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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Celebration
This year ECAT celebrates their 30th anniversary. During the ECAT symposium in September we will celebrate this anniversary.
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EQA for Fibrin(ogen) Degradation Products
In 2024 we have extended our EQA programme with a module for fibrin(ogen) degradation products (FDP). This modules includes 4 surveys per year. Samples will cover a wide concentration range of FDP. If you are interested in participation please contact the ECAT office (info@ecat.nl) or your ECAT distributor.
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FVIII/FIX Replacement products
In 2023 ECAT started with regular surveys for factor VIII and FIX replacement products. Currently we offer surveys for the following products:
• Kovaltry (Bayer)
• Jivi (Bayer)
• Esperoct (Novo Nordisk)
• NovoEight (Novo Nordisk)
• Refixia (Novo Nordisk)
We hope to extend this surveys with additional products in the future.
If you are interested in participation please contact the ECAT office (info@ecat.nl) or your ECAT distributor.
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ECAT Information:
Platelet Light Transmission Aggregation Pilot Study
Light-transmission aggregometry (LTA) plays an important role in the detection of platelet disorders in the laboratory. Despite this role, assuring the quality of LTA-testing is a challenge for laboratories, due in part to the lack of standardised reference materials representing platelet disorders and the need to process platelets within hours of sample collection. Nanobodies targeting platelet proteins can be used to create standardised reference samples from fresh material collected by the participating laboratories. Read more
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ECAT Information:
Bivariate Z-score analysis
In 2022 the ECAT Foundation introduced the bivariate Z-score analysis into several of their survey reports (e.g. Screen, D-Dimer, Main, Haemophilia and Anticoagulation reports). The Z-score is a measure of the accuracy of measurement, and informs the participants how many times the standard deviation their results deviates from the assigned value. In most surveys two different samples are distributed. Each of the Z-scores obtained can be evaluated on an individual basis (univariate approach). However, most times a laboratory will measure both ECAT samples in the same analytical run. This means that the results, and as such the Z-scores, should be considered inter-dependent. In this case it is more logical to monitor the Z-score pair simultaneously. For this purpose we developed the so-called bivariate Z-score analysis. The details of this analysis have now been published in the Journal of Clinical Chemistry and Laboratory Medicine (CCLM).
If you are interested in the background to this analysis and want to be able to evaluate appropriately the bivariate Z-score plots in our survey reports, we strongly recommend you to read this publication. You can download this open-access publication with the following link: https://www.degruyter.com/document/doi/10.1515/cclm-2023-0835/htmlOn the ECAT website there is also a recorded webinar which deals with this topic. Go to the ECAT website (www.ecat.nl), see under ECAT Education, and select Special Information. Log in with your labcode and password and select ECAT webinars. Here you can find the recorded webinar on how to interpret Z-scores in the ECAT survey reports.
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ECAT Information:
New Publications
Over the last couple of months several publications in which ECAT was involved have appeared.
You will find them listed below.
1) A special IFCC/ISTH working group works on the development of a reference method and primary standard for the international normalised ration (INR). As a first result the metrological traceability and sustainable calibration hierarchy has now been published in the Journal of Thrombosis and Haemostasis.
van den Besselaar A, Stavelin A, Kitchen S, Bryant M, Tripodi A, Scalambrino E, et al. Defining a metrologically traceable and sustainable calibration hierarchy of international normalized ratio for monitoring of vitamin K antagonist treatment in accordance with International Organization for Standardization (ISO) 17511:2020 standard: communication from the International Federation of Clinical Chemistry and Laboratory Medicine-SSC/ISTH working group on prothrombin.
2) Recently the 2023 ACR/EULAR antiphospholid syndrome (APS) classification criteria have been published (1). From an analytical perspective there are concerns regarding these updated criteria. This has been demonstrated with data from the ECAT external quality assessment programme.
Huisman A, Urbanus RT, Meijer P. Antiphospholipid antibody solid phase-based assays: problems and proposed solutions for the 2023 ACR/EULAR classification criteria for antiphospholipid syndrome. J Thromb Haemost. 2024;22:874-6.
Reference:
1. Barbhaiya M, Zuily S, Naden R, Hendry A, Manneville F, Amigo MC, et al. 2023 ACR/EULAR antiphospholipid syndrome classification criteria. Annals of Rheumatic Diseases. 2023;82:1258-70.
