Biochemical multi-item liquid quality control product for 67 analytes and preparation method of biochemical multi-item liquid quality control product

Abstract

The invention discloses a biochemical multi-item liquid quality control product containing 67 analytes and a preparation method of the biochemical multi-item liquid quality control product, and belongs to the technical field of biochemical quality control products, non-analytes of the quality control product comprise a cryoprotectant compound with the addition amount of 0.1-1%, the cryoprotectant compound comprises antifreeze protein and a protein stabilizer, and the antifreeze protein and the protein stabilizer are added into the quality control product. The mass ratio of the antifreeze protein to the protein stabilizer is (0.1: 1)-(0.5: 1); the biochemical multi-liquid quality control product is frozen liquid. According to the invention, antifreeze protein and elongation factor 1-alpha homologous protein cooperate through physical-chemical dual pathways, complete-cycle protection is provided for protein and enzyme in a quality control product aiming at'mechanical factor 'and'oxidation factor' of freezing damage, and inter-batch consistency and storage stability can be improved; and errors caused by redissolution can be avoided, the detection convenience and accuracy of inspectors are greatly improved, and the labor and time cost of a laboratory is reduced.

Description

Technical Field

[0001] The present invention mainly relates to the technical field of biochemical quality control products, and particularly to a biochemical multi-item liquid quality control product for 67 analytes and a preparation method thereof. Background Art

[0002] Currently, two types of quality control products are mainly used in laboratories: single-item quality control products (independent quality control for a single test item) and composite quality control products (integrated quality control for multiple items). Due to the increasing number of clinical test items, if single-item quality control products are used, dozens of quality control products need to be managed simultaneously, which is not only cumbersome in operation but also prone to introducing human errors. In contrast, composite quality control products integrate more than a dozen to dozens of test items in the fields of biochemistry, immunology, etc., significantly improving the quality control efficiency and reducing the management cost, and have now become the mainstream choice.

[0003] Most of the current biochemical composite quality control products on the market exist in freeze-dried form. Although freeze-drying technology extends the shelf life by removing water, it still faces multiple challenges in practical applications. First, the reconstitution process of freeze-dried products has very high standardization requirements, and improper operation may lead to concentration deviation, thus affecting the reliability of quality control results. Second, the stability of the liquid quality control product after reconstitution drops significantly, and it needs to be used in a short period of time, otherwise it may become invalid due to the loss of enzyme activity or component degradation. In addition, the freeze-drying process may cause irreversible damage to heat-sensitive or labile biomolecules (such as enzymes and proteins), resulting in differences in the biological behavior between the quality control product and the actual sample. In the transportation and storage links, although freeze-dried products are more tolerant to temperature fluctuations, strict light and moisture protection are still required. Once the packaging is damaged or stored improperly, it is easy to absorb moisture and agglomerate, thus affecting the homogeneity. At the same time, the production cost of freeze-dried quality control products is relatively high, and the reconstitution step increases the operation complexity of the laboratory, especially significantly reducing the work efficiency in the scenarios of multi-item and high-frequency testing. More critically, during the freeze-drying process, components with different physical and chemical properties may lead to uneven distribution due to phase separation, and it is very difficult to ensure the homogeneity between batches and between bottles after reconstitution, thus weakening the comparability of quality control data. These factors jointly limit the practicality and long-term stability of freeze-dried quality control products in clinical tests.

[0004] Meanwhile, with the development of precision medicine, new detection markers such as 5'-nucleotidase (5’NT), glycated serum protein (GSP), glycated albumin (GA), glutathione reductase (GR), and homocysteine (HCY) have gradually been included in the clinical routine test catalog. However, existing composite quality control products do not cover these emerging items, forcing laboratories to return to the single-item quality control mode. The root cause of this dilemma lies in the stability bottleneck of enzyme markers: for example, the activity of 5’NT is easily interfered by fluctuations in ion concentration and pH. Developing multi-item composite quality control products requires overcoming heterogeneous stability technology, that is, achieving the synchronous preservation of different enzyme activities in a single matrix, which poses extremely high requirements for buffer system design, antioxidant protection, and cryopreservation. Although current technologies can partially improve the stability of single enzymes by adding stabilizers (such as metal chelator EDTA and sugar protectants), the matrix effect and cross-interference when multiple enzymes coexist are still industrialization difficulties, and breakthroughs need to be achieved through research on molecular stability mechanisms and the development of new stabilizers. Summary of the Invention

[0005] The technical solution of the present invention aims at the technical problem that the existing technical solutions are too single, and provides a solution significantly different from the existing technologies. Specifically, it provides a biochemical multi-item liquid quality control product for 67 analytes and its preparation method to achieve a composite quality control product in which multiple analytes including emerging items coexist stably.

[0006] The technical solution adopted by the present invention to solve the above technical problems is as follows: A biochemical multi-item liquid quality control product for 67 analytes, which uses human serum as the matrix and contains non-analytes and 67 analytes; the non-analytes include a cryoprotectant complex with an addition amount of 0.1%-1%, and the cryoprotectant complex includes antifreeze protein and protein stabilizer, and the mass ratio of the antifreeze protein to the protein stabilizer is 0.1:1 - 0.5:1; this biochemical multi-item liquid quality control product is a frozen liquid.

[0007] Preferably, the antifreeze protein is one or several of antifreeze glycoprotein, type I antifreeze protein, and type II antifreeze protein.

[0008] Preferably, the protein stabilizer is one or several of casein, elongation factor 1-α homologous protein, and gelatin.

[0009] The appropriate addition amounts of antifreeze protein and protein stabilizer synergistically protect the proteins and enzymes in the quality control product, and their action mechanisms include: 1. Synergistic protection network at the molecular level (1) Construction of a two-phase hydration layer The antifreeze protein binds to the exposed region of the protein through the hydrophobic core, forming a local high-concentration water molecule arrangement layer (low entropy state) to inhibit ice nucleation.

[0010] Casein covers the hydrophobic residues of proteins through its amphiphilic structure, overlaps with the hydration layer of antifreeze proteins, and forms a "dynamic buffer zone" to jointly block the contact between ice crystals and protein active sites.

[0011] The elongation factor 1-α homologous protein further stabilizes the native folding state of proteins through its inherent molecular chaperone function, forming a "conformation-ice crystal" double lock with the thermal hysteresis effect of antifreeze proteins.

[0012] (2)Charge-space steric hindrance synergy Casein is negatively charged at physiological pH, reducing protein aggregation through electrostatic repulsion; the rigid structure of antifreeze proteins (such as β-helix) provides physical steric hindrance, and the two work together to inhibit the collision-induced denaturation of proteins during the freeze-thaw process.

[0013] The antioxidant protection of the elongation factor 1-α homologous protein can neutralize the ROS generated by freezing stress, preventing the oxidation and damage of the antifreeze protein-target protein complex.

[0014] 2. Functional complementarity during the dynamic freezing process (1)Full-course regulation of ice crystal growth Initial freezing stage: Antifreeze proteins preferentially adsorb on the surface of ice nuclei, inhibiting the formation of critical ice crystal size (thermal hysteresis effect); casein delays the ice crystal growth kinetics by increasing the solution viscosity.

[0015] Rewarming stage: Antifreeze proteins inhibit recrystallization; the elongation factor 1-α homologous protein repairs the protein misfolding caused by local phase transitions.

[0016] (2)Interface tension balance The emulsifying property of casein reduces the water-ice interface tension, working in synergy with the ice crystal adsorption effect of antifreeze proteins to reduce the free energy required for ice crystal growth and make the ice crystal size distribution more uniform.

[0017] 3. Synergistic mechanism in complex matrices Casein forms a micelle structure to simulate the serum / milk matrix, and antifreeze proteins are embedded in the micelle gaps to protect endogenous proteins. The two work together to maintain the stability of the quality control product in a complex environment.

[0018] Furthermore, the non-analyte also includes components at the following concentrations: 0.1 - 100 mmol / L buffer, 0.01% - 1% w / v surfactant, and 0.1 - 80 mg / L preservative.

