使用Ceveron s100分析仪对一种测量ADAMTS - 13活性的新型自动化方法进行真实世界评估。
Real-world evaluation of a novel automated method for measuring ADAMTS-13 activity using the Ceveron s100 analyzer.
作者信息
Joly Bérangère S, Deniau Hélène, Doinel Chloé, Brouillard Adeline, Siguret Virginie, Coppo Paul, Veyradier Agnès
机构信息
Service d'Hématologie Biologique, Hôpital Lariboisière, Assistance Publique Hôpitaux de Paris (AP-HP).Nord, Université Paris Cité, Paris, France; INSERM UMR-S 1138, Centre de Recherche des Cordeliers, Université Paris Cité, Sorbonne Université, Paris, France.
Service d'Hématologie Biologique, Hôpital Lariboisière, Assistance Publique Hôpitaux de Paris (AP-HP).Nord, Université Paris Cité, Paris, France.
出版信息
J Thromb Haemost. 2025 Jul;23(7):2178-2189. doi: 10.1016/j.jtha.2025.02.038. Epub 2025 Mar 7.
BACKGROUND
Thrombotic thrombocytopenic purpura (TTP) is a thrombotic microangiopathy characterized by a severe functional deficiency of ADAMTS-13. Measuring ADAMTS-13 activity is crucial for diagnosing TTP (<10 IU/dL), monitoring treatments, and detecting relapses (<20 IU/dL). The Technofluor assay (Technoclone) allows a rapid ADAMTS-13 activity measurement using the Ceveron s100 analyzer (Technoclone).
OBJECTIVES
This study aimed to evaluate the analytical and clinical performance of this new test under real-world conditions.
METHODS
ADAMTS-13 activity was measured using 2 fluorometric methods: the Technofluor ADAMTS-13 activity on the Ceveron s100 (Technoclone) and our reference fluorescence resonance energy transfer-VWF73 method, in plasma samples collected under real-life conditions (January 12, 2024, to April 4, 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 coefficient of variation of <11%, and reproducibility coefficient of variation 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; 95% CI, 0.90-1.01; negative predictive value, 0.98; 95% CI, 0.97-1.00). No analytical interference was observed.
CONCLUSION
The Technofluor assay on the Ceveron s100 is a fast, reliable method for measuring ADAMTS-13 activity, proving effectiveness for diagnosis and monitoring of TTP patients. However, it remains crucial to interpret ADAMTS-13 activity measurement with clinical context to ensure accurate diagnosis and management.
背景
血栓性血小板减少性紫癜（TTP）是一种血栓性微血管病，其特征是ADAMTS - 13严重功能缺陷。测量ADAMTS - 13活性对于诊断TTP（<10 IU/dL）、监测治疗以及检测复发（<20 IU/dL）至关重要。Technofluor检测法（Technoclone公司）可使用Ceveron s100分析仪（Technoclone公司）快速测量ADAMTS - 13活性。
目的
本研究旨在评估这种新检测方法在实际应用中的分析性能和临床性能。
方法
使用两种荧光法测量ADAMTS - 13活性：在Ceveron s100分析仪上进行的Technofluor ADAMTS - 13活性检测（Technoclone公司）以及我们的参考荧光共振能量转移 - VWF73法，对在实际生活条件下（2024年1月12日至2024年4月4日）采集的血浆样本以及从我们的生物样本库中回顾性选取的样本进行检测。评估了新检测方法的分析性能和临床性能，重点关注临界低水平（<30 IU/dL）。
结果
在实际应用条件下对400个样本进行了检测，另外回顾性检测了100个样本。Technofluor检测法显示出优异的分析性能，检测限为0.1 IU/dL，重复性变异系数<11%，再现性变异系数在高水平（90 IU/dL）时为6.1%，在低水平（40 IU/dL）时为7.5%。在诊断时（临界值为10 IU/dL；敏感性和阳性预测值均为1.0）以及随访期间（临界值为20 IU/dL；特异性为1.0；95%置信区间为0.99 - 1.oo；阳性预测值为0.96；95%置信区间为0.90 - 1.01；阴性预测值为0.98；95%置信区间为0.97 - 1.00）临床性能良好。未观察到分析干扰。
结论
在Ceveron s100分析仪上进行的Technofluor检测法是一种快速、可靠的测量ADAMTS - 13活性的方法，证明对TTP患者的诊断和监测有效。然而，结合临床背景解读ADAMTS - 13活性测量结果对于确保准确诊断和管理仍然至关重要。
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