Immunochromatography detection kit for detecting viscous sample

By using the combination of S-carboxymethyl-L-cysteine ​​and Tricine buffer in the sample pad treatment solution, the false positive and background unclean problems of traditional immunochromatography detection kits are solved when detecting viscous samples, and the validity period of the product is extended, achieving higher anti-interference ability and detection performance.

CN119667154AActive Publication Date: 2025-03-21INNOVITA BIOLOGICAL TECH CO LTD +1
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Patent Information

Application Number
CN202411907885.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-23
Publication Date
2025-03-21
Estimated Expiration
2044-12-23

AI Technical Summary

Technical Problem

Traditional immunochromatography detection kits are prone to false positives and unclear background problems when detecting viscous samples, and functional substances fail for a long storage time, which affects the validity period of the product.

Method used

The sample pad treatment solution containing S-carboxymethyl-L-cysteine, buffer, surfactant, sealant, preservative and neutral inorganic salts is used to store it with heating to prolong the validity of the immunochromatography product, and to enhance the anti-interference ability through the combination of S-carboxymethyl-L-cysteine ​​and Tricine buffer at a specific concentration.

Benefits of technology

It significantly improves the anti-interference ability of the immunochromatography detection kit to viscous samples, completely eliminates false positive signals, improves background cleanliness, and extends the product's validity period, ensuring long-term stability of detection performance and color rendering quality.

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Abstract

The invention relates to the field of immunochromatography, in particular to an immunochromatography detection kit for detecting a viscous sample. The invention provides a sample pad treating fluid, which is characterized in that the sample pad treating fluid at least comprises the following components: S-carboxymethyl-L-cysteine, a buffer solution, a surfactant and a sealing agent. The sample pad treating fluid provided by the invention can enhance the anti-interference capability of the immunochromatography detection kit on different viscous samples and prolong the actual validity period of the immunochromatography detection kit by using relatively simple components, and can ensure that the detection performance and the color development quality of the immunochromatography detection kit prepared based on the sample pad treating fluid are kept at a very high level for a long time.
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Description

Technical Field

[0001] The invention relates to the field of immunochromatography, and in particular to an immunochromatography detection kit for detecting viscous samples. Background Art

[0002] Due to its simplicity, speed and low cost, immunochromatography has been widely used in many fields, such as disease diagnosis, pesticide residues, pregnancy control, pet epidemics, disease prevention and control, etc. However, since the samples are generally not specially treated during the detection process of products based on immunochromatography methods, traditional immunochromatography test kits will be interfered by some special samples (such as viscous samples), which will lead to abnormal results. For example, the highly viscous oropharyngeal swab samples for respiratory tract testing are complex in composition and rich in mucin, which will cause the aggregation of tracer particles during the test process, resulting in problems such as NC membrane blocking, unclean background or false positives; the same is true for vaginal / cervical swab samples.

[0003] Although the sample pad in the traditional immunochromatographic test kit can adjust the pH value of the sample and filter large particulate matter to a certain extent, the above problems will still be encountered for viscous samples such as oropharyngeal swab samples. Chinese patent application CN117129691A discloses a test strip for detecting human chorionic gonadotropin in saliva, wherein the sample pad of the test strip is treated with a sample pad treatment solution (containing Tris, casein, Tween-20, NaCl, dodecyltrimethylammonium bromide, 4-nonylphenyl-polyethylene glycol, borax, polyvinylpyrrolidone, dithiothreitol and L-cysteine). Although the sample pad treatment solution disclosed therein can eliminate the false positive phenomenon of saliva sample detection to a certain extent, there are still problems such as complex composition and short storage time. Summary of the invention

[0004] In a first aspect, the present invention provides a sample pad treatment solution, characterized in that the sample pad treatment solution comprises at least the following components: S-carboxymethyl-L-cysteine, a buffer, a surfactant and a blocking agent.

[0005] In some embodiments, the mass fraction of S-carboxymethyl-L-cysteine ​​comprises 0.1%-5%.

