EP0217403A2 — Solid-phase analytical device and method for usin…

Claim 1

Independent Claim 58 words

A material useful in a binding assay to determine the presence or amount of an analyte in a test sample, which material comprises a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of from 0.1 to 10 microns, and particles being retained and immobilized within said matrix upon the fibers.

Claim 2

Dependent Claim 58 words

A material useful in a binding assay to determine the presence or amount of an analyte in a test sample, which material comprises a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of from 0.1 to 10 microns, and particles being retained and immobilized within said matrix upon the fibers.

Claim 3

Dependent Claim 23 words

The material of Claim 1, wherein said particles have on their surfaces a substance capable of reacting with the analyte in the sample.

Claim 4

Dependent Claim 22 words

The material of Claim 1, wherein the average diameter of the particles is less than the average pore size of the matrix.

Claim 5

Dependent Claim 127 words

a solid-phase assay device useful in a binding assay to determine the presence or amount of an analyte in a fluid sample, the device comprises a substantially planar layer of a material having a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of from 0.1 to 10 microns, the particles being retained and immobilized within said matrix uponm the fibers, the substantially planar layer having a first, sample-contacting surface and a second surface opposed to the first surface, and being disposed in the device such that, when the device is in use in the performance of the assay, at least a protion of the sample contacting the first surface passes through the substantially planar layer to the second surface.

Claim 6

Dependent Claim 127 words

a solid-phase assay device useful in a binding assay to determine the presence or amount of an analyte in a fluid sample, the device comprises a substantially planar layer of a material having a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of from 0.1 to 10 microns, the particles being retained and immobilized within said matrix uponm the fibers, the substantially planar layer having a first, sample-contacting surface and a second surface opposed to the first surface, and being disposed in the device such that, when the device is in use in the performance of the assay, at least a protion of the sample contacting the first surface passes through the substantially planar layer to the second surface.

Claim 7

Dependent Claim 40 words

The assay device of Claim 4, wherein the device additionally comprises filtering means disposed in relationship to the first surface of the substantially planar layer, such that sample fluid passes through said filtering means prior to contacting the first surface.

Claim 8

Dependent Claim 46 words

The assay device of Claim 4, wherein the device additionally comprises absorbent means disposed in relationship to the lower surface of the substantially planar layer, such that at least a portion of the fluid passing through the substantially planar layer is absorbed by the absorbent means.

Claim 9

Dependent Claim 44 words

The assay device of Claim 6, wherein the device additionally comprises a barrier layer interposed between the substantially planar layer and the absorbent means, the barrier layer being adapted, to restrict fluid retained by the absorbent means from returning to the substantially planar layer.

Claim 10

Dependent Claim 17 words

The assay device of Claim 7, wherein the barrier layer is composed of a polyethylene weave material.

Claim 11

Dependent Claim 167 words

A binding assay to determine the presence or amount of an analyte in a test sample, comprising the steps of: a) contacting a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of form 0.1 to 10 microns, the particles being retained and immobilized within said matrix upon the fibers with the sample, whereby analyte in the sample becomes bound to the particles forming an analyte complex on the particles; b) contacting the material containing the complex on the particles with a second substance capable of reaction with the analyte, which is labeled with a substance capable of producing a detectable response in the presence of the analyte and an indicator substance, whereby the labeled substance becomes bound to the complex on the particles; c) removing unbound labeled substance from the material; d) contacting the material with the indicator substance; and e) detecting the response produced as a function of the presence or amount of the analyte in the sample.

Claim 12

Dependent Claim 167 words

A binding assay to determine the presence or amount of an analyte in a test sample, comprising the steps of: a) contacting a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of form 0.1 to 10 microns, the particles being retained and immobilized within said matrix upon the fibers with the sample, whereby analyte in the sample becomes bound to the particles forming an analyte complex on the particles; b) contacting the material containing the complex on the particles with a second substance capable of reaction with the analyte, which is labeled with a substance capable of producing a detectable response in the presence of the analyte and an indicator substance, whereby the labeled substance becomes bound to the complex on the particles; c) removing unbound labeled substance from the material; d) contacting the material with the indicator substance; and e) detecting the response produced as a function of the presence or amount of the analyte in the sample.

