Validation of a Blood-Based Laboratory Test to Aid in the Confirmation of a Diagnosis of Schizophrenia

Abstract

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.

Estudos traducionais de neuropsiquiatria e esquizofrenia: modelos animais genéticos e de neurodesenvolvimento

“…This is in line with biomarker findings which have focussed on altered patterns rather than changes of single proteins 200 . For example it has been shown that a combination of 51 serum biomarkers can be used in humans to help with the diagnosis of schizophrenia 201 . Further molecular analyses of molecular patterns in psychiatric animal models need to be correlated with human studies to identify signatures associated with specific alterations on the genetic level or with the consequences of environmental insults.…”

Altered apolipoprotein C expression in association with cognition impairments and hippocampus volume in schizophrenia and bipolar disorder

“…The trapping and analytical columns were C18 (180 µmx20mm, 5-µm particle size) and C18 BEH nanocolumn (75 µmx200mm, 1.7-mm particle size), respectively. Forty-two plasma proteins were quantified using Psynova Human Blood Panel-42 (Psynova Neurotech Ltd. Cambridge, UK) (Alsaif et al, 2012;Enaw & Smith, 2013;Schwarz et al, 2012;Schwarz et al, 2010a)(see Table 2). This selection was based on current findings in Schizophrenia and Bipolar disorder regarding the relevance of plasma proteins for etiological models of the diseases (see e.g., (Alsaif et al, 2012;Enaw et al, 2013;Schwarz et al, 2012;Schwarz et al, 2010b)).…”

Testes sanguíneos de biomarcadores para diagnóstico e tratamento de desordens mentais: foco em esquizofrenia

“…To this end, we recently developed a blood-based biomarker test (VeriPsych TM ) based on an algorithm of 51 molecular biomarkers which has now been launched in the USA 5,48 . This is…”

“…This algorithm was trained to identify molecules associated with schizophrenia and then we were able to identify stable molecular differences in the patient populations. Through studies of first onset patients we have discovered that most patients with schizophrenia have differences in the levels of insulinrelated molecules 28 , other hormones of the diffuse neuroendocrine system 49 , inflammatory factors 5,50 and molecules associated with endothelial cell function 48 . It is anticipated that determination of which of these factors are altered in each subject will be useful for patient stratification prior to antipsychotic treatment.…”

“…This has served to increase the accuracy of the findings and minimize the amount of sample required and the running costs. We have recently employed a multiplexed immunoassay profiling platform to analyze serum samples from schizophrenia patients which led identification of a panel of molecules that could classify schizophrenia subjects compared to controls with an accuracy of greater than 80% 5 .…”