Methods for aiding in diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin i and early biomarkers

A biomarker, subject technology, applied in biochemical equipment and methods, biological testing, and microbial determination/examination, etc., can solve the unresearched myocardial injury correlation, disease spectrum bias, unresearched myocardial injury effect, etc. question

Pending Publication Date: 2020-01-21
ABBOTT LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these findings were subject to disease spectrum bias because the findings were derived from retrospective studies and troponin measurements were at the discretion of clinicians (who rarely do so in the routine care of TBI patients)
Furthermore, the correlation between myocardial injury and neurological outcomes in TBI has not been studied
Additionally, the role of myocardial injury in mild and moderate TBI has not been studied

Method used

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  • Methods for aiding in diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin i and early biomarkers
  • Methods for aiding in diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin i and early biomarkers
  • Methods for aiding in diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin i and early biomarkers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0514] UCH-L1 assay

[0515] A pair of monoclonal antibodies (such as antibody A) as capture monoclonal antibodies and antibodies B and C as detection monoclonal antibodies were tested. 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 antigen in samples, were developed by Banyan Biomarkers (Alachua, Florida). Other antibodies developed in-house at Abbott Laboratories (Abbott Park, IL) also showed or were expected to show similar signal enhancement when used together in various combinations as capture or detection antibodies. The UCH-L1 assay design was evaluated for key performance attributes. Cassette configuration is antibody configuration: Antibody A (capture antibody) / Antibody B+C (detection antibody); reagent conditions: 0.8% solids, 125 μg / mL Fab alkaline phosphatase cluster conjugate; and injection print: UCH-L1 stand...

Embodiment 2

[0517] GFAP assay

[0518] Will The GFAP assay was used in a population study of TBI patients. Use a monoclonal antibody pair such as antibody A as the capture monoclonal antibody and use antibody B as the detection monoclonal antibody. Antibody A and Antibody B are exemplary anti-GFAP antibodies developed in-house at Abbott Laboratories (Abbott Park, IL). The GFAP assay design was evaluated for key performance attributes. The cartridge configuration was antibody configuration: Antibody A (capture antibody) / Antibody B (detection antibody); reagent conditions: 0.8% solids, 250 μg / mL Fab alkaline phosphatase cluster conjugate; and injection print: GFAP specific. The assay time was 10-15 min (with a sample capture time of 7-12 min).

Embodiment 3

[0520] Study 1 - TBI Population

[0521] Study 1 is a large and complex project. Its institutional and public-private partnerships consist of more than 11 clinical sites, seven cores, and a total of nearly 50 partner institutions, companies and charities. An early pilot study based on clinical data from three clinical sites helped refine TBI common data elements and created a prototype for TBI information sharing for Study 1.

[0522] Subject Groups: A total of 2700 to 3000 TBI patients were recruited, averaged into 3 clinical groups divided by clinical care pathways: 1. Patients evaluated in the Emergency Department and discharged (ED); 2. Patients admitted to the hospital but not Patients admitted to ICU (ADM); and 3. Patients admitted to ICU (ICU). An additional 100 patients with extracranial trauma but not TBI were included in each clinical group (n=300) as controls for a total of 3000 patients recruited. This stratification scheme facilitates Comparative Effects Study ...

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Abstract

Disclosed herein are methods that aid in the diagnosis and evaluation of a human subject that has sustained or may have sustained an injury to the head, such as mild or a moderate, severe, or moderateto severe traumatic brain injury (TBI), by detecting levels of cardiac troponin I (cTnI) and one or more early biomarkers which are not cTnI, such as ubiquitin carboxy-terminal hydrolase L1 (UCH-L1),glial fibrillary acidic protein (GFAP), or a combination thereof, in biological samples taken from a human subject at time points within about 24 hours of injury after the subject has sustained or may have sustained the injury to the head.

Description

[0001] Related application information [0002] This application claims U.S. Application No. 62 / 512,688, filed May 30, 2017, U.S. Application No. 62 / 512,710, filed May 30, 2017, and U.S. Application No. 62 / 528,214, filed July 3, 2017 priority, the respective contents of which are incorporated herein by reference. technical field [0003] The present disclosure relates to methods of aiding in the diagnosis and evaluation of having suffered or may have suffered (or actual or suspected) a head injury, such as mild traumatic brain injury (TBI), by: In biological samples taken from human subjects at later time points, cardiac troponin I (cTnI) and one or more early biomarkers other than cTnI, such as ubiquitin carboxy-terminal hydrolase L1 (UCH-L1 ), glial fibrillary acidic protein (GFAP), or a combination thereof. Background technique [0004] In the United States alone, more than 5 million mild traumatic brain injuries (TBIs) occur each year. Currently, there are no simple, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N2800/28G01N2800/56G01N33/6896A61B5/4064C12Q1/6883G01N33/533G01N33/54366G01N33/564G01N33/54346G01N33/577G01N33/6893G01N2800/52G01N2800/60
Inventor B·麦奎斯顿F·科利A·贝希里J·马力诺S·德特维勒
Owner ABBOTT LAB INC
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