Blocking stage treatment agent for solid phase carrier in immunodiagnostic reagent and its application and product

Abstract

The present invention relates to the field of immunodiagnosis. Specifically, it provides a blocking-stage treatment agent for solid-phase carriers in immunodiagnostic reagents, as well as applications and products thereof. The blocking-stage treatment agent for solid-phase carriers in immunodiagnostic reagents provided by the present invention can, after blocking the solid-phase carrier, reduce nonspecific reactions during immunoassays and significantly reduce the false-positive detection rate in immunodiagnostic tests.

Description

Technical Field

[0001] The present invention relates to the field of immunodiagnosis, and in particular to a blocking phase treating agent for a solid phase carrier in an immunodiagnosis reagent, and its application and product. Background Art

[0002] In immunodiagnostic analysis, blocking reagents are usually used to block sites on the solid phase carrier that are not coated with specific detection substances, so as to reduce or eliminate the detectable signal caused by nonspecific binding between the uncoated sites on the solid phase carrier and the substance containing the detectable label, thereby reducing the background value and false positive rate, and improving the specificity of the test. In blocking reagents, unrelated proteins (also known as inert proteins, blocking proteins) are usually used to block the uncoated sites after the solid phase carrier is coated. The most commonly used blocking agents include bovine serum albumin, calf serum, gelatin, casein, and skim / low-fat milk powder. Blocking is very necessary for most immunoassay methods, especially in indirect detection, because the indirect method methodology itself has a lot of nonspecificity.

[0003] In addition, in actual applications, although blocking proteins can block solid phase carriers, individual false positives may still occur. How to reduce the false positive rate is a problem that needs to be solved in the existing technology.

[0004] In view of this, the present invention is proposed. Summary of the Invention

[0005] The first object of the present invention is to provide a blocking phase treating agent for solid phase carriers in immunodiagnostic reagents.

[0006] The second object of the present invention is to provide the use of the above-mentioned blocking stage treatment agent in immunoturbidimetry, ELISA, chemiluminescence immunoassay, and immunochromatography.

[0007] The third object of the present invention is to provide an immunodiagnostic kit with good accuracy and low false positive detection rate.

[0008] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are adopted:

[0009] A blocking phase treating agent for a solid phase carrier in an immunodiagnostic reagent comprises at least one anionic surfactant.

[0010] Furthermore, the concentration of the anionic surfactant is 0.005-0.5 w / v%, preferably 0.01-0.4 w / v%, and more preferably 0.15-0.25 w / v%;

[0011] Optionally, the anionic surfactant is selected from sulfate type anionic surfactants and carboxylate type anionic surfactants;

[0012] Optionally, the anionic surfactant is selected from fatty alcohol sulfates and N-acylamino carboxylates;

[0013] Optionally, the anionic surfactant is selected from lauryl sulfate, lauroyl-N-methylamino acetate, and N-oleoyl polycarboxylic acid amino acid salt;

[0014] Optionally, the anionic surfactant is selected from sodium lauroyl-N-methylaminoacetate and sodium lauryl sulfate.

[0015] Furthermore, the blocking stage treatment agent further includes a buffering agent;

[0016] Optionally, the buffering agent is selected from histidine buffer, glycine buffer, borax buffer, sodium hydrogen phosphate-citrate buffer, phosphate buffer, potassium dihydrogen phosphate-sodium hydroxide buffer, barbital buffer, ammonia-ammonium chloride buffer, ADA buffer, PIPES buffer, MOPSO buffer, BES buffer, MOPS buffer, TES buffer, HEPES buffer, Tris buffer, EPPS buffer, Tricine buffer, Bicine buffer, TAPS buffer, BIS-tris buffer, HEPES buffer, MES buffer or TEA buffer;

[0017] Optionally, the concentration of the buffer reagent is 5-100 mM, more preferably 5-50 mM, and even more preferably 10-25 mM;

[0018] Optionally, the working pH of the treatment agent in the sealing stage is 7-8.5, more preferably 7-8, and even more preferably 7.2-7.6;

[0019] Optionally, the seal stage treatment agent further comprises at least one metal salt;

[0020] Optionally, the metal salt is selected from sodium chloride and potassium chloride;

[0021] Optionally, the concentration of the metal salt is 100-500 mM, preferably 150-300 mM.

