Quality control serum diluent as well as preparation method and application thereof

Abstract

The invention relates to the technical field of enzyme-linked immunosorbent assay, and discloses a quality control serum diluent as well as a preparation method and application thereof, and the quality control serum diluent is prepared from the following raw materials: boric acid, borax, sodium caseinate, liquid gelatin, aminopyrine, an osmotic pressure stabilizer and bovine serum. The quality control serum diluent prepared by adopting the formula has no potential interfering substances (such as formaldehyde and thiomersalate), has excellent thermal stability and long-term stability, is applied to quality control serum dilution, is beneficial to improving the detection accuracy, ensures that the characteristics of the diluent meet the requirements when the diluent is used every time, and provides stable reference data for the detection process.

Description

Technical Field

[0001] This invention relates to the field of enzyme-linked immunosorbent assay (ELISA) technology, and in particular to a quality control serum diluent, its preparation method, and its application. Background Technology

[0002] In EBV enzyme-linked immunosorbent assays (ELISA), the stability and homogeneity of control serum directly affect the accuracy of test results. Traditional control serum diluents often use a simple combination of PBS buffer and fetal bovine serum, which suffers from short shelf life and susceptibility to microbial contamination. Furthermore, the safety of preservatives (such as thimerosal) in these formulations is controversial, and excessive use of surfactants can alter antibody activity or interfere with detection. There is also a lack of optimization to address specific interferences with ELISA kits.

[0003] Therefore, it is of great significance to develop a quality control serum diluent with clearly defined components, high stability, and no interference. Summary of the Invention

[0004] The first objective of this invention is to provide a quality control serum diluent.

[0005] The second objective of this invention is to provide a method for preparing a quality control serum diluent.

[0006] A third aspect of the present invention aims to provide the use of a quality control serum diluent in the preparation of serum products or test kits.

[0007] The fourth aspect of this invention is to provide a quality control serum.

[0008] The fifth aspect of this invention aims to provide an enzyme-linked immunosorbent assay (ELISA) kit for detecting Epstein-Barr virus (EBV) capsid antigen IgA antibody.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In a first aspect, the present invention provides a quality control serum diluent, the raw materials for which are prepared include: Boric acid, borax, sodium caseinate, liquid gelatin, aminopyrine, osmotic pressure stabilizer, bovine serum and solvent.

[0010] In some embodiments of the present invention, the osmotic pressure stabilizer includes glycerol, and at least one of sucrose and mannose.

[0011] In some embodiments of the present invention, the bovine serum includes at least one of calf serum and fetal bovine serum.

[0012] In some embodiments of the present invention, the raw materials for preparation include: Boric acid 0.1~0.5% (w / v); Borax 0.2~0.5% (w / v); Sucrose 3-6% (w / v); Aminopyrine 0.05~0.2% (w / v); Sodium caseinate 0.1~0.5% (w / v); Liquid gelatin 1-3% (v / v); Glycerin 0.5~15% (v / v); Bovine serum 15-25% (v / v).

[0013] In some embodiments of the present invention, the boric acid content in the quality control serum diluent is 0.1-0.5% (w / v). For example, it can be 0.1%, 0.13%, 0.15%, 0.18%, 0.2%, 0.23%, 0.25%, 0.28%, 0.3%, 0.33%, 0.35%, 0.38%, 0.4%, 0.43%, 0.45%, 0.48%, or 0.5% (w / v), etc.

[0014] In some embodiments of the present invention, the content of borax in the quality control serum diluent is 0.2-0.5% (w / v). For example, it can be 0.2%, 0.23%, 0.25%, 0.28%, 0.3%, 0.33%, 0.35%, 0.38%, 0.4%, 0.43%, 0.45%, 0.48%, or 0.5% (w / v).

[0015] In some embodiments of the present invention, the sucrose content in the quality control serum diluent is 3-6% (w / v). For example, it can be 3.0%, 3.3%, 3.5%, 3.8%, 4.0%, 4.3%, 4.5%, 4.8%, 5.0%, 5.3%, 5.5%, 5.8%, or 6.0%, etc.

