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.
Alzheimers Dement. 2020 Nov;16(11):1493-1503. doi: 10.1002/alz.12145. Epub 2020 Aug 4.
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 .
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.
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%.
The Aβ CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ .
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。
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。
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%。
Aβ CRM 可确保方法之间以及不同平台之间 Aβ 测量结果的等效性。
