Methods for aiding in diagnosing and evaluating a traumatic brain injury in a human subject using a combination of gfap and uch-l1

A UCH-L1, assisted diagnostic technology, applied in the field of assisted diagnosis and evaluation of traumatic brain injury in human subjects using a combination of GFAP and UCH-L1, capable of resolving obstacles, and within days to weeks, TBI or difficult to detect concussion

Pending Publication Date: 2020-03-17
ABBOTT LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Mild TBI or concussion is difficult to detect objectively and presents a daily challenge worldwide
Concussion does not usually cause pathology such as massive hemorrhage, nor does it cause abnormalities on routine computed tomography scans, but causes rapid-onset neuronal dysfunction that resolves spontaneously within days to weeks

Method used

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  • Methods for aiding in diagnosing and evaluating a traumatic brain injury in a human subject using a combination of gfap and uch-l1
  • Methods for aiding in diagnosing and evaluating a traumatic brain injury in a human subject using a combination of gfap and uch-l1
  • Methods for aiding in diagnosing and evaluating a traumatic brain injury in a human subject using a combination of gfap and uch-l1

Examples

Experimental program
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Embodiment 1

[0693] Assays used in the examples

[0694] UCH-L1 assay. The UCH-L1 assay was used in a TBI patient population study. Use a monoclonal antibody pair, such as Antibody A as the capture mAb and Antibodies B and C as the detection mAbs. Antibody A is an exemplary anti-UCH-L1 antibody developed in-house at Abbott Laboratories (Abbott Park, IL). Antibodies B and C, which recognize different epitopes of UCH-L1 and enhance detection of the antigen in samples, were developed by Banyan Biomarkers (Alachua, Florida). When used together, the combination of antibodies provides a synergistic effect and provides an enhanced signal compared to using uncombined antibodies. Other antibodies developed in-house at Abbott Park, IL, or other commercially available antibodies, also showed or were expected to show similar signal enhancement in various combinations when used together as capture or detection antibodies. The UCH-L1 assay design was evaluated for key performance characteristics....

Embodiment 2

[0697] TBI Population Study (TRACK-TBI)

[0698] The Translational Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is a large and complex project. Its institutional and public-private partnerships include 11 clinical sites, 7 cores, and a total of nearly 50 partner institutions, companies and charities. The earlier TRACK-TBI pilot study was based on clinical data from three clinical bases, which helped improve the TBI Common Data Elements and created a prototype of TBI information sharing for TRACK-TBI research.

[0699] Subject Groups: An average of 2,700 to 3,000 TBI patients were enrolled in 3 clinical groups, differentiated by clinical care pathways: 1. Patients were evaluated in the emergency department and discharged (ED); 2. Patients admitted but not admitted to the ICU Patient (ADM); and 3. Patient admitted to ICU (ICU). Each clinical group (n=300) additionally included 100 patients with traumatic cranial injury (without TBI) as controls, ...

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Abstract

Disclosed herein are methods of aiding in the diagnosis and evaluation of a subject that has sustained or may have sustained an injury to the head. For example, the present disclosure provides methodsfor aiding in the diagnosis and evaluation of a subject to determine whether the subject has sustained a traumatic brain injury (TBI) by detecting or measuring a combination of the levels of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in samples taken at various time points within 48 hours after the subject has sustained or may have sustained an injury to the head.

Description

[0001] related application [0002] This application claims U.S. Application No. 62 / 596,814 filed December 9, 2017, U.S. Application No. 62 / 610,805 filed December 27, 2017, U.S. Application No. 62 / 663,811 filed April 27, 2018, and 2018 Priority to U.S. Application No. 62 / 667,227, filed May 4, the contents of each of which are hereby incorporated by reference. technical field [0003] The present disclosure relates to methods of aiding in the diagnosis and evaluation of subjects who have suffered or may have suffered a head injury. For example, the present disclosure provides the detection or measurement of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) in samples collected at different time points within 48 hours after a subject has suffered or may have suffered a head injury. A combination of glial fibrillary acidic protein (GFAP) levels and glial fibrillary acidic protein (GFAP) to aid in the diagnosis and methods of evaluating a subject to determine whether the subject h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/6893G01N2800/2871G01N33/6896G01N2800/28G01N2800/60
Inventor B·麦奎斯顿S·德特维勒R·钱德拉J·马力诺
Owner ABBOTT LAB INC
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