CN110967494A - Quality control product of inflammation marker and preparation method thereof - Google Patents
Quality control product of inflammation marker and preparation method thereof Download PDFInfo
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Abstract
The application belongs to the field of clinical medical detection, and discloses a quality control product of an inflammation marker and a preparation method thereof. The quality control product of the inflammation marker consists of a matrix liquid and inflammation marker components; the matrix liquid consists of: matrix, 5-100mmol/L buffer, 0.01-5g/L protein protective agent, 5-100g/L saccharide, 0.05-5g/L preservative; the inflammation marker component comprises procalcitonin, C-reactive protein, serum amyloid A, myeloperoxidase, interleukin-6 and lipoprotein-associated phospholipase. The quality control product of the inflammation marker of the invention contains a plurality of inflammation markers, and realizes the joint detection of different inflammation items. Meanwhile, the commercial human serum or plasma is used as a matrix, the source of the channel is stable, mass production can be realized, the clinical sample has high conformity degree and strong universality, the matrix effect can be reduced to the greatest extent, and the uniformity, the stability and other properties are good.
Description
Technical Field
The invention belongs to the field of clinical medical detection, and particularly relates to a quality control product of an inflammation marker and a preparation method thereof.
Background
The quality control material refers to a quality control material (fixed value and non-fixed value) for in vitro diagnosis, which is a material, article or apparatus used in a detection system intended for medical use, and is intended to evaluate or verify performance characteristics such as measurement precision, measurement accuracy, analysis deviation that may occur in the detection system due to a change in a reagent or an analysis instrument, and the like. The quality control product can be used for capability verification and quality control in a laboratory and is used for verifying the performance of an analytical instrument or method.
The quality control product has the following characteristics: the composition of the quality control product should be similar or identical to the substrate from which the patient sample is to be tested. The ideal matrix is human serum, urine, cerebrospinal fluid, or the like; the quality control product should be uniform and stable, the conditions allow, the dosage of one year can be stored, and the variation between bottles should be smaller than that of an analysis system; the quality control material may be a liquid or lyophilized material containing one or more components (analytes) at known concentrations; the quality control must be tested in the same manner as the patient sample.
Inflammation markers are routine test items in clinical medicine laboratories at present, and include C-reactive protein (CRP), Procalcitonin (PCT), interleukin-6 (IL-6), interleukin-10 (IL-10), white blood cell count (WBC), Tumor Necrosis Factor (TNF) and the like. For example, C-reactive protein is an acute phase-reactive protein, is an acute phase reactant generated and released by the liver when the body is subjected to acute infection and inflammation, and can be used as an acute inflammation marker. The C-reactive protein is often used as a basis for judging the severity of general inflammation and is used for distinguishing viral or mild bacterial infection, general bacterial infection and severe bacterial infection.
Most of the inflammation quality control products aiming at the inflammation markers in the market at present comprise a single item, such as a procalcitonin quality control product and a C-reactive protein quality control product. There are also quality control products compounded by a plurality of inflammation markers, but the included items are not comprehensive enough and cannot meet the clinical requirements. And the complex degree of the quality control product is low, the quality control product is mostly buffer solution matrix or non-human serum matrix, the consistency with the detection result of a clinical sample is poor, matrix effect exists, and great inconvenience is caused to the daily quality control of a laboratory.
Disclosure of Invention
In view of the above, the present invention aims to provide a stable inflammation marker quality control product and a preparation method thereof, aiming at the problems of the existing inflammation quality control products.
In order to realize the purpose of the invention, the invention adopts the following technical scheme:
a quality control product for inflammation marker comprises matrix liquid and inflammation marker components;
the matrix liquid comprises the following components: matrix, 5-100mmol/L buffer, 0.01-5g/L protein protective agent, 5-100g/L saccharide, 0.05-5g/L preservative;
the inflammation marker component comprises Procalcitonin (PCT), C-reactive protein (CRP), Serum Amyloid A (SAA), Myeloperoxidase (MPO), interleukin-6 (IL-6), and lipoprotein-associated phospholipase (LP-PLA 2).
In the invention, the matrix in the matrix liquid is one or more of normal human serum, normal human plasma, deethanized serum and degreased serum. The normal human serum, the normal human plasma, the de-biotin serum and the degreased serum are all commercial products, have stable purchasing channels, do not need centrifugal screening and can realize mass production. The detection results of HBsAg, HCV-Ab, HIV-Ab, TP and the like in the matrix are negative.
