SEQC Spanish Society of Laboratory Medicine

Spanish Society of Laboratory Medicine

VIII International Symposium of Laboratory Medicine and Quality Barcelona, April 15 and 16

29/11/2024

Experts defend role of Clinical Laboratory in development of personalized medicine

VIII International Symposium of Laboratory Medicine and Quality Barcelona, April 15 and 16
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• Laboratory Medicine allows us to detect changes in a patient's health and predict pathologies thanks to the study of biological variation and with the help of artificial intelligence and machine learning tools.

• The Symposium addressed all phases of the overall laboratory process, from the pre-analytical phase and the stability of samples to the importance of the information contained in the laboratory report in aiding clinical decision making.

Laboratory Medicine plays a crucial role in the development of personalized medicine, by allowing changes in the health of each patient to be detected through biological variation and personalized reference intervals. This is one of the conclusions shared by the renowned speakers during the VIII International Symposium on Laboratory Medicine and Quality, which was held on April 15 and 16 in Barcelona. 

At the event, organized by the Spanish Society of Laboratory Medicine (SEQCML) and sponsored by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), the news and issues of greatest interest in the different phases of Clinical Laboratory work, from the pre-analytical phase and the stability of samples to the importance of the Laboratory report in helping clinical decision-making. 

The work of the Clinical Laboratory has a broad range of applicability in the field of personalized medicine. In the words of Dr. Pilar Fernández-Calle, president of the Symposium Organizing Committee, president of the External Programs Organizing Committee and member of the Analytical Quality Commission of the SEQCML, a patientdiagnosis is obtained by comparing the result obtained with a reference. This reference is usually, as Dr. Fernández-Calle highlights, a reference interval obtained from a reference population to which the patient supposedly belongs. “However, there are cases in which the patient does not belong to that population (for example, because he or she is of a different ethnicity than the reference population), so that this element of comparison, the population reference interval, is no longer right for him or her.” 

According to Dr. Fernández-Calle, personalized medicine would consist of being able to individually link each patient with their own own reference intervals, “so that when there is a change in a test parameter it can be assigned to a change in their own health status, which may be different from another individual even if they belong to the same population.” 

In this context, the Clinical Laboratory, through biological variation and personalized reference intervals, "is a tool that can be used to provide this information, in continuous communication with the healthcare professional." In addition, the Symposium speakers shared the latest developments in artificial intelligence and machine learning, which are capable of generating predictive models for the development of diseases, such as diabetes, or the progression of a disease.

Sample transport 

In addition to focusing on the possibilities of personalized medicine, the speakers participating in the Symposium delved into key aspects related to the pre-analytical phase of the Clinical Laboratory, among them, the appropriateness of demand. “That is, the relevance of making a request regarding a specific patient at a specific time and its diagnostic validity,” as Dr. Fernández Calle explained. Likewise, the relevance of factors such as the transport time of the samples was shown, which, although sometimes considered as “secondary aspects”, have an important influence on the quality of the sample.

External Quality Assurance Programs 

Regarding the analytical phase, the Laboratory Medicine specialists stressed the importance of the standardization of the External Quality Assurance Programs for Clinical Laboratories, which constitute an essential tool for knowing and improving the analytical reliability of Clinical Laboratory results.As Dr. Fernández-Calle indicated, one of the ways to diagnose a patient is to use a cut-off point. “This cut-off point, such as 200 milligrams (mg) of cholesterol per deciliter (dL) of blood, which determines whether we are at desirable levels or not in terms of cardiovascular risk, is made in epidemiological studies with a method of measurement. However, if that measurement method is not interchangeable with others, that cut-off point should not be the same for all methods.” In this way, the aim is to ensure that all methods are standardized and that, when they give 200 mg/dL, the same result is obtained throughout the world. However, as Dr. Fernández-Calle pointed out, this is not always possible for all tests. Thus, what the organizers of the External Quality Assurance Programs do is detect these differences, identify whichtest typeshave problems, and raise awareness among scientists and in vitro diagnostic providers, so as to work towards achieving the harmonization and standardization of these methods and being able to use that single cut-off point. The problem is that this is unknown to clinicians, but not to laboratory specialists, and we must work side-by-side in this, according to Dr. Fernandez-Calle's presentation. 

Harmonization of laboratory reports

Finally, Laboratory Medicine specialists addressed the need to standardize laboratory reports, which transcend their function as simple issuers of numerical results. Right now, as Dr. Fernández-Calle evidenced, “any report that reflects a numerical value is not taking advantage of all the knowledge and all the tools that the laboratory hasat its disposal to help in clinical decision-making.”

A major effort is being made to transmit and make health professionals aware of the extent of the Clinical Laboratory’s knowledge. This is how Fernández-Calle explained it: “A clinical guideline on the diagnosis of myocardial infarction or diabetes cannot be prepared by establishing cut-off points without the laboratory being involved because clinicians are unaware of many of the aspects that are influencing the methods and patient results. For example, clinical studies may have been carried out with a method whose results are not transferable to others. “These types of particularities are only known by the Clinical Laboratory and it is, therefore, very important that laboratory specialists are present in all these fields because this adds value to the specialty of Laboratory Medicine and, above all, offers greater security to clinicians and patients. ”