Detection kit for detecting human excrement hemoglobin

Abstract

The utility model provides a detection kit for detecting human excrement hemoglobin, which comprises a shell and an excrement sampling rod component, the shell comprises an upper shell and a lower shell, an inlet sleeve is formed on the upper shell, the upper shell and the lower shell are buckled and connected to form an internal accommodating space, the inlet sleeve extends into the internal accommodating space, and the excrement sampling rod component is arranged on the lower shell. A sealing sheet is integrally formed at the extending tail end of the inlet sleeve; the inner accommodating space comprises a chromatography cavity, a detection test strip is arranged in the chromatography cavity, and the detection test strip is coated with a goat anti-mouse second antibody serving as a C line and a specific mouse anti-human hemoglobin antibody serving as a T line; the first end of the sampling rod can pierce the sealing sheet so that liquid sealed by the sealing sheet flows into the chromatography cavity and is in contact with the detection test strip. In the downward insertion process of the excrement sampling rod assembly, the sample liquid can be infiltrated and contacted with the detection test strip, so that the human excrement hemoglobin can be detected, the operation is simple, and the result is intuitively judged.

Description

Technical Field

[0001] The utility model belongs to the technical field of instant detection, and in particular relates to a detection kit for detecting human fecal hemoglobin. Background Art

[0002] The testing of stool samples has become a common examination item in clinical medicine. The examinees usually need to collect samples by themselves and send them to the testing agency as soon as possible. Professionals will dilute the samples accordingly and use test strips for testing. After the test is completed, the test strips will be discarded. During the testing process, the stool samples will drip out of the bottle and be exposed to the environment, causing environmental pollution. The discarding process is not safe and hygienic enough.

[0003] With the development of society, stool samples can be used to detect and prevent a variety of diseases. The usage environment has gradually shifted from hospitals and testing institutions to ordinary consumers' home environments, improving the efficiency of detection. Currently, devices that integrate collection and detection have appeared on the market, but there are still limitations such as complex operation.

[0004] Fecal testing is one of the effective methods for evaluating digestive system diseases. It provides a certain diagnostic basis for intestinal health assessment and clinical diagnosis of intestinal inflammatory diseases. Fecal occult blood test is an effective routine examination for diagnosing and monitoring gastrointestinal bleeding diseases. It is mainly used for small amounts of gastrointestinal bleeding that cannot be judged by the naked eye. It has a wide range of clinical diagnostic value in the diagnosis of gastrointestinal bleeding. It is also one of the important means to discover gastrointestinal tumors. The most commonly used methods are chemical methods (including o-tolidine method, occult blood powder method, guaiac method) and immunological methods (colloidal gold labeled sandwich immunoassay). The traditional chemical method is low in cost, but has many false positives, low sensitivity, and is carcinogenic to operators; the emerging immunocolloidal gold method is slightly more expensive, but because of its good specificity, no dietary restrictions, rapid, simple, accurate, and convenient clinical use, it is becoming more and more widely used. There are many detection methods for fecal occult blood tests. Compared with the previous chemical method, the immunoassay is simple to operate, the results are displayed quickly, it is easy to observe, and no reagent preparation is required. It avoids the harm caused by the toxicity of certain chemical reagents to operators, which brings convenience to daily work.

[0005] The immunocolloidal gold method combines monoclonal technology with colloidal gold technology, and uses the highly specific characteristics of monoclonal antibodies against human hemoglobin or human erythrocyte matrix to detect fecal occult blood. The preparation of monoclonal antibodies against human hemoglobin can be used to specifically detect fecal occult blood using various immunological techniques. This method is much more sensitive than chemical methods. It can detect 100ng / ml of hemoglobin, that is, it can detect trace amounts of hemoglobin in feces, which is very important for the early diagnosis of gastrointestinal bleeding diseases, and has no cross-reaction with a variety of meats, vegetables and drugs.

[0006] Therefore, it is necessary to develop a device that integrates the collection and detection of fecal samples, with convenient sampling and simple operation; the detection can achieve sample quantification, chromatography fluid quantification, and improve detection sensitivity and accuracy; and the device has few assembled parts. Utility Model Content

[0007] The utility model provides a detection kit for detecting human fecal hemoglobin, which can solve the technical problem of complicated operation of the detection kit for detecting human fecal hemoglobin in the prior art.

