CN113607962A - Preservation solution for cTnI antibody coated magnetic beads and preparation method thereof - Google Patents

Preservation solution for cTnI antibody coated magnetic beads and preparation method thereof Download PDF

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CN113607962A
CN113607962A CN202110905348.5A CN202110905348A CN113607962A CN 113607962 A CN113607962 A CN 113607962A CN 202110905348 A CN202110905348 A CN 202110905348A CN 113607962 A CN113607962 A CN 113607962A
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preservation solution
concentration
magnetic beads
ctni antibody
ctni
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CN113607962B (en
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周倩
毛善检
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Sinocare Inc
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Sinocare Inc
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6887Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from muscle, cartilage or connective tissue
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326Magnetic particles
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/4712Muscle proteins, e.g. myosin, actin, protein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/32Cardiovascular disorders
    • G01N2800/324Coronary artery diseases, e.g. angina pectoris, myocardial infarction
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The application discloses preservation liquid of cTnI antibody coated magnetic bead, the solvent is water, its characterized in that includes: buffer salt; a protein; a surfactant; an inorganic salt; ceteareth-25 as a protectant; a preservative; the pH value of the preservation solution is 7.0-8.0. The application also provides a preparation method of the preservation solution of the cTnI antibody coated magnetic beads. The preservation solution for the cTnI antibody coated magnetic beads can effectively improve the stability of the cTnI antibody coated magnetic beads in the storage and use processes; particularly, the protective agent is added, so that the stability, the sensitivity and the linear gradient of the reagent can be obviously improved. The preservation solution for the cTnI antibody coated magnetic beads is simple in components, simple and convenient to prepare, low in cost and convenient for mass production.

Description

Preservation solution for cTnI antibody coated magnetic beads and preparation method thereof
Technical Field
The application relates to the technical field of detection reagents, in particular to a preservation solution of cTnI antibody coated magnetic beads and a preparation method thereof.
Background
Troponin (Tn) complexes are composed of troponin I, troponin T and troponin C, and are capable of regulating muscle contraction. Cardiac troponin I (cTnI I) is an isoform of troponin I present in cardiac muscle cells, has high myocardial specificity, and can be used to identify clinical conditions associated with myocardial injury and skeletal muscle injury.
Acute Myocardial Infarction (AMI) is one of the major diseases threatening human life at present. When myocardial cells are damaged by myocardial infarction or ischemia, cTnI rapidly penetrates through the myocardial cell membrane into the blood. Therefore, the rapid, sensitive and accurate determination of cTnI and the change trend thereof in human blood in the early stage of the onset of the disease has important clinical significance for the diagnosis and treatment of acute myocardial infarction.
The cTnI is used as a first-choice marker of myocardial damage, a chemiluminescence immunoassay method is a common method for clinical detection at present, and a magnetic particle chemiluminescence method is mainly adopted at present. The magnetic bead coated antibody plays an important role in the chemiluminescence detection reagent, so that the stability of the magnetic bead coated antibody lays a solid foundation for high-quality chemiluminescence reagents.
At present, the stability of the magnetic bead coated antibody is improved mainly from two aspects of optimization of a magnetic bead coating process or optimization of a formula. However, the former process is complicated, while the latter usually employs a commercial magnetic bead preservation solution, which is expensive and has a certain batch difference, thereby affecting the performance of the reagent.
Therefore, it is an urgent technical problem to be solved by those skilled in the art to provide a storage solution that improves the use and storage stability of magnetic beads coated with a cTnI antibody, improves the storage stability, reduces batch-to-batch variation, and reduces the cost.
Disclosure of Invention
In order to solve the above technical problems, a first object of the present invention is to provide a preservation solution for magnetic beads coated with cTnI antibody; the second object of the present invention is to provide a method for preparing a preservation solution for magnetic beads coated with the cTnI antibody; the preservation solution for the cTnI antibody coated magnetic beads can effectively improve the stability of the cTnI antibody coated magnetic beads in the storage and use processes, and does not need to add sugar, alcohol, lipid and other protective agents; particularly, the protective agent is added, so that the stability, the sensitivity and the linear gradient of the reagent can be obviously improved. The preservation solution for the cTnI antibody coated magnetic beads is simple in components, simple and convenient to prepare, low in cost and convenient for mass production.
