TBI Plasma CARTRIDGE

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Cartridge Details
 

TBI_marker-icon.pngTraumatic Brain Injury
 
cTnI
TBI Plasma

TBI Plasma - INTENDED USE
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 (GCS 13-15) within 12 hours of injury to assist in determining the need for a CT 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 [thereby not requiring a head CT of the patient.
545_x_545_TBI_Plasma_Cartridge.png

TBI Biomarkers:

• GFAP (glial fibrillary acidic protein)
• UCH-L1 (ubiquitin carboxyl-terminal esterase L1)


Description:

To assist in determining the need for a CT scan of the head 

Sample Size:

95 μL

Sample type:

Plasma

Part Number:

04X64-25 

  • Note: The i-STAT TBI Plasma test is not intended for use as a point-of-care device. 
Expected Values
 

TBI_marker-icon.pngTraumatic Brain Injury
 
Limit of Quantitation (LoQ) Less than or equal to 65 pg/mL
Limit of Detection (LoD) No greater than 50 pg/mL
Within Lot Precision Less than or equal to Sa1

(At or below 3600 pg/mL: the greater of 13 pg/mL or 15% CV, Above 3600 pg/mL: 20% CV)
Deviation from Linearity Within +/- the maximum of 13 pg/mL or 10%, for samples that span the reportable range.
Cut-off values GFAP = 30 and UCH-L1 = 360

ABOUT TBI PLASMA

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.

  

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Time to result

15-minutes following application of the plasma sample in the cartridge

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