Glass fiber treating fluid suitable for various detection target colloidal gold products

Abstract

The invention provides a glass fiber treating fluid suitable for various detection target colloidal gold products. The treating fluid comprises the following components: 0.1 to 1.0 wt% of a surfactant, 0.1 to 5.0 wt% of a sealing agent, 1 to 5 wt% of a saccharide stabilizer, 0.1 to 1.0 wt% of a preservative and the balance of a buffer solution with the pH value of 7.3 to 7.5. According to the treating fluid, through cooperative regulation and control of multiple components, the strong permeation cleaning requirement of crude fibers and the mild protection requirement of fine fibers are considered, and broad-spectrum compatibility and efficient treatment of different types of glass fibers are achieved.

Description

Technical Field

[0001] The present application relates to the field of in vitro diagnostic reagents, and in particular to a glass fiber treatment fluid suitable for a variety of detection target colloidal gold products. Background Art

[0002] In vitro diagnostic reagents, especially colloidal gold immunochromatographic reagent products, are widely used in disease screening and health monitoring. Glass fiber, as a sample pad or binding pad, is an important component of the colloidal gold reagent strip, and its surface treatment directly affects the sensitivity and specificity of the test. Existing glass fiber treatment fluids are mostly optimized for a single type of glass fiber or a specific detection target, and are difficult to be compatible with glass fiber materials of different specifications and surface properties. For example, the process described in patent document CN111638327A requires the use of different formulas for two types of glass fibers to undergo multiple steps such as cleaning, soaking, and drying to adjust the interface effects of different types of fibers. Not only is it time-consuming and prone to operational errors, affecting the pretreatment effect, but it can also cause process splits due to differences in formulas.

[0003] With the diversification of testing needs and the continuous expansion of product specifications, the market demand for universal glass fiber treatment fluids is growing. The existing technology still has shortcomings in terms of compatibility, process simplification and batch stability, which leads to complex production processes, increased costs, and affects the performance consistency of the final product. The poor compatibility of different product processes forces companies to develop multiple production lines. For example, the gold standard pad treatment fluid and sample pad treatment fluid described in patent documents CN119044472A, CN118150821A, and CN118348242A have different formulas and treatment processes. This limitation requires the procurement, storage and use of materials for different pretreatment fluids during the production process, resulting in a 35%-50% increase in raw material costs and increased complexity in raw material management.

[0004] In summary, there is an urgent need to develop a pretreatment solution that is highly versatile, has a simple and stable process, and can be adapted to multiple detection targets. Summary of the Invention

[0005] Based on this, a glass fiber processing liquid suitable for a variety of detection target colloidal gold products is disclosed.

[0006] The first aspect of the present invention provides a glass fiber treatment fluid suitable for a variety of detection target colloidal gold products, the treatment fluid comprising the following components: 0.1-1.0 wt% of a surfactant, 0.1-5.0 wt% of a blocking agent, 1-5 wt% of a carbohydrate stabilizer, 0.1-1.0 wt% of a preservative, and the remainder having a pH of 7.3-7.5.

[0007] The glass fiber treatment fluid of the present application can be applied to both coarse fibers (such as RB65, which contains a hydrophobic lubricant on the surface) and fine fibers (such as SB06, which has a hydrophilic silane layer on the surface). The core lies in the scientific ratio and synergistic effect of the components. For coarse fibers such as RB65, there are residual hydrophobic lubricants on the surface, which are difficult to completely wet and remove with conventional treatment fluids, resulting in uneven distribution of subsequent sealants and decreased detection sensitivity. The surfactants in this treatment fluid can significantly reduce interfacial tension, enhance the treatment fluid's ability to penetrate and wrap around hydrophobic surfaces, effectively disperse and remove lubricants, fully expose the glass fiber surface, and create conditions for the uniform adsorption of subsequent sealants. For fine fibers such as SB06, their surface has a hydrophilic silane layer with a dense structure and large specific surface area, which is easy to adsorb impurities and is sensitive to the chemical environment. Traditional strong penetration or high-concentration surfactant treatment fluids can easily damage its surface functional layer, affecting its binding performance. By optimizing the type and concentration of surfactants, this treatment fluid not only ensures the cleaning ability of coarse fibers, but also avoids damage to the hydrophilic layer on the surface of fine fibers. The protein layer of the blocking agent forms a stable protective film on the fine fiber surface, further improving binding uniformity and detection consistency. The synergistic effect of the carbohydrate stabilizer and buffer provides a mild, stable chemical environment for both types of fibers, preventing protein denaturation and surface structural damage, ensuring repeatable and batch-to-batch consistency in treatment results. Through the coordinated regulation of multiple components, this treatment solution balances the strong penetrating cleaning requirements of coarse fibers with the gentle protection requirements of fine fibers, achieving broad compatibility and efficient treatment of different glass fiber types.