[0016] In some embodiments of the present invention, the content of aminopyrine in the quality control serum diluent is 0.05~0.2% (w / v). For example, it can be 0.05%, 0.08%, 0.1%, 0.13%, 0.15%, 0.18% or 0.2% (w / v), etc.

[0017] In some embodiments of the present invention, the sodium casein content in the quality control serum diluent is 0.1-0.5% (w / v). For example, it can be 0.1%, 0.13%, 0.15%, 0.18%, 0.2%, 0.23%, 0.25%, 0.28%, 0.3%, 0.33%, 0.35%, 0.38%, 0.4%, 0.43%, 0.45%, 0.48%, or 0.5% (w / v), etc.

[0018] In some embodiments of the present invention, the content of liquid gelatin in the quality control serum diluent is 1-3% (v / v). For example, it can be 1%, 1.3%, 1.5%, 1.8%, 2%, 2.3%, 2.5%, 2.8%, or 3% (v / v).

[0019] In some embodiments of the present invention, the glycerol content in the quality control serum diluent is 0.5% to 15% (v / v). For example, 0.5%, 1%, 2%, 5%, 8%, 10%, 13%, or 15% (v / v).

[0020] In some embodiments of the present invention, the content of bovine serum in the quality control serum diluent is 15-25% (v / v). For example, it can be 15%, 18%, 20%, 13%, or 25% (v / v), etc.

[0021] In some embodiments of the present invention, the raw materials for preparation further include nonionic surfactants, preservatives, and solvents.

[0022] In some embodiments of the present invention, the nonionic surfactant includes at least one of Triton X-100, Tween-20, Tween-80, and Tween-60.

[0023] In some embodiments of the present invention, the preservative includes Proclin 300.

[0024] In some embodiments of the present invention, the concentration of the nonionic surfactant is 0.001~0.01% (v / v). For example, it can be 0.001%, 0.003%, 0.005%, 0.008% or 0.01% (v / v), etc.

[0025] In some embodiments of the present invention, the concentration of the preservative is 0.05~0.2% (v / v). For example, it can be 0.05%, 0.08%, 0.1%, 0.1%, 0.13%, 0.15%, 0.18% or 0.2% (v / v), etc.

[0026] In some embodiments of the present invention, the solvent is water. It will be understood that the solvent is used to bring the volume to the target level.

[0027] In some embodiments of the present invention, the pH value of the quality control serum diluent is 5 to 6; for example, it can be 5.4, 5.5, 5.6, 5.7 or 5.8, etc.

[0028] A second aspect of the present invention provides a method for preparing a quality control serum diluent as described in the first aspect, comprising the following steps: The raw materials for preparing the quality control serum diluent are mixed to obtain the solution.

[0029] A third aspect of the invention provides the use of the quality control serum diluent as described in the first aspect in the preparation of serum products or test kits.

[0030] In a fourth aspect, the present invention provides a quality control serum, which is obtained by treatment with the quality control serum diluent described in the first aspect.

[0031] In some embodiments of the present invention, the processing method includes: collecting the inactivated positive serum, and using the quality control serum diluent to gradient dilute the positive serum to the target concentration, thereby obtaining the solution.

[0032] In some embodiments of the present invention, the positive serum includes EB virus VCA antibody positive serum or Zta antibody positive serum.

[0033] In some embodiments of the present invention, the inactivation includes treatment at 50-60°C for 8-12 hours.

[0034] In some embodiments of the present invention, the OD value of the quality control serum ranges from 1.8 to 2.2.

[0035] In a fifth aspect, the present invention provides an EB virus capsid antigen IgA antibody enzyme-linked immunosorbent assay kit, comprising the quality control serum diluent described in the first aspect, or the quality control serum described in the fourth aspect.

[0036] In some embodiments of the present invention, the kit further includes at least one of an ELISA plate coated with EBV antigen, an ELISA-labeled antibody (HRP-labeled), a substrate solution (TMB), and a stop solution.

