Chromatographic exclusion agglutination assay and methods of use thereof

An aggregate, detected technology, used in measurement devices, biological testing, analysis by chemically reacting materials, etc., to solve problems such as lack of sensitivity and false positive results

Inactive Publication Date: 2007-08-15
BINAX INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Many available agglutination assays suffer from a lack of sensitivity and a tendency to produce false positive results

Method used

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  • Chromatographic exclusion agglutination assay and methods of use thereof
  • Chromatographic exclusion agglutination assay and methods of use thereof
  • Chromatographic exclusion agglutination assay and methods of use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0136] Embodiment 1: Detect Staphylococcus aureus

[0137] This example provides a device for the detection of methycillin-resistant Staphylococcus aureaus ("MRSA"). The feasibility and utility of the present invention was demonstrated with Pastorex Staph Plus (Biorad, #65356). As an experimental control, slide agglutination assays were performed on MRSA slurries according to the manufacturer's instructions. Moderate agglutination was observed in wells containing a mixture of test latex and MRSA, no agglutination was observed in wells containing a mixture of MRSA and control latex.

[0138] To identify suitable chromatographic media, suspensions of red latex test particles are applied to several types of media, including nitrocellulose and porous polyethylene. Choose a porous polyethylene membrane (Porex, Cat #181071) with suitable chromatographic properties. When untreated particles were applied to this membrane, the particles filled evenly into the pore volume, imparting ...

Embodiment II

[0141] Example II: Detection of Streptococcus agalactiae

[0142] This example provides a device for the detection of Streptococcus agalactiae ("StrepA").

[0143] Construct agglutination separation strips:

[0144] Materials for Constructing Agglutination Separation Strips:

[0145] -Millipore Nitrocellulose Membrane: 18 mm long, 6 mm wide (Millipore, Inc., Cat #PK002057; 100% Nitrocellulose Membrane)

[0146] - Bridge pads (Ahlstrom 1281; 90% cellulose fibers, 10% rayon, with traces of polyacrylamide wet strength resin and polyacrylamide dry strength resin)

[0147] - Absorbent pad (Ahlstrom 939; 100% cellulose with traces of polymide wet strength resin)

[0148] -Lexan backing plate (Lexan #8010)

[0149] Materials for construction of antibody capture strips:

[0150] -Millipore Nitrocellulose Membrane: 18mm long, 6mm wide (Millipore, Inc., Cat#PK002057)

[0151] - Bridge pads (Ahlstrom 1281)

[0152] - Conjugate pad (conjugate pad, Hollingsworth & Vose, H&V 7304 n...

Embodiment III

[0184] Example III: Detailed Practice of a Device for Detecting the Presence or Absence of One or More Analytes of Interest in a Test Sample

[0185] Implementation method

[0186] Referring to Figure 1A, the present invention includes an optional absorbent pad 11 fluidly connected to a first porous member 12 at one end thereof. The first porous part is in fluid communication with the second porous part 14 forming a connection 13 . An important aspect of the first porous member 12 of the present invention is that it is substantially capable of free passage of any detectable specific binding reagent through the first porous member 12 only when the detectable specific binding reagent is not bound to any analyte. . An important aspect of the second porous member 14 is that it is substantially capable of capturing or preventing any bound detectable specific binding reagent from flowing out of the second porous member 14, especially when the bound detectable specific binding reag...

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PUM

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Abstract

The present invention relates to agglutination assays and in particular to chromatographic exclusion assays and methods of use thereof. The present invention includes a novel strategy for determining the presence of one or more analytes on interest in a test sample by using chromatographic exclusion of aggregates of bound detectable specific binding reagents that are accumulated at a particular and non-random location on the test device. In the absence of analytes of interest in the sample under test, the specific detectable binding reagent aggregates are not formed, and hence not excluded from the chromatographic media creating a distinct and readily differentiating event. The present invention is particularly adaptable as a simple test device for detection of diseases or monitoring of treatments at a doctor's office or in the home.

Description

field of invention [0001] The present invention relates generally to the field of agglutination assays, and in particular to chromatographic exclusion assays and methods of use thereof. Background of the invention [0002] Various air agglutination assays are commercially available. These agglutination assays can be used for a variety of purposes, such as diagnosing disorders or monitoring treatment by analyzing samples for trace analytes of interest. Some agglutination assays are performed entirely in solution, and the presence of visible analyte-induced aggregates in solution is indicative of a positive result. Other agglutination assays are performed using flow-through systems that pass reaction samples through small holes to concentrate analyte-induced aggregates. For other agglutination assays performed on dried porous strips, the presence of analyte-induced aggregates on the strip is a positive result. [0003] Many available agglutination assays suffer from a lack ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/558G01N21/77G01N21/78
CPCG01N2021/7786G01N33/558G01N33/5304G01N21/78G01N21/77
Inventor N·特纳R·皮亚西奥E·皮亚西奥
Owner BINAX INC
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