The quality control product of the inflammation marker of the invention is added with the buffering agent, which can adjust the pH of the matrix liquid to the serum level of normal people, simultaneously keep the pH of the matrix liquid stable and reduce the influence of other additives on the pH. In the invention, the buffer is one or more of phosphate buffer, HEPES buffer, sodium citrate buffer and Tris buffer. In some embodiments, the buffer is HEPES buffer.
In the invention, the protein protective agent is one or more of aminopyrine, PVP, glycerol, Tween 80 and sodium glutamate.
In the invention, the saccharide is one or more of trehalose, sucrose, mannose, maltose and cellobiose.
In the invention, the preservative is one or more of Proclin300, NaN3, Bronidox, BIT and MIT.
In some embodiments, the quality control product of the inflammation marker comprises the following components: normal human serum, 50mmol/LHEPES buffer, 2.0g/L aminopyrine, 50g/L trehalose, 2.0g/L Proclin 300.
In the invention, the content of the inflammation marker component in the quality control product of the inflammation marker is 0.01-100ng/ml of Procalcitonin (PCT), 0-300mg/L of C-reactive protein (CRP), 10-200mg/L of Serum Amyloid A (SAA), 50-1000ng/ml of Myeloperoxidase (MPO), 10-1000pg/ml of interleukin-6 (IL-6) and 100-1600 mu g/L of lipoprotein-related phospholipase (LP-PLA 2). The content is the amount of each inflammation marker component contained in the total volume of the quality control product.
The invention also provides a preparation method of the inflammation quality control product, which comprises the following steps:
(1) re-dissolving the matrix, recovering the temperature to room temperature, and then carrying out water bath for 1-3 hours at the temperature of 42-65 ℃;
(2) adding buffer solution to adjust pH to 5.0-9.0, adding 0.01-5g/L protein protectant, 0.05-5g/L antiseptic, and 5-100g/L saccharide, and mixing to obtain quality control matrix solution;
(3) dividing the prepared quality control substance matrix solution into high, medium and low levels of 3, adding inflammation markers with different contents, and mixing to prepare high, medium and low concentration inflammation composite quality control substance solution;
(4) subpackaging the prepared high, medium and low concentration level inflammation compound quality control product solution and drying.
Further, in the present invention, the contents of the inflammation markers in the high, medium and low 3 level inflammation complex quality control product are as follows:
1) the content of the inflammation markers in the high-level inflammation compound quality control product is 20ng/ml of Procalcitonin (PCT), 25mg/L of C-reactive protein (CRP), 50mg/L of Serum Amyloid A (SAA), 500ng/ml of Myeloperoxidase (MPO), 350pg/ml of interleukin-6 (IL-6), and 1000 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
2) the content of the inflammation markers in the medium-level inflammation compound quality control product is 1ng/ml of Procalcitonin (PCT), 5mg/L of C-reactive protein (CRP), 20mg/L of Serum Amyloid A (SAA), 400ng/ml of Myeloperoxidase (MPO), 150pg/ml of interleukin-6 (IL-6), and 400 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
3) the content of the inflammation markers in the low-level inflammation compound quality control product is 0.5ng/ml of Procalcitonin (PCT), 2.0mg/L of C-reactive protein (CRP), 10mg/L of Serum Amyloid A (SAA), 200ng/ml of Myeloperoxidase (MPO), 50pg/ml of interleukin-6 (IL-6) and 300 mu g/L of lipoprotein-related phospholipase (LP-PLA 2).
The quality control product of the inflammation marker is added with deionized water with the same volume during subpackaging before use for redissolution, then is detected in a corresponding item detection instrument, the target value and the quality control range of the quality control product are determined, and meanwhile, the performance of the quality control product is evaluated.