[0019] Preferably, the buffer is one or more of HEPES buffer, MES buffer, PIPES buffer, and Tris-HCl buffer.

[0020] Preferably, the surfactant is one or two of Tween 20, Triton X-100, and Poloxamer 188.

[0021] Preferably, the preservative is one or several of sodium azide, Proclin 300, Proclin 950, and gentamicin.

[0022] Furthermore, the analyte includes components at the following concentrations: 40 - 80 g / L total protein, 30 - 60 g / L albumin, 60 - 400 U / L alkaline phosphatase, 20 - 220 U / L alanine aminotransferase, 40 - 250 U / L aspartate aminotransferase, 10 - 80 μmol / L total bile acid, 5 - 40 μmol / L direct bilirubin, 10 - 120 μmol / L total bilirubin, 6000 - 10000 U / L cholinesterase, 20 - 150 U / L γ-glutamyl transferase, 100 - 460 U / L lactate dehydrogenase, 40 - 400 U / L amylase, 20 - 250 U / L pancreatic amylase, 60 - 550 μmol / L creatinine, 3 - 25 mmol / L urea, 120 - 520 μmol / L uric acid (urate), 0.5 - 3 mmol / L triglyceride, 2 - 10 mmol / L total cholesterol, 0.5 - 2 mmol / L high density lipoprotein cholesterol, 1 - 5 mmol / L low density lipoprotein cholesterol, 1 - 3 g / L apolipoprotein A1, 0.2 - 1.5 g / L apolipoprotein B, 20 - 250 U / L lipase, 80 - 480 U / L creatine kinase, 100 - 480 U / L α-hydroxybutyrate dehydrogenase, 3 - 20 mmol / L glucose, 0.5 - 10 mmol / L lactate (lactate), 10 - 40 mmol / L bicarbonate (carbon dioxide), 20 - 50 μmol / L unsaturated iron binding capacity, 2 - 10 mmol / L potassium, 100 - 180 mmol / L sodium, 80 - 150 mmol / L chloride, 1 - 5 mmol / L calcium, 0.2 - 1.8 mmol / L magnesium, 0.5 - 3 mmol / L inorganic phosphorus, 10 - 20 μmol / L copper, 10 - 40 μmol / L iron, 30 - 50 μmol / L zinc, 0.5 - 2.5 mmol / L lithium, 150 - 380 mg / L prealbumin, 0.5 - 1.5 g / L α1-acid glycoprotein, 0.5 - 2 g / L α1-antitrypsin, 1.5 - 3.5 g / L transferrin, 1 - 2 mg / L β2-microglobulin, 2 - 40 mg / L C-reactive protein, 1 - 3 g / L complement C3, 0.1 - 0.5 g / L complement C4, 1 - 5 g / L immunoglobulin A, 5 - 15 g / L immunoglobulin G, 0.5 - 1.5 g / L immunoglobulin M, 90 - 180 IU / mL antistreptolysin O, 2 - 50 IU / mL rheumatoid factor, 10 - 80 U / L mitochondrial isoenzyme of aspartate aminotransferase, 30 - 70 U / L glutathione reductase, 5 - 20 U / L 5'-nucleotidase, 180 - 450 μmol / L glycated albumin, 1 - 5 mmol / L glycated serum protein (fructosamine), 0.1 - 1.5 mmol / L small dense low density lipoprotein cholesterol, 50 - 250 mg / L lipoprotein (a), 0.5 - 5 mg / dL apolipoprotein E, 35 - 65 mg / L retinol - binding protein, 0.1 - 0.8 mg / L cystatin C, 5 - 20 U / L creatine kinase isoenzyme, 10 - 20 μmol / L homocysteine, 15 - 40 μg / mL glycocholic acid, 15 - 30 U / L leucine aminopeptidase, 0.5 - 2 mmol / L free fatty acids.

[0023] The present invention also provides a method for preparing a biochemical multi - analyte liquid quality control product for the above 67 analytes, comprising the following steps: S1. Using human serum negative for infectious diseases as a matrix, adding non - analytes, and stirring evenly to obtain a matrix solution; S2. Adjusting the pH of the matrix solution to 6.0 - 8.0; S3. Filtering the matrix solution with adjusted pH through a 0.2 - μm filter membrane; S4. Adding each analyte to the filtered matrix solution while stirring to obtain a quality control product; S5. Sub - packaging the quality control product; S6. Freezing the sub - packaged quality control product under the temperature condition of - 20 °C to - 80 °C to obtain a biochemical multi - analyte liquid quality control product in frozen liquid form for 67 analytes; The operations in steps S1 - S5 are all carried out in an environment below 4 °C.

[0024] Compared with the prior art, the beneficial effects of the present invention are as follows: In the quality control product including 67 analytes such as 5’NT, GSP, GA, GR, HCY, etc., the present invention adds 1% - 5% of a cryoprotectant complex. The cryoprotectant complex includes antifreeze protein and protein - based stabilizer with a mass ratio of 0.1:1 - 0.5:1. It can jointly inhibit the physical damage of ice crystals and reduce the damage of proteins during freeze - thawing; it can construct multiple protective layers to jointly maintain the conformational stability of the active centers of proteins and enzymes, and improve the active retention rate of proteins after cryopreservation. Finally, through the synergistic effect of antifreeze protein and protein - based stabilizer, the batch - to - batch consistency and storage stability of the quality control product can be improved.

[0025] The quality control product of the present invention is in frozen liquid form, different from freeze - dried powder. It eliminates the error caused by reconstitution. Compared with avoiding the interference caused by matrix effect and cross - reaction through freeze - drying, in this aspect, by adding a cryoprotectant complex to the liquid quality control product, the stability of emerging markers and other enzymes in this specific quality control product is enhanced, greatly improving the detection convenience and accuracy of testers, and reducing the labor and time costs of the laboratory.

[0026] The following will explain the present invention in detail through specific examples. Detailed implementation mode

[0027] To facilitate the understanding of the present invention, the present invention will be described more comprehensively below. However, the present invention can be implemented in different forms and is not limited to the embodiments described in the text. On the contrary, these embodiments are provided to make the disclosure of the present invention more thorough and comprehensive.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the description of the present invention in this specification are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0029] Example 1: Prepare three biochemical multi-item liquid quality control products with different concentrations of 67 analytes. The preparation method is as follows: In an environment at 4°C, the following substances are successively added to human serum, and stirred and dissolved repeatedly: Non-analyte: 50 mmol / L HEPES buffer, 0.5% Tween 20, 1 mL / L ProClin300, 0.5% cryoprotectant complex (0.1% antifreeze glycoprotein + 0.4% elongation factor 1-α homologous protein). After all are dissolved, adjust the pH to 7.5; filter with a 0.2 μm filter membrane; then add the analyte.

