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 • Chu, Steven • Swenson, David • Huang, Helen • Kelly, Colin

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 a housing-based apparatus for molecular diagnostics that receives an input sample and includes a sample input module, an amplification module defining a reaction volume with a heater, and a detection module. A nonpathogenic solid positive control is included within the sample input module, where the positive control is rehydrated and mixed with the input sample when conveyed from the sample input volume. The amplification module amplifies a control nucleic acid within the positive control to produce a control amplicon while also amplifying a target nucleic acid within the input sample to produce a target amplicon.

The apparatus includes a reagent formulated to produce a first signal indicating the presence of the target amplicon and a second signal indicating the presence of the control amplicon. The detection module receives an output produced by the amplification module that includes both the target amplicon and the control amplicon, and the detection module contains a first detection surface and a second detection surface. The first detection surface interacts with the target amplicon and the second detection surface interacts with the control amplicon so that separate signals are produced from the respective detection surfaces.

The disclosed configurations describe a serpentine amplification flow path and heater-defined temperature zones. The detection module produces colorimetric, enzyme-linked detection signals on multiple probe-spotted surfaces, including probe-based target species and positive and negative controls, viewable through a window as non-fluorescent signals. The system is implemented as a point-of-care device with a disposable amplification format and a fluid-transfer workflow that supports mixing, fluid delivery, sequential reagent delivery, timed incubation, and signal generation.

Claims Coverage

The document includes two independent claims. Both are directed to a housing-based point-of-care molecular diagnostic apparatus that amplifies target and control nucleic acids and then produces separate signals on distinct detection surfaces. The claims collectively recite a nonpathogenic solid positive control that is rehydrated and mixed, an amplification module with a heater, a reagent producing signals for target and control amplicons, and a detection module with first and second detection surfaces.

Across the independent claims, the inventive concept is a housing-based apparatus that amplifies both a target nucleic acid and a control nucleic acid derived from a nonpathogenic solid positive control, then uses a reagent and a detection module with distinct detection surfaces to generate separate signals for the target amplicon and the control amplicon.

Stated Advantages

Documented Applications