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 initiatives in the ECAT EQA programme
A number of new initiatives are planned for 2023 in the ECAT external quality assessment programme.
Haemophilia Programme:
The modules relating to laboratory testing for haemohilia A and B are now included in a separate programme the Haemophilia Programme, and a separate survey report for this has been provided. These modules are no longer included in the Main Report.
The Haemophilia Programme includes the following modules: Haemophilia (Factor VIII Factor IX), Factor VIII Inhibitor, Factor IX Inhibitor, Emicizumab, Kogenate FS, Kovaltry and Jivi.
Factor VIII / Factor IX Replacement Products:
In 2023 we will start a stepwise introduction to FVIII and FIX replacement products. using regular surveys. Currently we can offer specific surveys for the following FVIII products: Kogenate FS, Kovaltry and Jivi (Bayer). Kogenate FS (Bayer) is a human recombinant Factor VIII product. It has been used since 1993 and will be discontinued after 2023. Kovaltry (Bayer) is a next-generation human recombinant Factor VIII product and has been used since 2016. Jivi (damoctocog alfa pegol, Bayer) is a so-called extended half-life Factor VIII product and has been in use since 2018.
Separate samples will be provided for each of these products. In 2023 only one survey per product will be conducted. After 2023 we aim to carry out 2 surveys per product per year.
It will be possible to submit results for both the measurement with the one-stage clotting assay and the chromogenic assay. The results will be evaluated on the basis of the reagent used.
We are still working on a further extension of these surveys with other products, and will inform you when specific surveys for other products become available.
ACT Programme:
The activated clotting time (ACT) is used primarily to monitor anticoagulation (heparin), e.g. during heart bypass surgery, coronary angioplasty or dialysis. The ACT is a point-of-care test. For this programme samples will be used that are applicable to an ACT POCT monitor.
The results will be evaluated on the basis of the type of monitor and reagent used. Samples from other surveys will be distributed separately.
In 2023 we will start to introduce this new programme only for laboratories that have a direct subscription to ECAT. Unfortunately, participants who have a subscription via one of our distributors cannot yet register for this new programme, but this programme will become available to them in 2024.
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Subscription for 2023
You are now able to subscribe to the ECAT external quality assessment programme 2023. If you are a participant with a direct subscription to the ECAT EQA programme, please go to the Participant Area on our website and select Subscription 2023.
If you are registered via one of our distributors please contact your distributor, if you have not yet received any information from them.
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New publications
We are proud to announce a recent new ECAT publication entitled “How Do Laboratories Perform von Willebrand Disease Diagnostics and Classification of von Willebrand Disease Patients? Results from External Quality Data and an International Survey”. You can access this publication using the following link: https://pubmed.ncbi.nlm.nih.gov/36055267
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ECAT Information:
12th ECAT Symposium
A very successful 12th ECAT Symposium was held on 15 – 16 September 2022 in the Corpus Congress Center,
Leiden, The Netherlands, attended by 225 participants. Various different topics were discussed, such as COVID 19
and the role of the haemostasis laboratory, HIT and VITT, haemophilia and gene therapy, low von Willebrand Factor
and the diagnostic threshold, thrombogenomics, D-Dimer, Lupus Anticoagulant, Phospholipid antibody testing,
guidance for Factor VIII and IX inhibitor testing, biological variation in haemostasis, new developments in
antithrombin testing, and the lot-to-lot variation of reagents. Read more
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Case Report:
Effect of high haematocrit levels on coagulation testing
A 42-year-old man presented at the emergency department in April 2022 with rectal blood loss. The patient had a history of cardiac problems. He was diagnosed in 1979 with congenital tricuspid atresia. The patient had an extensive surgical history of treatment to ensure adequate pulmonary and systemic blood flow: bidirectional cavopulmonary anastomosis (bidirectional Glenn connection), systemic-to-pulmonary shunts (Blalock-Taussig shunt), central shunts (Waterston shunt), Rashkind septostomy and a Fontan procedure. As patients with Fontan circulation are at risk of systemic and pulmonary thromboembolic events, anticoagulation is required. He was therefore treated once daily with warfarin 5 mg and acetylsalicylic acid 80 mg. 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
- Margetic, S., I. Celap, A.L. Huzjan, M.B. Puretic, S.S. Goreta, A.C. Glojnaric, et al., DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation. Thromb Haemost, 2022; 122: 1542-1548.
- Marlar, R.A., J.N. Gausman and M.A. Rollins-Raval, Guidance for establishing a factor VIII testing protocol for the myriad of factor VIII products. Int J Lab Hematol, 2022; 44: 414-423.
- Vermeiren, P., A. Vandevelde, H. Peperstraete and K.M.J. Devreese, Monitoring of heparin therapy beyond the anti-Xa activity assay: Evaluation of a thrombin generation assay. Int J Lab Hematol, 2022; 44: 785-795.
- Bauca, J.M., E. Ajzner, J. Cadamuro, A. Hillarp, A.H. Kristoffersen, P. Meijer, et al., An international study on activated partial thromboplastin time prolongation. Part 1: Analytical results. Clin Chim Acta, 2022; 535: 167-173.
- Bauca, J.M., E. Ajzner, J. Cadamuro, A. Hillarp, A.H. Kristoffersen, P. Meijer, et al., An international study on activated partial thromboplastin time prolongation. Part 2: Interpretative commenting. Clin Chim Acta, 2022; 535: 174-179.
Quality
- Testa, S., P. Meijer, D. Lasne and F. Mullier, Implementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing. Int J Lab Hematol, 2022; 44 Suppl 1: 71-78.
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Upcoming Events
MEDICA 2022
14-17 November 2022, Düsseldorf,
website
BSTH 2022
24-25 November 2022, Mechelen,
website
64th ASH Annual Meeting
10-13 December 2022, New Orleans, LA,
website
15th DHC
25-27 January 2023, Arnhem,
website
Labquality days 2023
09-10 February 2022, Helsinki,
website
For more events, please have a look into our Calendar.
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