Evaluation of the impact of CSF prion RT-QuIC and amended criteria on the clinical diagnosis of Creutzfeldt-Jakob disease: a 10-year study in Italy.


Journal

Journal of neurology, neurosurgery, and psychiatry
ISSN: 1468-330X
Titre abrégé: J Neurol Neurosurg Psychiatry
Pays: England
ID NLM: 2985191R

Informations de publication

Date de publication:
02 2023
Historique:
received: 12 08 2022
accepted: 09 10 2022
pubmed: 26 11 2022
medline: 14 1 2023
entrez: 25 11 2022
Statut: ppublish

Résumé

The introduction of the prion Real-Time Quaking-Induced Conversion assay (RT-QuIC) has led to a revision of the diagnostic criteria for sporadic Creutzfeldt-Jakob disease (sCJD).Validation studies are needed for the amended criteria, especially for their diagnostic value in the clinical setting. We studied 1250 patients with suspected CJD referred for diagnosis to two Italian reference centres between 2010 and 2020. Focusing on the first diagnostic assessment, we compared the diagnostic value of the old and the amended criteria and that of different combinations of clinical variables and biomarker results. The studied cohort comprised 850 participants with CJD (297 definite sCJD, 151 genetic CJD, 402 probable sCJD) and 400 with non-CJD (61 with neuropathology). At first clinical evaluation, the sensitivity of the old criteria (76.8%) was significantly lower than that of the amended criteria (97.8%) in the definite CJD cohort with no difference between definite and probable sCJD cases. Specificity was ~94% for both criteria against the non-CJD cohort (82.0% against definite non-CJD group). Cerebrospinal fluid (CSF) RT-QuIC was highly sensitive (93.9%) and fully specific against definite non-CJD patients. Limiting the criteria to a positive RT-QuIC or/and the combination of a clinical course compatible with possible CJD with a positive MRI (Q-CM criteria) provided higher diagnostic accuracy than both the old and amended criteria, overcoming the suboptimal specificity of ancillary test results (ie, CSF protein 14-3-3). CSF RT-QuIC is highly sensitive and specific for diagnosing CJD in vitam. The Q-CM criteria provide a high diagnostic value for CJD.

Sections du résumé

BACKGROUND
The introduction of the prion Real-Time Quaking-Induced Conversion assay (RT-QuIC) has led to a revision of the diagnostic criteria for sporadic Creutzfeldt-Jakob disease (sCJD).Validation studies are needed for the amended criteria, especially for their diagnostic value in the clinical setting.
METHODS
We studied 1250 patients with suspected CJD referred for diagnosis to two Italian reference centres between 2010 and 2020. Focusing on the first diagnostic assessment, we compared the diagnostic value of the old and the amended criteria and that of different combinations of clinical variables and biomarker results.
RESULTS
The studied cohort comprised 850 participants with CJD (297 definite sCJD, 151 genetic CJD, 402 probable sCJD) and 400 with non-CJD (61 with neuropathology). At first clinical evaluation, the sensitivity of the old criteria (76.8%) was significantly lower than that of the amended criteria (97.8%) in the definite CJD cohort with no difference between definite and probable sCJD cases. Specificity was ~94% for both criteria against the non-CJD cohort (82.0% against definite non-CJD group). Cerebrospinal fluid (CSF) RT-QuIC was highly sensitive (93.9%) and fully specific against definite non-CJD patients. Limiting the criteria to a positive RT-QuIC or/and the combination of a clinical course compatible with possible CJD with a positive MRI (Q-CM criteria) provided higher diagnostic accuracy than both the old and amended criteria, overcoming the suboptimal specificity of ancillary test results (ie, CSF protein 14-3-3).
CONCLUSIONS
CSF RT-QuIC is highly sensitive and specific for diagnosing CJD in vitam. The Q-CM criteria provide a high diagnostic value for CJD.

Identifiants

pubmed: 36428087
pii: jnnp-2022-330153
doi: 10.1136/jnnp-2022-330153
doi:

Substances chimiques

Prions 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

121-129

Informations de copyright

© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Auteurs

Andrea Mastrangelo (A)

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Angela Mammana (A)

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.

Simone Baiardi (S)

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.

Dorina Tiple (D)

Department of Neuroscience, Istituto Superiore di Sanità, Roma, Italy.

Elisa Colaizzo (E)

Department of Neuroscience, Istituto Superiore di Sanità, Roma, Italy.

Marcello Rossi (M)

IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.

Luana Vaianella (L)

Department of Neuroscience, Istituto Superiore di Sanità, Roma, Italy.

Barbara Polischi (B)

IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.

Michele Equestre (M)

Department of Neuroscience, Istituto Superiore di Sanità, Roma, Italy.

Anna Poleggi (A)

Department of Neuroscience, Istituto Superiore di Sanità, Roma, Italy.

Sabina Capellari (S)

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.
IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.

Anna Ladogana (A)

Department of Neuroscience, Istituto Superiore di Sanità, Roma, Italy.

Piero Parchi (P)

Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy piero.parchi@unibo.it.
IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.

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