Immunoassay incubation device

Claim 2

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying the soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, said incubation chamber defining one or more apertures positively immersible within the liquid medium of said vessel, the apertures having a cross sectional area sufficiently large for passing detectable quantities of the soluble analyte and a cross sectional diameter sufficiently small for blocking passage of unextracted components between said vessel and said incubation chamber, and a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, the apertures of said incubation chamber effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber.

Claim 3

An immunoassay incubation device as described in claim 1 wherein the solid or semisolid sample is fecal material and wherein: the apertures have a cross sectional diameter of approximately one millimeter.

Claim 4

An immunoassay incubation device as described in claim 2 wherein: the binding immunological reagent is an anti-E. histolytica antibody.

Claim 5

An immunoassay incubation device as described in claim 2 wherein: the binding immunological reagent is an anti-chlamydia antibody.

Claim 6

The immunoassay incubation device as described in claim 2 wherein: the binding immunological reagent is an anti-HSV antibody.

Claim 7

An immunoassay incubation device as described in claim 2 wherein: the binding immunological reagent is an anti-human hemoglobin antibody.

Claim 8

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying the soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, said incubation chamber defining one or more apertures positively immersible within the liquid medium of said vessel, the apertures having a cross sectional area sufficiently large for passing detectable quantities of the soluble analyte and a cross sectional diameter sufficiently small for blocking passage of unextracted components between said vessel and said incubation chamber, a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, the apertures of said incubation chamber effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber, and a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said solid phase assay member within said incubation chamber, said cap engageable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel.

Claim 9

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying the soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, said incubation chamber defining one or more apertures positively immersible within the liquid medium of said vessel, the apertures having a cross sectional area sufficiently large for passing detectable quantities of the soluble analyte and a cross sectional diameter sufficiently small for blocking passage of unextracted components between said vessel and said incubation chamber, a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, the apertures of said incubation chamber effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber, and a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said solid phase assay member within said incubation chamber, said cap engageable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel.

Claim 10

An immunoassay incubation device as described in claim 7 wherein: said extraction means includes one or more fixed vanes attached to said vessel and one or more rotatable vanes attached to said incubation chamber for extracting the sample into the liquid medium.

Claim 11

An immunoassay incubation device as described in claim 7 wherein: said extraction means includes one or more fixed grinding members attached to said vessel and one or more rotatable grinding members attached to said incubation chamber for extracting the sample into the liquid medium.

Claim 12

An immunoassay incubation device as described in claim 7 wherein: said extraction means includes one or more fixed serrated surfaces attached to said vessel and one or more rotatable serrated surfaces attached to said incubation chamber for extracting the sample into the liquid medium.

Claim 13

An immunoassay incubation device as described in claim 7 further comprising: a scoop for securing a plug of the solid or semisolid sample, said scoop joined to said incubation chamber for introducing the plug of solid or semisolid sample to said vessel.

Claim 14

An immunoassay incubation device as described in claim 11 wherein: said scoop is engagable with said extraction means for supplying the plug of solid or semisolid sample to said extraction means and for axially centering said incubation chamber within said vessel.

Claim 15

An immunoassay incubation device as described in claim 7 further comprising: a means for defining a well within the incubation chamber below the apertures for retaining a deposit of dried labelled immunological reagents.

Claim 16

An immunoassay incubation device as described in claim 7 wherein: said solid phase assay member is incorporated onto a dip stick, the dip stick being attached to said cap and being inserted within the incubation chamber with said cap attached to said vessel when assaying the soluble analyte.

Claim 17

An immunoassay incubation device as described in claim 7 for assaying two or more sample soluble analytes wherein: said solid phase assay member including two or more separate subsections, each subsection differing from the remaining subsections with respect to its specificity for assaying the sample soluble analytes.

Claim 18

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying the soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, said incubation chamber defining one or more apertures positively immersible within the liquid medium of said vessel, the apertures having a cross sectional area sufficiently large for passing detectable quantities of the soluble analyte and a cross sectional diameter sufficiently small or blocking passage of unextracted components between said vessel and said incubation chamber, a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, the apertures of said incubation chamber effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber, a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said solid phase assay member within said incubation chamber, said cap engagable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel, said solid phase assay member incorporated onto an elongated dip stick, the elongated dip stick attached to said cap and insertable into the incubation chamber while said cap seals off said vessel, and a means for defining a well within the incubation chamber below the apertures for retaining a deposit of dried labelled immunological reagents.

Claim 19

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying the soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, said incubation chamber defining one or more apertures positively immersible within the liquid medium of said vessel, the apertures having a cross sectional area sufficiently large for passing detectable quantities of the soluble analyte and a cross sectional diameter sufficiently small or blocking passage of unextracted components between said vessel and said incubation chamber, a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, the apertures of said incubation chamber effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber, a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said solid phase assay member within said incubation chamber, said cap engagable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel, said solid phase assay member incorporated onto an elongated dip stick, the elongated dip stick attached to said cap and insertable into the incubation chamber while said cap seals off said vessel, and a means for defining a well within the incubation chamber below the apertures for retaining a deposit of dried labelled immunological reagents.

Claim 20

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying a soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, a valve incorporated into said incubation chamber immersible with said incubation chamber within the liquid medium for controlling the passage of the liquid medium and the soluble analyte and for blocking the passage of unextracted components between said vessel and said incubation chamber, and a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, said valve effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber.

