Validation of a blood-based laboratory test to aid in the confirmation of a diagnosis of schizophrenia.
We describe the validation of a serum-based test developed by Rules-Based Medicine which can be used to help confirm the diagnosis of schizophrenia. In preliminary studies using multiplex immunoassay profiling technology, we identified a disease signature comprised of 51 analytes which could distinguish schizophrenia (n = 250) from control (n = 230) subjects. In the next stage, these analytes were developed as a refined 51-plex immunoassay panel for validation using a large independent cohort of schizophrenia (n = 577) and control (n = 229) subjects. The resulting test yielded an overall sensitivity of 83% and specificity of 83% with a receiver operating characteristic area under the curve (ROC-AUC) of 89%. These 51 immunoassays and the associated decision rule delivered a sensitive and specific prediction for the presence of schizophrenia in patients compared to matched healthy controls.
Schwarz
Emanuel
E
Institute of Biotechnology, University of Cambridge, Cambridge, UK (consultants to Rules-Based Medicine).
Izmailov
Rauf
R
Spain
Michael
M
Barnes
Anthony
A
Mapes
James P
JP
Guest
Paul C
PC
Rahmoune
Hassan
H
Pietsch
Sandra
S
Leweke
F Markus
FM
Rothermundt
Matthias
M
Steiner
Johann
J
Koethe
Dagmar
D
Kranaster
Laura
L
Ohrmann
Patricia
P
Suslow
Thomas
T
Levin
Yishai
Y
Bogerts
Bernhard
B
van Beveren
Nico Jm
NJ
McAllister
George
G
Weber
Natalya
N
Niebuhr
David
D
Cowan
David
D
Yolken
Robert H
RH
Bahn
Sabine
S