[0022] Furthermore, the blocking stage treatment agent further comprises at least one sugar;

[0023] Optionally, the sugar is selected from sucrose, dextran, mannitol or pullulan;

[0024] Optionally, the concentration of sugar is 1-10 w / v%, preferably 2.5-8 w / v%, and more preferably 5 w / v%.

[0025] Furthermore, the blocking stage treatment agent further comprises at least one blocking protein in a sufficient amount.

[0026] Optionally, the blocking protein is selected from casein, BSA, gelatin, hydrolyzed gelatin, tryptone, fish gelatin, calf serum, low-fat milk powder, skim milk powder;

[0027] Optionally, the blocking protein is used at a concentration such as 0.05-5 w / v% BSA, 5-30 v / v% calf serum, 0.5-2 w / v% fish gelatin, 0.1-3 w / v% casein, 0.5-4 w / v% tryptone.

[0028] Furthermore, the closed stage treatment agent further comprises at least one preservative;

[0029] Optionally, the preservative is selected from ProClin300, sodium azide;

[0030] Optionally, the concentration of the preservative is 0.1-3 v / v%, preferably 0.1-0.5 v / v%, and more preferably 0.1 v / v%.

[0031] Furthermore, the material of the solid phase carrier is, for example, plastic, derivatized plastic, magnetic or non-magnetic metal, glass or silicon;

[0032] Optionally, the solid phase carrier is of a type such as microparticles, beads, test tubes, microtiter plates, cuvettes, membranes, scaffold molecules, filter paper, discs or chips;

[0033] Optionally, the solid phase carrier is, for example, magnetic particles, microtiter plates, or PVDF membranes.

[0034] Application of the blocking phase treatment agent in immunoturbidimetry, ELISA, chemiluminescence immunoassay or immunochromatography.

[0035] An immunodiagnostic kit comprises the above-mentioned blocking phase treatment agent.

[0036] Furthermore, the immunodiagnosis includes the detection of antibodies against infectious pathogens;

[0037] Optionally, the infectious pathogen comprises a virus, bacteria, fungus, chlamydia, mycoplasma, or parasite;

[0038] Optionally, the infectious pathogens include HIV, hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, hepatitis G virus, rubella virus, human cytomegalovirus, herpes simplex virus type 1, herpes simplex virus type 2, rabies virus, human T-lymphotropic virus, dengue virus, human papillomavirus, West Nile virus, forest encephalitis virus, measles virus, influenza virus, parainfluenza virus, varicella virus, echovirus, coxsackie virus, Japanese encephalitis virus, coxsackie virus, Epstein-Barr virus, mumps virus, Treponema pallidum, Borrelia burgdorferi, Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Ureaplasma urealyticum, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Helicobacter pylori, Neisseria gonorrhoeae, Plasmodium, Trypanosoma cruzi, and Toxoplasma.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] The present invention provides a blocking-stage treatment agent for solid-phase carriers in immunodiagnostic reagents. The blocking-stage treatment agent includes at least one anionic surfactant. The inventors unexpectedly discovered that the presence of an anionic surfactant during the blocking process of the solid-phase carrier can effectively reduce the false positive rate in immunoassays. DETAILED DESCRIPTION

[0041] The embodiments of the present invention will be described in detail below with reference to the examples. However, it will be understood by those skilled in the art that the following examples are intended only to illustrate the present invention and are not to be construed as limiting the scope of the present invention. Where specific conditions are not specified in the examples, the procedures were carried out according to conventional conditions or the conditions recommended by the manufacturer.

[0042] Unless otherwise indicated, the professional and scientific terms used herein are the same as those familiar to those skilled in the art. In addition, any method or material similar or equivalent to the described content can also be applied to the present invention.

