Editorial
Today we are pleased to send you our digital Newsletter which aims to provide you with some important ECAT information and relevant articles in the fields of quality control and/ or laboratory diagnosis in thrombosis & haemostasis.
Enjoy reading.
Petra van Velp
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New Educative website: CLOTPEDIA
During the recently held ECAT symposium we have launched a new educational website: CLOTPEDIA.
www.clotpedia.nl
This new website is your resource for:
- Information about haemostasis parameters and assays
- Clinical cases
- ECAT related information:
- Special surveys and studies
- Quality related documents
- Publications
- Abstracts and presentations ECAT symposia
- Special issues
- Etc.
We invite you to visit Clotpedia and experience this valuable resource for anybody working in a laboratory in the field of thrombosis and haemostasis.
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Abstracts, presentations and recordings ECAT symposium
Most of the abstracts, presentations and recordings of the most recent ECAT symposium are now available at the ECAT website. Some presentations and recordings are lacking because those speakers did not give permission to publish their presentation and recording on our website.
Please go to the ECAT website and select “Symposium” followed by “Video recordings and presentations symposium”. After you have logged-in with your labcode and password you have access to the abstracts, presentations and recordings.
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Distribution of samples
Since the COVID pandemic we observe more problems with the distribution of samples via postal services to some of our participants. We do the utmost to get the samples for each survey timely delivered in your institution.
For this reason we use the “track-and-trace” distribution option to be able to keep an eye on the delivery of the samples.
However, it is outside our sphere of influence if postal service companies have delays in their delivery of the samples. If this is the case, we do the utmost to trace the problem and see how delivery can be speed up. Unfortunately, we do not have any influence on the way of action of foreign postal services.
In addition, we also see that sometimes our packages with samples are not accepted by the reception desk of an institution and as such returned to ECAT or the package can be picked-up from a postal service pick-up point by the participant. It is outside our sphere of influence when a package is rejected by the reception of your institution. It is the responsibility of the participant to ensure that our packages *are accepted within your institution.
It is also your responsibility that ECAT has your correct address details to avoid any delay in the delivery of the samples. You can check and modify your address details within the participant area of our website.
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New privacy statement
On our website (www.ecat.nl) you can find a new privacy statement. With this new statement we clearly inform you about how take care for the security of your contact details and your rights with respect to access information about you held by the ECAT Foundation.
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ECAT Information:
13th ECAT Symposium
On 26 – 27 September 2024 a very successful 13th ECAT Symposium was held in the Corpus Congress Center, Leiden, The Netherlands. Over 200 participants took part in this symposium. A variety of topics were discussed, such as personalised medicine for thrombosis and haemostasis treatment; new developments in haemophilia treatment; Anti-PF4-induced thrombotic disorders (APIT); Factor XI inhibitors: the holy grail of antithrombotic treatment(?); TTP: pathophysiology and diagnosis.
A number of topics relating to laboratory diagnostics were also discussed: Novel Mass Spectometry-based technologies for coagulation diagnostics; flow-chamber-based platelet analysis; whole blood thrombin generation to study the risk of thrombosis in cancer; whole blood analyses: what do we miss by measuring blood plasma?; current practice in thrombophilia testing: from phenotype to genotype; nanobodies as potential tools for platelet diagnostics; Is the new ACR/EULAR for Antiphospholipid antibody testing fit for purpose?; and Harmonization of antiphospholipid antibody test results?
There were several presentations regarding results in ECAT surveys and new developments: results of Light Transmission Aggregometry pilot survey; laboratory testing for ADAMTS13: What can we learn from EQA data?; long-term evaluation of FVIII and FIX testing; and new EQA approaches: From analytical to diagnostic performance.
Dr. F. Mullier (Belgium) presented a project of the International Council for Standardization in Hematology (ICSH) on the consequences of the IVDR for laboratories. This project focuses on the information which is available in the instructions for use of commercially available methods in order to consider whether a method application in the laboratory should be considered as a lab-developed test.
Another ICSH project was presented by Dr. Davidson (UK) on the laboratory detection of rare inhibitors.
Artificial Intelligence (AI) is an issue that can also effect laboratory medicine. Dr. M. Nagler (Switzerland) gave us an interesting lecture on how we could apply AI in our daily laboratory practice.
The highlight of the meeting was the Haverkate Lecture, this time given by Professor P. Bossuyt, Amsterdam, The Netherlands, entitled: ‘When can we guarantee that a test fit for purpose?’. This outstanding lecture was very well received by the audience and given a score of 8.6.
Another highlight was a debate between Prof. K. Devreese (Belgium) and Prof. G. Moore (UK) on the topic: Is the testing dogma for Lupus Anticoagulants perfect? This debate which demonstrates some different opinions, especially on the role of the mixing test in lupus diagnostics, was also very well received.
Prof. P. Tsiarmytzis from Athens, Greece gave an very educative lecture on modern approaches in statistical process control for IQC and EQA. He presented a new approach to the long-term Z-score analysis, which will be implemented in the ECAT survey reports in 2025.
Most of the lectures, abstracts and recordings are now available on the ECAT website. See https://ecat.nl/symposium-2/education/.
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ECAT Information:
How to interpret the Z-score in relation to the homogeneity of the sample used in a survey
An important aspect for the comparison of the results between participants in an external quality assessment programme is the homogeneity of the samples distributed. The more homogeneous a sample, the less impact it has on the variation in test results between participants. In this short communication we explain the relationship between the homogeneity of a sample and the between-laboratory variation as well as the impact of the homogeneity on the interpretation of the Z-score by a participant. Read more
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ECAT Information:
New in the ECAT EQA Programme 2025
In 2025 we will introduce two new modules into our external quality assessment programme.