The technical scheme provided by the invention is as follows:
a preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is water, comprises:
buffer salt;
a protein;
a surfactant;
an inorganic salt;
ceteareth-25 as a protectant;
a preservative;
the pH value of the preservation solution is 7.0-8.0.
Preferably, the method comprises the following steps:
20-100mmol/L of buffer salt;
2-20g/L protein;
0.5-5g/L of surfactant;
0.1-0.5mol/L of inorganic salt;
ceteareth-251-10 g/L as a protective agent;
0.5-5g/L of preservative;
the pH value of the preservation solution is 7.0-8.0.
Preferably, the buffer salt is any one of Tris, MES, MOPS and HEPES; and/or the presence of a gas in the gas,
the concentration of the buffer salt is 50-60 mmol/L.
Preferably, the protein is one or more of bovine serum albumin, casein and gelatin.
Preferably, the protein is bovine serum albumin, and the concentration of the bovine serum albumin is 10-15 g/L.
Preferably, the surfactant is any one or more of triton x-100, triton x-405, tween 20 and tween 80; and/or the presence of a gas in the gas,
the concentration of the surfactant is 1-2 g/L.
Preferably, the inorganic salt is a combination of sodium chloride, magnesium chloride and zinc chloride; or the ionic salt is a combination of potassium chloride, magnesium chloride and zinc chloride; the concentration of sodium chloride is 0.1-0.3 mol/L; the concentration of magnesium chloride is 0.5-5 mmol/L; the concentration of zinc chloride is 0.05-1 mmol/L; the concentration of potassium chloride is 0.1-0.3 mol/L.
Preferably, in the inorganic salt combination, the concentration of sodium chloride is 0.1-0.2 mol/L; the concentration of magnesium chloride is 2.5-5 mmol/L; the concentration of zinc chloride is 0.1-0.5 mmol/L; the concentration of potassium chloride is 0.1-0.2 mol/L.
More preferably, the inorganic salt composition used is: 0.15mol/L of sodium chloride, 5mmol/L of magnesium chloride and 0.1mmol/L of zinc chloride;
or potassium chloride is 0.15mol/L, magnesium chloride is 5mmol/L, and zinc chloride is 0.1 mmol/L;
or 0.15mol/L of sodium chloride, 2.5mmol/L of magnesium chloride and 00.5mmol/L of zinc chloride;
or potassium chloride 0.15mol/L, magnesium chloride 2.5mmol/L, zinc chloride 00.5 mmol/L.
Preferably, the preservative is any one or more of sodium azide, PC300, chloramphenicol and gentamicin; and/or the presence of a gas in the gas,
the concentration of the preservative is 1-2 g/L.
Preferably, the pH of the preservation solution is adjusted using an inorganic acid or an inorganic base. Among them, the inorganic acid is preferably hydrochloric acid, and the inorganic base is preferably sodium hydroxide.
A preparation method of a preservation solution of cTnI antibody coated magnetic beads comprises the following steps:
respectively adding buffer salt, protein, surfactant, inorganic salt, protective agent ceteareth-25 and preservative into water, and mixing uniformly to ensure that the concentration of the buffer salt is 20-100mmol/L and the concentration of the protein is 2-20 g/L; the concentration of the surfactant is 0.5-5 g/L; the concentration of the inorganic salt is 0.1-0.5 mol/L; the concentration of the protective agent ceteareth-25 is 1-10g/L, and the concentration of the preservative is 0.5-5 g/L; and adjusting the pH to 7.0-8.0;
and (5) fixing the volume and filtering. According to the preparation method of the preservation solution of the cTnI antibody coated magnetic beads, the adding sequence of buffer salt, protein, a surfactant, inorganic salt, a protective agent ceteareth-25 and a preservative is not required, each substance is added independently and uniformly mixed, then the next substance is added, and finally, the pH is adjusted, the constant volume is determined, and the filtration is carried out.
