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US5314804A Expired / Lapsed US ⏱️ 0.0 years remaining

Test for Helicobacter pylori

Assignee: SERIM RESEARCH Corp A CORP OF
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Filing: 1992-03-24
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Granted: 1994-05-24
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Expires: 2012-03-24
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Abstract

Abstract A rapid method and easy to use unitized test device is disclosed for determining the presence of Helicobacter pylori in a biological tissue specimen by detecting the presence of urease in the tissue. The system basically utilizes a multilayer test device for separating and optimizing the various reactions involved, i.e. the urease in the specimen with a substrate and the ammonia generated thereby with an indicator element.

Inventors

  • 👤 Robert C. Boguslaski
  • 👤 Robert J. Carrico

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 16:38
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/58; C12Q1/02; C12Q1/04; G; G01; G01N; G01N2333/00; G01N2333/195; G01N2333/205; Y; Y10; Y10S; Y10S435/00; Y10S435/81; Y10S436/00; Y10S436/811

Claims Analysis

Total Claims: 10
Claim 1
Independent Claim 116 words
A method for detecting urease in a biological tissue specimen comprising: A. positioning the tissue specimen on one side of a diffusion element permeable to ammonia; B. contacting the specimen with a pH optimized urease substrate comprising a solution of urea and a buffer having a pH of about from 7.0 to 9.0, said contacting producing ammonia; C. allowing the ammonia to permeate through the diffusion element to contact an indicator element positioned to the opposite side of and in contiguous relationship to the diffusion element, said indicator element comprising a matrix containing a pH indicator having a pKa of about 2.0 to 6.0; and, D. observing the reaction of the ammonia with the indicator element.
Claim 2
Independent Claim 116 words
A method for detecting urease in a biological tissue specimen comprising: A. positioning the tissue specimen on one side of a diffusion element permeable to ammonia; B. contacting the specimen with a pH optimized urease substrate comprising a solution of urea and a buffer having a pH of about from 7.0 to 9.0, said contacting producing ammonia; C. allowing the ammonia to permeate through the diffusion element to contact an indicator element positioned to the opposite side of and in contiguous relationship to the diffusion element, said indicator element comprising a matrix containing a pH indicator having a pKa of about 2.0 to 6.0; and, D. observing the reaction of the ammonia with the indicator element.
Claim 3
Dependent Claim 23 words
The method of claim 1 wherein the diffusion element is a membrane having a pore size of about from 0.05 to 10 μm.
Claim 4
Dependent Claim 24 words
The method of claim 1 wherein the said solution of urea and a buffer is contained in a matrix to form the urease substrate.
Claim 5
Dependent Claim 54 words
The method of claim 3 wherein the tissue specimen is placed on the diffusion element and the urease substrate is placed over the tissue specimen to form a multilayered structure and a means is utilized to hold the diffusion element and the urease substrate together in intimate contact with the tissue specimen included therebetween.
Claim 6
Dependent Claim 45 words
A method as in claim 1 wherein a quantity of a material which reacts with ammonia is included in the indicator element or the diffusion element, said quantity being determined in accordance with the desired sensitivity of the test to urease in the tissue sample.
Claim 7
Dependent Claim 17 words
A method as in claim 1 wherein the pH optimized urease substrate is contained in a matrix.
Claim 8
Dependent Claim 12 words
A method as in claim 6 wherein the matrix is absorbent paper.
Claim 9
Dependent Claim 25 words
A method as in claim 6 wherein the urea is contained in the matrix and the buffer solution is added thereto as a rehydrating solution.
Claim 10
Dependent Claim 17 words
A method as in claim 6 wherein the urea and the buffer are contained in the matrix.

References Cited (Backward Citations)

US3876502A Cited
US4748113A Cited
US4830010A Cited
US4923801A Cited
EP0458231A1 Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1997-05-23 1997-11-22 1998-05-24 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2001-05-23 2001-11-22 2002-05-24 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2005-05-23 2005-11-22 2006-05-24 $7700.00 Window Closed / Lapsed

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