probe generates a mechanical impulse that propagates deep into the liver. The speed of this wave's movement depends on the liver's consistency ("stiffness"). This stiffness increases directly proportionally to the degree of fibrosis advancement.




Key features of FibroScan®

Advanced diagnostic capabilities in one device

Liver stiffness measurement (LSM)

LSM using the VCTE™ method measures stiffness at a shear wave frequency of 50 Hz. It is the standard for non-invasive assessment of liver stiffness and a marker of liver fibrosis, appropriate for all chronic liver diseases.

Controlled Attenuation Parameter (CAP™)

CAP (dB/m) measures the attenuation of ultrasound sent into the liver. It is a marker of liver steatosis. The CAP measurement range is from 100 to 400 dB/m.

Spleen Stiffness Measurement (SSM)

SSM measures stiffness in kPa at a shear wave frequency of 100 Hz. It is a marker of portal hypertension and is used for risk stratification of complications of liver cirrhosis and monitoring esophageal varices.

Advantages of the FibroScan® method for clinicians

Why doctors choose FibroScan®

Non-invasiveness

Fibrosis measurement is completely non-invasive, does not involve tissue damage or blood sampling. There are practically no absolute contraindications to the examination, and its performance carries no risks.

High consistency

Numerous scientific studies have shown high consistency in determining the degree of fibrosis advancement between the elastography method and histopathological examination of liver biopsy.

Fast results

The examination result is obtained immediately after its performance, allowing for quick diagnosis and treatment planning.

Objectivity

The result is an average of 10 measurements, which ensures an objective assessment and minimizes the risk of error.

Less influence of external factors

Elastography examination results are significantly less influenced by coexisting diseases, metabolic disorders, or medications used compared to biochemical methods of fibrosis assessment.

Versatility of applications

FibroScan® can be used not only for diagnosis in patients with recognized disease but also for screening to detect asymptomatic liver damage at an early stage.

Clinical application

FibroScan® offers wide diagnostic possibilities in many liver diseases

Chronic viral hepatitis

Assessment of fibrosis stage in patients with HBV and HCV infection. Monitoring disease progression and response to antiviral treatment.

Non-alcoholic fatty liver disease (NAFLD)

Quantitative assessment of steatosis (CAP) and fibrosis. Identification of patients with NASH and advanced fibrosis requiring further diagnostics.

Alcoholic liver disease

Diagnosis and monitoring of patients with ALD. Early detection of cirrhosis, allowing for prevention of complications and appropriate therapeutic management.

Autoimmune liver diseases

Monitoring fibrosis progression in autoimmune hepatitis, primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC).

Assessment before and after liver transplantation

Monitoring for recurrence of the underlying disease or development of complications after liver transplantation, such as rejection-related fibrosis or recurrence of viral hepatitis.

Screening

Early identification of patients with asymptomatic liver damage, especially in risk groups (type 2 diabetes, obesity, metabolic syndrome).

Indications for FibroScan® examination

FibroScan® is used to assess the degree of fibrosis and/or steatosis in a wide range of liver diseases and clinical situations:

  • Chronic viral hepatitis B and C
  • Fatty liver disease (NASH), currently MASLD/MASH
  • Alcoholic liver disease (ASH), currently ALD/MetALD
  • Primary biliary cirrhosis
  • Primary sclerosing cholangitis
  • Autoimmune hepatitis (ancillary method)
  • Liver storage diseases
  • Toxic liver inflammation
  • Cryptogenic liver inflammation
  • Monitoring patients after liver transplants
  • Unexplained elevation of AlAT and AspAT activity

FibroScan® examination is a dedicated system used as an aid in managing patients with confirmed or suspected chronic liver diseases. It helps assess fibrosis, steatosis, and the likelihood of cirrhosis and its complications (in the case of the 630 Expert model).

Patient preparation for the examination

  • The examination should be performed fasting or at least 3 hours after a meal (optimally after 4-6 hours).
  • The patient should bring medical documentation regarding liver and coexisting diseases.
  • Before the examination, the patient should lie on their back for at least 5 minutes.
  • Correct patient positioning: on the back, right hand under the head, right leg crossed over the left, body shaped like a banana.
  • The operator should sit on the patient's right side.
  • The probe should be placed in the intercostal space, between the armpit and the hip bone.
  • Avoid fatty tissue, lungs, and vascular structures.
  • Consistent maintenance of perpendicular probe position to the skin surface is necessary, as lack of perpendicularity can overestimate the liver stiffness result.

Advanced features and FibroScan® technology

  • Different probes (S, M, XL) adapted to the patient's anatomical conditions.
  • S probe designed for small children, XL probe for significantly obese patients.
  • Devices such as FibroScan 502 Touch® are equipped with M and XL probes, allowing for examination of obese patients.
  • Probe selection is partially automated based on the distance of the probe from the liver hilum or chest circumference.
  • Intuitive SmartExam™ and Guided VCTE™ functions for faster and simplified examinations.
  • Features include indicators identifying the optimal measurement site, AutoScan, SmartDepth, and Continuous CAP™.
  • Models such as 630 Expert have built-in ultrasound guidance to facilitate targeting both the liver and spleen.

Technical information

Detailed data for specialists

Interpretation of results

Fibrosis stage Value (kPa) Clinical interpretation
F0-F1 <7.0 No or minimal fibrosis
F2 7.0-9.5 Moderate fibrosis
F3 9.5-12.5 Advanced fibrosis
F4 >12.5 Liver cirrhosis

* Cut-off values may vary depending on the etiology of liver disease

Vibration-Controlled Transient Elastography (VCTE) Parameter

FibroScan uses Vibration-Controlled Transient Elastography (VCTE), which allows for measuring liver stiffness by assessing the propagation speed of a mechanical wave in liver tissue. Results are expressed in kilopascals (kPa).

