CA2224551A1 - A quick in situ diagnostic method for detecting alimentary diseases - Google Patents
A quick in situ diagnostic method for detecting alimentary diseases Download PDFInfo
- Publication number
- CA2224551A1 CA2224551A1 CA 2224551 CA2224551A CA2224551A1 CA 2224551 A1 CA2224551 A1 CA 2224551A1 CA 2224551 CA2224551 CA 2224551 CA 2224551 A CA2224551 A CA 2224551A CA 2224551 A1 CA2224551 A1 CA 2224551A1
- Authority
- CA
- Canada
- Prior art keywords
- detection
- alimentary
- gastric
- diseases
- infection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56911—Bacteria
- G01N33/56922—Campylobacter
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B2010/0061—Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
- G01N2333/205—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Campylobacter (G)
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biotechnology (AREA)
- Pathology (AREA)
- General Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Microbiology (AREA)
- Analytical Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Cell Biology (AREA)
- Physics & Mathematics (AREA)
- Virology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Helicobacter pylori can infect gastric mucosa and is implicated in diseases such as gastritis, gastric and duodenal ulcer. Once a diagnosis is made, the disease can usually be cured by using antibiotic regimens to eradicate the infection.
This invention embodies a novel in situ diagnostic method which detect diseases in the alimentary tract in a fast and convenient way using a detection capsule restrained by a control string. In particular, the method embodied by this invention can be used to test for Helicobacter infection of the gastric mucosa which is implicated in gastritis, as well as gastric and duodenal ulcer.
This invention embodies a novel in situ diagnostic method which detect diseases in the alimentary tract in a fast and convenient way using a detection capsule restrained by a control string. In particular, the method embodied by this invention can be used to test for Helicobacter infection of the gastric mucosa which is implicated in gastritis, as well as gastric and duodenal ulcer.
Description
Specification:
This invention embodies a diagnostic method which detects disease antigens in situ in the alimentary tract, such as infection of the gastric mucosa by Helicobacter pylori, using a detection capsule restrained by a control string.
Helicobacter pylori can infect gastric mucosa and is implicated in diseases such as gastritis and gastric and duodenal ulcer. Once a diagnosis is made, the disease can usually be cured by using antibiotic regimens to eradicate the infection.
Current commercially available diagnosis are including invasive endoscopic gastric biopsies followed by urease test using urea and a pH indicator, microscopic examination or bacterial culture, which requires very skilled medical workers to perform, expensive equipment and very time consuming. Serological test measuring bacterial antigen-specific antibody levels is less invasive and a relatively routine clinical assay. But the presence of the antibodies in patients blood samples does not necessarily indicating there is a current infection. Other non-invasive method, such as '3C-labeled COZ breath test, in which radioactive material is administered, and special equipment is required to measure the results.
This invention embodies a in situ diagnostic method for alimentary diseases, such as Helicobacter infection. Compared to other commercially available method for detecting alimentary diseases, such as Helicobacter infection in the stomach, this detection method is very suitable for rapid in-office diagnosis and therapeutically monitoring disease conditions. It can also be used by patients themselves for at-home monitoring of such conditions with simple instructions. There are no radioactive or other hazardous materials used, no special equipment required, and the results can be easily interpreted. That is in addition to the rapid assay format (the whole process can be done within 20 min) and as a result of all these, the diagnostic test embodied by this invention is very cost effective.
f 1 The whole assembly embodies the detection capsule is the size of a pharmaceutical capsule.
In drawings which illustrate embodiments of the invention, Figure 1 is a plan view of the embodiment, Figure 2 is a top view of the Part B and C of the embodiment, Figure 3 is a plan view of Part C, and Figure 4 is a section of Part C.
Part A in Figure 1, is the control string which is used to hold and control the destination of the detection capsule. The destination of the detection capsule is simply controlled by the length of the string. Color paint or other markers can be used to mark the length of the string. A chart is provided as the reference of individuals body height compared to the physiological location of the specific alimentary organs, such as the stomach.
Part B in Figures 1, is attached by Part A. Part B embodies a plastic material non-digestible under physiological conditions of the alimentary tract. Part B' can be totally transparent or with a transparent window for monitoring the detection results.
