US4859612A — Metal sol capture immunoassay procedure, kit for …

Claim 1

Independent Claim 196 words

In a process for the determination and detection of an immunologically reactive analyte in an aqueous sample, the steps of: (a) providing a labelled component comprising the coupling product of a first immunologically reactive substance and a metal-containing particle of a size and character to facilitate the maintenance of a stable, monodispersed suspension of the labelled component; (b) providing a solid phase component comprising the coupling product of a second immunologically reactive substance and a solid phase particle of a size and character to facilitate the maintenance of a stable suspension of the solid phase component and subsequent collection of a composite formed therefrom; (c) forming a mixed aqueous suspension of said components and which contains a sample to be analyzed for the analyte, said first and second substances being different and capable of binding directly or indirectly as a function of the presence of said analyte to thereby form a collectible, solid phase, metal-containing composite; (d) allowing the substances to bind to form said composite; (e) collecting the composite; and (f) determining or detecting the analyte in the sample by evaluating, through direct visual examination, the presence of metal in the collected solid phase composite.

Claim 2

Dependent Claim 196 words

In a process for the determination and detection of an immunologically reactive analyte in an aqueous sample, the steps of: (a) providing a labelled component comprising the coupling product of a first immunologically reactive substance and a metal-containing particle of a size and character to facilitate the maintenance of a stable, monodispersed suspension of the labelled component; (b) providing a solid phase component comprising the coupling product of a second immunologically reactive substance and a solid phase particle of a size and character to facilitate the maintenance of a stable suspension of the solid phase component and subsequent collection of a composite formed therefrom; (c) forming a mixed aqueous suspension of said components and which contains a sample to be analyzed for the analyte, said first and second substances being different and capable of binding directly or indirectly as a function of the presence of said analyte to thereby form a collectible, solid phase, metal-containing composite; (d) allowing the substances to bind to form said composite; (e) collecting the composite; and (f) determining or detecting the analyte in the sample by evaluating, through direct visual examination, the presence of metal in the collected solid phase composite.

Claim 3

Dependent Claim 22 words

The process of claim 1, wherein said analyte is a biologically active substance selected from the group consisting of ligands and anti-ligands.

Claim 4

Dependent Claim 13 words

The process of claim 1, wherein said metal-containing particles are metal sol particles.

Claim 5

Dependent Claim 26 words

The process of claim 3, wherein said metal sol particles have a particle size in the range of from about 50 Angstroms to about 1000 Angstroms.

Claim 6

Dependent Claim 25 words

The process of claim 4, wherein said metal sol particles have a particle size in the range of from about 135 to about 500 Angstroms.

Claim 7

Dependent Claim 12 words

The process of claim 3, wherein said particles are gold sol particles.

Claim 8

Dependent Claim 12 words

The process of claim 4, wherein said particles are gold sol particles.

Claim 9

Dependent Claim 12 words

The process of claim 5, wherein said particles are gold sol particles.

Claim 10

Dependent Claim 21 words

The process of claim 1, wherein said labelled component is prepared by coupling the first substance directly to the metal-containing particle.

Claim 11

Dependent Claim 24 words

The process of claim 1, wherein ,said labelled component is prepared by coupling the first substance to the particle using a biotin avidin linkage.

Claim 12

Dependent Claim 40 words

The process of claim 10, wherein said labelled component is prepared by biotinylating the first substance, coating the metal containing particle with an avidin compound and reacting the biotin on the first substance with the avidin compound on the particle.

Claim 13

Dependent Claim 23 words

The process of claim 1, wherein said labelled component is prepared by coupling the first substance to the particle using bovine serum albumin.

Claim 14

Dependent Claim 23 words

The process of claim 1, wherein said solid phase component is prepared by coupling the second substance directly to the solid phase particle.

Claim 15

Dependent Claim 26 words

The process of claim 1, wherein said solid phase component is prepared by coupling the second substance to the particle using a bovine serum albumin linkage.

Claim 16

Dependent Claim 22 words

The process of claim 1, wherein said solid phase component is prepared by coupling the second substance to the particle using gelatin.

Claim 17

Dependent Claim 37 words

The process of claim 11, wherein the labelled component is formed by adding the avidin coated metal-containing particle to the aqueous suspension after all of the other ingredients of the mixed aqueous suspension have been mixed together.

Claim 18

Dependent Claim 27 words

The process of claim 1, wherein said first and second substances are each capable of binding a respective different site of the analyte to form a sandwich.

Claim 19

Dependent Claim 20 words

The process of claim 17, wherein said first and second substances are each antibodies and the analyte is an antigen.

Claim 20

Dependent Claim 14 words

The process of claim 1, wherein said first and second substances bind each other.

Claim 21

Dependent Claim 19 words

The process of claim 19, wherein one of said substances in an antibody and the other is an antigen.

Claim 22

Dependent Claim 16 words

The process of claim 19, wherein the first substance of the labelled component is an antibody.

Claim 23

Dependent Claim 35 words

A process as set forth in claim 1, wherein said collecting comprises capturing the composite on the surface of a porous filtration element which permits passage of the filtrate but prevents passage of the composite.

Claim 24

Dependent Claim 30 words

A process as set forth in claim 1, wherein said collecting comprises causing the composite to gravitate into a limited volumetric space by sedimentation to thereby form a concentrated pellet.

Claim 25

Dependent Claim 35 words

A process as set forth in claim 1, wherein said collecting comprises subjecting the aqueous suspension to centrifugation to force the composite into a limited volumetric space to thereby form therefrom a densely packed pellet.