[0008] In order to solve the above problems, the utility model provides a detection kit for detecting human fecal hemoglobin, comprising a shell and a feces sampling rod assembly, the shell comprising an upper shell and a lower shell, the upper shell forming an inlet sleeve for inserting the feces sampling rod assembly, the upper shell and the lower shell being snap-fitted and connected to form an internal accommodating space, the inlet sleeve extending into the internal accommodating space, and a sealing sheet integrally formed at the extended end of the inlet sleeve; the internal accommodating space comprises a chromatography cavity, a detection assembly is arranged in the chromatography cavity, the detection assembly comprises a detection test strip, the detection test strip is coated with a sheep anti-mouse secondary antibody as a C line and a specific mouse anti-human hemoglobin antibody as a T line, the feces sampling rod assembly comprises a sampling rod, when the feces sampling rod assembly is inserted into the inlet sleeve, the first end of the sampling rod can pierce the sealing sheet so that the liquid sealed by the sealing sheet flows into the chromatography cavity and contacts the detection test strip.

[0009] In some embodiments, the test strip includes a PVC backboard, a nitrocellulose membrane is connected to the first side of the PVC backboard, an absorbent paper is stacked on the first end of the nitrocellulose membrane, a gold label pad is stacked on the second end of the nitrocellulose membrane, a sample pad is stacked on the end of the gold label pad away from the nitrocellulose membrane, and the C line and the T line are sequentially spaced on the nitrocellulose membrane in a direction from the first end to the second end of the nitrocellulose membrane.

[0010] In some embodiments, the detection component also includes a test paper strip, a first side of the test paper strip is formed with a test paper slot for positioning the test paper strip, and a second side is formed with a desiccant slot for positioning the desiccant, the first side and the second side are respectively located on opposite sides of the test paper strip, and a notch is formed at the top of the desiccant slot.

[0011] In some embodiments, the stool sampling rod assembly also includes a sealing cover, which has a cover plate and an outer ring tube and an inner ring tube formed on one side end surface of the cover plate, and the inner ring tube is concentrically arranged inside and outside the outer ring tube; the first end of the sampling rod is formed with a sampling portion, and the second end of the sampling rod can be detachably inserted into the inner ring tube.

[0012] In some embodiments, a plurality of clamping strips spaced around the sampling rod are provided on the outer peripheral wall of the rod body of the sampling rod corresponding to the second end, and clamping grooves corresponding to each of the clamping strips are formed on the inner cylinder wall of the inner ring cylinder.

[0013] In some embodiments, each of the clamping strips further has a protrusion, and a groove matching each of the protrusions is formed on the bottom wall of the clamping slot.

[0014] In some embodiments, a sealing ring groove is provided on the outer circumferential wall of the rod body of the sampling rod for mounting a first sealing ring, and the sealing ring groove is provided adjacent to one end of the clamping strip close to the sampling portion.

[0015] In some embodiments, the sampling portion is a spiral groove arranged around the outer circumferential wall of the sampling rod.

[0016] In some embodiments, an annular flange protruding radially inwardly along the outer ring cylinder is formed on the inner cylinder wall of the outer ring cylinder, and an annular groove is formed on the outer circumferential wall of the inlet sleeve, and the annular flange and the annular groove are adapted to be snap-connected to each other.

[0017] In some embodiments, a scraper rubber ring is assembled inside the inlet sleeve, and the diameter of the through hole of the scraper rubber ring is equal to the outer circumference diameter of the sampling part.

[0018] The utility model provides a detection kit for detecting human fecal hemoglobin, which has the following beneficial effects:

[0019] The feces sampling rod assembly and the detection assembly are integrated in the shell, realizing collection, dilution and detection in one, which is suitable for the environmental requirements of self-testing in hospitals, testing institutions and ordinary consumers; the detection assembly includes a test strip coated with a sheep anti-mouse secondary antibody as a C line and a specific mouse anti-human hemoglobin antibody as a T line. During the insertion process of the feces sampling rod assembly, the sample liquid and the test strip can be infiltrated and contacted to realize the detection of human fecal hemoglobin. The operation is simple and the result judgment is intuitive. It is not only suitable for professional testers, but also patients can operate and judge the results by themselves. After the test is completed, it is discarded together with the entire device. The sample and the tested test strip are completely sealed in the device, which is safe, clean and convenient. In addition, the test kit of the utility model has a simple structure and low production cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the implementation of the utility model or the technical solution in the prior art, the following is a brief introduction to the drawings required for the implementation or the prior art description. Obviously, the drawings in the following description are only exemplary, and for ordinary technicians in this field, other implementation drawings can be derived from the provided drawings without creative work.

