CN116593719A - FOB fecal occult blood and HP helicobacter pylori combined detection strip and detection method thereof - Google Patents

FOB fecal occult blood and HP helicobacter pylori combined detection strip and detection method thereof Download PDF

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Publication number
CN116593719A
CN116593719A CN202310307528.2A CN202310307528A CN116593719A CN 116593719 A CN116593719 A CN 116593719A CN 202310307528 A CN202310307528 A CN 202310307528A CN 116593719 A CN116593719 A CN 116593719A
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detection
strip
helicobacter pylori
occult blood
fecal
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王金鹏
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Hangzhou Yiteng Xingrui Biotechnology Co ltd
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Hangzhou Yiteng Xingrui Biotechnology Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G01N33/721Haemoglobin
    • G01N33/726Devices
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • G01N33/54387Immunochromatographic test strips
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56911Bacteria
    • G01N33/56916Enterobacteria, e.g. shigella, salmonella, klebsiella, serratia
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Immunology (AREA)
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  • Urology & Nephrology (AREA)
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Abstract

The invention relates to a FOB occult blood and HP helicobacter pylori combined detection strip and a detection method thereof, wherein the detection method comprises the following steps: s1, randomly inserting and sampling human excrement through a sample chromatographic zone at the end part of a detection strip, and then carrying out upward chromatography under the capillary effect; s2, after the detection strip stands for a period of time, whether the FOB fecal occult blood and the HP helicobacter pylori in the fecal sample are positive or not is judged through the color band change of the first detection area, the second detection area and the quality control area on the detection strip. The detection strip can realize synchronous detection of two antigens FOB and HP, and can display two detection results simultaneously after single fecal sample sampling, so that patients do not need invasive detection and non-invasive detection of medical institutions, and the home autonomous detection results are clear at a glance.

