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IT'S MORE THAN A TEST.
IT'S REAL LIFE. THEIRS.

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© 2023 Abbott, Abbott Park, Illinois, U.S.A.

INTENDED USE

The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the Alinity i system.

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) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan.

The TBI test is intended for use in clinical laboratory settings by healthcare professionals. 

IMPORTANT SAFETY INFORMATION

Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions. 

• For In Vitro Diagnostic Use

• Rx Only (For use by or on the order of a physician only) 

CAUTION: This product requires the handling of human specimens. It is recommended that all human-sourced materials and all consumables contaminated with potentially infectious materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens. This product contains sodium azide. Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations. 

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