[0006] As used herein, buffer refers to a solution prepared by a buffering agent and a solvent, generally referring to a combination of a strong acid and an organic weak acid, a weak acid and its salt, a weak acid and a basic salt, a strong base and an organic weak acid, a strong acid and a weak base, or a strong base and a weak acid. The solvent is usually water.

[0007] In some embodiments, the buffer may be one or more of a phosphate buffer, a borate buffer, and a tris(hydroxymethyl)methylglycine buffer.

[0008] In some embodiments, the concentration of the buffer comprises 25 mM-200 mM.

[0009] In some embodiments, the buffer is Tricine buffer.

[0010] In some embodiments, the pH of the sample pad treatment solution is comprised between 7.6 and 8.4.

[0011] In some embodiments, the surfactant includes one or more of Triton X-100, Tween 20, Tween 80, S9, NP-40 and CHAPS.

[0012] In some embodiments, the mass fraction of the surfactant comprises 0.1-5.0%.

[0013] In some embodiments, the blocking agent includes one or more of BSA, CASEIN, CASEIN-Na, gelatin, and skim milk powder.

[0014] In some embodiments, the mass fraction of the sealing agent comprises 0.1-5.0%.

[0015] In some embodiments, the sample pad treatment solution further comprises a preservative.

[0016] In some embodiments, the preservative includes one or more of ProClin 150, ProClin 200, ProClin 300, and ProClin 950.

[0017] In some embodiments, the mass fraction of the preservative comprises 0.02-0.2%.

[0018] In some embodiments, the sample pad treatment solution further comprises a neutral inorganic salt.

[0019] In some embodiments, the neutral inorganic salt comprises sodium chloride and / or potassium chloride.

[0020] In some embodiments, the concentration of the neutral inorganic salt comprises 25-200 mM.

[0021] In some embodiments, the sample pad treatment solution comprises the following components: S-carboxymethyl-L-cysteine, a buffer, a surfactant, a blocking agent, a preservative, and a neutral inorganic salt.

[0022] In some embodiments, the sample pad treatment solution comprises the following components: 25 mM-200 mM buffer, 0.1%-5% (mass fraction) S-carboxymethyl-L-cysteine, 25-200 mM neutral inorganic salt, 0.1-5.0% (mass fraction) surfactant, 0.1-5% (mass fraction) blocking agent and 0.02-0.2% (mass fraction) preservative.

[0023] In some embodiments, the sample pad treatment solution comprises the following components: 25mM-200mM tris(hydroxymethyl)methylglycine buffer, 0.1%-5% (mass fraction) S-carboxymethyl-L-cysteine, 25-200 mM NaCl, 0.1-5.0% (mass fraction) BSA, 0.1-5% (mass fraction) Triton X-100 and 0.02-0.2% (mass fraction) ProClin300.

[0024] In some embodiments, the concentration of the Tris buffer is 50 mM.

[0025] In some embodiments, the mass fraction of S-carboxymethyl-L-cysteine ​​is 2%.

[0026] In some embodiments, the mass fraction of the sealing agent is 0.5%.

[0027] In some embodiments, the concentration of the neutral inorganic salt is 150 mM.

[0028] In some embodiments, the mass fraction of the preservative is 0.05%.

[0029] In a second aspect, the present invention provides a sample pad, characterized in that the sample pad is obtained by being treated with the sample pad treatment solution.

[0030] In some embodiments, the treatment method specifically includes: soaking and / or coating a glass fiber membrane with the sample pad treatment solution, and then drying the glass fiber membrane to obtain the sample pad.

[0031] In some embodiments, the drying method includes drying at 37°C±1°C for 8-24 hours.

[0032] In a third aspect, the present invention provides a test strip for detecting a viscous sample, wherein the test strip comprises the sample pad described above.

