CN110736841A - integration device for rapidly detecting fecal transferrin and detection method - Google Patents

integration device for rapidly detecting fecal transferrin and detection method Download PDF

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Publication number
CN110736841A
CN110736841A CN201911133178.2A CN201911133178A CN110736841A CN 110736841 A CN110736841 A CN 110736841A CN 201911133178 A CN201911133178 A CN 201911133178A CN 110736841 A CN110736841 A CN 110736841A
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China
Prior art keywords
transferrin
detection
line
groove
fecal
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CN201911133178.2A
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Chinese (zh)
Inventor
孙喜元
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Jiangsu Yuanhen Biotechnology Co Ltd
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Jiangsu Yuanhen Biotechnology Co Ltd
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Priority to CN201911133178.2A priority Critical patent/CN110736841A/en
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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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/6428Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
    • 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
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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

Abstract

The invention provides a device for quickly detecting fecal transferrin of , which is characterized by comprising a sampling rod, a detection reagent bottle main body, a reagent bottle main body shell and a puncture needle, wherein the device is simple and convenient to detect samples without complex sample processing process, the detection process is carried out in a closed environment, is friendly to non-professionals (such as family users or non-inspection doctors) due to no peculiar smell, can reduce the workload for professional use and can quickly process a large amount of samples.

Description

integration device for rapidly detecting fecal transferrin and detection method
Technical Field
The invention relates to detection devices, in particular to a quick detection device and a detection method for biological samples.
Background
The method is characterized in that the conventional fecal occult blood detection can find a small amount of bleeding of the digestive tract, and is favorable for clearly determining the reason of the bleeding of the digestive tract, when the bleeding of the digestive tract is small, particularly the bleeding of an upper digestive tract focus, hemoglobin in the blood is subjected to the action of gastric acid, digestive enzymes and bacteria to cause the antigenicity of the hemoglobin to be reduced, so that the hemoglobin is negatively influenced by the hemoglobin detection by a double-antibody sandwich method, false negative easily occurs and missed diagnosis is caused, and transferrin in the blood enters the gastrointestinal tract during the bleeding of the digestive tract, and the transferrin in the blood can overcome the false negative occurring when the hemoglobin in a detected specimen is decomposed and damaged due to long retention time in the gastrointestinal tract by detecting the fecal transferrin, so that whether the bleeding of the digestive tract exists or not can be judged by detecting the fecal transferrin, and the accurate diagnosis can be facilitated in step .
the transferrin in feces is detected by immunochromatography, which requires taking feces by a sampling rod into a specimen processing tube containing diluent, mixing them evenly, unscrewing a bottle cap, dropping the sample and detecting, interpreting the result, leakage of the liquid when the sample is mixed and uncovered, peculiar smell in the whole process of dropping the sample and interpreting the result, etc., which affects the detecting personnel.
Disclosure of Invention
The invention aims to provide devices and methods for rapidly detecting body of fecal transferrin.
The invention designs an integrated device to ensure that the sampling quantity of excrement is constant, improve the consistency of detection results, integrate the sampling and the detection into a body to simplify the operation, complete the detection and the result interpretation in a closed isolation space, isolate peculiar smell and protect operators.
According to aspect of the invention, fast detection feces transferrin integrated device is provided, which comprises a sampling rod, a detection reagent bottle body, a reagent bottle body casing and a puncture needle.
According to aspects of the invention, devices for rapidly detecting fecal transferrin are provided, wherein a sampling rod is provided with an inverted buckle and a front end column body, and the end of the front end column body of the sampling rod is provided with a thread;
the detection reagent bottle main body is provided with a test strip, a top ring opening, a bottom ring opening, a pipe body inclined baffle, a test strip clamping groove seat, a bottom gap of the test strip clamping groove seat, two cylindrical cavities, a conical cavity and a sample preservation solution, wherein the top ring opening and the bottom ring opening are both sealed by thin films, the top of the detection reagent bottle main body is provided with a groove, the groove is combined with the inverted buckle when in use, and the detection reagent bottle main body is provided with an inverted hook;
according to aspects of the invention, solid device for rapidly detecting fecal transferrin is provided, a reagent bottle main body shell is provided with a test strip card reading window, an inner boss, a test strip guide groove, a flow guide limiting column, a base solution receiving groove, a puncture needle limiting retaining ring and a puncture needle mounting hole.
