首个用于校准商业免疫分析的经过认证的β淀粉样蛋白 1-42 参考物质。

First amyloid β1-42 certified reference material for re-calibrating commercial immunoassays.

机构信息

European Commission, Joint Research Centre (JRC), Geel, Belgium.

Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry, The Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Mölndal, Sweden.

出版信息

Alzheimers Dement. 2020 Nov;16(11):1493-1503. doi: 10.1002/alz.12145. Epub 2020 Aug 4.

INTRODUCTION

Reference materials based on human cerebrospinal fluid were certified for the mass concentration of amyloid beta (Aβ)1-42 (Aβ ). They are intended to be used to calibrate diagnostic assays for Aβ .

METHODS

The three certified reference materials (CRMs), ERM-DA480/IFCC, ERM-DA481/IFCC and ERM-DA482/IFCC, were prepared at three concentration levels and characterized using isotope dilution mass spectrometry methods. Roche, EUROIMMUN, and Fujirebio used the three CRMs to re-calibrate their immunoassays.

RESULTS

The certified Aβ mass concentrations in ERM-DA480/IFCC, ERM-DA481/IFCC, and ERM-DA482/IFCC are 0.45, 0.72, and 1.22 μg/L, respectively, with expanded uncertainties (k = 2) of 0.07, 0.11, and 0.18 μg/L, respectively. Before re-calibration, a good correlation (Pearson's r > 0.97), yet large biases, were observed between results from different commercial assays. After re-calibration the between-assay bias was reduced to < 5%.

DISCUSSION

The Aβ CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ .

简介

基于人脑脊液的参考物质已通过认证，可用于测定淀粉样蛋白β（Aβ）1-42（Aβ）的质量浓度。这些参考物质旨在用于校准 Aβ 的诊断检测。

方法

三个经过认证的参考物质（CRM），ERM-DA480/IFCC、ERM-DA481/IFCC 和 ERM-DA482/IFCC，在三个浓度水平下制备，并使用同位素稀释质谱法进行了特征描述。罗氏、EUROIMMUN 和富士瑞必欧利用这三种 CRM 重新校准了他们的免疫测定法。

结果

ERM-DA480/IFCC、ERM-DA481/IFCC 和 ERM-DA482/IFCC 中认证的 Aβ 质量浓度分别为 0.45、0.72 和 1.22μg/L，扩展不确定度（k=2）分别为 0.07、0.11 和 0.18μg/L。在重新校准之前，不同商业检测方法之间的结果相关性很好（Pearson's r>0.97），但存在较大的偏倚。经过重新校准，检测之间的偏倚降低到<5%。