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Portable molecular diagnostic device and methods for the detection of target viruses

A technology of molecular diagnostics and testing devices, applied in the field of bedside devices exempted by CLIA, which can solve problems such as viral load level rebound

Pending Publication Date: 2020-09-11
VISBY MEDICAL INC
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although in many cases ARV regimens reduce the HIV viral load in the blood to undetectable levels, some patients will experience changes in viral load levels due to problems with adhesion, development of drug resistance, and toxicity. rebound

Method used

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  • Portable molecular diagnostic device and methods for the detection of target viruses
  • Portable molecular diagnostic device and methods for the detection of target viruses
  • Portable molecular diagnostic device and methods for the detection of target viruses

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Embodiment Construction

[0048] In some embodiments, the device is configured for a disposable, portable, single use, inexpensive molecular diagnostic modality. The device may include one or more modules configured to perform high quality molecular diagnostic tests including, but not limited to, sample preparation, nucleic acid amplification (e.g., by polymerase chain reaction, isothermal increase, etc.) and testing. In some embodiments, sample preparation can be performed by isolating target pathogens / entities and removing unwanted amplification (eg, PCR) inhibitors. The target entity can subsequently be cleaved to release the target nucleic acid for amplification. The target nucleic acid in the target entity can be amplified by subjecting a polymerase to temperature cycling or by isothermal incubation to generate a large number of copies of the target nucleic acid sequence for detection.

[0049] In some embodiments, the devices described herein are self-contained devices that include all the nece...

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Abstract

A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of thetarget amplicon within the output solution. A result associated with the signal is then read.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application Serial No. 62 / 583,789, filed November 9, 2017, entitled "Portable Molecular Diagnostic Test Device With Reverse Transcription Module," and filed December 5, 2017, entitled "Portable Molecular Diagnostic Test Device and Method for Detecting Target Viruses," US Provisional Application Serial No. 62 / 594,905, each of which is incorporated herein by reference in its entirety. Background technique [0003] Embodiments described herein relate to devices and methods for molecular diagnostic testing. More specifically, embodiments described herein relate to disposable, self-contained devices and methods for molecular diagnostic testing that include reverse transcription capabilities. [0004] There are more than one billion infections in the United States each year, many of which are incorrectly treated due to inaccurate or delayed diagnostic results. Many known point-of-care...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/686B01L7/00
CPCB01L3/502715B01L7/52B01L2200/028B01L2200/04B01L2200/10B01L2200/16B01L2400/0487C12Q1/686B01L2300/1805B01L2300/0883B01L2300/041B01L2300/046C12Q2565/629C12Q1/70B01L2200/0663C12Q1/6806B01L3/5027B01L7/00C12Q2600/112B01L2300/04B01L2300/087C12Q2600/16
Inventor D·斯文森B·安德雷叶夫V·布里昂内斯R·T·塞纳A·德拉泽达C·凯利G·龙内G·斯库尼克
Owner VISBY MEDICAL INC
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