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 a sample input volume configured to receive a biological sample;   a reagent module disposed within the housing, the reagent module including a reagent container containing a reagent;   a reagent actuator coupled to the housing, the reagent actuator configured to be moved from a first position to a second position when actuating the apparatus, movement of the reagent actuator to the second position configured to cause the reagent to be released from the reagent container,   the reagent actuator including a lock protrusion configured to engage a shoulder of the housing to irreversibly maintain the reagent actuator in the second position relative to the housing;   a lysis module disposed within the housing and configured to heat the biological sample to lyse a portion of the biological sample to produce an input sample;   an amplification module disposed within the housing, the amplification module configured to heat the input sample to amplify a nucleic acid within the input sample to produce a detection solution containing a target amplicon; and   a detection module disposed within the housing and having a detection surface defining at least a portion of a detection channel, the detection surface including a plurality of capture probes configured to capture the target amplicon such that in response to the reagent being conveyed into the detection module, a signal indicating a presence of the target amplicon is produced from the detection surface.   
     
     
         2 . The apparatus of  claim 1 , wherein:
 the reagent includes a precipitating substrate formulated to produce the signal by producing an insoluble colored product when the reagent is reacted within the detection module.   
     
     
         3 . The apparatus of  claim 2 , wherein the housing includes a window configured to provide access to a result associated with the signal. 
     
     
         4 . The apparatus of  claim 1 , further comprising:
 a pump disposed within the housing, the pump producing a force to convey the reagent into the detection channel.   
     
     
         5 . The apparatus of  claim 1 , wherein the reagent actuator includes a guide rail that matingly engages the housing to guide movement of the reagent actuator between the first position and the second position. 
     
     
         6 . The apparatus of  claim 1 , wherein the reagent actuator includes a protrusion configured to deform a covering of the reagent container to release the reagent from the reagent container. 
     
     
         7 . The apparatus of  claim 1 , wherein the housing defines an input opening in communication with the input volume, the input volume configured to receive the biological sample through the input opening, the apparatus further comprising:
 a lid coupled to the housing, the lid configured to be moved from a first position relative to the housing, in which the input opening is accessible, to a second position, in which the lid is disposed over the input opening.   
     
     
         8 . The apparatus of  claim 1 , wherein the reagent is one of a first reagent or a second reagent, the first reagent formulated to be bound to the target amplicon in response to the first reagent being conveyed into the detection module, the second reagent formulated to produce the signal when catalyzed by the first reagent. 
     
     
         9 . An apparatus, comprising:
 a housing defining a sample input volume in fluid communication with an input opening, the input volume configured to receive a biological sample through the input opening;   a lid coupled to the housing, the lid configured to be moved from a first position relative to the housing, in which the input opening is accessible, to a second position, in which the lid is disposed over the input opening,   the lid including a lock protrusion configured to engage a lock surface of the housing to limit movement of the lid in the first position, the lid being disengagable from the lock surface of the housing to move the lid to the second position, the lock protrusion configured to engage a lock shoulder when the lid is in the second position to prevent the lid from moving back towards the first position, the apparatus configured to be actuated when the lid is in the second position;   an amplification module disposed within the housing, the amplification module configured to heat the biological sample to amplify a nucleic acid within the biological sample to produce a detection solution containing a target amplicon; and   a detection module disposed within the housing and having a detection surface defining at least a portion of a detection channel, the detection surface including a plurality of capture probes configured to capture the target amplicon such that when the amplicon and a reagent are reacted within the detection module a signal indicating a presence of the target amplicon is produced from the detection surface.   
     
     
         10 . The apparatus of  claim 9 , further comprising:
 a reagent module disposed within the housing, the reagent module including a reagent container containing a reagent; and   a reagent actuator coupled to the housing, the reagent actuator configured to be moved from a first reagent actuator position to a second reagent actuator position when actuating the apparatus, movement of the reagent actuator to the second reagent actuator position configured to cause the reagent to be released from the reagent container,   the reagent actuator including a lock protrusion configured to engage a shoulder of the housing to irreversibly maintain the reagent actuator in the second reagent actuator position relative to the housing.   
     
     
         11 . The apparatus of  claim 10 , wherein the reagent actuator includes a guide rail that matingly engages the housing to guide movement of the reagent actuator between the first reagent actuator position and the second reagent actuator position. 
     
     
         12 . The apparatus of  claim 10 , wherein the reagent actuator includes a protrusion configured to deform a covering of the reagent container to release the reagent from the reagent container. 
     
     
         13 . The apparatus of  claim 10 , further comprising:
 a pump disposed within the housing, the pump producing a force to convey the reagent into the detection channel.   
     
     
         14 . The apparatus of  claim 9 , wherein the housing includes a window configured to provide access to a result associated with the signal. 
     
     
         15 . The apparatus of  claim 9 , wherein:
 the lid includes a rail that slides within a corresponding channel defined by the housing when the lid is moved from the first position to the second position, the lock protrusion of the lid expanding within the channel to engage the lock shoulder of the housing.   
     
     
         16 . An apparatus, comprising:
 a housing defining a sample input volume configured to receive a biological sample;   a reagent module disposed within the housing, the reagent module including a reagent container configured to contain a reagent;   a lysis module disposed within the housing, the lysis module including a heater configured to heat the biological sample to lyse a portion of the biological sample to produce an input sample containing a target nucleic acid;   a detection module disposed within the housing and having a detection surface defining at least a portion of a detection channel, the detection surface including a plurality of capture probes configured to capture the target nucleic acid such that in response to the reagent being conveyed into the detection module a signal indicating a presence of the target nucleic acid is produced from the detection surface;   an electronic controller within the housing, the electronic controller configured to control current to the heater; and   an actuator coupled to the housing, the actuator configured to be moved from a first position to a second position, movement of the actuator to the second position configured to cause a reagent protrusion to puncture the reagent container to release the reagent, movement of the actuator to the second position further configured to cause a switch within the apparatus to be triggered to start the electronic controller.   
     
     
         17 . The apparatus of  claim 16 , further comprising:
 an amplification module disposed within the housing, the amplification module configured to heat the biological sample to amplify the target nucleic acid within the biological sample to produce a detection solution containing a target amplicon.   
     
     
         18 . The apparatus of  claim 16 ,wherein the actuator includes a lock mechanism configured to engage a portion of the housing to irreversibly maintain the actuator in the second position relative to the housing. 
     
     
         19 . The apparatus of  claim 16 , further comprising:
 a pump disposed within the housing, the pump producing a force to convey the reagent into the detection channel.   
     
     
         20 . The apparatus of  claim 16 , wherein the actuator includes a guide rail that matingly engages the housing to guide movement of the actuator between the first position and the second position. 
     
     
         21 . The apparatus of  claim 16 , wherein the housing defines an input opening in communication with the input volume, the input volume configured to receive the biological sample through the input opening, the apparatus further comprising:
 a lid coupled to the housing, the lid configured to be moved from a first lid position relative to the housing, in which the input opening is accessible, to a second lid position, in which the lid is disposed over the input opening.