[0037] The quality control serum diluent, its preparation method, and its application according to the embodiments of the present invention have at least the following beneficial effects: (1) The quality control serum diluent system of the present invention adopts a boric acid-borax buffer system, which is more conducive to maintaining the native conformation of antibodies in serum and preserving antibody activity compared with PBS or phosphate buffer systems. The sucrose and glycerol components are used to provide osmotic pressure protection to prevent protein denaturation caused by repeated freeze-thaw cycles. Aminopyrine, as a stabilizer, can reduce the impact of oxidation on the detection results. In addition, in the system of the present invention, sodium caseinate and liquid gelatin have a synergistic stabilizing effect. Sodium caseinate provides charge stabilization, and liquid gelatin provides network embedding, which can effectively inhibit the precipitation of serum components. Nonionic surfactants (such as Triton X-100) help to further improve the solubility of lipid-soluble components, thereby improving the detection sensitivity.

[0038] (2) The quality control serum diluent prepared using the formulation of this invention has no potential interfering substances (such as formaldehyde and thimerosal) and has excellent stability (including accelerated thermal stability and long-term stability).

[0039] (3) The quality control serum prepared using the quality control serum diluent of the present invention is non-biohazardous, conforms to standard specifications, and has good accuracy and stability. It can maintain good stability even under short-term room temperature storage (such as short-term storage during experimental operations), ensuring that its characteristics meet the requirements each time it is used, and providing stable reference data for the detection process.

[0040] Other features and advantages of the present invention will be set forth in the following description. Detailed Implementation

[0041] The following will describe the concept and technical effects of the present invention clearly and completely with reference to embodiments, so as to fully understand the purpose, features and effects of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are all within the scope of protection of the present invention.

[0042] When a numerical range is disclosed herein, the range is considered continuous and includes the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. Additionally, when multiple ranges are provided to describe a feature or characteristic, the ranges may be combined. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are incorporated.

[0043] In the description of this invention, the reference term "and / or" includes all and any combination of one or more of the associated listed items.

[0044] In the description of this invention, the terms "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0045] Unless otherwise specified in the examples, the procedures should be performed under standard conditions or conditions recommended by the manufacturer. Reagents or instruments whose manufacturers are not specified are all commercially available products.

[0046] Example 1 This embodiment provides a quality control serum diluent and its preparation method. The raw material formulation for preparing the quality control serum diluent in this embodiment is as follows: Boric acid 3.92 g / L; Borax 3.26 g / L; Sucrose 50 g / L; Aminopyrine 1.0 g / L; Sodium caseinate 2.0 g / L; Liquid gelatin 20 ml / L; Triton X 1000.03 ml / L; Glycerin 10 ml / L; 200 ml / L of calf serum; Proclin 3001 ml / L; Add water to a final volume of 1L.

[0047] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh out boric acid, borax, sucrose, aminopyrine, and sodium caseinate according to the above proportions, and mix thoroughly. Then, add some purified water to dissolve them. Next, add the specified amounts of liquid gelatin, Triton X100, glycerol, calf serum, and Proclin 300 in sequence. After all additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 5.6 ± 0.1 as needed.

[0048] Example 2 This embodiment provides a quality control serum diluent and its preparation method. The difference between the raw materials used in this embodiment and those in Example 1 is that Triton X100 is not added; otherwise, the ingredients are the same. The specific formula is as follows: Boric acid 3.92 g / L; Borax 3.26 g / L; Sucrose 50 g / L; Aminopyrine 1.0 g / L; Sodium caseinate 2.0 g / L; Liquid gelatin 20 ml / L; Glycerin 10 ml / L; 200 ml / L of calf serum; Proclin 3001 ml / L; Add water to a final volume of 1L.

[0049] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh out boric acid, borax, sucrose, aminopyrine, and sodium caseinate according to the above proportions, and mix thoroughly. Then, add some purified water to dissolve them, followed by the specified amounts of liquid gelatin, glycerin, fetal bovine serum, and Proclin 300. After all additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 5.6 ± 0.1 as needed.

