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Methods for aiding in the hyperacute diagnosis and determination of traumatic brain injury using early biomarkers on at least two samples from the same human subject

A biomarker, subject technology, used in radiological diagnostic instruments, diagnostics, biological testing, etc., to solve problems such as test failures and inability to assess subtle differences in results

Pending Publication Date: 2019-12-20
ABBOTT LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In addition, current brain injury trials rely on outcome measures such as the Glassow OutcomeScale Extended, which capture global phenomena but fail to assess subtle differences in outcome
As a result, 30 consecutive trials of brain-injury therapeutics fail

Method used

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  • Methods for aiding in the hyperacute diagnosis and determination of traumatic brain injury using early biomarkers on at least two samples from the same human subject
  • Methods for aiding in the hyperacute diagnosis and determination of traumatic brain injury using early biomarkers on at least two samples from the same human subject
  • Methods for aiding in the hyperacute diagnosis and determination of traumatic brain injury using early biomarkers on at least two samples from the same human subject

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0425] UCH-L1 assay

[0426] Will The UCH-L1 assay was used in a TBI patient cohort study. A pair of monoclonal antibodies, such as antibody A, is used as the capture monoclonal antibody, and antibodies B and C are used as the detection monoclonal antibodies. 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 F...

Embodiment 2

[0428] GFAP assay

[0429] 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

[0431] Development of a multimodal classification scheme for traumatic brain injury

[0432] The aim of this study was to develop a classification scheme for brain injuries that specifies the nature (type) and severity of the injury. For example, serum biomarkers reveal cell type. Trauma patients were divided into three groups for analysis: brain injury only, non-brain injury only, and combined injury. Brain-injured and non-brain-injured trauma groups were compared to each other and to the brain / non-brain-trauma combination. These trauma groups were compared to a non-trauma control group. The CSF of trauma patients was compared with that of non-trauma patients. A secondary objective was to determine whether any of the measures (alone or in combination) could be used as an indicator of clinical outcome after TBI.

[0433] An objective multimodal classification scheme and outcome measures for traumatic brain injury were developed based on several measures: 1) blood-based bio...

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Abstract

The present invention discloses methods that aid in the hyperacute diagnosis and evaluation of a human subject that has sustained or may have sustained an injury to the head, such as mild, moderate, severe, or moderate to severe traumatic brain injury (TBI), using an early biomarker, such as ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combinationthereof. Also disclosed here are methods that aid in the hyperacute determination of whether a human subject that has sustained an injury or may have sustained to the head would benefit from and thusreceive a head computerized tomography (CT) scan based on the levels of UCH-L1. These methods involve detecting changes of levels of an early biomarker, such as ubiquitin carboxy-terminal hydrolase L1(UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof, in samples taken from a human subject at a time point within about 2 hours, such as about 10, 12, or 20 minutes, after thesubject has sustained or may have sustained an injury to the head and a second time point about 3 hours to about 6 hours after the first sample is taken.

Description

[0001] Related application information [0002] This application claims priority to US Provisional Application Serial No. 62 / 491,600, filed April 28, 2017, the contents of which are incorporated herein by reference. technical field [0003] The present invention relates to methods of aiding in the hyperacute diagnosis and evaluation of human subjects who have suffered or may have suffered an injury to the head such as mild, moderate, severe or moderate to severe traumatic brain injury (TBI) by : detecting an early biomarker such as ubiquitin carboxyl in an initial sample taken from a human subject at a time point within about 2 hours, such as about 10, 12 or 20 minutes, of the subject having suffered or may have suffered an injury to the head Levels of 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 y...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N2333/948G01N33/6896G01N2800/28G01N33/573A61B6/032G01N2333/916G01N2333/46A61B6/501
Inventor B·麦奎斯顿J·罗杰斯S·德特维勒J·马力诺
Owner ABBOTT LAB INC
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