Molecular diagnostic assay device and method of use

A detection area and detection device technology, applied in the directions of labeling used in chemical analysis, material analysis using immobilized reagents, and analyzing materials, etc., can solve problems such as hindering the use of POC, expensive and complicated instruments, etc.

Active Publication Date: 2014-06-11
CREDO BIOMEDICAL PTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Typically, there are two common problems with detection and monitoring: background interference and limit of detection (LOD)
In addition, the equipment required for PCR is expensive and complicated
The above considerations are harsh limitations that hinder the use of POC (on-site detection) or provide rapid sample-results within 30 minutes

Method used

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  • Molecular diagnostic assay device and method of use
  • Molecular diagnostic assay device and method of use
  • Molecular diagnostic assay device and method of use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0205] Example 1: Specific implementation of lateral flow device

[0206] Figure 4 shows specific embodiments of various lateral flow devices that can be used in the practice of the present invention. Sample area 1 is provided. The flow in the direction of the arrow produces the combination of the sample and the reporting carrier 7 in the sample area 2 of the reporting carrier. The detection zone 4 contains capture components (solid arrows pointing upwards) and materials that display the results, such as substrates, and if necessary, additional zymogen to further amplify the signal. A positive control zone 5 is provided. If there is a supporting scaffold matrix for sample movement, it can be a chemical coating or porous matrix membrane or branched polymer. Such as Figure 4B-4D In this case, the scaffold matrix can be mounted on a solid non-porous support 8, which can be flexible or porous. In some specific embodiments, the detection zone 1 may contain one type of fixative ar...

Embodiment 2

[0207] Example 2: Operation of specific implementation of lateral flow device

[0208] Figure 5 shows the operation of different embodiments of the invention. The sample target 13 is introduced into the sample loading area 1 (step A). The lateral flow in the direction indicated by the arrow carries the sample target 13 into contact with the report carrier 7 (step B). Further lateral flow carries the complex of the sample target and the reporting carrier 14 into the detection area 5 (step C). The capture component (solid arrow pointing upward) in the detection zone immobilizes the complex of the sample target and the reporting carrier 15 (steps D and 4-E). In various embodiments, the capture component can be a single or multiple variants (compare the upward pointing arrows in steps D and E). Excess materials such as unbound reporter carrier, unbound sample target, etc. are removed along the lateral flow of the capture component and immobilized sample target and reporter carrier...

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Abstract

Lateral flow devices and methods of use for a molecular diagnostic assay are provided. The method is suitable for detection or monitoring of targets, including biological, chemical, and material targets that exist in very low concentrations in biological samples. The methods and devices of the present application are amenable to power source-free point of care testing.

Description

Technical field [0001] The present invention relates to the comprehensive fields of molecular biology, molecular diagnosis, nucleic acid detection (NAT), medical science and biotechnology. The present invention is suitable for detecting or monitoring trace chemical and / or biological targets present in a sample at a very low concentration, including but not limited to biological samples, materials, organic or inorganic samples. Trace chemical and / or biological targets can include biological / chemical products, fragments, or entire targets, such as nucleic acid sequences, cells, viruses, pathogens, chemicals, etc., such as pharmacogenomics, pathogen detection and monitoring, and genetic determination. Tendency to susceptibility, genetic classification for clinical trials, diagnostics, predictive science, infectious disease diagnosis and monitoring, biological protection, forensic analysis, paternity testing, animal and plant breeding, food testing, human identification, genetically...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/531G01N33/68
CPCG01N33/558G01N33/581G01N33/54386G01N21/80G01N2021/752G01N2458/15G01N2021/757G01N2333/918
Inventor 温斯顿·王斯蒂芬·昌-智·卡奥
Owner CREDO BIOMEDICAL PTE
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