Certification of Amyloid-Beta (Aβ) Certified Reference Materials by Amino Acid-Based Isotope Dilution High-Performance Liquid Chromatography Mass Spectrometry and Sulfur-Based High-Performance Liquid Chromatography Isotope Dilution Inductively Coupled Plasma Mass Spectrometry.

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.