[0030] Analyte: See Table 1 specifically: Table 1 Analyte Statistical Table Project Name Concentration Unit Level 1 Level 2 Level 3 Total Protein g / L 46.3 55.7 79.8 Albumin g / L 31.4 37 53.6 Alkaline Phosphatase U / L 65.2 199.8 396.2 Alanine Aminotransferase U / L 27.5 106.2 204.6 Aspartate Aminotransferase U / L 41.1 113.2 239.9 Total Bile Acid μmol / L 14.9 34.3 77.6 Direct Bilirubin μmol / L 5.8 17 37.1 Total Bilirubin μmol / L 16.3 51.7 114.1 Cholinesterase U / L 6309 7357 9807 γ-Glutamyltransferase U / L 23 70.2 143.4 Lactate Dehydrogenase U / L 117.2 238.4 444 Amylase U / L 40.8 121.3 376.4 Pancreatic Amylase U / L 20.4 58.7 244 Creatinine μmol / L 63.5 148.7 544.1 Urea mmol / L 3.13 13.9 21.93 Uric Acid (Urate) μmol / L 143.7 371.9 506.8 Triglyceride mmol / L 0.8 1.49 2.92 Total Cholesterol mmol / L 2.94 4.31 6.5 High-Density Lipoprotein Cholesterol mmol / L 0.86 1.19 1.68 Low-Density Lipoprotein Cholesterol mmol / L 1.68 2.55 4.03 Apolipoprotein A1 g / L 1.18 1.63 2.28 Apolipoprotein B g / L 0.48 0.79 1.21 Lipase U / L 29 66.3 228.7 Creatine Kinase U / L 86.8 243.6 461 α-Hydroxybutyrate Dehydrogenase U / L 105.3 238.1 459.2 Glucose mmol / L 3.05 7.04 17.99 Lactic Acid (Lactate) mmol / L 0.88 1.67 6.27 Bicarbonate (Carbon Dioxide) mmol / L 14.6 23.2 30.9 Unsaturated Iron-Binding Capacity μmol / L 27.15 31.29 43.61 Potassium mmol / L 2.16 3.96 8.51 Sodium mmol / L 123 137 167 Chloride mmol / L 92.8 96.4 113.8 Calcium mmol / L 1.59 2.67 3.57 Magnesium mmol / L 0.48 0.86 1.45 Inorganic Phosphorus mmol / L 0.76 1.34 2.56 Copper μmol / L 12.04 13.58 19.01 Iron μmol / L 17.6 20.5 33.3 Zinc μmol / L 30.01 35.6 49.25 Lithium mmol / L 0.61 1.14 2.04 Prealbumin mg / L 176 219 344 α1-Acid Glycoprotein g / L 0.58 0.65 1.08 α1-Antitrypsin g / L 0.98 1.14 1.74 Transferrin g / L 1.958 2.341 3.393 β2-Microglobulin mg / L 1.05 1.15 1.73 C-Reactive Protein mg / L 4 11.4 35.8 Complement C3 g / L 1.18 1.42 2.28 Complement C4 g / L 0.177 0.229 0.326 Immunoglobulin A g / L 1.79 2.14 3 Immunoglobulin G g / L 7.9 9.3 13.71 Immunoglobulin M g / L 0.68 0.81 1.21 Anti-Streptolysin O IU / mL 94.97 125.4 173.09 Rheumatoid Factor IU / mL 2.14 23.18 49.86 Aspartate Aminotransferase Mitochondrial Isoenzyme U / L 11.5 33.6 72.7 Glutathione Reductase U / L 35.7 45.3 65.5 5'-Nucleotidase U / L 5.3 9 19.1 Glycated Albumin μmol / L 194 248 419 Glycated Serum Protein (Fructosamine) mmol / L 1.67 2.31 4.3 Small, Dense Low-Density Lipoprotein Cholesterol mmol / L 0.36 0.62 1.26 Lipoprotein (a) mg / L 51 72 218 Apolipoprotein E mg / dL 0.71 1.19 3 Retinol-Binding Protein mg / L 36.7 43.4 59 Cystatin C mg / L 0.178 0.147 0.534 Creatine Kinase Isoenzyme U / L 5.8 12 17.5 Homocysteine μmol / L 12.6 12.9 19.5 Glycocholic Acid μg / mL 16.87 43.88 36.12 Leucine Aminopeptidase U / L 16.69 21.03 29.01 Free Fatty Acids mmol / L 0.69 0.73 1.88 In an environment at 4°C, dispense the quality control product; then, freeze it under the temperature condition of -20°C to -80°C to obtain a biochemical multi-item liquid quality control product of 67 analytes in a frozen liquid form.

[0031] Conduct an analytical performance evaluation experiment and a stability experiment on the biochemical multi-item liquid quality control product of 67 analytes corresponding to the analyte concentration level 2 above: (1) Analytical performance evaluation experiment: After the quality control product is prepared and stored at low temperature for 1 month, take a total of 10 bottles of biochemical multi-item liquid quality control products, measure each bottle 3 times on a suitable biochemical analyzer, and calculate the within-bottle coefficient of variation (CV within-bottle) and the between-bottle coefficient of variation (CV between-bottle). The results are shown in Table 2.

[0032] Table 2 Homogeneity Test Results of Biochemical Multi-item Liquid Quality Control Products at Level 2 Concentration Project Name Total Protein Albumin Alkaline Phosphatase Alanine Aminotransferase Aspartate Aminotransferase Total Bile Acid CV within Bottle 0.6% 0.4% 0.6% 0.6% 0.6% 0.6% CV between Bottles 0.1% 0.2% 0.6% 0.6% 0.6% 0.1% Project Name Direct Bilirubin Total Bilirubin Cholinesterase γ-Glutamyltransferase Lactate Dehydrogenase Amylase CV within Bottle 0.6% 0.5% 0.4% 0.5% 0.6% 0.7% CV between Bottles 0.1% 0.5% 0.4% 0.1% 0.2% 0.1% Project Name Pancreatic Amylase Creatinine Urea Uric Acid (Urate) Triglyceride Total Cholesterol CV within Bottle 0.4% 0.5% 0.6% 0.6% 0.5% 0.6% CV between Bottles 0.1% 0.5% 0.6% 0.6% 0.5% 0.6% Project Name High-Density Lipoprotein Cholesterol Low-Density Lipoprotein Cholesterol Apolipoprotein A1 Apolipoprotein B Lipase Creatine Kinase CV within Bottle 0.6% 0.6% 0.5% 0.9% 0.5% 0.6% CV between Bottles 0.6% 0.3% 0.5% 0.9% 0.2% 0.6% Project Name α-Hydroxybutyrate Dehydrogenase Glucose Lactic Acid (Lactate) Bicarbonate (Carbon Dioxide) Unsaturated Iron-Binding Capacity Potassium CV within Bottle 0.5% 0.7% 0.6% 0.5% 0.6% 0.5% CV between Bottles 0.1% 0.1% 0.3% 0.3% 0.6% 0.2% Project Name Sodium Chloride Calcium Magnesium Inorganic Phosphorus Copper CV within Bottle 0.6% 0.6% 0.7% 0.9% 0.6% 0.6% CV between Bottles 0.6% 0.6% 0.2% 0.9% 0.6% 0.6% Project Name Iron Zinc Lithium Prealbumin α1-Acid Glycoprotein α1-Antitrypsin CV within Bottle 0.6% 0.6% 0.7% 0.6% 0.6% 0.8% CV between Bottles 0.6% 0.2% 0.7% 0.2% 0.3% 0.8% Project Name Transferrin β2-Microglobulin C-Reactive Protein Complement C3 Complement C4 Immunoglobulin A CV within Bottle 0.6% 0.8% 0.7% 0.6% 0.7% 0.7% CV between Bottles 0.6% 0.8% 0.7% 0.6% 0.7% 0.7% Project Name Immunoglobulin G Immunoglobulin M Anti-streptolysin O Rheumatoid factor Aspartate aminotransferase mitochondrial isoenzyme Glutathione reductase Within CV vials 0.6% 0.9% 0.5% 0.6% 0.7% 0.6% Between CV vials 0.6% 0.9% 0.3% 0.6% 0.1% 0.6% Project name 5'-Nucleotidase Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein(a) Apolipoprotein E Within CV vials 0.5% 0.7% 0.5% 0.8% 0.7% 0.6% Between CV vials 0.1% 0.7% 0.1% 0.8% 0.7% 0.3% Project name Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Leucine aminopeptidase Within CV vials 0.5% 0.6% 0.6% 0.7% 0.4% 0.5% Between CV vials 0.3% 0.2% 0.1% 0.7% 0.1% 0.5% Project name Free fatty acids Within CV vials 0.8% Between CV vials 0.8% As can be seen from Table 2, for various analytes under this formulation, the maximum CV does not exceed 1%. Therefore, the biochemical multi-analyte liquid quality control material corresponding to analyte concentration level 2 has good homogeneity.