[0033] In a fourth aspect, the present invention provides an immunochromatographic detection kit for detecting viscous samples, characterized in that the immunochromatographic detection kit comprises a test strip, the test strip comprises a base plate, the above-mentioned sample pad, binding pad, nitrocellulose membrane and water absorbent pad which are arranged on the base plate and overlapped in sequence.

[0034] As used herein, a viscous sample refers to a biological sample containing a certain amount of mucin. In some embodiments, the viscous sample further contains pathogenic microorganisms, such as one or more of bacteria, viruses, fungi, and parasites. In some embodiments, the viscous sample is secreted from the oral cavity, nasal cavity, eyes, gastrointestinal tract, vagina, and respiratory tract. In some embodiments, the viscous sample includes an oropharyngeal swab sample, a nasopharyngeal swab sample, a vaginal secretion sample, a sputum sample, or a saliva sample.

[0035] In some embodiments, the immunochromatographic detection kit is used to detect pathogenic microorganisms that cause respiratory system infections and / or reproductive system infections, such as influenza A virus, influenza B virus, respiratory syncytial virus, rhinovirus, adenovirus, parainfluenza virus, coronavirus, metapneumovirus, bocavirus, human papillomavirus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Neisseria gonorrhoeae, Candida albicans, Bordetella pertussis, and Mycobacterium tuberculosis.

[0036] In some embodiments, the conjugate pad is provided with colloidal gold-labeled antibody-1 for specific detection of pathogenic microorganisms.

[0037] In some embodiments, a detection line and a quality control line are provided on the nitrocellulose membrane.

[0038] In some embodiments, the detection line is provided with antibody-2 for specific detection of pathogenic microorganisms.

[0039] In some embodiments, the antibody-1 for specifically detecting pathogenic microorganisms and the antibody-2 for specifically detecting pathogenic microorganisms specifically detect the same pathogenic microorganism.

[0040] In some embodiments, the immunochromatographic detection kit is used to detect respiratory viruses.

[0041] In some embodiments, the immunochromatographic detection kit is used to detect the new coronavirus.

[0042] In some embodiments, the conjugate pad is provided with colloidal gold-labeled antibody-1 for specific detection of the new coronavirus.

[0043] In some embodiments, the detection line is provided with antibody-2 for specific detection of the novel coronavirus.

[0044] In some embodiments, the quality control line is provided with goat anti-mouse antibody.

[0045] In some embodiments, the test line is prepared by a 0.5-1 mg / mL solution of antibody-2 specifically detecting the new coronavirus.

[0046] In some embodiments, the quality control line is prepared by 0.5-1 mg / mL goat anti-mouse antibody solution.

[0047] Compared with the prior art, the beneficial effects of the present invention include at least the following aspects: Although the existing technology attempts to add additional functional substances to the sample pad treatment liquid to increase the sample application range of the immunochromatography product, on the one hand, the existing technology has very limited processing capabilities for special samples (such as viscous samples), and the existing immunochromatography test kits are still interfered by viscous samples, resulting in false positives, unclean background and other problems that seriously affect the interpretation of the results. On the other hand, unlike the idea of ​​pre-treatment of viscous samples, the shelf life of immunochromatography products is usually required to be 12 to 24 months, which places higher requirements on the stability of functional substances on the sample pad. In particular, for immunochromatography products involving sea transportation exports, it is necessary to consider the impact of high temperatures in containers during sea transportation on the stability of immunochromatography products, which specifically requires that the immunochromatography products be stable at 55°C for more than 14 days.

[0048] The results of the present invention using heated storage to infer the room temperature shelf life of the immunochromatography product (for example, the stability at 55°C for one month is equivalent to the stability at room temperature for 24 months) show that although the sample pad treatment solution containing conventional functional substances (such as dithiothreitol, tris(2-carboxyethyl)phosphine, L-cysteine) can reduce the false positive phenomenon of viscous samples in the short term, as the storage time increases (especially at high temperatures), the functional substances in the sample pad treatment solution will gradually become ineffective, and there will even be no difference from the control group without the addition of functional substances.

