Abstract
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease of motor neurons located in the motor cortex, brainstem and spinal cord. There currently are no diagnostic tests for ALS, and a rapid diagnostic test would assist clinicians to initiate treatments and/or enroll subjects into clinical trials at early disease stages. We used mass spectrometry based proteomics to discover candidate biomarkers for ALS. Our current study uses separate training and test sets to verify and validation protein biomarkers for ALS. Cerebrospinal fluid (CSF) from 105 patients with ALS, and 60 control subjects (including healthy controls, ALS disease mimics, and other neurologic disease controls) were used for further mass spectrometry and enzyme‐linked immunosorbent assay (ELISA) studies. We validated our prior mass spectrometry results, demonstrating that cystatin C and transthyretin are contained in a predictive biomarker panel for ALS. ELISA studies were performed for a number of candidate biomarkers and we determined that a combination of phosphorylated neurofilament protein and complement c3 provided an overall sensitivity of 87% and specificity of 94% for ALS. These results indicate that an ELISA based assay may provide a predictive assay for ALS. Funding support to RB by NIH grants ES013469 and NS061867.
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