[0008] Furthermore, the surfactant is Triton-100. As a nonionic surfactant, Triton-100 forms a stable adsorption layer on the glass fiber surface, significantly reducing interfacial tension and promoting lubricant dispersion and removal. Its mild molecular structure does not damage the hydrophilic silane layer of the fine fibers, ensuring the integrity of the fiber structure and facilitating rapid penetration and uniform distribution of the sample.

[0009] Furthermore, the blocking agent is one or more of sodium caseinate and bovine serum albumin. Both sodium caseinate and bovine serum albumin are high-molecular-weight proteins that can form a dense protein layer on the glass fiber surface through physical adsorption and partial chemical bonding. This protein layer effectively shields active sites on the glass fiber surface, blocking nonspecific adsorption of biomolecules such as antibodies and antigens, significantly reducing background signal, and improving the signal-to-noise ratio and detection limit of the test strip.

[0010] Furthermore, the carbohydrate stabilizer is one or more of sucrose, glucose, and lactose. The carbohydrate stabilizer prevents irreversible denaturation of the protein during drying and storage by regulating osmotic pressure and forming a hydration protective layer.

[0011] Furthermore, the preservative is one or more of ProClean-300, benzalkonium chloride, and potassium sorbate. These three preservatives can protect against a wide range of microorganisms, including bacteria, fungi, and yeast, significantly broadening the antimicrobial spectrum of the treatment fluid, preventing degradation of the treatment fluid due to microbial contamination, and ensuring batch stability and safety of the product. ProClean-300 is a preservative that acts on multiple targets, including microbial cell membranes, cell walls, and enzymes, to inhibit or disrupt microbial cell division and growth, thereby suppressing microbial reproduction and achieving its preservative effect.

[0012] Furthermore, the buffer solution is 0.02 mol / L borate buffer solution, pH 7.3-7.5. As a solvent, borate buffer solution has good solubility and volatility, and can evaporate rapidly during the pretreatment process, so that the effective ingredients in the pretreatment solution can be firmly attached to the surface of the glass fiber, while ensuring that the surface of the treated glass fiber is clean and free of residue. This buffer system can stabilize the pH of the system, prevent protein-based blocking agents from being inactivated due to pH fluctuations, and at the same time contribute to the uniform distribution of sugars and surfactants, thereby improving the overall stability of the treatment solution and the batch consistency of the glass fiber.

[0013] The second aspect of the present application provides a method for preparing a glass fiber treatment liquid, comprising sequentially adding a surfactant, a sealing agent, a carbohydrate stabilizer and a buffer solution to water, stirring until the components are uniformly dissolved, adjusting the pH to 7.3-7.5, adding a preservative, and mixing uniformly.

[0014] This method ensures the complete dissolution of macromolecules such as proteins and carbohydrates by adding each component stepwise and stirring thoroughly, avoiding protein precipitation or carbohydrate crystallization caused by localized overconcentration. Adding a preservative after adjusting the pH to 7.3-7.5 effectively prevents conformational changes or degradation of proteins at extreme pH levels, thereby enhancing the physical and chemical stability of the treated solution. This simple process facilitates industrialized continuous production and quality control.

