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Alzheimers Dement (Amst). 2018 Jul 7;10:461-470. doi: 10.1016/j.dadm.2018.06.005. eCollection 2018.

Interlaboratory validation of cerebrospinal fluid α-synuclein quantification in the diagnosis of sporadic Creutzfeldt-Jakob disease.

Author information

1
Institute for Neuropathology, University Medical Center Göttingen, Göttingen, Germany.
2
Department of Molecular Neuroscience, Institute of Neurology, University College London, London, UK.
3
Neurochemistry Laboratory and Biobank, Department of Clinical Chemistry, Amsterdam Neuroscience, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.
4
Department of Neurology, University Medicine Göttingen, Göttingen, Germany.
5
German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
6
Université de Montpellier, CHU de Montpellier, Laboratoire de Biochimie Protéomique Clinique, INSERM U1183, Montpellier, France.
7
Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.
8
Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.
9
UK Dementia Research Institute at UCL, London, UK.
10
Paracelsus-Elena Klinik, Center for Parkinsonism and Movement Disorders, Kassel, Germany.
11
Network Center for Biomedical Research in Neurodegenerative Diseases, (CIBERNED), Institute Carlos III, Ministry of Health, Barcelona, Spain.
12
Bellvitge Biomedical Research Institute (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain.

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.

KEYWORDS:

Biomarker; Cerebrospinal fluid; Diagnostic accuracy; Interlaboratory reproducibility; Round robin test; Sporadic Creutzfeldt-Jakob disease; α-Synuclein

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