Clinical-to-sensor translation roadmap for mTBI CT triage (IMAGE)
Caption
The framework starts from a clearly defined intended use (adults with suspected mTBI, GCS 13–15, sampling within ≤12 h) and a CT-based endpoint (acute intracranial lesion on head CT). Biomarker anchors (GFAP/UCH-L1 as the primary CT-triage anchor and S100B as an implementation comparator) guide selection of near-patient testing platforms, ranging from cleared cartridge-based POCT and near-ED automation to emerging biosensors. The rightmost panel summarizes the decision-level analytical validation and clinical benchmarking requirements, which must address matrix effects to ensure reliability, emphasizing robustness to matrix effects and interference, calibration/QC, method comparison, and clinically meaningful performance metrics (sensitivity/NPV and invalid rate). CT, computed tomography; ECL, electrochemiluminescence; ED, emergency department; GCS, Glasgow Coma Scale; GFAP, glial fibrillary acidic protein; mTBI, mild traumatic brain injury; NPV, negative predictive value; POCT, point-of-care testing; QC, quality control; UCH-L1, ubiquitin C-terminal hydrolase-L1.
Credit
Jiayu Liu, Xiuting Liang
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License
CC BY-NC