The i-STAT TBI Plasma test measures the level of biomarkers associated with brain injury in the blood stream to assist in determining the need for a CT scan of the head.
The i-STAT TBI Plasma test is only available for use on the i-STAT Alinity instrument.
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.
| Traumatic Brain Injury |
| TBI Plasma® |
| Traumatic Brain Injury |
Limit of Quantitation (LoQ) |
GFAP = 23 pg/mL and UCH-L1 = 70 pg/mL |
Cut-off values |
GFAP = 30 pg/mL and UCH-L1 = 360pg/mL* |
Reportable Range |
GFAP = 30 - 10000 pg/mL and UCH-L1 = 200 - 3200 pg/mL |
*Decision limits rather than reference intervals are used to determine test interpretation.
i-STAT System |
Code |
i-STAT TBI Plasma |
04X64-25 |
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