Issue n. 5/2018

In this issue:
 Hot topics in Laboratory Medicine
Harmonisation in autoantibody testing: a dream or areality?
 News from EFLM Committees
and Working Groups

THE EFLM BI-MONTHLY NEWSLETTER Vacancies in EFLM Functional Units EFLM Bursary Programme Updates on EFLM Publications
 News from EFLM National Societies
 Calendar of EFLM eventsand events under EFLM auspices

EFLM Connects National Societies of Clinical Chemistry
and Laboratory Medicine and Creates a Platform for all
European “Specialists in Laboratory Medicine”

Forewordby Harjit Pal Bhattoa, Editor EFLM EuroLabNews

HOT TOPICS IN LABORATORY MEDICINE

Harmonisation in autoanti­
body testing: a dream or areality?
by Dr Joanna Sheldon PhD, FRCPath
Consultant Immunologist, St. George’s Hospital, Lon­don, UK

Detection and quantification of autoantibodies
is firmly embedded in diagnostic laboratories.
These tests contribute to the diagnosis, treatment
and management of patients with autoimmune
diseases. Over the last three decades, the reque­sting of autoantibody testing has increased dra­
matically. Considering the incidence and preva­
lence of many autoimmune type diseases had not change significantly,
the demand and increase in demand seems inappropriate.
To be continued on page 2

Editorial information:
Newsletter Editor: Dr. Harjit Bhattoa, Faculty of Medicine,
Dept of Laboratory Medicine, University of Debrecen, Hungary
EFLM Executive Board:
M. Neumaier, S. Sandberg, AM. Simundic, G. Lippi, H. Storm,
T. Guimaraes, T. Zima

In the present issue, Consultant
Immunologist Dr. Joanna Sheldon
explores the challenges in har­monizing autoantibody testingunder the Hot Topic column.
Rita Andrea Horvath and Andrew
St John, members of the EFLM
Working Group on Test Evalua­tion, present a report on the
EFLM­AACB Workshop “Value of
Biomarker” held in Sydney inMarch this year where they discuss the possibilities of
how to improve the process of test development. Daria
Pasalic, Chair of the EFLM Education and Training Com­mittee reports the activities of the committee in thepast six months. Call for nomination for 3 full members
and a young scientist member is advertised by the
EFLM Preanalytical Phase Working Group. Anotherexciting opportunity for young participants is presented
as an EFLM bursary programme to the attend the 5th
EFLM Conference on Preanalytical Phase to be held in
Zagreb on 22­23 March, 2019. MariaStella Graziani,
Chair of the EFLM Communications Committee, provides
an update on the EFLM publications list. The National
Society of Spain outlines their latest professional activities.
Additionally first experience of EFLMLabX is presented
by the Medical University of Bialystok, Poland. The 5th
EFLM­UEMS Conference in Turkey and EuroMedLab inBarcelona are some of the exciting upcoming eventsenlisted in the Calendar of Events.

The EFLM Newsletter is published bi­monthly
To send your news or advertisement for publication on
the newsletter write to: news@eflm.eu
Contents may not be reproduced without the priorpermission of the Newsletter Editor.

For example, ANCA vasculitis is classified as rare disease [affecting lessthan 200,000 people (US) or less than 1 in 2000 of the population(Europe)]. Pearce et al. reported the annual incidence of ANCA
associated vasculitis in the whole of the UK as 1835 cases orapproximately 35 new cases per week (1). It is hard to relate this to
my laboratory which serves a population of approximately 1.3 million
people where we receive over 200 ANCAs requests per week. Thisapparent indiscriminate requesting is seen across many autoantibody
specificities and in many laboratories across world; maybe this is also
an area where harmonisation is needed. Never the less, this increase
in workload, consolidation and de­skilling of laboratories is driving
autoantibody testing methods away from labour intensive qualitative
analysis requiring training and experience towards automated andtracked quantitative testing. The reporting of an autoantibody
concentration with units and a reference range gives the impressionthat these are robust results in terms of analytical and clinical validity.
Unfortunately this is not the case, autoantibodies have had limited
standardisation and there are no reference methods.
We have a rather simplistic perception that because we use a common
name for an analyte, every method measures the same thing in thesame way and all results for that analyte will be comparable.
Autoantibody quantification is complex with the potential to introduce
variability in every aspect of the analytical process. Figure 1 shows thepossible sources of variation in an autoantibody test, but also reminds
us that each method or manufacturer is working in a closed loop
without any external or independent point of reference. To reduce thevariability of autoantibody testing, we need to better understand thesevariations and identify the areas where harmonisation will have apositive impact.

