Доступные курсы

Harmonisation of Autoimmune tests

Speaker: Joanna Sheldon (UK)
Moderator: Tommaso Trenti (IT)

Date: 24th September 2019 at 18:00

Abstract:

The importance of standardisation is only just being realised and addressed in autoantibody measurements.  Immunoglobulins have a high degree of molecular heterogeneity, there are subclasses of IgG and IgA, and the affinity and avidity of antigen-antibody binding can vary both between and within individuals.  An immune stimulus may generate a monoclonal, oligoclonal or polyclonal response and this pattern of response will vary between individuals and even within an individual over the disease course.  There are multiple methods available for autoantibody detection which will vary in their abilities to detect different types of immunoglobulins.  Finally, the antigen to which we are trying to measure antibodies is usually a protein with its own molecular heterogeneity which may also be influenced by the source of the antigens and the preparation process.  Considering these complexities, it is unsurprising that there is marked variation in autoantibody concentrations measured with different methods.  However, the increasing reliance on automated quantitative autoantibody results has made standardisation or harmonisation of these tests vital.  The IFCC through a working group and more recently a committee have been integral to investigating and producing certified materials for IgG anti myeloperoxidase (ERM-DA476/IFCC) and IgG anti proteinase 3 (ERM-DA483/IFCC) with values assigned in mg/L, traceable to ERM Da 470k/IFCC (the certified reference materials for IgG).  Evaluation of patient samples showed that use of these materials will give a significant reduction in the spread of the numerical results over different methods.  However, there was only 30% concordance between positivity and negativity of results when interpreted with respect to each methods reference ranges.  The introduction of certified reference material (CRM) will be the essential first step in standardisation of autoantibody testing and although it does not solve every issue, it should give us a point of reference to identify the other components of the methods that need to be harmonised before we can have comparability in autoantibody results.

How should a medical laboratory specialist prepare for accreditation according to the ISO 15189

Speaker: Diler Aslan (TR)
Moderator: Sedef Yenice (TR)

Date: 8th October 2019 at 18:00 CET

Abstract

The “ISO 15189:2012 Medical laboratories – Requirements for quality and competence” Standard is globally accepted accreditation standard for medical laboratories. It is based upon the “ISO 9001 Quality management systems – Requirements” and “ISO 17025 General requirements for the competence of testing and calibration” Standards. The last versions of these standards, ISO 9001:2015 and ISO 17025:2017, focus on process approach and risk-based thinking, and they can be adapted more easily to the “Plan-Do-Check-Act” Cycle that is the fundamental continuous quality improvement tool. It is expected that the next ISO 15189 version has the similar approach since the ISO 9001:2015 is a high-level structure standard in quality management. In this context, if the "Total Testing Process" of a medical laboratory and sub-processes (pre-pre-, pre-examination/analytical, examination/analytical, post-, post-post-examination/analytical processes) are established according to the “Business Process Management” principles, the requirements of ISO 15189 can be fulfilled. Laboratory accreditation impacts positively on patient care and health system if it is executed at the laboratory, health institution, and national levels in a coordinative manner. This positive effect depends upon the knowledge, skills and competencies of the laboratory specialists and/or laboratory professionals. In this webinar, we will try to explain: 1) how to establish the total testing process and its sub-processes of a medical laboratory (also for a specific analyte that has inherent characteristics) according to the process approach and risk-based quality control; 2) how to correlate the process components to the requirements for the ISO 15189; and 3) which knowledge and competencies are necessary according to the requirements of the ISO 15189.

Учитель: Ada Aita, Diler Aslan

Monitoring of Internal Quality Control System Using Patients’ Data

Speaker: Abdurrahman Coşkun
Moderator: Merve Sibel Gungoren

Date: 18th June at 18:00 CET

Registration is open (enter the course to register).

How to enter the course?

Internal quality control (QC) is the backbone of quality system in laboratory medicine, which serves to validate patients test results. However, it monitors the system intermittently, not continuously. Classical QC monitoring system depends on periods such as weeks, days, or predetermined time intervals and therefore detects some but not all analytical defects. In this situation, we have not much information about what is going on between these periods. To overcome this problem, we need a real-time monitoring system to detect the possible errors while the instruments are running.

Autoverification programs evaluate and release test results as soon as they receive data from the instruments. Therefore, when we detect errors using classical QC monitoring system, the test results of a large number of patients might have been reported to clinicians and/or patients already. This is a major risk for patients’ safety and when we detect errors, it wouldn’t be easy to re-analyse all reported patients’ samples. 

The devil is in the detail. We should monitor the system continuously using a suitable algorithm based on patients’ data. The aim of this webinar is to raise awareness for the necessity to monitor analytical instruments continuously while reporting test results. 