Controlled Attenuation Parameter (CAP)

Steatosis stage CAP Value (dB/m) Interpretation
S0 <238 No steatosis (<10%)
S1 238-259 Mild steatosis (11-33%)
S2 260-290 Moderate steatosis (34-66%)
S3 >290 Severe steatosis (>67%)

Support for clinicians and interpretation tools

Comprehensive support for professionals

Echosens provides comprehensive support for FibroScan® operators:

  • The Echosens Academy platform (www.echosensacademy.com) offers:
    • Training modules
    • Video tutorials
    • Clinical webinars
    • Expert chat
  • Access to the platform is free after providing the device serial number.

Additionally, a free myFibroScan mobile application is available for iOS and Android:

  • Guides for interpreting liver stiffness and CAP results, based on peer-reviewed scientific publications.
  • Assistance for clinicians in decision-making, with bar charts of steatosis and fibrosis stages.
  • Access to results based on FibroScan® data, combining FibroScan parameters with biological markers:
    • FAST Score (LSM, CAP, AST) - identification of patients with suspected NAFLD (MASLD) at risk of active fibrotic NASH (MASH).
    • Agile 3+ Score (LSM, AST, ALT, platelet count, diabetes status, gender) - identification of advanced fibrosis in patients with MASLD.
    • Agile 4 Score (LSM, AST, ALT, platelet count, diabetes status, gender, age) - identification of liver cirrhosis in patients with MASLD.

Note: These tools are intended for licensed healthcare professionals and do not replace personalized medical advice. They should not be the sole basis for clinical decisions.

Interpretation of results and the role of the physician

The crucial role of the specialist in the diagnostic process

  • The elastography examination result should ALWAYS be interpreted by a physician specializing in liver diseases.
  • Interpretation must take place in the context of coexisting diseases, laboratory test results, and the patient's complete medical documentation.
  • FibroScan® examinations should be performed by an operator certified by the manufacturer or its representative.
  • FibroScan® is supported by a broad base of scientific evidence:
    • Over 4200 peer-reviewed publications
    • 180 international guidelines recommending its use
    • Recognized as the reference non-invasive solution for assessing liver fibrosis, cirrhosis, and steatosis in all etiologies of chronic liver disease

Recommendations from scientific societies

Recognition in international guidelines

European Association for the Study of the Liver (EASL)

EASL recommends non-invasive methods for assessing fibrosis, including FibroScan, as the first line of diagnosis in chronic liver diseases. Liver biopsy is recommended in cases of ambiguous non-invasive test results or suspicion of coexisting pathologies.

American Association for the Study of Liver Diseases (AASLD)

AASLD recognizes FibroScan examination as a useful tool in assessing liver fibrosis in patients with chronic hepatitis B and C and NAFLD. It recommends combining different non-invasive methods to increase diagnostic accuracy.

World Health Organization (WHO)

WHO recommends the use of non-invasive methods for assessing liver fibrosis, including FibroScan, in the diagnosis and monitoring of patients with chronic hepatitis B and C, especially in countries with limited access to specialized healthcare.

Scientific literature

Studies confirming the effectiveness of the method

Key publications

  • Sandrin L, et al.

    Transient elastography: a new noninvasive method for assessment of hepatic fibrosis. Ultrasound Med Biol 2003; 29:1705-1713.

    First publication describing the FibroScan technology

  • European Association for Study of Liver, et al.

    EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J Hepatol 2015;63:237-264.

    Comprehensive guidelines on non-invasive liver diagnostics

  • Wong VW, et al.

    Diagnosis of fibrosis and cirrhosis using liver stiffness measurement in nonalcoholic fatty liver disease. Hepatology 2010;51:454-462.

    Application of FibroScan in NAFLD

  • Tsochatzis EA, et al.

    Elastography for the diagnosis of severity of fibrosis in chronic liver disease: a meta-analysis of diagnostic accuracy. J Hepatol 2011;54:650-659.

    Meta-analysis on the diagnostic accuracy of elastography

  • Karlas T, et al.

    Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol 2017;66:1022-1030.

    Meta-analysis regarding CAP technology in steatosis assessment

Clinical application examples

Real-world cases from medical practice

Case 1: Chronic Hepatitis C

Male, 52 years old

Patient with newly diagnosed HCV infection, genotype 1b. Laboratory tests showed elevated AlAT (82 U/l) and AspAT (64 U/l) activity. FibroScan examination showed liver stiffness at 8.2 kPa (F2) and CAP 245 dB/m (S1).

Conclusions: Based on FibroScan results, the patient was qualified for antiviral treatment without the need for a biopsy. After completing therapy, the patient achieved SVR (sustained virological response), and a control FibroScan examination showed a decrease in liver stiffness to 6.8 kPa.

Case 2: NAFLD

Female, 48 years old

Patient with obesity (BMI 33.2 kg/m²), type 2 diabetes, and hyperlipidemia. Laboratory tests showed slightly elevated liver enzyme values. FibroScan examination showed liver stiffness of 13.2 kPa (F4) and CAP 320 dB/m (S3).

Conclusions: Based on FibroScan results, non-alcoholic steatohepatitis (NASH) with cirrhosis was diagnosed. The patient was referred for screening for hepatocellular carcinoma and esophageal varices. An intensive weight reduction and lifestyle modification program was implemented.