Inflammatory infection complex quality control product and preparation method and application thereof

Abstract

The application discloses an inflammation infection compound quality control product and a preparation method and application thereof. The quality control product comprises a matrix liquid and inflammation markers. The matrix liquid contains human serum, a buffer, a protein protective agent, a plasticizing agent, amino acids, saccharides, a surfactant and a preservative. The inflammation markers include C-reactive protein, procalcitonin, serum amyloid A and interleukin-6. The quality control product is stable in performance, can be placed for 1 year under 2-8 DEG C and in the dark, and is suitable for combined detection of different inflammation items, is convenient for clinical operation, saves cost, and provides guarantee for the accuracy of clinical test results.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of clinical detection, and particularly relates to a compound quality control product for inflammation infection and a preparation method thereof. BACKGROUND

[0002] Inflammation is a defensive response of the body to external stimulation, is a common and frequently-occurring disease in clinic, is mainly caused by the invasion of bacteria, viruses and fungi into the body, and is accompanied by fever in most cases. Infectious diseases caused by pathogens such as bacteria, viruses and fungi and their products are still one of the main reasons for human death and disability, and threaten human health. In clinic, infectious inflammatory diseases are usually diagnosed by the detection results of markers in the blood of patients, and the accuracy of the measurement results of the inflammation detection and diagnosis system cannot be separated from the stable and qualified quality control. In clinic, whether the quality control product is in control is usually used to monitor whether the entire laboratory detection system including detection instruments and reagents is effective, and to ensure the accuracy and reliability of the detection results of patients.

[0003] Indoor quality control and daytime quality control are main links to ensure the accuracy of the detection system, and the quality of the quality control product directly affects the accuracy of diagnosis. The quality control product should have a high degree of coincidence with the clinical sample, the ideal quality control product should have no matrix effect between the patient sample, be uniform and stable, the inter-bottle variability should be less than the variability of the analysis system, and contain one or more known concentrations of analytes. The quality control product must be detected in the same way as the patient sample.

[0004] Inflammation markers are currently routine test items in clinical medical laboratories, and are sensitive substances in blood whose contents increase under the influence of infectious inflammatory factors when the body is affected by infection, trauma or other conditions. For example, procalcitonin (PCT), C-reactive protein (CRP), serum amyloid A (SAA) and interleukin-6 (IL-6) are proteins that react during inflammation and have important auxiliary diagnostic significance in the early stage of infection and the development of inflammation. Their detection is not affected by antibacterial drugs, immunosuppressants and hormones, and they can be used as reliable detection markers for inflammation infection composite quality control products. The contents of various inflammation markers increase at different times after the body is affected by infection, and the detection significance and clinical application of each item are different. There is a possibility of misdiagnosis when the degree of infection is determined by the content of a single marker in clinical detection, so the use of multiple markers for joint detection as a diagnostic basis will make the detection results more sufficient and reliable. However, most of the inflammation detection items on the market are single quality control products, and there is a lack of commercialized composite quality control products, which means that clinical medical laboratories need to repeat single marker quality control detection multiple times when performing quality control, which is relatively complex and tedious. Therefore, there is an urgent need for a commercialized inflammation infection composite quality control product with good stability for indoor quality control and interlaboratory quality evaluation in clinical medical laboratories. SUMMARY

[0005] Therefore, the present application aims to provide an inflammation infection composite quality control product with stable performance. After multiple inflammation markers are compounded, the quality control product still has good accuracy and stability, can be prepared into a freeze-dried agent, and has excellent reconstitution stability, greatly facilitating the use of clinical medical laboratories.

[0006] The technical solution of the present application is as follows:

[0007] An inflammation infection composite quality control product comprises a matrix liquid and inflammation markers, and the matrix liquid is composed of human serum and protective substances, specifically:

[0008] The matrix liquid uses human serum as the matrix and contains 10-100 mM buffer, 10-30 g / L protein protective agent, 1-50 g / L plasticizing agent, 1-50 g / L amino acid, 1-50 g / L sugar, 0.1-1 v / v% surfactant and 0.01-0.5 w / v% preservative.

