Enhanced liver fibrosis: A Blood Test for Liver Fibrosis

Introduction

Chronic liver disease (CLD) is a leading cause of death globally.

What is CLD??

Dr Lal Path Labs - LogoChronic liver disease is a disease process of the liver that involves a process of progressive destruction and regeneration of the functional part of liver leading to fibrosis and cirrhosis.

Chronic liver disease refers to disease of the liver which lasts over a period of six months.

Significant contributors include viral Hepatitis B and C (HBV, HCV), Alcoholic liver disease (ALD), and Non-alcoholic fatty liver disease (NAFLD), although several other factors also exist and some of these causes may co-exist.

Chronic liver disease takes several years to develop and the condition may not be recognised unless there is clinical awareness of subtle signs and investigation of abnormal liver function tests e.g SGOT, SGPT, GGT and many more.

Testing for chronic liver disease involves blood tests, imaging including ultrasound and a biopsy of the liver.

Risk factors for CLD

These differ according to the type of chronic liver disease.

  • Excessive alcohol use
  • Obesity
  • Metabolic syndromeincluding raised blood lipids
  • Health care professionals who are exposed to body fluidsand infected blood
  • Sharing infected needle and syringes
  • Having unprotected sex and multiple sex partners
  • Working with toxic chemicals without wearing safety clothes
  • Certain prescription medications

Management of patients with CLD requires assessment and staging of fibrosis to identify those most at risk and in need of treatment or lifestyle modification.

Suppression or reversal of fibrosis, and possibly even early cirrhosis, can restore liver functionality and minimize complications.

Biopsy has long been considered the gold standard for diagnosis, but in recent years significant limitations have been acknowledged that compromise both sensitivity and diagnostic accuracy.

Non-invasive alternatives to biopsy have recently become available, including both imaging modalities and blood tests.  Enhanced Liver Fibrosis (ELF) test is a novel blood test that measures levels of three direct markers [Hyaluronic acid (HA), Amino-terminal propeptide  of type III collagen (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1)] of fibrosis and utilizes an algorithm to generate a numeric score. Application of this score to patients with chronic liver disease allows physicians to better assess fibrotic progression and can significantly reduce the number of patients requiring biopsy.

Alternatives to Biopsy

In contrast to biopsy, which only evaluates approximately 0.002% of the total liver mass on average, blood tests offer the possibility of measuring the extent of total liver fibrosis, and can supply clinically relevant information.

ELF Test: A Multimarker Algorithm that Generates a Single Score

The ELF markers and algorithm were originally investigated and validated in a large study of over 1,000 patients with multiple forms of chronic liver disease, including HCV, ALD, and NAFLD, for the detection of fibrotic damage.

The ELF score provides a valuable enhancement over biopsy staging in that it more sensitive to disease status and change. ELF score thresholds have been identified in populations of patients with known chronic liver disease to identify these commonly used categories of fibrosis.

Conclusion

An accurate characterization of liver fibrosis is critical in the optimal management of CLD. Distinguishing patients with significant fibrosis from those with benign disease has historically required an invasive biopsy, which can still fail to accurately assess damage.

In addition, biopsy is associated with pain, risk, and substantial cost. The number of CLD patients is expected to grow substantially in the coming years, driven by anticipated increases in undiagnosed HCV infected patients presenting with advanced disease as well as the growing burden of NAFLD in many countries.

For this reason, a direct and reproducible blood test for fibrosis offers great clinical appeal. The ELF test has been clinically validated in a range of chronic liver disease states.

Routine adoption of the ELF test into clinical practice presents an appealing alternative to both biopsy and imaging modalities that require significant capital investment, a trained clinician, and limited patient access.

The test is exclusively available at Dr Lal PathLabs currently in India

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