Automated point of care detection system including complete sample processing capabilities

An assay cartridge for use in an analytical instrument, the assay cartridge comprising:

• a bottom member comprising an optical reading well and a test surface;
• and
• a top member comprising a rotatable reagent carousel, said reagent carousel comprising a sample receiving port, a plurality of reagent wells, a reagent flow channel, and a differential seal,
• wherein said test surface lies in said optical reading well,
• wherein one or more of said regent wells comprise a reagent and a reagent well piston for delivery of said reagent to the test surface, and
• wherein said reagent flow channel is adjacent to said sample receiving port, a top part of said reagent flow channel is connected to a top part of said sample receiving port, and said differential seal lies between a bottom part of said reagent flow channel and a bottom part of one of said reagent wells, thereby allowing flow to occur from one of said reagent wells through said reagent flow channel to said sample receiving port.

An analytical instrument for determining the presence or amount of an analyte in a sample, the analytical instrument comprising:

• an assay cartridge comprising
• (i) a bottom member comprising an optical reading well and a test surface;
• and
• (ii) a top member comprising a reagent carousel, said reagent carousel comprising a sample receiving port and a plurality of reagent wells, wherein one or more of said reagent wells comprise a reagent and a reagent well piston for delivery of said reagent to the test surface, said top member attached to said bottom member such that the reagent carousel may be rotated relative to the bottom member.
• a mechanism for receiving said assay cartridge;
• a rotation element for rotating and indexing said reagent carousel;
• a plunger element for engaging said reagent well pistons to deliver reagent from said reagent wells to said sample receiving port and/or said test surface;
• a vacuum element for directing sample and/or reagent to said test surface;
• a detector for detecting a signal from said test surface;
• a control processor for controlling the rotating, plunger, and vacuum elements according to an assay algorithm;
• and
• a signal processor for relating the generated signal to the presence or amount of said analyte.

A method of determining the presence or amount of an analyte in a sample, the method comprising:

• providing an assay cartridge comprising
• (i) a bottom member comprising an optical reading well and a test surface;
• and
• (ii) a top member comprising a reagent carousel, said reagent carousel comprising a sample receiving port and a plurality of reagent wells, wherein one or more of said reagent wells comprise a reagent and a reagent well piston for delivery of said reagent to the test surface, said top member attached to said bottom member such that the reagent carousel may be rotated relative to the bottom member;
• providing an analytical instrument comprising
• (i) a mechanism for receiving said assay cartridge;
• (ii) a rotation element for rotating and indexing said rotatable carousel;
• (iii) a plunger element for engaging said reagent well pistons to deliver reagent from said reagent wells to said test surface;
• (iv) a vacuum element for directing sample and/or reagent to said test surface;
• (v) a detector for generating a signal from said test surface;
• (vi) a control processor for controlling the rotating, plunger, and vacuum mechanisms according to an assay algorithm;
• and
• (vii) a signal processor for relating the generated signal to the presence or amount of said analyte;
• placing said sample into the sample receiving port of said cartridge;
• placing said assay cartridge into said receiving mechanism;
• performing an assay using said analytical instrument according to said assay algorithm, whereby said signal processor determines the presence or amount of said analyte in said sample.

A method of determining the presence or amount of an analyte in a sample, the method comprising:

• providing an assay cartridge comprising
• a test surface;
• a sample receiving port;
• all reagents necessary for performing an assay;
• a bottom member comprising an optical reading well and said test surface;
• and
• a top member comprising a rotatable reagent carousel, said reagent carousel comprising said sample receiving port and a plurality of reagent wells, wherein one or more of said reagent wells comprise a reagent and a reagent well piston for delivery of said reagent to the test surface;
• and
• providing an analytic instrument comprising
• (i) a mechanism for receiving said assay cartridge;
• (ii) a mechanism for delivering said sample to said test surface;
• (iii) a mechanism for delivering said reagents to said test surface;
• (iv) a detector for generating a signal from said test surface;
• (v) a control processor for controlling said delivery mechanisms according to an assay algorithm;
• and
• (vi) a signal processor for relating the generated signal to the presence or amount of said analyte;
• placing said sample into the sample receiving port of said cartridge;
• placing said assay cartridge into said receiving mechanism;
• and
• performing said assay automatically using said analytical instrument according to said assay algorithm, whereby said signal processor determines the presence or amount of said analyte in said sample.