Antibodies in the patient
sample: affinity and avidity,
epitope reactivity, place indisease course, subclassof antibody

Antigen: source,
preparation,
stability, epitope
expression

Standardisation or
harmonisation - where
ever we star it is likely to
be more than 1 stepMethod: binding of theantigen to the support
medium, support medium,
individual assay or
multiplex, analyticalspecificity and sensitivity,
pH, temperature, assay
speed

Detection system:
colorimetric,
fluorimetric,
multiplex

Figure 1. Sketch of the possible sources of variation in an
autoantibody testing

The EFLM Newsletter n. 5/2018

Every method will test for antibodies in the patient’s serumthat react to normal cellular components. The relevant
antigens may be from crude tissue preparations, purified
from tissue, or may even be recombinant. It is easy tobelieve that there will be differences between these three
preparation processes, but differences are also likely
within a preparation type e.g. between manufacturers andbetween lots.
The exact definition of the autoantibodies, themeasurands, is difficult. Typically, we test for IgG
autoantibodies, but all immunoglobulin classes can be
autoantibodies. Each individual person will make adifferent spectrum of polyclonal immunoglobulins that
can all bind to the antigen of interest. Between individuals,
the polyclonal immunoglobulins may differ regarding thetarget epitopes, antibody affinity and avidity, isotype etc.
It is also reported that within an individual, during thecourse of their disease and management, the epitope
specificity of the autoantibodies can change.
The methods available for quantification of antibodies
show considerable variation in the assay characteristic e.g.
isotype specificity, assay speed and temperature, and eventhe pH of the analytical phase. This all leads toinconsistencies in how the different methods detect
different types of immunoglobulins of different affinities
or avidities. In reality, different methods are often
measuring slightly different versions of the same analyte.
Materials called standards for autoantibodies have been
available for some years but external quality assurance
reports for an autoantibody, with an apparently common
standard would show that use of the ‘standards’ does not
generate harmonised results. Some analytes show up to
1000x variation between the lowest and highest values fora single sample! We also know that in addition to theenormous variation in the concentrations given bydifferent methods, the interpretation of the result withrespect to the manufacturer’s reference range is notconsistent. Samples from certain patients give different
interpretation of results across various methods.
Considering all these issues, it is not surprising thatstandardisation of autoimmune serology is a major
challenge and it was the IFCC Scientific Division who took
on the task by forming the Working Group on
Harmonisation of Autoantibody Testing (WG­HAT) in2010. The group had a broad remit; in addition to trying
to prepare certified reference materials, it is also aimed todevelop a better understanding of the causes of highvariation in autoantibody testing. Certified referencematerials for IgG anti myeloperoxidase and IgG anti
proteinase 3 were produced by the Institute for Reference
Materials and Measurements (IRMM) and are now
available (2,3).
The studies leading to the certification of these materials
produced robust data by analysing over 30 samples and
11 different methods. It showed that not all samples
behaved in the same way; more than 60% of samples
showed some differences in result interpretation between
methods and there was no consistent pattern. This kind of
discrepancy will not be solved by introducing a common
standard but it has generated another phase ofinvestigation. The group is currently trying to identify the
epitope reactivity of these samples which may reveal why
the samples behave inconsistently between methods. The
October issue of CCLM (4) is devoted to standardisation2

and harmonisation in laboratory medicine. It is encouraging to see that nine papers are dedicated to the harmonization of autoimmune
testing putting this previously ignored area of laboratory testing firmly on the standardisation/harmonisation map.
Producing a certified reference material is a major undertaking and although there are many complex steps, it is generally within thecontrol of a small group who all have the same focus. Introducing a new reference material is a completely different challenge. There
must be interaction with the reagent manufacturers and producers, medical device approval agencies e.g. FDA (USA) or European
Community, laboratories, clinicians, patient focus associations, professional societies, etc. To achieve harmonisation or standardisation,
all these groups must be on board with the process and benefits.
So, is harmonisation in autoantibody testing a dream or a reality? It is certainly not a reality, but we have made some huge steps
forward. There is general agreement that we need to harmonise or standardise these tests. We know some of the possible causes ofvariation and we need to investigate them further. Reference materials are now available that fulfil the rigorous requirements of acertification process, but as we develop our understanding of the complex behaviours of autoantibodies, we may need to adapt or
improve what we have. To make the dream into reality, we need to adopt these reference materials understanding that true
standardisation of autoantibody tests is unlikely to be a simple one­step process.
References
1. Pearce FA, Lanyon PC, Grainge MJ, Shaunak R, Mahr A, Hubbard RB, et al. Incidence of ANCA­associated vasculitis in a UK mixed
ethnicity population Rheumatology 2016;55:1656­63
2. Monogioudi E, Hutu DP, Martos G, Tuddenham E, Sheldon J, Schimmel H, et al. The Certification of Anti­myeloperoxidase
Immunoglobulin G in Human Serum ERM® — DA476/IFCC, EUR 27092 EN, European Commission, Luxembourg, 2015(ISBN 978­92­79­45349­6.
3. Monogioudi E, Hutu DP, Charoud­Got J, Sheldon J, Schimmel H, Trapmann S, et al. The Certification of the mass concentration if
Immunoglobulin G proteinase 3 anti­neutrophil cytoplasmic autoantibodies in Human Serum ERM® — DA483/IFCC, EUR 28537
EN, European Commission, Luxembourg, 2015 (ISBN 978­92­79­66974­3).
4. Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56, Issue 10 (October 2018).

