Methods of Making Assay Devices Utilizing Hollow Particles

• US 20110020541A1
• Filed: 09/28/2010
• Published: 01/27/2011
• Est. Priority Date: 04/03/2003
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Atanassov, Zdravko Savov, Wei, Ning, Yang, Kaiyuan, Chidebelu-Eze, Chibueze Obinna, Kaylor, Rosann
• Granted Patent: US 8,034,397 B2
• Time in Patent Office: Days
• US Class Current: 427/222
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/587 Nanoparticles

Abstract

Hollow particles for use in various types of assay devices are provided. Due to their hollow or voided structure, the particles may exhibit a variety of beneficial properties. For instance, hollow particles are generally lightweight, and thus, relatively inexpensive in comparison to other types of particles. Hollow particles may also form a stable system without requiring refrigeration or rotation. In addition, hollow particles may possess enhanced light diffraction capabilities, which may be particularly beneficial in certain types of assay devices, e.g., diffraction-based assay devices.

Claims

1. A method of forming an assay device for detecting an analyte in a test sample, the method comprising:

providing a plurality of latex particles, wherein the latex particles individually define a polymeric shell about a hollow interior constituting at least about 20% of the spatial volume occupied by the particle, wherein the polymeric shell of the latex particles comprises an organic polymer having carboxylic functional groups, wherein the latex particles have an average size of from about 0.1 nanometer to about 100 microns;

activating the carboxylic functional groups on the organic polymer of the polymeric shell to form activated carboxylic functional groups;

reacting the activated carboxylic functional groups with an amino group of an antibody to form an amide bond such that the antibody is covalently bonded to the hollow particle;

blocking any remaining activated carboxylic functional groups on the organic polymer of the polymeric shell; and

incorporating the hollow particles into an assay device.

2. The method of claim 1, wherein the carboxylic functional groups on the organic polymer are activated using a carbodimide.

3. The method of claim 2, wherein the carbodiimide comprises 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide.

4. The method of claim 1, wherein the carboxylic functional groups on the organic polymer are activated in a buffer.

5. The method of claim 4, wherein the buffer comprises phosphate-buffered saline.

6. The method of claim 4, wherein the buffer comprises 2-(N-morpholino) ethane sulfonic acid.

7. The method of claim 1, wherein any remaining activated carboxylic functional groups on the organic polymer of the polymeric shell are blocked with ethanolamine.

8. The method of claim 1, wherein the antibody comprises an immunoreactive specific binding member.

9. The method of claim 8, wherein the immunoreactive specific binding member comprises an antigen, hapten, aptamer, antibody, or complexes thereof.

10. The method of claim 8, wherein the immunoreactive specific binding member comprises an antigen.

11. The method as in claim 1, wherein the assay device comprises a porous membrane that defines a detection zone, wherein the hollow particles are positioned within the detection zone.

12. The method of claim 1 wherein the hollow interior constitutes at least about 30% of the spatial volume occupied by the particle.

13. The method of claim 1, wherein the average size of the latex particles ranges from about 1 nanometer to about 10 microns.

14. The method of claim 1, wherein the organic polymer has a glass transition temperature that is greater than about 50°

C.

15. The method of claim 1, wherein the organic polymer is formed from one or more ethylenically unsaturated monomers.

16. The method of claim 1, wherein the latex particles have a spherical shape.