CN114276437A - Preparation method of compound high-value reference substance for five immune terms - Google Patents
Preparation method of compound high-value reference substance for five immune terms Download PDFInfo
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- CN114276437A CN114276437A CN202111468314.0A CN202111468314A CN114276437A CN 114276437 A CN114276437 A CN 114276437A CN 202111468314 A CN202111468314 A CN 202111468314A CN 114276437 A CN114276437 A CN 114276437A
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- 150000001875 compounds Chemical class 0.000 title claims abstract description 18
- 239000013558 reference substance Substances 0.000 title claims abstract description 17
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- 239000000047 product Substances 0.000 claims abstract description 82
- 239000002131 composite material Substances 0.000 claims abstract description 48
- 239000003223 protective agent Substances 0.000 claims abstract description 24
- 238000004108 freeze drying Methods 0.000 claims abstract description 19
- 238000000034 method Methods 0.000 claims abstract description 15
- 238000003908 quality control method Methods 0.000 claims abstract description 13
- 210000002966 serum Anatomy 0.000 claims abstract description 12
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229910052921 ammonium sulfate Inorganic materials 0.000 claims abstract description 11
- 235000011130 ammonium sulphate Nutrition 0.000 claims abstract description 11
- 239000012043 crude product Substances 0.000 claims abstract description 11
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims abstract description 9
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims abstract description 9
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 9
- 229930006000 Sucrose Natural products 0.000 claims abstract description 9
- 235000004279 alanine Nutrition 0.000 claims abstract description 9
- 239000000600 sorbitol Substances 0.000 claims abstract description 9
- 239000005720 sucrose Substances 0.000 claims abstract description 9
- 238000012870 ammonium sulfate precipitation Methods 0.000 claims abstract description 7
- 239000002244 precipitate Substances 0.000 claims abstract description 7
- 239000006228 supernatant Substances 0.000 claims abstract description 7
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims abstract description 5
- 239000012467 final product Substances 0.000 claims abstract description 5
- 238000002156 mixing Methods 0.000 claims abstract description 5
- 108060003951 Immunoglobulin Proteins 0.000 claims description 13
- 102000018358 immunoglobulin Human genes 0.000 claims description 13
- 230000003053 immunization Effects 0.000 claims description 3
- 238000002649 immunization Methods 0.000 claims 2
- 230000036039 immunity Effects 0.000 abstract description 6
- 238000005516 engineering process Methods 0.000 abstract description 3
- 238000010219 correlation analysis Methods 0.000 description 10
- 238000012360 testing method Methods 0.000 description 8
- 238000002835 absorbance Methods 0.000 description 7
- 108010028780 Complement C3 Proteins 0.000 description 6
- 102000016918 Complement C3 Human genes 0.000 description 6
- 108010028778 Complement C4 Proteins 0.000 description 6
- 239000003153 chemical reaction reagent Substances 0.000 description 5
- 238000000338 in vitro Methods 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 238000010200 validation analysis Methods 0.000 description 5
- 238000001514 detection method Methods 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 238000012544 monitoring process Methods 0.000 description 3
- 230000009467 reduction Effects 0.000 description 3
- 238000011161 development Methods 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940072221 immunoglobulins Drugs 0.000 description 2
- 239000008176 lyophilized powder Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 208000023275 Autoimmune disease Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 235000021028 berry Nutrition 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 201000001981 dermatomyositis Diseases 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
The invention discloses a preparation method of a compound high-value reference substance for five immune terms, which comprises the following steps: s1: adding ammonium sulfate into human serum, performing ammonium sulfate precipitation treatment, removing precipitate, collecting supernatant, and dialyzing to obtain crude product of five-item immunity compound high-value reference product; s2: adding a protective agent, and uniformly mixing, wherein the protective agent comprises BSA, sucrose, sorbitol and alanine; s3: and (5) freeze-drying in a freeze-drying machine to obtain a final product of the composite high-value reference product. The method can prepare the calibrator and the quality control product of five projects simultaneously, solve the problem that multiple products can not coexist, reduce the interference problem and fill the product blank of the quality control product and the calibrator in China. The protective agent is adopted for freeze-drying, and the preparation cost is far lower than that of an imported product by means of a freeze-drying technology, but the anti-interference performance and the stability of the product are not lower than that of the imported product.
Description
Technical Field
The invention belongs to the technical field of in-vitro diagnosis, and particularly relates to a preparation method of a composite high-value reference product of immune globulin IgA, IgG and IgM, and complement C3 and C4 immune five items, which is used for preparing corresponding calibration products and quality control products.
Background
At present, 70 percent of in vitro diagnostic reagents depend on import, and along with the rapid development of the in-vitro diagnostic reagent industry in China, the reagent has to face a reality, and antibodies, quality control products and calibration products generally depend on British Landau, American Berry and other manufacturers, so that the independent development is urgent.