Unmet clinical needs

Unmet clinical needs assessment for biomarker evaluation - a practical toolbox for Laboratory Medicine.

Speaker: Phillip Monaghan (UK)
Moderator: Christa Cobbaert (NL)
Date: 23rd April 2019 at 18:00 CET

Registration is open (enter the course to register). 

How to enter the course?

The translation of promising biomarkers to clinical application is a critical opportunity for laboratory medicine; to provide information that enables clinicians to make better decisions about the care of their patients. The realisation of this goal is itself critically dependent on the appropriate evaluation of novel biomarkers for use in the clinical setting.

Inherent to this concept is consideration of the unmet clinical need that a laboratory test is aiming to address.  However, as testing guides downstream clinical interventions to improve patient outcomes, the link between testing and outcomes is often indirect. As such, a full mapping of the clinical care pathway to define the purpose and role of the laboratory test and importantly, the clinical management decisions that the test will inform, thus enables the unmet clinical need to be addressed and furthermore complemented by the anticipated impact on patient outcomes.

The corollary from this approach is the early specification of analytical and clinical performance criteria to subsequently evaluation studies in a cyclical manner, keeping the clinical care pathway and outcomes as the key drivers in the process. In doing so, biomarker development can be aligned to address existing gaps in clinical care and mitigate research waste and inappropriate utilisation of laboratory tests where clinical benefit is uncertain or at worst potentially harmful.

There is a major opportunity here for laboratory professionals to play a key role in the development and implementation of clinical care pathways for new and existing laboratory tests. Stakeholder involvement; working together to overcome the conventional silos across disciplines is paramount to drive the adoption of innovative tests with robust implementation planning, so that test results are available and acted upon in an appropriate and timely manner, with a strong link to clinical intervention and outcomes. To realise the value of laboratory medicine in this context, the EFLM Working Group for Test Evaluation (WG-TE) has developed a ‘practical toolbox’ providing a Test Evaluation Framework and Interactive Unmet Clinical Needs Checklist (hosted on the EFLM eLearning platform) to assist laboratories and other key stakeholders in clinical translational research, to undertake clinical needs assessment and clinical care pathway development.



New parameters of hematology analyzers and their clinical significance

Speaker: Johannes (Hans) Hoffmann (DE)
Moderator: Giuseppe Lippi (IT)

Date: 12th Fbruary 2019 at 18:00 CET

Abstract

Modern hematology analyzers do much more than just counting blood cells. Practically all instruments currently available also perform a white blood cell (WBC) differential and they produce flags or alerts for possible morphological abnormalities. Hematology analyzers have completely replaced traditional methods of cell counting and microscopic blood smear examination for the vast majority of blood samples.

In addition to these capabilities, hematology analyzers generate an ever-increasing amount of raw data, which can be transformed into cell parameters, for which no historical equivalent exist. This trend already started in the early days when measuring and reporting mean red cell volume (MCV) became possible. MCV has evidently established its clinical significance, due to the crucial role in classifying anemia. After MCV, many other parameters have been developed, not only for red blood cells, but also for platelets and white blood cells. However, in contrast to MCV, the clinical relevance of many of the new parameters is still unclear. Hematology analyzer manufacturers are generally launching these new parameters as research tools, without the slightest clue whether they can be of clinical value. This then opens possibilities for laboratory professionals examining the potential clinical significance of such parameters. Unfortunately, this type of research is plagued by serious challenges: most of the new parameters are not internationally standardized, limiting their widespread use in clinical practice. Sometimes the parameters depend on a certain technology, meaning that only laboratories using a specific make of hematology analyzer can use the parameter. And last but not least, some parameters are even specific for one individual hematology analyzer; other analyzers of the same model may produce different results and thus require separate clinical validation. An example of the latter are the so-called cell population data that have attracted a lot of interest in recent years; some interesting and promising applications were described, but one should also be aware of the limitations of this type of parameters.

The primary aim of this presentation is to discuss the technological principles used by the major hematology analyzers and to demonstrate how these technologies generate new cellular parameters. The second part will focus on understanding the potential use and limitations of new parameters, which are essential for researchers who are interested in investigating their clinical application. 