[0021] The structures, proportions, sizes, etc. illustrated in this specification are only used to match the contents disclosed in the specification so as to facilitate understanding and reading by persons familiar with the technology. They are not used to limit the conditions under which the present invention can be implemented, and therefore have no substantial technical significance. Any structural modification, change in proportion or adjustment of size shall still fall within the scope of the technical contents disclosed in the present invention without affecting the effects and purposes that can be achieved by the present invention.

[0022] Figure 1 It is a structural schematic diagram (cross section) of a stool sampling rod assembly according to an embodiment of the utility model;

[0023] Figure 2 for Figure 1 Schematic diagram of the structure of the sampling rod (front view);

[0024] Figure 3 for Figure 1 A schematic diagram of the structure of the sealing cover (section);

[0025] Figure 4 This is a schematic diagram of the internal structure of a test kit for detecting human fecal hemoglobin according to an embodiment of the utility model;

[0026] Figure 5 A schematic diagram of the three-dimensional structure of a test kit for detecting human fecal hemoglobin;

[0027] Figure 6 for Figure 4 A schematic diagram of the three-dimensional structure of the upper shell in FIG.

[0028] Figure 7 for Figure 4 A side view of the detection assembly in FIG.

[0029] Figure 8 for Figure 7 A front view of

[0030] Fig. 9 It is a schematic diagram of the structure of the test strip in the embodiment of the utility model;

[0031] Fig.10 It is a judgment standard for the detection result of the detection kit for detecting human fecal hemoglobin in the embodiment of the utility model in actual application.

[0032] The reference numerals are:

[0033] 1. Sealing cover; 11. Cover plate; 12. Outer ring cylinder; 121. Annular flange; 13. Inner ring cylinder; 131. Groove; 2. Sampling rod; 21. Sampling part; 22. Card strip; 221. Bump; 23. Sealing ring groove; 24. First sealing ring; 3. Upper shell; 31. Inlet sleeve; 311. Annular card groove; 312. Sealing sheet; 32. Scraper rubber ring; 4. Lower shell; 51. Test paper pressure strip; 511. Test paper strip; 5111. PVC back plate; 5112. Nitrocellulose membrane; 5113. Absorbent paper; 5114. Gold label pad; 5115. Sample pad; 512. Desiccant; 6. Observation window; 7. Second sealing ring. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means a limitation on the utility model and its application or use. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the utility model.

[0035] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0036] It should be understood that the term "and / or" used in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship.

[0037] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps described in these embodiments do not limit the scope of the utility model. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be regarded as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, so once a certain item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0038] In the description of the present utility model, it needs to be understood that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present utility model and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction, and therefore cannot be understood as limiting the scope of protection of the present utility model; the directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0039] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0040] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the utility model.

[0041] See also Figures 1 to 9 As shown, according to an embodiment of the utility model, a detection kit for detecting human fecal hemoglobin is provided, comprising a shell (not labeled in the figure) and a feces sampling rod assembly (not labeled in the figure), the shell comprising an upper shell 3 and a lower shell 4, the upper shell 3 is formed with an inlet sleeve 31 for inserting the feces sampling rod assembly, the upper shell 3 and the lower shell 4 are snap-fitted and connected to form an internal accommodating space, the inlet sleeve 31 extends into the internal accommodating space, and a sealing sheet 312 is integrally formed at the extended end of the inlet sleeve 31 to seal the reaction reagent in the inlet sleeve 31; the internal accommodating space comprises a chromatography cavity (not labeled in the figure), a detection assembly (not labeled in the figure) is arranged in the chromatography cavity, and the detection assembly comprises a detection test strip 511, the detection test strip 511 is coated with a sheep anti-mouse secondary antibody as a C line and a specific mouse anti-human hemoglobin antibody as a T line (see Fig. 9 As shown), the stool sampling rod assembly includes a sampling rod 2. When the stool sampling rod assembly is inserted into the inlet sleeve 31, the first end of the sampling rod 2 can pierce the sealing film 312 to allow the liquid sealed by the sealing film 312 to flow into the chromatography chamber and contact the test paper strip 511, so that the reacted sample liquid presents the test result after contacting the test paper strip 511.

