CN101231284B - Urea kit for diagnosing pylorus helicobacterium infestation - Google Patents
Urea kit for diagnosing pylorus helicobacterium infestation Download PDFInfo
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- CN101231284B CN101231284B CN200710073017A CN200710073017A CN101231284B CN 101231284 B CN101231284 B CN 101231284B CN 200710073017 A CN200710073017 A CN 200710073017A CN 200710073017 A CN200710073017 A CN 200710073017A CN 101231284 B CN101231284 B CN 101231284B
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- Prior art keywords
- urea
- reagent
- ubt
- sensitizer
- diagnosing
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- 239000004202 carbamide Substances 0.000 title claims abstract description 50
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 title claims abstract description 42
- 206010061217 Infestation Diseases 0.000 title 1
- 210000001187 pylorus Anatomy 0.000 title 1
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 27
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 18
- XSQUKJJJFZCRTK-OUBTZVSYSA-N Urea-13C Chemical compound N[13C](N)=O XSQUKJJJFZCRTK-OUBTZVSYSA-N 0.000 claims description 11
- 206010019375 Helicobacter infections Diseases 0.000 claims description 9
- 239000002552 dosage form Substances 0.000 claims description 2
- 238000012360 testing method Methods 0.000 abstract description 13
- 238000001514 detection method Methods 0.000 abstract description 4
- 241000590002 Helicobacter pylori Species 0.000 abstract description 3
- 229940037467 helicobacter pylori Drugs 0.000 abstract description 3
- 208000015181 infectious disease Diseases 0.000 abstract description 3
- 238000001574 biopsy Methods 0.000 description 5
- 239000002775 capsule Substances 0.000 description 5
- 235000015165 citric acid Nutrition 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 5
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 4
- 108010046334 Urease Proteins 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 229940069428 antacid Drugs 0.000 description 3
- 239000003159 antacid agent Substances 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 2
- 206010046274 Upper gastrointestinal haemorrhage Diseases 0.000 description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 2
- 235000010323 ascorbic acid Nutrition 0.000 description 2
- 229960005070 ascorbic acid Drugs 0.000 description 2
- 239000011668 ascorbic acid Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 235000011090 malic acid Nutrition 0.000 description 2
- 239000001630 malic acid Substances 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 235000002906 tartaric acid Nutrition 0.000 description 2
- 239000011975 tartaric acid Substances 0.000 description 2
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 description 1
- 108010011485 Aspartame Proteins 0.000 description 1
- 229960004998 acesulfame potassium Drugs 0.000 description 1
- 235000010358 acesulfame potassium Nutrition 0.000 description 1
- 239000000619 acesulfame-K Substances 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- 235000010357 aspartame Nutrition 0.000 description 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- 239000013043 chemical agent Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 238000002575 gastroscopy Methods 0.000 description 1
- 230000002285 radioactive effect Effects 0.000 description 1
- 230000001235 sensitizing effect Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention relates to a medical chemical reagent, in particular to a urea reagent box which uses <13>C-UBT (Urea Breath Test) to diagnose helicobacter pylori (Hp) infection, and the reagent box comprises a urea<13>C reagent with a certain dosage, a conduit used for huffing, a CO2 collecting bag and also comprises a sensitizer, wherein, the urea<13>C reagent in each dosage contains 15 to 25 mg of urea<13>C, or the richness of the <13>C in each dosage urea<13>C is 40 to 90 percent, the contained quantity of the urea<13>C is equal to 15 to 25mg of urea<13>C with 99 percent of <13>C richness. The urea reagent box of the invention comprises the sensitizer, reduces the false rate, and ensures that the detection result also can be ensured through using the urea<13>C reagent with small dosage or using the urea<13>C reagent with lower <13>C richness, thereby effectively reducing the cost of the reagent.
Description
Technical Field
The present invention relates to medical chemical agents, and more particularly to the use thereof13C-UBT (Urea breath test) for diagnosing Helicobacter pylori (Hp) infection.
Background
UBT for detecting helicobacter pylori (Hp) infection is widely applied to clinic due to the characteristics of no pain, no wound, accuracy, rapidness and safety. The current clinical use of UBT is classified into14C-UBT and13two kinds of C-UBT. Wherein,14C-UBT is radioactive and is not suitable for subjects such as pregnant women and children.13Stable isotopes used in C-UBT13C, no radioactivity, plus urea is also a normal component of the human body, so it is suitable for all ages and types of subjects. However, practice13The cost of C-UBT is high, and limits13The wide application of C-UBT.
Urea [ 2 ]13C]The cost of the reagent is high13One of the main reasons for the high cost of C-UBT. Urea [ alpha ]13C]In the reagent, the reaction solution is added with a solvent,13c abundance is high (generally 99%), and the dosage is large (generally 75mg), which results in higher cost of the medicament, thereby affecting13The wide use of C-UBT.
In addition, the misjudgment rate of patients with upper gastrointestinal hemorrhage and patients who use antacids and anti-Hp drugs recently is higher. How to improve the accuracy rate of the part of patients is the key to further improve the overall accuracy.
