DEVICES AND METHODS FOR BIOMARKER DETECTION PROCESS AND ASSAY OF NEUROLOGICAL CONDITION

摘要

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.

主权项

1. An in vitro diagnostic device for detecting a neural injury or neuronal disorder in a subject, the device comprising:
a sample chamber for holding a first biological sample collected from the subject; an assay module in fluid communication with said sample chamber, said assay module containing an agent for detecting one or more biomarkers of a neural injury or neuronal disorder selected from the group consisting of (GFAP) or one of its breakdown products, Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), neuron specific enolase (NSE), Microtubule-associated protein 2 (MAP2), myelin basic protein (MBP), α-II spectrin breakdown product (SBDP) preferably SBDP150, SBDP150i SBDP145, SBDP120, S100 calcium binding protein B (S100b), vesicular membrane protein neurensin-1 (p24), collapsin response mediated proteins (CRMP's) and breakdown products thereof, or synaptotagmin and breakdown products thereof, wherein said assay module analyzes the first biological sample to detect the amount of the one or more biomarker present in said sample; a user interface, wherein said user interface relates the amount of the one or more biomarker measured in the assay module to detecting a neural injury or neuronal disorder in the subject or the severity of neural injury or neuronal disorder in the subject.