Every claim on this site traces to a published source. This page lists those sources with a plain-language note on what each one found and what it did not. Entries are dated and updated quarterly.
1. FDA, De Novo classification DEN170045, Banyan Brain Trauma Indicator (GFAP, UCH-L1), granted Feb 14, 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170045.pdf. Boundary: serum within 12 hours, adults, CT-triage aid, not a stand-alone diagnostic.
2. FDA, 510(k) K201778, Abbott i-STAT TBI Plasma, Jan 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201778.pdf. Boundary: plasma, 12-hour window, CT-triage.
3. Abbott, FDA clearance of Alinity i TBI lab-based test, Mar 7, 2023. https://abbott.mediaroom.com/2023-03-07-Abbott-Receives-FDA-Clearance-for-First-Commercially-Available-Lab-based-Blood-Test-to-Help-Evaluate-Concussion. Boundary: window remains 12 hours.
4. Abbott, FDA clearance of i-STAT TBI whole-blood bedside test, Apr 1, 2024. https://abbott.mediaroom.com/2024-04-01-Abbott-Receives-FDA-Clearance-for-Whole-Blood-Rapid-Test-to-Help-with-Assessment-of-Concussion-at-the-Patients-Bedside. Boundary: 24 hours is the outer bound of any cleared indication.
5. National Academies of Sciences, Engineering, and Medicine. Traumatic Brain Injury: A Roadmap for Accelerating Progress. 2022. https://doi.org/10.17226/25394. Boundary: endorses no specific commercial test.
6. NASEM. Biomarkers for Traumatic Brain Injury: Proceedings of a Workshop. 2023. https://nap.nationalacademies.org/catalog/26932. Boundary: most evidence presented was acute-phase, cite for research direction.
7. Manley GT, et al. A new characterisation of acute traumatic brain injury: the NIH-NINDS TBI Classification and Nomenclature Initiative. Lancet Neurology. 2025;24(6):512-523. https://doi.org/10.1016/S1474-4422(25)00154-1. Boundary: acute framework, proposed for validation.
8. Silverberg ND, et al. The ACRM Diagnostic Criteria for Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2023;104(8):1343-1355. https://doi.org/10.1016/j.apmr.2023.03.036. Boundary: biomarkers supportive, not sufficient, cutoffs unestablished.
9. Shahim P, et al. Time course and diagnostic utility of NfL, tau, GFAP, and UCH-L1 in subacute and chronic TBI. Neurology. 2020;95(6):e623-e636. https://doi.org/10.1212/WNL.0000000000009985. Boundary: UCH-L1 and tau weak beyond the acute phase in this cohort.
10. Newcombe VFJ, et al. Post-acute blood biomarkers and disease progression in traumatic brain injury. Brain. 2022;145(6):2064-2076. https://doi.org/10.1093/brain/awac126. Boundary: cohort research, largely moderate-severe, no individual diagnostic cutoff.
11. Spitz G, et al. Plasma biomarkers in chronic single moderate-severe traumatic brain injury. Brain. 2024;147(11):3690-3701. https://doi.org/10.1093/brain/awae255. Boundary: UCH-L1 and p-tau181 only, GFAP and NfL not elevated in this cohort, moderate-severe population.
12. Hicks AJ, et al. Blood-Based Protein Biomarkers in the Chronic Phase of Traumatic Brain Injury: A Systematic Review. J Neurotrauma. 2025;42(9-10). https://doi.org/10.1089/neu.2024.0294. Boundary: authors rate overall evidence strength as limited.
13. Korley FK, et al. Prognostic value of day-of-injury plasma GFAP and UCH-L1 for predicting functional recovery: TRACK-TBI. Lancet Neurology. 2022;21(9):803-813. https://doi.org/10.1016/S1474-4422(22)00256-3. Boundary: day-of-injury samples.
14. Nelson LD, et al. Recovery after mild traumatic brain injury in patients presenting to US Level I trauma centers: TRACK-TBI. JAMA Neurology. 2019;76(9):1049-1059. https://doi.org/10.1001/jamaneurol.2019.1313. Boundary: trauma-center population, not all concussions.
15. CDC. Report to Congress on Traumatic Brain Injury in the United States: Epidemiology and Rehabilitation. 2015. https://stacks.cdc.gov/view/cdc/29214. Boundary: population epidemiology, not diagnostics.
16. Mucha A, et al. A Brief Vestibular/Ocular Motor Screening (VOMS) Assessment to Evaluate Concussions. Am J Sports Med. 2014;42(10):2479-2486. https://doi.org/10.1177/0363546514543775. Boundary: screening adjunct, sport-concussion population.
17. FDA, 510(k) K181771, RightEye Vision System, Sep 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181771.pdf. Boundary: cleared for recording and analyzing eye movements in support of identifying visual tracking impairment, nothing about diagnosing concussion, and the manufacturer was warned by FDA (Dec 2022) for claims beyond this. Site wording is locked to the cleared indication.
18. Tenney JR, et al. Practice Guideline: Use of Quantitative EEG for the Diagnosis of Mild Traumatic Brain Injury (ACNS). J Clin Neurophysiol. 2021;38(4):287-292. https://doi.org/10.1097/WNP.0000000000000853. Boundary: this is the contrary position, Level U against stand-alone diagnostic use, and any qEEG content must coexist with it.
19. Amico F, Koberda JL. Quantitative Electroencephalography Objectivity and Reliability in the Diagnosis and Management of TBI: A Systematic Review. Clin EEG Neurosci. 2023/2025;56(5):432-445. https://doi.org/10.1177/15500594231202265. Boundary: supportive review, does not reverse the ACNS guideline.
20. Powell JM, et al. Accuracy of mild traumatic brain injury diagnosis. Arch Phys Med Rehabil. 2008;89(8):1550-1555. https://doi.org/10.1016/j.apmr.2007.12.035. Boundary: single Level I center, N=197, finding is undocumented diagnosis in the ED record.
21. Cota MR, et al. Discordance between documented criteria and documented diagnosis of traumatic brain injury in the emergency department. J Neurotrauma. 2019;36(8):1335-1342. https://doi.org/10.1089/neu.2018.5772. Boundary: documentation study, 47 percent received a documented diagnosis.
22. Master CL, et al. Vision diagnoses are common after concussion in adolescents. Clin Pediatr. 2016;55(3):260-267. https://doi.org/10.1177/0009922815594367. Boundary: adolescents 11-17 at a specialty concussion clinic, not generalizable to adults or unselected populations.
23. Yue JK, et al. Association between plasma GFAP and MRI abnormalities in patients with CT-negative TBI: TRACK-TBI. Lancet Neurology. 2019;18(10):953-961. https://doi.org/10.1016/S1474-4422(19)30282-0. Boundary: 27 percent of CT-negative patients MRI-positive, GFAP AUC 0.777, research cohort.
24. Undén J, Romner B. Can low serum levels of S100B predict normal CT findings in head injury patients? Eur J Emerg Med. 2010. https://doi.org/10.1097/MEJ.0b013e3283329b63. Boundary: acute screening context.
25. Thelin EP, et al. A review of the clinical utility of serum S100B protein levels in the assessment of traumatic brain injury. Acta Neurochir. 2017. https://doi.org/10.1007/s00701-016-3046-3. Boundary: review, notes extracranial sources of S100B.