Sepsis Biomarkers

Speaker: Giuseppe Lippi
Moderator: Dirk Roggenbuck
Recorded on 22nd January

Abstract: Sepsis is a severe, often life-threatening, condition developing when the organism’s response to an infection triggers a paramount biological effect, which finally generate injuries to its own tissues and organs, up to septic shock, multi-organ failure (MOF) and death. Evidence has been provided that the measurement of some biomarkers in serum or plasma may have clinical values for diagnosing and monitoring sepsis. Consensus has now been reached that procalcitonin is the biomarker for which the most solid evidence has been garnered, that whatever sepsis biomarkers shall always be available on prescription, that test results should always be interpreted according to clinical data, and that test ordering should follow specific biomarker’s kinetics. Sepsis biomarkers assessment may be sometimes combined for diagnosing sepsis. In such case, the combination of procalcitonin with C reactive protein (CRP) or presepsin is the most widely suggested. Sepsis biomarkers should be integrated into diagnostic threshold, prioritizing the high negative predictive value and based on analytically sensitive techniques. Evidence is also strongly emerging that some of these biomarkers, especially procalcitonin and presepsin, may retain clinical usefulness for antibiotic stewardship, and that serial testing shall be set according to biomarker’s kinetics. The assessment of biomarkers other than procalcitonin, presepsin and CRP is now discouraged, at least until stronger evidence will be published. Molecular biology techniques are also emerging as potential alternatives for rapid etiological diagnosis of infections. Further refinements of molecular assays would probably help overcoming the current limitations of their diagnostic performance.
Учитель: Giuseppe Lippi

Pre-analytical mysteries

Speaker: Pieter Vermeersch (BE)
Moderator: Janne Cadamuro (AT)

Recorded on 27th November 2018 at 18:00 CET

Abstract: The pre-analytical phase is the major source of errors in the total  testing process. The fact that many of the processes take place outside of the direct control of the laboratory and the involvement of different parties such as patients, clinicians, phlebotomists and logistics personnel make keeping the preanalytical phase under control a major challenge. The EFLM Working Group for the Preanalytical Phase has in recent years issued a number of recommendations and guidelines with the to improve standardization and harmonization of the preanalytical phase in Europe. While recommendations and guidelines are important to improve the overall quality, the devil is often in the detail. Laboratory professionals must continue to keep a careful eye (or two if they can spare them) on the preanalytical phase. The aim of this webinar is to make participants aware of the wide range of possible causes of preanalytical errors, both outside the laboratory and inside the laboratory  and illustrate these a number of mysteries from routine practice which ultimately allowed the identification of a pre-analytical problem.


Учитель: Janne Cadamuro

Catheter Blood Collection Practices: Can A High Quality Sample for Laboratory Diagnostics Be Obtained?

Speaker: Stephen Church (BD) ; on behalf of the EFLM Working Group on the Preanalytical Phase (WG-PRE)

Moderator: Zorica Sumarac (SRB)

Recorded on 18th September 2018 at 18:00 CET

Abstract:

Vascular Access (VA) is a routine procedure, conducted worldwide, with an estimated 60-90% of hospital inpatients expected to require an intra-venous catheter (Helm et al., 2015), particularly in emergency situations or departments.  A number of vascular access devices (VADs) or IV catheters could potentially be used to collect blood samples, including peripherally-inserted venous catheters, centrally-inserted venous catheters and arterial catheters.  Practices and procedures for blood collection from conventional blood collection needles are well defined (Simundic et al., 2018).  Until recently, many guidelines have not commented on or proposed a best practice for collection from a VAD. The CLSI document GP41-A6 (2007) stated that without complete, thorough and documented training, “Phlebotomists should not draw blood from VADs.”  However the 2017 edition, GP41-A7, is the first to make recommendations for blood collection using VADs.  Trauma from VAD insertion, together with a tortuous blood path with increased shear forces, can contribute to increased cell lysis.  Further incomplete flushing of the collection site resulting in contamination and/or dilution of the specimen has the significant potential to create test errors and inaccurate results. While haemolysis is the most widely reported error (Lippi et al., 2011), impacts on coagulation parameters have also been reported (Strauss et al., 2012).  Furthermore, the collection may lead to dislodgement of the catheter and require a replacement.  In special circumstances, for example when obtaining samples from paediatric patients, adults with difficult venous access, presence of bleeding disorders or when serial tests are requested, blood collection from a short peripheral catheter may be clinically beneficial. In these patients, guidance on the best practice is required to ensure patient safety and care. 

This webinar will overview the risks associated with blood collections from VADs, the type of VAD from which samples may be collected and also provide recommendations on best practices to obtain the highest quality sample and ensure patient care.

The order of draw

Speaker: Michael Cornes (UK)
Moderator: João Tiago Guimarães (PT)

Recorded on 15th May 2018

Abstract

National and international (WHO, CLSI) guidelines recommended that order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes for example sodium citrate or more commonly potassium EDTA (K3EDTA).

These recommendations are based on a case report by and a follow up study by Calam and Cooper in 1982 which reported that incorrect order of draw caused hyperkalaemia and hypocalcaemia. By measuring EDTA, it has been demonstrated that reverse order of draw of blood samples using closed loop venesection systems does not cause EDTA contamination. It is difficult to reconcile the directly conflicting results of these studies but it may be that reversed order of draw using poor technique and/or difficult venepuncture may result in sample tube cross-contamination.

