Real-world evaluation of a novel automated method for measuring ADAMTS13 activity using the Ceveron® s100 analyzer.

IF 5.5 2区医学 Q1 HEMATOLOGY Journal of Thrombosis and Haemostasis Pub Date : 2025-03-07 DOI:10.1016/j.jtha.2025.02.038

Bérangère S Joly, Hélène Deniau, Chloé Doinel, Adeline Brouillard, Virginie Siguret, Paul Coppo, Agnès Veyradier

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Abstract

Introduction: Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy characterized by a severe functional deficiency of ADAMTS13. Measuring ADAMTS13 activity is crucial for diagnosing TTP (<10 IU/dL), monitoring treatments, and detecting relapses (<20 IU/dL). The Technofluor® assay allows a rapid ADAMTS13 activity measurement using the CEVERON® s100 analyzer. This study aims to evaluate the analytical and clinical performance of this new test under real-world conditions.

Materials and methods: ADAMTS13 activity was measured using two fluorometric methods: the Technofluor® ADAMTS13 activity on the CEVERON® s100 (Technoclone, Austria) and our reference FRETS-VWF73 method, in plasma samples collected under real-life conditions (01/12/2024-04/04/2024) and retrospectively selected samples from our biobank. The analytical and clinical performance of the new test was assessed, focusing on the critical low levels (<30 IU/dL).

Results: Four hundred samples were tested under real-world conditions and 100 others tested retrospectively. The Technofluor® assay showed excellent analytical performance, with a detection limit of 0.1 IU/dL, repeatability CV <11%, and reproducibility CV of 6.1% (high level [90 IU/dL]) and 7.5% (low level [40 IU/dL]). Clinical performances were strong at diagnosis (threshold: 10 IU/dL; sensitivity and positive predictive value: 1.0) and during the follow-up (threshold: 20 IU/dL; specificity: 1.0 [95% CI: 0.99;1.00], positive predictive value: 0.96 [0.90;1.01]; negative predictive value: 0.98 [0.97;1.00]). No analytical interference was observed.

Conclusion: The Technofluor® assay on the CEVERON® s100 is a fast, reliable method for measuring ADAMTS13 activity, proving effectiveness for diagnosis and monitoring of TTP patients. However, it remains crucial to interpret ADAMTS13 activity measurement with clinical context to ensure accurate diagnosis and management.

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来源期刊

Journal of Thrombosis and Haemostasis 医学-外周血管病

CiteScore

24.30

自引率

3.80%

发文量

321

审稿时长

1 months

期刊介绍： The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.