The preservation solution for the cTnI antibody coated magnetic beads can effectively improve the stability of the cTnI antibody coated magnetic beads in the storage and use processes, and does not need to add sugar, alcohol, lipid and other protective agents; particularly, the protective agent is added, so that the stability, the sensitivity and the linear gradient of the reagent can be obviously improved. The preservation solution for the cTnI antibody coated magnetic beads is simple in components, simple and convenient to prepare, low in cost and convenient for mass production.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments described in the present application, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is a graph showing the results of a dose-response curve test in an example of the present invention;
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or be indirectly disposed on the other element; when an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.
It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, refer to an orientation or positional relationship illustrated in the drawings for convenience in describing the present application and to simplify description, and do not indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the present application.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "plurality" or "a plurality" means two or more unless specifically limited otherwise.
It should be understood that the structures, ratios, sizes, and the like shown in the drawings are only used for matching the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the practical limit conditions of the present application, so that the modifications of the structures, the changes of the ratio relationships, or the adjustment of the sizes, do not have the technical essence, and the modifications, the changes of the ratio relationships, or the adjustment of the sizes, are all within the scope of the technical contents disclosed in the present application without affecting the efficacy and the achievable purpose of the present application.
The embodiments of the present application are written in a progressive manner.
Example 1
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 10g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mol/L; magnesium chloride: 5.00 mmol/L; zinc chloride: 0.10 mmol/L;
a protective agent: ceteareth-251 g/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding inorganic salt into water and mixing uniformly;
adding protein into water and mixing;
adding a surfactant into water and uniformly mixing;
adding a protective agent into water and uniformly mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, and filtering with 0.22um filter element.
Ceteareth-25, a protectant added in the above examples, Cremophor A25; the protective agent added in the subsequent examples was ceteareth-25 (Cremophor A25).
Example 2
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 15g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mol/L; magnesium chloride: 2.50 mmol/L; zinc chloride: 0.50 mmol/L;
a protective agent: ceteareth-2510 g/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding protein into water and mixing; adding inorganic salt into water and mixing uniformly;
adding a surfactant into water and uniformly mixing;
adding a protective agent into water and uniformly mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, and filtering with 0.22um filter element.
Example 3
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 10g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mmol/L; magnesium chloride: 2.50 mmol/L; zinc chloride: 0.50 mmol/L;
a protective agent: ceteareth-255 g/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding a surfactant into water and uniformly mixing;
adding a protective agent into water and uniformly mixing;
adding inorganic salt into water and mixing uniformly;
adding protein into water and mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, and filtering with 0.22um filter element.
Comparative example 1
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 10g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mol/L; magnesium chloride: 2.50 mmol/L; zinc chloride: 0.50 mmol/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding inorganic salt into water and mixing uniformly;
adding protein into water and mixing;
adding a surfactant into water and uniformly mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, and filtering with 0.22um filter element.
Comparative example 2
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 10g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mol/L; magnesium chloride: 2.50 mmol/L; zinc chloride: 0.50 mmol/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
a protective agent: 50g/L of glycerin, 10g/L of cane sugar and 40001 g/L of polyethylene glycol;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding inorganic salt into water and mixing uniformly;
adding protein into water and mixing;
adding a surfactant into water and uniformly mixing;
adding a protective agent into water and uniformly mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, and filtering with 0.22um filter element.