Platelet Light Transmission Aggregometry (LTA):
After a recent successful pilot study, we will start in 2025 with regular surveys for light transmission aggregometry (LTA).
Participants will receive two different tubes to which platelet-rich plasma from a local healthy donor has to be added. The platelet-rich plasma has to be prepared according to the laboratories own procedure. Subsequently platelet light transmission aggregometry has to be performed with different agonists at locally used concentrations. The maximum aggregation for each condition has to be reported. It is expected that the maximum required amount platelet-rich plasma for each survey will be between 4 and 8 mL.
This survey will run 2 times per year.
Functional Heparin-Induced Thrombocytopenia Testing (Functional HIT):
In 2025 we will also introduce regular surveys for functional HIT testing (HIT-II module). The participant will receive each survey two different samples. Any method for functional HIT testing can be used. For this module citrated plasma will be used.
This survey will run 2 times per year.
If you are interested in one of these new modules and have not yet registered for it, please contact the ECAT office (info@ecat.nl) or your local ECAT distributor.
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ECAT Information:
New Publication
Recently a new publication in which ECAT was involved has been appeared.
Together with colleagues from Canada we have evaluated results of our D-Dimer surveys for the period 2017 - 2023. This evaluation has now been published in Seminars in Thrombosis and Haemostasis.
Abstract:
D-dimer assessment has several established roles in venous thromboembolism (VTE) and disseminated intravascular coagulation diagnosis, and recently the risk stratification of coronavirus disease 2019 (COVID-19). D-dimer assays are neither standardized nor harmonized, use varying methodologies, and use different reporting units, all resulting in a lack of interchangeability and generalizability of assays. Using large multiyear datasets from an international laboratory quality assurance program, we assessed (1) common D-dimer assays in use worldwide, (2) differences in analytical performance between different
methods, and (3) interlaboratory variability between positive samples. External proficiency testing results from laboratories participating in the External Quality Control for Assays and Tests (ECAT) Foundation were analyzed from 2017 to 2023. Annually, between 578 and 690 laboratories participated in the D-dimer sample surveys with response rates ranging from 88 to97%. The three most common assays in use in 2023 were the Siemens Innovance D-dimer (42%), the IL HemosIL D-dimer HS 500 (20%), and the Diagnostica Stago (Stago) Liatest D-dimer Plus (10%) —all these are automated, quantitative, latex immunoassays expressed in fibrinogen equivalent units (FEU). The highest interlaboratory variability was observed around the typical VTE exclusion threshold of 0.5 mg/L FEU. Lower interlaboratory variability was observed at values above 0.8 mg/L FEU. Our study provides recent, international performance data on currently used D-dimer assays and describes the significant variability between assays and across D-dimer concentrations. We demonstrate that assays are not interchangeable and that using them interchangeably has the potential to result in clinically important errors. There is an urgent need to educate users about these issues and to work towards harmonizing D-dimer units and reporting.
This publication can be approached with the following link: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0044-1791700
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Literature Highlights:
Recent publications
Below we list some interesting recent publications in the field of thrombosis and haemostasis, and laboratory diagnostics. Because of the enormous number of publications we have limited our reporting to just a small list of interesting publications. It is not our intention to provide you with a complete overview. We hope this list supports you in your awareness of interesting publications.
Laboratory testing
- Gosselin RC, Moore GW, Kershaw GW, Montalvao S, Adcock DM. International Council for Standardization in Haematology Field Study Evaluating Optimal Interpretation Methods for Activated Partial Thromboplastin Time and Prothrombin Time Mixing Studies. Archives of pathology & laboratory medicine. 2024;148:880-9.
- Yan, J., L. Liao, D. Deng, W. Zhou, P. Cheng, L. Xiang, et al., Guideline for diagnosis and management of congenital dysfibrinogenemia. Clin Chim Acta, 2024; 561: 119680.
- Kershaw, G., Strategies for Performing Factor Assays in the Presence of Emicizumab or Other Novel/Emerging Hemostatic Agents. Semin Thromb Hemost, 2024; 50: 1163-1172.
- Dees, D.C., Heparin Induced Thrombocytopenia Testing. Clin Lab Med, 2024; 44: 541-550.
- Gosselin, R.C. and A. Cuker, Assessing Direct Oral Anticoagulants in the Clinical Laboratory. Clin Lab Med, 2024; 44: 551-562.
Quality
- Gosselin RC, Castellone D, Dorgalaleh A, Hickey K, Lippi G, Moffat K, et al. International Council for Standardization in Haematology Guidance for New Lot Verification of Coagulation Reagents, Calibrators, and Controls. Seminars in thrombosis and hemostasis. 2024;50:1091-102.
- Reilly-Stitt, C., I. Jennings, S. Kitchen and I.D. Walker, Internal Quality Control in Hemostasis Assays. Semin Thromb Hemost, 2024; 50: 1084-1090.
- Horvath, A.R., K.J.L. Bell, F. Ceriotti, G.R.D. Jones, T.P. Loh, S. Lord, et al., Outcome-based analytical performance specifications: current status and future challenges. Clin Chem Lab Med, 2024; 62: 1474-1482.
- Sandberg, S., A. Coskun, A. Carobene, P. Fernandez-Calle, J. Diaz-Garzon, W.A. Bartlett, et al., Analytical performance specifications based on biological variation data - considerations, strengths and limitations. Clin Chem Lab Med, 2024; 62: 1483-1489.
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Upcoming Events
66th ASH
07-10 December 2024, San Diego, USA
website
17th DHC
22-24 January 2024, Arnhem, The Netherlands
website
SLAS 2025
25-29 January 2025, San Diego, CA, USA
website
MEDLAB
03-06 Fenruary 2025, Dubai, UAE
website
For more events, please have a look into our Calendar.
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