[0033] (2) Stability experiment: The biochemical multi-analyte liquid quality control material was stored at -20°C and below. Two bottles were taken out for testing at 0, 6, 12, 18, 24, 30, 36, and 38 months respectively. Each bottle was tested 3 times and the average value was taken. The t-test method was used for the significance test of differences. It was required that the differences in the test results were not significant. The results are shown in Table 3.

[0034] Table 3 Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Total protein Albumin Alkaline phosphatase Alanine aminotransferase Aspartate aminotransferase Unit g / L g / L U / L U / L U / L Month 0 55.22 37.53 198.07 104.88 114.02 Month 6 55.18 37.4 197.35 103.93 113.32 Month 12 55.32 37.28 196.38 104.4 113.73 Month 18 55.32 37.28 196.82 104.17 113.75 Month 24 55.05 37.4 195.92 104.17 114.45 Month 30 55.22 37.38 196.98 104.22 112.95 Month 36 55.27 37.4 196.47 104.17 112.77 Month 38 55.03 37.4 197.12 104.02 112.7 Syx 0.1103 0.0833 0.6216 0.266 0.5378 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.003 0.0023 0.0169 0.0072 0.0146 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0.0027 0.0012 0.0231 0.0114 0.0278 t0.05,n-2×s(b1) 0.0073 0.0055 0.0413 0.0177 0.0357 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant Table 3 (Continued Table 1) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Total bile acid Direct bilirubin Total bilirubin Cholinesterase γ-Glutamyltransferase Unit μmol / L μmol / L μmol / L U / L U / L Month 0 34.58 17.02 50.7 7364.83 68.72 Month 6 34.22 16.82 49.83 7220.67 67.52 Month 12 34.2 16.8 50.05 7255.33 67.1 Month 18 34.07 16.82 49.75 7237.17 67.27 Month 24 34.28 16.7 49.83 7265.5 67.67 Month 30 34.17 16.8 49.95 7218.33 67.38 Month 36 34.05 16.73 50.08 7232.33 67.07 Month 38 34.23 16.78 49.9 7225.83 67.33 Syx 0.1442 0.0725 0.2885 41.229 0.4523 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0039 0.002 0.0078 1.1188 0.0123 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0.007 0.0047 0.0098 2.1247 0.0231 t0.05,n-2×s(b1) 0.0096 0.0048 0.0192 2.7376 0.03 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant Table 3 (Continued Table 2) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Lactate dehydrogenase Amylase Pancreatic amylase Creatinine Urea Unit U / L U / L U / L μmol / L mmol / L Month 0 239.45 122.27 58.68 148.32 13.97 Month 6 234.57 119.57 57.32 148.32 13.92 Month 12 234.23 119.62 57.38 147.1 14.03 Month 18 233.98 119.13 57.32 147.92 13.94 Month 24 234.05 119.32 57.17 148.18 14 Month 30 233.4 119.45 57.2 147.45 14.05 Month 36 233.62 119.4 57.35 148.17 13.99 Month 38 234.1 119.32 57.48 147.48 13.97 Syx 1.5384 0.8535 0.4426 0.4754 0.0438 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0417 0.0232 0.012 0.0129 0.0012 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0.0969 0.0469 0.0197 0.0105 0.001 t0.05,n-2×s(b1) 0.1021 0.0567 0.0294 0.0316 0.0029 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant Table 3 (Continued Table 3) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Uric acid (urate) Triglyceride Total cholesterol High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Unit μmol / L mmol / L mmol / L mmol / L mmol / L Month 0 366.72 1.49 4.37 1.2 2.59 Month 6 368.12 1.48 4.34 1.19 2.61 Month 12 367.33 1.49 4.38 1.19 2.59 Month 18 367.53 1.5 4.36 1.2 2.6 Month 24 368.03 1.49 4.39 1.2 2.58 Month 30 366.72 1.49 4.37 1.2 2.58 Month 36 365.7 1.48 4.41 1.2 2.59 Month 38 366.35 1.5 4.38 1.2 2.59 Syx 0.7584 0.0088 0.0186 0.0045 0.0098 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0206 0.0002 0.0005 0.0001 0.0003 Sum of squared deviations from the mean 1358 1358 1358 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 36.85 36.85 36.85 b1 0.0332 0.0001 0.0008 0 0.0003 t0.05,n-2×s(b1) 0.0504 0.0006 0.0012 0.0003 0.0006 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant Table 3 (Continued Table 4) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Apolipoprotein A1 Apolipoprotein B Lipase Creatine kinase α-Hydroxybutyric dehydrogenase Unit g / L g / L U / L U / L U / L Month 0 1.62 0.77 66.18 243.55 236.72 Month 6 1.62 0.76 65.6 241.73 232.55 Month 12 1.62 0.77 65.87 240.75 233.37 Month 18 1.62 0.77 65.7 240.77 233.28 Month 24 1.62 0.77 65.57 240.5 233.15 Month 30 1.61 0.77 65.87 240.32 232.8 Month 36 1.62 0.77 65.47 241.42 232.43 Month 38 1.61 0.76 65.83 240.87 232.73 Syx 0.0041 0.003 0.2182 0.8726 1.1396 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0001 0.0001 0.0059 0.0237 0.0309 Sum of squared deviations from the mean 1358 1358 1358 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 36.85 36.85 36.85 b1 0.0003 0.0001 0.0074 0.0474 0.065 t0.05,n-2×s(b1) 0.0003 0.0002 0.0145 0.0579 0.0757 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant Table 3 (Continued Table 5) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Glucose Lactic acid (lactate) Bicarbonate (carbon dioxide) Unsaturated iron-binding capacity Potassium Unit mmol / L mmol / L mmol / L μmol / L mmol / L Month 0 7.16 1.67 23.13 31.37 3.92 Month 6 7.19 1.66 23.15 31.26 3.9 Month 12 7.09 1.66 23.18 31.26 3.92 Month 18 7.15 1.67 23.07 31.3 3.91 Month 24 7.12 1.66 23.08 31.32 3.94 Month 30 7.12 1.66 23.17 31.18 3.91 Month 36 7.11 1.66 23.03 31.22 3.93 Month 38 7.11 1.66 23.1 31.31 3.92 Syx 0.028 0.0048 0.0493 0.0608 0.0144 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0008 0.0001 0.0013 0.0017 0.0004 Sum of squared deviations from the mean 1358 1358 1358 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 36.85 36.85 36.85 b1 0.0015 0.0001 0.0018 0.0019 0.0004 t0.05,n-2×s(b1) 0.0019 0.0003 0.0033 0.004 0.001 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant Table 3 (Continued Table 6) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Sodium Chloride Calcium Magnesium Inorganic phosphorus Unit mmol / L mmol / L mmol / L mmol / L mmol / L Month 0 138 96.88 2.63 0.86 1.33 Month 6 141 97.23 2.64 0.86 1.31 Month 12 139.33 97.3 2.63 0.86 1.32 Month 18 140.17 97.08 2.65 0.86 1.3 Month 24 137.5 96.32 2.63 0.86 1.32 Month 30 138.33 96.67 2.63 0.87 1.31 Month 36 139.83 96.62 2.63 0.86 1.32 Month 38 140.33 96.52 2.65 0.86 1.32 Syx 1.3403 0.28 0.011 0.0043 0.0078 t0.05,n-2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0364 0.0076 0.0003 0.0001 0.0002 Sum of squared deviations from the mean 1358 1358 1358 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 36.85 36.85 36.85 b1 0.0077 0.0175 0.0001 0.0001 0 t0.05,n-2×s(b1) 0.089 0.0186 0.0007 0.0003 0.0005 Result determination |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05,n-2×s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (Continued Table 7) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Copper Iron Zinc Lithium Prealbumin Unit μmol / L μmol / L μmol / L mmol / L mg / L Month 0 13.62 20.2 35.51 1.16 219.17 Month 6 13.71 20.12 34.41 1.16 219.17 Month 12 13.62 20.07 35.57 1.15 218.67 Month 18 13.8 20.3 35.81 1.15 