First amyloid ß1-42 certified reference material for re-calibrating commercial immunoassays.
Alzheimers Dement
; 16(11): 1493-1503, 2020 11.
Article
en En
| MEDLINE
| ID: mdl-32755010
ABSTRACT
INTRODUCTION:
Reference materials based on human cerebrospinal fluid were certified for the mass concentration of amyloid beta (Aß)1-42 (Aß42 ). They are intended to be used to calibrate diagnostic assays for Aß42 .METHODS:
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.RESULTS:
The certified Aß42 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%.DISCUSSION:
The Aß42 CRMs can ensure the equivalence of results between methods and across platforms for the measurement of Aß42 .Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Inmunoensayo
/
Péptidos beta-Amiloides
Límite:
Humans
Idioma:
En
Revista:
Alzheimers Dement
Año:
2020
Tipo del documento:
Article
País de afiliación:
Bélgica