According to aspects of the invention, devices for rapidly detecting fecal transferrin are provided, each device for rapidly detecting fecal transferrin comprises an outer package, an upper cover of the outer package, an inner cavity, a circular hole, an inner cavity, a concave ring in the outer package and a concave ring, the concave ring and the concave ring are small and fit to form a combined cover, the inner cavity is a shell for containing a kit main body, and a sampling rod is fixed in the circular hole and the inner cavity.
According to aspects of the invention, devices for rapidly detecting fecal transferrin are provided, each device for rapidly detecting fecal transferrin is provided with a sealing ring, and a sampling rod is provided with a sealing groove, wherein the size of the sealing groove is matched with that of the sealing ring.
According to aspects of the invention, devices for rapidly detecting fecal transferrin are provided, the main body of the detection reagent bottle is also provided with a sealing ring groove, a sealing ring desiccant storage groove, a desiccant, a test strip clamping groove seat transverse blocking table and a vertical blocking table, sealing films of a top ring opening and a bottom ring opening are in aluminum foil plastic package, and the cavity is matched with the groove and the sealing ring in size.
According to aspects of the invention, devices for rapidly detecting fecal transferrin are provided, the reagent bottle main body shell is further provided with a sealing groove, a water absorption paper groove and water absorption paper, and the size of the sealing ring groove, the sealing ring and the sealing groove are matched.
According to the aspect of the invention, devices for rapidly detecting fecal transferrin are provided, wherein the puncture needle is provided with a conical puncture needle, a plurality of sealing rings, a diversion trench, three sealing ring grooves and a puncture needle bottom convex ring, and the sealing ring grooves are matched with the sealing rings in size.
According to aspects of the invention, devices for rapidly detecting fecal transferrin are provided, the device for rapidly detecting fecal transferrin is further provided with a detection base, the detection base is provided with a detection base top pillar and a detection base shell, the inner diameter of the detection base shell is matched with the size of the kit main body shell, a puncture needle at the bottom of the kit main body shell is guided to be in contact with the detection base top pillar, a conical surface puncture needle is pushed to be pushed upwards, so that aluminum foil plastic package of a bottom ring opening is punctured, and a solution enters a base solution receiving groove for immunochromatography detection.
According to aspect of the invention, devices for rapidly detecting feces transferrin are provided, wherein the test strip in the test strip clamping groove seat is a feces transferrin detection test strip, the test strip comprises absorbent paper, a nitrocellulose membrane coated with a quality control line and a detection line, a marker binding pad and glass fiber, the marker binding pad contains colloidal gold-labeled mouse anti-transferrin monoclonal antibody A, the detection line (T line) on the nitrocellulose membrane contains coated mouse anti-transferrin monoclonal antibody B, and the quality control line (C line) on the nitrocellulose membrane contains coated goat anti-mouse IgG antibody.
According to aspect of the invention, methods for rapidly detecting fecal transferrin are provided, the method uses any devices for detection, and the detection method comprises the following steps:
step 1: opening the outer package, tearing the sealing film on the top ring opening (13) of the detection reagent bottle main body;
step 2: taking out the sampling rod, and randomly sampling at multiple points on the sample to be detected;
and step 3: inserting a sampling rod into the detection reagent bottle main body;
and 4, step 4: gently shaking and uniformly mixing the detection reagent bottle;
and 5: the detection reagent bottle main body is inserted into the kit main body shell and is placed into the detection base;
step 6: after 10-15 minutes, observing the detection result from the test strip card reading window; (ii) a
And 7: interpretation of the test results: the strip is positive when the quality control line (C line) and the detection line (T line) both show strips; only the band of the quality control line (line C) is negative; and if no strip appears in the quality control line (C line) and the detection line (T line), or a strip appears only in the detection line (T line), the experiment is invalid.
