Comparative evaluation of routine coagulation testing on Stago sthemO 301 and Werfen ACL TOP 750.

IF 2.2 Q2 MEDICINE, GENERAL & INTERNAL

Diagnosis Pub Date : 2025-04-02 DOI:10.1515/dx-2025-0018

Simone Denitto, Elia Ponchini, Nicola Baratto, Alessandro Lorenzetto, Davide Demonte, Gian Luca Salvagno, Emmanuel J Favaloro, Giuseppe Lippi

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引用次数: 0

Abstract

Objectives: We performed a comparative evaluation of analytical performance between the novel bench-top Stago sthemO 301 hemostasis analyzer and the Werfen ACL TOP 750 coagulometer using routine plasma samples.

Methods: A minimum of 100 fresh plasma samples per test were analyzed using both analytical systems. The tests included prothrombin time (PT) expressed as international normalized ratio (INR) and seconds (s), activated partial thromboplastin time (APTT) in ratio and seconds, fibrinogen, antithrombin and D-dimer. Clotting assays were performed using mechanical clot detection on sthemO and optical detection on ACL TOP. The comparative evaluation included the calculation of Spearman's correlation, Passing-Bablok regression and Bland-Altman plots.

Results: Correlation coefficients ranged between 0.76 for APTT to 0.98 for PT-INR and D-dimer, indicating a generally acceptable/good agreement. The regression slopes varied from 0.82 for D-dimer to 1.17 for APTT-s. A significant bias was observed for all tests except antithrombin, with differences for sthemO ranging between -31 % for D-dimer and 13.7 % for PT-s.

Conclusions: SthemO demonstrates acceptable global comparability with ACL TOP for routine coagulation testing. Nevertheless, reagent- and method-dependent bias has been observed, which highlight the need for additional harmonization efforts.

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Stago sthemO 301与Werfen ACL TOP 750常规凝血试验的比较评价。

目的：采用常规血浆样本，对新型Stago sthemO 301台式止血分析仪和Werfen ACL TOP 750凝血仪的分析性能进行了比较评价。方法：使用两种分析系统对每次试验至少100份新鲜血浆样品进行分析。检测包括凝血酶原时间（PT）以国际标准化比值（INR）和秒数(s)表示，活化部分凝血活素时间（APTT）以比值和秒数表示，纤维蛋白原、抗凝血酶和d -二聚体。凝血测定采用sthemO的机械凝血检测和ACL TOP的光学检测。比较评价包括Spearman相关计算、Passing-Bablok回归和Bland-Altman图。结果：APTT的相关系数在0.76到0.98之间，PT-INR和d -二聚体的相关系数大致可接受。回归斜率从d -二聚体的0.82到APTT-s的1.17不等。除抗凝血酶外，所有试验均观察到显著偏倚，d -二聚体的sthemO差异在-31 %和PT-s的13.7 %之间。结论：SthemO与ACL TOP在常规凝血检测中具有可接受的全球可比性。然而，已经观察到试剂和方法相关的偏差，这突出了需要额外的协调努力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnosis MEDICINE, GENERAL & INTERNAL-

CiteScore

7.20

自引率

5.70%

发文量

期刊介绍： Diagnosis focuses on how diagnosis can be advanced, how it is taught, and how and why it can fail, leading to diagnostic errors. The journal welcomes both fundamental and applied works, improvement initiatives, opinions, and debates to encourage new thinking on improving this critical aspect of healthcare quality.　 Topics: -Factors that promote diagnostic quality and safety -Clinical reasoning -Diagnostic errors in medicine -The factors that contribute to diagnostic error: human factors, cognitive issues, and system-related breakdowns -Improving the value of diagnosis – eliminating waste and unnecessary testing -How culture and removing blame promote awareness of diagnostic errors -Training and education related to clinical reasoning and diagnostic skills -Advances in laboratory testing and imaging that improve diagnostic capability -Local, national and international initiatives to reduce diagnostic error