The five immune items refer to IgA, IgG, IgM, complements C3 and C4. The concentration of the index can be increased or decreased under the condition of certain diseases according to different age groups, and the index has value in disease diagnosis. IgA, IgG and IgM are immunoglobulins whose activity changes under many pathological conditions. Changes in complement levels are also observed dynamically in the clinic. If the test results show an increase in the first three tests, it may be caused by infection or autoimmune disease. If complement C3 is high, it may be due to in vivo inflammation, and if complement C4 is elevated, it may be due to myocardial infarction, dermatomyositis, etc.
At present, the test items of the calibrator and the quality control product matched with the in-vitro diagnostic reagent in China are mostly single, five items of immunity are taken as clinical routine examination items, the time can be saved by using the composite high-value reference product to prepare the calibrator and the quality control product, the process is simplified, a plurality of items are universal, and the trouble of spending more time to research a single high-value reference product is avoided.
Therefore, there is a need to develop a complex high-value reference product of immunoglobulins IgA, IgG and IgM, and complements C3 and C4 for immune, which can solve the problem that multiple products cannot coexist and reduce interference.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a composite high-value reference product of five immune items of immunoglobulin IgA, IgG and IgM and complements C3 and C4, which can solve the problems that multiple items cannot coexist and the interference is reduced.
In order to solve the technical problems, the technical scheme adopted by the invention is that the preparation method of the immune five-item composite high-value reference product comprises the following steps:
s1: adding ammonium sulfate into human serum, wherein the mass volume ratio of ammonium sulfate to serum is 280-300 g/L, performing ammonium sulfate precipitation treatment, removing precipitate, collecting supernatant, and dialyzing to obtain crude product of immune five-item compound high-value reference product.
The immune five-item composite high-value reference product prepared by the technical scheme can be used for preparing calibration products and quality control products of five items at the same time, solves the problem that multiple items cannot coexist, reduces the interference problem, and fills the blank of domestic quality control products and calibration products.
Preferably, the method also comprises the following steps:
s2: adding a protective agent, and uniformly mixing, wherein the protective agent comprises BSA, sucrose, sorbitol and alanine.
Preferably, the method also comprises the following steps:
s3: and (5) freeze-drying in a freeze-drying machine to obtain a final product of the composite high-value reference product.
The protective agent is adopted for freeze-drying, and no other components except individual ions exist, so that the guarantee is provided for the later traceability by citing national standard substances and international standard substances; by means of the freeze-drying technology, the preparation cost is far lower than that of an imported product, but the anti-interference performance and the stability of the product are not lower than that of the imported product.
Preferably, the composite high-value reference product prepared in the step S3 is prepared into corresponding immunoglobulin IgA, IgG and IgM, and a calibrator and a quality control product of complement C3 and C4.
Preferably, in step S2, the protective agent component is 5% BSA, 1% sucrose, 1% sorbitol, and 1.2% alanine by mass/volume.
Preferably, in the step S3, the lyophilized powder is prepared by split-charging, 1mL each, when the lyophilized powder is put into a lyophilizer for lyophilization.
Preferably, in the step S3, the lyophilized composite high-value reference product final product is left at 37 ℃.
Preferably, the method also comprises the following steps:
s3: after addition of the protectant, the cells were stored at 37 ℃.
Preferably, the method also comprises the following steps:
s3: adding protective agent, freeze-drying, re-dissolving, and storing at 4 deg.C.
Compared with the prior art: the composite calibrator and the quality control product prepared from the composite high-value reference product prepared by the method have greatly improved anti-interference performance and stability, provide possibility for replacing imported products for domestic markets, are expected to break the monopoly situation of the imported composite quality control products on the domestic markets, and relieve the situation that in-vitro diagnostic reagent manufacturers excessively rely on the imported products. The invention has small interference and solves the problem of coexistence of multiple items in the product. The product prepared by the freeze-drying technology greatly prolongs the storage life of the high-value reference product and has low preparation cost.
Drawings
The following further detailed description of embodiments of the invention is made with reference to the accompanying drawings:
FIG. 1 is a graph of a correlation analysis of immunoglobulin IgA performance validation in a composite high value reference according to one embodiment;
FIG. 2 is a graph of correlation analysis of performance validation of immunoglobulin IgM in a composite high value reference according to one embodiment;
FIG. 3 is a graph of correlation analysis of performance validation of immunoglobulin IgG in a composite high value reference according to one embodiment;
FIG. 4 is a graph of a performance-validation correlation analysis of complement C3 in a composite high-value reference according to one embodiment;
FIG. 5 is a graph of the correlation analysis of the performance validation of complement C4 in the composite high value reference of the first embodiment.