[0042] In this technical solution, a feces sampling rod assembly and a detection assembly are integrated in the shell to realize collection, dilution and detection in one, which is suitable for the environmental requirements of self-testing in hospitals, testing institutions and ordinary consumers; the detection assembly includes a test strip 511 coated with a sheep anti-mouse secondary antibody as a C line and a specific mouse anti-human hemoglobin antibody as a T line. During the insertion process of the feces sampling rod assembly, the sample liquid can be infiltrated and contacted with the test strip 511 to detect human fecal hemoglobin. The operation is simple and the result judgment is intuitive. It is not only suitable for professional testers, but also patients can operate and judge the results by themselves. After the test is completed, it is discarded together with the entire device. The sample and the tested test strip are completely sealed in the device, which is safe, clean and convenient. In addition, the test kit of the utility model has a simple structure and low production cost.

[0043] See Fig. 9 As shown, the test paper strip 511 includes a PVC backboard 5111, a nitrocellulose membrane 5112 is connected to the first side of the PVC backboard 5111, an absorbent paper 5113 is stacked on the first end of the nitrocellulose membrane 5112, a gold label pad 5114 is stacked on the second end of the nitrocellulose membrane 5112, a sample pad 5115 is stacked on the end of the gold label pad 5114 away from the nitrocellulose membrane 5112, and the C line and T line are sequentially arranged on the nitrocellulose membrane 5112 in a direction from the first end to the second end of the nitrocellulose membrane 5112. In a specific use process, the first end of the nitrocellulose membrane 5112 is its top end, that is, the absorbent paper 5113 is at the top of the test paper strip 511. When the sample liquid flows into the chromatography chamber and contacts therewith, it can be smoothly absorbed and infiltrated upward. It can be understood that the gold label pad 5114 has a max line.

[0044] The utility model also provides a stool sampling rod assembly, including a sealing cover 1, wherein the sealing cover 1 has a cover plate 11 and an outer ring tube 12 and an inner ring tube 13 formed on one side end surface of the cover plate 11, wherein the inner ring tube 13 is concentrically arranged inside and outside the outer ring tube 12 and an annular gap is formed therebetween; a sampling portion 21 is formed at the first end of the sampling rod 2, and the second end of the sampling rod 2 is detachably inserted into the inner ring tube 13.

[0045] In this technical solution, unlike the prior art method of integrally molding the sealing cover and the sampling rod, the sealing cover and the sampling rod in the utility model are detachably connected, so that the sealing cover and the sampling rod can be processed separately and independently, effectively avoiding the shortcomings of complex processes caused by the large differences in shape and structure between the sealing cover and the sampling rod, and reducing the manufacturing difficulty and production cost. Specifically, the sealing cover 1 and the sampling rod 2 can be molded separately, wherein the longer sampling rod 2 can be ejected from the mold in a radial manner without axial ejection, which significantly reduces the up and down movement distance of the corresponding mold. At the same time, since the mold can be ejected in the radial direction, the mold does not need to be specially designed for the smaller diameter annular groove on the sampling rod 2, all of which can reduce the manufacturing difficulty and production cost.

[0046] In a specific embodiment, the second end of the sampling rod 2 is snap-connected to the inner cylinder wall of the inner ring cylinder 13, which can simplify the connection between the two and improve the assembly efficiency of the two. Specifically, a plurality of clamping strips 22 arranged at intervals around the sampling rod 2 are provided on the outer peripheral wall of the sampling rod 2 corresponding to the second end, and a clamping groove (not shown in the figure) corresponding to each of the clamping strips 22 is formed on the inner cylinder wall of the inner ring cylinder 13.

[0047] In this technical solution, the corresponding cooperation between the clamping strips 22 designed with circumferential intervals and the clamping grooves can limit the relative rotation of the sealing cover 1 and the sampling rod 2, and at the same time achieve a snap connection between the two.