[0049] The present invention creatively uses S-carboxymethyl-L-cysteine ​​as a functional substance of the sample pad treatment liquid, and finds that S-carboxymethyl-L-cysteine ​​can effectively lyse mucin and reduce sample viscosity, while significantly improving the anti-interference ability of the immunochromatographic detection kit for viscous samples (this is specifically reflected in the ability to eliminate false positive signals of viscous samples and improve background, etc.), and avoid the problem of the immunochromatographic detection kit being oxidized and becoming ineffective, so as to further ensure the long-term anti-interference ability and validity period of the immunochromatographic detection kit for viscous samples (for example, more than 12 months at room temperature), and common problems such as tracer particle aggregation, membrane clogging, false positives, and unclean background will not occur. In addition, the present invention also finds that the combination of S-carboxymethyl-L-cysteine ​​at a specific concentration and Tricine buffer can synergistically improve the anti-interference ability of the immunochromatographic detection kit for viscous samples to completely eliminate false positive signals of viscous samples while maintaining the overall performance (for example, sensitivity) and work efficiency (for example, chromatography speed) of the immunochromatographic detection kit.

[0050] Based on this, the sample pad processing liquid of the present invention can enhance the anti-interference ability of the immunochromatographic detection kit for different viscous samples (such as oropharyngeal swab samples, nasopharyngeal swab samples, vaginal secretion samples, sputum samples or saliva samples) with relatively streamlined ingredients and extend its actual shelf life, and ensure that the detection performance and color development quality of the immunochromatographic detection kit prepared based on it remain at a high level for a long time. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, each element or part is not necessarily drawn according to the actual scale. Obviously, the drawings described below are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without paying creative labor.

[0052] Figure 1 This is a test result diagram of Example 4. DETAILED DESCRIPTION

[0053] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0054] In this document, the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", "front", "rear", "one end", "the other end", etc. are based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0055] Herein "and / or" includes any and all combinations of one or more of the associated listed items.

[0056] Herein, "plurality" means two or more than two, ie, it includes two, three, four, five, etc.

[0057] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0058] As used in this specification, the term "about" typically means + / - 5% of the stated value, more typically + / - 4% of the stated value, more typically + / - 3% of the stated value, more typically + / - 2% of the stated value, even more typically + / - 1% of the stated value, and even more typically + / - 0.5% of the stated value.

[0059] In this specification, some embodiments may be disclosed in a format of being in a range. It should be understood that this description of "being in a range" is only for convenience and brevity, and should not be interpreted as a rigid limitation on the disclosed range. Therefore, the description of the range should be considered to have specifically disclosed all possible sub-ranges and independent numerical values ​​within this range. For example, the description of the range 1-6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within this range, such as 1, 2, 3, 4, 5 and 6. Regardless of the breadth of the range, the above rules apply.

[0060] Embodiment 1 Functional substances dithiothreitol (DTT), tris(2-carboxyethyl)phosphine (TCEP), L-cysteine ​​and S-carboxymethyl-L-cysteine ​​were prepared into sample pad treatment solutions according to the formulas in Table 1, and were evenly soaked and coated on glass fiber (specifications: 200*300 mm) at 20-40 mL / sheet, and dried in an oven at 37°C to prepare sample pads.

[0061] Table 1 The processed sample pad was stacked with the gold pad and NC film, and then cut to form a test reagent strip, which was loaded into the card shell to form a test kit with inspection function. The test kit containing different sample pads was placed at 55℃ for 0 days, 1 week, 2 weeks, and 4 weeks for aging test. The viscous oropharyngeal swab samples 1#-5# of healthy people were tested using the test kits with different aging times to evaluate the treatment effect of each sample pad on the viscous oropharyngeal swab after different aging times.

[0062] Table 2 Note: C1-C10 indicates the color depth of the color band of the chromatographic test strip. The larger the number, the darker the color. When the color depth of the T color band is higher than C1, the result is positive, and "-" indicates no color band. The background evaluation criteria include: when the sample pad background is clean (no red), it is evaluated as "good"; when the sample pad background has red but does not affect the experimenter's interpretation of the results, it is evaluated as "average"; when the sample pad background has red and affects the experimenter's interpretation of the results, it is evaluated as "poor".