NEWS FROM THE EFLM WORKING GROUP ON TEST EVALUATION

How can we improve the process of test development?
A report on the EFLM­AACB Workshop “Value of Biomarker”, Sydney, March 2018
by Rita Andrea Horvath and Andrew StJohn, Members of the EFLM Working Group on Test Evaluation

The process of test development where supposedly promising biomarkers are developed into useful medical tests is known to be flawed.
Consider how many new tests have been added to the laboratory repertoire in recent years? Leaving aside genomic based testing theanswer is very few despite many new potential markers entering the pipeline. This unproductive process contributes to a reputed $200
million dollars being wasted every year on failed biomarker research. Laboratory professionals play a key role in this process albeit usually
towards the end, but what can they do to improve the situation?
To answer this question more than fifty professionals from all the sectors involved in biomarker development including the laboratory,
industry, biomarker researchers and health policy makers, gathered together at a 2­day Workshop in Sydney in March. The Workshop
entitled “Assessing the Value of Biomarkers” was delivered by the Test Evaluation Working Group (TE WG) which is a collaboration
between the Australasian Association of Clinical Biochemistry (AACB) and the European Federation of Laboratory Medicine (EFLM). The
Sydney Workshop was modelled on an inaugural workshop run in Leiden, The Netherlands in 2016.
The Sydney Workshop was opened by Adam Elshaug, who is Professor of Health Policy at the University of Sydney and a key memberof the Government’s Medicare Review Taskforce. His talk placed the workshop in the context of the Australian environment where thegovernment is looking to increase the value of healthcare through many different initiatives of which developing and implementing
better pathology testing is but one.
Having set the scene, members of the TE Working Group explained the concepts and tools that have been developed as part of a cyclicalframework for evaluation of clinical effectiveness of new medical tests. The aim of the workshop has been to go beyond the theory ofevidence­based medicine and provide practical strategies and tools that laboratory professionals can use to assess biomarkers, both in
the development phase and also during implementation in their own laboratories. Details of these activities are available on the Working
Group’s website (https://www.eflm.eu/site/page/a/1158).
The key concepts covered in the lectures included the understanding that test development is not just a linearly staged step­wise processfrom discovery to implementation, as we might like to believe. It is more of an interplay of various components of the test evaluation
cycle, all of which are primarily driven by how the test is going to be used in a clinical pathway.
Much biomarker development proceeds with no clear understanding of the unmet need or – “why and for what purpose are we using
this test?” A key achievement of the TE WG is to develop a checklist which can be used for both new and existing tests to identify theunmet need for a medical test; if such a checklist is used appropriately and early in the translational pipeline, it would help prevent whatturn out to be many ineffective tests being launched in the marketplace. This checklist can be found in an interactive form at

The EFLM Newsletter n. 5/20183https://elearning.eflm.eu/course/view.php?id=11. The Working
Group invites people to use this checklist and provide feedbackon their experience.
Another important concept addressed by the speakers is thatwhile analytical and clinical performance specifications are ofthemselves important, equally significant is that they interact
and, consideration of this leads to the iterative nature of testdevelopment. Lectures covered how analytical and clinicalperformance criteria could be set with yet again the clinicalpathway and the use of the test being central to suchconsiderations. This is because high analytical quality of a test
does not guarantee that the test will work well in clinical practice
and, vice versa, a clinically useful test does not always need toachieve the highest possible analytical quality if the test plays asmall part in a complex multi­test diagnostic pathway. Lectures
on clinical pathway mapping, diagnostic trial design, healtheconomics and a perspective from the IVD industry were alsopart of the lecture programme.
A key component of the workshop was to go beyond enunciatedtheory and ask the delegates to apply what they had heard in
the lectures to exercises where they worked with their tablecolleagues on interactive assignments based on real life casescenarios.

Prof. Ken Sikaris giving a lecture on the role of clinical decision support
in delivering value

Prof Rachael Morton lecturing on health technology assessment andcost effectiveness of tests

The Workshop concluded with two Australian speakers who reviewed specific initiatives that are taking place in Australia in terms ofimproving value, namely the greater use of decision support to help test requesters, and the need for a Centre of Excellence to conducttranslational research in the area of laboratory medicine.
At the completion of each day the delegates were asked to provide feedback on the talks and assignments, and over the two days, thefeedback was uniformly good but also identified areas for improvement in future workshops.
At the end of such a Workshop the question is inevitably what next? How do we translate knowledge into action and eventually improve
the process of test development and implementation? One action is to consider incorporating the key elements of this workshop into
the training curriculum of trainee scientists and pathologists.
Another action is to devote more resources to this important area of laboratory medicine and a proposal is currently being consideredby the AACB Executive to have a dedicated Value of Pathology Working Group or Committee. Tasks for such a group would be in partto continue the contribution of the AACB to the EFLM’s TE WG but there is also a need to translate the concepts and tools developedby that group into local practice.
If interested in this topic and would like to attend similar courses in the future or if your national society or professional organisation
is interested in hosting such an event, please contact the chair of the EFLM Test Evaluation Working Group, Christa Cobbaert, at
C.M.Cobbaert@lumc.nl.