[0009] The inflammation markers include C-reactive protein, procalcitonin, serum amyloid A and interleukin-6.

[0010] In the above-mentioned complex quality control product, the human serum should be normal human serum, that is, the routine detection results of HBsAg, HCV-Ab, HIV-Ab, TP and the like in the human serum are all negative. The use of commercial human serum as the matrix can maximize the reduction of matrix effect and improve the consistency with clinical samples. Moreover, the human serum is a commercial product, has a stable procurement channel, does not need to be screened and processed by centrifugation, and is beneficial to the production of quality control products.

[0011] In the above-mentioned complex quality control product, the buffer can keep the pH of the matrix liquid stable and reduce the influence of other additives on the pH. The buffer can be one or more of phosphate buffer, HEPES buffer, sodium citrate buffer, Tris buffer and Mops buffer, and the molar concentration is preferably 20-50 mM.

[0012] In the above-mentioned complex quality control product, the protein protective agent is one or more of casein, casein hydrolysate, bovine serum albumin and gelatin.

[0013] In the above-mentioned complex quality control product, the amino acid is one or more of glycine, lysine and arginine, and the concentration of the amino acid in the matrix liquid is preferably 1-20 g / L.

[0014] In the above-mentioned complex quality control product, the sugar is one or more of trehalose, sucrose, lactose and maltose, and the concentration of the sugar in the matrix liquid is preferably 1-20 g / L.

[0015] In the above-mentioned complex quality control product, the plasticizing agent is one or more of mannitol, PEG, PVP and hydroxyethyl starch, and the concentration of the plasticizing agent in the matrix liquid is preferably 1-20 g / L.

[0016] In the above-mentioned complex quality control product, the surfactant is one or more of polyethylene glycol 400, tween-20, trixon-100 and betaine, and the concentration of the surfactant in the matrix liquid is preferably 0.4-0.8 v / v%.

[0017] In the above-mentioned complex quality control product, the preservative is one or more of sodium azide, gentamicin sulfate and ProClin300.

[0018] As a preferred solution, the complex quality control product for inflammation and infection provided by the application specifically consists of a matrix liquid and an inflammation marker, wherein:

[0019] The matrix liquid takes human serum as a matrix, has a pH of 4.5-5.5, and contains 20-50 mM citric acid buffer, 10-30 g / L gelatin, 1-10 g / L mannitol, 1-10 g / L trehalose, 1-10 g / L glycine, 0.4-0.8 % trixon-100, 0.2-1 g / L sodium azide, 0.2-1 g / L gentamicin sulfate and 0.02-0.1 w / v % Proclin 300.

[0020] The two concentration levels of the inflammation markers are as follows: the procalcitonin level 1 is 0.4-0.6 ng / mL, and the level 2 is 16-24 ng / mL; the C-reactive protein level 1 is 0.8-1.2 ug / mL, and the level 2 is 16-24 ug / mL; the serum amyloid A level 1 is 4-6 ug / mL, and the level 2 is 16-24 ug / mL; and the interleukin-6 level 1 is 24-36 pg / mL, and the level 2 is 400-600 pg / mL.

[0021] In the preferred solution, the multiple preservatives are compounded to effectively remove the hazards of various potential pathogenic microorganisms, so that the quality control product is safer to use.

[0022] More preferably, the matrix liquid takes human serum as a matrix, has a pH of 5.0, and contains 50 mM citric acid buffer, 20 g / L gelatin, 5 g / L mannitol, 5 g / L trehalose, 5 g / L glycine, 0.6 % trixon-100, 0.9 g / L sodium azide, 0.9 g / L gentamicin sulfate and 0.05 w / v % Proclin 300. Experimental data show that the quality control product provided by the preferred solution has high long-term stability and can be placed at 2-8 DEG C in the dark for 1 year.

