Detailed Information on Publication Record
2022
Validation of the LUMIPULSE automated immunoassay for the measurement of core AD biomarkers in cerebrospinal fluid
GOBOM, J., L. PARNETTI, P. ROSA-NETO, Martin VYHNALEK, S. GAUTHIER et. al.Basic information
Original name
Validation of the LUMIPULSE automated immunoassay for the measurement of core AD biomarkers in cerebrospinal fluid
Authors
GOBOM, J. (guarantor), L. PARNETTI, P. ROSA-NETO, Martin VYHNALEK (203 Czech Republic), S. GAUTHIER, S. CATALDI, O. LERCH, J. LACZO, Katerina CECHOVA (203 Czech Republic), M. CLARIN, A. I. BENET, T. A. PASCOAL, N. RAHMOUNI, M. VANDIJCK, E. HUYCK, N. LE BASTARD, J. STEVENSON, M. CHAMOUN, D. ALCOLEA, A. LLEO, U. ANDREASSON, M. M. VERBEEK, G. BELLOMO, R. RINALDI, N. ASHTON, H. ZETTERBERG, Kateřina SHEARDOVÁ (203 Czech Republic, belonging to the institution), Jakub HORT (203 Czech Republic, belonging to the institution) and K. BLENNOW
Edition
Clinical Chemistry and Laboratory medicine, BERLIN, WALTER DE GRUYTER & CO, 2022, 1434-6621
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
20602 Medical laboratory technology ;
Country of publisher
Germany
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 6.800
RIV identification code
RIV/00216224:14110/22:00125190
Organization unit
Faculty of Medicine
UT WoS
000737400000003
Keywords in English
Alzheimer's disease; biomarkers; immunoassay; LUMIPULSE; validation
Tags
International impact, Reviewed
Změněno: 1/2/2022 11:33, Mgr. Tereza Miškechová
Abstract
V originále
Objectives The core cerebrospinal fluid (CSF) biomarkers; total tau (tTau), phospho-tau (pTau), amyloid beta 1-42 (A beta 1-42), and the A beta 1-42/A beta 1-40 ratio have transformed Alzheimer's disease (AD) research and are today increasingly used in clinical routine laboratories as diagnostic tools. Fully automated immunoassay instruments with ready-to-use assay kits and calibrators has simplified their analysis and improved reproducibility of measurements. We evaluated the analytical performance of the fully automated immunoassay instrument LUMIPULSE G (Fujirebio) for measurement of the four core AD CSF biomarkers and determined cutpoints for AD diagnosis. Methods Comparison of the LUMIPULSE G assays was performed with the established INNOTEST ELISAs (Fujirebio) for hTau Ag, pTau 181, beta-amyloid 1-42, and with V-PLEX Plus A beta Peptide Panel 1 (6E10) (Meso Scale Discovery) for A beta 1-42/A beta 1-40, as well as with a LC-MS reference method for A beta 1-42. Intra- and inter-laboratory reproducibility was evaluated for all assays. Clinical cutpoints for A beta 1-42, tTau, and pTau was determined by analysis of three cohorts of clinically diagnosed patients, comprising 651 CSF samples. For the A beta 1-42/A beta 1-40 ratio, the cutpoint was determined by mixture model analysis of 2,782 CSF samples. Results The LUMIPULSE G assays showed strong correlation to all other immunoassays (r>0.93 for all assays). The repeatability (intra-laboratory) CVs ranged between 2.0 and 5.6%, with the highest variation observed for beta-amyloid 1-40. The reproducibility (inter-laboratory) CVs ranged between 2.1 and 6.5%, with the highest variation observed for beta-amyloid 1-42. The clinical cutpoints for AD were determined to be 409 ng/L for total tau, 50.2 ng/L for pTau 181, 526 ng/L for beta-amyloid 1-42, and 0.072 for the A beta 1-42/A beta 1-40 ratio. Conclusions Our results suggest that the LUMIPULSE G assays for the CSF AD biomarkers are fit for purpose in clinical laboratory practice. Further, they corroborate earlier presented reference limits for the biomarkers.