Devices and methods for the detection of molecules using a flow cell

Abstract

A method includes conveying a detection solution containing a target amplicon into a detection module of a molecular diagnostic test device. The detection module includes a detection surface including a series of capture probes to which a first portion of the target amplicon is bound when the detection solution is conveyed. A first reagent formulated to produce a visible signal indicating a presence of the target amplicon is then conveyed into the detection module. The first reagent is bound to a second portion of the target amplicon when the first reagent is conveyed. A second reagent is conveyed into the detection module. The second reagent includes a precipitating substrate formulated to catalyze the production of the visible signal by producing an insoluble colored product when the second reagent is in contact with the first reagent. The method includes viewing the visible signal via a transparent portion of the detection module.

What is claimed is: 
     
         1 . An apparatus, comprising:
 a housing defining an input opening through which a biological sample can be loaded into a molecular diagnostic device;   a lid coupled to the housing, the lid configured to be moved within a channel from an opened position to a closed position, the input opening being accessible when the lid is in the opened position, the lid covering the opening when the lid is in the closed position;   a sample preparation module within the housing, the sample preparation module defining a holding volume configured to receive the biological sample, the sample preparation module configured to lyse the biological sample to produce an input solution;   an amplification module within the housing, the amplification module configured to heat the input sample to amplify a nucleic acid within the input solution to produce a detection solution containing a target amplicon;   a detection module within the housing and having a detection surface defining at least a portion of a detection channel, the detection channel configured to receive the detection solution from the amplification module and react the target amplicon with a detection reagent to produce a signal from the detection surface that indicates a presence of the target amplicon; and   an electronic controller including a sensor configured to produce an electronic signal indicating the presence of at least a portion of the biological sample within the holding volume, the electronic signal associated with actuation of the apparatus.   
     
     
         2 . The apparatus of  claim 1 , wherein the lid is sealed about the input opening to fluidically isolate the biological sample within the molecular diagnostic device when the lid is in the closed position. 
     
     
         3 . The apparatus of  claim 2 , wherein:
 the lid is configured to slide substantially parallel to a surface of the housing that defines the input opening when the lid is moved from the opened position to the closed positioned.   
     
     
         4 . The apparatus of  claim 2 , wherein:
 the lid includes a lock protrusion configured to engage a lock shoulder when the lid is in the closed position to prevent the lid from moving back towards the opened position.   
     
     
         5 . The apparatus of  claim 4 , wherein:
 the lid includes a detent configured to resist movement of the lid from the opened position towards the closed position.   
     
     
         6 . The apparatus of  claim 2 , wherein the sensor is configured to detect a characteristic of the biological sample to produce the electronic signal. 
     
     
         7 . The apparatus of  claim 6 , wherein the sensor includes an electrode configured to detect an electrical resistance of the biological sample within the holding volume. 
     
     
         8 . The apparatus of  claim 2 , wherein the signal is a non-fluorescent signal produced without an excitation light source within the housing. 
     
     
         9 . The apparatus of  claim 8 , wherein:
 the housing defines a detection window;   the signal is a visible signal; and   the visible signal is viewable via the detection window of the housing.   
     
     
         10 . An apparatus, comprising:
 a housing defining an input opening through which a biological sample can be loaded into a molecular diagnostic device;   a lid coupled to the housing, the lid configured to be moved along the housing from an opened position to a closed position, the input opening being accessible when the lid is in the opened position, the lid being sealed about the input opening to fluidically isolate the biological sample within the molecular diagnostic device when the lid is in the closed position, the lid includes a lock protrusion configured to engage a lock shoulder when the lid is in the closed position to prevent the lid from moving back towards the opened position;   a sample preparation module within the housing, the sample preparation module defining a holding volume configured to receive the biological sample, the sample preparation module configured to lyse the biological sample to produce an input solution;   an amplification module within the housing, the amplification module configured to heat the input sample to amplify a nucleic acid within the input solution to produce a detection solution containing a target amplicon;   a detection module within the housing and having a detection surface defining at least a portion of a detection channel, the detection channel configured to receive the detection solution from the amplification module and react the target amplicon with a detection reagent to produce a signal from the detection surface that indicates a presence of the target amplicon; and   an electronic controller including a sensor configured to detect the presence of at least a portion of the biological sample within the holding volume.   
     
     
         11 . The apparatus of  claim 10 , wherein:
 the lid is configured to resist movement of the lid from the opened position towards the closed position.   
     
     
         12 . The apparatus of  claim 10 , wherein:
 the lid is configured to slide within a channel when the lid is moved from the opened position to the closed position.   
     
     
         13 . The apparatus of  claim 10 , wherein:
 the housing defines a detection window;   the signal is a visible signal; and   the visible signal is viewable via the detection window of the housing.   
     
     
         14 . The single-use molecular diagnostic test device of  claim 10 , wherein the amplification module is configured to heat the input sample through a plurality of thermal cycles to amplify the target nucleic acid. 
     
     
         15 . The single-use molecular diagnostic test device of  claim 10 , wherein the detection surface includes a capture probe associated with the target amplicon. 
     
     
         16 . The apparatus of  claim 10 , wherein the sensor is configured to detect a characteristic of the biological sample to produce the electronic signal. 
     
     
         17 . The apparatus of  claim 16 , wherein the sensor is configured to detect the characteristic without impacting a biological reaction occurring within the molecular diagnostic device.