Detailed Description
The preparation method of the immune five-item composite high-value reference substance comprises the following steps:
s1: adding ammonium sulfate into human serum, wherein the mass volume ratio of the ammonium sulfate to the serum is 280g-300g/L, performing ammonium sulfate precipitation treatment, removing the precipitate, collecting supernatant, and dialyzing to obtain a compound high-value reference crude product of five immune terms;
s2: adding a protective agent into the crude product of the composite high-value reference product obtained in the step S1, and uniformly mixing, wherein the components of the protective agent are BSA, sucrose, sorbitol and alanine;
the protective agent comprises 5% of BSA, 1% of sucrose, 1% of sorbitol and 1.2% of alanine in percentage by mass and volume;
s3: and (3) putting the crude compound high-value reference product added with the protective agent into a Toffulong freeze dryer, and subpackaging and freeze-drying 1mL each to obtain a final compound high-value reference product.
The lyophilization program parameters are shown in table 1 below:
TABLE 1
And (4) preparing corresponding immunoglobulin IgA, IgG and IgM, and a calibrator and a quality control product of complement C3 and C4 from the composite high-value reference product prepared in the step S3.
The first embodiment is as follows: the preparation method of the immune five-item composite high-value reference substance comprises the following steps:
s1: adding ammonium sulfate with the mass-volume ratio of 291g/L into human serum, carrying out ammonium sulfate precipitation treatment, removing precipitates, collecting supernatant, and dialyzing to obtain the five-item immune compound high-value reference crude product.
The activity concentration is detected by using an immunoturbidimetric detection kit of Sichuan Mike Biotechnology corporation and a full-automatic biochemical analyzer device of Hitachi 7060.
The detection data of the active concentration of each item of the five-item immunity composite high-value reference product are shown in the following table 2:
| item | Detection parameters (R1: R2: Sample) | Reference Range (g/L) | Active concentration (g/L) |
| IgA | 225:75:3 | 0.02-6.2 | 8.1 |
| IgM | 225:75:3 | 0.03-5 | 6.5 |
| IgG | 225:75:3 | 0.05-40 | 49 |
| C3 | 240:60:3 | 0.02-3.7 | 5.3 |
| C4 | 240:60:3 | 0.02-0.8 | 1.7 |
TABLE 2
And (3) performing concentration gradient dilution on the compound high-value reference product of the immune five items, and respectively performing absorbance OD value measurement on the dilutions of the five items.
Composite high value reference individual item (immunoglobulin IgA) test data are shown in table 3 below:
TABLE 3
The correlation analysis of the concentration of the diluted solution with the absorbance value is shown in FIG. 1.
The composite high value reference individual item (immunoglobulin IgM) test data are shown in table 4 below:
TABLE 4
The correlation analysis of the concentration of the diluted solution with the absorbance value is shown in FIG. 2.
The composite high value reference individual item (immunoglobulin IgG) test data is shown in table 5 below:
TABLE 5
The correlation analysis of the concentration of the diluted solution with the absorbance value is shown in FIG. 3.
The test data for the composite high value reference single item (complement C3) is shown in table 6 below:
TABLE 6
The correlation analysis of the concentration of the diluted solution with the absorbance value is shown in FIG. 4.
The test data for the composite high value reference single item (complement C4) is shown in table 7 below:
TABLE 7
The correlation analysis of the concentration of the diluted solution with the absorbance value is shown in FIG. 5.
And (4) conclusion: the prepared immune five-item composite high-value reference product has the correlation between the concentration of the gradient diluent and the absorbance value of each item being more than 0.99, and the concentration of the high-value reference product being higher than the upper limit of the detection of the reference range, and can be used as the composite high-value reference product.
Embodiment two: the preparation method of the immune five-item composite high-value reference substance comprises the following steps:
s1: adding ammonium sulfate with the mass-volume ratio of 291g/L into human serum, performing ammonium sulfate precipitation treatment, removing precipitate, collecting supernatant, and dialyzing to obtain crude product of the five-item immunity composite high-value reference product;
and (5) directly freeze-drying the crude product obtained in the step S1, wherein each crude product is 1mL, and performing stability experimental verification after freeze-drying to verify whether a protective agent is necessary or not.
The stability performance of the compound high-value reference product with five immunity items is monitored by two experiments, namely, the freeze-dried product is directly placed at 37 ℃, the stability performance of the freeze-dried product is monitored by using a kit for 15 days, and the freeze-dried product is redissolved and determined in each experiment. Secondly, the freeze-dried product is redissolved (added with 1mL of pure water for redissolution) and then placed at 4 ℃, and the stability performance of the freeze-dried product is monitored by using the kit for 15 days.
