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Semi-quantitative immunochromatographic device

A predetermined quantity and quantity of technology, applied in the field of semi-quantitative immunochromatographic devices, can solve the problems of unsatisfactory complexity of analytical methods, etc.

Inactive Publication Date: 2008-05-07
BECTON DICKINSON & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The need to perform the washing or mixing steps makes the analytical method undesirably complex, making it unsuitable for use by laypersons, even those with a lower level of medical training

Method used

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  • Semi-quantitative immunochromatographic device
  • Semi-quantitative immunochromatographic device

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Embodiment approach

[0032] As used herein, the term "capture agent" means any particle or molecule capable of recognizing or binding an analyte of interest, or a detection ligand that binds to said analyte. The capture agent is immobile, so that once the capture agent binds to the analyte-detection ligand complex, it prevents the complex from continuing to flow laterally. The capture agent may include any suitable ligand, such as an antibody, an antigen-binding fragment, a peptide, an aptamer, and the like. According to an exemplary embodiment, the capture agent comprises an antibody to the CD4 antigen present in CD4 lymphocytes.

[0033] As used herein, the term "capture zone" denotes the region of the device in which a capture agent is immobilized in the material.

[0034] Herein, the term "specific binding" refers to a binding mechanism that is achieved through a receptor, or a capture agent, etc., and can only optionally bind to a specific reagent or substance.

[0035] A first embodiment d...

Embodiment 1

[0068] In this embodiment, the quantity of CD4 lymphocytes in human blood can be semi-quantitatively measured. A drop of blood was obtained from the test subject by pricking a finger with a lancing needle and applied to the site on the lateral flow device that received the biological sample. Two drops of a suitable buffer, such as phosphate buffered saline, are then added to the receiving site to facilitate lateral flow. The device consists of a pad, eg, rayon or fiberglass, for receiving a blood sample. A lysing agent is impregnated into the pad to lyse the blood cells. Also in the same pad is the detection antibody (a monoclonal antibody specific for the CD4 antigen), which is conjugated to colloidal gold. Underneath the pad is a strip of nitrocellulose, typically 5mm wide and 30mm long, with the pad at one end of the strip. At the other end of the strip, an absorbent pad contacts the strip to promote and maintain capillary flow of liquid. Fluid in the blood sample moves...

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Abstract

The present invention provides a device comprising one or more support materials capable of providing lateral flow. The one or more support materials contain an area for a receiving a biological sample containing a target analyte, an area having a movably contained detector ligand capable of forming a complex with the target analyte, a first capture area having a predetermined amount of an immobile capture reagent, where the immobile capture reagent is capable of specifically binding to the complex, a second capture area having the immobile capture reagent, and a lysing agent. Typically, the area for receiving the biological sample, the area having the movably contained detector ligand, the first capture area, and the second capture area are arranged in the one or more support materials such that a sample is capable of sequential lateral flow through these areas.

Description

[0001] related application [0002] This application claims priority to US Provisional Patent Application Serial No. 60 / 673,218, filed April 20, 2005. The contents of this provisional application are incorporated herein by reference. field of invention [0003] The present invention relates to devices and methods for the semi-quantitative analysis of target analytes of a sample. Background of the invention [0004] In the following discussion, certain articles and methods will be disclosed as background and introduction. Nothing contained herein is to be construed as an "admission" of prior art. The applicant expressly reserves the right to state, where necessary, that the articles and methods referred to herein do not constitute prior art under applicable statutory provisions. [0005] It has been found that various immune responses can be used as analytical techniques. Immunochemical assays generally fall into a number of different types. The two most common types are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543
Inventor P·E·古登鲍姆S·J·劳维尔
Owner BECTON DICKINSON & CO