[0023] The application further provides a preparation method of the above-mentioned complex quality control product for inflammation infection, which specifically comprises the following steps:

[0024] After the human serum is restored to room temperature, the serum is fully mixed, a certain amount of the serum is taken out, and a buffer is added to the serum; after the buffer is fully dissolved and mixed, the pH is adjusted; then, a protein protective agent, a plasticizing agent, a sugar, an amino acid and a preservative are added to the serum; after the protein protective agent, the plasticizing agent, the sugar, the amino acid and the preservative are completely dissolved, the serum is filtered; the serum is diluted with human serum to a certain volume and the pH is adjusted, so that the matrix liquid is obtained; then, the inflammation markers are added to the matrix liquid; after the concentration levels of the inflammation markers are tested, the complex quality control product is obtained.

[0025] In the above preparation method, the 0.22 mu m filter membrane is used for filtering.

[0026] In the above preparation method, the test results of the concentration levels of the inflammation markers should all be within the concentration fluctuation range; if the test results are not within the range, the corresponding antigen or matrix liquid can be appropriately adjusted to the required range.

[0027] The inflammation infection compound quality control provided by the application can be prepared into a freeze-dried powder after freeze-drying. The freeze-dried powder needs to be added with the same volume of deionized water for reconstitution before use, and then detected on a corresponding project detection instrument to determine the target value and quality control range of the quality control. Experimental data show that the reconstitution stability of the freeze-dried powder provided by the application is good, the reconstituted freeze-dried powder can be stably stored at 4℃ for one week, and the test results do not have an obvious change trend; and the reconstituted freeze-dried powder can be effectively stored at-20℃ for two months, greatly facilitating subsequent detection of users and reducing detection cost.

[0028] The inflammation infection compound quality control provided by the application or the freeze-dried powder thereof can be used for detection of inflammation markers C-reactive protein, procalcitonin, serum amyloid A and / or interleukin-6.

[0029] The application has the following beneficial effects:

[0030] 1. The compound quality control provided by the application includes multiple verification markers, so that quality control of multiple different detection projects can be achieved by detecting one quality control sample, joint detection of different inflammation projects is realized, the operation process is greatly simplified, and the compound quality control has the advantages of low production cost, high accuracy and simple operation.

[0031] 2. The quality control provided by the application is for simultaneous detection of multiple inflammation markers, reduces interference, solves the difficulty of single quality control project, simplifies the quality control operation, and greatly facilitates clinical use.

[0032] 3. The compound quality control provided by the application can be prepared into a freeze-dried powder, multiple projects can be monitored at one time, and the-20℃ reconstitution stability requirement of 60 days can be met, so that the production and use cost is greatly reduced.

[0033] 4. The compound quality control provided by the application uses commercial human serum as a matrix liquid, has stable channel source, can realize mass production, has high compliance degree with clinical samples, has strong universality, can greatly reduce the matrix effect, has good uniformity, stability and other performances, and increases the detection accuracy. DETAILED DESCRIPTION

[0034] In order to better understand the application, the content of the application will be further illustrated below in combination with specific examples. It should be understood that the specific examples described herein are only used to illustrate and explain the application, and are not used to limit the application.

[0035] If not specifically indicated, the examples are all according to conventional experimental conditions or according to the conditions suggested in the manufacturer's instruction. The reagents and materials used, if not specifically indicated, can be obtained from commercial channels.

[0036] Example 1

[0037] The example provides a stable inflammation infection type composite quality control product, which is composed of a matrix liquid and inflammation markers, and the specific components are as follows:

[0038] The matrix liquid takes human serum as the matrix and contains 50 mM citric acid buffer, 20 g / L gelatin, 5 g / L mannitol, 5 g / L trehalose, 5 g / L glycine, 0.6 v / v% trixon-100, 0.9 g / L sodium azide, 0.9 g / L gentamicin sulfate, and 0.05 w / v% Proclin 300 (i.e. 0.5 g Proclin 300 per 1 L of the matrix liquid).