[0043] A blocking phase treating agent for a solid phase carrier in an immunodiagnostic reagent comprises at least one anionic surfactant.

[0044] The inventors discovered that the presence of anionic surfactants during the solid-phase carrier blocking process can effectively reduce the false-positive rate in immunoassays. Research and analysis have shown that some false-positive results in immunoassays are related to blocking proteins. Blocking proteins acquire a positive charge in a near-neutral pH environment. Adding negatively charged anionic surfactants can neutralize the positive charge of the blocking proteins. This interaction blocks nonspecific binding caused by charge interactions, thereby reducing the occurrence of false-positive results during the assay.

[0045] It should be noted that anionic surfactants are partially negatively charged surfactants that play a surface active role after ionization in water. According to the different hydrophilic groups, anionic surfactants mainly include sulfate (salt) type (R-OSO3 - M + ), sulfonate type (R-SO3 - M + ), phosphate type (R-OPO3 - M + ), carboxylate type (R-COO - M + ), R is a hydrocarbon group, M + It is a cation, usually in the form of sodium, potassium, lithium, ammonium, calcium, triethanolamine or the like. Exemplary sulfate ester (salt) type anionic surfactants include fatty alcohol sulfates, sulfates of unsaturated alcohols such as fatty alcohol polyoxyethylene ether sulfates, etc. Exemplary sulfonate anionic surfactants include alkyl sulfonates such as sodium dodecylsulfonate, alkylbenzenesulfonates such as linear sodium alkylbenzenesulfonate and branched sodium alkylbenzenesulfonate, olefin sulfonates, succinate sulfonates, etc. Exemplary phosphate ester (salt) type anionic surfactants include alkyl phosphate monoesters, alkyl phosphate diesters, fatty alcohol polyvinyl ether phosphate monoesters, fatty alcohol polyvinyl ether phosphate diesters, alkylphenol polyoxyethylene ether monoesters, alkylphenol polyoxyethylene ether diesters, etc. Exemplary carboxylate type anionic surfactants include higher fatty acid salts such as soaps, N-acylamino carboxylates, alkyl ether carboxylates such as fatty alcohol polyoxyethylene ether carboxylates, and stearyl lactylates such as calcium stearyl lactylate.

[0046] In an alternative embodiment, the anionic surfactant is a fatty alcohol sulfate such as lauryl sulfate (i.e., dodecyl sulfate); N-acylaminocarboxylates (reaction products of fatty acid chlorides and amino acids), such as lauroyl sarcosinate (i.e., lauroyl-N-methylamino acetate), N-oleoyl polycarboxylic acid amino acid salts.

[0047] In alternative embodiments, the salt form includes cations such as sodium, potassium, lithium, ammonium, calcium, triethanolamine, etc.

[0048] In an alternative embodiment, the concentration of the anionic surfactant is 0.005-0.5 w / v%, preferably 0.01-0.4 w / v%, and further preferably 0.15-0.25 w / v%.

[0049] It should be noted that "w / v%" in the present invention refers to the mass g of a substance contained in every 100 mL of the sealing stage treatment agent. For example, if the concentration of the anionic surfactant is 0.005-0.5w / v%, it means that the content of the anionic surfactant in every 100 mL of the sealing stage treatment agent is 0.005-0.5g.

[0050] In the present invention, "v / v%" refers to the volume mL of a substance contained in 100 mL of the blocking stage treatment agent.