According to , methods for rapidly detecting fecal transferrin are provided, in the method, after a conical surface prick needle is pushed up, a bottom ring aluminum foil is punctured for plastic package, the solution enters a base solution receiving groove, glass fiber at the bottom end of a fecal transferrin detection test strip can firstly contact a preservative solution containing a sample to be detected, liquid flows along a nitrocellulose membrane to the direction of absorbent paper under the capillary action, immunochromatography detection is carried out, when transferrin is contained in feces, antigen-antibody specificity recognition is carried out on fluorescence-labeled mouse anti-transferrin monoclonal antibody A and transferrin in a marker binding pad, a transferrin-colloidal gold-labeled mouse anti-transferrin monoclonal antibody A binding substance is formed, the binding substance migrates to a detection area, namely a detection line (T line), along with the capillary action of the membrane, and reacts with mouse anti-transferrin monoclonal antibody B on the membrane to form mouse anti-transferrin monoclonal antibody B-transferrin-fluorescence-labeled mouse anti-transferrin monoclonal antibody A binding substance, a luminous strip appears under the excitation of ultraviolet light, no matter whether transferrin exists in the sample, and when the liquid surface migrates to a fixed mouse anti-transferrin antibody, namely a quality control line (C zone, the luminous strip appears under the excitation of ultraviolet light, whether the luminous strip appears normally appears or not appears.
Drawings
FIG. 1 is a schematic structural diagram of a body-made device shell for rapidly detecting fecal transferrin in implementation methods of the invention;
FIG. 2 is a schematic diagram of an outer package structure of a body device for rapidly detecting fecal transferrin in implementation methods;
FIG. 3 is a schematic diagram of a sampling rod of integrated device for rapid detection of fecal transferrin in practice methods of the present invention;
FIG. 4 is a schematic side structure diagram of a sampling rod of a integrated device for rapidly detecting fecal transferrin in implementation methods of the invention;
FIG. 5 is a schematic structural diagram of a sealing ring 29 in a body-based device for rapidly detecting fecal transferrin in implementation methods of the present invention;
FIG. 6 is a schematic structural diagram of a main body of a detection reagent bottle in a integrated device for rapidly detecting fecal transferrin in implementation methods of the invention;
FIG. 7 is a schematic view of a three-dimensional perspective structure of a detection reagent bottle main body in a integrated device for rapidly detecting fecal transferrin in practice methods of the invention;
FIG. 8 is another schematic diagram of a side view angle of a main body of a detection reagent bottle in a integrated device for rapidly detecting fecal transferrin in exemplary embodiments of the present invention;
FIG. 9 is a schematic structural diagram of a sealing ring 28 in a body-based device for rapidly detecting fecal transferrin in implementation methods of the present invention;
FIG. 10 is a schematic structural diagram of a main body housing of a reagent kit in a body-organizing device for rapidly detecting fecal transferrin in implementation methods of the invention;
FIG. 11 is a schematic diagram of the structure of a needle in a integrated device for rapid detection of fecal transferrin in ;
FIG. 12 is a schematic structural diagram of a sealing ring 38 in a body-based device for rapidly detecting fecal transferrin in exemplary embodiments of the present invention;
FIG. 13 is a schematic top view of the detection base of integrated device for rapid detection of fecal transferrin in exemplary embodiments of the present invention;
FIG. 14 is a schematic cross-sectional view of a sample rod, a main body of a detection reagent bottle, a casing of a kit main body and a puncture needle of a integrated device for rapidly detecting fecal transferrin in ;
FIG. 15 is a schematic representation of a cross-section of a human feces transferrin rapidly detected in volumetric apparatus according to ;
FIG. 16 is a graph showing the results of rapid detection of fecal transferrin in exemplary methods of the present invention.
Detailed Description
The present invention is further described in detail below with reference to the attached figures.
The structure of the sampling detection integration device is as follows
Example 1: shell structure
The cover 1 of the casing in fig. 1 and the outer shell 6 in fig. 2 form a complete casing, i.e. an outer package, of the reagent kit.
As in fig. 1, the housing inner concave ring 2, fig. 2, the inner concave ring 5 is sized and adapted to form a closure.
As shown in figure 2, the inner cavity 3 is a shell for containing the kit main body, and a sampling rod is fixed through the round hole 4 in figure 2 and the inner cavity 7 in figure 2.
Example 2: sampling rod
The upper end of the sampling rod is totally 12 inversions as 10 inversions in figure 3. Sample rod front end cylinder as in fig. 3 at 11, sample rod front end screw as in fig. 3 at 8: in order to ensure that enough sample amount is obtained, the thread length is lengthened and the thread groove is deepened. The sealing groove 9 in fig. 3 is dimensioned to the sealing ring 29 in fig. 5.
