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评估使用 AP22 ELITE 仪器的新 Sebia 游离轻链检测法。

Evaluation of the new Sebia free light chain assay using the AP22 ELITE instrument.

机构信息

Service de Chimie Clinique, CHU Liège, Belgium.

出版信息

Clin Chim Acta. 2018 Dec;487:161-167. doi: 10.1016/j.cca.2018.09.030. Epub 2018 Sep 20.

DOI:10.1016/j.cca.2018.09.030
PMID:30243748
Abstract

BACKGROUND

Serum kappa and lambda free light chains (FLC) are useful in the diagnosis, prognosis and monitoring of patients with monoclonal gammopathies. The Binding Site and Siemens were the only suppliers of kits for these analyses until recently, when Sebia introduced an enzyme-linked immunosorbent assay (ELISA) on an automated instrument, DAS AP22 ELITE.

METHOD

Samples from routine analysis, controls and chronic kidney disease (CKD) patients were tested using the automated version of Sebia FLC ELISA with the AP22 ELITE and results were compared with Freelite on the SPA PLUS (The Binding Site).

RESULTS

Sebia FLC ELISA showed a good performance using the AP22 ELITE. A concordance of 82% was found with the results obtained with Freelite. Sebia FLC is a reproducible assay, requiring less retesting than Freelite thanks to a broader range. Earlier findings that the results obtained are closer to the FLC monoclonal band measured by electrophoresis were confirmed. Higher kappa and lambda values obtained in CKD individuals were also shown, confirming that a kappa/lambda FLC ratio should be introduced by Sebia for CKD patients, as with The Binding Site.

CONCLUSIONS

Sebia put forward new technology that automatically measures free light chains. This technique is suitable for routine use; however, the results cannot be used interchangeably with Freelite kits.

摘要

背景

血清κ和λ游离轻链(FLC)可用于诊断、预后和监测单克隆丙种球蛋白病患者。Binding Site 和西门子是这些分析试剂盒的唯一供应商,直到最近,Sebia 在自动仪器 DAS AP22 ELITE 上推出了酶联免疫吸附测定(ELISA)。

方法

使用自动版 Sebia FLC ELISA 与 AP22 ELITE 对常规分析、对照和慢性肾脏病(CKD)患者的样本进行检测,并与 SPA PLUS(Binding Site)上的 Freelite 进行比较。

结果

Sebia FLC ELISA 在使用 AP22 ELITE 时表现出良好的性能。与 Freelite 相比,其结果具有 82%的一致性。与 Freelite 相比,Sebia FLC 是一种重现性好的检测方法,由于其范围更广,需要进行的复测较少。早期发现该检测方法获得的结果与电泳测量的 FLC 单克隆带更接近,这一结果得到了证实。还显示出 CKD 个体中获得的κ和λ值较高,这表明 Sebia 应该像 Binding Site 一样,为 CKD 患者引入κ/λ FLC 比值。

结论

Sebia 提出了自动测量游离轻链的新技术。该技术适用于常规使用;然而,其结果不能与 Freelite 试剂盒互换使用。

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