[0048] In another more preferred embodiment, each of the clamping strips 22 further has a convex point 221, and a groove 131 matching each of the convex points 221 is formed on the bottom wall of the clamping groove. The stability of the axial relative position of the sealing cover 1 and the sampling rod 2 can be further ensured by the cooperation between the convex point 221 and the groove 131. It can be understood that at least one of the aforementioned convex point 221 or the groove 131 should have a certain elastic deformation ability to ensure that the two can be connected in an interference fit manner.

[0049] See Figure 1 and Figure 2 The outer circumferential wall of the sampling rod 2 is provided with a sealing ring groove 23 for mounting a first sealing ring 24, and the sealing ring groove 23 is arranged adjacent to one end of the clamping strip 22 close to the sampling portion 21. The first sealing ring 24 is arranged in the sealing ring groove 23 to form a seal on the matching seam between the inner ring tube 13 of the sealing cover 1 and the sampling rod 2 in the covered state, thereby preventing liquids such as reagents or samples from entering the matching seam. More importantly, it can also effectively prevent the aforementioned liquid from leaking out of the outside of the test kit for detecting human fecal hemoglobin through the sealing cover 1.

[0050] The sampling portion 21 is a spiral groove arranged around the outer circumferential wall of the sampling rod 2. The depth of the spiral groove and the number of turns of the groove in the axial direction of the sampling rod 2 can realize quantitative collection of fecal samples.

[0051] See Figure 4 As shown, the utility model also provides a detection kit for detecting human fecal hemoglobin, including a shell and the above-mentioned feces sampling rod assembly, the shell includes an upper shell 3 and a lower shell 4 snap-fitted with the upper shell 3, the upper shell 3 is formed with an inlet sleeve 31 for inserting the feces sampling rod assembly, the inner cylinder wall of the outer ring cylinder 12 is formed with an annular flange 121 protruding radially inward along the outer ring cylinder 12, the outer circumferential wall of the inlet sleeve 31 is formed with an annular groove 311, and the annular flange 121 and the annular groove 311 are adapted to be snap-fitted with each other.

[0052] In this technical solution, the sealing cover 1 and the inlet sleeve 31 are sealed by a concave-convex fitting connection. Compared with the threaded connection method in the prior art, the snap-fit ​​connection structure is simpler and more convenient to process, with lower processing costs, and the sealing operation is simpler and more convenient.

[0053] The upper shell 3 and the lower shell 4 are snap-fitted together to form an internal accommodating space. The inlet sleeve 31 extends into the internal accommodating space, and a sealing sheet 312 is integrally formed at the extended end of the inlet sleeve 31. When the stool sampling rod assembly is inserted into the inlet sleeve 31, the first end of the sampling rod 2 can pierce the sealing sheet 312. For example, the sealing sheet 312 is integrally injection-molded with the upper shell 3. Compared with the method of sticking a sealing film on the bottom end of the inlet sleeve 31 (the end extending into the upper shell 3) in the prior art, the manufacturing efficiency of the present invention is obviously higher.

[0054] A scraper rubber ring 32 is assembled inside the inlet sleeve 31, and the aperture of the through hole of the scraper rubber ring 32 is equal to the outer circumferential diameter of the sampling part 21. It can reduce the difficulty of mold making of the upper shell 3, and then reduce the difficulty of molding the upper shell 3. It can be understood that the aperture of the inner ring through hole of the aforementioned scraper rubber ring 32 matches the maximum outer diameter of the aforementioned sampling part 21, so as to scrape off the excess sample on the sampling part 21 and ensure the quantitative sample. The scraper rubber ring 32 has a certain elastic deformation ability and can be conveniently arranged in the cylinder of the inlet sleeve 31. It can be understood that the diameter of the through hole of the inlet sleeve 31 can be gradually reduced along the assembly direction of the scraper rubber ring 32, and when the outer diameter of the scraper rubber ring 32 is larger than the diameter of the through hole at the corresponding position, it can be axially positioned.

[0055] See also Figure 4 , Figure 7 and Figure 8 As shown, the internal accommodating space includes a chromatography cavity, and a detection component is arranged in the chromatography cavity, and the detection component includes a test paper strip 51, and a test paper slot for positioning the test paper strip 511 is formed on the first side of the test paper strip 51, and a desiccant slot for positioning the desiccant 512 is formed on the second side, and the first side and the second side are respectively located on opposite sides of the test paper strip 51, and a notch is formed on the top of the desiccant slot. In this technical solution, the test paper strip 51 serves as an assembly carrier for the test paper strip 511 and the desiccant 512 in the chromatography cavity, wherein the desiccant slot has an upward opening, which can facilitate the assembly of the desiccant 512.