[0015] The second aspect of the present application provides a method for pretreating glass fibers, comprising the following steps: soaking clean glass fibers in the above-mentioned treatment solution for 10-60 min; taking out the glass fibers and drying them at 30-45°C for 8-24 h to obtain pretreated glass fibers. Through 10-60 minutes of soaking, the surfactants and sealants in the treatment solution can fully penetrate into the micropores and surface of the glass fibers, ensuring the complete removal of the lubricant and the uniform adsorption of the protein layer. Low-temperature drying at 30-45°C helps proteins and carbohydrates form a dense and uniform protective layer on the fiber surface, while avoiding protein denaturation and carbohydrate carbonization caused by high temperature, thereby ensuring batch consistency and long-term storage stability of the pretreated glass fibers.

[0016] Furthermore, the glass fibers are either or both of the following: coarse fibers with a fiber diameter of 10-20 μm and a surface hydrophobic lubricant; and fine fibers with a fiber diameter of 3-10 μm and a surface hydrophilic silane layer. The treatment solution, through the synergistic action of a surfactant and a protein blocking agent, effectively removes organic residues from the coarse fiber surface while forming a stable hydrophilic protective layer on the fine fiber surface, significantly improving sample absorption rate, binding uniformity, and detection sensitivity for different types of glass fibers.

[0017] Furthermore, the coarse fiber is model RB65, and the fine fiber is model SB06. For these two models, the component ratios of the treatment fluid and process parameters have been systematically optimized to achieve efficient and repeatable treatment results in actual production, significantly reducing performance fluctuations between batches and improving product consistency and pass rates.

[0018] A fourth aspect of this application provides the use of the aforementioned glass fiber treatment fluid in colloidal gold immunochromatographic reagent products, such as Helicobacter pylori detection reagents or fecal occult blood detection reagents. Glass fibers pretreated with this treatment fluid can significantly improve the sample release rate, binding uniformity, and detection sensitivity of the test strips, reduce background signals, and meet the clinical testing needs of multiple targets and scenarios, thus possessing significant market value. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This figure shows the effects of treated and untreated glass fibers as solid phase carriers for colloidal gold markers.

[0020] Figure 2 This is a test result diagram of products made of glass fiber treated with pretreatment liquid.

[0021] Figure 3 This is a comparison chart of the test results of products made of untreated glass fiber and treated glass fiber. DETAILED DESCRIPTION

[0022] For ease of understanding of the present application, the present application will be described more fully below. The present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present application more thorough and comprehensive.

[0023] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined. In the description of this application, the meaning of "several" is at least one, such as one, two, etc., unless otherwise clearly and specifically defined.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0025] In this application, the technical features described in an open manner include closed technical solutions composed of the listed features, and also include open technical solutions containing the listed features.

[0026] In this application, when referring to numerical ranges, unless otherwise specified, the numerical ranges are considered continuous and include the minimum and maximum values ​​of the range, as well as every value between such minimum and maximum values. Further, when a range refers to an integer, every integer between the minimum and maximum values ​​of the range is included. In addition, when multiple ranges are provided to describe a feature or characteristic, the ranges can be combined. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges subsumed therein.

[0027] Unless otherwise specified, the percentage contents mentioned in this application refer to mass percentage for solid-liquid mixture and solid-solid mixture, and refer to volume percentage for liquid-liquid mixture.

[0028] The percentage concentrations mentioned in this application, unless otherwise specified, refer to the final concentration, which refers to the percentage of the added component in the system after the addition of the component.

[0029] The temperature parameters in this application, unless otherwise specified, allow for both constant temperature treatment and treatment within a certain temperature range. The constant temperature treatment allows for temperature fluctuations within the precision range of instrument control.

[0030] The "particles" mentioned in this application, or materials with a defined particle size distribution, are not necessarily spherical in shape but may be irregular, primary or secondary. The particle size of irregular particles is the average of their maximum and minimum diameters.

[0031] Example 1: This example provides a glass fiber treatment solution A, whose formula is: Triton-100 0.5 wt%, sodium caseinate 2.0 wt%, sucrose 3.0 wt%, ProClean-300 0.5 wt%, and 0.02 mol / L borate buffer (pH 7.4) supplemented to 100 wt%.