218.33 Month 24 13.76 20.03 35.79 1.16 219 Month 30 13.71 20.17 36.04 1.16 219 Month 36 13.7 20.2 35.82 1.16 217.83 Month 38 13.77 20.2 35.83 1.17 218.83 Syx 0.0623 0.0913 0.4246 0.0071 0.4345 t0.05, n - 2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0017 0.0025 0.0115 0.0002 0.0118 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0.0024 0.0009 0.0228 0.0002 0.0164 t0.05, n - 2 × s(b1) 0.0041 0.0061 0.0282 0.0005 0.0289 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (Continued Table 8) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 α1 - Acid glycoprotein α1 - Antitrypsin Transferrin β2 - Microglobulin C - reactive protein Unit g / L g / L g / L mg / L mg / L Month 0 0.65 1.14 2.37 1.14 11.23 Month 6 0.65 1.14 2.36 1.14 11.13 Month 12 0.65 1.13 2.36 1.13 11.17 Month 18 0.65 1.14 2.36 1.14 11.13 Month 24 0.65 1.13 2.36 1.13 11.15 Month 30 0.65 1.13 2.35 1.13 11.17 Month 36 0.65 1.14 2.36 1.14 11.15 Month 38 0.65 1.13 2.37 1.13 11.13 Syx 0.003 0.0037 0.0074 0.0035 0.0307 t0.05, n - 2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0001 0.0001 0.0002 0.0001 0.0008 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0 0.0002 0.0001 0.0001 0.0013 t0.05, n - 2 × s(b1) 0.0002 0.0002 0.0005 0.0002 0.002 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (Continued Table 9) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Complement C3 Complement C4 Immunoglobulin A Immunoglobulin G Immunoglobulin M Unit g / L g / L g / L g / L g / L Month 0 1.41 0.23 2.12 9.26 0.8 Month 6 1.38 0.23 2.1 9.15 0.79 Month 12 1.4 0.23 2.1 9.1 0.79 Month 18 1.39 0.23 2.1 9.12 0.79 Month 24 1.4 0.23 2.1 9.18 0.79 Month 30 1.4 0.23 2.09 9.15 0.79 Month 36 1.39 0.23 2.1 9.13 0.79 Month 38 1.39 0.23 2.09 9.11 0.79 Syx 0.0079 0.0011 0.0082 0.047 0.0042 t0.05, n - 2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0002 0 0.0002 0.0013 0.0001 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0.0001 0 0.0004 0.0019 0.0002 t0.05, n - 2 × s(b1) 0.0005 0.0001 0.0005 0.0031 0.0003 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (Continued Table 10) Stability test results of the biochemical multi-analyte liquid quality control material at level 2 concentration Level 2 Antistreptolysin O Rheumatoid factor Mitochondrial isoenzyme of aspartate aminotransferase Glutathione reductase 5'-Nucleotidase Unit IU / mL IU / mL U / L U / L U / L Month 0 126.26 23.03 33.95 45.27 9.13 Month 6 122.63 22.32 33.02 44.27 8.95 Month 12 124.43 22.62 33.38 44.37 8.95 Month 18 124.28 22.59 33.38 44.45 8.97 Month 24 123.97 22.6 33.37 44.35 8.92 Month 30 123.81 22.58 33.22 44.25 8.95 Month 36 124.16 22.68 33.22 44.37 8.92 Month 38 124.15 22.5 33.17 44.23 8.93 Syx 1.0341 0.208 0.2551 0.2873 0.0551 t0.05, n - 2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0281 0.0056 0.0069 0.0078 0.0015 Sum of squared deviations 1358 1358 1358 1358 1358 Square root of the sum of squared deviations 36.85 36.85 36.85 36.85 36.85 b1 0.0204 0.0041 0.0105 0.0152 0.0035 t0.05, n - 2 × s(b1) 0.0687 0.0138 0.0169 0.0191 0.0037 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (continued Table XI) Stability test results of biochemical multi - analyte liquid quality control material at Level 2 concentration Level 2 Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein (a) Apolipoprotein E Unit μmol / L mmol / L mmol / L mg / L mg / dL Month 0 249 2.36 0.62 72.83 1.19 Month 6 241.83 2.3 0.61 70 1.15 Month 12 242.83 2.3 0.6 71.17 1.15 Month 18 242.83 2.31 0.61 70.67 1.16 Month 24 243.67 2.3 0.61 71 1.16 Month 30 242.83 2.31 0.6 70.5 1.16 Month 36 241.83 2.29 0.6 70.67 1.16 Month 38 242.83 2.3 0.61 70.33 1.16 Syx 2.089 0.0181 0.0045 0.7864 0.0111 t0.05, n - 2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0567 0.0005 0.0001 0.0213 0.0003 Sum of squared deviations from the mean 1358 1358 1358 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 36.85 36.85 36.85 b1 0.0917 0.0008 0.0002 0.0333 0.0004 t0.05, n - 2 × s(b1) 0.1387 0.0012 0.0003 0.0522 0.0007 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (continued Table XII) Stability test results of biochemical multi - analyte liquid quality control material at Level 2 concentration Level 2 Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Unit mg / L mg / L U / L μmol / L μg / mL Month 0 44.15 0.15 12.1 13.07 43.85 Month 6 42.88 0.15 11.72 12.68 42.64 Month 12 42.8 0.15 11.65 12.6 42.62 Month 18 43 0.15 11.72 12.67 42.66 Month 24 43.07 0.14 11.67 12.58 42.65 Month 30 42.78 0.15 11.72 12.65 42.65 Month 36 42.85 0.14 11.7 12.68 42.62 Month 38 42.93 0.15 11.62 12.63 43.69 Syx 0.3976 0.0023 0.126 0.1363 0.5626 t0.05, n - 2 2.4469 2.4469 2.4469 2.4469 2.4469 s(b1) 0.0108 0.0001 0.0034 0.0037 0.0153 Sum of squared deviations from the mean 1358 1358 1358 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 36.85 36.85 36.85 b1 0.0188 0 0.007 0.0064 0.0048 t0.05, n - 2 × s(b1) 0.0264 0.0002 0.0084 0.009 0.0374 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant Table 3 (continued Table XIII) Stability test results of biochemical multi - analyte liquid quality control material at Level 2 concentration Level 2 Leucine aminopeptidase Free fatty acids Unit U / L mmol / L Month 0 20.56 0.72 Month 6 19.91 0.72 Month 12 19.82 0.72 Month 18 19.9 0.72 Month 24 19.86 0.72 Month 30 19.88 0.72 Month 36 19.89 0.72 Month 38 19.95 0.73 Syx 0.219 0.0037 t0.05, n - 2 2.4469 2.4469 s(b1) 0.0059 0.0001 Sum of squared deviations from the mean 1358 1358 Square root of the sum of squared deviations from the mean 36.85 36.85 b1 0.0094 0.0001 t0.05, n - 2 × s(b1) 0.0145 0.0002 Result determination |b1| < t0.05, n - 2 × s(b1), the trend is not significant |b1| < t0.05, n - 2 × s(b1), the trend is not significant It should be understood that it is normal for the target values of different batches of composite quality control materials to vary. The basic concentrations of each item in each batch of serum are different. If the basic concentration is insufficient, analytes need to be added to increase the concentration. When it is too high, it can be diluted to the target level with physiological saline or buffer solution, but for some items, it may be difficult to adjust due to excessive concentration. During the freezing process, a small range of activity loss of bioactive substances may occur, and there is uncertainty in the product assignment itself. These factors together lead to the difference in target values between batches. Therefore, the target value of the composite quality control material only needs to meet the preset acceptable range, and there is no need to force the concentration to be absolutely fixed.

[0035] As can be seen from Table 3, the concentration changes of various analytes are very small after 0 months - 38 months, indicating that the 67 analytes all have good stability in the biochemical multi - analyte liquid quality control material provided by the present invention, and the shelf life can be up to three years.