The EFLM Newsletter n. 5/2018

4NEWS FROM EFLM EDUCATION AND TRAINING COMMITTEEEFLM Education and Training Committee – Report on a six­month activity
by Daria Pasalic, Chair of the EFLM Education and Training Committee

Since the first months of 2018, the structure of the Committee underwent a re­organisation. At the beginning of 2018, I have been
appointed as chair of the Committee and left my previous position as member of the Working group on Congresses and Postgraduate
Education (WG­CPE). At the same time, two additional functional units under the Committee umbrella have been established: the WG
on Laboratory Medicine Crediting Points (WG­LMCP), chaired by Patrick Twomay and the Task Group on EFLM European Syllabus (TG­
EuSy), chaired by Ralf Lichtinghagen.
The two other well established WGs (Congresses and Postgraduate Education chaired by Evgenija Homsak and Distance Education ande­Learing chaired by Daniel Rajdl) have continued their important work.

Working Group: Congresses and Postgraduate Education
1) The EFLM project of exchanging practice in Laboratory
Medicine (EFLMLabX) has been activated after three years of
preparation. In many EFLM countries, there is a need to acquire
additional practical knowledge and skills in different fields oflaboratory medicine (LM). This project gives the opportunity tolaboratory medicine professionals either to offer or find training inspecific fields of LM. All relevant information and offerings can befound at https://eflmlabx.eflm.eu/en. Since the beginning of thisyear, 10 countries with 12 laboratories offering 17 different
practices/topics were included as providers: Belgium, Croatia,
Czech Republic, France, Netherland, Poland, Portugal, Slovenia,
Spain and United Kingdom. This project still needs visibility to
improve the database of practice providers and to motivate theusers, especially young trainees: currently only 3 specialists appliedand completed the training.
2) A new EFLM educational tool has been proposed: the “brandmark” Postgraduate Courses (PGE). These courses are planned
to be 1­2 days long, educational, and low budget (not profitable),with maximum two lecturers for a small group (up to 50
participants) and oriented to applicative knowledge in form ofWorkshops. Their aim is to be attractive for young trainees,
residents and specialists. The topics, the programme, and the
speakers will be proposed by the WG­CPE. The courses will beorganized in different European countries upon application. Twoapplication options are planned: a single National Society (NS) canrequest to host the course in its country offering to cover the
related costs or, as an alternative, EFLM (once a year) will select a
NS, among those that applied to host the course, and will pay forthe faculty (travel expenses and accommodation for the speakers).
Applications will be evaluated by the EFLM Executive Board,according to established criteria. The first two courses proposedby the WG­CPE are “Biostatistics” and “How to write a scientificpaper” More relevant information will be posted on the EFLM
website soon.
3) A survey on “Understanding and implementation of
MedTechCode in EFLM­member societies” was conductedamong NS representatives and received 25 (out of 40 NSs) replies.
A second survey on the same topic was addressed to individual
members of EFLM NS and 322 replies were obtained. The goal of
the two surveys was to investigate the previous and current
practice in terms of cooperation between professionals or scientificsocieties and IVD industry, as well as to know the impact of the
MedTech Europe Code in the educational practice. At the moment
WG­CPE members are preparing the publication of the results ofthe surveys.

The EFLM Newsletter n. 5/2018

4) For the EFLM Application to become a Trusted Partner EthicalMedtech, 4 EFLM officers were involved: Ian Watson, Merve Sibel
Gungoren, Silvia Cattaneo and Ciriaco Carru.

Working Group: Distance Education and e­Learning
WG­DE recently launched the EFLM e­Learning platform
https://elearning.eflm.eu/ that provides a common framework for
all online EFLM educational activities. Over one year of its existence,
it attracted more than 1.500 newly registered participants.
The growing educational content of the platform consists of:•••live webinars – in 2018, WG­DE organized 8 live webinars thatare available as recordings and handouts. After passing an
educational questionnaire, participants can obtain a certificate
of participation. The same number of live webinars on actual
topics is planned for next year.
recordings from congresses – selected presentations from
EuroMedLab in Athens (2017) and the majority of presentations
from the 2nd EFLM Strategic Conference “The end of laboratory
medicine as we know it?” were recorded, processed andpublished by the WG­DE in the e­Learning platform.
Recordings from selected forthcoming congresses will beavailable on the platform.
e­learning courses – a new interactive course “Unmet clinicalneeds” developed by EFLM Test Evaluation Working Group (TE­WG) was launched in Spring 2018. Other EFLM WGs areplanning to create new e­learning courses. WG­DE closelycollaborates with the Task Group EFLM European Syllabus on
the realization of recordings, processioning and publication of
lectures organized by the TG.