According to the technical scheme, the invention provides a quality control product of an inflammation marker and a preparation method thereof. The quality control product of the inflammation marker consists of a matrix liquid and inflammation marker components; the matrix liquid comprises the following components: matrix, 5-100mmol/L buffer, 0.01-5g/L protein protective agent, 5-100g/L saccharide, 0.05-5g/L preservative; the inflammation marker component comprises Procalcitonin (PCT), C-reactive protein (CRP), Serum Amyloid A (SAA), Myeloperoxidase (MPO), interleukin-6 (IL-6), and lipoprotein-associated phospholipase (LP-PLA 2). The quality control product of the inflammation marker of the invention contains a plurality of inflammation markers, and the quality control of different detection items can be achieved by detecting one quality control sample, thereby realizing the combined detection of different inflammation items. Meanwhile, the commercial human serum or blood plasma is used as a matrix, the source of the channel is stable, mass production can be realized, the clinical sample has high conformity degree and strong universality, the matrix effect can be reduced to the greatest extent, the performances such as uniformity, stability and the like are good, and the storage validity period is 24 months at the temperature of 2-8 ℃. The quality control product of the inflammation marker has the advantages of simple preparation method and low preparation cost, and is convenient for clinical popularization and use.
Detailed Description
The invention discloses a quality control product of an inflammation marker and a preparation method thereof. Those skilled in the art can modify the process parameters appropriately to achieve the desired results with reference to the disclosure herein. It is expressly intended that all such similar substitutes and modifications which would be obvious to one skilled in the art are deemed to be included in the invention. While the methods and products of the present invention have been described in terms of preferred embodiments, it will be apparent to those of ordinary skill in the art that variations and modifications of the methods described herein, as well as other suitable variations and combinations, may be made to implement and use the techniques of the present invention without departing from the spirit and scope of the invention.
In order to realize the purpose of the invention, the invention adopts the following technical scheme:
a quality control product for inflammation marker comprises matrix liquid and inflammation marker components;
the matrix liquid comprises the following components: matrix, 5-100mmol/L buffer, 0.01-5g/L protein protective agent, 5-100g/L saccharide, 0.05-5g/L preservative;
the inflammation marker component comprises Procalcitonin (PCT), C-reactive protein (CRP), Serum Amyloid A (SAA), Myeloperoxidase (MPO), interleukin-6 (IL-6), and lipoprotein-associated phospholipase (LP-PLA 2).
The preparation method of the inflammation quality control product comprises the following steps:
(1) treating quality control product matrix liquid: re-dissolving commercial human serum or plasma, recovering to room temperature, and water-bathing at 42-65 deg.C for 1-3 hr.
(2) Preparing a quality control product matrix solution: adding HEPES buffer 5-100mmol/L to adjust pH to 5.0-9.0, adding aminopyrine 0.01-5g/L, Proclin300 0.05-5g/L and trehalose 5-100g/L respectively, and mixing;
3) preparing a quality control product: the prepared quality control substance matrix solution is evenly divided into high, medium and low levels of 3, and the test is carried out by adding the positive high value of the inflammation marker according to the content of the following inflammation markers: 0.01-100ng/ml Procalcitonin (PCT), 0-300mg/L C-reactive protein (CRP), 10-200mg/L Serum Amyloid A (SAA), 50-1000ng/ml Myeloperoxidase (MPO), 10-1000pg/ml interleukin-6 (IL-6), and 1600 μ g/L lipoprotein-associated phospholipase (LP-PLA 2). The content is the content in the total volume of the quality control product. The prepared high, medium and low concentration inflammation composite quality control product solution is mixed evenly and then precisely subpackaged in glass bottles, the subpackage amount of each bottle is 1ml or 2ml, then the opening is opened, the bottle is frozen and vacuum freeze-dried by a full-automatic vacuum freeze-drying machine, then the bottle is covered, plugged and sealed immediately, deionized water with the same volume as that of subpackage is added before use for redissolving, detection is carried out in a corresponding project detection instrument, the target value and the quality control range of the quality control product are determined, and meanwhile, the performance of the quality control product is evaluated.
Wherein, the level 1 is a reference value, the level 2 is a critical value, the level 3 is an abnormal value, and the three level target values are set according to the target value of the standard rod product of the inflammation quality control product, thereby meeting the clinical use requirement.