[0056] A specific implementation of the test strip 511 is as follows: Fig.10 As shown, the judgment criteria for the test results are displayed.

[0057] Several achievable manufacturing methods of the test strip 511 of the present invention are described in detail below.

[0058] Specific implementation 1: Preparation of a colloidal gold assay kit for detecting human fecal hemoglobin

[0059] 1. Preparation of colloidal gold in homemade test strips:

[0060] (1) Take 99mL ultrapure water and 1mL 1% chloroauric acid aqueous solution, mix well, and heat to boil with magnetic stirring; (2) Quickly add 1-2mL 1% trisodium citrate solution and continue heating and boiling; (3) When the color of the colloidal gold solution changes from light yellow to blue-black and finally to wine red, continue heating and boiling for 10-20 minutes; (4) When the temperature of the prepared colloidal gold solution drops to room temperature, adjust the volume of the prepared colloidal gold solution to 100mL. (5) Finally, put the prepared colloidal gold solution in a clean glass bottle and store it at 4℃ for later use.

[0061] 2. Colloidal gold labeled FOB antibody:

[0062] (1) Adjust the pH of the colloidal gold solution to 8.0-9.0 with 0.2M potassium carbonate solution; (2) Add 10-20ug FOB antibody per ml of colloidal gold and stir with a magnetic stirrer for 30-60 min; (3) Add 10% BSA to the solution at 20-50ul / mL and let stand at room temperature for 30-60 min; (4) Centrifuge the colloidal gold mixed solution at 10000rpm / min for 30 minutes, discard the supernatant and take the precipitate; (5) Dissolve the obtained precipitate in 0.02M pH7.4 Tris-HCl buffer (containing 1-5% BSA) at 1mL / 100ul for later use.

[0063] 3. Test strip preparation:

[0064] Spray the labeled colloidal gold-FOB antibody conjugate on the glass fiber at a spray rate of 2.0-4.0 μL / cm; prepare the FOB antibody with PBS buffer to 1 mg / mL, and use a film scribing machine to evenly apply it to the designated area of ​​the NC membrane T line at a spray rate of 1.0 μL / cm to form a T line; similarly, prepare the goat anti-mouse secondary antibody with PBS buffer to 1 mg / mL, and use a film scribing machine to evenly apply it to the designated area of ​​the NC membrane C line at a spray rate of 1.0 μL / cm to form a C line; fix it in a 45°C constant temperature drying oven for 8-12 hours, and dry it at room temperature for later use. Paste the NC membrane with the antibody fixed on the PVC bottom plate, fix the direction of the PVC bottom plate according to the direction of the C line and the T line, tear off the adhesive on the bottom plate, and paste absorbent paper on the top of the NC membrane, pressing the NC membrane for about 2 mm. The colloidal gold binding pad coated with the colloidal gold-FOB antibody complex below the NC membrane presses the NC membrane for about 2 mm; press the sample pad for about 2 mm. Cut the assembled reagent plate into test strips with a width of 4 mm.

[0065] Put the cut test strips into the above test kit, buckle the upper shell, and make the direction of the sample hole consistent with the direction of the sample pad. Put the test kit for detecting human fecal hemoglobin into an aluminum foil bag and seal it.

[0066] 4. Detection

[0067] Using FOB quality control as the test object, the FOB standard was diluted with PBS buffer in sequence to make the concentrations of 500 ng / mL, 200 ng / mL, 100 ng / mL, 50 ng / mL, 10 ng / mL, and 0 ng / mL. 2 mL was taken from each sample and added to the reagent tube (11). The experimental results were observed after 10 minutes.

[0068] It can be seen from the results that when the FOB concentration is greater than 100 ng / mL, the red intensity on the test line increases with the increase in the FOB standard concentration; when the FOB concentration is less than 100 ng / mL, the test line does not show color.

[0069] The above results show that the detection limit of the test strip is 100 ng / mL. The test kit described in the utility model solves the problem of poor sensitivity and inconvenience in qualitatively detecting human hemoglobin in human feces.