Claim 13

Dependent Claim 42 words

The assay of Claim 9, wherein the detectable response is a visually detectable "+" sign when detectable amounts of analyte are present in the sample, and a visually detectable "-" sign when detectable amounts of analyte are not present in the sample.

Claim 14

Dependent Claim 14 words

The assay of Claim 7, wherein the analyte is beta-hCG, Strep-A antigen, or HBsAg.

Claim 15

Dependent Claim 23 words

The assay of Claim 9 wherein the particles have on their surface a substance capable of reacting with the analyte in the sample.

Claim 16

Independent Claim 117 words

A method for producing a material useful for determining the presence or amount of an analyte in a fluid, comprising the steps of: a) incubating with a sample of the fluid a plurality of substantially spherical, solid particles having an average diameter of from about 0.1 to about 5 microns, the particles having immobilized upon their surfaces a binding substance capable of reacting with the analyte, whereby the analyte becomes bound to the substance to form an analyte/binding substance complex on the particles; and b) contacting a porous, fibrous matrix with the incubated particles, whereby at least a portion of the particles become retained and immobilized within the matrix upon at least a portion of the fibers.

Claim 17

Independent Claim 117 words

A method for producing a material useful for determining the presence or amount of an analyte in a fluid, comprising the steps of: a) incubating with a sample of the fluid a plurality of substantially spherical, solid particles having an average diameter of from about 0.1 to about 5 microns, the particles having immobilized upon their surfaces a binding substance capable of reacting with the analyte, whereby the analyte becomes bound to the substance to form an analyte/binding substance complex on the particles; and b) contacting a porous, fibrous matrix with the incubated particles, whereby at least a portion of the particles become retained and immobilized within the matrix upon at least a portion of the fibers.

Claim 18

Dependent Claim 107 words

A solid-phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample, comprising a reaction surface having a negative control area, a positive control area and an analyte binding area configured so that the positive control area interacts with the analyte binding area to form a first representational symbol having a first meaning upon the occurrence of a positive test result in the use of the device and to form a second representational symbol different from that of the first representational symbol upon the occurrence of a negative test result in the use of the device.

Claim 19

Dependent Claim 107 words

A solid-phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample, comprising a reaction surface having a negative control area, a positive control area and an analyte binding area configured so that the positive control area interacts with the analyte binding area to form a first representational symbol having a first meaning upon the occurrence of a positive test result in the use of the device and to form a second representational symbol different from that of the first representational symbol upon the occurrence of a negative test result in the use of the device.

Claim 20

Dependent Claim 26 words

The solid phase assay device of Claim 14 wherein the positive control are is formed on the reaction surface in the shape of a rectangular bar.

Claim 21

Dependent Claim 78 words

The solid phase assay device of Claim 15 wherein the analyte binding area is formed on the reaction surface in the shape of two rectangular bars on opposite sides of and oriented perpendicularly to the positive control area, whereby the analyte binding area taken together with the positive control area form the shape of a "+" sign and where the positive control area acts alone to form a "-" symbol upon the occurrence of a negative test result.

Claim 22

Dependent Claim 25 words

The solid phase assay device of Claim 14 wherein the positive control area and the analyte binding area are formed in the shape of dots.

Claim 23

Dependent Claim 23 words

The solid phase assay device of Claim 14 wherein the negative control area surrounds the positive control area and the analyte binding area.

Claim 24

Dependent Claim 66 words

The solid-phase assay device of Claim 14 having a fluid chamber for receiving a fluid sample and reagents used in the performance of the assay, the fluid chamber being defined by at least one sidewall and a base wall, the base wall comprising the reaction surface so as to be simultaneously contacted by a single volume of the fluid sample and reagents used in the assay.

Solid-phase analytical device and method for using same

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