Compared with the prior art, the invention has at least one of the following advantages:
1) the quality control product of the inflammation marker contains a plurality of inflammation markers, and the quality control of different detection items can be realized by detecting one quality control sample, so that the combined detection of different inflammation items is realized, the quality control can be efficiently carried out in a laboratory, the auxiliary clinical diagnosis can be more facilitated, the working efficiency can be improved, and the social benefit and the economic benefit can be higher;
2) the quality control product of the inflammation marker adopts commercial human serum or blood plasma as a matrix, has stable channel source, can realize mass production, has high conformity with clinical samples, and can reduce matrix effect to the maximum extent;
3) the quality control product of the inflammation marker is prepared into a freeze-dried quality control product, has good performances such as uniformity, stability and the like, is convenient for long-term storage and transportation, and has a storage validity period of 24 months at 2-8 ℃.
In order to further understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all 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 invention.
Unless otherwise specified, the reagents involved in the examples of the present invention are all commercially available products, and all of them are commercially available.
Example 1: the inflammation marker quality control product of the invention
The matrix liquid comprises the following components: normal human serum, 50mmol/LHEPES buffer solution, 2.0g/L aminopyrine, 50g/L trehalose, 2.0g/L Proclin 300;
the content of the inflammation marker is as follows:
1) the content of the inflammation markers in the high-level inflammation compound quality control product is 20ng/ml of Procalcitonin (PCT), 25mg/L of C-reactive protein (CRP), 50mg/L of Serum Amyloid A (SAA), 500ng/ml of Myeloperoxidase (MPO), 350pg/ml of interleukin-6 (IL-6), and 1000 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
2) the content of the inflammation markers in the medium-level inflammation compound quality control product is 1ng/ml of Procalcitonin (PCT), 5mg/L of C-reactive protein (CRP), 20mg/L of Serum Amyloid A (SAA), 400ng/ml of Myeloperoxidase (MPO), 150pg/ml of interleukin-6 (IL-6), and 400 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
3) the content of the inflammation markers in the low-level inflammation compound quality control product is 0.5ng/ml of Procalcitonin (PCT), 2.0mg/L of C-reactive protein (CRP), 10mg/L of Serum Amyloid A (SAA), 200ng/ml of Myeloperoxidase (MPO), 50pg/ml of interleukin-6 (IL-6) and 300 mu g/L of lipoprotein-related phospholipase (LP-PLA 2).
Example 2: the inflammation marker quality control product of the invention
The matrix liquid comprises the following components: normal human plasma, 10mmol/LHEPES buffer solution, 1.0g/L aminopyrine, 30g/L trehalose, 1.0g/L Proclin 300;
the content of the inflammation marker is as follows:
1) the content of the inflammation markers in the high-level inflammation compound quality control product is 20ng/ml of Procalcitonin (PCT), 25mg/L of C-reactive protein (CRP), 50mg/L of Serum Amyloid A (SAA), 500ng/ml of Myeloperoxidase (MPO), 350pg/ml of interleukin-6 (IL-6), and 1000 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
2) the content of the inflammation markers in the medium-level inflammation compound quality control product is 1ng/ml of Procalcitonin (PCT), 5mg/L of C-reactive protein (CRP), 20mg/L of Serum Amyloid A (SAA), 400ng/ml of Myeloperoxidase (MPO), 150pg/ml of interleukin-6 (IL-6), and 400 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
3) the content of the inflammation markers in the low-level inflammation compound quality control product is 0.5ng/ml of Procalcitonin (PCT), 2.0mg/L of C-reactive protein (CRP), 10mg/L of Serum Amyloid A (SAA), 200ng/ml of Myeloperoxidase (MPO), 50pg/ml of interleukin-6 (IL-6) and 300 mu g/L of lipoprotein-related phospholipase (LP-PLA 2).
Example 3: the inflammation marker quality control product of the invention
The matrix liquid comprises the following components: normal human serum, 80mmol/LHEPES buffer solution, 5.0g/L aminopyrine, 80g/L trehalose, 5.0g/L Proclin 300;
the content of the inflammation marker is as follows:
1) the content of the inflammation markers in the high-level inflammation compound quality control product is 20ng/ml of Procalcitonin (PCT), 25mg/L of C-reactive protein (CRP), 50mg/L of Serum Amyloid A (SAA), 500ng/ml of Myeloperoxidase (MPO), 350pg/ml of interleukin-6 (IL-6), and 1000 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
2) the content of the inflammation markers in the medium-level inflammation compound quality control product is 1ng/ml of Procalcitonin (PCT), 5mg/L of C-reactive protein (CRP), 20mg/L of Serum Amyloid A (SAA), 400ng/ml of Myeloperoxidase (MPO), 150pg/ml of interleukin-6 (IL-6), and 400 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
3) the content of the inflammation markers in the low-level inflammation compound quality control product is 0.5ng/ml of Procalcitonin (PCT), 2.0mg/L of C-reactive protein (CRP), 10mg/L of Serum Amyloid A (SAA), 200ng/ml of Myeloperoxidase (MPO), 50pg/ml of interleukin-6 (IL-6) and 300 mu g/L of lipoprotein-related phospholipase (LP-PLA 2).