Example 3: detection reagent bottle main body
As shown in fig. 6, the top ring opening 13 and the bottom ring opening 19 of fig. 6 are both sealed by aluminum foil. When the kit is used, the aluminum foil plastic package of the top ring opening 13 is torn off.
The top notch 14 of fig. 6, in combination with the reverse 10 of fig. 3, locks the sampling rod after sampling is complete, preventing unnecessary oversampling.
The seal ring groove 15 of fig. 6 is sized to accommodate the seal ring 28 of fig. 9.
As in fig. 6 desiccant storage tank 17: after the drying agent is placed, the sealed space where the test strip is positioned can be kept dry;
as shown in fig. 6, the tube body inclined baffle 18: the detection reagent bottle main body is guided to be conveniently arranged in the kit main body shell.
As shown in fig. 7, the test strip slot seat 23: the test strip is installed, the length and the width of the test strip clamping groove seat are matched with the size of the test strip, the test strip can be conveniently installed in the test strip clamping groove, and the test strip can be fixed.
As shown in FIG. 7, the horizontal block 22 and the vertical block 21 of the test strip slot seat are provided with appropriate spaces for keeping the test strip installed conveniently, i.e. not inclined after being loaded.
As shown in fig. 7, the bottom end notch 20 of the test strip slot seat: so that the glass fiber at the bottom of the test strip can fully contact with the solution in the solution receiving groove 36 of FIG. 10, and the detection can be smoothly performed.
For example, the size of the strip holder 23 in FIG. 7 is adapted to the size of the bottom of the solution receiving well 36 in FIG. 10. is kept as a gap to allow the liquid to contact the glass fibers at the bottom of the strip for easy detection.
As in fig. 8 cylindrical cavity 27: 2ml of sample preservation solution is contained, and a sample obtained by a sampling rod is preserved;
as shown in FIG. 8, the cylindrical cavity 26 is adapted to the front end of the sampling rod 11 in FIG. 3, and keeps a tight fit.
The conical cavity 25 facilitates the introduction of a sampling rod into the sample holding fluid and provides a holding space for excess sample, as shown in fig. 8.
If the cylindrical cavity 26 in fig. 8 is a slender round hole, the excessive sample can be scraped off gradually, and the excessive sample is retained in the conical cavity 25 in fig. 8, so that the amount of the sample entering the sample preservation solution is constant.
The cylindrical cavity 24 of fig. 8, the sealing groove 9 of fig. 3 and the sealing ring 29 of fig. 5 are of suitable size, and can keep sealing after sampling.
Example 4: kit main body shell
As shown in fig. 10 for the test strip card reading window 30: after the test strip is used, a test strip film shows that a test sample result shows that a test strip appears, and the strip is read. The front surface of the test strip card reading window 30 is pasted with a transparent sealing protective film which is light-permeable, can read the detection result and simultaneously keeps the sealing and drying of the inner space when not in use.
As shown in FIG. 6, the barb 16 forms a snap fit with the boss 32 in FIG. 10, so that the main body of the detection reagent bottle and the shell of the main body of the reagent kit are locked and fixed and are not detachable.
The sealing ring grooves 15, 28 and 31 in fig. 6, 9 and 10 are matched in size, and meanwhile, the sealing rings are coated with sealing glue to keep the inner space dry in a sealing mode.
As in the test strip guide groove 37 of fig. 10: the test strip slot seat 23 of fig. 7 is guided to be installed in place, i.e. the test strip card reading window is adapted to the display area on the test strip.
As shown in fig. 10, the flow guiding limiting fence 33: after the aluminum foil plastic package of the bottom rim 19 of FIG. 6 is pierced by the top of the conical spike 47 of FIG. 11, the outflow of solution is restricted and the solution is guided into the solution receiving well of the base.
As shown in fig. 10, the base solution receiving tank 36: the volume of the solution can be about 200 mul, so that the glass fiber at the bottom end of the test strip can contact with the liquid, and the liquid flows along the test strip under the capillary action to carry out immunochromatography detection; the solution exceeding the volume of the receiving tank flows out and is absorbed by the absorbent paper in the bottom absorbent paper tank 46.
As shown in fig. 2, the absorbent paper tank 46 at the bottom holds absorbent paper: and the redundant sample preservation solution is absorbed during testing, the liquid is kept not to flow disorderly, and the absorbent paper can absorb 2ml of the sample preservation solution.
