title: Algorithm development for diagnostic biomarker assays.
abstract: This chapter describes the ground-breaking development of a serum-based test to help confirm the diagnosis of schizophrenia. A multiplex panel of 51 immunoassays was developed that allowed reproducible identification of schizophrenia patients compared to controls with high sensitivity and specificity. Validation of this test consisted of developing a linear support vector machine decision rule and testing its performance using cross-validation. This resulted in readjustment of the panel and algorithm to a smaller set of 40 robust assays, along with a simple procedure for maintenance and recalibration across future measurement changes associated with different reagent lots. The resulting decision rule delivered a sensitive and specific prediction for presence of schizophrenia in subjects compared to matched controls, with a receiver operating characteristic area under the curve of 88%. Performance of the recalibrated decision rule remained constant across lot changes, ensuring consistency and accuracy.
authors: Rules-Based Medicine, Inc., Austin, Texas, USA.
authors: Rauf
authors: R
authors: Izmailov
authors: Paul C
authors: PC
authors: Guest
authors: Sabine
authors: S
authors: Bahn
authors: Emanuel
authors: E
authors: Schwarz
mesh_terms: D000465:Algorithms; D015415:Biomarkers / Q000032:analysis* / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000639:trends; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000639:trends; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012559:Schizophrenia / Q000097:blood / Q000175:diagnosis* / Q000503:physiopathology
chemical_list: D015415:Biomarkers