It has been shown that contamination is still relatively common and may be difficult to identify. As this is not due to reversed order of draw of blood samples in a closed loop system other mechanisms must be in operation. Here I will present the evidence for and against the need to follow an order of draw.

Учитель: Mike Cornes

The role of EQA in the verification of in vitro medical diagnostics

Presenter: Federica Braga (IT)
Moderator: Anne Stavelin (NO)

Recorded on 17th April 2018

The participation to EQA schemes that meet specific metrological criteria is mandatory for the evaluation of performance of participating laboratories in terms of standardization and clinical suitability of their measurements. The requirements for this type of EQA are as follows: in addition to the use of commutable control materials, it is necessary to assign values (and uncertainty) to them with reference measurement procedures (RMP) performed by an accredited laboratory and to define and apply clinically allowable performance specifications to verify the suitability of laboratory measurements in a clinical setting. Unfortunately, there are few permanent EQA programs covering these requirements because some practical constraints including technical, psychological and economic aspects, which limit their introduction. It is, however, clear that these aspects should be immediately solved. Indeed, EQA schemes are in a unique position to add substantial value to the practice of Laboratory Medicine, by identifying analytes that need improved harmonization and by stimulating and sustaining standardization initiatives that are needed to support clinical practice guidelines. This will definitively help those manufacturers that produce superior products to demonstrate the superiority of those products and oblige users (and consequently industry) to abandon assays with demonstrated insufficient quality.

Учитель: Federica Braga

How to perform tube validation?

Recorded on: 3rd April 2018 at 18:00 CET

Speaker: Tiago Guimaraes
Moderator: Giuseppe Lippi

Abstract:

Every laboratory has to be aware of the need to validate the tubes it is using.

The importance of the pre-analytical activities is well known but sometimes not valued.

For tube validation each place has to set its own objectives according to its particular needs.

The EFLM Working Group on pre-analytics tries to help in setting some consensus on these aspects.

A EFLM Recommendation on this is being prepared.


M-protein diagnostics of Multiple Myeloma patients treated with biologics

Speaker: J.F.M. (Hans) Jacobs (NL)

Moderator: Christopher McCudden (CA)

Recorded on  27th March 2018 at 14:00 CET

Treatment of multiple myeloma (MM) has substantially changed with the recent introduction of therapeutic monoclonal antibodies (mAb) which have further improved the rates and depth of clinical response. mAb therapy in MM patients has introduced new challenges in how therapy responses can be defined. On the one hand, recently approved mAb interfere with routine M-protein diagnostics. On the other hand, given the high rates of complete responses, new response categories need to be defined to measure minimal residual disease. As a reaction to these challenges research has focused on adaptations of conventional M-protein diagnostics to mitigate interference and on the introduction of novel methods that enable the identification of minimal residual disease. The aim of this e-seminar is to discuss how mAb therapy has changed both the therapeutic as well as the diagnostic landscape of MM. 

Reliable estimates of biological variation

Speaker: Aasne Karine Aarsand (NO)
Moderator: Bill Bartlett (UK)

Recorded: 06-03-2018 at h. 18.00 CET

Biological variation (BV) data has many appliances in the daily laboratory life, being used both when evaluating the diagnosis and monitoring of disease and for setting analytical performance specifications. Thus, the quality of our work directly depends on the reliability of the BV estimates used as basis for these processes. Widely varying BV estimates are available for different measurands, and it is likely that this may be caused by differences in study design and statistical handling. Addressing this issue, the EFLM established in 2014 an EFLM Task and Finish Group (TFG) for the Biological Variation Database. The TFG is made up by members from the EFLM Working Group on Biological Variation, the Analytical Quality Commission of the Spanish Society of Clinical Chemistry and experts in the area. The TFG has developed a critical appraisal list for evaluation of studies on BV and this will be used as basis for the setup of a database with measures of BV, the derived performance specifications and the evidence behind it.


Учитель: Aasne Aarsand

Faecal Haemoglobin: Newer Approaches to Screening and Diagnosis of Colorectal Disease

Speaker: Callum G. Fraser (UK)
Moderator: Sally C Benton (UK)

Date: 23rd January 2018 at h. 18.00 CET

Registration is open (enter the course to register).

How to enter the course?