Claim 21

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying a soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, a valve incorporated into said incubation chamber immersible with said incubation chamber within the liquid medium for controlling the passage of the liquid medium and the soluble analyte and for blocking the passage of unextracted components between said vessel and said incubation chamber, and a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, said valve effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said incubation chamber.

Claim 22

An immunoassay incubation device as described in claim 17 wherein: said valve including a radial protuberance protruding outward from said incubation chamber, the radial protuberance defining a valve hole communicating between said incubation chamber and said vessel, the valve hole occludable by contact with said vessel, said vessel including a depression which, when aligned with the valve hole, opens the valve hole for allowing the passage of liquid medium and soluble analyte from said vessel to said incubation chamber while blocking the passage of unextracted components.

Claim 23

An immunoassay incubation device as described in claim 17 further comprising: a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said assay member within said incubation chamber, said cap engagable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel, said cap engagable to said valve for opening and closing said valve by means of rotational motion.

Claim 24

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying a soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, a valve incorporated into said incubation chamber immersible with said incubation chamber within the liquid medium for controlling the passage of the liquid medium and the soluble analyte and for blocking the passage of unextracted components between said vessel and said incubation chamber, a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said assay member within said incubation chamber, said cap engagable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel, said cap engagable to said valve for opening and closing said valve by means of rotational motion, a first stop for limiting the rotational motion of the cap for maintaining said valve in a closed position while actuating said extraction means, and a second stop beyond said first stop for maintaining said valve in an open position.

Claim 25

An immunoassay incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying a soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means removably contained within said vessel, an incubation chamber removably contained within said vessel, a valve incorporated into said incubation chamber immersible with said incubation chamber within the liquid medium for controlling the passage of the liquid medium and the soluble analyte and for blocking the passage of unextracted components between said vessel and said incubation chamber, a solid phase assay member coated with a binding immunological reagent inserted within said incubation chamber when assaying the soluble analyte therein, a cap for sealing off said vessel, said cap connected to and serving as a handle for said solid phase assay member for positioning said assay member within said incubation chamber, said cap engagable to said extraction means while sealing off said vessel for actuating said extraction means by means of rotational motion for extracting the soluble analyte from the solid or semisolid sample within said vessel, said cap engagable to said valve for opening and closing said valve by means of rotational motion, a first stop for limiting the rotational motion of the cap for maintaining said valve in a closed position while actuating said extraction means, and a second stop beyond said first stop for maintaining said valve in an open position.

Claim 26

An immunological incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying a soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means containable within said vessel, a first incubation chamber removably contained within said vessel, a second incubation chamber removably contained within said vessel, labelled immunological reagents contained within said second incubation chamber, a means for sealing off said labelled immunological reagents within second chamber for preventing the entry of the liquid medium into said second chamber, a valve incorporated into said first incubation chamber immersible with said incubation chamber within the liquid medium for controlling the passage of the liquid medium and the soluble analyte and for blocking the passage of unextracted components between said vessel and said first incubation chamber, and a solid phase assay member coated with a binding immunological reagent inserted within said first incubation chamber when assaying the soluble analyte therein, said valve effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said first incubation chamber, said solid phase assay member capable of breaking said sealing means and being inserted into said second incubation chamber for contacting said labelled immunological reagents for developing said solid phase assay member and detecting the soluble analyte attached thereto.

Claim 27

An immunological incubation device for extracting a soluble analyte from a solid or semisolid sample into a liquid medium, for separating the soluble analyte from unextracted components of the solid or semisolid sample, and for assaying a soluble analyte, the device comprising: a vessel for receiving and containing the solid or semisolid sample and the liquid medium, a means for extracting the soluble analyte from the solid or semisolid sample into the liquid medium, said extraction means containable within said vessel, a first incubation chamber removably contained within said vessel, a second incubation chamber removably contained within said vessel, labelled immunological reagents contained within said second incubation chamber, a means for sealing off said labelled immunological reagents within second chamber for preventing the entry of the liquid medium into said second chamber, a valve incorporated into said first incubation chamber immersible with said incubation chamber within the liquid medium for controlling the passage of the liquid medium and the soluble analyte and for blocking the passage of unextracted components between said vessel and said first incubation chamber, and a solid phase assay member coated with a binding immunological reagent inserted within said first incubation chamber when assaying the soluble analyte therein, said valve effectively screening said solid phase assay member from contact with unextracted components from said vessel when said solid phase assay member is inserted into said first incubation chamber, said solid phase assay member capable of breaking said sealing means and being inserted into said second incubation chamber for contacting said labelled immunological reagents for developing said solid phase assay member and detecting the soluble analyte attached thereto.

Claim 30

A method for detecting a soluble analyte as described in claim 22 wherein: in Step (c) the extraction of the soluble analyte from the solid or semisolid sample is actuated by rotating a cap which also seals off the immunoassay incubation device.

Claim 31

A method for detecting a soluble analyte as described in claim 22 wherein: in Step (d) the passage of liquid medium and soluble analyte into the incubation chamber is controlled by means of a valve.

Claim 32

A method for detecting a soluble analyte as described in claim 22 wherein: in Step (g) the measurement of the soluble analyte bound to the solid phase assay member is accomplished by inserting the solid phase assay member into a second incubation chamber housed within the immunoassay incubation device, the second incubation chamber including a labelled immunological reagent and a means for sealing the labelled immunological reagent within the second chamber.