Abstract: The present disclosure relates to immunoassays for NF-L performed on liquid samples derived from physiological fluids such as venous blood to detect the presence or absence of a physiological condition by quantifying one or a combination of NF-L determinations at concentrations indicative of the condition.

Abstract: The present disclosure relates to immunoassays for NF-L, GFAP, UCH L1, and Tau performed on liquid samples derived from physiological fluids such as venous blood to detect the presence or absence of a physiological condition by quantifying one or a combination of NF-L, GFAP, UCH L1, and Tau at concentrations indicative of the condition.

Abstract: The present disclosure relates to digital immunoassays performed on diluted samples obtained from dried blood spots, for example dried capillary blood samples, to detect the presence or absence of a physiological condition by quantifying one or a combination of biomarkers at concentrations indicative of the condition.

Abstract: Biomarkers, methods, and systems for assessment of traumatic brain injury of different severities, as well as treatment efficacy and blood brain barrier or blood cerebrospinal fluid integrity and assessment of neurodegenerative conditions. The methods include detecting in a patient sample one or more of ubiquitin C-terminal hydrolase LI (UCH-L1), glial fibrillary acid protein (GFAP), aldehyde dehydrogenase 1 family member LI (ALDHILI), phosphorylated neurofilament heavy chain (pNFH), medium chain (NFM), or light chain (NFL), alpha-synuclein, visinin-like protein 1 (VILIP-1) and S100B.

Abstract: The present invention relates to an exemplary in vitro diagnostic (IVD) device used to detect the presence of and/or severity of neural injuries or neuronal disorders in a subject. The IVD device relies on an immunoassay which identifies biomarkers that are diagnostic of neural injury and/or neuronal disorders in a biological sample, such as whole blood, plasma, serum, cerebrospinal fluid (CSF). The inventive IVD device may measure one or more of several neural specific markers in a biological sample and output the results to a machine readable format wither to a display device or to a storage device internal or external to the IVD.

Abstract: A process and assay for diagnosing neurotoxicity in a subject is provided. The extent of a neurotoxic insult to a subject is assessed through the measurement of one or more biomarkers in a biological fluid, such as CSF or serum. Other uses and advantages afforded include pre-market drug discovery, monitoring, drug neurotoxicity screening and post market assessment of safety and monitoring for drug of known potential neurotoxicity.