[0050] Example 3 This embodiment provides a quality control serum diluent and its preparation method. The difference between the raw materials used in this embodiment and those in Example 1 is the glycerol content; all other ingredients are the same. The specific formula is as follows: Boric acid 3.92 g / L; Borax 3.26 g / L; Sucrose 50 g / L; Aminopyrine 1.0 g / L; Sodium caseinate 2.0 g / L; Liquid gelatin 20 ml / L; Triton X 1000.03 ml / L; Glycerin 100 ml / L; 200 ml / L of calf serum; Proclin 3001 ml / L; Add water to a final volume of 1L.

[0051] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh out boric acid, borax, sucrose, aminopyrine, and sodium caseinate according to the above proportions, and mix thoroughly. Then, add some purified water to dissolve them. Next, add the specified amounts of liquid gelatin, Triton X100, glycerol, calf serum, and Proclin 300 in sequence. After all additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 5.6 ± 0.1 as needed.

[0052] Comparative Example 1 This comparative example provides a quality control serum diluent and its preparation method. The quality control serum diluent uses a PBS buffer system, and its raw material formulation is as follows: 10mM PBS 915 ml / L; Bovine serum albumin 10 g / L; Sucrose 50 g / L; Liquid gelatin 20 ml / L; 50% PEG 40 ml / L; Proclin 300 1 ml / L; Water balance.

[0053] The formulation of the 10mM PBS solution is as follows: NaH2PO4•2H2O 2.5g / L; Na2HPO4•12H2O 30g / L; NaCl 80g / L; KCl 2g / L; Add water to a final volume of 1L.

[0054] The 50% PEG solution is obtained by dissolving and mixing PEG 6000 with purified water at a 1:1 ratio.

[0055] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh bovine serum albumin and sucrose according to the above proportions and mix well. Then, add some purified water to dissolve them, followed by the correct amounts of 10mM PBS, liquid gelatin, PEG, and Proclin 300. After all additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 6.8±0.1 as needed.

[0056] Comparative Example 2 This comparative example provides a quality control serum diluent and its preparation method. The quality control serum diluent uses a PBS buffer system. The difference between this diluent and Comparative Example 1 is the absence of PEG in the raw materials; otherwise, they are the same. The specific formulation is as follows: 10mM PBS 915 ml / L; Bovine serum albumin 10 g / L; Sucrose 50 g / L; Liquid gelatin 20 ml / L; Proclin 300 1 ml / L; Water balance.

[0057] The formulation of the 10mM PBS solution is as follows: NaH2PO4•2H2O 2.5g / L; Na2HPO4•12H2O 30g / L; NaCl 80g / L; KCl 2g / L; Add water to a final volume of 1L.

[0058] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh bovine serum albumin and sucrose according to the above proportions and mix well. Then, add some purified water to dissolve them, followed by the correct amounts of 10 mM PBS, liquid gelatin, and Proclin 300. After all additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 6.8 ± 0.1 as needed.

[0059] Comparative Example 3 This comparative example provides a quality control serum diluent and its preparation method. The raw material formulation for preparing the quality control serum diluent of this comparative example is as follows: NaH2PO4·2H2O 0.4 g / L; Na2HPO4·12H2O 4.8 g / L; Aminopyrine 0.5 g / L; Bovine serum albumin 10 g / L; Glycerin 40 ml / L; Fetal bovine serum 200 ml / L; 25% Tween - 200.015 ml / L; Proclin 3001 ml / L; Add water to a final volume of 1L.

[0060] The 25% Tween-20 was obtained by diluting Tween-20 with purified water at a ratio of 1:3.

[0061] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh out NaH2PO4·2H2O, Na2HPO4·12H2O, aminopyrine, and bovine serum albumin according to the above proportions, and mix them thoroughly. Then, add some purified water to dissolve them, followed by the corresponding amounts of glycerol, fetal bovine serum, Tween-20, and Proclin 300. After all the additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 7.4±0.1 as needed.

[0062] Comparative Example 4 This comparative example provides a quality control serum diluent and its preparation method. The difference between the raw materials used in the preparation of the quality control serum diluent in this comparative example and those in Comparative Example 3 is that the surfactant Tween-20 is not added; otherwise, they are the same. The specific formulation is as follows: NaH2PO4·2H2O 0.4 g / L; Na2HPO4·12H2O 4.8 g / L; Aminopyrine 0.5 g / L; Bovine serum albumin 10 g / L; Glycerin 40 ml / L; Fetal bovine serum 200 ml / L; Proclin 3001 ml / L; Add water to a final volume of 1L.