Part C is inside Part B and D and held by Part B at the filter unit, C6 as shown in Figures 1 and 2. Part C is a mini-detection device, which embodies a nitrocellulose membrane strip, C2 as shown in Figures 3 and 4, sitting on top of a plastic support, C7 in Figure 4. A filter paper C 1 is sitting on the left side of the plastic support as shown in Figures 3 and 4. Two or more different antibodies or other ligands can be immobilized on the nitrocellulose membrane strip forming invisible ligand bands and with certain distance in between each band. One of the ligand bands, C3 as shown in Figure 3, is used as the positive control band. The positive control band is composed of antibodies against the capture ligands conjugated with a colloidal dye. One or more additional different ligand bands can be used as detection ligand bands, C4, as shown in Figure 3, which is used to detect disease antigens (such as catalase and urease of Helicobacter) carried by the capture ligands conjugated with a colloidal dye. The capture ligands conjugate is pre-absorbed in excess into a small filter paper, CS as shown in Figure 3, that is attached to the opposite end of the positive control band with detection bands in between. The filter unit, C6 as shown in Figures 3 and 4, is buffered to neutralized the extreme conditions of the alimentary fluid, and with certain pore size to prevent macro-molecular and debris from entry into the detection device.
Part D as shown in Figure l, is the capsule cap that embodies a special membrane for coating the filter unit of Part C. Part D is sealed tightly with the outside of Part B to prevent premature contact with fluid before the detection capsule reaches the destined location.
Upon reaching the specific location of the alimentary tract, such as the stomach, the membrane can be solublized because of the specific physiological condition of that location, such as low pH and the presence of pepsin in the stomach. This allows the filter unit of Part C to have direct contact with the alimentary fluid.
To perform a test, the detection capsule is ingested by patients with the aid of drinking water, while one end of the control string is being held. The detection capsule restrained by the control string will then destined to certain locations of the alimentary tract, such as the stomach. Upon reaching such location of the alimentary tract, such as the stomach, the detection capsule restrained by the control string stays, and one end of the capsule coated by special membrane becomes soluble because of the physiological conditions of the specific alimentary location, such as low pH and the presence of pepsin in the stomach.
This allows the filter unit to have direct contact with the alimentary fluid, such as gastric juice. The alimentary fluid, such as gastric juice, filtered and buffered by the filter unit, is then moving towards the detection strip driven by capillary force.
The fluid first encounters the capture ligands conjugated with a colloidal dye, such as colloidal gold particles. Antigens present in the fluid sample bind with the capture ligand conjugate and travel together with free capture conjugate towards detection ligand bands.
Antigens carned by the capture conjugate that are recognized by the detection ligand bands pre-immobilized on the detection strip form the colloidal dye-specific color bands, such as red bands if colloidal gold particles are used for the capture conjugate. The unbound capture conjugate continues to move towards the positive control band and forms a colored-band upon binding with the positive control ligands pre-immobilized on the detection strip.
The maximal time course required for the detection is 20 min. Upon finishing the test, the detection capsule is then pulled out and testing results is inspected through the transparent Part A of the detection capsule.
The results can be easily interpreted by a layman with simple instructions. If the disease antigens, such as antigens from Helicobacter infection, are not present in the patient's alimentary fluid, i.e. gastric juice, only the positive control band is visible. Because free capture conjugate does not bind with the detection ligands by itself. But if the disease antigen is present in the in situ alimentary fluid sample, both the positive control and detection bands will be visible.
This invention can be used for detecting diseases, such as bacteria, viruses, fungi and parasites infection, as well as cancers, in the upper alimentary tract and its peripheral organs, including the mouth, esophagus, stomach, duodenum, gallbladder, bile duct and pancrease. In particular, this invention can be used for testing Helicobacter pylori infection in the stomach.
This invention embodies a diagnostic method which detects disease antigens in situ in the alimentary tract, such as infection of the gastric mucosa by Helicobacter pylori, using a detection capsule restrained by a control string.
Helicobacter pylori can infect gastric mucosa and is implicated in diseases such as gastritis and gastric and duodenal ulcer. Once a diagnosis is made, the disease can usually be cured by using antibiotic regimens to eradicate the infection.
Current commercially available diagnosis are including invasive endoscopic gastric biopsies followed by urease test using urea and a pH indicator, microscopic examination or bacterial culture, which requires very skilled medical workers to perform, expensive equipment and very time consuming. Serological test measuring bacterial antigen-specific antibody levels is less invasive and a relatively routine clinical assay. But the presence of the antibodies in patients blood samples does not necessarily indicating there is a current infection. Other non-invasive method, such as '3C-labeled COZ breath test, in which radioactive material is administered, and special equipment is required to measure the results.