As shown in FIG. 10, the lancet retention stop 34: the pushed position of the puncture needle is limited, and the sealing effect of the sealing ring is prevented from being influenced by excessive pushing; prevent from being pushed insufficiently and being unable to puncture the tube bottom for plastic package.
As with the lancet mounting holes 35 of FIG. 10: the lancet is guided and mounted so that the lancet is flush with the bottom of the cartridge body housing.
Example 5: pricking pin
After the conical pricker 47 of fig. 11 is pushed up, the aluminum foil plastic envelope of the bottom ring 19 of fig. 6 is pierced, and the solution enters the solution receiving groove of the base.
The seal ring grooves 40, 41, 42 in FIG. 11 are sized to accommodate the seal ring 38 in FIG. 12, maintain a seal with the cylindrical cavity 48 in FIG. 10, and only slide relative to each other during the process of pushing the lancet up, and remain sealed.
For example, the guiding groove 39 in FIG. 11 and the guiding limiting rail 33 in FIG. 10 guide the sample preservation solution into the base solution receiving groove to limit the solution outflow.
As shown in FIG. 11, the bottom convex ring 43 of the puncture needle and the stop collar 34 of the puncture needle in FIG. 10 define the pushed position of the puncture needle, and the puncture needle is prevented from being pushed too much to influence the sealing effect of the sealing ring; prevent from being pushed insufficiently and being unable to puncture the tube bottom for plastic package.
Example 6: detection base
As shown in FIG. 13, the inner diameter of the test base shell 45 is adapted to the size of the test base shell, the bottom of the test base shell is guided to contact with the top pillar 44 of the test base of FIG. 13, and the conical surface pricker 47 of FIG. 11 is pushed upwards, so that the aluminum foil plastic package of the bottom ring 19 of FIG. 6 is pierced, and the solution enters the solution receiving groove 36 of the base for immunochromatography test.
Example 7: chromatography test paper strip (fluorescence immunochromatography)
The test strip loaded in the test strip slot seat 23 of fig. 7 is a fecal transferrin detection test strip, and the test strip comprises absorbent paper, a nitrocellulose membrane (coated with a quality control line (C line) and a detection line (T line)), a marker binding pad, and glass fiber; the marker combination pad contains colloidal gold-labeled mouse anti-transferrin monoclonal antibody A, the detection line (T line) on the nitrocellulose membrane contains coated mouse anti-transferrin monoclonal antibody B, the quality control line (C line) on the nitrocellulose membrane contains coated goat anti-mouse IgG antibody, and the antibody is provided by Zhuhai Bomei biotechnology Limited.
When a detection reagent bottle main body containing a sample to be detected is placed in a detection base, a conical surface pricker 47 in a figure 14 is pushed up and then pierces an aluminum foil plastic package of a bottom ring opening 19 in a figure 7, a solution enters a solution receiving groove 36 in the base in a figure 12, glass fibers at the bottom end of a fecal transferrin detection test strip can firstly contact a preservation solution containing the sample to be detected, and the liquid flows along a nitrocellulose membrane to a water absorption paper direction under the capillary action to carry out immunochromatography detection. When the feces contain transferrin, the colloidal gold labeled mouse anti-transferrin monoclonal antibody A in the marker combination pad and transferrin are subjected to antigen-antibody specific recognition to form a transferrin-colloidal gold labeled mouse anti-transferrin monoclonal antibody A combination, the combination migrates to a detection zone, namely a detection line (T line), along with the capillary action of the membrane and reacts with mouse anti-transferrin monoclonal antibody B on the membrane to form a mouse anti-transferrin monoclonal antibody B-transferrin-colloidal gold labeled mouse anti-transferrin monoclonal antibody A combination, and a red strip appears. A red band appeared after the liquid surface continued to migrate to the zone of immobilized goat anti-mouse IgG antibodies, the control line (line C), regardless of the presence of transferrin in the sample. The red strip of the quality control line (C line) is simultaneously used as the internal control standard of the reagent, which is helpful for judging whether the sample amount is enough or whether the chromatography process is normal.
Example 8: order of installation
FIGS. 14 and 15 are sectional views showing the body of the test reagent bottle with the sampling rod inserted after sampling.
