罗氏cobas 8000 c502分析仪上LT-SYS铜检测法的特性分析与验证

Characterization and Validation of the LT-SYS Copper Assay on a Roche Cobas 8000 c502 Analyzer.

作者信息

Kraus F Bernhard, Mischereit Marlies, Eller Christoph, Ludwig-Kraus Beatrice

机构信息

Zentrallabor, Department of Laboratory Medicine, University Hospital Halle, Halle (Saale), Germany

Department of Biology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.

出版信息

Lab Med. 2017 Feb;48(1):10-17. doi: 10.1093/labmed/lmw049. Epub 2016 Sep 4.

DOI:10.1093/labmed/lmw049

PMID:27593171

Abstract

OBJECTIVE

Validation of the LT-SYS quantitative in vitro copper assay on a Roche Cobas 8000 c502 analyzer and comparison with a BIOMED assay on a Roche Cobas Mira analyzer.

METHODS

Imprecision and bias were quantified at different concentration levels (serum and plasma) over a 20-day period. Linearity was assessed covering a range from 4.08 µmol/L to 33.8 µmol/L. Limit of blank (LoB) and limit of detection (LoD) were established based on a total of 120 blank and low-level samples. The method comparison was based on 58 plasma samples.

RESULTS

Within-run imprecision ranged from 0.7% to 1.2% and within-laboratory imprecision from 1.4% to 3.3%. Relative bias for the 2 serum pools with known target values was less than 2.5%. The assay did not deviate from linearity over the tested measuring range. LoB and LoD were 0.12 µmol/L and 0.23 µmol/L, respectively. The method comparison revealed an average deviation of 11.5% (2.016 µmol/L), and the linear regression fit was y = 1.464 + 0.795x.

CONCLUSIONS

The LT-SYS copper assay characterized in this study showed a fully acceptable performance with good degrees of imprecision and bias, no deviation from linearity in the relevant measuring rangem, and very low LoB and LoD.

摘要

目的

在罗氏Cobas 8000 c502分析仪上验证LT-SYS定量体外铜检测法，并与罗氏Cobas Mira分析仪上的BIOMED检测法进行比较。

方法

在20天内对不同浓度水平（血清和血浆）的不精密度和偏倚进行定量。评估了4.08 µmol/L至33.8 µmol/L范围内的线性。基于总共120个空白和低水平样本确定了空白限（LoB）和检测限（LoD）。方法比较基于58个血浆样本。

结果

批内不精密度范围为0.7%至1.2%，实验室内不精密度范围为1.4%至3.3%。两个已知目标值血清池的相对偏倚小于2.5%。在测试的测量范围内，该检测法未偏离线性。LoB和LoD分别为0.12 µmol/L和0.23 µmol/L。方法比较显示平均偏差为11.5%（2.016 µmol/L），线性回归拟合为y = 1.464 + 0.795x。