[0051] In some embodiments, the anionic surfactant includes sodium lauroyl-N-methylamino acetate and / or sodium lauryl sulfate, wherein the anionic surfactant is sodium lauroyl-N-methylamino acetate, or, when it is sodium lauroyl-N-methylamino acetate and sodium lauryl sulfate, the concentration of sodium lauroyl-N-methylamino acetate is preferably 0.01-0.4w / v%, for example, 0.02w / v%; the anionic surfactant is sodium lauryl sulfate, or, when it is sodium lauroyl-N-methylamino acetate and sodium lauryl sulfate, the concentration of sodium lauryl sulfate is preferably 0.01-0.4w / v%, for example, 0.02w / v%. The concentration of sodium lauroyl-N-methylaminoacetate or sodium lauryl sulfate can independently be, but is not limited to, 0.01 w / v%, 0.02 w / v%, 0.05 w / v%, 0.1 w / v%, 0.17 w / v%, 0.2 w / v%, 0.25 w / v%, 0.27 w / v%, 0.3 w / v%, 0.32 w / v%, 0.35 w / v%, 0.38 w / v% or 0.4 w / v%.

[0052] In an optional embodiment, the blocking phase treatment agent further includes a buffering agent that can maintain the blocking phase treatment agent within a desired pH buffer range. Some buffers have multiple available buffer pairs, for example, borax buffers include borax-boric acid buffers and borax-calcium chloride buffers; for example, phosphate buffers are mainly hydrogen phosphate-dihydrogen phosphate buffer pairs. Buffering agents include, but are not limited to, histidine buffer, glycine buffer, borax buffer, disodium hydrogen phosphate-citric acid buffer, phosphate buffer, potassium dihydrogen phosphate-sodium hydroxide buffer, barbital buffer, ammonia-ammonium chloride buffer, ADA buffer, PIPES buffer, MOPSO buffer, BES buffer, MOPS buffer, TES buffer, HEPES buffer, Tris buffer, EPPS buffer, Tricine buffer, Bicine buffer, TAPS buffer, BIS-tris buffer, HEPES buffer, MES buffer, or TEA buffer.

[0053] In an alternative embodiment, the buffer should be present in an amount sufficient to achieve its intended function, ie, maintain the desired pH. The concentration of the buffer is, for example, 5-100 mM, more preferably 5-50 mM, and even more preferably 10-25 mM.

[0054] In an optional embodiment, the working pH of the sealing stage treatment agent is 7-8.5, further 7-8, and further preferably 7.2-7.6, and can be but not limited to 7, 7.2, 7.3, 7.4, 7.6, 8, 8.3 or 8.5.

[0055] In an alternative embodiment, the sealing stage treatment agent further comprises at least one metal salt. In an alternative embodiment, the metal salt is selected from sodium chloride and potassium chloride, but is not limited thereto.

[0056] In an alternative embodiment, the concentration of the metal salt is, for example, 100-500 mM, preferably 150-300 mM. The concentration of the metal salt can be, but is not limited to, 100 mM, 200 mM, 300 mM, 400 mM or 500 mM.

[0057] In an alternative embodiment, the blocking phase treatment agent further comprises at least one sugar. The sugar acts as a viscosity modifier, primarily to protect the protein adsorbed on the solid support, thereby acting as a protective agent. In an alternative embodiment, the sugar is selected from sucrose, dextran, mannitol, or pullulan, but is not limited thereto.

[0058] In an optional embodiment, the concentration of sugar is preferably 1-10 w / v%, more preferably 5 w / v%, and the concentration of sugar can be but is not limited to 1 w / v%, 2 w / v%, 3 w / v%, 4 w / v%, 5 w / v%, 6 w / v%, 7 w / v%, 8 w / v%, 9 w / v% or 10 w / v%.

[0059] In an alternative embodiment, the blocking stage treatment agent further comprises at least one sufficient amount of a blocking protein, where "sufficient amount" of the blocking protein means that the binding sites on the solid support are completely blocked. In an alternative embodiment, the blocking protein is selected from casein, BSA, gelatin, hydrolyzed gelatin, tryptone, fish gelatin, calf serum, low-fat milk powder, and skim milk powder, but is not limited thereto.

[0060] In alternative embodiments, blocking proteins are used at concentrations such as 0.05-5 w / v% BSA, 5-30 v / v% calf serum, 0.5-2 w / v% fish gelatin, 0.1-3 w / v% casein, or 0.5-4 w / v% tryptone.