[0032] The preparation method is as follows: in a clean stirring container, sucrose is first added to 0.02 mol / L borate buffer (pH 7.4), and after stirring until completely dissolved, sodium caseinate and Triton-100 are added in sequence. Stirring is continued to fully dissolve the components. After the solution is clarified, the pH is adjusted to 7.4. Finally, ProClean-300 is added, stirred evenly, and filtered to remove impurities to obtain a clarified glass fiber treatment liquid A.

[0033] The glass fiber treatment method is as follows: cut the RB65 model glass fiber into the required size, place it in the treatment liquid A, ensure it is completely immersed, soak it at room temperature for 30 minutes, and gently shake it several times during the soaking period to promote the penetration of the treatment liquid. After the soaking is completed, take out the glass fiber, use sterile filter paper to absorb the excess treatment liquid on the surface, spread it flat on a clean tray, dry it in a 37℃ forced air drying oven for 12 hours, cool it to room temperature, and then seal it for storage.

[0034] Example 2: This example provides a glass fiber treatment solution B, which has the following formula: Triton-100 0.3 wt %, bovine serum albumin (BSA) 1.0 wt %, glucose 2.0 wt %, benzalkonium chloride 0.3 wt %, and 0.02 mol / L borate buffer (pH 7.3) supplemented to 100 wt %.

[0035] The preparation method is as follows: add 0.02 mol / L borate buffer (pH 7.3) to a clean beaker, first add glucose and stir to dissolve, then add bovine serum albumin and Triton-100 in sequence, continue stirring until the solution is clear, adjust the pH to 7.3, and finally add benzalkonium chloride, stir evenly, filter and remove impurities to obtain glass fiber treatment solution B.

[0036] The glass fiber treatment method is as follows: cut the RB65 model glass fiber into the required size, place it in the treatment liquid B, ensure that it is completely immersed, soak it at room temperature for 20 minutes, and gently turn it over every 5 minutes. After soaking, take out the glass fiber, use sterile filter paper to absorb the excess treatment liquid on the surface, spread it flat on a clean tray, dry it in a 40℃ forced air drying oven for 10 hours, cool it to room temperature, and then seal it for storage.

[0037] Example 3: This example provides a glass fiber treatment liquid C, whose formula is: Triton-100 0.8 wt%, sodium caseinate 1.0 wt%, bovine serum albumin (BSA) 1.0 wt%, lactose 2.5 wt%, potassium sorbate 0.4 wt%, and 0.02 mol / L borate buffer (pH 7.5) supplemented to 100 wt%.

[0038] The preparation method is as follows: 0.02 mol / L borate buffer (pH 7.5) is added to a clean stirring container, lactose is first added and stirred to dissolve, sodium caseinate, bovine serum albumin and Triton-100 are then added in sequence, the solution is fully stirred until the solution is clear, the pH is adjusted to 7.5, and finally potassium sorbate is added, the mixture is stirred evenly, and impurities are removed by filtration to obtain glass fiber treatment liquid C.

[0039] The glass fiber treatment method is as follows: cut the RB65 model glass fiber into the required size, place it in the treatment liquid C, ensure it is completely immersed, soak it at room temperature for 25 minutes, and gently turn it over every 5 minutes. After soaking, take out the glass fiber, use sterile filter paper to absorb the excess treatment liquid on the surface, spread it flat on a clean tray, dry it in a 37℃ forced air drying oven for 10 hours, cool it to room temperature, and then seal it for storage.

[0040] Example 4: This example uses the treatment solution A from Example 1 to treat RB65 glass fiber, using the same treatment method as above. The pretreated RB65 glass fiber serves as a sample pad to assemble a colloidal gold immunochromatographic reagent strip for use in the production of Helicobacter pylori detection reagents. The assembly steps include: laying the treated glass fiber to the sample end of the strip according to the designed dimensions; sequentially overlapping the strip with the conjugate pad, reaction membrane, and absorbent pad; pressing the strip into shape; cutting and packaging the strips; and sealing and storing the strips.

