贝克曼库尔特化学分析仪血清β2-微球蛋白检测评估。

Evaluation of Serum Beta-2-Microglobulin Assay on Beckman Coulter Chemistry Analyzer.

出版信息

Clin Lab. 2022 Mar 1;68(3). doi: 10.7754/Clin.Lab.2021.210735.

DOI:10.7754/Clin.Lab.2021.210735

Abstract

BACKGROUND

Beta-2 microglobulin (β2M) has various clinical usages and is an important prognostic marker for multiple myeloma. Although there are concerns of harmonization between assays, performance evaluation and method comparison reports are rare. Here, we evaluated the performance of Beckman-Coulter β2M assay.

METHODS

The precision and linearity of the Beckman Coulter β2M assay were evaluated. Beckman-Coulter results were compared to DiaSorin Liaison results. The manufacturer provided reference interval was verified.

RESULTS

Within-laboratory imprecision percentage coefficient of variation was 1.73% and 2.19% for low- and high-level control material, respectively. The linearity was confirmed over a range of 0.08 to 15.60 mg/L. Passing-Bablok regression analysis showed that y (Beckman-Coulter) = 0.978 x (Liaison) + 0.079 (r = 0.996) with a mean difference of 1.0%. All healthy subjects were within the range of manufacturer provided reference interval.

CONCLUSIONS

The analytical performance of the Beckman-Coulter β2M assay was clinically acceptable.

摘要

背景

β2-微球蛋白（β2M）在临床上有多种用途，是多发性骨髓瘤的重要预后标志物。尽管人们担心检测方法之间的一致性，但性能评估和方法比较报告却很少。在这里，我们评估了贝克曼库尔特β2M 检测法的性能。

方法

评估了贝克曼库尔特β2M 检测法的精密度和线性。将贝克曼库尔特的结果与德赛诊断 Liaison 的结果进行比较。验证了制造商提供的参考区间。

结果

在实验室内部，低水平和高水平质控品的批内精密度变异系数分别为 1.73%和 2.19%。线性验证范围为 0.08 至 15.60mg/L。Passing-Bablok 回归分析显示，y（贝克曼库尔特）= 0.978x（Liaison）+ 0.079（r = 0.996），平均差值为 1.0%。所有健康受试者均在制造商提供的参考区间范围内。