[0036] Example 2: The difference between this example and Example 1 is that: Non - analyte: 100 mmol / L MES buffer, 1% poloxamer 188, 80 mg gentamicin, 1% cryoprotectant complex (0.2% type I antifreeze protein + 0.6% elongation factor 1 - α homologous protein + 0.2% casein). After all are dissolved, adjust the pH to 8.0.

[0037] Others are the same as in Example 1.

[0038] Perform an analytical performance evaluation experiment on the above - mentioned biochemical multi - analyte liquid quality control material, and the results are shown in Table 4.

[0039] Table 4 Homogeneity test results of biochemical multi - analyte liquid quality control material at Level 2 concentration Level 2 Total protein Albumin Alkaline phosphatase Alanine aminotransferase Aspartate aminotransferase Total bile acids CV within bottle 0.6% 0.6% 0.5% 0.4% 0.8% 1.0% CV between bottles 0.4% 0.5% 0.9% 0.1% 0.7% 0.9% Item name Direct bilirubin Total bilirubin Cholinesterase γ-Glutamyltransferase Lactate dehydrogenase Amylase CV within bottle 0.8% 0.7% 0.1% 0.9% 0.8% 0.2% CV between bottles 0.7% 0.7% 0.9% 0.8% 0.7% 0.4% Item name Pancreatic amylase Creatinine Urea Uric acid (urate) Triglycerides Total cholesterol CV within bottle 0.7% 0.4% 0.2% 0.3% 0.3% 0.4% CV between bottles 0.1% 0.1% 0.9% 0.5% 0.8% 0.1% Item name High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Apolipoprotein A1 Apolipoprotein B Lipase Creatine kinase Within the CV vial 0.8% 0.3% 0.5% 0.3% 0.5% 0.6% Between CV vials 0.2% 0.1% 0.4% 0.2% 0.8% 0.3% Project name α-Hydroxybutyric dehydrogenase Glucose Lactic acid (lactate) Bicarbonate (carbon dioxide) Unsaturated iron-binding capacity Potassium Within the CV vial 0.3% 0.7% 0.2% 0.4% 0.1% 0.8% Between CV vials 0.7% 0.3% 0.2% 0.2% 0.7% 0.3% Project name Sodium Chloride Calcium Magnesium Inorganic phosphorus Copper Within the CV vial 0.8% 1.0% 0.7% 0.6% 0.5% 0.9% Between CV vials 0.2% 0.9% 0.5% 0.5% 0.9% 0.8% Project name Iron Zinc Lithium Prealbumin α1-Acid glycoprotein α1-Antitrypsin Within the CV vial 0.7% 0.2% 0.1% 0.9% 0.6% 0.9% Between CV vials 0.9% 0.8% 0.1% 0.7% 0.6% 0.2% Project name Transferrin β2-Microglobulin C-reactive protein Complement C3 Complement C4 Immunoglobulin A Within the CV vial 0.6% 0.9% 0.5% 0.3% 0.4% 1.0% Between CV vials 0.6% 0.9% 0.6% 0.3% 0.3% 0.4% Project name Immunoglobulin G Immunoglobulin M Antistreptolysin O Rheumatoid factor Mitochondrial isoenzyme of aspartate aminotransferase Glutathione reductase Within the CV vial 0.5% 0.4% 0.1% 0.7% 0.4% 0.5% Between CV vials 0.5% 0.4% 0.8% 0.2% 0.2% 0.4% Project name 5'-Nucleotidase Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein (a) Apolipoprotein E Within the CV vial 0.2% 0.4% 0.4% 0.8% 0.1% 0.7% Between CV vials 0.6% 0.4% 0.1% 0.6% 0.6% 0.4% Project name Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Leucine aminopeptidase Within the CV vial 0.8% 0.5% 0.2% 0.6% 0.8% 0.4% Between CV vials 0.2% 0.3% 0.4% 0.3% 0.5% 0.9% Project name Free fatty acids Within the CV vial 1.0% Between CV vials 0.1% As can be seen from Table 4, under the condition of 1% cryoprotectant complex, the quality control material of the present application still has good homogeneity.

[0040] Example 3: The difference between this example and Example 1 is that: Non - analyte: 0.1 mmol / L HEPES buffer, 0.01% Triton X - 100, 0.1 mg gentamicin, 0.1% cryoprotectant complex (0.03% antifreeze glycoprotein + 0.05% elongation factor 1 - α homolog + 0.02% gelatin). After all are dissolved, adjust the pH to 6.0.

[0041] Others are the same as in Example 1.

[0042] Carry out an analytical performance evaluation experiment on the above - mentioned multi - biochemical liquid quality control product, and the results are shown in Table 5.

[0043] Table 5 Homogeneity test results of multi - biochemical liquid quality control product at level 2 concentration Level 2 Total protein Albumin Alkaline phosphatase Alanine aminotransferase Aspartate aminotransferase Total bile acids Within the CV vial 0.5% 1.0% 0.9% 0.7% 0.2% 0.1% Between CV vials 0.8% 0.4% 0.6% 0.6% 0.9% 0.3% Project name Direct bilirubin Total bilirubin Cholinesterase γ-Glutamyltransferase Lactate dehydrogenase Amylase Within the CV vial 0.9% 0.2% 1.0% 0.7% 1.0% 0.5% Between CV vials 0.6% 0.5% 0.6% 0.8% 0.3% 0.4% Project name Pancreatic amylase Creatinine Urea Uric acid (urate) Triglycerides Total cholesterol Within the CV vial 0.3% 0.2% 0.7% 0.9% 0.3% 0.4% Between CV vials 0.1% 0.9% 0.4% 0.3% 0.1% 0.8% Project name High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Apolipoprotein A1 Apolipoprotein B Lipase Creatine kinase Within the CV vial 0.8% 0.5% 0.6% 0.9% 0.3% 0.8% Between CV vials 0.8% 0.2% 1.0% 0.3% 0.2% 1.0% Project name α-Hydroxybutyric dehydrogenase Glucose Lactic acid (lactate) Bicarbonate (carbon dioxide) Unsaturated iron-binding capacity Potassium Within the CV vial 0.4% 0.4% 0.3% 0.3% 0.6% 0.9% Between CV vials 0.3% 0.7% 0.2% 0.6% 0.3% 0.8% Project name Sodium Chloride Calcium Magnesium Inorganic phosphorus Copper Within the CV vial 0.4% 0.2% 0.8% 0.5% 0.6% 0.2% Between CV vials 0.2% 0.1% 0.9% 0.3% 0.3% 0.1% Project name Iron Zinc Lithium Prealbumin α1-Acid glycoprotein α1-Antitrypsin Within the CV vial 0.2% 0.8% 0.3% 0.5% 0.2% 0.3% Between CV vials 0.6% 0.1% 0.4% 0.4% 0.9% 0.7% Project name Transferrin β2-Microglobulin C-reactive protein Complement C3 Complement C4 Immunoglobulin A Within the CV vial 0.3% 0.5% 0.9% 0.3% 0.5% 0.9% Between CV vials 0.8% 0.6% 0.7% 0.4% 0.8% 0.7% Project name Immunoglobulin G Immunoglobulin M Antistreptolysin O Rheumatoid factor Mitochondrial isoenzyme of aspartate aminotransferase Glutathione reductase Within the CV vial 0.8% 0.4% 0.4% 0.9% 0.5% 0.7% Between CV vials 1.0% 0.4% 0.3% 0.2% 0.2% 1.0% Project name 5'-Nucleotidase Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein (a) Apolipoprotein E Within the CV vial 0.2% 0.8% 0.2% 0.8% 0.2% 0.8% Between CV vials 0.5% 0.7% 0.7% 0.6% 0.4% 0.2% Project name Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Leucine aminopeptidase Within the CV vial 0.3% 0.1% 0.9% 0.3% 0.5% 0.8% Between CV vials 0.7% 0.1% 0.2% 0.2% 0.7% 0.3% Project name Free fatty acids Within the CV vial 0.7% Between CV vials 0.8% As can be seen from Table 5, under the condition of 0.1% cryoprotectant complex, the quality control product of this application still has good homogeneity.