[0041] Example 5: This example uses the same treatment fluid B from Example 1 to treat SB06 glass fiber. The treatment method is the same as above. The pretreated SB06 glass fiber is used as a sample pad to assemble a colloidal gold immunochromatographic reagent strip for use in the production of fecal occult blood detection reagents. The assembly steps are the same as in Example 4.

[0042] Comparative Example 1: In Comparative Example 1, untreated RB65 glass fiber was directly cut into the required size and used as a sample pad to assemble a colloidal gold immunochromatographic reagent strip for the production of Helicobacter pylori detection reagent products. The assembly steps were the same as in Example 4.

[0043] Comparative Example 2: In Comparative Example 2, untreated SB06 glass fiber was directly cut into the required size and used as a sample pad to assemble a colloidal gold immunochromatographic reagent strip for the production of fecal occult blood detection reagent products. The assembly steps were the same as in Example 4.

[0044] The above samples were tested for performance, and the corresponding positive and negative samples were used for colloidal gold immunochromatography experiments. The results are as follows Figure 1-3 shown.

[0045] Figure 1 The diagram shows the effects of treated and untreated glass fibers as solid phase carriers of colloidal gold markers. 1 is the experimental result of Comparative Example 1; 1, 1, and 1 are the experimental results of Examples 1-3, respectively.

[0046] Figure 2 The results of testing products made of glass fiber treated with the pretreatment solution are shown. The reference material for tests 5, 7, and 9 is a negative H. pylori reference material, while the reference material for tests 6, 8, and 10 is a H. pylori standard strain solution with a concentration of 2×10^5 CFU / mL.

[0047] The Helicobacter pylori detection reagent made of the same glass fiber (glass fiber RB65 purchased from Jinbiao Biological) pre-treated with the treatment solution of Example 1 detects the negative sample (5), the quality control line is clear (51), detects the positive reference (6), the quality control line is clear (61), and the detection line is clear (62); ( Figure 2 ) The Helicobacter pylori detection reagent made of the same glass fiber (glass fiber RB65 purchased from Jinbiao Biological) pre-treated with the treatment solution in Example 2 tested the negative sample (7), the quality control line was clear (71), tested the positive reference sample (8), the quality control line was clear (81), and the detection line was clear (82); ( Figure 2 ) The Helicobacter pylori detection reagent made of the same glass fiber (glass fiber RB65 purchased from Jinbiao Biological) pretreated with the ratio treatment solution in Example 3 detects the negative sample (9), the quality control line is clear (91), detects the positive reference (10), the quality control line is clear (101), and the detection line is clear (102) ( Figure 2 ).

[0048] Figure 3 This is a comparison diagram of the test results of products made of untreated glass fiber and treated glass fiber. The reference substances for tests 11 and 13 are Helicobacter pylori negative reference substances, and the reference substances for tests 12 and 14 are Helicobacter pylori standard strain solutions with a concentration of 2×105 CFU / mL; the reference substance for test 15 is fecal occult blood negative reference substance, and the reference substance for test 16 is fecal occult blood positive reference substance with a concentration of 1 μg / mL.

[0049] The product made of untreated glass fiber (Comparative Example 1) tested negative sample (11), the quality control line was unclear (111), tested positive sample (12), the quality control line was unclear (121), and the test line did not show color (122) ( Figure 3 ); The glass fiber of model RB65 (Example 4) treated with the pretreatment liquid is used as the gold standard pad and sample pad of the colloidal gold product. When the negative sample (13) is detected, the quality control line is clear (131). When the positive sample (14) is detected, the quality control line is clear (141) and the detection line is clear (142). Figure 3 ); The glass fiber of model RB65 treated with the pretreatment liquid (Example 4) was used as the gold standard pad of the colloidal gold product and the glass fiber of model SB06 treated with the pretreatment liquid (Example 5) was used as the sample pad to form a product. When testing negative samples (15), the quality control line was clear (151); when testing positive samples (16), the quality control line was clear (161) and the test line was clear (162) ( Figure 3 ).