[0061] In an optional embodiment, a reducing agent can be selectively added according to the specific diagnostic item to open the disulfide bonds of the antigen and fully expose the epitope. The reducing agent is a commonly used technical solution in this field and is not specifically limited here. For example, β-mercaptoethanol (BME), dithiothreitol (DTT) or tris-(2-formylethyl)phosphine hydrochloride (TCEP-HCl) can be used.

[0062] In an alternative embodiment, the seal-stage treatment agent further comprises at least one preservative, which can inhibit the growth of microorganisms in the seal-stage treatment agent. The preservative may be, but is not limited to, ProClin 300 or sodium azide. In an alternative embodiment, the concentration of the preservative is 0.1-3 v / v%, and may be, but is not limited to, 0.1 v / v%, 0.3 v / v%, 0.5 v / v%, 0.7 v / v%, 0.8 v / v%, or 1 v / v%, preferably 0.1-0.5 v / v%, and more preferably 0.1 v / v%.

[0063] In an optional embodiment, the material of the solid phase carrier is, for example, plastic, derivatized plastic, magnetic or non-magnetic metal, glass or silicon; in an optional embodiment, the type of the solid phase carrier is, for example, microparticles, beads, test tubes, microporous titration plates, cuvettes, membranes, scaffold molecules, filter paper, discs or chips; in some specific embodiments, the solid phase carrier is, for example, magnetic particles, microporous titration plates, PVDF membranes.

[0064] Since the blocking stage treatment agent provided by the present invention can solve the problem of false positives caused by non-specific binding reactions caused by blocking proteins in existing blocking treatments, the blocking stage treatment agent provided by the present invention can be applied to operations involving blocking solid phase carriers in immunodiagnosis, such as solid phase carriers used in detection methods such as indirect agglutination reactions, ELISA or chemiluminescence, such as latex, magnetic beads, polystyrene (ELISA plates, small test tubes, etc.), etc.

[0065] Application of the blocking phase treatment agent in immunoturbidimetry, ELISA, chemiluminescence immunoassay or immunochromatographic ELISA.

[0066] An immunodiagnostic kit comprises the blocking phase treatment agent provided by the present invention. The accuracy of the immunodiagnostic reagent in the kit is significantly improved, and the false positive detection rate is reduced.

[0067] In alternative embodiments, the immunodiagnostic comprises the detection of antibodies against an infectious pathogen;

[0068] In alternative embodiments, the infectious pathogen comprises a virus, bacteria, fungus, chlamydia, mycoplasma, or parasite;

[0069] In an alternative embodiment, the infectious pathogens include HIV, hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, hepatitis G virus, rubella virus, human cytomegalovirus, herpes simplex virus type 1, herpes simplex virus type 2, rabies virus, human T-lymphotropic virus, dengue virus, human papillomavirus, West Nile virus, forest encephalitis virus, measles virus, influenza virus, parainfluenza virus, varicella virus, echovirus, coxsackie virus, Japanese encephalitis virus, coxsackie virus, Epstein-Barr virus, mumps virus, Treponema pallidum, Borrelia burgdorferi, Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Ureaplasma urealyticum, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Helicobacter pylori, Neisseria gonorrhoeae, Plasmodium, Trypanosoma cruzi, and Toxoplasma.

[0070] The present invention is further described below by way of specific examples. However, it should be understood that these examples are merely provided for more detailed description and are not to be construed as limiting the present invention in any form.

[0071] Preparation of blocking stage treatment agent base solution 1: disodium hydrogen phosphate-sodium dihydrogen phosphate buffer 10mM, NaCl 150mM, tryptone 10g / L, sucrose 50g / L, Procline 300 1ml / 1000ml, pH adjusted to 7.4.

[0072] Preparation of blocking stage treatment agent base solution 2: Tris-HCl buffer 25mM, KCl 200mM, BSA 10g / L, trehalose 80g / L, Procline300 1ml / 1000ml, after mixing, dilute to 1L, divide into aliquots and store at 4℃, adjust pH to 7.2.

