Fecal test method

• US 6,057,166 A
• Filed: 12/22/1995
• Issued: 05/02/2000
• Est. Priority Date: 12/22/1995
• Status: Expired due to Fees

• Current Assignee: Committee Of Unsecured Creditors Of Medical Diagnostic Products, Inc., Wood Gundy Limited
• Original Assignee: Universal Health Watch, Inc.
• Inventors: Bernstein, David, Prakash, Anjana, Childs, Mary Ann
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US08/577,623
• Time in Patent Office: 1,593 Days
• Field of Search: 422/56, 422/61, 435/7.1, 435/7.92, 435/7.93, 435/7.94, 435/805, 435/810, 435/962, 435/970, 435/975, 436/518, 436/523, 436/525, 436/533, 436/808, 436/810, 436/811
• US Class Current: 436/525
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/553 Metal or metal coated
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

A method is disclosed for determining the presence or amount of analyte in a fecal sample. The method comprises the steps of (A) contacting the fecal sample with an extraction reagent comprised of at least one detergent and at least one buffer to form a mixture, (B) applying the mixture to an absorbent filter that is in proximity to or in contact with an immunoassay such that analyte present in the sample is transferred to the immunoassay, and (C) detecting the presence of analyte by said immunoassay. In a preferred embodiment, the immunoassay comprises a porous strip containing immunoreagents for detecting analyte.

Claims

1. A method for determining the presence or amount of analyte in an unfiltered fecal sample comprising the steps of:

A. contacting said fecal sample with an extraction reagent comprising at least one detergent at a concentration of at least its critical micelle concentration to form a mixture comprising fecal matter and fluid containing antigen, said antigen comprising at least some of said analyte from said fecal sample;

B. separating said fecal matter from said fluid containing antigen by wicking the mixture of step A into a test strip, wherein said test strip comprises absorbent material that contains immunoassay reagents, said absorbent material further comprising a fibrous filter that contacts said liquid and collects said fecal matter; and

C. detecting the presence of analyte from a signal produced by said test strip.

2. The method of claim 1, wherein said fibrous filter is selected from the group consisting of glass fiber and cellulose paper.

3. The method of claim 2, wherein said fibrous filter is further characterized as having an effective porosity of 5.0 microns.

4. The method of claim 1, wherein step C comprises detecting a color produced within said strip.

5. The method of claim 1, wherein said fecal sample is contacted with at least an equal volume of extraction reagent.

6. The method of claim 1, wherein said detergent is selected from the group consisting of deoxycholate, polyoxyethylene-sorbitan monolaurate, t-octylphenoxypolyethoxyethanol and sodium dodecyl sulfate.

7. The method of claim 1, wherein said reagents necessary to conduct an immunoassay comprises (i) a first group of selenium particles having bound thereto a binding component capable of specifically recognizing analyte, and (ii) a second group of gold particles having bound thereto a binding component capable of specifically recognizing said analyte, wherein the average diameter of said selenium particles in said first group is larger than the average diameter of said gold particles in said second group.

8. A method for determining the presence or amount of analyte in an unfiltered fecal sample comprising the steps of:

A. contacting said fecal sample with an extraction reagent comprising at least one detergent at a concentration of at least its critical micelle concentration to form a mixture comprising fecal matter and fluid containing antigen, said antigen comprising at least some of said analyte from said fecal sample;

B. separating said fecal matter from said fluid containing antigen by wicking the mixture of step A into a test strip, wherein said test strip comprises absorbent material that contains at least one immunoassay reagent, said absorbent material further comprising a filter that contacts said liquid and collects said fecal matter; and

C. detecting the presence of analyte from a signal produced by said test strip.