在西门子BNII分析仪上对N乳胶血清游离轻链检测法的评估以及与The Binding Site公司FreeLite检测法在特定蛋白分析仪上的一致性。

Evaluation of the N-latex serum free light chain assay on the Siemens BNII analyzer and agreement with The Binding Site FreeLite assay on the SPA.

作者信息

White-Al Habeeb Nicole M A, Earle Tammy, Spencer Megan, Blasutig Ivan M

机构信息

Department of Laboratory Medicine and Pathobiology, University of Toronto, Canada; Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada.

Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada.

出版信息

Clin Biochem. 2018 Jan;51:90-96. doi: 10.1016/j.clinbiochem.2017.05.009. Epub 2017 May 13.

DOI:10.1016/j.clinbiochem.2017.05.009

PMID:28512013

Abstract

OBJECTIVES

To evaluate the Siemens N-latex kappa free light chain (κFLC) and lambda FLC (λFLC) assays on the BNII nephelometer and assess agreement with The Binding Site Freelite FLC assays on the SPA.

DESIGN AND METHODS

Over 180 patient serum samples from routine analysis of κFLC and λFLC measured by the Freelite assay were collected for the study and measured with the N-latex κFLC and λFLC assays to assess precision, linearity, method comparison and dilutional effects.

RESULTS

Complex precision showed coefficients of variation of 4.8-7.2% for the κFLC assay and 3.6-6.0% for the λFLC assay. Linearity assessment showed both assays were linear (κFLC, y=1.00x-0.09 and λFLC, y=1.050x-1.252). Qualitative method comparison showed 87.9% (116/132) agreement and Cohen's kappa of 80.4% between the κFLC assays and 72.6% (98/135) agreement and Cohen's kappa of 55.4% for the λFLC assays. Quantitative method comparison for κFLC<150mg/L was y=0.92x+2.21, R=0.661 and for λFLC<150mg/L was y=7.90x-137.96, R=0.526. Dilutional effects including antigen excess and non-linearity were also examined.

CONCLUSIONS

The N-latex assay showed good precision and linearity with reasonable agreement to the Freelite assay. However, the assays should not be used interchangeably to monitor patients.

摘要

目的

评估西门子BNII散射比浊仪上的N-乳胶κ游离轻链（κFLC）和λ游离轻链（λFLC）检测，并评估其与The Binding Site公司Freelite游离轻链检测在特定蛋白分析仪上的一致性。

设计与方法

收集超过180份通过Freelite检测进行κFLC和λFLC常规分析的患者血清样本用于本研究，并用N-乳胶κFLC和λFLC检测进行测量，以评估精密度、线性、方法比较和稀释效应。

结果

复合精密度显示，κFLC检测的变异系数为4.8 - 7.2%，λFLC检测的变异系数为3.6 - 6.0%。线性评估显示两种检测均呈线性（κFLC，y = 1.00x - 0.09；λFLC，y = 1.050x - 1.252）。定性方法比较显示，κFLC检测之间的一致性为87.9%（116/132），Cohen's kappa值为80.4%；λFLC检测之间的一致性为72.6%（98/135），Cohen's kappa值为55.4%。κFLC<150mg/L时的定量方法比较为y = 0.92x + 2.21，R = 0.661；λFLC<150mg/L时为y = 7.90x - 137.96，R = 0.526。还检查了包括抗原过量和非线性在内的稀释效应。