This invention embodies a in situ diagnostic method for alimentary diseases, such as Helicobacter infection. Compared to other commercially available method for detecting alimentary diseases, such as Helicobacter infection in the stomach, this detection method is very suitable for rapid in-office diagnosis and therapeutically monitoring disease conditions. It can also be used by patients themselves for at-home monitoring of such conditions with simple instructions. There are no radioactive or other hazardous materials used, no special equipment required, and the results can be easily interpreted. That is in addition to the rapid assay format (the whole process can be done within 20 min) and as a result of all these, the diagnostic test embodied by this invention is very cost effective.
f 1 The whole assembly embodies the detection capsule is the size of a pharmaceutical capsule.
In drawings which illustrate embodiments of the invention, Figure 1 is a plan view of the embodiment, Figure 2 is a top view of the Part B and C of the embodiment, Figure 3 is a plan view of Part C, and Figure 4 is a section of Part C.
Part A in Figure 1, is the control string which is used to hold and control the destination of the detection capsule. The destination of the detection capsule is simply controlled by the length of the string. Color paint or other markers can be used to mark the length of the string. A chart is provided as the reference of individuals body height compared to the physiological location of the specific alimentary organs, such as the stomach.
Part B in Figures 1, is attached by Part A. Part B embodies a plastic material non-digestible under physiological conditions of the alimentary tract. Part B' can be totally transparent or with a transparent window for monitoring the detection results.
Part C is inside Part B and D and held by Part B at the filter unit, C6 as shown in Figures 1 and 2. Part C is a mini-detection device, which embodies a nitrocellulose membrane strip, C2 as shown in Figures 3 and 4, sitting on top of a plastic support, C7 in Figure 4. A filter paper C 1 is sitting on the left side of the plastic support as shown in Figures 3 and 4. Two or more different antibodies or other ligands can be immobilized on the nitrocellulose membrane strip forming invisible ligand bands and with certain distance in between each band. One of the ligand bands, C3 as shown in Figure 3, is used as the positive control band. The positive control band is composed of antibodies against the capture ligands conjugated with a colloidal dye. One or more additional different ligand bands can be used as detection ligand bands, C4, as shown in Figure 3, which is used to detect disease antigens (such as catalase and urease of Helicobacter) carried by the capture ligands conjugated with a colloidal dye. The capture ligands conjugate is pre-absorbed in excess into a small filter paper, CS as shown in Figure 3, that is attached to the opposite end of the positive control band with detection bands in between. The filter unit, C6 as shown in Figures 3 and 4, is buffered to neutralized the extreme conditions of the alimentary fluid, and with certain pore size to prevent macro-molecular and debris from entry into the detection device.
Part D as shown in Figure l, is the capsule cap that embodies a special membrane for coating the filter unit of Part C. Part D is sealed tightly with the outside of Part B to prevent premature contact with fluid before the detection capsule reaches the destined location.
Upon reaching the specific location of the alimentary tract, such as the stomach, the membrane can be solublized because of the specific physiological condition of that location, such as low pH and the presence of pepsin in the stomach. This allows the filter unit of Part C to have direct contact with the alimentary fluid.
To perform a test, the detection capsule is ingested by patients with the aid of drinking water, while one end of the control string is being held. The detection capsule restrained by the control string will then destined to certain locations of the alimentary tract, such as the stomach. Upon reaching such location of the alimentary tract, such as the stomach, the detection capsule restrained by the control string stays, and one end of the capsule coated by special membrane becomes soluble because of the physiological conditions of the specific alimentary location, such as low pH and the presence of pepsin in the stomach.
This allows the filter unit to have direct contact with the alimentary fluid, such as gastric juice. The alimentary fluid, such as gastric juice, filtered and buffered by the filter unit, is then moving towards the detection strip driven by capillary force.
The fluid first encounters the capture ligands conjugated with a colloidal dye, such as colloidal gold particles. Antigens present in the fluid sample bind with the capture ligand conjugate and travel together with free capture conjugate towards detection ligand bands.
Antigens carned by the capture conjugate that are recognized by the detection ligand bands pre-immobilized on the detection strip form the colloidal dye-specific color bands, such as red bands if colloidal gold particles are used for the capture conjugate. The unbound capture conjugate continues to move towards the positive control band and forms a colored-band upon binding with the positive control ligands pre-immobilized on the detection strip.
The maximal time course required for the detection is 20 min. Upon finishing the test, the detection capsule is then pulled out and testing results is inspected through the transparent Part A of the detection capsule.
