Feng Liuxing, Huo Zhongzhong, Xiong Jinping, Li Hongmei
Division of Chemical Metrology and Analytical Science, National Institute of Metrology, Beijing 100029, China.
College of Material Science and Technology, Beijing University of Chemical Technology, Beijing 100029, China.
Anal Chem. 2020 Oct 6;92(19):13229-13237. doi: 10.1021/acs.analchem.0c02381. Epub 2020 Sep 10.
The use of amyloid-beta (Aβ) biomarkers could contribute to an early diagnosis of Alzheimer's disease (AD); however, there are still large variations among results from different assays. This variability can be overcome by standardization of those assays through the use of certified reference materials (CRMs) and the establishment of a traceability chain. In this study, Aβ (GBW09874) and Aβ (GBW09875) solution CRMs with the certified values and uncertainties of 7.58 ± 0.30 and 7.62 ± 0.30 μg g were developed with high-purity Aβ as raw materials. For the first time, isotope dilution high-performance liquid chromatography mass spectrometry (ID-LC-MS) and high-performance liquid chromatography isotope dilution inductively coupled plasma mass spectrometry (HPLC-ID-ICP-MS) strategies were employed to certify the candidate Aβ solution CRMs. The two candidate CRMs showed good homogeneity, and good stability was also demonstrated for at least 5 days at -20 °C and 14 months at -70 °C. These CRMs are primarily intended to be used for value assignment to secondary calibrators or CRMs with a clinical matrix, which will help in early diagnosis of AD.
使用淀粉样β蛋白（Aβ）生物标志物有助于阿尔茨海默病（AD）的早期诊断；然而，不同检测方法的结果仍存在很大差异。通过使用经认证的参考物质（CRM）对这些检测方法进行标准化，并建立可追溯链，可以克服这种变异性。在本研究中，以高纯度Aβ为原料，开发了认证值和不确定度分别为7.58±0.30和7.62±0.30μg/g的Aβ（GBW09874）和Aβ（GBW09875）溶液CRM。首次采用同位素稀释高效液相色谱-质谱联用（ID-LC-MS）和高效液相色谱-同位素稀释电感耦合等离子体质谱联用（HPLC-ID-ICP-MS）策略对候选Aβ溶液CRM进行认证。两种候选CRM表现出良好的均匀性，在-20℃下至少5天以及在-70℃下14个月也显示出良好的稳定性。这些CRM主要用于为具有临床基质的二级校准品或CRM赋值，这将有助于AD的早期诊断。
