SEQC Spanish Society of Laboratory Medicine

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• Early diagnosis reduces morbidity and mortality, possible complications, and the need for advanced therapies such as liver transplantation.

• Liver diseases, whose prevalence are increasing, are diagnosed in advanced stages, when symptoms have developed, which is associated with a poor prognosis in the short and medium term.

Liver fibrosis is one of the late manifestations of chronic liver diseases where liver tissue is replaced by scar tissue, as a result of inflammation caused by alcohol consumption, viral hepatitis, or metabolic syndrome, among other factors. This is a long process, with symptoms that can remain unnoticed for years, so its early identification would prevent its progression into cirrhosis and facilitate the selection of patients for referral to specialists. 

In this context, the Spanish Society of Laboratory Medicine (SEQC^ML), within the framework of the XXI Scientific Committee Conference, which was held on February 29 and March 1 in Seville, introduced the importance of early non-invasive detection of liver fibrosis in the course, “Use of non-invasive biomarkers in the detection and assessment of liver fibrosis for occult liver disease”. Additionally, the various available serum biomarkers were presented, as well as the role of the Clinical Laboratory in the screening and evaluation of fibrosis. 

Liver diseases affect a high percentage of the world's population. In the European Union alone, nearly 29 million people suffer from chronic liver disease, according to data from the World Health Organization (WHO). Currently, viral hepatitis uses biomarkers for reference diagnostic tests, and thanks to effective screening strategies and direct antiviral treatment, its impact has decreased significantly. 

On the other hand, for both alcoholic liver disease (alcLD) and fatty metabolic liver disease (metHD), no effective diagnostic biomarkers are currently available. This was noted by Dr. Armando Raúl Guerra, coordinator of the course of the XXI Conference of the Scientific Committee and president of the SEQC^ML Commission for Biochemical Assessment of Liver Disease, who noted the role of liver fibrosis as the main prognostic factor of both diseases. In his words, “Our screening efforts for occult liver disease should focus on the detection and assessment of the degree of fibrosis, mainly in those cases in which the lesion has advanced and constitutes an imminent danger to the patient's health, even though noother symptoms have yet been detected."

According to Dr. Manuel Morales (researcher at IDIBAPS, CIBERehd and RedFibro), member of the SEQC^ML Biochemical Assessment of Liver Disease Commission and physician at the Hospital Clínic of Barcelona, this screening would have a major health impact,since, as he stated, “early diagnosis of the pathology translates into a decrease in associated complications and a reduction in morbidity and mortality and the need for advanced therapies such as liver transplantation.” In this way, as Dr. Morales stressed, it would be possible to implement therapeutic interventions aimed at reducing the effects of causal factors, “the implementation of new lifestyles and diet, the optimization or initiation of treatments for diabetes or obesity. and monitoring for the appearance of future complications.” 

What is more, according to Dr. Morales, when establishing a screening strategy the inclusion criteria in these programs should be clarified. “In addition, it is necessary to carry out more cost-effectiveness studies that maximize all the causal factors and representation in different health systems.”

Paradigm shift

Today there is no established health policy for screening the population for liver fibrosis. However, according to Dr. Morales, “we are undergoing a paradigm shift with regard to the diagnosis of liver fibrosis, “which is translating into a need to establish screening strategies for fibrosis using non-invasive diagnostic markers.” In the opinion of Dr. María Patricia Sanz, member of the SEQC^ML Biochemical Assessment of Liver Disease Commission, this is particularly true in populations with a very high risk of metabolic liver disease, such as patients with type 2 diabetes, “who would benefit from referral to a Hepatology specialist.” 

Dr. Adrià Juanola Mayos, hepatologist at the Hospital Clínic of Barcelona, (IDIBAPS and CIBERehd researcher), defined non-invasive biomarkers as measurable and observable indicators in the human body that are used to detect, diagnose or monitor diseases or health conditions without requiring invasive procedures. These markers, according to the specialist, would allow the early detection of liver fibrosis "by reflecting the biochemical, molecular, and structural changes that occur in the liver during the development of the disease." 

In the words of Dr. Juanola, the main advantage of non-invasive markers is that obtaining them does not imply significant risks for the patient's health, since they do not require invasive procedures such as biopsies or other methods that may cause discomfort, pain or complications. “This makes them especially useful in early diagnosis at a population level, as well as monitoring the progression of the disease and evaluating the effectiveness of treatments, since they can be collected more frequently and less traumatically than invasive biomarkers.”

The work of the Clinical Laboratory is fundamental in the implementation, dissemination, and appropriate use of serum biomarkers for liver fibrosis. According to Dr. Laura de La Hoz, member of the SEQC^ML Commission for Biochemical Assessment of Liver Disease, the interpretation of the results by a Clinical Laboratory professional is critical fortaking full advantage of these markers, since various factors other than liver fibrosis can affect the results. “Comments added to the laboratory report can neutralize these deviations and protect the true value of these tests,” she explained. 

In the opinion of Dr. Armando Raúl Guerra, president of the SEQC^ML Biochemical Assessment of Liver Disease Commission, for this process to develop its true potential, “the physician must be involved from the beginning in the conception of the tests, the evaluation of their diagnostic performance, and in the design of related health strategiesin each Ministry and Healthcare Management entity. In addition, they must be involved in teaching and disseminating this tool among their clinical colleagues, whether in Primary or Specialized Care.”

With the implementation of serum fibrosis markers there is the opportunity to stop liver disease at an earlier stage, where, as Dr. Guerra recalled, “therapeutic interventions are of lower material and personal cost, and have the potential for a greater impact on improving the patient's quality of life."