Method and apparatus for performing in vitro clinical diagnostic tests using a solid phase assay system
First Claim
1. A process for determining the amount of mobile component contained in a fluid sample which reacts with a fixed component immobilized on a solid phase insert matrix to produce a measurable change which is a function of the amount of the mobile component comprising the steps of:
- (a) providing a fluid receptacle containing a fluid sample having an unknown amount of the mobile component which is to be measured,(b) providing a removable impermeable unitary insert matrix comprising a handle member having attached at one end a plurality of elements having essentially smooth plane or curved surfaces so arranged with respect to one another and the handle member and of a size and shape such that when said matrix is inserted into said fluid receptacle, said matrix extends substantially throughout the depth of said fluid sample and the average diffusion distance of molecules of said mobile component to the surfaces of said elements is greatly reduced relative to the average diffusion distance of molecules of said mobile component to the fluid receptacle when no matrix is present therein, and having the fixed component immobilized on the surfaces of said elements, capable of reacting with said mobile component at a rate or to an extent measurable as a function of the concentration of said mobile component,(c) placing the insert in the fluid receptacle to cause contact between the fixed component of the insert matrix with the mobile component of unknown amount contained in the fluid sample for a given time interval to permit a reaction to occur, and(d) measuring the change which is a function of the concentration of the mobile component to determine the amount of the mobile component.
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Abstract
A method and apparatus for conducting chemical reactions at a liquid-solid interface wherein a reaction component is fixed on the surface of a solid phase immersed in a liquid phase containing a freely diffusing, mobile reaction component. The apparatus comprises a substantially smooth-surfaced matrix of appropriate geometrical configuration designed to provide a large surface to volume ratio, a short transfer distance from the mobile component to the fixed component distributed on the solid phase surface and to drain freely upon removal from the reaction liquid.
75 Citations
40 Claims
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1. A process for determining the amount of mobile component contained in a fluid sample which reacts with a fixed component immobilized on a solid phase insert matrix to produce a measurable change which is a function of the amount of the mobile component comprising the steps of:
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(a) providing a fluid receptacle containing a fluid sample having an unknown amount of the mobile component which is to be measured, (b) providing a removable impermeable unitary insert matrix comprising a handle member having attached at one end a plurality of elements having essentially smooth plane or curved surfaces so arranged with respect to one another and the handle member and of a size and shape such that when said matrix is inserted into said fluid receptacle, said matrix extends substantially throughout the depth of said fluid sample and the average diffusion distance of molecules of said mobile component to the surfaces of said elements is greatly reduced relative to the average diffusion distance of molecules of said mobile component to the fluid receptacle when no matrix is present therein, and having the fixed component immobilized on the surfaces of said elements, capable of reacting with said mobile component at a rate or to an extent measurable as a function of the concentration of said mobile component, (c) placing the insert in the fluid receptacle to cause contact between the fixed component of the insert matrix with the mobile component of unknown amount contained in the fluid sample for a given time interval to permit a reaction to occur, and (d) measuring the change which is a function of the concentration of the mobile component to determine the amount of the mobile component. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for producing a measurable reaction in a fluid sample in a reaction vessel comprising:
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providing a fixed component immobilized on a solid phase matrix, said matrix comprising a handle member having attached at one end a plurality of elements having essentially smooth plane or curved surfaces so arranged with respect to one another and the handle member and of a size and shape such that when said matrix is inserted into said reaction vessel said matrix extends substantially throughout the depth of said fluid sample and the average diffusion distance of molecules in said fluid sample to the surfaces of said elements is greatly reduced relative to the average diffusion distance of said molecules in said fluid sample to the reaction vessel when no matrix is present therein, said fixed component being immobilized on the surfaces of said elements, providing a mobile component capable of reacting measurably with the fixed component, and placing the fixed component in reactive proximity with the mobile component, thereby producing a measurable reaction. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23)
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- 24. A solid phase matrix for insertion into a reaction vessel containing a fluid sample comprising molecules of a mobile component to be measured or detected, which matrix comprises, (1) a handle member having attached at one end a plurality of elements having essentially smooth plane or curved surfaces so arranged with respect to one another and the handle member and of a size and shape such that when said matrix is inserted into said reaction vessel said matrix extends substantially throughout the depth of said fluid sample and the average diffusion distance of said molecules of a mobile component to the surfaces of said elements is greatly reduced relative to the average diffusion distance of said molecules of a mobile component to the reaction vessel when no matrix is present therein, and (2) a fixed component immobilized on the surfaces of said elements, capable of reacting with said mobile component at a rate or to an extent measurable as a function of the concentration of said molecules of a mobile component.
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35. A solid phase matrix for insertion into a reaction vessel containing a fluid sample to be assayed for the presence of a given mobile component, which matrix comprises (1) a handle member having affixed thereto at one end a plurality of elements having essentially smooth plane or curved surfaces so arranged with respect to one another and the handle member, and of a size and shape such that the average diffusion distance between mobile component molecules and solid surface is greatly reduced relative to the average diffusion distance between mobile component molecules and the walls of the reaction vessel when no solid matrix is present;
- (2) wherein each of said elements is substantially uniformly coated with a composition comprising a fixed component to which the mobile component being assayed for, if present, will adhere, the amount of said fixed component being so selected that adherence of the mobile component will occur at a rate measurable as a function of total concentration of mobile component in the fluid sample; and
(3) wherein the number, placement, size and shape of said elements is correlated with the amount of fixed component and the other physical and chemical characteristics of the coating composition to insure maximum availability of active fixed component at the surfaces of the elements. - View Dependent Claims (36, 37, 38, 39, 40)
- (2) wherein each of said elements is substantially uniformly coated with a composition comprising a fixed component to which the mobile component being assayed for, if present, will adhere, the amount of said fixed component being so selected that adherence of the mobile component will occur at a rate measurable as a function of total concentration of mobile component in the fluid sample; and
Specification