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评估Cobas 8000®用于血清和脑脊液中白蛋白和免疫球蛋白G的定量分析。

Evaluation of Cobas 8000® for the quantification of albumin and IgG in serum and cerebrospinal fluid.

作者信息

Puissant-Lubrano Bénédicte

机构信息

Laboratoire d'Immunologie, CHU de Toulouse, France.

出版信息

Clin Biochem. 2018 Jun;56:105-108. doi: 10.1016/j.clinbiochem.2018.04.005. Epub 2018 Apr 11.

Abstract

According to the 2017 revised McDonald criteria, the presence of oligoclonal bands (OCB) at isoelectric focusing (IEF) is useful for the diagnosis of Multiple Sclerosis (MS), including relapsing-remitting MS and primary progressive MS. In this context, the quantification of IgG in serum and CSF is required for IEF execution (to deposit the same amount of IgG in serum and CSF), while the quantification of albumin in serum and CSF allows the calculation of the albumin quotient. We have evaluated the analytical performances of Cobas 8000® analyzer for the quantification of albumin and IgG in serum and CSF. Coefficients of variation were below 3.3% for within-run precision and below 3.1% for between-run precision. Results were similar or better than those obtained on nephelometer Immage 800® and turbidimeter SPAPLUS®. The uncertainty of quantification of IgG in CSF was 9% and that of albumin in CSF was 12%. IgG and albumin measured on Cobas 8000® in serum and CSF showed good agreement with results obtained on the nephelometer Immage 800®, including for the classification of albumin quotient and CSF IgG index as normal or pathological. Therefore, Cobas 8000® is a valuable tool for the quantification of IgG and albumin in CSF, in the context of diagnosis of MS and other inflammatory disease affecting the central nervous system.

摘要

根据2017年修订的麦克唐纳标准,等电聚焦(IEF)时寡克隆带(OCB)的出现对多发性硬化症(MS)的诊断有用,包括复发缓解型MS和原发进展型MS。在此背景下,IEF检测需要对血清和脑脊液中的IgG进行定量(以便在血清和脑脊液中加入等量的IgG),而血清和脑脊液中白蛋白的定量可用于计算白蛋白商。我们评估了Cobas 8000®分析仪对血清和脑脊液中白蛋白和IgG定量的分析性能。批内精密度的变异系数低于3.3%,批间精密度的变异系数低于3.1%。结果与在免疫比浊仪Immage 800®和比浊仪SPAPLUS®上获得的结果相似或更好。脑脊液中IgG定量的不确定度为9%,脑脊液中白蛋白定量的不确定度为12%。在Cobas 8000®上检测的血清和脑脊液中的IgG和白蛋白与在免疫比浊仪Immage 800®上获得的结果显示出良好的一致性,包括白蛋白商和脑脊液IgG指数的正常或病理分类。因此,在MS和其他影响中枢神经系统的炎性疾病的诊断中,Cobas 8000®是定量脑脊液中IgG和白蛋白的有价值工具。

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