[0063] From the results in Table 2, it can be seen that although the sample pads treated with the sample pad treatment solutions using L-cysteine, tris(2-carboxyethyl)phosphine or dithiothreitol as functional substances can reduce the false positive signals to a certain extent in the short term, they cannot completely eliminate the false positive signals (which is reflected in the color depth of the T color strip being below C1). Moreover, as the storage time increases, the false positive signals of the sample pads treated with the above sample pad treatment solutions increase and the background becomes increasingly unclean, which seriously affects the interpretation of the experimental results.

[0064] The sample pad treated with the sample pad treatment solution using S-carboxymethyl-L-cysteine ​​as the functional substance has better thermal stability and better effect on eliminating false positive signals. The effect of eliminating false positive signals will not decrease with the extension of storage time, and the actual shelf life is long (for example, more than 1 year). In other words, compared with L-cysteine, tris(2-carboxyethyl)phosphine and dithiothreitol, S-carboxymethyl-L-cysteine ​​can improve the anti-interference ability of the immunochromatographic detection kit for viscous samples (such as viscous oropharyngeal swab samples) from multiple dimensions such as reducing false positives, improving the cleanliness of the background, and maintaining the sensitivity of the immunochromatographic detection kit. This may be because the introduction of the carboxymethyl group (-CH2COOH) at the thiol (-SH) position of L-cysteine ​​changes the chemical environment of cysteine. On the one hand, the carboxymethyl group can provide long-term spatial protection for the thiol group, making it difficult for oxidants and other reactive substances to approach the thiol group. On the other hand, the electronic effect of the carboxymethyl group may also affect the electron cloud distribution of the thiol group, making it less likely to lose electrons and be oxidized, thereby ensuring the stability of S-carboxymethyl-L-cysteine ​​and its long-term anti-interference ability against viscous samples (such as viscous oropharyngeal swab samples).

[0065] Embodiment 2 Prepare the COVID-19 antigen immunochromatographic detection kit according to the following scheme.

[0066] 2.1 Preparation of sample pad treatment solution and sample pad: Prepare the sample pad treatment solution according to the recipe in Table 3.

[0067] Table 3 The prepared sample pad treatment solution was evenly soaked and coated on a glass fiber (specification: 200*300 mm) at a rate of 20-40 mL / sheet, and dried in an oven at 37°C to prepare a sample pad.

[0068] 2.2 Preparation of gold label pad: Adjust the pH of the colloidal gold solution to 7.6, add the novel coronavirus antigen-specific monoclonal antibody 1# to the colloidal gold solution, let it stand for 10 minutes, then collect the precipitate by centrifugation, dilute it, apply it on a glass fiber pad and put it in an oven to dry at 37°C to prepare a gold label pad.

[0069] 2.3 Preparation of coating membrane: Use coating diluent to dilute the novel coronavirus antigen-specific monoclonal antibody 2# and goat anti-mouse antibody to 0.5 mg / mL and 1 mg / mL, respectively, and draw lines on the NC membrane at the T and C lines. Use a film drawer to draw lines on the NC membrane, and dry it in an oven to prepare a coating membrane.

[0070] 2.4 The coating membrane, gold label pad and sample pad prepared in the above steps are stacked and then cut to form a detection reagent strip, which is loaded into a cartridge to form a detection kit with a testing function.

[0071] The SARS-CoV-2 antigen immunochromatographic detection kit containing a control sample pad, sample pad 1#, sample pad 2#, and sample pad 3# was used to test 40 viscous oropharyngeal swab samples from random healthy people and 3 positive quality controls. The results are shown in Tables 4-1 and 4-2.