[0039] The inflammation markers have two levels of high and low, and the contents are specifically as follows:

[0040] In the low-level quality control product solution, 0.4-0.6 ng / mL procalcitonin, 0.8-1.2 μg / mL C-reactive protein, 4-6 μg / mL serum amyloid A, and 24-36 pg / mL interleukin-6 are contained.

[0041] In the high-level quality control product solution, 16-24 ng / mL procalcitonin, 16-24 μg / mL C-reactive protein, 16-24 μg / mL serum amyloid A, and 400-600 pg / mL interleukin-6 are contained.

[0042] The composite quality control product is prepared into a freeze-dried powder, and the specific steps are as follows:

[0043] (1) After the human serum is restored to room temperature, it is thoroughly mixed, a certain amount is taken out, and citric acid buffer is added to make the concentration reach 50 mM. After being thoroughly dissolved and mixed, the pH is adjusted to 5.0.

[0044] (2) After the pH of the human serum in (1) is adjusted, 20 g / L gelatin, 5 g / L mannitol, 5 g / L trehalose, 5 g / L glycine, 0.6 v / v% trixon-100, 0.9 g / L sodium azide, 0.9 g / L gentamicin sulfate, and 0.05 w / v% Proclin 300 are added. After complete dissolution, the volume is adjusted to the standard volume with human serum, and the pH is adjusted to 5.0 again.

[0045] (3) The prepared matrix liquid is filtered with a 0.22 μm filter membrane, and an appropriate amount of two portions is taken out, and different contents of inflammation markers are added to prepare two levels of inflammation infection type composite quality control products.

[0046] The contents of the inflammation markers in the low-level quality control product are adjusted to 0.4-0.6 ng / mL procalcitonin, 0.8-1.2 μg / mL C-reactive protein, 4-6 μg / mL serum amyloid A, and 24-36 pg / mL interleukin-6.

[0047] The content of the inflammation markers in the high-level quality control product is adjusted to: 16-24 ng / mL procalcitonin, 16-24 pg / mL C-reactive protein, 16-24 pg / mL serum amyloid A, and 400-600 pg / mL interleukin-6.

[0048] The above content is the content contained in the final lyophilized product of the quality control product.

[0049] (4) The prepared high and low level concentration composite quality control solution is precisely packaged in glass bottles, then semi-capped with a butyl rubber plug, and then freeze-dried by a full-automatic vacuum freeze-drying machine. After freeze-drying, the plug is sealed under vacuum, and then a threaded plastic cap is added after removal, and the value is assigned.

[0050] (5) Add the same volume of deionized water as the volume of the semi-finished product during packaging to reconstitute, and measure and analyze the content of each component in the quality control product using a full-automatic chemiluminescence immunoassay analyzer (see Table 1). After testing to determine that the target value and quality control range of the quality control product are qualified, the labeling and packaging steps are performed.

[0051] Table 1

[0052]

[0053] Note: The target value in the table is the average of the measured value after reconstitution of the lyophilized product, and the reference range is the average of the measured value ± 3SD (general requirements for quality control materials for in vitro diagnostic reagents --- YY / T 1652-2019).

[0054] The results show that the two levels of detection items contained in the inflammation infection composite quality control product described in this embodiment are within the given range.

[0055] The final prepared product quality control product of Example 1 is subjected to performance verification, including the following aspects:

[0056] 1. Uniformity test.