Task Group: EFLM European Syllabus
This new established TG chaired by Ralf Lichtinghagen, has the taskof organising EFLM European Syllabus Courses which should
support the continuous educational process for young laboratory
professionals in EFLM countries. On the basis of the EFLM European
Syllabus, it should be possible to recapitulate the required
knowledge in a reasonable time, in order to be able to collect CPD
points at the same time. The courses will be realised in cooperation
with the WG­DE for the technical realization of the project thus
including post­processing, upload on the EFLM e­learning platform
and support for using e­learning authoring tools. The Task groupwill manage, together with the lecturers, the creation of
autodidactic questionnaires. In cooperation with WG­LMCP, thecourses will be certificated and attendants will get credit points forattendance and for participation. The practical realisation of thisproject is expected to start at the beginning of 2019.

5

UPCOMING EFLM EVENTS

Do not miss to participate at the
5th EFLM­UEMS European
Joint Congress in Laboratory Medicine“Laboratory Medicine
at the Clinical Interface”
in Antalya (TR)from October 10 to 13, 2018!

Click here to view the fullscientific programme

http://eflm­uems­antalya2018.org/
The EFLM Newsletter n. 5/2018

6

VACANCIES IN EFLM FUNCTIONAL UNITSEFLM Working Group “Preanalytical Phase” ­ deadline to send nominations:
31 October 2018
This Working Group was established in 2013 with the aim to achieve harmonization in the preanalytical phase across European member
societies. This group headed by now­President­Elect Ana­Maria Simundic, has been very successful e.g. performing surveys that have
led to various recommendations like the definition of fasting status, patient and blood tubes identification issues, colour coding andvalidation of blood collection tubes, the sequential order of draw, hemolysis detection and management, quality assurance of HIL indicesand others. Also, WG­PRE has organized four European conferences to promote the visibility of Preanalytics in laboratory diagnostics.
As all members of WG­PRE will be finishing their terms by the end of 2018, the group needs to be refurbished in all positions. At thistime, EFLM is calling for the nomination of:⇒ 3 full members⇒ 1 young scientist member (must be below 35 years of age at the time of nomination).
In order to complement the successful work on guidelines and recommendations of the past, the EB of EFLM has decided to put majoremphasis and support future collaborative laboratory studies in areas of Preanalytics, also with the goal of attracting public grant funding.
Accordingly, the scientific profile of the nominates candidates will be highly considered. The EFLM EB expects that the nominated groupmembers are willing to interact with scientists within the EFLM to further said collaborative project activities.
______________________________________________________________________________________________________________________________________________The WG terms of reference are available at www.eflm.eu. For all the above mentioned positions, the term of office will be for 2 years (1Jan 2019 ­ 31 Dec 2020). The position could be renewable for other two more terms if the work for the Group is deemed essential at thattime. The work is mainly conducted by e­mail and teleconferencing, the WG usually meets once per year.
Procedure for applications: each EFLM National Society Member in good standing with the membership fee can submit one nomination
using the form circulated to the National Society’s representatives to be sent back to silvia.cattaneo@eflm.eu. A brief plan of theapplicant’s contribution to the aims and objectives of the relevant Working Group has to be included in the form. Together with theapplication, a short CV should also be submitted underlining the qualifications and prior experience and publications in the relevant
area. Candidates have to be officially recommended by their National Society through a formal letter of support. Applicants who are notselected as full members may be eligible for corresponding membership.

EFLM BURSARY PROGRAMMEEFLM BURSARY PROGRAMME TO ATTEND THE_______________________________________________________________

5th EFLM CONFERENCE ON
PREANALYTICAL PHASE“Preanalytical challenges ­ time for solutions”

http://www.preanalytical­phase.org/

This is to inform you that EFLM is promoting a bursary programme for young scientists attending the 5th EFLM Conference
on Preanalytical Phase to be held in Zagreb on 22­23 March 2019.
A limited number of bursaries is available, the bursaries will cover the cost of the travel and 2­night accommodation for a
maximum of Eur 750,00. EFLM bursary recipients will also receive the free conference registration and a free on­line yearlysubscription to CCLM, kindly offered by W. de Gruyter.
Eligible candidates must come from an EFLM Member Society and meet the following criteria:­ Young participants (≤35y at the date of the conference);­ Having a poster abstract accepted as First Author (deadline for abstract submission December 1, 2018)
Applications must be submitted through the dedicated application form (downloadable from www.eflm.eu) and accompaniedby the following documentation:
1) Copy of the ID or passport,
2) Document proving the membership to the National Society,3) Notification of poster acceptance (acceptance/rejection will be sent by the conference organizers within January 13)
Applications have to be sent to silvia.cattaneo@eflm.eu within January 31, 2019.
We assume that people submitting the application for the bursary have already decided to attend the conference (having an
abstract accepted). So we expect that non­selected applicants do not withdrawn the abstract. Thanks!
With kindest regards,
Daria Pasalic
Chair of the EFLM Education and Training Committee

The EFLM Newsletter n. 5/2018

7

Providing Correct Estimates of Biological Variation—Not an
Easy Task. The Example of S100­ Protein and Neuron­Specific
Enolase.
Carobene A, Guerra E, Locatelli M, Ceriotti F, Sandberg S, Fernandez­
Calle P, Coskun A, Aarsand AK on behalf of the EFLM Working Groupon Biological Variation.
Clin Chem 2018; doi: 10.1373/clinchem.2018.292169.