1. Inserting the lancet into the cartridge body housing (fig. 14, 15);
2. a detection reagent bottle main body containing a test strip and a sample preservation solution is inserted into a main body shell of the kit (figures 14 and 15);
3. placing the assembled kit main body shell into the cavity 3 in the figure 2;
4. the sampling rod is fixed through the round hole 4 in fig. 2 and the inner cavity 7 in fig. 2;
5. the upper cover 1 of the outer shell in figure 1 is covered on the outer shell 6 in figure 2;
6. and (4) placing the assembly into an aluminum foil bag for sealing and storing.
Example 9: device using method
1. Opening the package of the shell, and tearing off the aluminum foil plastic package on the detection reagent bottle;
2. taking out the sampling rod, and randomly sampling at multiple points on the sample to be detected;
3. inserting a sampling rod into the main body of the detection reagent bottle;
4. gently shaking and uniformly mixing the detection reagent bottle main body;
5. the main body of the detection reagent bottle is inserted into the shell of the main body of the kit and is placed into a detection base;
6. after 10-15 minutes, observing the detection result from the test strip card reading window;
7. interpretation of the test results: the quality control line (C line) and the detection line (T line) show that the strip is positive (as shown in the left picture of figure 16); only the band of the control line (line C) is negative (see right panel of FIG. 16); and if no strip appears in the quality control line (C line) and the detection line (T line), or a strip appears only in the detection line (T line), the experiment is invalid.
Example 10: comparison with commercial kits
200 fecal samples are detected by using the fecal transferrin integrated detection device and a commercial fecal transferrin detection kit (commercial detection card), the commercial fecal transferrin detection kit (commercial detection card) performs sampling and sample adding according to the instruction of the detection card and reads the detection sample, and the obtained data statistics is as follows:
note: in the table, "+" represents positive detection and "-" represents negative detection.
The result of fecal transferrin is considered to be equivalent by the two kits and can be replaced by each other by the experiment, the result of the test of the two kits is considered to be equivalent by the two kits, the result of the test of the invention integrated device can be seen to be simple and convenient, the complicated sample processing process is not needed, the test process is free from peculiar smell because the test process is carried out in a closed environment, and the test process is friendly to non-professional persons (such as family users or non-inspection doctors), the workload can be reduced, and the samples can be rapidly processed by the professional persons.
It can be seen that the present invention can be used for biological sample testing without the need for complex sample processing procedures, and is more convenient for non-professional users, such as home users or non-clinical laboratory doctors, and the professional users can reduce the workload and rapidly process a large number of samples.
It is apparent to those skilled in the art that the above embodiments are of the present invention, and that various changes and modifications can be made without departing from the spirit and scope of the invention.

Claims (10)

1. An body device for rapidly detecting fecal transferrin is characterized by comprising a sampling rod, a detection reagent bottle body, a reagent bottle body shell and a puncture needle.
2. The device for rapidly detecting fecal transferrin according to claim 1, wherein said sampling rod is provided with a back-off (10) and a sampling rod front end column (11), said sampling rod front end column (11) is provided with a thread (8);
the detection reagent bottle main body is provided with a test strip, a top ring opening (13), a bottom ring opening (19), a pipe body inclined baffle plate (18), a test strip clamping groove seat (23), a bottom end notch (20) of the test strip clamping groove seat, a cylindrical cavity (27), a cylindrical cavity 26, a conical cavity 25 and a sample preservation solution, wherein the top ring opening (13) and the bottom ring opening (19) are both sealed films, the top of the detection reagent bottle main body is provided with a groove (14), the groove (14) is combined with the inverted buckle (10) during use, and the detection reagent bottle main body is provided with an inverted buckle (16);
the reagent bottle main body shell is provided with a test strip reading card window (30), an inner boss (32), a test strip guide groove (37), a flow guide limiting column (33), a base solution receiving groove (36), a puncture needle limiting retainer ring (34) and a puncture needle mounting hole (35).
3. The device for rapidly detecting fecal transferrin according to claim 1, wherein said device for rapidly detecting fecal transferrin is provided with a sealing ring (29), said sampling rod is provided with a sealing groove (9), said sealing groove (9) is adapted to the size of the sealing ring (29).