Description

FOB fecal occult blood and HP helicobacter pylori combined detection strip and detection method thereof
Technical Field
The invention relates to the field of biomedical detection, in particular to a FOB fecal occult blood and HP helicobacter pylori combined detection strip and a detection method thereof.
Background
When the human body is detected healthily, helicobacter pylori detection and fecal occult blood detection are involved, and the helicobacter pylori detection modes comprise:
1. blood drawing examination: this method is mainly to judge helicobacter pylori infection by checking the amount of helicobacter pylori antibodies by blood drawing, and is generally inaccurate. Since helicobacter pylori is colonized on the surface of the gastric mucosa, it is generally not available to the blood, and after healing, the patient remains in the blood for 1 to 2 years with helicobacter pylori antibodies, during which time false positive results occur when blood is drawn.
2. C13 and C14 urea breath test: because C14 pollutes human body and environment, the isotope can not be degenerated in human body (6 ten thousand years in the whole degenerated period) after taking, so the method is not suitable for pregnant women and children. C13 is non-radioactive and does not pollute the environment, and the method needs to take corresponding C13 marked urea, but can not take medicines such as stomach and the like to medical institutions for empty stomach and within a week.
3. Saliva detection method: the saliva test board is used for detecting the humor antigen indirectly, and the urease sensitivity and specificity are measured, but the detection needs to be completed by a professional medical institution.
4. Gastroscope and gastric mucosa biopsy: the method is characterized in that the accuracy of histological examination pathological section is high, the accuracy of quick urease test chemical reaction is low, and because the method belongs to an invasive mode, helicobacter pylori in the stomach is distributed in a focus shape, and the mucous membrane part possibly taken is free of bacteria, miss diagnosis, cause false negative and have high cost, some patients are relatively exclusive, and the method is not suitable for general investigation.
In summary, helicobacter pylori detection mainly includes both invasive and non-invasive tests. Blood sampling tests, C13 and C14 breath tests, saliva tests are non-invasive tests, while gastroscopy and gastric mucosal biopsies are invasive tests.
The fecal occult blood test (FOB) is a test in which blood is carried in the feces when the amount of hemorrhage in the digestive tract is small, and a small amount of red blood cells in the feces are destroyed, and the test can be only performed by a chemical or immunological method, and the test method of the fecal occult blood test includes:
1. the traditional method comprises the following steps: method for reducing phenolphthalein benzidine method, o-toluidine method, colorless malachite green method, guaiacyl ester method and Piramide hole method
2. An immunization method;
3. hemoglobin detection method (FOB) -detecting hemoglobin (Hb) in feces;
4. transferrin detection method- -a chemical method for detecting transferrin in feces 2.1;
5. conventional method
Principle of: the heme peroxidase activity in the hemoglobin can catalyze hydrogen peroxide, emit nascent oxygen, oxidize acceptor reagent and develop color.
The advantages are that: the results showed fast and clear, and the results could be semi-quantitative.
Disadvantages: A. poor specificity and is greatly affected by diet. Food and drugs containing ferrous ions interfere with the results and the false positive rate is 30%. Before the occult blood test, the patient is instructed to avoid taking iron, animal blood, liver, lean meat and a large amount of green leaf vegetables for 3 days, such as gingival bleeding, and not to swallow blood saliva, so as to prevent the fecal occult blood test from being false positive.
B. The sensitivity is low, and the bleeding amount is more than 90 mug/ml.
C. The methodological constraints are as follows: the patient is prepared for a long time in advance. Because of different material-drawing parts, different reaction time and different judgment on color development, errors can also be generated in the test of the same method.
Moreover, at present, no means and method for synchronously detecting the foetus occult blood and the HP helicobacter pylori are available, and the patent designs a method for carrying out joint detection on the foetus occult blood and the HP helicobacter pylori based on the existing technical problems.
Disclosure of Invention
The invention aims to solve the defects in the prior art and provides a FOB fecal occult blood and HP helicobacter pylori combined detection strip and a detection method thereof.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the FOB fecal occult blood and HP helicobacter pylori combined detection strip consists of a sample chromatographic zone, a reagent part and an unfolding part;
the sample chromatographic zone is positioned at the end part of the detection strip, the reagent part is connected with the sample chromatographic zone, and the unfolding part is connected with the reagent part;
the unfolding part is provided with a first detection area, a second detection area and a quality control area.
A detection method of a FOB occult blood and HP helicobacter pylori combined detection strip comprises the following steps:
s1, randomly inserting and sampling human excrement through a sample chromatographic zone at the end part of a detection strip, and then carrying out upward chromatography under the capillary effect;
s2, after the detection strip stands for a period of time, whether the FOB fecal occult blood and the HP helicobacter pylori in the fecal sample are positive or not is judged through the color band change of the first detection area, the second detection area and the quality control area on the detection strip.
If a purple red strip appears in the first detection area, the detection result is that the FOB occult blood is positive, the fecal sample contains human hemoglobin, otherwise, the detection result is that the FOB occult blood is negative;
if a purple red strip appears in the second detection area, the detection result is positive for HP helicobacter pylori, the fecal sample contains fecal HP antigen, otherwise, the detection result is negative for HP helicobacter pylori;
the mauve band appears in the quality control zone regardless of whether human hemoglobin and/or fecal HP antigen is present in the fecal sample.
The purplish red band appearing in the quality control area is a standard for judging whether enough samples exist or not and whether the chromatography process is normal or not, and is also used as an internal control standard of the reagent.
The outside of the detection strip is provided with a shell, the shell is provided with a display window, and the first detection area, the second detection area and the quality control area are displayed through the display window.
The detection reagent of the reagent part adopts a monoclonal antibody technology and an immunochromatography technology, specifically a colloidal gold and latex method, and the detection principle is a double-antibody sandwich method.
The beneficial effects of the invention are as follows: the detection strip can realize synchronous detection of two antigens FOB and HP, and after single fecal sample sampling, the detection strip can display two detection results simultaneously, so that patients do not need invasive detection and non-invasive detection of medical institutions, and the home autonomous detection results are clear at a glance;
moreover, the invention adopts the method of detecting by using the gold and latex, thereby being more accurate and effective; the embarrassment of queuing and sampling in hospitals is avoided in home detection; the operation is simple and rapid, only a few steps are needed, and the detection result is obtained within 5-10 minutes.
Drawings
FIG. 1 is a graph showing the results of the test strips when FOB shows positive occult blood and HP has negative helicobacter pylori;
FIG. 2 is a graph showing the results of the test strips when HP helicobacter pylori is positive and FOB occult blood is negative;
FIG. 3 is a graph showing the results of the test strips when FOB is positive for occult blood and HP helicobacter pylori;
FIG. 4 is a graph showing the results of the test strips when FOB is negative for occult blood and HP helicobacter pylori;
FIG. 5 is a graph showing the results of a test strip detection when it is not valid;
FIG. 6 is a graph showing another display of test strip detection invalidity.
Detailed Description
The FOB fecal occult blood and HP helicobacter pylori combined detection strip consists of a sample chromatographic zone 1, a reagent part 2 and an unfolding part 3;
the sample chromatographic zone 1 is positioned at the end part of the detection strip, the reagent part 2 is connected with the sample chromatographic zone 1, and the unfolding part 3 is connected with the reagent part 2;
the unfolding part 3 is provided with a first detection area A, a second detection area B and a quality control area C, a shell is arranged outside the detection strip, a display window is arranged on the shell, and the first detection area A, the second detection area B and the quality control area C are displayed through the display window.
The detection method of the FOB occult blood and HP helicobacter pylori combined detection strip specifically comprises the following steps:
s1, randomly inserting and sampling human excrement through a sample chromatographic zone 1 at the end part of a detection strip, and then carrying out upward chromatography under the capillary effect;
s2, after the detection strip stands for a period of time, whether FOB in the fecal sample is positive to occult blood and HP helicobacter pylori is judged through the color band change of the first detection area A, the second detection area B and the quality control area C on the detection strip.
As shown in fig. 1, a purple red band appears in the first detection area a, the detection result is positive for the FOB occult blood, the fecal sample contains human hemoglobin, otherwise, the detection result is negative for the FOB occult blood;
as shown in FIG. 2, a purple red strip appears in the second detection zone B, the detection result is positive for HP helicobacter pylori, the fecal sample contains fecal HP antigen, otherwise, the detection result is negative for HP helicobacter pylori;
as shown in FIG. 3, the first detection zone A has a purple red band, the second detection zone B has a purple red band, the detection result is that FOB is positive in occult blood, the fecal sample contains human hemoglobin, the detection result is that HP helicobacter pylori is positive, and the fecal sample contains fecal HP antigen.
As shown in FIG. 4, the first detection zone A and the second detection zone B have no mauve band, and when the quality control zone C has a mauve band, the detection result is that FOB is negative in occult blood and HP helicobacter pylori is negative.
As shown in fig. 5 and 6, no matter whether human hemoglobin and/or fecal HP antigen exist in fecal samples, mauve bands appear in quality control zone C, otherwise, the detection result is invalid.
The purple red band appearing in the quality control region C is a standard for judging whether a sufficient sample exists or not, and whether the chromatographic process is normal or not, and is also used as an internal control standard of the reagent.
The detection reagent of the reagent part adopts a monoclonal antibody technology and an immunochromatography technology, specifically a colloidal gold and latex method, and the detection principle is a double-antibody sandwich method.
The detection strip can realize synchronous detection of two antigens FOB and HP, and after single fecal sample sampling, the detection strip can display two detection results simultaneously, so that patients do not need invasive detection and non-invasive detection of medical institutions, and the home autonomous detection results are clear at a glance;
moreover, the invention adopts the method of detecting by using the gold and latex, thereby being more accurate and effective; the embarrassment of queuing and sampling in hospitals is avoided in home detection; the operation is simple and rapid, only a few steps are needed, and the detection result is obtained within 5-10 minutes.
The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made therein without departing from the spirit and scope of the invention, which is defined by the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims (8)