[0044] Comparative Example 1: The difference from Example 1 is as follows: Non - analyte: 50 mM HEPES buffer, 0.5% Tween 20, 1 mL / L ProClin 300. After all are dissolved, adjust the pH to 7.5; (compared with Example 1, the cryoprotectant complex is not added); Analyte: Specifically shown in Table 1 level 2.

[0045] Others are the same as in Example 1.

[0046] Carry out an analytical performance evaluation experiment on the above - mentioned multi - biochemical liquid quality control product, and the results are shown in Table 6.

[0047] Table 6 Homogeneity test results of multi - biochemical liquid quality control product in Comparative Example 1 Level 2 Total protein Albumin Alkaline phosphatase Alanine aminotransferase Aspartate aminotransferase Total bile acids Within the CV vial 2.6% 3.4% 2.3% 3.3% 3.2% 2.3% Between CV vials 3.9% 2.5% 2.7% 2.3% 2.7% 2.1% Project name Direct bilirubin Total bilirubin Cholinesterase γ-Glutamyltransferase Lactate dehydrogenase Amylase Within the CV vial 3.1% 3.0% 2.1% 3.6% 2.3% 2.8% Between CV vials 2.1% 3.4% 4.0% 2.7% 3.7% 2.5% Project name Pancreatic amylase Creatinine Urea Uric acid (urate) Triglycerides Total cholesterol Within the CV vial 3.3% 2.4% 3.4% 3.2% 2.1% 2.0% Between CV vials 2.6% 2.3% 3.2% 3.6% 3.0% 3.7% Project name High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Apolipoprotein A1 Apolipoprotein B Lipase Creatine kinase Within the CV vial 3.3% 2.4% 2.6% 2.6% 2.5% 2.6% Between CV vials 2.7% 3.2% 3.0% 2.1% 2.8% 3.3% Project name α-Hydroxybutyric dehydrogenase Glucose Lactic acid (lactate) Bicarbonate (carbon dioxide) Unsaturated iron-binding capacity Potassium Within the CV vial 3.4% 2.6% 2.3% 2.2% 3.9% 3.3% Between CV vials 3.8% 3.2% 2.1% 2.3% 3.2% 2.4% Project name Sodium Chloride Calcium Magnesium Inorganic phosphorus Copper Within the CV vial 3.7% 2.2% 2.6% 2.0% 3.9% 3.4% Between CV vials 2.9% 3.8% 2.4% 3.2% 2.3% 2.9% Project name Iron Zinc Lithium Prealbumin α1-Acid glycoprotein α1-Antitrypsin Within the CV vial 2.8% 3.1% 3.6% 2.2% 3.4% 2.2% Between CV vials 3.3% 2.1% 2.9% 2.6% 2.7% 3.4% Project name Transferrin β2-Microglobulin C-reactive protein Complement C3 Complement C4 Immunoglobulin A Within the CV vial 3.9% 2.5% 2.1% 2.3% 3.2% 4.0% Between CV vials 2.1% 2.4% 2.3% 3.3% 3.2% 2.7% Project name Immunoglobulin G Immunoglobulin M Antistreptolysin O Rheumatoid factor Mitochondrial isoenzyme of aspartate aminotransferase Glutathione reductase Within the CV vial 3.9% 2.5% 3.6% 3.0% 2.4% 2.6% Between CV vials 3.3% 2.3% 3.2% 2.1% 3.7% 3.9% Project name 5'-Nucleotidase Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein(a) Apolipoprotein E Within the CV vial 2.6% 3.9% 4.0% 2.4% 2.5% 2.1% Between CV vials 3.8% 2.8% 2.5% 2.9% 3.8% 2.2% Project name Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Leucine aminopeptidase Within the CV vial 2.2% 2.3% 2.9% 3.6% 3.7% 3.8% Between CV vials 3.9% 3.1% 3.8% 2.4% 2.3% 3.0% Project name Free fatty acids Within the CV vial 2.0% Between CV vials 3.2% Comparing Table 2 and Table 6, it can be seen that the homogeneity of the quality control product with the cryoprotectant complex added in Example 1 is significantly better than that in Comparative Example 1, which is more conducive to ensuring the production quality.

[0048] Comparative Example 2: The difference from Example 1 is as follows: Non - analyte: 50 mM HEPES buffer, 0.5% Tween 20, 1 mL / L ProClin 300 and 0.01% cryoprotectant complex (0.002% antifreeze glycoprotein + 0.008% elongation factor 1 - α homolog). Adjust the pH to 7.5 (compared with Example 1, the addition amount of the cryoprotectant complex is reduced).

[0049] Analyte: Specifically shown in Table 1 level 2.

[0050] Others are the same as in Example 1.

[0051] The above-mentioned multi-biochemical liquid quality control product was subjected to an analytical performance evaluation experiment, and the results are shown in Table 7.

[0052] Table 7 Homogeneity test results of the multi-biochemical liquid quality control product of Comparative Example 2 Level 2 Total protein Albumin Alkaline phosphatase Alanine aminotransferase Aspartate aminotransferase Total bile acids Within the CV vial 3.4% 2.3% 3.0% 2.7% 2.4% 2.1% Between CV vials 2.2% 3.3% 3.2% 2.8% 2.2% 2.0% Project name Direct bilirubin Total bilirubin Cholinesterase γ-Glutamyltransferase Lactate dehydrogenase Amylase Within the CV vial 2.4% 3.5% 2.6% 3.1% 2.7% 3.1% Between CV vials 3.0% 2.8% 2.9% 3.3% 2.6% 2.1% Project name Pancreatic amylase Creatinine Urea Uric acid (urate) Triglycerides Total cholesterol Within the CV vial 3.4% 3.1% 3.0% 2.5% 2.5% 3.2% Between CV vials 2.5% 2.7% 2.7% 3.3% 2.0% 2.7% Project name High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Apolipoprotein A1 Apolipoprotein B Lipase Creatine kinase Within the CV vial 2.7% 3.5% 2.8% 2.0% 2.4% 2.1% Between CV vials 3.3% 2.8% 2.3% 2.7% 3.1% 3.1% Project name α-Hydroxybutyric dehydrogenase Glucose Lactic acid (lactate) Bicarbonate (carbon dioxide) Unsaturated iron-binding capacity Potassium Within the CV vial 3.4% 2.4% 3.4% 2.9% 3.3% 3.3% Between CV vials 3.2% 3.0% 2.1% 3.3% 3.0% 3.1% Project name Sodium Chloride Calcium Magnesium Inorganic phosphorus Copper Within the CV vial 3.2% 3.2% 2.6% 2.1% 3.2% 2.9% Between CV vials 3.2% 2.6% 2.1% 3.1% 2.7% 3.4% Project name Iron Zinc Lithium Prealbumin α1-Acid glycoprotein α1-Antitrypsin Within the CV vial 2.4% 3.2% 2.5% 2.7% 3.0% 2.6% Between CV vials 2.3% 2.8% 2.3% 2.5% 2.5% 2.6% Project name Transferrin β2-Microglobulin C-reactive protein Complement C3 Complement C4 Immunoglobulin A Within the CV vial 3.4% 2.6% 2.3% 2.4% 2.5% 3.2% Between CV vials 2.4% 2.3% 3.3% 2.3% 2.9% 2.5% Project name Immunoglobulin G Immunoglobulin M Antistreptolysin O Rheumatoid factor Mitochondrial isoenzyme of aspartate aminotransferase Glutathione reductase Within the CV vial 3.4% 2.1% 3.1% 2.3% 3.1% 3.5% Between CV vials 2.0% 3.1% 3.3% 3.0% 3.1% 3.3% Project name 5'-Nucleotidase Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein(a) Apolipoprotein E Within the CV vial 3.1% 2.9% 2.4% 3.2% 3.1% 2.2% Between CV vials 2.8% 2.9% 2.7% 3.0% 3.3% 2.8% Project name Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Leucine aminopeptidase Within the CV vial 3.2% 2.7% 2.9% 2.1% 2.0% 3.0% Between CV vials 2.1% 2.4% 2.3% 3.4% 2.1% 2.1% Project name Free fatty acids Within the CV vial 2.0% Between CV vials 2.9% Comparing Table 2 and Table 7, it can be seen that in Comparative Example 2, the addition amount of the cryoprotectant complex was too small, and the homogeneity of the quality control product decreased significantly.