UPDATES OF THE EFLM PUBLICATION LIST

Quite a number of interesting
papers by EFLM functional units
have been published recently

These two papers present robust data on biological variation (BV)of prostate specific antigen, protein S100 and Neuron­Specific
Enolase, confirming once again that the adoption of the Biological
Variation Data Critical Appraisal Checklist (BIVAC), recently publishedby the same group allows obtaining reliable Reference Change
Values and more stringent analytical performance specifications withsignificant clinical implications for patient monitoring.
A stimulating review on the role of personalized medicine
Personalized laboratory medicine: a patient­centered future
approach.

by Maria Stella Graziani, Chair of the Communication Committee

This is a very important achievement of EFLM and its WG on pre­analytical phase and a joint effort between EFLM and COLABIOCLI
Joint EFLM­COLABIOCLI Recommendation for venous blood
sampling.
Simundic AM, Bolenius K, Cadamuro J, Church S, Cornes MP, vanDongen­Lases EC, Eker P, Erdeljanovic T, Grankvist K, Joao Tiago JT,
Hoke R, Ibarz M, Ivanov H, Kovalevskaya S, Kristensen GBB, Lima­
Oliveira G, Lippi G, von Meyer A, Nybo M, de la Salle B, Seipelt C,
Zorica Sumarac, Vermeersch P on behalf of the Working Group for
Preanalytical Phase (WG­PRE), of the European Federation of Clinical
Chemistry and Laboratory Medicine (EFLM) and Latin American
Working Group for Preanalytical Phase (WGPRE­LATAM) of the Latin
America Confederation of Clinical Biochemistry (COLABIOCLI).

Prodan Zitnik I, Cerne D, Mancini I, Simi L, Pazzagli M, Di Resta C,
Podgornik H, Repic Lampret B, Trebusak Podkrajsek K, Sipeky C, van
Schaik R, Brandslund I, Vermeersch P, Schwab M, Marc J on behalfof EFLM/ESPT Working Group of Personalised Laboratory Medicine
Clin Chem Lab Med doi.org/10.1515/cclm­2018­0181.
The review is focused to illustrate the growing importance of
personalized medicine within laboratory medicine profession in thenear future. This specific approach will allow a more effective
diagnostics with more effective and safer treatments: to reach thesegoals, however there is an urgent need of a more stringent
cooperation between different disciplines within laboratory
medicine.

Clin Chem Lab Med 2018 doi 10.1515/cclm­2018­0602
The document provides practical guidance for ensuring a safe andpatient­centred blood collection. The target audience for therecommendation (based on the best available evidence) arehealthcare staff members directly involved in blood collection. To
facilitate implementation of the recommendation, the WG­PRE has
prepared a number of tools that are freely available at the EFLM
web site dedicated page (https://www.eflm.eu/site/page/a/1194).
Professionals are encouraged to adopt the procedure anddownload and use the tools to establish a quality system and tomaintain and continuously improve the quality of a harmonizedprocedure for blood collection across Europe and South America.
Two more papers by the very active WG on Biological variation.

NEWS FROM EFLM NATIONAL SOCIETIESNews from the Spanish Society ofLaboratory Medicine (SEQCML)XVI Conferences of the Scientific Committee of the Spanish
Society of Laboratory Medicine (SEQCML)The use of biomarkers improves the diagnosis and treatment of
autoimmune diseases

Biological variation estimates for prostate specific antigen fromthe European Biological Variation Study; consequences fordiagnosis and monitoring of prostate cancer.

•

The new edition of the SEQCML Scientific Committee
Conferences has allowed professionals to update theirknowledge of biological markers

Carobene A, Guerra E, Locatelli Ma, Vito Cucchiara Vc, Alberto
Briganti A, Aarsand AK, Coşkun A, Díaz­Garzón J, Fernandez­CalleP, Røraas T, Sandberg S, Jonker N, Ferruccio Ceriotti C, on behalf ofthe EFLM Working Group on Biological Variation•

The use of these techniques in the clinical laboratory to detect
neurological and hormonal autoimmune diseases, among thehighlighted topics•

In the conference, which included six courses, the techniques ofmassive DNA sequencing were also examined in depth