Comparative example 3
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 10g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mol/L; magnesium chloride: 2.50 mmol/L; zinc chloride: 0.50 mmol/L;
a protective agent: ceteareth-250.5 g/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding inorganic salt into water and mixing uniformly;
adding protein into water and mixing;
adding a surfactant into water and uniformly mixing;
adding a protective agent into water and uniformly mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, filtering with 0.22um filter core
Comparative example 4
A preservation solution of magnetic beads coated with cTnI antibodies, wherein a solvent is pure water, comprises:
buffer salt: tris 50 mmol/L;
protein: 10g/L of bovine serum albumin;
surfactant (b): triton x-1001 g/L;
inorganic salts, including sodium chloride: 0.15 mol/L; magnesium chloride: 2.50 mol/L; zinc chloride: 0.50 mol/L;
a protective agent: ceteareth-2520 g/L;
preservative: sodium azide 1g/L, and PC 3001 g/L;
the pH of the preservation solution was 7.4.
The preparation method of the preservation solution of the cTnI antibody coated magnetic beads comprises the following steps:
adding buffer salt into water and uniformly mixing;
adding inorganic salt into water and mixing uniformly;
adding protein into water and mixing;
adding a surfactant into water and uniformly mixing;
adding a protective agent into water and uniformly mixing;
adding antiseptic into water, and mixing;
adjusting the pH value to 7.40 +/-0.05;
constant volume, filtering with 0.22um filter core
The storage solutions of the magnetic beads coated with the cTnI antibody of examples 1 to 3 and comparative examples 1 to 4 were tested.
Experiment one: stability verification
The magnetic bead reagent is prepared by adding cTnI antibody coated magnetic bead mother liquor into the preservation solution.
Dividing the reagent into 2 parts, placing one part in 37 ℃ for accelerated aging for 7 days, and placing the other part in 2-8 ℃ for storage. After being placed for 7 days, the same sample is synchronously tested by two reagents by taking the reagent placed at 2-8 ℃ as a control. The test results were as follows:
table 1 stability test results
Figure BDA0003200275640000101
From the results of experimental examples 1 to 3, it can be seen that the working solution obtained by diluting cTnI antibody-coated magnetic beads with the preservation solution of the present invention is accelerated at 37 ℃ for 7 days, and the reduction of the luminescence value is within 3.0%; ceteareth-25 concentrations in the range of 1-10g/L had no significant effect on stability. As can be seen from comparative example 1, the luminescence value without the addition of the protecting agent was reduced by 20.0% or more. As is clear from comparative example 2, the luminescence value decreased by about 15.0% when a protective agent such as an alcohol, a saccharide or a polymer was added to the storage solution. From comparative examples 3-4, it is clear that too much or too little ceteareth-25 concentration affected the stability of the agent.
Experiment two: sensitivity verification
The magnetic bead reagent is prepared by adding a cTnI antibody coated magnetic bead mother solution into the preservation solution, and is matched with an enzyme marker to form the cTnI reagent, a 0-concentration sample is tested for 20 times, a blank limit is calculated, and the test result is as follows:
TABLE 2 sensitivity test results
Figure BDA0003200275640000102
Figure BDA0003200275640000111
From the results of experimental examples 1 to 3, it is understood that the blank limit of the working solution obtained by diluting magnetic beads coated with cTnI antibody with the preservation solution of the present invention is 0.002. As can be seen from comparative examples 1-2, the blank limit was greatly affected without adding ceteareth-25 protector or adding other protectors such as alcohols, saccharides, polymers, etc. As can be seen from comparative examples 3-4, the ceteareth-25 concentration was either too high or too low, and the clear limit test was not favored.
The concentrations of examples 1-3 and comparative examples 1-4 were plotted against RLU to obtain a dose-response curve, as shown in figure 1.
