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• W2897557265 abstract "Years of research have shown the usefulness of CSF Beta-Amyloid 1-42 in Alzheimer's diagnostics. However, in the absence of a certified reference material Beta-Amyloid 1-42 values are assay dependent which makes it difficult to compare studies. Therefore, the Working Group for CSF Proteins of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the Joint Research Centre (JRC) of the European Commission have developed and produced three Certified Reference Materials (CRMs) based on human CSF, with low, middle and high concentrations of Aβ1-42. This study describes a possible approach to standardize the EUROIMMUN Beta-Amyloid kits against the reference material. 3 CRM samples sets have been measured at EUROIMMUN using several lot numbers of EUROIMMUN Beta-Amyloid 1-42 ELISA and the newly developed ChLIA assay by different operators over several days. Different methods to include proportional dilution of the CRMs were assessed, including tube type selection and method of dilution. In addition, the impact of additional freeze/thawing was assessed. The EUROIMMUN Beta-Amyloid 1-42 ELISA and ChLIA show a very nice correlation (R2=0.99). With both assays the CRMs were measured ∼20% lower than the IFCC assigned values. Target (measured) level 1: 450pg/ml (383pg/ml), level 2: 720 pg/ml (581pg/ml), level 3: 1220pg/ml (966pg/ml), while all three levels followed a linear correlation. Therefore the calibration of the EUROIMMUN assays could be adapted by using the linear regression of: Euroimmun old value x 1,32 – 51pg/ml = recalibrated value. The assignment of CSF beta amyloid concentrations from the reference material to the kit calibrator needs metrological traceability. The three CRM levels produced by IFCC are potential tools to standardize the calibrators from measuring systems for beta amyloid 42.Due to the nature of amyloid peptide, a well designed protocol is required to standardize the calibrators. The choice of tubes and handling approach to prepare proportional dilutions are important parameters. The verification of harmonization of test systems is required to support a global cut-point for AB42 analysis." @default.
• W2897557265 created "2018-10-26" @default.
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• W2897557265 date "2018-07-01" @default.
• W2897557265 modified "2023-10-16" @default.
• W2897557265 title "P1‐273: EVALUATION OF CERTIFIED REFERENCE MATERIALS FOR BETA‐AMYLOID 1‐42 IN EUROIMMUN BETA‐AMYLOID 1‐42 ELISA AND CHLIA" @default.
• W2897557265 doi "https://doi.org/10.1016/j.jalz.2018.06.279" @default.
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