Device for use in analyte detection assays

An assay device for use in analyte detection comprising at least one assay path, wherein said assay path comprises:

• (a) a main flow path comprising
• (i) a sample addition port for adding a sample suspected of containing an analyte;
• (ii) a main reagent area that is adjacent said sample addition port and that contains a reagent;
• (iii) a transport conduit downstream from said main reagent area comprising two inlet ports in opposing relationship;
• (iv) an incubation area downstream from said transport conduit;
• and
• (v) a waste area downstream from said incubation area;
• (b) two side reagent channels on opposite sides of said main flow path comprising:
• (i) a liquid addition port and
• (ii) a side reagent area, wherein each of said side reagent channels is in fluid communication with said main flow path at a corresponding inlet port at said transport conduit;
• and
• (c) at least one capillary valve in said main flow path or side reagent channel upstream from said incubation area;
• wherein said analyte, if present, reacts with a reagent to produce a detectable in said incubation area.

An assay device for use in analyte detection comprising at least two assay paths, wherein each of said assay paths comprises:

• (a) a main flow path comprising:
• (i) a sample addition port for adding a sample suspected of containing analyte;
• (ii) a main reagent area adjacent said sample addition port comprising at least one reagent trough for containing reagent and an agitation means;
• (iii) a transport conduit that is downstream of the main reagent area, upstream of an incubation area and comprises two inlet ports in opposing relationship;
• (iv) an incubation area being downstream of said transport conduit;
• and
• (v) a waste area that is downstream of said incubation area and that comprises an outlet port;
• (b) two side reagent channels on opposite sides of said main flow path, wherein each of said side channels comprises:
• (i) a liquid addition port;
• and
• (ii) a side reagent area comprising an agitation means and at least one reagent trough for containing reagent, wherein each of said side reagent channels is in fluid communication with said transport conduit at one of said inlet ports of said transport conduit;
• (c) at least one capillary valve in at least one of said main flow path and side reagent channels upstream from said incubation area;
• and
• (d) a reagent in the reagent trough of at least one of said main reagent area or said side reagent areas, wherein said analyte, if present, reacts with a reagent to produce a detectable signal in said incubation area.

A method for determining the presence of an analyte in a sample using a device having:

• (a) a main flow path comprising:
• (i) a sample addition port for adding a sample suspected of containing an analyte;
• (ii) at least one reagent incubation area downstream from said sample addition port;
• and (iii) a waste area downstream from said incubation area;
• (b) at least one side channel comprising (i) a liquid addition port and (ii) a side reagent area, wherein said side channel is in fluid communication with said main flow path upstream of said incubation area;
• (c) at least one fluid interruption means in one of said main flow path and side channel;
• and (d) at least one reagent that is a member of a signal producing system and that is in said main flow path or said side channel, wherein said side channel is in fluid communication with said main flow path at a region of said main flow path upstream from said waste area,
• said method comprising:
• introducing sample suspected of containing an analyte into said sample addition port, whereby said sample flows down said main flow path and reacts with a reagent member of said signal producing system;
• washing said reagent incubation area substantially free of sample components unreacted with a member of said signal producing system;
• introducing liquid comprising at least one additional member of said signal producing system into said incubation area, whereby an optically detectable signal is produced in said incubation area;
• and
• detecting said optical signal at least one time to determine the presence of analyte in said sample.

A disposable assay device for use in analyte detection, said device comprising:

• a sample addition port for adding a sample suspected of containing analyte, which port is in fluid communication with at least one main channel, wherein at least a portion of said main channel is a capillary and said main channel comprises:
• at least one reagent incubation area;
• and
• a waste area, wherein said waste area is downstream from said incubation area;
• and
• at least one side channel, said side channel comprising:
• a liquid addition port and
• a side reagent area downstream from said liquid addition port;
• wherein (i) there is at least one reagent in the main channel or side channel, (ii), side reagent area of said side channel is in fluid communication with said main channel at a region of said main channel upstream from said reagent incubation area, and (iii) said analyte, if present, reacts with a reagent to produce a detectable signal in said reagent incubation area.

A detection system for use in analyte detection comprising:

• an optical sensor and
• an assay device comprising:
• (a) a main flow path comprising:
• a sample addition port for adding a sample suspected of containing an analyte,
• at least one reagent incubation area downstream from said sample addition port, and
• a waste area downstream from said reagent incubation area;
• (b) at least one side channel, said side channel comprising:
• a liquid addition port and
• a side reagent area for introducing a liquid into said reagent incubation area;
• (c) at least one fluid interruption means positioned along said main flow or side reagent channel upstream from said reagent incubation area;
• and
• (d) at least one reagent in said main flow path or said side channel,
• wherein said side channel is in fluid communication with said main flow path at a region of said main flow path upstream from said incubation area, and said analyte, if present, reacts with a reagent to produce a detectable signal in said reagent incubation area and said optical sensor reads said detectable signal.