US 5,149,622 A · Solid phase analytical device and method for using same

Abstract

A novel material and device useful in solid-phase binding assays to determine the presence or amount of an analyte in a test sample, particularly antigens or antibodies, is disclosed. The material comprises a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of from about 0.1 to about 5 microns. The particles are retained and immobilized upon the fibers of the matrix. Preferably, the particles have on their surfaces a substance capable of reaction with the analyte in the sample, and the average diameter of the particles is less than the average pore size of the matrix. The device, in a preferred embodiment, comprises a substantially planar layer of the described material.

Claims18

Dependent claims

A method for determining the presence or amount of an analyte in a fluid, comprising the steps of:

a) incubating a sample of the fluid with 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 which specifically binds the analyte, whereby the analyte becomes bound to the substance to form an analyte/binding substance complex on the particles;
b) contacting a porous, fibrous matrix with the incubated particles, wherein the average diameter of said particles is less than the particle retention rating of said matrix and whereby at least a portion of the incubated particles become retained and immobilized within the matrix upon at least a portion of the fibers thereof;
c) contacting said fibrous matrix containing the complex of the particles with a with a labeled substance capable of specifically binding the analyte, said labeled 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;
d) washing unbound labeled substance from said fibrous matrix;
e) contacting said fibrous matrix with the indicator substance;
and
f) detecting the response produced as a function of the presence or amount of analyte in the sample.

4 more elements

A solid-phase assay device useful in a binding assay to determine the presence or an amount of an analyte in a fluid sample comprising

a) a rigid carrier means for holding a porous matrix of fibers,
b) a porous matrix of fibers arranged in a substantially planar layer having a first sample-contacting surface and a second surface opposed to said first surface, said matrix being disposed in said carrier means such that, when the device is used in the performance of an assay, at least a portion of the sample contacting the first surface passes through said substantially planar layer to the second surface, and
c) substantially spherical, solid particles retained and immobilized on the fibers of said porous matrix, said particles having a substance adsorbed or bound to their surfaces which specifically binds analyte, said coated particles having an average diameter between about 0.1 and about 5 microns and wherein the average diameter of said particles is less than the particle retention rating of said porous matrix.

Dependencies are inferred from the claim text.

Solid phase analytical device and method for using same

Life of this patent

Solid phase analytical device and method for using same

Life of this patent

Abstract

Claims18