[0070] Specific implementation 2: Preparation of a test kit for detecting human fecal hemoglobin by latex microsphere method

[0071] 1. Latex microspheres labeled with FOB antibody

[0072] Use 25mM MES buffer to activate the microspheres for 20 minutes, centrifuge and discard the supernatant; add an equal volume of 25mM HEPES buffer to wash, centrifuge and discard the supernatant; add 1 / 2 volume of 25mM HEPES buffer, add FOB antibody at a ratio of 50μg / mg microspheres, and react for 2 hours; block with 1 / 5 volume of blocking solution for 1 hour, centrifuge and discard the supernatant; add 1 / 4 volume of the original volume of re-solution to resuspend the microspheres to obtain latex microsphere labeled complex.

[0073] 2. Test Strip Preparation

[0074] The labeled complex was sprayed on the glass fiber at a dosage of 0.001 mL / cm2 labeled FOB antibody to obtain a labeled FOB binding pad. The FOB antibody was prepared into 1 mg / mL with PBS buffer, and was evenly applied to the designated area of ​​the NC membrane T line with a film scribing machine at a spray volume of 1.0 μL / cm2 to form a T line; similarly, the goat anti-mouse secondary antibody was prepared into 1 mg / mL with PBS buffer, and was evenly applied to the designated area of ​​the NC membrane C line with a film scribing machine at a spray volume of 1.0 μL / cm2 to form a C line; after being fixed in a 45°C constant temperature drying oven for 8 to 12 hours, it was dried and stored at room temperature for later use. The NC membrane fixed with antibodies was pasted on the PVC bottom plate, the direction of the PVC bottom plate was fixed according to the direction of the C line and the T line, the adhesive on the bottom plate was torn off, and absorbent paper was pasted on the top of the NC membrane, pressing the NC membrane for about 2 mm. The colloidal gold binding pad coated with the colloidal gold-FOB antibody complex below the NC membrane pressed the NC membrane for about 2 mm; the sample pad pressed the colloidal gold binding pad for about 2 mm. Cut the assembled reagent plate into test strips with a width of 4 mm.

[0075] Put the cut test strips into the above test kit, buckle the upper shell, and make the direction of the sample hole consistent with the direction of the sample pad. Put the test kit for detecting human fecal hemoglobin into an aluminum foil bag and seal it.

[0076] 3. Detection

[0077] Using FOB quality control as the test object, the FOB standard was diluted with PBS buffer in sequence to make the concentrations of 500 ng / mL, 200 ng / mL, 100 ng / mL, 50 ng / mL, 10 ng / mL, and 0 ng / mL. 2 mL was taken from each sample and added to the reagent tube (11). The experimental results were observed after 10 minutes.

[0078] It can be seen from the results that when the FOB concentration is greater than 100 ng / mL, the red intensity on the test line increases with the increase in the FOB standard concentration; when the FOB concentration is less than 100 ng / mL, the test line does not show color.

[0079] The above results show that the detection limit of the test strip is 100 ng / mL. The test kit described in the utility model solves the problem of poor sensitivity and inconvenience in qualitatively detecting human hemoglobin in human feces.

[0080] Specific implementation 3: Preparation of the detection kit of the present invention and clinical validation of the kit

[0081] 1. Reagent preparation

[0082] Prepare 300 test kits as described in the above example.

[0083] 2. Test samples

[0084] The samples were tested simultaneously using the test kit and the comparison reagent. The test results are as follows:

[0085]

[0086] Positive compliance rate: 100%;

[0087] Negative compliance rate: 100%;

[0088] Total compliance rate: 100%.

[0089] The consistency rate between the test results of the above 300 clinical samples and the results of the comparison reagents was 100%.

[0090] The above is only a preferred embodiment of the utility model, and is not intended to limit the utility model. Any modifications, equivalent replacements and improvements made within the spirit and principles of the utility model should be included in the protection scope of the utility model. The above is only a preferred implementation of the utility model. It should be pointed out that for ordinary technicians in this technical field, several improvements and variations can be made without departing from the technical principles of the utility model, and these improvements and variations should also be regarded as the protection scope of the utility model.

