The i-STAT TBI Plasma test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in plasma and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity Instrument.
The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A “not elevated” TBI test interpretation is associated with the absence of acute traumatic intracranial lesions visualized on a head CT scan.
The test is to be used with plasma prepared from EDTA anticoagulated specimens in clinical laboratory settings by a healthcare professional. The i-STAT TBI Plasma test is not intended to be used in point-of-care settings.