Test example and quality control quality verification of the invention
1) Detection value
The detection results of the markers of the quality control product described in example 1 are shown in Table 1.
TABLE 1 results of quality control test values of the present invention
The results show that the three levels of the inflammation marker quality control product are in the given range.
2) Uniformity of
Taking 10 bottles of quality control products of the same batch number in each horizontal example 1, testing each bottle of quality control products by using a corresponding kit for 1 time, and calculating the average value of 10 test results
And standard deviation S1；
Further, 1 of the above 10 bottles of quality control materials were continuously tested 10 times, and the average of 10 test results was calculated
And standard deviation S2(ii) a The coefficient of variation between bottles, CV, was calculated according to the following formula, and the results were in accordance with the requirement of 2.3.
Equation 1:
equation 2:
equation 3:
equation 4:
when S1< S2, let CV bottle-to-bottle equal to 0
In the formula:
Uniformity results are shown in Table 2
Table 2 uniformity results for quality control articles of the invention
The result shows that the quality control product of the inflammation marker meets the requirement on three-level uniformity.
3) Stability of
After the quality control product of example 1 with 3 levels of inflammation is redissolved once, the quality control product is stored for 7 days at the temperature of 2-8 ℃, the freeze-dried state is accelerated for 14 days at the temperature of 37 ℃, and the relative deviation with the quality control product of a new opened bottle is detected, wherein the relative deviation is not more than +/-15%. The data are shown in Table 3.
TABLE 3 stability results of quality control products according to the invention
The result shows that the degradation of the quality control product in 7 days of redissolution stability and 14 days of accelerated stability is less than 15%.
The quality control materials described in the embodiments 2 and 3 were tested according to the above method, and the results were similar to those of the quality control material described in the embodiment 1.
Claims (10)
1. A quality control product for inflammation marker comprises matrix liquid and inflammation marker components;
the matrix liquid comprises the following components: matrix, 5-100mmol/L buffer, 0.01-5g/L protein protective agent, 5-100g/L saccharide, 0.05-5g/L preservative;
the inflammation marker component comprises Procalcitonin (PCT), C-reactive protein (CRP), Serum Amyloid A (SAA), Myeloperoxidase (MPO), interleukin-6 (IL-6), and lipoprotein-associated phospholipase (LP-PLA 2).
2. The quality control product of claim 1, wherein the matrix is one or more of normal human serum, normal human plasma, serotonin serum and degreased serum.
3. The quality control product according to claim 1, wherein the buffer is one or more of phosphate buffer, HEPES buffer, sodium citrate buffer and Tris buffer.
4. The quality control product of claim 1, wherein the protein protective agent is one or more of aminopyrine, PVP, glycerol, Tween 80 and sodium glutamate.
5. The quality control product of claim 1, wherein the saccharide is one or more of trehalose, sucrose, mannose, maltose and cellobiose.
6. The quality control product of claim 1, wherein the preservative is Proclin300, NaN3One or more of Bronidox, BIT and MIT.
7. The quality control product according to any one of claims 1 to 6, wherein the matrix liquid comprises the following components: normal human serum, 50mmol/LHEPES buffer, 2.0g/L aminopyrine, 50g/L trehalose, 2.0g/L Proclin 300.
8. The quality control product according to claim 1, wherein the content of the inflammation marker component is 0.01-100ng/ml Procalcitonin (PCT), 0-300mg/L C-reactive protein (CRP), 10-200mg/L Serum Amyloid A (SAA), 50-1000ng/ml Myeloperoxidase (MPO), 10-1000pg/ml interleukin-6 (IL-6), 100-1600 μ g/L lipoprotein-associated phospholipase (LP-PLA 2).
