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希森美康CS-5100全自动凝血分析仪的性能评估

Performance Evaluation of the Sysmex CS-5100 Automated Coagulation Analyzer.

作者信息

Chen Liming, Chen Yu

出版信息

Clin Lab. 2015;61(7):653-60. doi: 10.7754/clin.lab.2014.141124.

DOI:10.7754/clin.lab.2014.141124
PMID:26299062
Abstract

BACKGROUND

Coagulation testing is widely applied clinically, and laboratories increasingly demand automated coagulation analyzers with short turn-around times and high-throughput. The purpose of this study was to evaluate the performance of the Sysmex CS-5100 automated coagulation analyzer for routine use in a clinical laboratory.

METHODS

The prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (Fbg), and D-dimer were compared between the Sysmex CS-5100 and Sysmex CA-7000 analyzers, and the imprecision, comparison, throughput, STAT function, and performance for abnormal samples were measured in each.

RESULTS

The within-run and between-run coefficients of variation (CV) for the PT, APTT, INR, and D-dimer analyses showed excellent results both in the normal and pathologic ranges. The correlation coefficients between the Sysmex CS-5100 and Sysmex CA-7000 were highly correlated. The throughput of the Sysmex CS-5100 was faster than that of the Sysmex CA-7000. There was no interference at all by total bilirubin concentrations and triglyceride concentrations in the Sysmex CS-5100 analyzer.

CONCLUSIONS

We demonstrated that the Sysmex CS-5100 performs with satisfactory imprecision and is well suited for coagulation analysis in laboratories processing large sample numbers and icteric and lipemic samples.

摘要

背景

凝血检测在临床上广泛应用,实验室对周转时间短和高通量的自动凝血分析仪的需求日益增加。本研究的目的是评估Sysmex CS - 5100自动凝血分析仪在临床实验室常规使用中的性能。

方法

比较了Sysmex CS - 5100和Sysmex CA - 7000分析仪之间的凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、纤维蛋白原(Fbg)和D - 二聚体,并分别测量了两者的不精密度、可比性、通量、急诊功能以及对异常样本的性能。

结果

PT、APTT、INR和D - 二聚体分析的批内和批间变异系数(CV)在正常和病理范围内均显示出优异的结果。Sysmex CS - 5100和Sysmex CA - 7000之间的相关系数高度相关。Sysmex CS - 5100的通量比Sysmex CA - 7000更快。Sysmex CS - 5100分析仪中总胆红素浓度和甘油三酯浓度均无干扰。

结论

我们证明了Sysmex CS - 5100具有令人满意的不精密度,非常适合处理大量样本以及黄疸和脂血样本的实验室进行凝血分析。

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