[0063] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh out NaH2PO4·2H2O, Na2HPO4·12H2O, aminopyrine, and bovine serum albumin according to the above proportions, and mix them thoroughly. Then, add some purified water to dissolve them, followed by the corresponding amounts of glycerol, fetal bovine serum, and Proclin 300. After all the additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 7.4±0.1 as needed.

[0064] Comparative Example 5: This comparative example provides a quality control serum diluent and its preparation method. The only difference between the raw materials used in preparing the quality control serum diluent of this comparative example and those in Example 1 is that liquid gelatin is replaced with PEG; all other materials are the same. The specific formulation is as follows: Boric acid 3.92 g / L; Borax 3.26 g / L; Sucrose 50 g / L; Aminopyrine 1.0 g / L; Sodium caseinate 2.0 g / L; 50% PEG 20 ml / L; Triton X 1000.03 ml / L; Glycerin 10 ml / L; 200 ml / L of calf serum; Proclin 3001 ml / L; Add water to a final volume of 1L.

[0065] The preparation method of the above-mentioned quality control serum diluent is as follows: Weigh out boric acid, borax, sucrose, aminopyrine, and sodium caseinate according to the above proportions, and mix thoroughly. Then, dissolve the mixture in a portion of purified water, followed by the sequential addition of 50% PEG, Triton X100, glycerol, fetal bovine serum, and Proclin 300. After all additions are complete, bring the volume to a final level with purified water. Finally, adjust the pH to 5.6 ± 0.1 as needed.

[0066] Test Example 1: Thermal Stability Test This test example examines the thermal stability of the quality control serum diluents prepared in Examples 1-3 and Comparative Examples 1-6, using the following specific methods: (1) Preparation of quality control serum: Rabbit anti-positive serum from batch 2022081101 provided by Wuhan Aokebotai Biotechnology Co., Ltd. was inactivated and then serially diluted with diluent to an OD value of 0.8-2.4. Quality control serum with an OD value of 1.8-2.2 was selected. After determining the titer of the quality control positive serum, it was prepared in large quantities, aliquoted, and stored at 2-8℃ for later use; (2) Kit detection: The quality control serum was tested by ELISA using the EBV VCA IgA enzyme immunoassay kit (batch 202304002-2) from Zhongshan Bioengineering Co., Ltd., according to the instructions. The specific method is as follows: The titer of batch 2022081101 quality control serum was determined to be 1:7500 through serial dilution testing. After preparation, the quality control serum was divided into two portions: one portion was stored at 2-8℃, and the other portion was stored at 37±0.5℃ for 6 days. After sufficient storage time, both portions of quality control serum were tested in duplicate according to the instructions, and their thermal stability was calculated (the decrease in thermal stability should be ≤15%).

[0067] The method for calculating thermal stability data is as follows: Thermal stability = (mean value of serum OD at 4℃ - mean value of serum OD at 37℃) ÷ mean value of serum OD at 4℃ × 100%.

[0068] The test results are shown in Table 1.

[0069] Table 1:

[0070] As can be seen from Table 1, the thermal stability of the control serum prepared with the quality control serum diluent prepared according to the examples all met the requirements, with Example 3 showing the best thermal stability; the thermal stability of the control serum prepared with the quality control serum diluent prepared according to the comparative proportions fluctuated greatly and did not meet the requirements.