Claim 26

Dependent Claim 16 words

The process of claim 22, wherein the filtrate is pulled through the element by centrifugal force.

Claim 27

Dependent Claim 16 words

The process of claim 22, wherein the filtrate is pulled through the element by capillary force.

Claim 28

Dependent Claim 208 words

A kit of materials for use in determining and detecting an immunologically reactive analyte in an aqueous sample comprising: a labelled component comprising the coupling product of a first immunologically reactive substance and a metal-containing particle of a size and character to facilitate the maintenance of a stable, monodisperse suspension of the labelled component; a solid phase component comprising the coupling product of a second immunologically reactive substance and a solid phase particle of a size and character to facilitate the maintenance of a stable suspension of the solid phase component and subsequent collection of a composite formed therefrom, said components being operable and cooperable to permit formation therefrom of a mixed aqueous suspension of said components and which contains a sample to be analyzed for the analyte, the first substance of said labelled component and the second substance of said solid phase component being different and capable of binding directly or indirectly as a function of the presence of said analyte to thereby form a dispersed, collectible, solid phase, metal-containing composite; and collector means for collecting and directly visually examining the composite to evaluate the presence of metal bound in the collected solid phase composite and thereby detect or determine the presence of analyte in the sample.

Claim 29

Dependent Claim 208 words

A kit of materials for use in determining and detecting an immunologically reactive analyte in an aqueous sample comprising: a labelled component comprising the coupling product of a first immunologically reactive substance and a metal-containing particle of a size and character to facilitate the maintenance of a stable, monodisperse suspension of the labelled component; a solid phase component comprising the coupling product of a second immunologically reactive substance and a solid phase particle of a size and character to facilitate the maintenance of a stable suspension of the solid phase component and subsequent collection of a composite formed therefrom, said components being operable and cooperable to permit formation therefrom of a mixed aqueous suspension of said components and which contains a sample to be analyzed for the analyte, the first substance of said labelled component and the second substance of said solid phase component being different and capable of binding directly or indirectly as a function of the presence of said analyte to thereby form a dispersed, collectible, solid phase, metal-containing composite; and collector means for collecting and directly visually examining the composite to evaluate the presence of metal bound in the collected solid phase composite and thereby detect or determine the presence of analyte in the sample.

Claim 30

Dependent Claim 30 words

A kit as set forth in claim 27, wherein said first and second substances are each capable of binding a respective different site of the analyte to form a sandwich.

Claim 31

Dependent Claim 23 words

A kit as set forth in claim 28, wherein said first and second substances are each antibodies and the analyte is an antigen.

Claim 32

Dependent Claim 17 words

A kit as set forth in claim 27, wherein said first and second substances bind each other.

Claim 33

Dependent Claim 16 words

A kit as set forth in claim 27, wherein said metal-containing particles are metal sol particles.

Claim 34

Dependent Claim 28 words

A kit as set forth in claim 31, wherein said metal sol particles have a particle size in the range of from about 50 to about 1000 Angstroms.

Claim 35

Dependent Claim 28 words

A kit as set forth in claim 32, wherein said metal sol particles have a particle size in the range of from about 135 to about 500 Angstroms.

Claim 36

Dependent Claim 15 words

A kit as set forth in claim 31, wherein said particles are gold sol particles.

Claim 37

Dependent Claim 15 words

A kit as set forth in claim 32, wherein said particles are gold sol particles.

Claim 38

Dependent Claim 15 words

A kit as set forth in claim 33, wherein said particles are gold sol particles.

Claim 39

Dependent Claim 131 words

A stable, collected mass of a solid phase metal-containing composite capable of being directly visually observed to indicate the initial presence, absence or amount of an analyte in an aqueous sample, said composite comprising: a labelled component comprising the coupling product of a first immunologically reactive substance and a metal-containing particle of a size and character to initially facilitate the maintenance of a stable, monodispersed suspension of the labelled component; and a solid phase component comprising the coupling product of a second immunologically reactive substance and a solid phase particle of a size and character to initially facilitate the maintenance of a stable suspension of the solid phase component and subsequent collection of said composite, said substances being different and directly or indirectly bound to each other to present said composite.

Claim 40

Dependent Claim 131 words

A stable, collected mass of a solid phase metal-containing composite capable of being directly visually observed to indicate the initial presence, absence or amount of an analyte in an aqueous sample, said composite comprising: a labelled component comprising the coupling product of a first immunologically reactive substance and a metal-containing particle of a size and character to initially facilitate the maintenance of a stable, monodispersed suspension of the labelled component; and a solid phase component comprising the coupling product of a second immunologically reactive substance and a solid phase particle of a size and character to initially facilitate the maintenance of a stable suspension of the solid phase component and subsequent collection of said composite, said substances being different and directly or indirectly bound to each other to present said composite.

Claim 41

Dependent Claim 32 words

The collected mass of claim 37, wherein said composite includes the analyte and said first and second substances are each bound to a respective different site of the analyte in sandwich form.

Claim 42

Dependent Claim 14 words

The composite of claim 38, wherein said mass is collected on porous filter element.

Claim 43

Dependent Claim 17 words

The composite of claim 38, wherein said mass is collected at the bottom of a test tube.

Claim 44

Dependent Claim 18 words

The collected mass of claim 37, wherein said first and second substances are bound directly to each other.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1992-08-21	1993-02-20	1993-08-22	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1996-08-21	1997-02-20	1997-08-22	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2000-08-21	2001-02-20	2001-08-22	$7700.00	Window Closed / Lapsed

Metal sol capture immunoassay procedure, kit for use therewith and captured metal containing composite

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