1. The FOB fecal occult blood and HP helicobacter pylori combined detection strip is characterized by comprising a sample chromatographic zone, a reagent part and an unfolding part;
the sample chromatographic zone is positioned at the end part of the detection strip, the reagent part is connected with the sample chromatographic zone, and the unfolding part is connected with the reagent part;
the unfolding part is provided with a first detection area, a second detection area and a quality control area.
2. A detection method of a FOB occult blood and HP helicobacter pylori combined detection strip is characterized by comprising the following steps:
s1, randomly inserting and sampling human excrement through a sample chromatographic zone at the end part of a detection strip, and then carrying out upward chromatography under the capillary effect;
s2, after the detection strip stands for a period of time, whether the FOB fecal occult blood and the HP helicobacter pylori in the fecal sample are positive or not is judged through the color band change of the first detection area, the second detection area and the quality control area on the detection strip.
3. The method of claim 2, wherein if a purple red band appears in the first detection zone, the detection result is positive for the foetus-occult blood, and the faecal sample contains human hemoglobin, otherwise, the detection result is negative for the foetus-occult blood.
4. The method according to claim 2, wherein if a purple red band appears in the second detection zone, the detection result is positive for HP helicobacter pylori, and the fecal sample contains fecal HP antigen, otherwise, the detection result is negative for HP helicobacter pylori.
5. The method of claim 2, wherein the purple-red band is present in the quality control zone regardless of whether human hemoglobin and/or fecal HP antigen is present in the fecal sample.
6. The method according to claim 5, wherein the purple red band appearing in the quality control region is a criterion for judging whether there is a sufficient sample and whether the chromatographic process is normal, and is also used as an internal control criterion for the reagent.
7. The method for detecting the combined detection strip of the foetus occult blood and the HP helicobacter pylori according to claim 5, wherein a shell is arranged outside the detection strip, a display window is arranged on the shell, and the first detection area, the second detection area and the quality control area are displayed through the display window.
8. The method for detecting a combined test strip of foetus occult blood and HP helicobacter pylori according to claim 5, wherein the detection reagent of the reagent section adopts a monoclonal antibody technique and an immunochromatography technique.
CN202310307528.2A 2023-03-27 2023-03-27 FOB fecal occult blood and HP helicobacter pylori combined detection strip and detection method thereof Pending CN116593719A (en)

Priority Applications (1)

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CN202310307528.2A CN116593719A (en) 2023-03-27 2023-03-27 FOB fecal occult blood and HP helicobacter pylori combined detection strip and detection method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310307528.2A CN116593719A (en) 2023-03-27 2023-03-27 FOB fecal occult blood and HP helicobacter pylori combined detection strip and detection method thereof

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CN116593719A true CN116593719A (en) 2023-08-15

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