US 12,092,647 B2
Methods for aiding in the determination of whether to perform imaging on a human subject who has sustained or may have sustained an injury to the head using early biomarkers
Beth McQuiston, Abbott Park, IL (US); Justin Rogers, Abbott Park, IL (US); Jaime Marino, Abbott Park, IL (US); Raj Chandran, Abbott Park, IL (US); Tianming Zhang, Abbott Park, IL (US); and Saul Datwyler, Abbott Park, IL (US)
Assigned to ABBOTT LABORATORIES, Abbott Park, IL (US)
Filed by Abbott Laboratories, Abbott Park, IL (US)
Filed on Nov. 16, 2020, as Appl. No. 17/099,668.
Application 17/099,668 is a continuation of application No. 15/990,091, filed on May 25, 2018, granted, now 10,866,251.
Claims priority of provisional application 62/511,126, filed on May 25, 2017.
Prior Publication US 2021/0088533 A1, Mar. 25, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/68 (2006.01); A61B 5/00 (2006.01); A61B 5/055 (2006.01); A61B 6/03 (2006.01); A61B 6/50 (2024.01)
CPC G01N 33/6893 (2013.01) [A61B 5/0042 (2013.01); A61B 5/055 (2013.01); A61B 6/03 (2013.01); G01N 33/6896 (2013.01); A61B 6/032 (2013.01); A61B 6/501 (2013.01); G01N 2333/914 (2013.01); G01N 2333/918 (2013.01); G01N 2800/28 (2013.01); G01N 2800/40 (2013.01); G01N 2800/60 (2013.01)] 19 Claims
 
1. A method comprising:
a) performing at least one assay for at least one early biomarker selected from the group consisting of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), and ubiquitin carboxy-terminal hydrolase L1 and glial fibrillary acidic protein on at least one sample that is whole blood, serum, plasma, or cerebrospinal fluid, obtained from a human subject within about 24 hours after an actual or suspected injury to the head;
b) performing a magnetic resonance imaging (MRI) procedure on the subject, and
c) treating the subject for a moderate, severe, or a moderate to severe TBI when the level of UCH-L1, GFAP, or UCH-L1 and GFAP in the sample is higher than a reference level of UCH-L1, GFAP, or UCH-L1 and GFAP; and wherein the reference level is between at least about 20 pg/mL to about 200 pg/mL and
wherein the subject is treated (a) with one or more therapeutic agents selected from the group consisting of a diuretic, an anti-convulsant medication and a medication to sedate an individual or induce a coma, or any combination thereof; (b) with one or more surgical procedures selected from the group consisting of removal of a hematoma, repairing a skull fracture, and a decompressive craniectomy, or any combinations thereof; (c) with one or more therapies selected from the group consisting of rehabilitation for TBI, cognitive behavioral therapy, anger management, counseling psychology and any combinations thereof; or (d) with any combination of (a)-(c).