# US 5,702,911 A · Diagnostic test composition

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- Number: US 5,702,911 A
- Document ID: US5702911A
- Status: Granted
- Kind: A
- Application number: 08/698,384
- Filed: 1996-08-15
- Granted: 1997-12-30
- Earliest claimed: 1996-08-15
- Assignees: Chek-Med Systems, Inc.
- Inventors: Robert G. Whalen
- Web page: https://patentgrep.com/patent/US5702911A

## CPC

- C12Q 1/045: {Culture media therefor}
- C12Q 1/30: involving catalase
- G01N 33/56922: {Campylobacter}
- G01N 2333/205: from Campylobacter (G)
- G01N 2333/908: acting on hydrogen peroxide as acceptor (1.11)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention relates to an improved test composition for the diagnosis of gastric ulcers, duodenal ulcers, gastritis, gastric lymphoma and gastric carcinoma by the detection of the bacteria Helicobacter pylori and the enzyme catalase associated with such conditions. The new test composition differs from the prior art agar compositions in being an aqueous solution containing hydrogen peroxide, urea, monobasic sodium phosphate and bromthymol blue as an indicator, and in being far more rapid than the prior art test compositions.

## Claims

### Claim 1

An improved test composition for detecting Helicobacter pylori in a specimen comprising by weight:
a) an aqueous solution containing about 0.5% to about 6% hydrogen peroxide;
b) about 0.5% to about 2.0% urea;
c) about 0.001% to about 0.01% monobasic sodium phosphate;
d) about 0.01% to about 0.1% bromthymol blue indicator; and
the remaining percent is water.

### Claim 2 (depends on 1)

The test composition of claim 1 in which the aqueous solution has an initial pH of about 4.0 to about 5.2.

### Claim 3 (depends on 1)

The test composition of claim 1 wherein the aqueous solution contains by weight:
a) about 1.5% hydrogen peroxide;
b) about 1.5% urea;
c) about 0.01% to about 0.05% monobasic sodium phosphate;
d) about 0.03% bromthymol blue; and the remaining percent is water.

### Claim 4 (depends on 1, 2)

The test composition of claim 1, 2, or 3 further comprising an additional indicator.

### Claim 5 (depends on 4)

The test composition of claim 4 wherein the additional indicator is methyl red.

### Claim 6

A test composition comprising a) an aqueous solution containing about 0.5% to about 6.0% hydrogen peroxide; b) about 0.5% to about 2.0% urea; c) about 0.001% to about 0.01% monobasic sodium phosphate; d) about 0.01% to about 0.1% bromthymol blue indicator; and the remaining percent is water that exploits the presence of catalase in a microorganism test specimen and/or a biopsy test specimen to expedite the decomposition of urea by the urease enzyme.