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[两种止血分析仪(STA R Max和Cobas t 511)的方法比较]

[Method comparison between two hemostasis analyzers: STA R Max and Cobas t 511].

作者信息

Melicine Sophie, Bayani Nazanine, Xuan Juliette Vo, Deleray Maeva, Chouk Rym, Creidy Rita, Khazem Bassem

出版信息

Ann Biol Clin (Paris). 2024 Sep 19;82(4):387-403. doi: 10.1684/abc.2024.1904.

DOI:10.1684/abc.2024.1904
PMID:39210594
Abstract

The STA R Max3 (Stago, France) and Cobas t511 (Roche Diagnostics, Germany) are two automated hemostasis analysers that can be used to perform a wide range of tests. The STA R Max3 uses a mechanical clot detection system to measure coagulation times, while the Cobas t511 uses optical detection. The aim of this study was to compare the analytical performance of these two analysers using fresh plasma samples with or without a risk of interference due to hemolysis or lipemia. For plasma samples without interference, acceptable agreement was observed for prothrombin time (PT) (n = 55), activated partial thromboplastin time (APTT) (n = 56), fibrinogen (n = 56) and factor II (n = 43) with R² of 0.907, 0.963, 0.979 and 0.968 respectively. For factor V (n = 43) and D-dimers (n = 45), agreement was less acceptable, with respective R² of 0.756 and 0.887, but with no clinical impact. For hemolysed samples, acceptable results were observed for PT, fibrinogen and D-dimers, but three results were clinically discordant for APTT, and STA R Max3 offered greater robustness for processing highly lipemic samples.

摘要

STA R Max3(法国思塔高公司)和Cobas t511(德国罗氏诊断公司)是两款自动化止血分析仪,可用于进行多种检测。STA R Max3使用机械凝血检测系统来测量凝血时间,而Cobas t511使用光学检测。本研究的目的是使用有无溶血或脂血干扰风险的新鲜血浆样本,比较这两款分析仪的分析性能。对于无干扰的血浆样本,凝血酶原时间(PT)(n = 55)、活化部分凝血活酶时间(APTT)(n = 56)、纤维蛋白原(n = 56)和因子II(n = 43)观察到可接受的一致性,R²分别为0.907、0.963、0.979和0.968。对于因子V(n = 43)和D-二聚体(n = 45),一致性不太理想,R²分别为0.756和0.887,但无临床影响。对于溶血样本,PT、纤维蛋白原和D-二聚体观察到可接受的结果,但APTT有三个结果在临床上不一致,并且STA R Max3在处理高脂血样本方面具有更高的稳健性。

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