[0072] Table 4-1 Table 4-2 As can be seen from Table 4-2, the COVID-19 antigen immunochromatographic detection kits treated with sample pad treatment solutions of different formulations shown in Table 3 can detect positive quality control products of various intensities well. However, as can be seen from Table 4-1, the test results of samples from healthy people show that the COVID-19 antigen immunochromatographic detection kit based on the control sample pad has the highest false positive and the background is easily unclean. The false positive results of the COVID-19 antigen immunochromatographic detection kit using sample pads with S-carboxymethyl-L-cysteine ​​as the functional substance (such as sample pad 1# and sample pad 2#) are significantly reduced; when S-carboxymethyl-L-cysteine ​​and Tricine buffer are used in combination (ie, sample pad 3#), the false positive results of the COVID-19 antigen immunochromatographic detection kit are reduced to 0, that is, the false positive signal is completely eliminated, and the cleanliness of the background is significantly improved.

[0073] Embodiment 3 Prepare the COVID-19 antigen immunochromatographic detection kit according to the following scheme (the method is the same as Example 2).

[0074] Preparation Example 1: The components of the sample pad treatment solution include: 25mM Tricine buffer, 150mM NaCl, 0.2% TritonX-100, 0.1% S-carboxymethyl-L-cysteine, 0.5% BSA, 0.05% Proclin 300, pH 7.6.

[0075] Preparation Example 2: The difference between this preparation example and preparation example 1 is that 50 mM PB buffer is used.

[0076] Preparation Example 3: This preparation example differs from Preparation Example 1 in that 50 mM boric acid buffer is used.

[0077] Preparation Example 4: This preparation example differs from Preparation Example 1 in that 5% S-carboxymethyl-L-cysteine ​​is used.

[0078] Preparation Example 5: This preparation example differs from Preparation Example 1 in that 200 mM Tricine buffer is used.

[0079] Comparative Example 1: This comparative example differs from Preparation Example 1 in that S-carboxymethyl-L-cysteine ​​is not used.

[0080] Comparative Example 2: This comparative example differs from Preparation Example 1 in that 6% S-carboxymethyl-L-cysteine ​​is used.

[0081] The SARS-CoV-2 antigen immunochromatographic detection kit prepared using the sample pad prepared based on the above scheme was used to test viscous oropharyngeal swab samples from 4 healthy people and 1 positive quality control. The results are shown in Table 5.

[0082] Table 5 From the results of Comparative Example 1, it can be seen that without the addition of S-carboxymethyl-L-cysteine, the viscous oropharyngeal swab samples 1#-4# will produce different degrees of false positive signals and the background is not clean, which seriously affects the interpretation of the results. Preparation Example 1 shows that the addition of 0.1% S-carboxymethyl-L-cysteine ​​can significantly improve the anti-interference ability of the immunochromatographic detection kit, eliminate the false positive signals of the viscous oropharyngeal swab samples 1#-4#, and significantly improve the background.

[0083] It can be seen from Preparation Examples 1, 2, and 3 that when the buffer of the sample pad treatment solution uses 25mM Tricine, it is combined with 0.1% S-carboxymethyl-L-cysteine ​​to further enhance the anti-interference ability of the immunochromatographic detection kit. It can be seen from Preparation Examples 1 and 5 that using 50mM-200mM Tricine as a buffer and combining it with S-carboxymethyl-L-cysteine ​​can enhance the anti-interference ability of the immunochromatographic detection kit and completely eliminate false positive signals.

[0084] It can be seen from Preparation Examples 1, 4 and Comparative Example 2 that when the concentration of S-carboxymethyl-L-cysteine ​​in the sample pad treatment solution exceeds 5%, the anti-interference ability of the immunochromatographic detection kit does not decrease, but the slight decrease in the intensity of the T color band when detecting the positive quality control indicates that the high concentration of S-carboxymethyl-L-cysteine ​​in the sample pad treatment solution may cause a slight decrease in the sensitivity of the immunochromatographic detection kit (the above result may also be caused when the concentration of Tricine is higher than 200mM).

