Abstract
IntroductionReference materials based on human cerebrospinal fluid were certified for the mass concentration of amyloid beta (Aβ)1‐42 (Aβ42). They are intended to be used to calibrate diagnostic assays for Aβ42.MethodsThe 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.ResultsThe certified Aβ42 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%.DiscussionThe Aβ42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aβ42.
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