Abstract: Colorectal cancer (CRC) is still a very important health problem world-wide.  It is the third most common cancer and the fourth leading cause of cancer-related death. Fortunately, many screening programmes have now been set up to detect neoplasia in those who do not have any symptoms of bowel disease. These programmes lead to early detection of CRC and its precursors, which significantly improves outcomes.  There are a number of strategies available for CRC screening, but faecal immunochemical test for haemoglobin (FIT) are now considered as the best currently available non-invasive investigation and are being widely established.  FIT are available in two formats, qualitative FIT and quantitative FIT: the former are often used in opportunistic screening, whereas the latter are widely used in population-based programmatic screening. Quantitative FIT have many advantages, a major benefit being that the faecal haemoglobin concentration (f-Hb) can be estimated. This Webinar will explore the diagnostic accuracy of FIT, and factors affecting f-Hb, including age, sex and socioeconomic status.  The difficulties in selecting the f-Hb cut-off to be used for CRC screening will be addressed in detail.  

However, most CRC are not detected through screening programmes, but when a person with symptoms seeks medical advice. The symptoms of serious bowel disease are very common presentations in primary care, but most with these do not have serious disease. Generally, people with symptoms are referred to secondary care for colonoscopy, which is inadequate in many countries. A particular problem is that the number of patients with symptoms being referred from primary care is increasing rapidly, in large part due to local, regional and national campaigns raising awareness of the need to get symptoms investigated. This Webinar will discuss the significant evidence now available that demonstrates that triage using FIT at a low cut-off around 10 μg Hb/g faeces has the potential to correctly rule-out CRC and avoid colonoscopy in many symptomatic patients. Importantly, secondary care referral following a positive FIT allows the identification of other significant bowel pathology in patients who are found not to have CRC, mainly inflammatory bowel disease. This very recent use of FIT is an excellent example of translation of research into clinical practice: the first study investigating the use of quantitative FIT using numerical data on f-Hb was published on-line in 2012 and, only five years later, a national guideline has recommended its use in routine clinical practice.

Учитель: Callum Fraser

Laboratory hemostasis

Speaker: Giuseppe Lippi (IT)

Recorded on 19th December 2017 at h. 18.00 CET

Hemostasis is a complicated mechanism finalized to preventing unjustified bleeding during vascular injury, or unwarranted thrombosis when the vessels are substantially intact. Hemostasis is typically classified in two essential steps. The first event is an endothelial injury, which activates primary hemostasis and is then followed by activation of secondary hemostasis. Specifically, primary hemostasis develops with recruitment of a many platelets being at site of vascular injury. Platelets are subjected to a sequential process of activation, adhesion and aggregation. This initial hemostatic plug is however unstable, since it is vulnerable to fast dissolution within in the local blood, especially in arteries. To prevent dissolution, additional fundamental mechanisms of secondary hemostasis (also known as blood coagulation) are activated, with the aim to stabilize the initial plot by large fibrin deposition.

The diagnostics of bleeding disorders of primary and secondary hemostasis remains a challenge for laboratory professionals, especially those lacking experience background, experience and skill on this topic. Bleeding is essentially due to many acquired or congenital conditions, impairing either primary or secondary hemostasis. A universal consensus on the diagnostics of bleeding diseases remains an unmet target, so that the aim of this Webinar is providing practical guidance for laboratory professionals who are less familiar with this important area of in vitro diagnostic testing. A practical strategy for diagnosing bleeding disorders of primary and secondary hemostasis is necessarily based on a multifaceted and multistep strategy, entailing accurate personal and family history collection, interpretation results of the so-called first-line hemostasis tests, then followed by interpretation (when necessary) of second- and third-line test to identify the both nature and severity of bleeding disease.

The observation of profound hemorrhages rather than muco-cutaneous bleeding suggests a disorder of secondary hemostasis. Although positive family history can be frequently seen in patients with congenital disorders, the absence of clinically significant symptoms in relatives cannot be considered always suggestive of acquired disorders. The next phase is based on performance of the so-called first-line coagulation tests, mainly represented by activated partial thromboplastin time (APTT), prothrombin time (PT) and fibrinogen, especially when the family history is not indicative of specific factor deficiencies. The observation of abnormal results of these tests and the combination of results can help driving performance of the so-called second-line tests, which especially entail clotting factor assays. The so-called third-line tests (especially entailing immunologic tests of coagulation factors and molecular biology) are then useful to make a final diagnosis and/or for detecting the specific nature of the protein deficiency.

Учитель: Giuseppe Lippi

Harmonization of preanalytical phase in Europe

Speaker: Ana-Maria Simundic (HR)
Moderator: João Tiago Guimarães (PT)

Recorded on 21st November 2017 at 18:00 CET

European National Societies, members of EFLM, have agreed in Porto, during the 3rd EFLM-BD European Preanalytical Phase Conference that harmonization of preanalytical practices and policies is necessary and possible in each and every country in Europe as well as internationally, at the European level. The Working group for Preanalytical phase (WG-PRE) of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM), has taken the leading role in this process. The aim of this e-seminar is to present past, ongoing and future WG-PRE activities and various projects which aim is to improve the quality of preanalytical phase in Europe as well as to promote wide harmonization of preanalytical practices, patient safety improvement and reduction of unnecessary waste and healthcare expenses.

