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User Guide for Abbott i-STAT TBI Cartridge
Quick reference guide for the i-STAT TBI Cartridge, covering intended use, specimen collection, testing procedures, result interpretation, and performance characteristics for healthcare professionals.
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The i-STAT TBI cartridge is an in vitro diagnostic immunoassay for the quantitative measurement of GFAP and UCH-L1 in venous whole blood. It is intended for use by healthcare professionals to aid in the evaluation of patients 18 years or older with suspected mild traumatic brain injury (GCS 13-15) to determine the need for a head CT scan. The test is designed exclusively for use with the i-STAT Alinity instrument.
Intended Use and Clinical Significance
The test provides a semi-quantitative interpretation ('Elevated' or 'Not Elevated') based on biomarker concentrations. A 'Not Elevated' result is associated with the absence of acute traumatic intracranial lesions on a head CT scan. 'Elevated' results suggest that further evaluation by head CT scan should be considered.
Specimen Collection and Preparation
- Sample Type: Venous whole blood collected with EDTA anticoagulant.
- Sample Volume: 20 µL.
- Timing: The test must be performed within 1 hour of blood collection.
- Storage: Cartridges should be stored at 2–8 °C (35–46 °F) until the expiration date. They may be stored at room temperature (18–30 °C) for up to 14 days.
- Equilibration: Refrigerated cartridges must equilibrate at room temperature for 5 minutes (single cartridge) or 1 hour (entire box) before use.
Procedure for Cartridge Testing
- Power on the i-STAT Alinity instrument and select 'Perform Patient Test'.
- Follow on-screen prompts to enter Operator and Patient IDs.
- Scan the cartridge pouch barcode when prompted.
- Invert the EDTA blood collection tube at least 10 times.
- Fill the cartridge sample well until the sample reaches the 'fill to' mark. Ensure the sample is continuous with no bubbles.
- Slide the closure clip over the sample well.
- Immediately insert the cartridge into the instrument port until it clicks.
- Wait approximately 15 minutes for the test to complete.
Interpretation of Results
Results are displayed on two pages. The first page shows the interpretation (Elevated, Not Elevated, or Repeat Test). The second page provides quantitative results for GFAP and UCH-L1. The assay cutoffs are 65 pg/mL for GFAP and 360 pg/mL for UCH-L1.
Safety and Limitations
- Single-use only: Do not reuse cartridges.
- Disposal: Dispose of used cartridges as biohazardous waste.
- Interferences: Certain substances (e.g., high levels of albumin, amphetamine, methadone, metoprolol, propoxyphene, or rheumatoid factor) may interfere with results.
- Altitude: The test has not been evaluated at altitudes above 7,500 feet.
- Handling: Avoid vortexing or mechanical rotation of the blood sample.
Manufacturer information
Abbott Laboratories
Practical help
Common problems
Quality Check Failure (QCF)
The instrument will display a code and instructions. Refer to the i-STAT Alinity System Operations Manual. If the failure persists, use a fresh cartridge.
Suppressed results
Ensure the instrument remains on a level surface during testing. High altitude (>7,500 ft) may increase the frequency of suppressed results.
Condensation on cartridge
Allow refrigerated cartridges to equilibrate at room temperature for 5 minutes (single) or 1 hour (box) before use to prevent contact issues.
Before use
- Verify the cartridge is at room temperature (18–30 °C).
- Check that the portion pack is not damaged or punctured.
- Ensure the blood sample is venous whole blood with EDTA.
- Invert the blood collection tube at least 10 times.
- Ensure the instrument is on a level surface.
Specs in practice
- UCH-L1 Cutoff
- 360 pg/mL; results above this are considered elevated.
- Analysis Time
- Approximately 15 minutes.
- Sample Volume
- 20 µL of venous whole blood.
Images and diagrams
- The home screen allows initiation of the patient testing pathway via the 'Perform Patient Test' button.
- The interpretation screen displays the test result (e.g., 'Elevated') with a yellow indicator.
- The results screen provides specific quantitative values for GFAP and UCH-L1 compared to their respective cutoffs.
Model compatibility
- Designed exclusively for use with the i-STAT Alinity instrument.
- Not intended as a stand-alone diagnostic device; use as an adjunct to clinical information.
- Not evaluated for use at altitudes above 7,500 feet.
Manual page author
Michael Turner
Technical manual editor
Reviews PDF manuals for structure, safety notes, and practical product details so readers can find the right information quickly.