Clin Chim Acta 2018;486:185­91.
The EFLM Newsletter n. 5/2018

8

Madrid, May 24, 2018 ­ In recent years there have been important advances in the development and incorporation into the clinicallaboratory of new biomarkers­biological indicators that can be used in medicine to understand the processes that are taking place in an
organism. These advances mean that healthcare professionals specializing in this field are in constant need of updating their knowledge.
With this in mind, the XVI Conference of the Scientific Committee of the Spanish Society of Laboratory Medicine (SEQCML) was held, inwhich experts in different areas of the laboratory gave a total of six courses to help spread awareness of the latest developments in thisfield.
These courses addressed aspects such as biomarkers applied to endocrine or neurological diseases and the massive sequencing of DNA,and sought to increase attendees´ skills and knowledge of these analytical techniques, which allow identification of diseases via thepresence of different molecules in the body. The clinical usefulness of the different biomarkers was analyzed, in both the diagnosis andthe management of these diseases. New recommendations and protocols were also presented.
One of the highlights of this new edition of the Scientific Committee Conferences was the use of these biomarkers to detect autoimmune
neurological diseases. One of the courses, organized by the SEQCML Committees of the Biochemistry of Immunological Diseases and of
Neurochemistry and Neurological Diseases, sought to expand knowledge in this "continuously developing area". "New autoantibodies
associated with neurological autoimmune diseases are constantly being described; at the same time that the clinical application of new
and existing markers is being analyzed and reviewed," explains Dr. Concepción González, Head of the Clinical Biochemistry Section of theVirgen Macarena University Hospital (Sevilla), who participated in the aforementioned course.
An autoantibody is an antibody developed by the immune system that acts directly against one or more antigens of the individual itself.
As explained by Dr. José Luis García de Veas, a specialist in Clinical Analysis and Clinical Biochemistry at the Campus de Salud University
Hospital (Granada), each year between two and four new autoantibodies are identified that are associated with diseases such as
autoimmune encephalitis or paraneoplastic neurological syndromes, among others. "This has allowed us to significantly improve thediagnosis and treatment of these pathologies, and therefore it is necessary to stay up­to­date in this area". In this course, theautoantibodies associated with the aforementioned diseases were presented as well as the techniques used to identify them. This course
was recommended, in addition to laboratory professionals, for neurologists who care for these patients, "as they will have a vision of what
the autoimmunity laboratory can provide depending on the patient´s pathology", concludes Dr. García de Veas.

Hormonal markers
Another topic that was a focus of the courses of the SEQCML XVI Conference of the Scientific Committee was the analyses applied tohormonal diseases and endocrine system. The course 'Protocols of diagnostic orientation and monitoring in endocrine pathology' offeredspecific information on the different biochemical tests available today to analyze endocrine pathologies and diagnostic algorithms suitablefor diagnosis and monitoring in these diseases.
"In recent years many laboratories have expanded their activity in hormonal measurements. This has created a need for professionals to
be involved in the development of diagnostic protocols, with the aim of adapting to the new scientific guidelines and ensuring that agreater number of clinicians (specialists or family doctors) make the request for testing in a more rationalized way", explained Dr. Eulàlia
Urgell, of the Biochemistry service of the Santa Creu and Sant Pau Hospital (Barcelona) and Dr. Roser Ferrer, of the Vall d'Hebron University
Hospital (Barcelona), both coordinators of the course.
"This course responds to the need to stay up­to­date and offer a broad and specific training on the protocols used and endorsed bydifferent scientific societies for diagnostic orientation and monitoring in endocrine pathology. A series of objectives to be developed havebeen established in order to offer a tool for the different biochemical tests currently available, so as to be more efficient and effective inthe diagnosis and monitoring of the most common endocrine pathologies," they explained.

DNA sequencing
Lastly, another of the key topics of the conference was genome sequencing. In the course 'Massive sequencing: methodological aspects
and interpretation of data', the currently available sequencing platforms were presented, along with the methodology used by each ofthem and their limitations, emphasizing the genetic alterations that massive sequencing does not allow us to detect. In addition to briefly
explaining the bioinformatic analyses that are carried out in this type of study, the course explained how the analysis of the data generated
by this computational process is carried out at present.
"Massive sequencing by itself is a very new technology, of recent implementation in public centers for genetic diagnosis. But in addition,commercial kits, bioinformatic analysis, and databases are evolving and improving by leaps and bounds, which is allowing for increasingly
high quality analysis, "explains Dr. Pilar Carrasco Salas, of the Genetics Unit of the Juan Ramón Jiménez Hospital (Huelva), who noted thatthe course she offered was aimed at those professionals who dedicate or want to dedicate themselves to the diagnosis of hereditarydiseases.
The SEQCMLThe Spanish Society of Laboratory Medicine (SEQCML) ­founded in 1976­ now includes more than 2,500 professionals and has as its main
objective to bring together all interested scientists in the field of the Clinical Laboratory, to promote the dissemination of scientific andtechnical publications, to organize meetings, courses, and congresses of national and international character, and to cooperate with otherscientific societies. Likewise, the Society aims to contribute to the study and recommendation of standardized methods and to establish
guidelines and recommendations for training in the field of Laboratory Medicine.
For more information: www.seqc.es

The EFLM Newsletter n. 5/2018

9Snapshots of different courses during the SEQCML
Scientific Committee Conferences

Calendar of EFLM
events and events under EFLM auspices
Do not miss the opportunity to have your event listed here.
Apply for EFLM auspices! For more information visit: https://www.eflm.eu/site/page/a/1048/ or email eflm@eflm.eu

3­5 October 2018
26th Meeting of Balkan Clinical Laboratory Federation and the 6th
National Congress of the Macedonian Society for Medical
Biochemistry and Laboratory Medicine
Skopje, Macedonia
http://www.bclf.info/index.htm

