SUMMARY OF CHANGES

1. Title changed from “Use of Traumatic Brain Injury Plasma Biomarkers after a Potentially Concussive Event (CPG ID:90)” to “Use of Traumatic Brain Injury Biomarkers after a Potentially Concussive Event (CPG ID:90)” to reflect FDA approval of the Abbott whole blood test cartridge in March 2024. The existing plasma cartridge version, applicable to the existing CPG, will not be fielded and guidelines on its use have been removed.
2. The term “plasma” was changed to “whole blood” throughout document.
3. The time period post injury in which the assay is approved to be used was changed from 12 hours to 24 hours throughout document.
4. Background: New assay cartridge added
5. Structure to Support Optimal Use of TBI Biomarker: Use of ADVISOR system added in the case that a Role 3 TBI/Neuro consultant is not available. Reference to Appendix D (and original Appendix D: Biomarker Data Collection Tool) removed.
6. Initial Evaluation: Clarifications of the use of the MACE2 and Red Flags.
7. Moderate Risk: Test TBI Whole Blood Biomarkers Before Evacuation: Removed Appendix D reference, added use of ADVISOR system.
8. Locations with On-Site Head CT: Removed discussion of Appendix D-Biomarker Data Collection Tool.
9. Primary Concussive Blast: Removed discussion of Appendix D
10. Appendix A: Time post injury changed from 12 to 24 hours.
11. Appendix B: Detailed Information on the TBI Whole Blood Biomarker: Changes relevant to the Whole Blood cartridge added, info relevant to Plasma cartridge removed. Study #3 (Whole Blood Pivotal Trial) data added. Intended Use Statement modified to FDA Whole Blood approved IFU.
12. Appendix C: Summary of Research: Updated/info from Study #3 (whole blood pivotal) added.
13. Appendix D: Changed from “Biomarker Data Collection Tool”, which was removed (was intended for use during the Clinical Implementation and Operational Assessments at selected sites in Iraq-this was completed).