[0057] Take 10 bottles of each level of Example 1 quality control product of the same batch number, randomly numbered as 1-10, and test on a full-automatic chemiluminescence immunoassay analyzer with good precision. Each concentration level is measured 3 times for each item. The 3 tests are performed in different orders, for example, 1, 3, 5, 7, 9, 2, 4, 6, 8, 10, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 2, 4, 6, 8, 10, 1, 3, 5, 7, 9. Record the test results, and when the test results have numerical values, calculate F, Sbb, Sr and CV according to Formulas 1-11 瓶间 ;

[0058] Formula 1:

[0059] Formula 2:

[0060] Equation 3: SS 瓶内 = SS 总和 - SS 瓶间 ;

[0061] Equation 4:

[0062] Equation 5:

[0063] Equation 6:

[0064] Equation 7: v1 = a - 1;

[0065] Equation 8: v2 = N - a;

[0066] Equation 9:

[0067] Equation 10:

[0068] Equation 11:

[0069] Where: SS - variance, x i - the ith measurement or calculated result of the specified parameter, overall mean, n i - the number of replicate measurements of sample i, x ij - the jth result of sample i, MS - mean square, v - degrees of freedom, F - F test value, n0 - effective number of measurements, a - the number of samples drawn, N - total number of tests, s bb - inter-bottle standard deviation, s r - intra-bottle standard deviation (repeatability standard deviation).

[0070] When F < 1, replace sbb with sr to calculate CVinter-bottle, the result should be CV 瓶间 ≤ 10.0%;

[0071] When , the test result shows that the inter-bottle uniformity has no significant difference, the result should be CV 瓶间 ≤ 10.0%;

[0072] When sbb≤ 0.3δ, it is considered that the inter-bottle uniformity is good, and the result should be CV 瓶间 ≤ 10.0%;

[0073] When sbb> 0.3δ, it is considered that the inter-bottle uniformity is poor, which does not meet the requirements.

[0074] The uniformity test results are shown in Tables 2-5:

[0075] Table 2

[0076]

[0077] The results of Table 2 show that the two levels of C-reactive protein (CRP) detection item contained in the composite quality control product of Example 1 meet the uniformity requirements.

[0078] Table 3

[0079]

[0080]

[0081] The results of Table 3 show that the two levels of serum amyloid A (SAA) detection item contained in the composite quality control product of Example 1 meet the uniformity requirements.

[0082] Table 4

[0083]

[0084] The results of Table 4 show that the two levels of procalcitonin (PCT) detection item contained in the composite quality control product of Example 1 meet the uniformity requirements.

[0085] Table 5

[0086]

[0087]

[0088] The results of Table 5 show that the two levels of interleukin-6 (IL-6) detection item contained in the composite quality control product of Example 1 meet the uniformity requirements.

[0089] 2. Accelerated stability test.

[0090] Take 6 bottles of each level of the quality control product described in Example 1, of which 3 sets are placed in a 2-8°C refrigerator for cold storage in the dark, and the other 3 bottles are placed in a 37°C constant temperature oven. Then test one bottle of sample at the 1st, 4th, and 7th days, respectively, and at the same time, take one bottle of cold storage quality control product as a control sample for testing at each node. When testing, the two levels of samples are measured twice in duplicate, and the average value is calculated. The relative deviation of the average value of the quality control product determination at each time node and the average value of the determination of the cold control quality control product at each node is calculated, and the relative deviation is not more than ±10%. The data are shown in Table 6.

[0091] Table 6

[0092]

[0093]

[0094]

[0095] The results of Table 6 show that the accelerated stability deviation of the two levels of the detection items contained in the composite quality control sample of Example 1 is less than 10%.

[0096] 3. 2-8°C reconstitution stability test.

[0097] Take 6 bottles of each level of the quality control sample described in Example 1, take 3 sets as the opening reconstitution experimental sample, and store them in a 2-8°C refrigerator after reconstitution, and store the remaining 3 sets in a 2-8°C refrigerator as the non-reconstitution control sample. Take one set of the opening reconstitution sample at the 1st, 4th, and 7th day for testing, and take another set of the non-reconstitution control sample at each node for testing. During testing, each quality control sample concentration level sample is measured twice, and the average value is calculated. The reconstituted quality control sample and the non-reconstituted quality control sample should be measured in the same run, and the relative deviation of the average value of the quality control sample at the end of the reconstitution period and the average value of the non-reconstituted quality control sample is calculated.