11­13 October 2018
16th EEKX­KB National Congress of Clinical Chemistry
Paris (FR)
http://www.eekx­kb.gr/

4­6 October 2018
9th Russian Conference on Clinical Hemostasiology
and Hemorheology
St Petersburg, Russia
http://coith2018.com/en/main

16­17 October 20182èmes Journées Francophones de Biologie Médicale
Paris (FR)www.jfbm.fr

The EFLM Newsletter n. 5/201810

10­13 October 2018
5th EFLM­UEMS Joint Congress
Laboratory Medicine at the clinical interface
Antalya, Turkey
http://eflm­uems­antalya2018.org/

7­8 December 2018
JBP 2018 ­ Journees de Biologie Praticienne
Paris (FR)mf.gaudeau.toussaint@gmail.com

16­18 October 2018
50th National Congress of S.I.Bio.C. ­ Laboratory Medicine"Innovation in Laboratory Medicine"
Naples, Italy
http://congresso.sibioc.it/2018/home24­27 December 2018
ICB 2018 ­ 2nd International Congress on Biomedicine
Tehran, Iran
http://www.icb2018.com/

18­19 October 2018
EQALM Symposium 2018
Zagreb, Croatia

7­8 February 2019
International Congress on Quality in Laboratory Medicine
Helsinki, Finland
https://www.labquality.fi/en

www.eqalm.org

24­26 October 2018
LABCLIN 2018 ­ XII National Congress of Clinical Laboratory
Bilbao, Spain
www.labclin2018.es

22­23 March 2019
5th EFLM­BD European Conference on Preanalytical Phase
Biannual Conference organized by the EFLM Working Group on"Preanalyical Phase" in collaboration with BD
Zagabria, Croatia
http://www.preanalytical­phase.org/

26­30 October 2018
International Biochemistry Congress 2018 / 29th National
Biochemistry Congress of TBS
Bodrum, Turkey
https://www.biyokimyakongresi.org/

4­5 April 2019
10thEuropean Symposium on Clinical Laboratory and In Vitro Diagnostic
Industry ‘The clinical laboratory in the pregnancy monitoring’
Barcelona, Spain
http://www.iec.cat/jornades/laboratoriclinic2019.asp

30 October 2018
International Conference on Laboratory Medicine “Laboratory
Medicine: 25 years on"
Padova (IT) http://www.lccongressi.it/laboratorymedicine2018/18 May 2019
VII International Symposium Laboratory Medicine and Quality.
Satellite Meeting EuroMedLab 2019
Barcelona, Spainwww.seqc.es

13 November 2018
Workshop on Alzheimer’s Disease “Making the point”
For more information:
pragueworkshop2018@cbttravel.cz
Prague, Czech Rep.

19­23 May 2019
EuroMedLab 2019
23rd IFCC­EFLM European Congress of Clinical Chemistry andLaboratory Medicine
Barcelona, Spain
http://www.euromedlab2019barcelona.org

27 November 2018
Preanalytical mysteries
EFLM webinaron­linehttps://elearning.eflm.eu

19 May 2019
International Symposium: Breast Cancer and Environment.
Satellite Meeting EuroMedLab 2019
Barcelona, Spainwww.seqc.es

29 November 2018
12th International Scientific CIRME Meeting "Standardizationin Laboratory Medicine and Patient Safety"
Milan (IT)
http://users.unimi.it/cirme/home/

19 May 2019
International Symposium: Standardization
and Recommendations in the Laboratory of Haematology.
Satellite Meeting EuroMedLab 2019
Barcelona, Spainwww.seqc.es

29 November 2018
Place and role of the medical biology and lab medicine in the
Health System Transformation Strategy
Paris, France
Click here for information

9­12 June 2020
XXXVII Nordic Congress in Medical Biochemistry
Trondheim, Norway
www.nfkk2020.no

The EFLM Newsletter n. 5/201811

a database of medical laboratories willing to offer practicaleducation/training in different specialties of Laboratory Medicine
where Specialists can search for practice

Do notnot hehesitate!
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abroadabroadEFLMLabX: the experience of an hosting laboratory
by Olga M. Koper, Dept of Clinical Laboratory Diagnostics, Med. Univ. of Bialystok Poland

Last week an applicant from Ukraine (Zoryana Lavro, MD from the University of Lviv) attended
our training at the Department of Clinical Laboratory Diagnostics in the Medical Universityof Bialystok (Poland).
It was a great opportunity to exchange experiences and to collect even small bits of
information about how laboratory diagnostics works in Ukraine.
The language barrier did not stop us from communicating, we talked in three languages:
Polish, English and Ukrainian. I think that our offer is especially attractive for our easternneighbors.
Currently, I am exploring opportunities for free accommodation at our University's dormitory
for future applicants, which will make our offer even more encouraging. In my opinion,
EFLMLabX is a very good project and we look forward to receiving new applications!
From left: Dr Olga M. Koper, Zoryana Lavro, MD, Dr Joanna Kamińska and Prof Joanna Matowicka­Karna

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The EFLM Newsletter n. 5/201812