[0050] according to Figure 1-3 As can be seen from the data, the results of the examples are better than those of the comparative examples. This is because the glass fiber treatment fluid of the present application is applicable to both coarse fibers (such as RB65, which contains a hydrophobic lubricant on the surface) and fine fibers (such as SB06, which has a hydrophilic silane layer on the surface). The core lies in the scientific ratio and synergistic effect of the components. For coarse fibers such as RB65, there is residual hydrophobic lubricant on the surface, which is difficult to completely wet and remove with conventional treatment fluids, resulting in uneven distribution of subsequent sealants and decreased detection sensitivity. The surfactants in this treatment fluid can significantly reduce interfacial tension, enhance the treatment fluid's ability to penetrate and wrap around hydrophobic surfaces, effectively disperse and remove lubricants, and fully expose the glass fiber surface, creating conditions for uniform adsorption of subsequent sealants. For fine fibers such as SB06, their surface has a hydrophilic silane layer with a dense structure and large specific surface area, which is easy to adsorb impurities and sensitive to the chemical environment. Traditional strong penetration or high-concentration surfactant treatment fluids easily damage their surface functional layers, affecting binding performance. By optimizing the type and concentration of surfactants, this treatment fluid not only ensures cleaning ability for coarse fibers but also avoids damage to the hydrophilic layer on the surface of fine fibers. The protein layer of the blocking agent forms a stable protective film on the surface of fine fibers, further improving binding uniformity and detection consistency. The synergistic effect of the carbohydrate stabilizer and buffer provides a mild, stable chemical environment for both types of fibers, preventing protein denaturation and surface structural damage, ensuring repeatable and batch-to-batch consistency in treatment results. Therefore, through the coordinated regulation of multiple components, this treatment solution balances the strong penetrating cleaning requirements of coarse fibers with the gentle protection requirements of fine fibers, achieving broad compatibility and efficient treatment of different types of glass fibers.

[0051] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0052] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A glass fiber treatment solution suitable for a variety of detection target colloidal gold products, characterized in that: The treatment solution comprises the following components: 0.1-1.0 wt % of a surfactant, 0.1-5.0 wt % of a blocking agent, 1-5 wt % of a carbohydrate stabilizer, 0.1-1.0 wt % of a preservative, and the balance a buffer solution with a pH of 7.3-7.

5.

2. The glass fiber treating liquid according to claim 1, characterized in that The surfactant is Triton-100.

3. The glass fiber treating liquid according to claim 1, characterized in that The blocking agent is one or more of sodium caseinate and bovine serum albumin.

4. The glass fiber treating liquid according to claim 1, characterized in that The sugar stabilizer is one or more of sucrose, glucose and lactose.

5. The glass fiber treating liquid according to claim 1, characterized in that The preservative is one or more of ProClean-300, benzalkonium chloride, and potassium sorbate.

6. The method for preparing a glass fiber treating solution according to any one of claims 1 to 5, characterized in that: Add surfactant, blocking agent, carbohydrate stabilizer and buffer into water in sequence, stir until all components are evenly dissolved, adjust pH to 7.3-7.5, add preservative, and mix evenly to obtain the product.

7. A method for pretreating glass fiber, characterized in that: The following steps are involved: The clean glass fiber is immersed in the treatment solution according to any one of claims 1 to 5 for 10 to 60 minutes; the glass fiber is taken out and dried at 30 to 45° C. for 8 to 24 hours to obtain the pretreated glass fiber.

8. The pretreatment method according to claim 7, characterized in that The glass fiber is one or both of the following two categories: coarse fiber with a fiber diameter of 10-20 μm and a hydrophobic lubricant on the surface; and fine fiber with a fiber diameter of 3-10 μm and a hydrophilic silane layer on the surface.

9. The pretreatment method according to claim 8, characterized in that The coarse fiber is RB65, and the fine fiber is SB06.

10. Use of the glass fiber treatment solution according to any one of claims 1 to 5 in a colloidal gold immunochromatography reagent product, characterized in that: The product is a Helicobacter pylori detection reagent or a fecal occult blood detection reagent.

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