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The Banyan BTI is an in vitro diagnostic chemiluminescent enzyme-linked immunosorbent assay (ELISA). The assay provides a semi-quantitative measurement of the concentrations of ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in human serum, and is used with the Synergy 2 Multi-mode Reader. 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 18 years of age and older with suspected traumatic brain injury (Glasgow Coma Scale score 13-15). A negative assay result is associated with the absence of acute intracranial lesions visualized on a head CT (computed tomography) scan. The Banyan BTI is for prescription use only.

The Banyan BTI consists of two kits, one for the UCH-L1 assay components and one for GFAP assay components. Each kit is packaged individually in a box and consists of the following: 96-well microtiter strip plate, each well coated with mouse monoclonal UCH-L1 antibody or mouse monoclonal GFAP capture antibody (1 plate); UCH-L1 or GFAP calibrators (1 vial); UCH-L1 or GFAP calibrator diluent (1 vial, 4 mL); UCH-L1 or GFAP control 1 (1 vial); UCH-L1 or GFAP control 2 (1 vial); mouse monoclonal UCH-L1 or mouse monoclonal GFAP detection antibody (1 vial, 0.23 mL); UCH-L1 or GFAP detection antibody diluent (2 vials, 6.5 mL per vial for UCH-L1 or 1 vial, 14 mL for GFAP); ready-to-use assay diluent (2 vials, 5 mL per vial for UCH-L1 or 1 vial, 10 mL for GFAP), chemiluminescent substrate solution A (2 vials, 4.5 mL per vial) and solution B (2 vials, 4.5 mL per vial); a wash tablet and four adhesive plate seals. Components within the same kit are intended to be used together. In each kit, sufficient quantities of each component are provided to test samples from up to 30 patients. Each kit is stored at 2°C to 8°C until ready for use.