VALIDATION OF A BLOOD-BASED LABORATORY TEST TO AID IN THE CONFIRMATION OF A DIAGNOSIS OF SCHIZOPHRENIA
Biomark Insights. 2010;5:39-47. Published online 2010 May 12
1, Institute of Biotechnology, University of Cambridge, Cambridge, UK (consultants to Rules-Based Medicine); 2, Rules-Based Medicine, Inc., Austin, Texas, USA; 3, Department of Psychiatry and Psychotherapy, University of Cologne, Germany; 4, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany; 5, Department of Psychiatry, University of Muenster, Germany; 6, Department of Psychiatry, University of Magdeburg, Germany; 7, Department of Psychiatry, Erasmus University, Medical Center, Rottterdam, Netherlands; 8, Psynova Neurotech Ltd (a subsidiary of Rules-Based Medicine), Cambridge, UK; 9, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA; 10, The Stanley Medical Research Institute, Chevy Chase, MD, USA.
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.