Immunoassay elements having stable leuco dye coatings
AssigneeJohnson & Johnson Clinical Diagnostics, Inc.
InventorsJohn F. Bishop, Linda A. Mauck
Life of this patent
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Abstract
An immunoassay element comprising at least one layer containing a leuco dye coating composition comprising: ______________________________________ Dry Weight Component Ratio (Range) ______________________________________ a) Triarylimidazole leuco dye 55-80 b) Antioxidant 7-40 c) Poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) Alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________
Claims7
A dry immunoassay analytical element for determining a ligand comprising:
- (i) a receptor capable of specifically binding a member selected from the group consisting of the ligand, a ligand analog and a specific binder which specifically binds to the ligand and the ligand analog;
- and
- (ii) at least one layer comprising a leuco dye composition comprising:
- ______________________________________ Dry Weight Component Ratio w/v % ______________________________________ a) triarylimidazole leuco dye 55-80 b) antioxidant 7-40 c) poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________
A dry immunoassay analytical element for determining a ligand comprising, in the following order:
- (A) a layer containing a labeled immunoreagent comprising a label conjugated to the ligand or a ligand analog thereof;
- (B) a spreading layer comprising a bead matrix;
- (C) a receptor layer comprising
- (i) a fixed concentration of a receptor capable of specifically binding the labeled immunoreagent, wherein the receptor is covalently bonded to polymeric beads that are smaller than the beads in layer (B), and
- (ii) a leuco dye composition comprising
- ______________________________________ Dry Weight Component Ratio w/v % ______________________________________ a) triarylimidazole leuco dye 55-80 b) antioxidant 7-40 c) poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________
- (D) a cross-linked hydrophilic polymer layer;
- and,
- (E) a support;
- wherein the label is capable of reacting directly or indirectly with the leuco dye composition to generate a detectable dye.
A dry immunoassay analytical element for determining a ligand comprising, in the following order:
- (A) a layer containing a labeled immunoreagent comprising a label conjugated to the ligand or a ligand analog thereof;
- (B) a spreading layer comprising a bead matrix;
- (C) a cross-linked polymer layer;
- and
- (D) a support;
- wherein the spreading layer (B) comprises:
- (i) beads having a size in the range of 20-35 .mu.m;
- (ii) a fixed concentration of a receptor capable of specifically binding the labeled immunoreagent, wherein the receptor is covalently bonded to polymeric beads that are
- (a) smaller than the beads comprising the matrix of layer (B)(i) and
- (b) are immobilized within the bead matrix of layer (B);
- and,
- (iii) a leuco dye composition comprising:
- ______________________________________ Dry Weight Component Ratio w/v % ______________________________________ a) triarylimidazole leuco dye 55-80 b) antioxidant 7-40 c) poly[poly(ethylene oxide)-block- 6-20 poly(propylene oxide)] nonionic block copolymer d) alkylaryloxypoly(alkylene oxide) 1-16 nonionic surfactant ______________________________________
- wherein the label is capable of reacting directly or indirectly with the leuco dye composition to generate a detectable dye.
The element of any one of claims 1, 2 or 10 wherein the leuco dye is 4,5-bis(4-dimethylaminophenyl)-2-(3,5-dimethyloxy-4-hydroxyphenyl) imidazole.
Dependencies are inferred from the claim text.