3) At the ISTH congress 2023 in Montreal Dr. Rita Selby from Toronto, Canada held a state-of-the-art lecture entitled: D-Dimer diagnostics: can I use any D-Dimer assay? Bridging the knowledge-to-action gap. This lecture was further elaborated in a recent publication in Research and Practice in Thrombosis and Haemostasis (RPTH). The role of D-dimer, primarily in the outpatient diagnosis of patients with venous thromboembolism (VTE) when combined with clinical decision rules is reviewed, with a focus on recent large management trials that have studied adjustments of VTE exclusion thresholds for D-dimer based on either prior clinical probability of VTE or patient age, and the resultant benefit of reduced imaging for VTE and improved diagnostic efficiency. In this context, the significant variability between D-dimer results and the multiple D-dimer assays in use worldwide using data from international external quality assurance programs were reported. This variability is particularly high at typical VTE exclusion thresholds. The potential clinical impact of D-dimer assay substitution on accuracy of diagnosis and risk stratification of patients with VTE was discussed. Finally, relevant new data on this topic presented during the 2023 International Society on Thrombosis and Haemostasis Congress and outline future priorities urgently needed to harmonize D-dimer results and reporting that will require international collaboration among multiple stakeholders with as an overall goal, to close this knowledge-to-action gap were summarized.
Selby R, Meijer P, Favaloro EJ. D-dimer diagnostics: can I use any D-dimer assay? Bridging the knowledge-to-action gap. Res Pract Thromb Haemost. 2024;8:102335.
This open-access publication can be found using the following link: https://doi.org/10.1016/j.rpth.2024.102335
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Case Report:
Interference of antiphospholipid antibodies with point-of-care
INR testing
In June 2022, a 48-year-old man presented to the Emergency department of the University Medical Center Utrecht with sudden onset of aphasia and right-sided hemi-paresis. His medical history noted the antiphospholipid syndrome (APS), which had been diagnosed in 2016 on the basis of a spontaneous deep venous thrombosis (DVT) in the left leg, livedo reticularis and migraine, in combination with persistent triple positivity for the serological markers of APS (lupus anticoagulant and high levels of anti-β2-Glycoprotein-IgG antibodies and anticardiolipin-IgG antibodies). There were no additional signs of autoimmune disease. Read more
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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
- Valke L, Verhagen MJA, Mulders B, Polenewen R, Blijlevens NMA, Jansen JH, et al. The Nijmegen ultra-sensitive Bethesda Assay detects very low-titer factor VIII inhibitors in patients with congenital and acquired hemophilia A. Thrombosis research. 2023;231:112-20.
- Kumano O, Moore GW. Validation of mixing test-specific cut-off in lupus anticoagulant mixing test interpretation for multiple reagents. Thrombosis research. 2023;231:39-43.
- Savard, P., V. Leguy-Seguin, C. Chavy, F. Genre-Volot, A. Callegarin, J. Amiral, et al., Iodoacetamide blank compensation in FXIII functional assays: Is it still necessary? Int J Lab Hematol, 2023; 45: 969-971.
- Apipongrat, D., R. Lamool, P. Arnutti, C. Ruangpratheep and W. Chantkran, Comparison of different algorithms for lupus anticoagulant detection: a single-center experience. Res Pract Thromb Haemost, 2024; 8: 102333.
Quality
- Sonntag, O. and T.P. Loh, Calibration – an under-appreciated component in the analytical process of the medical laboratories. Adv Lab Med, 2023:
https://www.degruyter.com/document/doi/10.515/almed-2023-0127/html
- Coskun, A. and G. Lippi, Personalized laboratory medicine in the digital health era: recent developments and future challenges. Clin Chem Lab Med, 2024; 62: 402-409.
- Mackie, I., A. Casini, M. Pieters, R. Pruthi, C. Reilly-Stitt and A. Suzuki, International council for standardisation in haematology recommendations on fibrinogen assays, thrombin clotting time and related tests in the investigation of bleeding disorders. Int J Lab Hematol, 2024; 46: 20-32.
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Upcoming Events
12th ICTHIC
17-19 May 2024, Bergamo, Italy
website
92st EAS Congress
26-29 May 2024, Lyon, France
website
ISLH 2024
30 May-1 June 2024, Nantes, France
website
XXXI ISTH and SSC 2024
22-26 June 2024, Bangkok, Thailand
website
For more events, please have a look into our Calendar.
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