Disclosure of Invention
The invention aims to reduce the detection effect on the premise of ensuring the detection effect13Cost of C-UBT; while reducing the pair13Misjudgment rate of C-UBT for specific subjects such as patients recently administered antacids, anti-Hp drugs.
The invention thus achieves the object: provides a urea kit for diagnosing helicobacter pylori infection, which comprises a certain dosage form of urea13C]Reagent, catheter for insufflation, characterized by CO2The collection bag also comprises a sensitizer.
In the urea kit for diagnosing helicobacter pylori infection, the sensitizer comprises any one or any combination of citric acid, malic acid, ascorbic acid and tartaric acid.
In the urea kit for diagnosing helicobacter pylori infection, each dose of the sensitizer contains 1-5 g of citric acid.
In the urea kit for diagnosing helicobacter pylori infection of the present invention, each dose of urea [ 2 ]13C]The reagent contains 15-25 mg of urea13C]。
In the urea kit for diagnosing helicobacter pylori infection of the present invention, each dose of urea [ 2 ]13C]In the reagent13The abundance of C is 40-90%, and the contained urea [ alpha ]13C]The amount of (A) is equivalent to 15 to 25 mg13Urea with C abundance of 99%13C]。
The urea kit for diagnosing helicobacter pylori infection comprises a sensitizer, and the sensitivity can be improved13The accuracy and the sensitivity of the C-UBT for diagnosing the helicobacter pylori infection reduce the misjudgment rate and ensure the use of low dose of urea13C]The reagent is used or lower13Urea of C abundance13C]The reagent can also ensure the detection result. Thereby effectively reducing the cost of the reagent.
Detailed Description
Example 1
1. Subject: 30 volunteers, all of the 30 volunteers were older than 18 years. Wherein 15 men are 19-65 years old, and 37 years old on average; 15 women aged 20-53 years, and the average age was 33 years.
2. The experimental method comprises the following steps:
(1) the method comprises the following steps of performing gastroscopy on a volunteer firstly, then extracting a biopsy specimen, and performing conventional pathological test and urease test on the biopsy specimen.
(2) Preparing a sensitizing agent into a 100ml solution, and taking a dose of urea from the prepared solution13C]Capsule, observation of pathology, urease and13C-UBT results.
The main component of the sensitizer is citric acid, and each sensitizer contains 5 g of citric acid. Each dose of urea13C]In capsules13The abundance of C is 99%, and the C contains urea13C]17 mg, lower than conventional content.
(3) By CO2A collection bag to collect the gas exhaled by the volunteer. The method is to inhale deeply and exhale for a long time, the exhaling process is roughly divided into two parts, in the embodiment, the gas exhaled by the front part is not collected, and only the gas exhaled by the rear part is collected, so that the collected gas is the gas in the alveoli.
3. Results of the experiment
The results of the experiment are shown in the following table, wherein "+" indicates positive results and "-" indicates negative results.
Table 1: test results of biopsy specimen pathology, urease, and UBT-13
4. Conclusion
As can be seen from Table 1, with the aid of a sensitizer, lower than conventional urea [ alpha ], [ beta ] is used13C]In an amount of13The C-UBT test results are quite accurate and meet the clinical requirements.
The sensitizer may include any one or any combination of citric acid, malic acid, ascorbic acid and tartaric acid. Sweetening agents such as aspartame and acesulfame potassium can be added into the sensitizer to improve the taste of the sensitizer.
Example two
The experimental procedure of this example is substantially the same as that of the previous example, except that: in this example, urea [ 2 ]13C]In capsules13The C abundance was not the conventional 99% but 45%. In addition, each dose of urea [ 2 ]13C]Urea contained in the capsule13C]The amount of (a) is equivalent to 15 to 25 mg13Urea with C abundance of 99%13C]。
The experimental result shows that under the action of the sensitizer, the method adopts13C abundance of 45%13The C-UBT test results are quite accurate and meet the clinical requirements.13Urea with C abundance of 45%13C]The preparation cost is far lower than that of13Urea with C abundance of 99%13C]Thereby reducing the cost of the reagent. Note that each dose of urea [ 2 ]13C]Urea contained in the capsule13C]The amount is preferably 15 to 75mg13Urea with C abundance of 99%13C]。
EXAMPLE III
In this example, volunteers with upper gastrointestinal bleeding, who recently used antacids and anti-Hp drugs, were selected. The volunteers were first gastroscoped, then biopsy specimens were taken, and routine pathological and urease tests were performed on the biopsy specimens.
Then, the volunteers were subjected to the routine13C-UBT test (hereinafter referred to as first test)13C-UBT assay). No sensitizers were administered in this trial.
Conventional (B) is13After the C-UBT test, the volunteers fasted for 6 hours. Then the volunteers were given a second time13C-UBT assay. In this test, the test procedure was urea13C]Reagent and urea13C]The amount of reagent used is the same as the first time13C-UBT assay is the same; the difference is that the subject was given a sensitizer in this trial.
