US 5,656,448 AGranted

Dipstick immunoassay device

AssigneePrinceton Biomeditech Corporation

InventorsJemo Kang, John A. Colanduoni, Dong Joon Lee, Byungwoo Youn, Chiyoung Ok, Walter J. Kang

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Abstract

The invention pertains to dipstick immunoassay devices. The device comprises a base member and a single, combined sample contact zone and test zone, wherein the test zone incorporates the use of symbols to detect analytes in a sample of biological fluid. A first immunological component, an anti-immunoglobulin capable of binding to an enzyme-labeled antibody, is immobilized in a control indicia portion. A second immunological component, capable of specifically binding to a target analyte which is bound to the enzyme-labeled antibody to form a sandwich complex, is immobilized in a test indicia portion. The enzyme-labeled antibody produces a visual color differential between a control indicia portion and a non-indicia portion in the test zone upon contact with a substrate. The device additionally includes a first polyol and a color differential enhancing component selected from the group consisting of an inhibitor to the enzyme and a competitive secondary substrate for the enzyme distributed throughout the non-indicia portion of the test zone.

Claims26

Dependent claims

A dipstick immunoassay device comprising:

a base member;
a single, combined sample contact zone and test zone, defined on said base member, said test zone including a control indicia portion, a test indicia portion and a non-indicia portion;
a first immobilized immunological component being disposed solely in said control indicia portion, said first immunological component being an anti-immunoglobulin which is capable of binding to an enzyme-labeled antibody, said enzyme-labeled antibody producing a visual color differential between said control indicia portion and said non-indicia portion upon contact with a substrate;
a second immobilized immunological component being disposed solely in said test indicia portion, said second immunological component being capable of specifically binding to a target analyte which is bound to said enzyme-labeled antibody to form a sandwich complex, said enzyme-labeled antibody producing a visually discernable difference between said indicia portions and said non-indicia portion, upon contact with a substrate;
a first polyol distributed throughout said non-indicia portion of said test zone;
and
a color differential enhancing component selected from the group consisting of an inhibitor to said enzyme and a competitive secondary substrate for said enzyme, said component distributed throughout said non-indicia portion of said test zone.

4 more elements

A dipstick immunoassay device comprising:

a base member;
a single, combined sample contact zone and test zone, defined on said base member, said test zone including a control indicia portion, a test indicia portion and a non-indicia portion;
a first immobilized antibody being disposed solely in said control indicia portion, said first immobilized antibody being an anti-immunoglobulin antibody which is capable of binding to an alkaline phosphatase-labeled antibody, said alkaline phosphatase-labeled antibody producing a visual color differential between said control indicia portion and said non-indicia portion upon contact with a substrate;
a second immobilized antibody being disposed solely in said test indicia portion, said second antibody being capable of specifically binding to a target analyte which is bound to said alkaline phosphatase-labeled antibody to form a sandwich complex, said alkaline phosphatase-labeled antibody producing a visually discernable difference between said indicia portions and said non-indicia portion, upon contact with a substrate;
a first polyol distributed throughout said non-indicia portion of said test zone;
and
a color differential enhancing component selected from the group consisting of an inhibitor to said alkaline phosphatase and a competitive secondary substrate for said alkaline phosphatase, said component distributed throughout said non-indicia portion of said test zone.

4 more elements

Dependencies are inferred from the claim text.

Facts

Application: 08/182,512Filed 14 Jan 1994 · continuation
Priority: 10 Jan 1990
Granted: 12 Aug 1997
Term ends: Not estimatedThe source records don’t support an estimate.

Classification13 codes

G01N 33/76
Involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and…:…
G01N 33/54366
With an insoluble carrier for immobilising immunochemicals: apparatus specially adapted for solid-phase testing
G01N 33/54386
Apparatus specially adapted for solid-phase testing: analytical elements
Y10S 435/805
Chemistry: molecular biology and microbiology: test papers