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Publication Number
US-10928394-B2
Publication Date
2021-02-23
Expiration Date
Abstract
The subject matter disclosed herein provides a method and a device for detection of one or more bacteria in a sample.
Core Innovation
The invention relates to a rapid lateral-flow competitive immunoassay for detecting Lyme disease agents, including Borrelia burgdorferi, in a sample obtained from tick/vector material. A homogenized sample is applied to a sample pad and contacted with biotinylated C6 peptide and streptavidin-gold with a flow buffer to obtain a homogenized sample solution. Capillary flow carries the homogenized sample solution along an elongated nitrocellulose strip contacting the sample pad at a first short edge.
Read-out is provided by two read-out lines on the nitrocellulose strip. The first read-out line comprises at least one VisE-specific antibody, and the second read-out line comprises biotinylated albumin as a control. Color outcomes are defined by the color behavior of the first read-out line, with the assay distinguishing whether the first read-out line changes color based on whether bacterial is detected in the sample.
Excess sample is collected by a cellulose wick contacting a second short edge of the nitrocellulose strip. The disclosure also describes an associated device or holder architecture in which the nitrocellulose strip is arranged with regions including the read-out lines, and waste collection is provided by a cellulose waste wick, for use in a rapid test workflow for detecting Borrelia proteins in tick/vector samples.
Claims Coverage
The relevant portion contains one independent claim describing a method for detecting Borrelia burgdorferi bacteria using a lateral-flow competitive immunoassay with specified reagents, an elongated nitrocellulose strip having two read-out lines, and a defined color behavior relationship for the first read-out line.
Homogenizing a sample on a sample pad and preparing a homogenized sample solution
Homogenizing a sample on a sample pad and applying biotinylated C6 peptide, streptavidin-gold, and flow buffer to obtain a homogenized sample solution.
Capillary flow along an elongated nitrocellulose strip with two read-out lines
Allowing capillary flow of the homogenized sample solution along an elongated nitrocellulose strip contacting the sample pad at a first short edge, and contacting a first read-out line and a second read-out line on the nitrocellulose strip.
Competitive read-out line composition using VisE-specific antibody and biotinylated albumin
Configuring the first read-out line to comprise at least one VisE-specific antibody and the second read-out line to comprise biotinylated albumin.
Defined color behavior of the first read-out line to indicate presence or absence
Defining detection by the first read-out line color behavior, where the first read-out line does not change color if bacterial is detected in the sample, or changes color if bacteria is not detected in the sample.
Excess sample collection using a cellulose wick at a second short edge
Collecting excess sample in a cellulose wick contacting a second short edge of the nitrocellulose strip.
Across the single independent claim, detection of Borrelia burgdorferi is achieved by a defined competitive lateral-flow format: a homogenized sample solution prepared with biotinylated C6 peptide and streptavidin-gold is driven by capillary action along an elongated nitrocellulose strip having a VisE-specific-antibody first read-out line and a biotinylated-albumin second read-out line, with assay result determined by whether the first read-out line changes color, while excess sample is collected by a cellulose wick.
Stated Advantages
Provides a rapid lateral-flow competitive immunoassay for detecting Lyme disease agents, including Borrelia burgdorferi, in tick/vector samples.
Documented Applications
Detecting Lyme disease agents (Borrelia burgdorferi) in tick/vector samples using a rapid lateral-flow competitive immunoassay (QuickLyme).
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