[0071] Test Example 2: Long-term stability test This test example examines the long-term stability of the quality control serum diluents prepared in Examples 1-53 and Comparative Examples 1-6. The specific method is as follows: (1) Preparation of quality control serum: Rabbit anti-positive serum of batch 2022081101 provided by Wuhan Aokebotai Biotechnology Co., Ltd. was inactivated and then serially diluted with diluent to an OD value of 0.8-2.4. Quality control serum with an OD value of 1.8-2.2 was selected. After determining the titer of the quality control positive serum, it was prepared in large quantities, aliquoted, and stored at 2-8℃ for later use; (2) Kit Detection: The EBV VCA IgA enzyme immunoassay kit (batch 202304002-2) from Zhongshan Bioengineering Co., Ltd. was used to perform ELISA detection on the quality control serum according to the instructions. Specifically, the titer of the quality control serum (batch 2022081101) was determined to be 1:7500 through serial dilution detection. Sufficient quality control serum was prepared and stored at 2-8℃. At month 0, month 3, month 6, month 9, month 12, and month 13 after preparation, two quality control serum samples were tested in duplicate according to the instructions, and their OD values ​​were recorded and tabulated.

[0072] The test results are shown in Table 2.

[0073] Table 2:

[0074] As shown in Table 2, the long-term stability of Examples 1-3 was <15% in December, which met the requirements; among them, Example 3 showed the best long-term stability. However, the long-term stability of Comparative Examples 1-5 did not meet the requirements.

[0075] In summary, this invention provides a quality control serum diluent, its preparation method, and its application. The quality control serum prepared using this invention is biohazardous, meets standard specifications, and exhibits good accuracy and stability. It maintains good stability even under short-term room temperature storage (such as brief storage during experimental procedures), ensuring its characteristics meet requirements for each use and providing stable reference data for the detection process.

[0076] The embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention. Furthermore, the embodiments of the present invention and the features thereof can be combined with each other unless otherwise specified.

Claims

1. A quality control serum diluent, characterized in that, The raw materials for preparation include: Boric acid, borax, sodium caseinate, liquid gelatin, aminopyrine, osmotic pressure stabilizer, and bovine serum.

2. The quality control serum diluent according to claim 1, characterized in that, The osmotic pressure stabilizer includes glycerol, and at least one of sucrose and mannose; The bovine serum includes at least one of calf serum and fetal bovine serum.

3. The quality control serum diluent according to claim 2, characterized in that, The raw materials used in the preparation include: Boric acid 0.1~0.5% (w / v); Borax 0.2~0.5% (w / v); Sucrose 3-6% (w / v); Aminopyrine 0.05~0.2% (w / v); Sodium caseinate 0.1~0.5% (w / v); Liquid gelatin 1-3% (v / v); Glycerin 0.5~15% (v / v); Bovine serum 15-25% (v / v).

4. The quality control serum diluent according to claim 3, characterized in that, The raw materials used in the preparation also include nonionic surfactants, preservatives, and solvents; Preferably, the nonionic surfactant includes at least one of Triton X-100, Tween-20, Tween-80, and Tween-60; Preferably, the preservative includes Proclin 300.

5. The quality control serum diluent according to claim 4, characterized in that, The concentration of the nonionic surfactant is 0.001~0.01% (v / v). And / or, the concentration of the preservative is 0.05~0.2% (v / v).

6. The quality control serum diluent according to claim 5, characterized in that, The raw materials used in the preparation include: Boric acid 0.2~0.4% (w / v); Borax 0.2~0.4% (w / v); Sucrose 3-6% (w / v); Aminopyrine 0.05~0.2% (w / v); Sodium caseinate 0.1~0.4% (w / v); Liquid gelatin 1.5~2.5% (v / v); Triton X-1000.001~0.01% (v / v) Glycerin 0.5~15% (v / v); Bovine serum 15-25% (v / v); Proclin 3000.05~0.2% (v / v); Solvent.

7. A method for preparing the quality control serum diluent as described in any one of claims 1 to 6, characterized in that, Includes the following steps: The raw materials for preparing the quality control serum diluent are mixed to obtain the solution.

8. The use of the quality control serum diluent as described in any one of claims 1 to 6 in the preparation of serum products or test kits.

9. A quality control serum, characterized in that, It is obtained by treating with the quality control serum diluent as described in any one of claims 1 to 6.

10. An EB virus capsid antigen IgA antibody enzyme-linked immunosorbent assay kit, characterized in that, Includes the quality control serum diluent as described in any one of claims 1 to 6, or the quality control serum as described in claim 9.

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