4. The device for rapidly detecting fecal transferrin according to claim 1, wherein the detection reagent bottle body is further provided with a sealing ring groove (15), a sealing ring (28), a desiccant storage tank (17), a desiccant, a test strip card slot seat crosspiece platform (22) and a vertical crosspiece platform (21), sealing films of a top collar (13) and a bottom collar (19) are plastic-sealed with aluminum foil, and the cavity (24) is matched with the groove (9) and the sealing ring (29) in size.
5. The device for rapidly detecting fecal transferrin according to claim 1, wherein the reagent bottle main body housing is further provided with a sealing groove (31), a paper absorbent groove (46) and paper absorbent, and the sealing ring groove (15), the sealing ring (28) and the sealing groove (31) are adapted in size.
6. The device for rapidly detecting fecal transferrin according to claim 1, wherein the needle is provided with a conical needle (47), a plurality of sealing rings (38), a guiding groove (39), a sealing ring groove (40), a sealing ring groove (41), a sealing ring groove (42) and a needle bottom convex ring (43), and the sealing ring groove (40), the sealing ring groove (41) and the sealing ring groove (42) are adapted to the size of the sealing ring (38).
7. The device for rapidly detecting fecal transferrin according to claim 1, wherein the device for rapidly detecting fecal transferrin is further provided with a detection base, the detection base is provided with a detection base top pillar (44) and a detection base housing (45), the inner diameter of the detection base housing (45) is adapted to the size of the kit body housing, the bottom puncture needle of the kit body housing is guided to contact with the detection base top pillar (44) and pushes against the conical surface puncture needle (47) to puncture (6) the bottom ring opening (19) of the plastic package of aluminum foil, and the solution enters the base solution receiving groove (36) for immunochromatography detection.
8. The device for rapidly detecting fecal transferrin according to claim 4, wherein the test strip in the test strip holder 23 is a fecal transferrin detection test strip, the test strip comprises absorbent paper, a nitrocellulose membrane coated with a quality control line and a detection line, a label binding pad containing colloidal gold labeled mouse anti-transferrin monoclonal antibody A, a detection line (line T) on the nitrocellulose membrane containing coated mouse anti-transferrin monoclonal antibody B, and a glass fiber, the quality control line (line C) on the nitrocellulose membrane containing coated goat anti-mouse IgG antibody.
9. A method for rapid detection of fecal transferrin, said method comprising the steps of using any of the devices of claims 1 to 8 to detect:
step 1: opening the outer package, and tearing off the sealing film on the top ring opening (13) of the detection reagent bottle main body;
step 2: taking out the sampling rod, and randomly sampling at multiple points on the sample to be detected;
and step 3: inserting a sampling rod into the detection reagent bottle main body;
and 4, step 4: gently shaking and uniformly mixing the detection reagent bottle;
and 5: the detection reagent bottle main body is inserted into the kit main body shell and is placed into the detection base;
step 6: after 10-15 minutes, observing the detection result from the test strip card reading window;
and 7: interpretation of the test results: the strip is positive when the quality control line (C line) and the detection line (T line) both show strips; only the band of the quality control line (line C) is negative; and if no strip appears in the quality control line (C line) and the detection line (T line), or a strip appears only in the detection line (T line), the experiment is invalid.
10. A method for rapidly detecting fecal transferrin is characterized in that a conical surface pricking pin (47) is pushed up and then pierces a bottom ring opening (19) of a graph (7) through aluminum foil plastic package, the solution enters a base solution receiving groove (36) of a graph (12), glass fiber at the bottom end of a fecal transferrin detection test strip can contact a preserving fluid containing a sample to be detected firstly, the liquid flows along a nitrocellulose membrane to the direction of absorbent paper under the capillary action to carry out immunochromatography detection, when the fecal contains transferrin, a colloidal gold-labeled mouse anti-transferrin monoclonal antibody A in a marker combination pad and transferrin carry out antigen-antibody specificity recognition to form a transferrin-colloidal gold-labeled mouse anti-transferrin monoclonal antibody A combination, the combination migrates to a detection zone, namely a detection line (T line), along with the capillary action of the membrane and reacts with the mouse anti-transferrin monoclonal antibody B on the membrane, and (3) forming a mouse anti-transferrin monoclonal antibody B-transferrin-colloidal gold labeled mouse anti-transferrin monoclonal antibody A conjugate, and generating a red strip no matter whether transferrin exists in the sample, after the liquid surface continuously migrates to a fixed goat anti-mouse IgG antibody zone, namely a quality control line (C line), the red strip of the quality control line (C line) is simultaneously used as an internal control standard of the reagent, so that the judgment of whether the sample amount is enough or whether the chromatography process is normal is facilitated.
