The Banyan BTITM is an in vitro diagnostic assay that uses the chemiluminescent enzyme-linked immunosorbent assay (ELISA) technique to provide a semi-quantitative measurement of the concentrations of ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in human serum. The assay is intended to be used with the Synergy 2 Multi-mode Reader and is used in the evaluation of patients 18 years of age and older with suspected traumatic brain injury. The assay results obtained from serum collected within 12 hours of suspected head injury are used, along with other available clinical information, to aid in the evaluation of patients with suspected traumatic brain injury.
The Banyan BTI assay measures UCH-L1 and GFAP concentrations in human serum using a 96-well microplate immunochemical chemiluminescent assay. It consists of two separate kits, one for measuring UCH-L1 concentration and one for measuring GFAP concentration. Both kits use the same chemiluminescent sandwich immunoassay technique, which uses capture and detection antibodies that recognize different epitopes on the target analyte. The assay involves adding samples to wells of a microplate that are coated with either a UCH-L1 or GFAP-specific mouse monoclonal antibody that captures the target analyte, immobilizing it to the well. After washing unbound proteins, a second UCH-L1 or GFAP-specific mouse monoclonal antibody conjugated to horseradish peroxidase (HRP) is added to the well. HRP catalyzes a specific reaction with the chemiluminescent substrate to produce light at 300-700nm, which is detected with the Synergy 2 Multi-mode Reader. The results from the wells containing standards are used to create a dose-response curve to quantify the amount of target analyte in the sample.