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VIDAS®高敏肌钙蛋白I检测法与贝克曼库尔特Unicel® DXI AccuTnI+3检测法在检验科的分析性能

Analytical Performance of the VIDAS® High-Sensitivity Troponin I Assay and the Beckman Coulter Unicel® DXI AccuTnI+3 Assay in a Stat Laboratory.

作者信息

Er Tze-Kiong, Su Yu-Fa, Chan Tzu-Hsien

出版信息

Clin Lab. 2019 Jan 1;65(1). doi: 10.7754/Clin.Lab.2018.180626.

Abstract

BACKGROUND

The aim of this study was to compare the validity of two different cTnI assay methodologies.

METHODS

We collected 82 plasma samples from a stat laboratory. The plasma values of cTnI ranged from 0.012 to 29.715 ng/mL when tested on the Access® platform and from 4.5 to >40,000 ng/L when tested on the VIDAS platform. The patients included 34 females ranging in age from 49 to 100 years of age [76.7 ± 12 years] and 48 males ranging from 29 to 97 years of age [69.7 ± 12 years].

RESULTS

Our results showed that the correlation between the two troponin results was r2 = 0.9836 (p < 0.001). In this study, the kappa statistic (0.89) indicated a high degree of agreement between the VIDAS® High-sensitivity Troponin I assay and the Beckman Coulter Unicel® DXI AccuTnI+3 assay.

CONCLUSIONS

In summary, the VIDAS® High-sensitivity Troponin I assay is a reliable and feasible method for determining the levels of cTnI in plasma, but it requires manual operation, hands-on technical expertise, and time.

摘要

背景

本研究的目的是比较两种不同的肌钙蛋白I(cTnI)检测方法的有效性。

方法

我们从一家急诊实验室收集了82份血浆样本。在Access®平台上检测时,血浆中cTnI的值范围为0.012至29.715 ng/mL,在VIDAS平台上检测时为4.5至>40,000 ng/L。患者包括34名女性,年龄在49至100岁之间[76.7±12岁],48名男性,年龄在29至97岁之间[69.7±12岁]。

结果

我们的结果显示,两种肌钙蛋白检测结果之间的相关性为r2 = 0.9836(p < 0.001)。在本研究中,kappa统计量(0.89)表明VIDAS®高敏肌钙蛋白I检测法与贝克曼库尔特Unicel® DXI AccuTnI+3检测法之间具有高度一致性。

结论

总之,VIDAS®高敏肌钙蛋白I检测法是一种可靠且可行的测定血浆中cTnI水平的方法,但它需要人工操作、实际操作技术专长和时间。

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