Devices and methods for molecular diagnostic testing

Abstract

A hand-held 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 defines 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 a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application No. 62 / 098,769, filed December 31, 2014, entitled "Molecular Diagnostic Devices," and filed September 2, 2015, entitled "Devices and Methods for Molecular Diagnostic Testing Priority and benefit of U.S. 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, embodiments described herein relate to disposable, self-contained devices and methods for molecular diagnostic testing. [0004] There are more than one billion infections each year in the United States, many of which are mismanaged due to inaccurate or delayed diagnostic results. Many known point-of-care (POC) tests have poor sensitivity (30% to 70%), while more sensitive tests, such as those invo...

AI Technical Summary

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

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