Devices and methods for molecular diagnostic testing

A technology of reagents and amplicons, applied in the direction of sterilization methods, chemical instruments and methods, biochemical equipment and methods, etc., can solve the problems of late diagnosis of viral infection, loss of time, infection, etc.

Active Publication Date: 2022-05-27
VISBY MEDICAL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This has dramatic consequences: antibiotics are not prescribed when needed, leading to infection; or antibiotics are prescribed when not needed, leading to new antibiotic resistant strains in the community
In addition, known systems and methods often lead to too late diagnosis of severe viral infections such as H1N1 swine flu, limiting lockdown efforts
Additionally, patients lose many hours in unnecessary repeat doctor visits

Method used

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  • Devices and methods for molecular diagnostic testing
  • Devices and methods for molecular diagnostic testing
  • Devices and methods for molecular diagnostic testing

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Embodiment Construction

[0084] In some embodiments, the device is configured for a single-use, portable, single-use, inexpensive molecular diagnostic approach. The apparatus may include one or more modules configured to perform high quality molecular diagnostic tests including, but not limited to, sample preparation, nucleic acid amplification (eg, via polymerase chain reaction or PCR), and detection. In some embodiments, sample preparation can be performed by isolating target pathogens / entities and removing unwanted PCR inhibitors. The target entity can then be solubilized to release the target nucleic acid for PCR amplification. The target nucleic acid in the target entity can be amplified with a temperature cycled polymerase to generate higher copy numbers of the target nucleic acid sequence for detection.

[0085] In some embodiments, detection can occur by a colorimetric reaction in the read lane. Multiple nucleic acid targets can be read in a lane, allowing multiplexed detection / testing. The...

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Abstract

A handheld molecular diagnostic test device includes a housing, an amplification (or PCR) module and a detection module. The amplification module is configured to receive an input sample and define a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and reagents formulated to generate a signal indicative of the presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims US Provisional Application Nos. 62 / 098,769, filed on December 31, 2014, and entitled "Molecular Diagnostic Devices," and filed on September 2, 2015, and entitled "Devices and Methods for Molecular Diagnostic Tests." Priority and benefit of US Provisional Application No. 62 / 213,291, the entire disclosure of each of which is incorporated herein by reference in its entirety. Background technique [0003] Embodiments described herein relate to methods and devices for molecular diagnostic testing. More specifically, the embodiments described herein relate to disposable, self-contained devices and methods for molecular diagnostic testing. [0004] There are more than one billion infections in the United States each year, many of which are mishandled due to inaccurate or delayed diagnoses. Many known point-of-care (POC) tests have poor sensitivity (30% to 70%), while more sensitive tests, such as those ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12M1/34C12M1/02C12M1/38C12M1/12C12M1/00C12Q1/6844B01L7/00
CPCB01L3/5027B01L3/5029B01L3/527B01L2200/025B01L2200/028B01L2200/0647B01L2200/0689B01L2300/0672B01L2300/0681B01L2300/0867B01L2300/1844B01L2400/0457B01L2400/0478B01L2400/0605B01L2300/0627B01L2300/18B01L2300/0883B01L2200/10B01L2400/0487B01L2300/0654B01L2300/1822B01L7/525B01L7/52B01L3/502715B01L2200/0684B01L2400/0611B01L2400/0644
Inventor B·安德列耶夫B·西奥派克A·德拉泽达K·莫拉维克D·斯文森G·朗内J·钦C·凯利V·布里奥尼斯S·丘H·黄
Owner VISBY MEDICAL INC
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