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 is a disposable handheld, single-use molecular diagnostic test device in which the sample input module, the amplification module, and the detection module are integrated within a housing. The device conveys a solution comprising a target nucleic acid from a sample input module to an amplification module, amplifies by polymerase chain reaction to produce a target amplicon, conveys the solution to a detection module, and detects the target amplicon in the solution. The amplifying and detecting steps do not use any external instrument, and the device is discarded after a single use.

The invention addresses performing nucleic acid amplification and detection in a molecular diagnostic test device without using any external instrument while maintaining specified diagnostic performance. The method provides detection of a target nucleic acid with a sensitivity of at least about 93 percent and a specificity of at least about 95 percent. The device is positioned for decentralized use and includes a stand-alone molecular diagnostic test device with a flow path adapted to receive a biological sample from an input module.

The integrated device architecture enables amplifying and detecting steps within a housing-contained flow path, and includes process steps that convey a biological sample into a flow path, amplify within the flow path to produce a target amplicon, and detect within the same flow path. The invention also covers a one-time detection method in which the molecular diagnostic test device performs, at most one time before the molecular diagnostic test device is discarded, process steps comprising conveying a solution comprising a target nucleic acid from a sample input module to an amplification module, amplifying by polymerase chain reaction to produce a target amplicon, conveying the solution to a detection module, and detecting the target amplicon in the solution.

Claims Coverage

The independent claims are directed to a stand-alone, single-use molecular diagnostic test device and methods for detecting a target nucleic acid by conveying sample to internal modules for polymerase chain reaction amplification and detection within the same housing and flow path without external instrumentation, with sensitivity and specificity thresholds. Across the independent claims, the main inventive features are integrated module workflow, stand-alone operation at a decentralized location, single-use or at-most-one processing, and claimed sensitivity and specificity thresholds.

Across the independent claims, the inventive coverage centers on a stand-alone, single-use molecular diagnostic test device with integrated sample input, PCR amplification, and detection modules within a housing, performing amplifying and detecting without any external instrument, and achieving sensitivity at least about 93 percent and specificity at least about 95 percent for detecting the target nucleic acid.

Stated Advantages

Documented Applications