[0085] Embodiment 4 Prepare the sample pad treatment solution according to the following formula, evenly soak and coat 20-40 mL / sheet of glass fiber (specification: 200*300 mm), and dry in an oven at 37°C to prepare the sample pad. The sample pad treatment solution includes: 50mM Tricine buffer, 150mM NaCl, 0.2% TritonX-100, 2% S-carboxymethyl-L-cysteine, 0.5% BSA, 0.05% Proclin 300, PH 7.6.

[0086] The processed sample pad was stacked with the gold pad and NC film, and then cut to form a test reagent strip, which was loaded into the cartridge to form a test kit with testing function. The kit was used to test viscous nasopharyngeal swab samples from 5 healthy people. The results were as follows Figure 1 shown.

[0087] from Figure 1 The results on the left show that the viscous nasopharyngeal swab samples will produce different degrees of false positive signals and the background is not clean, which seriously affects the interpretation of the results. The sample pad treatment solution of the present invention significantly improves the anti-interference ability of the immunochromatographic detection kit, and can completely eliminate the false positive signals of the viscous nasopharyngeal swab samples 1#-5# and significantly improve the background.

[0088] It can be seen from the above results that the sample pad treatment solution of the present invention enhances the anti-interference ability of the immunochromatographic detection kit, making it applicable to the detection of samples with different viscosities while maintaining the sensitivity of the immunochromatographic detection kit itself at a relatively high level.

[0089] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. A sample pad treatment solution, characterized in that: The sample pad treatment solution includes at least the following components: S-carboxymethyl-L-cysteine, a buffer, a surfactant and a blocking agent, wherein the mass fraction of the S-carboxymethyl-L-cysteine ​​includes 0.1%-5%, the buffer includes one or more of a phosphate buffer, a borate buffer and a tris(hydroxymethyl)methylglycine buffer, and the concentration of the buffer includes 25mM-200mM.

2. The sample pad treatment solution according to claim 1, characterized in that: The pH of the sample pad treatment solution is within the range of 7.6-8.

4.

3. The sample pad treatment solution according to claim 1, characterized in that The surfactant includes one or more of Triton X-100, Tween20, Tween80, S9, NP-40 and CHAPS; the mass fraction of the surfactant may optionally include 0.1-5.0%.

4. The sample pad treatment solution according to claim 1, characterized in that: The blocking agent includes one or more of BSA, CASEIN, CASEIN-Na, gelatin and skimmed milk powder; the mass fraction of the blocking agent may optionally include 0.1-5.0%.

5. The sample pad treatment solution according to claim 1, wherein The sample pad treatment solution includes the following components: 25mM-200mM buffer, 0.1%-5% (mass fraction) S-carboxymethyl-L-cysteine, 25-200 mM neutral inorganic salt, 0.1-5.0% (mass fraction) surfactant, 0.1-5% (mass fraction) sealing agent and 0.02-0.2% (mass fraction) preservative.

6. The sample pad treatment solution according to any one of claims 1 to 5, characterized in that: The buffer is tris(hydroxymethyl)methylglycine buffer.

7. A sample pad, characterized in that: The sample pad is obtained by being treated with the sample pad treating solution according to any one of claims 1 to 6.

8. An immunochromatographic detection kit for detecting viscous samples, characterized in that: The immunochromatographic detection kit comprises a test strip, which comprises a bottom plate, a sample pad as claimed in claim 7, a conjugate pad, a nitrocellulose membrane and a water-absorbing pad which are arranged on the bottom plate and overlapped in sequence.

9. The kit according to claim 8, characterized in that The conjugate pad is provided with colloidal gold-labeled antibody-1 for specific detection of pathogenic microorganisms, and the nitrocellulose membrane is provided with a detection line and a quality control line.

10. The kit according to claim 8, characterized in that The viscous sample includes an oropharyngeal swab sample, a nasopharyngeal swab sample, a vaginal secretion sample, a sputum sample or a saliva sample.

Citation Information

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