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Improved methods of assessing gfap status in patient samples

A state, biological sample technology, applied in the direction of chemical instruments and methods, biochemical equipment and methods, instruments, etc.

Active Publication Date: 2019-09-17
ABBOTT LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] There is an unmet need for tools to assess patients with mild TBI in the field, emergency rooms, inpatient hospitals and clinics, in sports areas and in military activities such as military combat

Method used

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  • Improved methods of assessing gfap status in patient samples
  • Improved methods of assessing gfap status in patient samples
  • Improved methods of assessing gfap status in patient samples

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0375] GFAP assay

[0376] Screening of antibodies employs a target assay format (i-STAT). Select antibody pairs that generate a signal in the assay. Initial selection criteria were based on several factors, including the use of paired antibody detection signals when screening with low calibrator concentrations. Test monoclonal antibody pairs, such as Antibody A as a capture mAb and Antibody B as a detection mAb. Antibody A and Antibody B are exemplary anti-GFAP antibodies developed in-house at Abbott Laboratories (Abbott Science Park, IL). Antibody A and Antibody B both bind the epitope in the same GFAP breakdown product (BDP). When used in combination, the combination of antibodies produces a synergistic effect and a stronger signal. This data is generated by purchasing short overlapping peptide sequences and determining which peptides the antibody binds to in a 96-well plate format. The GFAP assay design is evaluated against key performance attributes. Cartridge con...

Embodiment 2

[0413] potential assay interference

[0414] An evaluation of potential interferences and cross-reactants for the GFAP assay is shown in Table 12. Briefly, the interferor was spiked into an aliquot of GFAP strip at a target concentration of 150-200 pg / mL. Interference testing concentration based on CLSI EP7-A2 guidelines (Clinical and Laboratory Standards Institute.Interference Testing in ClinicalChemistry; Approved Guideline-Second Edition.CLSI document EP7-A2[ISBN 1-56238-584-4].Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.). Testing for potential cross-reactants was performed at a concentration level of 500 ng / mL. The acceptance criterion was interference <10%.

[0415] Specifically, GFAP assays were evaluated for potential endogenous interference. Potential interfering substances are prepared in selected buffer solutions / solvents and then added to test samples containing target analytes. A cont...

Embodiment 3

[0427] TBI Population Study

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PUM

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Abstract

Disclosed herein are improved methods of assessing Glial fibrillary acidic protein (GFAP) status in a subject (such as for examples, as a measure of traumatic brain injury or for other clinical reasons).

Description

[0001] Related Application Cross Reference [0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 403,293, filed October 3, 2016, and U.S. Provisional Patent Application No. 62 / 455,269, filed February 6, 2017, and adopts these applications in their entirety Incorporated herein by reference. [0003] Incorporation by reference of electronically submitted material [0004] This immediate application incorporates by reference the Sequence Listing submitted in ASCII format via EFS-Web in its entirety. The ASCII copy was created on October 2, 2017, named 2017_10_02_12850W001-SEQ-LIST.txt, and 4,317 bytes in size. technical field [0005] The present disclosure relates to methods of assessing the improvement of GFAP (glial fibrillary acidic protein) status, eg, as a measure of traumatic brain injury or other clinical causes. Background technique [0006] In many cases, traumatic brain, spinal cord, and other neurological injuries need to be o...

Claims

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Application Information

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IPC IPC(8): G01N33/573
CPCG01N33/573G01N2333/916G01N2333/948G01N2333/978C12N9/16C12Y301/02015G01N33/581G01N33/566G01N33/6896G01N2800/28G01N2800/50G01N2800/52C07K2317/92C07K2317/94G01N33/535G01N2800/2871
Inventor S·德特维勒B·麦奎斯顿E·布拉特J·莱普D·帕森缇
Owner ABBOTT LAB INC
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