Claims

1. A detection kit for detecting human fecal hemoglobin, characterized in that: The invention comprises a housing and a stool sampling rod assembly, wherein the housing comprises an upper housing (3) and a lower housing (4), wherein the upper housing (3) is formed with an inlet sleeve (31) for inserting the stool sampling rod assembly, wherein the upper housing (3) and the lower housing (4) are snap-fitted and connected to form an internal accommodating space, wherein the inlet sleeve (31) extends into the internal accommodating space, and a sealing sheet (312) is integrally formed at the extended end of the inlet sleeve (31); wherein the internal accommodating space comprises a chromatography chamber, wherein a detection The detection component comprises a detection test strip (511), the detection test strip (511) is coated with a sheep anti-mouse secondary antibody as a C line and a specific mouse anti-human hemoglobin antibody as a T line, and the feces sampling rod component comprises a sampling rod (2), when the feces sampling rod component is inserted into the inlet sleeve (31), the first end of the sampling rod (2) can pierce the sealing sheet (312) so that the liquid sealed by the sealing sheet (312) flows into the chromatography chamber and contacts the detection test strip (511).

2. The detection kit for detecting human fecal hemoglobin according to claim 1, characterized in that: The test paper strip (511) includes a PVC backboard (5111), a nitrocellulose membrane (5112) is connected to the first side of the PVC backboard (5111), an absorbent paper (5113) is stacked on the first end of the nitrocellulose membrane (5112), a gold label pad (5114) is stacked on the second end of the nitrocellulose membrane (5112), a sample pad (5115) is stacked on the end of the gold label pad (5114) away from the nitrocellulose membrane (5112), and the C line and the T line are sequentially arranged on the nitrocellulose membrane (5112) in a direction from the first end to the second end of the nitrocellulose membrane (5112) at intervals.

3. The detection kit for detecting human fecal hemoglobin according to claim 2, characterized in that: The detection component further comprises a test paper strip (51), a test paper slot for positioning the test paper strip (511) being formed on a first side of the test paper strip (51), and a desiccant slot for positioning the desiccant (512) being formed on a second side, the first side and the second side being located at opposite sides of the test paper strip (51), and a notch being formed at the top of the desiccant slot.

4. The detection kit for detecting human fecal hemoglobin according to claim 1, characterized in that: The stool sampling rod assembly further comprises a sealing cover (1), wherein the sealing cover (1) comprises a cover plate (11), an outer ring tube (12) and an inner ring tube (13) formed on one side end surface of the cover plate (11), wherein the inner ring tube (13) is arranged concentrically with the outer ring tube (12) inside and outside; a sampling portion (21) is formed at the first end of the sampling rod (2), and the second end of the sampling rod (2) is detachably inserted into the inner ring tube (13).

5. The detection kit for detecting human fecal hemoglobin according to claim 4, characterized in that: A plurality of clamping strips (22) are arranged at intervals around the sampling rod (2) on the outer peripheral wall of the sampling rod (2) corresponding to the second end, and clamping grooves corresponding to each of the clamping strips (22) are formed on the inner cylinder wall of the inner ring cylinder (13).

6. The detection kit for detecting human fecal hemoglobin according to claim 5, characterized in that: Each of the clamping strips (22) also has a convex point (221), and a groove (131) matching with each of the convex points (221) is formed on the bottom wall of the clamping slot.

7. The detection kit for detecting human fecal hemoglobin according to claim 6, characterized in that: A sealing ring groove (23) is provided on the outer circumferential wall of the sampling rod (2) for fitting a first sealing ring (24). The sealing ring groove (23) is arranged adjacent to one end of the clamping strip (22) close to the sampling portion (21).

8. The detection kit for detecting human fecal hemoglobin according to claim 5, characterized in that: The sampling portion (21) is a spiral groove arranged around the outer circumferential wall of the sampling rod (2).

9. The detection kit for detecting human fecal hemoglobin according to claim 5, characterized in that: An annular flange (121) is formed on the inner cylinder wall of the outer ring cylinder (12) and protrudes inwardly along the radial direction of the outer ring cylinder (12), and an annular groove (311) is formed on the outer circumferential wall of the inlet sleeve (31), and the annular flange (121) and the annular groove (311) are adapted to be snap-fitted and connected to each other.

10. The detection kit for detecting human fecal hemoglobin according to claim 9, characterized in that: A scraper rubber ring (32) is assembled inside the inlet sleeve (31), and the diameter of the through hole of the scraper rubber ring (32) is equal to the outer circumference diameter of the sampling portion (21).

Images