Device for preventing assay interference using silver or lead to remove the interferant

• US 5,945,345 A
• Filed: 08/27/1996
• Issued: 08/31/1999
• Est. Priority Date: 08/27/1996
• Status: Expired due to Term

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Metrika, Inc. (Bayer AG)
• Inventors: Blatt, Joel M., Mangan, Wilma M., Patel, Paul J., Manneh, Victor A.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): PORTNER, VIRGINIA ALLEN
• Application Number:
  US08/703,479
• Time in Patent Office: 1,099 Days
• Field of Search: 422/56, 422/57, 422/58, 422/59, 422/60, 422/61, 422/63, 422/68.1, 422/81, 422/99, 422/100, 435/805, 435/962, 435/970, 436/175, 436/514, 436/535, 436/538, 436/518, 436/528, 436/529, 436/530, 436/824, 436/825, 436/525
• US Class Current: 436/518
• CPC Class Codes: G01N 33/5306 Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/70 involving creatine or creatinine

Abstract

The present invention provides a filter for effectively removing substances from a sample of bodily fluid which can interfere with the results of an assay. The filter includes a solid phase support and an active chemical component for binding to the interfering substance. The active chemical component is insoluble in the sample and is immobilized on the solid phase support. The present invention also includes a filter device, transport matrix, assay device, and method for removing substances which interfere with determining the presence of one or more analytes in a sample.

Claims

1. A transport matrix for removing one or more substances which interfere with determining the presence of an analyte in an immunoassay sample of physiological fluid, the transport matrix adapted for use in a sealed housing of an immunoassay device, the transport matrix comprising:

a sample receptor zone configured to receive the sample of physiological fluid directly on the matrix;

a detection zone having an immunoassay reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample to provide a quantitative immunoassay result within the housing, the detection zone being in fluid communication by capillary action with the sample receptor zone; and

an active chemical component including silver or lead is immobilized by chemically binding on the transport matrix prior to the detection zone, the active chemical component having an affinity for binding to and immobilizing the interfering substance, the active chemical component being insoluble in the sample of physiological fluid.

2. The transport matrix of claim 1 wherein the transport matrix further comprises a solid phase support being immobilized within the transport matrix whereby the active chemical component is immobilized on the solid phase support which is also immobilized within the transport matrix.

3. The transport matrix of claim 2 wherein the solid phase support is a nonporous material and the transport matrix is a porous material.

4. The transport matrix of claim 3 wherein the non-porous solid phase support is selected from a group consisting of beads, magnetic particles, paramagnetic particles, microparticles, and macroparticles.

5. The transport matrix of claim 1 wherein the active chemical component is immobilized directly on the transport matrix.

6. The transport matrix of claim 1 wherein the transport matrix is selected from the group consisting of carboxymethyl polymers, diethylaminoethyl polymers, sulfoxyethyl polymers, trimethylhydroxy propyl quaternary ammonium polymers, orthophosphate polymers, iminodicarboxylic acid polymers, diethylaminoethyl Sephadex polymers, diethyl amino ethyl Sephadex polymers, Sepharose polymers, epichlorohydrin triethanolamine cellulose polymers, polyethyleneimine cellulose polymers, quaternary alkylamine polymers, quaternary alkylalkanolamine polymers, trimethylbenzylammonium polymers, dimethylethanolbenzylammonium polymers, trimethylbenzylammonium polymers, dimethylethanolamine polymers, polyamine polymers, alkylamine polymers, quaternary ammonium polymers, tertiary amine polymers, carboxymethyl Sephadex polymers, sulfopropyl Sephadex polymers, sulfoxyethyl cellulose polymers, sulfonic acid polymers, nuclear sulfonic acid polymers, carboxylic acid polymers, and triethylaminoethyl cellulose polymers.

7. The transport matrix of claim 6 wherein the transport matrix has a derivative content in an amount less than about 10 mg/cm² which effectively immobilizes the interfering substance.

8. The transport matrix of claim 1 wherein the active chemical component is applied to the transport matrix in an amount less than about 1M which effectively immobilizes the interfering substance.

9. The transport matrix of claim 1 wherein the amount of active chemical component immobilized on the transport matrix provides about the same number of binding sites as the amount of interfering substance in the assay sample.

10. An immunoassay device for removing one or more substances which interfere with determining the presence of an analyte in an immunoassay sample of physiological fluid, the device comprising:

a housing having an exterior surface and sealing an interior space;

sample receptor means for directly receiving the sample of physiological fluid containing an analyte selected for determining its presence, the sample receptor means being located on the exterior surface of the housing; and

a transport matrix located within the interior space of the housing and in fluid communication with the sample receptor means, the transport matrix having;

a sample receptor zone configured to directly receive the sample of physiological fluid from the sample receptor means;

a detection zone having a immunoassay reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample to provide a quantitative immunoassay result within the housing, the detection zone being in fluid communication by capillary action with the sample receptor zone; and

an active chemical component including silver or lead is immobilized by chemically binding on the transport matrix prior to the detection zone, the active chemical component having an affinity for binding to and immobilizing the interfering substance, the active chemical component being insoluble in the sample of physiological fluid.

11. The immunoassay device of claim 10 wherein the active chemical component is immobilized directly on the transport matrix.

12. The immunoassay device of claim 10 wherein the transport matrix is selected from the group consisting of carboxymethyl polymers, diethylaminoethyl polymers, sulfoxyethyl polymers, trimethylhydroxy propyl quaternary ammonium polymers, orthophosphate polymers, iminodicarboxylic acid polymers, diethylaminoethyl Sephadex polymers, diethyl aminoethyl Sephadex polymers, Sepharose polymers, epichlorohydrin triethanolamine cellulose polymers, polyethyleneimine cellulose polymers, quaternary alkylamine polymers, quaternary alkylalkanolamine polymers, trimethylbenzylammonium polymers, dimethylethanolbenzylammonium polymers, trimethylbenzylammonium polymers, dimethylethanolamine polymers, polyamine polymers, alkylamine polymers, quaternary ammonium polymers, tertiary amine polymers, carboxymethyl Sephadex polymers, sulfopropyl Sephadex polymers, sulfoxyethyl cellulose polymers, sulfonic acid polymers, nuclear sulfonic acid polymers, carboxylic acid polymers, and triethylaminoethyl cellulose polymers.

13. The immunoassay device of claim 12 wherein the transport matrix has a derivative content in the amount of about 2.5 mg/cm² to about 2.0 mg/cm².

14. The immunoassay device of claim 10 wherein the active chemical component is applied to the transport matrix in an amount less than about 1M which effectively immobilizes the interfering substance.

15. The immunoassay device of claim 10 wherein the amount of active chemical component immobilized on the solid phase support provides about the same number of binding sites as the amount of interfering substance in the assay sample.