Ring trial of 2nd generation RT-QuIC diagnostic tests for sporadic CJD.
Journal
Annals of clinical and translational neurology
ISSN: 2328-9503
Titre abrégé: Ann Clin Transl Neurol
Pays: United States
ID NLM: 101623278
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
03
09
2020
accepted:
14
09
2020
entrez:
13
11
2020
pubmed:
14
11
2020
medline:
25
9
2021
Statut:
ppublish
Résumé
Real-time quaking-induced conversion (RT-QuIC) assays detect prion-seeding activity in a variety of human biospecimens, including cerebrospinal fluid and olfactory mucosa swabs. The assay has shown high diagnostic accuracy in patients with prion disorders. Recently, advances in these tests have led to markedly improved diagnostic sensitivity and reduced assay times. Accordingly, an algorithm has been proposed that entails the use of RT-QuIC analysis of both sample types to diagnose sporadic Creutzfeldt-Jakob disease with nearly 100% accuracy. Here we present a multi-center evaluation (ring trial) of the reproducibility of these improved "second generation" RT-QuIC assays as applied to these diagnostic specimens. Cerebrospinal fluid samples were analyzed from subjects with sporadic Creutzfeldt-Jakob (n = 55) or other neurological diseases (n = 45) at multiple clinical centers. Olfactory mucosa brushings collected by multiple otolaryngologists were obtained from nine sporadic Creutzfeldt-Jakob disease cases and 19 controls. These sample sets were initially tested blindly by RT-QuIC by a coordinating laboratory, recoded, and then sent to five additional testing laboratories for blinded ring trial testing. Unblinding of the results by a third party indicated 98-100% concordance between the results obtained by the testing of these cerebrospinal fluid and nasal brushings at the six laboratories. This second-generation RT-QuIC assay is highly transferrable, reproducible, and therefore robust for the diagnosis of sporadic Creutzfeldt-Jakob disease in clinical practice.
Identifiants
pubmed: 33185334
doi: 10.1002/acn3.51219
pmc: PMC7664259
doi:
Substances chimiques
Prions
0
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, N.I.H., Intramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2262-2271Subventions
Organisme : NIH HHS
ID : NIA R01 AG AG031189
Pays : United States
Organisme : NIH HHS
ID : R56 AG055619
Pays : United States
Organisme : Chief Scientist Office
ID : ETM/58
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/J016071/1
Pays : United Kingdom
Organisme : NIH HHS
ID : R01AG062562
Pays : United States
Organisme : NIAID NIH HHS
ID : 000309CK14
Pays : United States
Organisme : NINDS NIH HHS
ID : R01 NS103848
Pays : United States
Organisme : NIA NIH HHS
ID : RF1 AG058267
Pays : United States
Informations de copyright
© 2020 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association.
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