Devices and methods for molecular diagnostic testing

Inventors

Andreyev, Boris • Moravick, Keith E. • Ciopyk, Brian • Briones, Victor • Loney, Gregory • De La Zerda, Adam • Ching, Jesus • Kelly, Colin • Chu, Steven • Swenson, David • Huang, Helen

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.

Core Innovation

The invention relates to an apparatus with a housing defining a detection window, a sample input module enclosed by the housing, and an amplification module fixedly coupled within the housing. The sample input module receives an input sample and conveys it to the amplification module, which includes a heater and defines a reaction volume. The amplification module amplifies a nucleic acid within the input sample to produce a target amplicon and amplifies a control nucleic acid within a solid control organism to produce a control amplicon.

A solid control organism is stored within the sample input module or within a flow path enclosed by the housing, where it is nonpathogenic to humans and is rehydrated and mixed with the input sample when the input sample is conveyed. A reagent module within the housing contains a reagent formulated to produce a first visible signal indicating a presence of the target amplicon and a second visible signal indicating a presence of the control amplicon. The detection module receives output produced by the amplification module including the target amplicon and the control amplicon and includes first and second detection surfaces positioned for viewing via the detection window.

The detection module defines a detection channel through which amplification output flows across the first detection surface and the second detection surface. The first detection surface interacts with the target amplicon and the second detection surface interacts with the control amplicon to produce the first visible signal and the second visible signal, respectively. In some configurations, the visible signals are non-fluorescent and are produced without an excitation light source inside the housing.

Claims Coverage

The independent claims include three inventive features centered on an apparatus that rehydrates a nonpathogenic solid control organism with an input sample, performs amplification to produce both a target amplicon and a control amplicon, and produces two visible signals on first and second detection surfaces viewable through a housing detection window; some claim refinements further require fluid pumping and non-fluorescent signal production without an internal excitation light source.

Across the independent claims, the inventive core is an integrated housing-based apparatus that performs amplification while using a nonpathogenic solid control organism to generate a control amplicon alongside a target amplicon, and that produces two distinct visible signals on two detection surfaces positioned for viewing through a detection window; additional inventive limitations include a fluid pump generating forces for sample/output and reagent flow and, in some claim refinements, non-fluorescent signal production without an internal excitation light source.

Stated Advantages

Documented Applications