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 stand-alone molecular diagnostic test device used to detect a target nucleic acid within a biological sample at a decentralized location without using any external instrument to amplify the target nucleic acid and react each of the target amplicon and the reagent. The device is coupled to a power source and includes a flow path with a sample input opening, a reaction volume, and a detection volume, together with a control module, a fluid pump, and a heater. The device actuates itself by providing power to the heater and the fluid pump under control of the control module.

During actuation, the fluid pump produces a flow rate of the biological sample within the flow path by moving a movable member in a first direction. The control module regulates heater power based on a temperature set point so that the heater amplifies the target nucleic acid within the reaction volume to produce a target amplicon. The device then moves the movable member in a second direction to produce a flow of a reagent within the detection volume, where the reagent is formulated to produce a signal indicating a presence of the target amplicon.

The detection is performed by reacting, within the detection volume, each of the target amplicon and the reagent and reading a result associated with the signal. In the stand-alone decentralized operation, the flow path, the control module, the fluid pump, and the heater are contained within a housing, and the result is read from an outer surface of the housing. The claims further support implementations where the heater and reaction flow path provide thermally cycling amplification by using a serpentine reaction flow path and a heater having first and second heating portions that create first and second temperature zones.

Claims Coverage

The provided material includes two independent claims. Each independent claim is grounded in a stand-alone, decentralized molecular diagnostic approach that integrates power-coupled fluid pumping, heater-based amplification, reagent delivery into a detection volume, and signal-based result reading without external amplification or external reaction instrumentation. Across the independent claims, the inventive features collectively define (i) device self-actuation with pump/heater control, (ii) in-device amplification and reagent reaction, and (iii) housing-contained operation with result readout and discarding.

Across the independent claims, the coverage centers on a stand-alone, decentralized molecular diagnostic test device that self-manages fluid flow (sample and reagent) and heater-based amplification within in-device reaction and detection volumes, generates a signal from a reagent reaction with the target amplicon, reads a result from the housing, and does not rely on any external instrument for amplification and reaction.

Stated Advantages

Documented Applications