[0098] Table 7

[0099]

[0100]

[0101] The results of Table 7 show that the 2-8°C stability deviation of the two levels of the detection items contained in the composite quality control sample of Example 1 is less than 10%, i.e., the quality control sample has good reconstitution stability.

[0102] 4. -20°C reconstitution stability.

[0103] Take 10 bottles of each level of the quality control sample described in Example 1, take 5 sets as the opening reconstitution experimental sample, and store them in a -20°C refrigerator after reconstitution, and store the remaining 5 sets in a 2-8°C refrigerator as the non-reconstitution control sample. Take one set of the opening reconstitution sample at the 10th, 20th, 30th, 45th, and 60th day for testing, and take another set of the non-reconstitution control sample at each node for testing. During testing, each quality control sample concentration level sample is measured twice, and the average value is calculated. The reconstituted quality control sample and the non-reconstituted quality control sample should be measured in the same run, and the relative deviation of the average value of the quality control sample at the end of the reconstitution period and the average value of the non-reconstituted quality control sample is calculated.

[0104] Table 8

[0105]

[0106]

[0107]

[0108] The results of Table 8 show that the two levels of the inflammation infection type composite quality control product contained in the detection items have a 20℃ stability deviation of less than 10%.

[0109] Example 2

[0110] The quality control product provided in this example is composed of a matrix liquid and inflammation markers, and the specific components are as follows:

[0111] The matrix liquid is based on human serum and contains 50mM citric acid buffer, 20g / L gelatin, 5g / L mannitol, 5g / L trehalose, 5g / L glycine, 0.8v / v% trixon-100, 0.9g / L sodium azide, 0.9g / L gentamicin sulfate, and 0.05w / v% Proclin300 (i.e. 0.5g Proclin300 per 1L of matrix liquid).

[0112] The inflammation markers have high and low levels and the contents are specifically as follows:

[0113] In the low level quality control product solution, 0.4-0.6ng / mL procalcitonin, 0.8-1.2μg / mL C-reactive protein, 4-6μg / mL serum amyloid A, and 24-36pg / mL interleukin-6 are contained.

[0114] In the high level quality control product solution, 16-24ng / mL procalcitonin, 16-24μg / mL C-reactive protein, 16-24μg / mL serum amyloid A, and 400-600pg / mL interleukin-6 are contained.

[0115] The composite quality control product is prepared into a lyophilized powder, and the specific steps are as follows:

[0116] (1) After the human serum is restored to room temperature, it is thoroughly mixed, a certain amount is taken out, and citric acid buffer is added to make the concentration reach 50mM. After thorough dissolution and mixing, the pH is adjusted to 5.0.

[0117] (2) After the pH of the human serum in (1) is adjusted, 20g / L gelatin, 5g / L mannitol, 5g / L trehalose, 5g / L glycine, 0.8v / v% trixon-100, 0.9g / L sodium azide, 0.9g / L gentamicin sulfate, and 0.05w / v% Proclin300 are added. After complete dissolution, the volume is adjusted to the standard volume with human serum, and the pH is adjusted to 5.0 again.

[0118] (3) The prepared matrix liquid is filtered with a 0.22μm filter membrane, and an appropriate amount of two portions is taken out, and different contents of inflammation markers are added to prepare two levels of inflammation infection type composite quality control products.

[0119] The contents of the inflammatory markers in the low-level quality control product are adjusted to: 0.4-0.6 ng / mL procalcitonin, 0.8-1.2 μg / mL C-reactive protein, 4-6 μg / mL serum amyloid A, and 24-36 pg / mL interleukin-6.

[0120] The contents of the inflammatory markers in the high-level quality control product are adjusted to: 16-24 ng / mL procalcitonin, 16-24 μg / mL C-reactive protein, 16-24 μg / mL serum amyloid A, and 400-600 pg / mL interleukin-6.

