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Immunoassay and reagents and kits for performing the same

a technology of immunoassay and reagents, which is applied in the field of immunoassay methods and devices or kits, can solve the problems of difficulty in execution by the operator, sequential addition and transfer of multiple reagents to produce an assay, and the involvement of present assay procedures and reagent preparation, so as to minimize the number of steps performed, improve the signal-to-noise ratio, and facilitate the effect of carrying ou

Inactive Publication Date: 2007-03-08
STC UNM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This approach significantly reduces the complexity and time required for antigen detection, enhances the signal-to-noise ratio, and minimizes background signal, making it suitable for rapid, reliable, and user-friendly detection by non-technical personnel.

Problems solved by technology

Although reliable for positive identification, present assay procedures and reagent preparation are involved and time consuming.
The major drawback associated with present procedures is the sequential addition and transfer of multiple reagents to produce an assay.
Each additional step for a detection assay increases the degree of difficulty for execution by the operator and is prone to misuse, thereby, resulting in a higher margin for error.

Method used

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  • Immunoassay and reagents and kits for performing the same
  • Immunoassay and reagents and kits for performing the same
  • Immunoassay and reagents and kits for performing the same

Examples

Experimental program
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examples

I. Protocols

[0083] The following protocols were used throughout the Examples described below.

[0084] 1. Protocol 1: Standard Lyophilization Procedure for FASTube Preparation

Materials and Equipment:

[0085] Dura-Top Microprocessor Freeze Dryer. FTS Systems

[0086] Ruthenium anti-BG conjugate product

[0087] Biotin anti-BG conjugate product

[0088] Analytical balance (top loading or equivalent)

[0089] Lyophilization vials—1 ml clear

[0090] Vortex Genie 2

[0091] Butyl rubber lyophilization stopper, 13 mm

[0092] Flip tear aluminum seal, 13 mm

[0093] Eppendorf Repeater Pipette w / 2.5 ml Combitip

[0094] Disposable latex gloves

[0095] Surgical mask

[0096] 70% alcohol

Method:

[0097] 1. Lyophilization material is placed into vials in the following manner: [0098] a. Use an area dedicated to filling vials only. [0099] b. Wipe area surface with 70% alcohol [0100] c. Arrange clean, dust free vials for easy access and filling. [0101] 2. Calibrate filling apparatus to fill within the following spec...

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Abstract

A sandwich immunoassay is disclosed that provides simple to perform yet sensitive identification of analytes in samples. All assay constituents needed (except analyte to be detected) for one assay are dried. Upon reconstitution with sample, a 10 to 15 minute incubation gives a rapid and convenient detection assay capability. The method incorporates the capture of antigen to an immobilized capture antibody. A labeled reporter antibody with the molecule, binds to the antigen to form an immunocomplex capable of generating a detectable signal.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of Invention [0002] The present invention relates to novel immunoassay methods and devices or kits that utilize a sandwich assay for detection of an antigen or hapten in a sample, particularly a biological sample. In a preferred embodiment, the present invention relates to a simple one-step electrochemiluminescent (ECL) assay approach that requires approximately 15 minutes for identification and / or quantification of an antigen or analyte. The present invention also relates to reagents and kits useful for carrying our such immunoassays. [0003] 2. Discussion of the Background [0004] In the medical, environmental, and food safety communities, immunodiagnostic testing has become the means to provide simplistic assessment and rapid identification of diseases and contaminants that are harmful to society. To prevent the occurrence of protracted illness and / or endemic disease, there is a need for simplistic confirmatory assays that provide qualita...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/53C07K16/46G01N33/543G01N33/58
CPCG01N33/543Y10S435/975G01N33/582
Inventor GATTO-MENKING, DEBORAH L.GOODE, MICHAEL T.
Owner STC UNM
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