Portable molecular diagnostic device and methods for the detection of target viruses

Inventors

Andreyev, Boris • Briones, Victor • CENA, Ryan T. • De La Zerda, Adam • Kelly, Colin • Loney, Gregory • Schoolnik, Gary • Swenson, David

Abstract

A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution. A result associated with the signal is then read.

Core Innovation

The invention relates to an apparatus with a housing that performs sample preparation, amplification, and detection. The sample preparation module within the housing includes a heater and a sample preparation housing that defines a sample input volume receiving an unprocessed biological sample via an input opening, and defines a flow channel in fluid communication with the sample input volume. The heater heats the unprocessed biological sample as it flows through the flow channel to extract RNA from a target virus and to produce a reverse transcription solution containing cDNA.

The apparatus further includes an amplification module within the housing that receives the reverse transcription solution from the sample preparation module. The amplification module heats the reverse transcription solution to amplify the cDNA within the reverse transcription solution to produce a detection solution containing a target amplicon. A reagent module within the housing includes a reagent container containing a detection reagent formulated to facilitate production of a signal that indicates a presence of the target amplicon, and the detection module includes a detection surface configured to capture the target amplicon from the detection solution.

The lid is movably coupled to the housing and includes a cover portion, a switch portion, and a reagent actuator. The lid moves relative to the housing between a first lid position and a second lid position such that the input opening is exposed when the lid is in the first lid position and is covered by the cover portion when the lid is in the second lid position. In response to the lid moving from the first lid position to the second lid position, the switch portion causes actuation of a switch to provide power to the heater, and the reagent actuator causes the detection reagent to be released from the reagent container.

Claims Coverage

Two independent claims are identified. Across the independent claims, the inventive features center on heating unprocessed biological samples to extract RNA and generate reverse transcription solution, amplifying cDNA to generate a target amplicon, and lid-position-triggered actuation that powers the heater and releases the detection reagent.

The independent claims require an apparatus that heats an unprocessed biological sample in a flow channel to extract RNA and produce a reverse transcription solution with cDNA, heats the reverse transcription solution to amplify cDNA into a detection solution containing a target amplicon, and detects the amplicon using a detection reagent. The key structural actuation feature is a lid that moves between first and second positions to expose or cover the input opening, to provide power to the heater via a switch, and to cause release of the detection reagent in response to lid movement.

Stated Advantages

Documented Applications