The monitoring data are shown in the following tables 8 and 9:
TABLE 8
TABLE 9
And (4) conclusion: under the condition of not adding a protective agent, immunizing five-item composite high-value reference products, and when the five-item composite high-value reference products are placed at 37 ℃ in a freeze-dried product state, the average stability reduction amplitude of the freeze-dried products is 44%; after redissolving, the freeze-dried product is placed at 4 ℃ for 14 days, the reduction amplitude is more than 50 percent, which indicates that the stability of the composite high-value reference product without the protective agent is not good.
The third embodiment is as follows: the preparation method of the immune five-item composite high-value reference substance comprises the following steps:
s1: adding ammonium sulfate with the mass-volume ratio of 291g/L into human serum, performing ammonium sulfate precipitation treatment, removing precipitate, collecting supernatant, and dialyzing to obtain crude product of the immune five-item composite high-value reference product;
s2: adding a protective agent into the crude product of the composite high-value reference product obtained in the step S1, and uniformly mixing, wherein the components of the protective agent are BSA, sucrose, sorbitol and alanine;
the main components of the protective agent are 5% of BSA, 1% of sucrose, 1% of sorbitol and 1.2% of alanine in mass volume ratio; s3: and (3) putting the crude compound high-value reference product added with the protective agent into a Toffulong freeze dryer, and subpackaging and freeze-drying 1mL each to obtain a final compound high-value reference product.
Performing stability experimental verification after freeze-drying, and monitoring the stability performance of the five-item immunity composite high-value reference product by two experiments, wherein firstly, the freeze-dried product is directly placed at 37 ℃, the stability performance of the freeze-dried product is monitored by using a kit for 15 days, and the freeze-dried product is redissolved and measured in each experiment; secondly, the freeze-dried product is redissolved (added with 1mL of pure water for redissolution) and then placed at 4 ℃, and the stability performance of the freeze-dried product is monitored by using the kit for 15 days.
The monitoring data are shown in the following tables 10 and 11:
watch 10
TABLE 11
And (4) conclusion: under the condition of adding the protective agent, the stability of the five immune compound high-value reference products is obviously enhanced, and the average reduction amplitude is less than 10%.
The foregoing illustrates and describes the principles, general features, and advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited by the foregoing examples, which are provided for illustrating the principles of the present invention, and that various changes and modifications may be made without departing from the spirit and scope of the invention, for example, the ratio of the mass volume of ammonium sulfate added to human serum to the mass volume of human serum may be arbitrarily selected from 280g to 300g/L, and such changes and modifications are within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (9)
1. A preparation method of a compound high-value reference substance for five immune terms is characterized by comprising the following steps:
s1: adding ammonium sulfate into human serum, wherein the mass volume ratio of ammonium sulfate to serum is 280-300 g/L, performing ammonium sulfate precipitation treatment, removing precipitate, collecting supernatant, and dialyzing to obtain crude product of immune five-item compound high-value reference product.
2. The method for preparing the compound high-value reference substance for five immunization items according to claim 1, which is characterized by further comprising the following steps:
s2: adding a protective agent, and uniformly mixing, wherein the protective agent comprises BSA, sucrose, sorbitol and alanine.
3. The method for preparing the compound high-value reference substance for five immunization items according to claim 2, which is characterized by further comprising the following steps:
s3: and (5) freeze-drying in a freeze-drying machine to obtain a final product of the composite high-value reference product.
4. The method for preparing the composite high-value reference substance of the immune five items of any one of claims 1 to 3, wherein the composite high-value reference substance prepared in the step S3 is prepared into corresponding immunoglobulin IgA, IgG and IgM, and calibration and quality control products of complements C3 and C4.
5. The method for preparing the composite high-value reference substance according to any one of claims 1 to 3, wherein in the step S2, the protective agent components comprise 5% BSA, 1% sucrose, 1% sorbitol and 1.2% alanine by mass/volume.
6. The method for preparing the composite high-value reference substance according to any one of claims 1 to 3, wherein in the step S3, the composite high-value reference substance is lyophilized in a freeze dryer by split charging, wherein each dose is 1 mL.
7. The method for preparing a composite high-value reference substance according to claim 3, wherein in step S3, the final product of the lyophilized composite high-value reference substance is left at 37 ℃.
8. The method for preparing the composite high-value reference product according to claim 1 or 2, characterized by further comprising the following steps: s3: after addition of the protectant, the cells were stored at 37 ℃.
9. The method for preparing the composite high-value reference product according to claim 1 or 2, characterized by further comprising the following steps: s3: adding protective agent, freeze-drying, re-dissolving, and storing at 4 deg.C.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117471108A (en) * | 2023-12-28 | 2024-01-30 | 北京万泰德瑞诊断技术有限公司 | Complement C1q reference substance, preparation method and application thereof |
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Cited By (2)
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| CN117471108B (en) * | 2023-12-28 | 2024-03-01 | 北京万泰德瑞诊断技术有限公司 | Complement C1q reference substance, preparation method and application thereof |
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