[0121] The above contents are the contents in the final lyophilized product of the quality control product.

[0122] (4) The prepared high and low level concentration composite quality control product solution is precisely dispensed into glass bottles, then semi-capped with a butyl rubber plug, and then freeze-dried in a full-automatic vacuum freeze-drying machine. After freeze-drying, the plug is sealed under vacuum, and then a threaded plastic cap is added after removal, and the value is assigned.

[0123] (5) The semi-finished product is added with the same volume of deionized water for reconstitution, and the content of each component in the quality control product is measured and analyzed by a full-automatic chemiluminescence immunoassay analyzer (see Table 9). After the target value and quality control range of the quality control product are determined to be qualified, the labeling and packaging steps are performed.

[0124] Table 9

[0125]

[0126] The results show that the two levels of the detection items contained in the inflammatory infection type composite quality control product described in the example are within the given range.

[0127] The performance verification of the final prepared quality control product of Example 2 is performed:

[0128] 1. Accelerated stability test.

[0129] Six bottles of each level of the quality control product described in Example 1 are taken, of which three sets are placed in a 2-8℃ refrigerator for cold storage in the dark, and the other three bottles are placed in a 37℃ constant temperature oven. Then one bottle of sample is tested at the 1st, 4th, and 7th day, respectively, and at the same time, one bottle of cold storage quality control product is taken as a control sample for testing at each node. When testing, the two levels of samples are measured twice, and the average value is calculated. The relative deviation data of the quality control product determination average value at each time node and the determination average value of the cold storage control quality control product at each node are shown in Table 10.

[0130] Table 10

[0131]

[0132]

[0133]

[0134] The results of Table 10 show that when the content of trixon-100 in the composite quality control sample of Example 2 is increased to 0.8%, the relative deviation of the PCT item in the 7-day test is more than 10%, and there is a significant change trend during the 7-day test; and there is no better direction optimization for other items, which shows that the performance of this example is worse than the formula of Example 1.

[0135] In summary, the composite quality control sample provided by the present application has good uniformity and stability, especially the reconstitution stability, can be stored at 4℃ for one week after reconstitution, the test results have no obvious change trend, and can be effectively stored at -20℃ for 2 months after reconstitution once, which has important significance for clinical detection.

[0136] The above-described embodiments are part of the embodiments of the present application, rather than all the embodiments. The detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without creative labor belong to the scope of protection of the present application.

Claims

1. A lyophilized powder of a compound quality control product for inflammation and infection, characterized in that, The composite quality control material for inflammation and infection is obtained by freeze-drying, and the composite quality control material for inflammation and infection consists of a matrix solution and inflammatory markers; The matrix solution uses human serum as the matrix, has a pH of 5.0, and contains 50 mM citrate buffer, 20 g / L gelatin, 5 g / L mannitol, 5 g / L trehalose, 5 g / L glycine, 0.6% trixon-100, 0.9 g / L sodium azide, 0.9 g / L gentamicin sulfate, and 0.05 w / v% Proclin 300. The inflammatory markers consist of C-reactive protein, procalcitonin, serum amyloid A, and interleukin-6. Each inflammatory marker has two concentration levels: procalcitonin level 1 is 0.4–0.6 ng / mL, and level 2 is 16–24 ng / mL; C-reactive protein level 1 is 0.8–1.2 μg / mL, and level 2 is 16–24 μg / mL; serum amyloid A level 1 is 4–6 μg / mL, and level 2 is 16–24 μg / mL; interleukin-6 level 1 is 24–36 pg / mL, and level 2 is 400–600 pg / mL.

2. The application of the lyophilized powder of the inflammatory infection composite quality control product as described in claim 1 in the detection of inflammatory markers C-reactive protein, procalcitonin, serum amyloid A and / or interleukin-6.

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