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...

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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

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