CN201911133178.2A 2019-11-19 2019-11-19 integration device for rapidly detecting fecal transferrin and detection method Pending CN110736841A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111458502A (en) * 2020-03-08 2020-07-28 北京化工大学 Microfluidic HIV urine detection device
CN115201469A (en) * 2022-09-07 2022-10-18 艾康生物技术(杭州)有限公司 Detection device
CN115267175A (en) * 2022-07-05 2022-11-01 杭州莱和生物技术有限公司 Integrated medical detector
CN115629064A (en) * 2022-11-30 2023-01-20 神州医疗科技股份有限公司 Sampling and detection integrated device and control method thereof
WO2023029054A1 (en) * 2021-09-06 2023-03-09 皮乐迪有限公司 Acquisition assembly
WO2024087868A1 (en) * 2022-10-26 2024-05-02 石家庄禾柏生物技术股份有限公司 Integrated sampling sealing kit

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103217313A (en) * 2013-03-25 2013-07-24 万华普曼生物工程有限公司 Stool collection and detection device, and stool detection method based on stool collection and detection device
CN106680477A (en) * 2017-02-14 2017-05-17 杭州诺辉健康科技有限公司 Excrement sampling and occult blood detection integrated device
CN207133293U (en) * 2017-05-18 2018-03-23 迈卓泰科(天津)医疗科技有限公司 A kind of portable feces occult blood detector
CN110018013A (en) * 2019-03-27 2019-07-16 江苏宝卫士生物科技有限公司 A kind of Medical sampling, detection integrated apparatus
CN209167324U (en) * 2018-10-26 2019-07-26 上海芯超生物科技有限公司 It is a kind of to detect the detecting device integrated of helicobacter pylori in fecal specimens
CN110261622A (en) * 2019-07-23 2019-09-20 珠海科域生物工程股份有限公司 A kind of fecal sample transferrins Test paper and preparation method thereof
CN110456048A (en) * 2019-09-10 2019-11-15 杭州和壹基因科技有限公司 Multi-functional excrement acquisition and detection device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103217313A (en) * 2013-03-25 2013-07-24 万华普曼生物工程有限公司 Stool collection and detection device, and stool detection method based on stool collection and detection device
CN106680477A (en) * 2017-02-14 2017-05-17 杭州诺辉健康科技有限公司 Excrement sampling and occult blood detection integrated device
CN207133293U (en) * 2017-05-18 2018-03-23 迈卓泰科(天津)医疗科技有限公司 A kind of portable feces occult blood detector
CN209167324U (en) * 2018-10-26 2019-07-26 上海芯超生物科技有限公司 It is a kind of to detect the detecting device integrated of helicobacter pylori in fecal specimens
CN110018013A (en) * 2019-03-27 2019-07-16 江苏宝卫士生物科技有限公司 A kind of Medical sampling, detection integrated apparatus
CN110261622A (en) * 2019-07-23 2019-09-20 珠海科域生物工程股份有限公司 A kind of fecal sample transferrins Test paper and preparation method thereof
CN110456048A (en) * 2019-09-10 2019-11-15 杭州和壹基因科技有限公司 Multi-functional excrement acquisition and detection device

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111458502A (en) * 2020-03-08 2020-07-28 北京化工大学 Microfluidic HIV urine detection device
WO2023029054A1 (en) * 2021-09-06 2023-03-09 皮乐迪有限公司 Acquisition assembly
CN115267175A (en) * 2022-07-05 2022-11-01 杭州莱和生物技术有限公司 Integrated medical detector
CN115201469A (en) * 2022-09-07 2022-10-18 艾康生物技术(杭州)有限公司 Detection device
CN115201469B (en) * 2022-09-07 2023-08-29 艾康生物技术(杭州)有限公司 Detection device
WO2024087868A1 (en) * 2022-10-26 2024-05-02 石家庄禾柏生物技术股份有限公司 Integrated sampling sealing kit
CN115629064A (en) * 2022-11-30 2023-01-20 神州医疗科技股份有限公司 Sampling and detection integrated device and control method thereof

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