Учитель: Ana-Maria Simundic

The development of guidelines and recommendations for peripheral blood film review internationally

Speaker: Anna Merino (ES)
Moderator: Ciriaco Carru (IT)

Recorded at  7th November 2017 18:00 CET

With the advance of the technology of hematology analyzers, the indications for peripheral blood film (PBF) review by an expert have declined, but still remain essential. PBF review contributes to the following: 1) Complements/validates the findings of automated hematology analyzers, 2) Provides information on hematologic abnormalities that cannot be assessed by the current hematology analyzers, 3) Abnormal red cell morphology detection, 4) Identification of blasts, lymphoma or other abnormal cells, 4) Platelet clumping or abnormal platelet morphology inspection and 5) Dyshematopoiesis detection. Some examples are provided in the presentation. It also discusses on some issues related to who performs the PBF review.

 The PBF review by laboratory technologists validates hematology analyzer flags and identifies specific cells or qualitative abnormalities that cannot be identified by hematology analyzers. In addition, technologists triage blood films that require expert morphology review. The contribution of the pathologists is relevant since they are able to make a specific diagnosis, provide differential diagnosis, and/or recommend further testing based on all hematologic quantitative and qualitative values. In addition, they can summarize the findings in a narrative interpretation that becomes part of patient’s medical chart.

 The International Council of Standardization in Hematology (ICSH) is developing standards, guidelines and recommendations in peripheral blood film review internationally, which can provide the following benefits for pathologists: 1) Define the role and standardize the expectations of laboratory physicians, 2) Narrow the indications for PBF review by pathologists to those that contribute to patient care, 3) Provide a framework for reporting and 4) Opportunity for national and international collaboration & advancement of the field. Some of the ICSH recommendations are discussed in the presentation.



Учитель: Anna Merino

Hepatic fibrosis assessment using multiparametric biomarker tests

Webinar recording + quiz.

Speaker: Ralf Lichtinghagen (GER)

Moderator: Merve Sibel Gungoren (TR)

Recorded at 18th October 2017

The stage of fibrosis is the most important single predictor of significant morbidity and mortality in chronic liver disease. The mechanisms leading to fibrosis and eventually cirrhosis are thought to be similar, irrespective of the underlying etiology. At cellular level, hepatic stellate cells (HSC) undergo a phenotypic switch usually addressed as transactivation. Activated HSC are regarded as the main source of extracellular matrix (ECM) in the fibrotic liver. Additional cell types namely fibroblasts and myofibroblasts may also contribute to ECM deposition. Despite the similarities in pathophysiology at cellular level, morphogenesis and histologic appearance of the fibrotic liver may differ according to the etiology.

Liver biopsy remains the gold standard to evaluate liver fibrosis. Not least, one has to keep in mind that liver biopsy provides additional information like histological grading and etiology that may be overlooked when surrogate markers are used. Ideally, those tests should answer two questions. 1) What is the stage of fibrotic organ damage (i.e. the amount of deposited ECM and the disturbed balance of hepatic microarchitecture)? 2) What is the net balance between ECM deposition and degradation (i.e. the dynamics of ECM turnover)? The former serves to evaluate the prognosis and indicate therapy, while the latter might be used to control the efficacy of treatment with regard to disease progression.

Many different parameters including standard clinical chemistry and parameters of matrix metabolism have been evaluated. In the last decade, markers were assembled to multiparametric scores. Here, we can distinguish scores assembled of standard clinical chemistry markers (e.g. aspartate aminotransferase-to-platelet ratio index, FibroTest, Forns’ index) from scores using circulating markers of hepatic matrix metabolism like hyaluronic acid (HA), tissue inhibitor of metalloproteinases-1 (TIMP-1), matrix metalloproteinase-2, propeptide of type III procollagen (PIIINP).

In the webinar we will learn further details about the relevant complex scores, the clinical evaluation and current practical guidelines.

Учитель: Ralf Lichtinghagen

Patient with shock and multiorgan failure

A 66-year-old woman was admitted to our hospital with shock and multiorgan failure. She was resident in the United States, in a rural area of New Jersey. She had been on vacation in Europe for 3 weeks and had suffered fever and chills for 1 week, and nausea, vomiting and abdominal pain for 2 days.On admission she showed respiratory, hepatic and renal failure, anemia, lymphopenia, thrombocytopenia, high lactate dehydrogenase (3500 IU/L; normal: 250–450) and negative direct and indirect Coombs test.The peripheral blood (PB) film revealed the diagnosis of the patient. Some interesting images of the morphological findings in blood cells will be discussed during the presentation. It will be useful for the participants to learn about the differential diagnosis in this special case, since the abnormalities that we found in blood cells can be easily confused with those of other more frequent disease. Diagnosis can be challenging and therefore knowledge of the distinguishing clinical features and epidemiology of these diseases is important. In addition to morphology, an adequate clinical history is important for speedy and accurate diagnosis.