The results can be easily interpreted by a layman with simple instructions. If the disease antigens, such as antigens from Helicobacter infection, are not present in the patient's alimentary fluid, i.e. gastric juice, only the positive control band is visible. Because free capture conjugate does not bind with the detection ligands by itself. But if the disease antigen is present in the in situ alimentary fluid sample, both the positive control and detection bands will be visible.
This invention can be used for detecting diseases, such as bacteria, viruses, fungi and parasites infection, as well as cancers, in the upper alimentary tract and its peripheral organs, including the mouth, esophagus, stomach, duodenum, gallbladder, bile duct and pancrease. In particular, this invention can be used for testing Helicobacter pylori infection in the stomach.
Claims
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2224551 CA2224551A1 (en) | 1998-02-25 | 1998-02-25 | A quick in situ diagnostic method for detecting alimentary diseases |
| AU32423/99A AU3242399A (en) | 1998-02-25 | 1999-02-25 | Encapsulated diagnostics for alimentary analytes |
| PCT/CA1999/000172 WO1999044066A1 (en) | 1998-02-25 | 1999-02-25 | Encapsulated diagnostics for alimentary analytes |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2224551 CA2224551A1 (en) | 1998-02-25 | 1998-02-25 | A quick in situ diagnostic method for detecting alimentary diseases |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2224551A1 true CA2224551A1 (en) | 1999-08-25 |
Family
ID=4161889
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2224551 Abandoned CA2224551A1 (en) | 1998-02-25 | 1998-02-25 | A quick in situ diagnostic method for detecting alimentary diseases |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU3242399A (en) |
| CA (1) | CA2224551A1 (en) |
| WO (1) | WO1999044066A1 (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK1232392T3 (en) * | 1999-10-12 | 2003-07-28 | Connex Ges Zur Optimierung Von | Improved method for detecting acid-resistant bacteria of the genus Helicobacter in feces |
| AT4305U1 (en) * | 1999-11-15 | 2001-05-25 | Dipro Diagnostics Handels Gmbh | TEST DEVICE FOR A ONE-WAY TEST |
| ITPS20010019A1 (en) * | 2001-06-26 | 2002-12-26 | Muretto Pietro Aurelio Gaetano | ENDOGASTRIC CAPSULE |
| US7611480B2 (en) * | 2003-04-24 | 2009-11-03 | Levy Mark M | Gastrointestinal bioreactor |
| GB0805296D0 (en) | 2008-03-20 | 2008-04-30 | Iti Scotland Ltd | Uses of reagents in sample collection and cartridge systems |
| WO2013088396A1 (en) * | 2011-12-14 | 2013-06-20 | Stellenbosch University | Specimen collection apparatus |
| WO2013120184A1 (en) * | 2012-02-17 | 2013-08-22 | Micropharma Limited | Ingestible medical device |
| EP3883634A1 (en) | 2018-11-19 | 2021-09-29 | Progenity, Inc. | Methods and devices for treating a disease with biotherapeutics |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5479937A (en) * | 1989-09-21 | 1996-01-02 | Epitope, Inc. | Oral collection device |
| US5607863A (en) * | 1991-05-29 | 1997-03-04 | Smithkline Diagnostics, Inc. | Barrier-controlled assay device |
| BR9407718A (en) * | 1993-10-28 | 1997-11-11 | Barry J Marshall | In vivo diagnostic method for diseases of the upper gastrointestinal tract |
| GB2300914B (en) * | 1995-04-28 | 1998-04-29 | Tepnel Medical Ltd | Analytical device |
| US5874226A (en) * | 1995-05-22 | 1999-02-23 | H. Lee Browne | In situ immunodetection of antigens |
| US5716791A (en) * | 1996-05-09 | 1998-02-10 | Meridian Diagnostics, Inc. | Immunoassay for H. pylori in fecal specimens |
| US5738110A (en) * | 1996-05-29 | 1998-04-14 | Beal; Charles B. | Device for the diagnosis of certain gastrointestinal pathogens |
-
1998
- 1998-02-25 CA CA 2224551 patent/CA2224551A1/en not_active Abandoned
-
1999
- 1999-02-25 AU AU32423/99A patent/AU3242399A/en not_active Abandoned
- 1999-02-25 WO PCT/CA1999/000172 patent/WO1999044066A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| AU3242399A (en) | 1999-09-15 |
| WO1999044066A1 (en) | 1999-09-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |