Composition for use as an assay reagent

• US 8,546,148 B2
• Filed: 04/09/2012
• Issued: 10/01/2013
• Est. Priority Date: 06/14/2010
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Lele, Bhalchandra, Singh, Pratap, Bartz, Raphael, Kellogg, Jason A.
• Primary Examiner(s): Haq, Shafiqul
• Assistant Examiner(s): YAKOVLEVA, GALINA M
• Application Number:
  US13/442,503
• Publication Number:
  US 20120208297A1
• Time in Patent Office: 540 Days
• Field of Search: None
• US Class Current: 436/501
• CPC Class Codes: C08F 120/60 containing nitrogen in addition to the carbonamido nitrogen
• CPC Class Codes: C08F 126/10 N-Vinyl-pyrrolidone
• CPC Class Codes: C08F 220/06 Acrylic acid; Methacrylic acid; Metal salts or ammonium salts thereof
• CPC Class Codes: C08F 220/26 Esters containing oxygen in addition to the carboxy oxygen
• CPC Class Codes: C08F 220/58 containing oxygen in addition to the carbonamido oxygen , e.g. N-methylolacrylamide, N-(meth)acryloylmorpholine
• CPC Class Codes: C08F 2800/20 as weight or mass percentages
• CPC Class Codes: C09D 133/26 Homopolymers or copolymers of acrylamide or methacrylamide
• CPC Class Codes: C09D 139/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C09D 177/06 Polyamides derived from polyamines and polycarboxylic acids C09D177/10 takes precedence
• CPC Class Codes: C09D 179/04 Polycondensates having nitrogen-containing heterocyclic rings in the main chain; Polyhydrazides; Polyamide acids or similar polyimide precursors
• CPC Class Codes: C09D 181/00 Coating compositions based on macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing sulfur, with or without nitrogen, oxygen, or carbon only; Coating compositions based on polysulfones; Coating compositions based on derivatives of such polymers
• CPC Class Codes: G01N 33/533 with fluorescent label
• CPC Class Codes: G01N 33/582 with fluorescent label

Abstract

A composition for use as an assay reagent comprises a solid support comprising a member of a signal producing system and a coating of a synthetic copolymer. The synthetic copolymer comprises a first polymerized monomer comprising a pendant moiety comprising a reactive functionality or a derivative of a reactive functionality and a second polymerized monomer comprising a pendant moiety comprising at least 1 carbon atoms and at least 2 heteroatoms. In some embodiments the copolymer comprises a polyethylenic backbone comprising the pendant moiety comprising a reactive functionality or a derivative of a reactive functionality and the pendant moiety comprising at least 1 carbon atom and at least 2 heteroatoms.

Claims

1. A composition for use as an assay reagent, the composition comprising:

a solid support comprising a member of a signal producing system and a coating of a synthetic copolymer wherein the synthetic consists of

(i) a first copolymerized monomer comprising a pendant moiety wherein the pendant moiety has the formula;

—

C(O)-A-(CH₂)_n-G

wherein A is NR¹ wherein R¹ is H or alkyl of from 1 to 6 carbon atoms and n is 1 to 10 and wherein G is CHO;

CH(OR⁸)₂ wherein R⁸ is alkyl of from 1 to 6 carbon atoms;

or a member of a specific binding pair; and

(ii) a second copolymerized monomer comprising a pendant moiety wherein the pendant moiety has the formula;

2. The composition according to claim 1 wherein the solid support is a particle.

3. The composition according to claim 2 wherein the particle is a latex particle.

4. The composition according to claim 1 wherein the member of the signal producing system is selected from the group consisting of sensitizers and chemiluminescent compounds.

5. The composition according to claim 1 wherein the copolymer comprises an polyethylenic backbone.

6. The composition according to claim 1 wherein the pendant moiety of the first copolymerized monomer is —

C(O)—

NH—

(CH₂)_n—

CHO or —

C(O)—

NH—

(CH₂)_n—

CH(OCH₃)₂ wherein n is 1.

7. The composition according to claim 1 wherein the pendant moiety of the second copolymerized monomer is

8. The composition according to claim 1 wherein a member of a specific binding pair is associated with the solid support.

9. A method of determining in a sample the presence and/or amount of an analyte, the method comprising:

(a) providing in combination in a medium;

(i) the sample, and

(ii) the composition according to claim 8 wherein the member of the specific binding pair (sbp) binds to the analyte or to a second sbp member to form a complex related to the presence of the analyte,

(b) subjecting the combination to conditions for binding of the analyte to the composition to form a complex, and

(c) activating the member of the signal producing system and detecting the amount of the complex, the amount of the complex being related to the presence and/or amount of analyte in the sample.

10. A method of determining in a sample the presence and/or amount of an analyte, the method comprising:

(a) providing in combination in a medium;

(i) the sample, and

(ii) a composition comprising;

a particle comprising;

(A) a member of a signal producing system,

(B) a member of the specific binding pair that binds to the analyte or to a second sbp member to form a complex related to the presence of the analyte and

(C) a coating of a copolymer of the formula;

11. The method according to claim 10 wherein the member of the signal producing system is selected from the group consisting of sensitizers and chemiluminescent compounds.

12. The method according to claim 10 wherein the member of the signal producing system is incorporated into the particle.

13. The method according to claim 10 wherein the member of the signal producing system is a photosensitizer and the combination further comprises a chemiluminescent reagent or wherein the member of the signal producing system is a chemiluminescent compound and the combination further comprises a photosensitizer reagent.