First amyloid ß1-42 certified reference material for re-calibrating commercial immunoassays.
Alzheimers Dement
; 16(11): 1493-1503, 2020 11.
Article
em 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 .Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoensaio
/
Peptídeos beta-Amiloides
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article