[0073] Preparation of blocking stage treatment agent base solution 3: 50 mM boric acid-sodium borate buffer, 300 mM NaCl, 5 g / L casein, 25 g / L dextran, 1 ml / 1000 ml Procline 300, pH adjusted to 7.6.

[0074] Example 1

[0075] Sodium lauroyl-N-methylaminoacetate was added to the base solution 1 at a concentration of 0.02 w / v%.

[0076] Example 2

[0077] Sodium lauryl sulfate was added to the base solution 1 at a concentration of 0.02 w / v%.

[0078] Example 3

[0079] Sodium lauryl sulfate and sodium lauroyl-N-methylaminoacetate were added to the base solution 1, with the concentration of both being 0.02 w / v%.

[0080] Example 4

[0081] Sodium lauroyl-N-methylaminoacetate was added to base solution 2 at a concentration of 0.4 w / v%.

[0082] Example 5

[0083] Sodium lauroyl-N-methylaminoacetate was added to the base solution 3 at a concentration of 0.01 w / v%.

[0084] Example 6

[0085] Sodium lauryl sulfate was added to the base solution 2 at a concentration of 0.4 w / v%.

[0086] Example 7

[0087] Sodium lauryl sulfate was added to the base solution 3 at a concentration of 0.01 w / v%.

[0088] Comparative Example 1

[0089] To the base solution 1, nonionic surfactant TWEEN-20 was added at a concentration of 0.02 w / v%.

[0090] Comparative Example 2

[0091] On the basis of base solution 1, nonionic surfactant Tritonx-100 was added at a concentration of 0.02 w / v%.

[0092] Comparative Example 3

[0093] On the basis of base liquid 1, nonionic surfactant BRIJ-35 was added at a concentration of 0.02 w / v%.

[0094] Comparative Example 4

[0095] Base fluid 1, without adding any surfactant.

[0096] Comparative Example 5

[0097] Base fluid 2, without adding any surfactant.

[0098] Comparative Example 6

[0099] Base fluid 3, without adding any surfactant.

[0100] Test example

[0101] Taking the HCV enzyme immunoassay project as an example

[0102] 1. Use CBS (pH 9.6, 50mM CB, and 150mM NaCl) as the coating solution. Add 1:10,000 SDS to the coating solution and mix thoroughly before use. Add HCV antigen to the above coating solution according to the proportion and mix thoroughly before coating directly. Add 100μl to each well and coat at 4℃ for 20-24 hours.

[0103] 2. Blocking: Remove the coated plate and equilibrate it at room temperature. Wash the plate twice with detergent, pat dry and then block. Add 200 μl of blocking agent to each well and block at 37°C for 2 hours (or at 4°C overnight). Dry it in a drying room or electronic drying oven with a humidity of less than 30% for 24 hours before use.

[0104] 3. Prepare enzyme-labeled secondary antibody working solution: dilute anti-human IgG-HRP with enzyme diluent according to the recommended titer and mix well, set aside;

[0105] 4. Reaction mode and reaction time: 100 μl sample diluent + 10 μl test sample, react at 37°C in a constant temperature box for 60 minutes, wash the plate 5 times, pat dry and add 100 μl enzyme-labeled secondary antibody working solution, react at 37°C for 30 minutes, wash the plate 5 times, add 50 μl each of color developer A and B, develop for 30 minutes, add 50 μl stop solution, read the value at a dual wavelength of 450nm-630nm, and the reading should be completed within 10 minutes.

[0106] The sample diluent contains 10 mM PB, pH 7.4, 10% NBS, 0.75% Casein-2Na, 500 mM NaCl, 0.2% Triton X-100 and 0.1% Procline 300.

[0107] The enzyme diluent composition contains 10 mM PB, pH 7.4, 150 mM NaCl, 30% NBS, 0.2% Casein-2Na, 5‰ Tween-20 and 0.05% thimerosal.

