三种分析系统（Milliplex、Elecsys 和 RIA）上进行的 NTproBNP 免疫测定比较。

Comparison of immunoassays for NTproBNP conducted on three analysis systems: Milliplex, Elecsys and RIA.

机构信息

Christchurch Heart Institute, Department of Medicine, Christchurch School of Medicine and Health Sciences, University of Otago, Dunedin, Otago, New Zealand.

出版信息

Clin Biochem. 2013 Mar;46(4-5):388-90. doi: 10.1016/j.clinbiochem.2012.11.022. Epub 2012 Dec 4.

DOI:10.1016/j.clinbiochem.2012.11.022

PMID:23219736

Abstract

OBJECTIVES

The aim of this study was to evaluate a Milliplex NTproBNP immunoassay and to compare its performance with the Roche Elecsys assay and an in house NTproBNP radioimmunoassay (RIA).

DESIGN AND METHODS

Samples were analyzed for NTproBNP in all 3 assays following the manufacturer's instructions and/or our previously published methodologies.

RESULTS

Similar plasma concentrations and assay reproducibility were observed for the Roche assay and in house RIA. However, the Milliplex assay produced much lower concentrations than the other two assays (versus Roche Elecsys bias of -367.9 pg/mL, (LOA -907.6 and 171.8)), and only quantified results for 63 of the 111 samples assessed. Of these 46 samples had acceptable errors of measurement (within sample coefficients of variation <20%) equating to 41% of the total samples measured.

CONCLUSIONS

The Milliplex assay, in its current form, does not produce results comparable with the Roche Elecsys 2010 assay or our in house RIA, and does not perform well as a quantitative assay. It may provide qualitative results (ie high, medium or low concentration), and serve as a rudimentary screening assay.

摘要

目的

本研究旨在评估一种 Milliplex NTproBNP 免疫测定法，并将其性能与罗氏 Elecsys 测定法和我们内部的 NTproBNP 放射免疫测定法（RIA）进行比较。

设计和方法

根据制造商的说明和/或我们之前发表的方法，对所有 3 种测定法中的 NTproBNP 进行样品分析。

结果

罗氏测定法和内部 RIA 观察到相似的血浆浓度和测定重现性。然而，与其他两种测定法相比，Milliplex 测定法产生的浓度要低得多（与罗氏 Elecsys 的偏差为-367.9pg/mL，（LOA-907.6 和 171.8）），并且仅对评估的 111 个样本中的 63 个进行了定量结果。其中 46 个样本的测量误差可接受（样本内变异系数 <20%），相当于测量的总样本的 41%。