The results show that for the first time13A certain misjudgment rate occurs in the C-UBT. And a second time13And C-UBT has no misjudgment rate.
Experiments show that each dose of urea [ alpha ], [ beta ], [ alpha ] form of urea ] is obtained by using13C]The reagent contains 15-25 mg of urea13C]The requirements of clinical tests can be met; or, adopt13Urea with C abundance of 40-90%13C]A reagent in which the amount of urea in each reagent is appropriately increased so that each reagent contains urea13C]Urea [ alpha ], [ alpha ]13C]The content is between 15 and 75mg, which can also meet the requirements of clinical trials. In addition, the kit provided by the invention also has a lower misjudgment rate.
Claims (2)
1. A urea kit for diagnosing helicobacter pylori infection comprises urea of a certain dosage form13C]Reagents, catheters for insufflation, CO2The collection bag is characterized by further comprising a sensitizer, each dose of the sensitizer contains 1-5 g of citric acid, and each dose of the urea13C]The reagent contains 15-25 mg of urea13C]。
2. The urea kit according to claim 1, wherein each dose of urea [ 2 ]13C]In the reagent13C FengThe content of the urea is 40 to 90 percent13C]The amount of (A) is equivalent to 15 to 25 mg13Urea with C abundance of 99%13C]。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710073017A CN101231284B (en) | 2007-01-23 | 2007-01-23 | Urea kit for diagnosing pylorus helicobacterium infestation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710073017A CN101231284B (en) | 2007-01-23 | 2007-01-23 | Urea kit for diagnosing pylorus helicobacterium infestation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101231284A CN101231284A (en) | 2008-07-30 |
| CN101231284B true CN101231284B (en) | 2012-09-26 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200710073017A Expired - Fee Related CN101231284B (en) | 2007-01-23 | 2007-01-23 | Urea kit for diagnosing pylorus helicobacterium infestation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101231284B (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103045468A (en) * | 2011-10-14 | 2013-04-17 | 深圳太太基因工程有限公司 | Kit used for detecting helicobacter pylori infection |
| CN102539424B (en) * | 2011-12-23 | 2013-11-20 | 李雄 | Rapid detection method of urease in tongue coating by using pH value-ethanol method and kit |
| CN105717187A (en) * | 2016-02-02 | 2016-06-29 | 长沙三相医疗器械有限公司 | Reagent and kit for helicobacter pylori detection and method for detecting ammonia gas exhaled from human body |
| CN108982825A (en) * | 2018-05-11 | 2018-12-11 | 合肥安为康医学检验有限公司 | A kind of helicobacter pylori detection kit and detection method |
| CN111289505A (en) * | 2020-03-16 | 2020-06-16 | 南京康容健康科技有限公司 | Helicobacter pylori detect reagent box |
| CN114807298B (en) * | 2022-05-31 | 2022-10-25 | 浙江省立同德医院(浙江省精神卫生研究院) | Helicobacter pylori detect reagent box |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1219238A (en) * | 1996-11-12 | 1999-06-09 | 伊索梅德公司 | Method and kit for detecting helicobacter pylori |
| WO2001087353A1 (en) * | 2000-05-19 | 2001-11-22 | Otsuka Pharmaceutical Co., Ltd. | Preparations for diagnosing infection with helicobacter pylori |
| KR20030078489A (en) * | 2002-03-29 | 2003-10-08 | (주)위드교역 | Direct Urea Breath Test System For Detection of Helicobacter Pylori. |
-
2007
- 2007-01-23 CN CN200710073017A patent/CN101231284B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1219238A (en) * | 1996-11-12 | 1999-06-09 | 伊索梅德公司 | Method and kit for detecting helicobacter pylori |
| WO2001087353A1 (en) * | 2000-05-19 | 2001-11-22 | Otsuka Pharmaceutical Co., Ltd. | Preparations for diagnosing infection with helicobacter pylori |
| CN1489478A (en) * | 2000-05-19 | 2004-04-14 | 大V制药株式会社 | Medicine preparations for diagnosing infection with helicobacter pyloni |
| KR20030078489A (en) * | 2002-03-29 | 2003-10-08 | (주)위드교역 | Direct Urea Breath Test System For Detection of Helicobacter Pylori. |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101231284A (en) | 2008-07-30 |
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| ASS | Succession or assignment of patent right |
Owner name: SHENZHEN CITY XIANYA BIOLOGICAL SCIENCE CO., LTD. Free format text: FORMER OWNER: ZHANG HOUDE Effective date: 20090814 |
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Effective date of registration: 20090814 Address after: Shenzhen city Nanshan District Nanxin East Road and Taoyuan North Road Xiamen 15A1 SOHO post encoding: 518000 Applicant after: Zhang Houde Address before: Building 6, building R1-B, South District, Shenzhen hi tech Industrial Park, Guangdong Province, China: 518057 Applicant before: Zhang Houde |
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