Учитель: Daniel Rajdl

Biomarkers in HF: How to Guide Clinicians

Biomarkers that are surrogates for cardiac pathophysiology may help us understand the "state of the heart" in heart failure and may be indications for certain treatments. A good biomarker will also be able to be monitored and a change in the level will reflect a change in the condition. I will speak of three biomarkers that do exactly this (natriuretic peptides, high sensitivity troponins and sST2). Natriuretic peptides (NPs) (BNP and NTproBNP) are guideline standards to confirm the diagnosis of heart failure. They are good for monitoring volume as we diurese the patient. Their weaknesses include wide variability in levels in a given patient as well as elevations not secondary to an increase in left sided filling pressures. Additionally, their value is questionable in patients receiving Entresto (a drug that inhibits breakdown of NPs). High sensitivity troponin in the setting of acute heart failure (and maybe chronic) represents subendocardial necrosis and has a bad prognosis. It is possible that drugs like nitrates will be used in heart failure treatment more commonly when levels of high sensitivity troponin are high. Finally, sST2 is a marker of fibrosis and is elevated in virtually all patients with heart failure. In the acute setting, it defines a "sicker" patient who needs advanced treatment to avoid re-hospitalization. In the chronic setting, titrating medication to a sST2 level below 35 ng/ml appears to mitigate risk, even in the setting of a continued high NP level. Data with Entresto suggest sST2 levels are going to be useful in both selection of patients for Entresto as well as monitoring treatment and maybe regulating the dose.

Учитель: Daniel Rajdl

Non-fasting lipid profiles: implications for lipoprotein testing and reporting

Fasting blood samples have been the standard for measurement of triglycerides and cholesterol, despite the fact that we spend the vast majority of our time in non-fasting conditions. However, when recent studies suggest that postprandial effects do not substantially alter lipid concentrations and do not weaken, and even may strengthen, their association with cardiovascular risk, then a non-fasting blood draw has many practical advantages. Non-fasting cholesterol measurements include the ‘remnant cholesterol’ fraction, a strong risk factor for developing atherosclerosis independent of LDL cholesterol. Remnant cholesterol reflects the cholesterol in chylomicron- and VLDL-remnant particles and it is included in the ‘non-HDL cholesterol’ calculation.
Until recently, most guidelines focused on targeting primarily LDL cholesterol for the prevention of cardiovascular disease, but they now recognize that non-HDL cholesterol (or apolipoprotein B, the molecule carried by all non-HDL particles) is a more accurate and comprehensive predictor of atherogenic lipoprotein-related risk.
In 2016, the European Atherosclerosis Society (EAS) and EFLM Joint Consensus Panel recommended using non-fasting lipid testing for routine clinical practice and provided specific cutpoints for desirable fasting and non-fasting lipid concentrations to be reported by the laboratories uniformly.

Учитель: Daniel Rajdl

The estimate of measurement uncertainty

The estimate of measurement uncertainty is important in Laboratory Medicine because it is required for reference measurement laboratories to obtain/maintain the accreditation according to ISO 17025:2003 and ISO 15195:2005 and for clinical laboratories to obtain the accreditation according to ISO 15189:2012. There are two approaches to estimate measurement uncertainty, the so-called ‘bottom-up’ and ‘top-down’ approaches.

Rational use of laboratory tests

At the beginning of 2015 the monograph “Rational Ordering of Laboratory Parameters” in Slovak language has been issued. The monograph with 185 pages from 4 editors and 18 authors represents an attempt to create a common denominator contributing to the consensus between clinicians, laboratory specialists and healthcare providers. This webinar discusses common problems in rational ordering of laboratory test.

Учитель: Daniel Rajdl

5 ways how to use e-learning in laboratory medicine effectively

E-learning offers a broad variety of tools that can bridge information gap between these worlds. In this interactive webinar, we will cover following objectives:

  • overview of basic tools used in e-learning
  • familiarize attendants with 5 commonly used ways of delivering content by e-learning (webinar, voice-over presentation, quiz, user generated content + social media, e-book)
  • give examples and practical hints for creating attractive educational materials

Учитель: Daniel Rajdl

Management of the quality in the pre-analytical phase

The preanalytical phase is the main contributor to diagnostic errors. Modifying staff behaviour to conform to venous specimen collection practice guidelines and other recommended practices has proved to be a difficult task.

