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US 5,420,016 AGranted
Test device and kit for detecting 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.
Claims15
A multilayer test device for detecting urease in biological tissue specimens comprising:
- A. a substrate element comprising a matrix containing a substrate for urease;
- B. a diffusion element comprising a membrane permeable to ammonia and impermeable to water;
- C. an indicator element comprising a matrix containing a means for detecting ammonia, the indicator element being in contiguous relationship with the diffusion element;
- D. wherein a predetermined quantity of sulfamic acid sufficient to react with ammonia to produce a desired sensitivity is present in the indicator element or the diffusion element;
- and
- E. means for placing and maintaining a biological tissue specimen between the substrate element and the diffusion element.
3 more elements
A test kit for detecting urease in biological tissue specimens comprising:
- A. an aqueous rehydrating solution;
- B. a buffer having a pH of about from 7.0 to 9.0;
- C. a substrate element comprising a matrix having therein a dried residue of urea;
- D. a diffusion element comprising a membrane permeable to ammonia and impermeable to water;
- E. an indicator element comprising a matrix containing a dried residue of a pH indicator having a pKa of about from 2.0 to 6.0 for detecting ammonia, the indicator element being in contiguous relationship with the diffusion element;
- F. wherein a predetermined quantity of sulfamic acid sufficient to react with ammonia to produce a desired sensitivity is present in the indicator element or the diffusion element;
- and
- G. means for placing and maintaining a biological specimen between the substrate element and the diffusion element whereby any urease in the biological specimen will react with the urea to generate ammonia which will permeate the diffusion membrane and be detected by the indicator element.
5 more elements
Dependencies are inferred from the claim text.