eprintid: 10058278
rev_number: 18
eprint_status: archive
userid: 608
dir: disk0/10/05/82/78
datestamp: 2018-10-15 09:14:29
lastmod: 2021-09-20 22:17:44
status_changed: 2018-10-15 09:14:29
type: article
metadata_visibility: show
creators_name: Kruse, N
creators_name: Heslegrave, A
creators_name: Gupta, V
creators_name: Foiani, M
creators_name: Villar-Piqué, A
creators_name: Schmitz, M
creators_name: Lehmann, S
creators_name: Teunissen, C
creators_name: Blennow, K
creators_name: Zetterberg, H
creators_name: Mollenhauer, B
creators_name: Zerr, I
creators_name: Llorens, F
title: Interlaboratory Validation of Cerebrospinal Fluid Α-synuclein Quantification in the Diagnosis of Sporadic Creutzfeldt-jakob Disease
ispublished: pub
divisions: UCL
divisions: B02
divisions: C07
divisions: D07
divisions: F86
divisions: FD9
keywords: Sporadic Creutzfeldt-Jakob disease, α-Synuclein, Cerebrospinal fluid, Biomarker, Diagnostic accuracy, Interlaboratory reproducibility, Round robin test
note: This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
abstract: INTRODUCTION:
Cerebrospinal fluid α-synuclein level is increased in sporadic Creutzfeldt-Jakob disease cases. However, the clinical value of this biomarker remains to be established. In this study, we have addressed the clinical validation parameters and the interlaboratory reproducibility by using an electrochemiluminescent assay.

METHODS
Cerebrospinal fluid α-synuclein was quantified in a total of 188 sporadic Creutzfeldt-Jakob disease and non–Creutzfeldt-Jakob-disease cases to determine sensitivity and specificity values and lot-to-lot variability. Two round robin tests with 70 additional cases were performed in six independent laboratories.

RESULTS:
A sensitivity of 93% and a specificity of 96% were achieved in discriminating sporadic Creutzfeldt-Jakob disease. No differences were detected between lots. The mean interlaboratory coefficient of variation was 23%, and the intralaboratory coefficient of variations ranged 2.70%–11.39%. Overall, 97% of samples were correctly diagnosed.

DISCUSSION:
The herein validated α-synuclein assay is robust, accurate, and reproducible in identifying Creutzfeldt-Jakob disease cases. Thus, it is ready for implementation in the clinical practice to support the diagnosis of Creutzfeldt-Jakob disease.
date: 2018-07-07
date_type: published
official_url: https://doi.org/10.1016/j.dadm.2018.06.005
oa_status: green
full_text_type: pub
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1591040
doi: 10.1016/j.dadm.2018.06.005
lyricists_name: Foiani, Martha
lyricists_name: Heslegrave, Amanda
lyricists_name: Zetterberg, Henrik
lyricists_id: MFOIA63
lyricists_id: AJHES09
lyricists_id: HZETT94
actors_name: Cuccu, Clara
actors_id: CCCUC40
actors_role: owner
full_text_status: public
publication: Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring
volume: 10
pagerange: 461-470
issn: 2352-8729
citation:        Kruse, N;    Heslegrave, A;    Gupta, V;    Foiani, M;    Villar-Piqué, A;    Schmitz, M;    Lehmann, S;                         ... Llorens, F; + view all <#>        Kruse, N;  Heslegrave, A;  Gupta, V;  Foiani, M;  Villar-Piqué, A;  Schmitz, M;  Lehmann, S;  Teunissen, C;  Blennow, K;  Zetterberg, H;  Mollenhauer, B;  Zerr, I;  Llorens, F;   - view fewer <#>    (2018)    Interlaboratory Validation of Cerebrospinal Fluid Α-synuclein Quantification in the Diagnosis of Sporadic Creutzfeldt-jakob Disease.                   Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring , 10    pp. 461-470.    10.1016/j.dadm.2018.06.005 <https://doi.org/10.1016/j.dadm.2018.06.005>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10058278/1/Kruse_Cerebrospinal%20Fluid%20BiomarkersInterlaboratory%20validation.pdf