9. The method for preparing the inflammation quality control product of any one of claims 1-8, comprising the steps of:
(1) re-dissolving the matrix, recovering the temperature to room temperature, and then carrying out water bath for 1-3 hours at the temperature of 42-65 ℃;
(2) adding buffer solution to adjust pH to 5.0-9.0, adding 0.01-5g/L protein protectant, 0.05-5g/L antiseptic, and 5-100g/L saccharide, and mixing to obtain quality control matrix solution;
(3) dividing the prepared quality control substance matrix solution into high, medium and low levels of 3, adding inflammation markers with different contents, and mixing to prepare high, medium and low concentration inflammation composite quality control substance solution;
(4) subpackaging the prepared high, medium and low concentration level inflammation compound quality control product solution and drying.
10. The preparation method of claim 9, wherein the content of the inflammation markers in the high, medium and low 3-level inflammation compound quality control product is as follows:
1) the content of the inflammation markers in the high-level inflammation compound quality control product is 20ng/ml of Procalcitonin (PCT), 25mg/L of C-reactive protein (CRP), 50mg/L of Serum Amyloid A (SAA), 500ng/ml of Myeloperoxidase (MPO), 350pg/ml of interleukin-6 (IL-6), and 1000 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
2) the content of the inflammation markers in the medium-level inflammation compound quality control product is 1ng/ml of Procalcitonin (PCT), 5mg/L of C-reactive protein (CRP), 20mg/L of Serum Amyloid A (SAA), 400ng/ml of Myeloperoxidase (MPO), 150pg/ml of interleukin-6 (IL-6), and 400 mu g/L of lipoprotein-associated phospholipase (LP-PLA 2);
3) the content of the inflammation markers in the low-level inflammation compound quality control product is 0.5ng/ml of Procalcitonin (PCT), 2.0mg/L of C-reactive protein (CRP), 10mg/L of Serum Amyloid A (SAA), 200ng/ml of Myeloperoxidase (MPO), 50pg/ml of interleukin-6 (IL-6) and 300 mu g/L of lipoprotein-related phospholipase (LP-PLA 2).
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| CN111499727A (en) * | 2020-06-01 | 2020-08-07 | 南京申基医药科技有限公司 | Preparation method of stable liquid SAA calibrator |
| CN111579803A (en) * | 2020-05-25 | 2020-08-25 | 北京康思润业生物技术有限公司 | Multi-item inflammation marker quality control product and preparation method thereof |
| CN112904028A (en) * | 2021-01-21 | 2021-06-04 | 宁波职业技术学院 | Serum amyloid protein A quality control product and preparation method thereof |
| CN114350708A (en) * | 2022-01-17 | 2022-04-15 | 巴迪泰（广西）生物科技有限公司 | Fusion expression protein and preparation method and application thereof |
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| CN110133282A (en) * | 2019-05-06 | 2019-08-16 | 中生北控生物科技股份有限公司 | Compound quality-control product of inflammation class marker and the preparation method and application thereof |
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| CN109342723A (en) * | 2018-10-18 | 2019-02-15 | 郑州标源生物科技有限公司 | A kind of uniformity and repeated preferably immune quality-control product |
| CN110133282A (en) * | 2019-05-06 | 2019-08-16 | 中生北控生物科技股份有限公司 | Compound quality-control product of inflammation class marker and the preparation method and application thereof |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111579803A (en) * | 2020-05-25 | 2020-08-25 | 北京康思润业生物技术有限公司 | Multi-item inflammation marker quality control product and preparation method thereof |
| CN111499727A (en) * | 2020-06-01 | 2020-08-07 | 南京申基医药科技有限公司 | Preparation method of stable liquid SAA calibrator |
| CN112904028A (en) * | 2021-01-21 | 2021-06-04 | 宁波职业技术学院 | Serum amyloid protein A quality control product and preparation method thereof |
| CN112904028B (en) * | 2021-01-21 | 2023-11-24 | 宁波职业技术学院 | Serum amyloid A quality control product and preparation method thereof |
| CN114350708A (en) * | 2022-01-17 | 2022-04-15 | 巴迪泰（广西）生物科技有限公司 | Fusion expression protein and preparation method and application thereof |
| CN114350708B (en) * | 2022-01-17 | 2024-02-13 | 巴迪泰（广西）生物科技有限公司 | Fusion expression protein and preparation method and application thereof |
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