Experiment three: linear gradient verification
The magnetic bead reagent is prepared by adding a cTnI antibody coated magnetic bead mother solution into the preservation solution, and is matched with an enzyme marker to form the cTnI reagent for linear gradient test, and the test result is as follows:
TABLE 3 Linear gradient test results
Figure BDA0003200275640000121
From the results of experimental examples 1-3, the working solution obtained by diluting cTnI antibody-coated magnetic beads with the preservation solution of the invention has obvious linear gradient and is in an obvious rising trend within the range of 0-50 ng/mL. From comparative examples 1-2, it is clear that the linear gradient is significantly reduced without adding ceteareth-25 protector or with other protectors such as alcohols, saccharides, polymers, etc. From comparative examples 3-4, it can be seen that the use of too much or too little ceteareth-25 concentration is not advantageous for the linear gradient test.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

1. A preservation solution of cTnI antibody coated magnetic beads is characterized in that the preservation solution comprises water as a solvent:
buffer salt;
a protein;
a surfactant;
an inorganic salt;
ceteareth-25 as a protectant;
a preservative;
the pH value of the preservation solution is 7.0-8.0.
2. The preservation solution for magnetic beads coated with a cTnI antibody according to claim 1, comprising:
20-100mmol/L of buffer salt;
2-20g/L protein;
0.5-5g/L of surfactant;
0.1-0.5mol/L of inorganic salt;
ceteareth-251-10 g/L as a protective agent;
0.5-5g/L of preservative;
the pH value of the preservation solution is 7.0-8.0.
3. The preservation solution for magnetic beads coated with a cTnI antibody according to any one of claims 1 to 2, wherein the buffer salt is any one of Tris, MES, MOPS and HEPES; and/or the presence of a gas in the gas,
the concentration of the buffer salt is 50-60 mmol/L.
4. The preservation solution for magnetic beads coated with a cTnI antibody according to any one of claims 1 to 2, wherein the protein is one or more of bovine serum albumin, casein and gelatin.
5. The preservation solution for magnetic beads coated with a cTnI antibody according to claim 4, wherein the protein is bovine serum albumin, and the concentration of the bovine serum albumin is 10-15 g/L.
6. The preservation solution for magnetic beads coated with a cTnI antibody according to any one of claims 1 to 2, wherein the surfactant is any one or more of Triton x-100, Triton x-405, Tween 20 and Tween 80; and/or the presence of a gas in the gas,
the concentration of the surfactant is 1-2 g/L.
7. The preservation solution for magnetic beads coated with a cTnI antibody according to any one of claims 1 to 2, wherein the inorganic salt is a combination of sodium chloride, magnesium chloride, and zinc chloride; or, a combination of potassium chloride, magnesium chloride, zinc chloride; wherein the concentration of sodium chloride is 0.1-0.3 mol/L; the concentration of magnesium chloride is 0.5-5 mmol/L; the concentration of zinc chloride is 0.05-1 mmol/L; the concentration of potassium chloride is 0.1-0.3 mol/L.
8. The preservation solution for cTnI antibody-coated magnetic beads according to claim 7, wherein the concentration of sodium chloride in the inorganic salt composition is 0.1 to 0.2 mol/L; the concentration of the magnesium chloride is 2.5-5 mmol/L; 0.1-0.5 mmol/L zinc chloride; the concentration of potassium chloride is 0.1-0.2 mol/L.
9. The preservation solution for magnetic beads coated with cTnI antibodies according to any one of claims 1 to 2, wherein the preservative is any one or more of sodium azide, PC300, chloramphenicol and gentamicin; and/or the presence of a gas in the gas,
the concentration of the preservative is 1-2 g/L.
10. A preparation method of a preservation solution of cTnI antibody coated magnetic beads is characterized by comprising the following steps:
respectively adding buffer salt, protein, surfactant, inorganic salt, protective agent ceteareth-25 and preservative into water, and mixing uniformly to ensure that the concentration of the buffer salt is 20-100mmol/L and the concentration of the protein is 2-20 g/L; the concentration of the surfactant is 0.5-5 g/L; the concentration of the inorganic salt is 0.1-0.5 mol/L; the concentration of the protective agent ceteareth-25 is 1-10g/L, and the concentration of the preservative is 0.5-5 g/L; and adjusting the pH to 7.0-8.0;
and (5) fixing the volume and filtering.
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