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US 5,314,804 AGranted
Test for Helicobacter pylori
AssigneeSerim Research Corporation
InventorsRobert C. Boguslaski, Robert J. Carrico
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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.
Claims9
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.
2 more elements
Dependencies are inferred from the claim text.