Учитель: Daniel Rajdl

The end of laboratory medicine as we know it? [2nd EFLM Strategic Conference in Mannheim]

2nd EFLM Strategic Conference in Mannheim

Handling disruption of Laboratory Medicine in digital health

  • the impact that the on-going digitalization of technologies and a digitalized society on the medical laboratory in future health care
  • changing our capabilities to compile, integrate and visualize complex diagnostic data
  • providing the opportunity for radical changes to diagnostic health strategies.

With the digital revolution spreading into every realm of modern medicine, we will experience a democratisation of health care, i.e. a comprehensive data usage not just being in the hands of health care professionals, but also in the patients´. Indeed, a central concept of digital health medicine is patient empowerment as demonstrated by key words like “electronic health record”, “patient access”, “health apps”, “wearable health tech” etc. In this rapidly changing health care environment, Laboratory Medicine must redefi ne its positions, not only acting in its classical role as provider of laboratory results, but also adopting new roles and responsibilities in the clinical dialogue.

Recorded on 18-19 June 2018.

Performance specifications in laboratory medicine - Part 2 (Athens 2017)

The course will provide an overview of different models to set performance specifications in laboratory medicine; 1) based on clinical outcome, on 2) biological variation, and 3) state of the art. In addition, it will address the total error concept, and performance specifications in external quality assessment schemes and in the extra-analytical phases.


Cardiac Markers (Athens 2017)

The availability of highly sensitive troponin assays (hsTn) allows the safe clinical application of international recommendations and the introduction of fast-track protocols for the definition of AMI. However, hsTn assays have not always been welcomed by clinicians, claiming an increase in false-positive results. To guide interpretation of results, laboratory specialists need to get involved in communicating with clinicians through education, test interpretation and internal audits of test usage and patient outcomes. Since natriuretic peptides were successfully integrated into the clinical practice of heart failure (HF), the possibility of using new biomarkers to advance the management of affected patients has been explored. However, very few have made the difficult translation from initial promise to clinical application. These markers mirror the complex pathophysiology of HF: fibrosis (ST2 and galectin-3), infection (procalcitonin), and renal disease (renal markers). Traditional predictors suboptimally predict cardiovascular disease in individuals with chronic kidney disease (CKD). Recent studies propose new cardiac and kidney markers for the improvement of cardiovascular prediction among those subjects with CKD.

Учитель: Mauro Panteghini

Promoting clinical and laboratory interaction by harmonization

A recording of a plenary presentation by professor Mauro Panteghini, recorded at 4th Joint EFLM-UEMS Congress: Warsaw, Poland, 21–24 September, 2016

Harmonization in laboratory testing is more than merely analytical harmonization. Although the focus was mainly on the standardization and harmonization of measurement procedures and their results, the scope of harmonization goes beyond method and analytical results. It includes all aspects of the total examination process from the “pre-pre-analytical” phase through analysis to the “post-post-analytical” phase. Rapidly available and precise results can indeed be of very limited value if they cannot be compared with each other, are produced on a wrong material or within an inappropriate diagnostic workflow. In particular, as evidence collected in last decades demonstrates that pre-pre- and post-post-analytical steps are more vulnerable to errors, harmonization initiatives should be performed to improve procedures and processes at the laboratory–clinical interface. Managing upstream demand, down-stream interpretation of laboratory results, and subsequent appropriate action through close relationships between laboratorians and clinicians remains a crucial issue of the laboratory testing process. Therefore, initiatives to improve test demand management from one hand and to harmonize procedures to improve physicians’ acknowledgment of laboratory data and their interpretation from the other hand are needed in order to assure quality and safety in the total examination process. A harmonized context will increase the value of laboratory results facilitating their interpretation and thus improving the patient’s outcome.


Учитель: Mauro Panteghini

Unmet clinical needs

The unmet clinical need checklist produced by the EFLM Test Evaluation Working Group (TE-WG) is a practical tool to assist the work of professionals involved in the discovery or implementation of new biomarkers. The tool is aligned with the IOM recommendations and the FDA and CE regulating body’s requirements. An interactive version of the checklist is available in this course. We encourage pilot testing and regular use of the checklist and the TE-WG would appreciate feedback which would inform future refinements of the checklist based on users’ experience.

Webinar Lime Survey

Short introduction to the new EFLM survey platform.

Registration is open (enter the course to register).

How to enter the course?


Учитель: Daniel Rajdl

EFLM "Speakers bureau"

This course serves as a database of presenters and authors that provide EFLM learning materials or organize educational events. There is also an interface to apply to be an EFLM author/presenter.