[0108] In the above test, the closed stage treatment agents in Examples 1-3 and Comparative Examples 1-4 were used to conduct experiments, and 10 positive samples, 5 negative samples, and 1358 clinical samples were tested. The positive samples and suspected false positive samples were verified using the sandwich method and the RIBA method. The results are shown in Table 1 below:

[0109] Table 1

[0110]

[0111] The results in the table above show that, by comparison, the anionic surfactant sodium lauroyl-N-methylaminoacetate was the most effective when used as a blocking agent, with better specificity than the other conditions. The anionic surfactant sodium lauryl sulfate was also more effective than the other three non-ionic surfactants. This indicates that the addition of anionic surfactants to the blocking agent can further eliminate false positives, resulting in higher specificity in the test results. The addition of non-ionic surfactants to the blocking agent resulted in a false positive rate similar to that of the base solution, indicating that the addition of non-ionic surfactants did not eliminate more false positive specimens.

[0112] False positive samples reported on the market were collected and tested using Examples 1 and 2, Examples 4-7, and Comparative Examples 4-6 to check the positive detection rate. The results are shown in Table 2 below:

[0113] Table 2

[0114]

[0115]

[0116] By contrast, anionic surfactants can further eliminate false positives in blocking stage treatments.

[0117] The blocking stage treatment agents in Example 1 and Comparative Example 1 were used to make blocking plates, prepare matching test kits, and compare the national standard plates. The results are shown in Table 3 below:

[0118] Table 3

[0119]

[0120]

[0121] Note: "0.5 NCU / ml" refers to the Conchestan standard; "CV" refers to the results of three replicate wells of the same precision serum; "L1-L4" refers to the results of the serial dilution of serum in the serum plate.

[0122] By comparison, the effect of the test kit made by adding sodium lauroyl-N-methylaminoacetate to the blocking stage treatment agent is significantly better than that made by adding TWEEN-20 to the blocking stage treatment agent. This is reflected in that sodium lauroyl-N-methylaminoacetate, as a representative of anionic surfactants, has better sensitivity and specificity than TWEEN-20.

[0123] Although the present invention has been illustrated and described with specific embodiments, it will be appreciated that many other changes and modifications may be made without departing from the spirit and scope of the present invention. It is therefore intended that the appended claims include all such changes and modifications that fall within the scope of the present invention.

Claims

1. Use of lauroyl-N-methylaminoacetate in a solid phase carrier blocking phase treatment agent for preparing an immunodiagnostic reagent, wherein the immunodiagnosis includes the detection of antibodies against infectious pathogens, the blocking phase treatment agent includes at least one blocking protein, and the concentration of lauroyl-N-methylaminoacetate is 0.01-0.4 w / v%.

2. The use according to claim 1, wherein the solid phase carrier is made of plastic, magnetic or non-magnetic metal, glass or silicon.

3. The use according to claim 2, wherein the solid phase carrier material is a derivatized plastic.

4. The method according to claim 1, wherein the solid phase carrier is a microparticle, a test tube, a microtiter plate, a cuvette, a membrane, a scaffold molecule, a filter paper, a disc or a chip.

5. The method according to claim 1 or claim 4, wherein the solid phase carrier is a microtiter plate or beads.

6. The use according to claim 1, wherein the infectious pathogen comprises a virus, a bacterium, a fungus, a chlamydia, a mycoplasma or a parasite.

7. The use according to claim 1 or 6, wherein the infectious pathogen comprises hepatitis C virus.

8. The use according to claim 1, wherein the lauroyl-N-methylaminoacetate is sodium lauroyl-N-methylaminoacetate.

9. An immunodiagnostic kit, characterized in that The kit comprises a blocking stage treatment agent, wherein the blocking stage treatment agent comprises lauroyl-N-methylaminoacetate and at least one blocking protein, and the concentration of the lauroyl-N-methylaminoacetate is 0.01-0.4 w / v %.

10. The kit according to claim 9, wherein the kit is used for detecting antibodies to hepatitis C virus.

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