Global Point of Care
The i-STAT TBI cartridge is the first point-of-care test that measures the level of biomarkers associated with brain injury in whole blood to help assess patients with suspected mTBI within 24 hours after injury.
The i-STAT TBI cartridge is only available for use on the i-STAT Alinity instrument.
The i-STAT TBI cartridge provides objective data to help assess patients with suspected mild traumatic brain injury (mTBI) and provides lab-quality results in approximately 15 minutes.
| Traumatic Brain Injury |
| TBI |
Explore the science behind the evaluation of traumatic brain injury.
The i-STAT TBI 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 whole blood 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 score 13-15) which may include one of the following four clinical criteria: 1) any period of loss of consciousness, 2) any loss of memory for events immediately before and after the accident, 3) any alteration in mental state at the time of accident, and/or 4) focal neurological deficits, within 24 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 venous whole blood collected with EDTA anticoagulant in point-of-care or clinical laboratory setting by a healthcare professional.
| Traumatic Brain Injury |
Limit of Quantitation (LoQ) | GFAP = 47 pg/mL and UCH-L1 = 32 pg/mL |
Cut-off values | GFAP = 65 pg/mL and UCH-L1 = 360 pg/mL* |
Reportable Range | GFAP = 47 - 10000 pg/mL and UCH-L1 = 87 - 3200 pg/mL |
*Decision limits rather than reference intervals are used to determine test interpretation.
i-STAT System | Code | Quantity per Box |
i-STAT TBI Cartridge | 03S09-25 | 25 |
| i-STAT TBI Control Level 1 | 06P17-25 | 6 |
| i-STAT TBI Control Level 2 | 06P17-26 | 6 |
| i-STAT TBI Calibration Verification 1-3 | 06P17-27 | 6 (2 vials for each calibration verification level) |
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Not all products are available in all regions. Check with your local representative for availability in specific markets. For in vitro diagnostic use only. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.
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