[0053] Comparative Example 3: The difference from Example 1 is that: Non-analyte: 50 mM HEPES buffer, 0.5% Tween 20, 1 mL / L ProClin 300 and 6% cryoprotectant complex (2% antifreeze glycoprotein + 4% elongation factor 1-α homologous protein), and the pH was adjusted to 7.5 (compared with Example 1, the addition amount of the cryoprotectant complex increased).

[0054] Analyte: Specifically shown in Table 1, Level 2.

[0055] Others are the same as in Example 1.

[0056] The above-mentioned multi-biochemical liquid quality control product was subjected to an analytical performance evaluation experiment, and the results are shown in Table 8.

[0057] Table 8 Homogeneity test results of the multi-biochemical liquid quality control product of Comparative Example 2 Project name Total protein Albumin Alkaline phosphatase Alanine aminotransferase Aspartate aminotransferase Total bile acids Within the CV vial 0.4% 0.4% 0.6% 0.6% 0.8% 0.3% Between CV vials 0.1% 0.2% 0.2% 0.1% 0.4% 0.2% Project name Direct bilirubin Total bilirubin Cholinesterase γ-Glutamyltransferase Lactate dehydrogenase Amylase Within the CV vial 0.9% 0.8% 0.4% 0.5% 0.6% 0.7% Between CV vials 0.1% 0.5% 0.5% 0.5% 0.4% 0.5% Project name Pancreatic amylase Creatinine Urea Uric acid (urate) Triglycerides Total cholesterol Within the CV vial 0.4% 0.7% 0.8% 0.6% 0.5% 0.6% Between CV vials 0.2% 0.5% 0.6% 0.3% 0.2% 0.2% Project name High-density lipoprotein cholesterol Low-density lipoprotein cholesterol Apolipoprotein A1 Apolipoprotein B Lipase Creatine kinase Inside the CV bottle 0.6% 0.9% 0.5% 0.7% 0.5% 0.6% Between CV bottles 0.3% 0.3% 0.2% 0.1% 0.1% 0.2% Project name α-Hydroxybutyric dehydrogenase Glucose Lactic acid (lactate) Bicarbonate (carbon dioxide) Unsaturated iron-binding capacity Potassium Inside the CV bottle 0.2% 0.7% 0.6% 0.3% 0.8% 0.9% Between CV bottles 0.2% 0.5% 0.4% 0.3% 0.6% 0.2% Project name Sodium Chloride Calcium Magnesium Inorganic phosphorus Copper Inside the CV bottle 0.6% 0.6% 0.4% 0.2% 0.1% 0.8% Between CV bottles 0.1% 0.3% 0.2% 0.2% 0.1% 0.2% Project name Iron Zinc Lithium Prealbumin α1-Acid glycoprotein α1-Antitrypsin Inside the CV bottle 0.9% 0.8% 0.9% 0.8% 0.3% 0.9% Between CV bottles 0.2% 0.2% 0.5% 0.2% 0.1% 0.2% Project name Transferrin β2-Microglobulin C-reactive protein Complement C3 Complement C4 Immunoglobulin A Inside the CV bottle 0.6% 0.8% 0.7% 0.8% 0.2% 0.8% Between CV bottles 0.2% 0.4% 0.3% 0.6% 0.2% 0.7% Project name Immunoglobulin G Immunoglobulin M Anti-streptolysin O Rheumatoid factor Aspartate aminotransferase mitochondrial isoenzyme Glutathione reductase Inside the CV bottle 0.6% 0.9% 0.8% 0.6% 0.7% 0.6% Between CV bottles 0.3% 0.4% 0.3% 0.4% 0.3% 0.4% Project name 5'-Nucleotidase Glycated albumin Glycated serum protein (fructosamine) Small, dense low-density lipoprotein cholesterol Lipoprotein(a) Apolipoprotein E Inside the CV bottle 0.5% 0.7% 0.5% 0.8% 0.8% 0.6% Between CV bottles 0.3% 0.3% 0.3% 0.4% 0.3% 0.4% Project name Retinol-binding protein Cystatin C Creatine kinase isoenzyme Homocysteine Glycocholic acid Leucine aminopeptidase Inside the CV bottle 0.5% 0.5% 0.6% 0.9% 0.8% 0.6% Between CV bottles 0.1% 0.2% 0.5% 0.7% 0.4% 0.8% Project name Free fatty acids Inside the CV bottle 0.8% Between CV bottles 0.3% It can be seen from Table 8 that the above-mentioned quality control product has good homogeneity. However, the viscosity of the quality control product will increase after re-fusion, which does not meet the standard of the actual production character requirements; too large an addition amount of the cryoprotectant complex will interfere with the detection of the total protein item in the quality control product; and considering economic benefits and costs, a more appropriate data range should be selected: below 1%.

[0058] The above content has made an exemplary description of the present invention. Obviously, the specific implementation of the present invention is not limited by the above methods. As long as such non-substantial improvements are made by adopting the method concept and technical solution of the present invention, or the concept and technical solution of the present invention are directly applied to other occasions without improvement, they are all within the protection scope of the present invention.

Claims

1. A biochemical multi - analyte liquid quality control material for 67 analytes. The quality control material is based on human serum and contains non - analytes and 67 analytes. It is characterized in that: The non-analytes include a cryoprotectant complex added in an amount of 0.1%-1%, the cryoprotectant complex comprising an antifreeze protein and a protein stabilizer, and the mass ratio of the antifreeze protein to the protein stabilizer being 0.1:1 - 0.5:1; This biochemical multi-item liquid quality control product is a frozen liquid.

2. The biochemical multi - analyte liquid quality control product for 67 analytes according to claim 1, characterized in that: The antifreeze protein is one or more of antifreeze glycoprotein, type I antifreeze protein, and type II antifreeze protein.

3. A biochemical multi - analyte liquid quality control product for 67 analytes according to claim 1, characterized in that: The protein stabilizer is one or more of casein, elongation factor 1-α homologous protein, and gelatin.

4. A biochemical multi - analyte liquid quality control product for 67 analytes according to claim 1, characterized in that: The non-analytes further include components at the following concentrations: 0.1 - 100 mmol / L buffer, 0.01% - 1% w / v surfactant, and 0.1 - 80 mg / L preservative.

5. A biochemical multi - analyte liquid quality control product for 67 analytes according to claim 4, characterized in that: The buffer is one or more of HEPES buffer, MES buffer, PIPES buffer, and Tris-HCl buffer.

6. A biochemical multi - analyte liquid quality control product for 67 analytes according to claim 4, characterized in that: The surfactant is one or two of Tween 20, Triton X-100, and Poloxamer 188.

7. A biochemical multi - analyte liquid quality control product for 67 analytes according to claim 4, characterized in that: The preservative is one or more of sodium azide, Proclin 300, Proclin 950, and gentamicin.

8. A biochemical multi - analyte liquid quality control product for 67 analytes according to claim 1, characterized in that: The analyte includes components at the following concentrations: 40 - 80 g / L total protein, 30 - 60 g / L albumin, 60 - 400 U / L alkaline phosphatase, 20 - 220 U / L alanine aminotransferase, 40 - 250 U / L aspartate aminotransferase, 10 - 80 μmol / L total bile acid, 5 - 40 μmol / L direct bilirubin, 10 - 120 μmol / L total bilirubin, 6000 - 10000 U / L cholinesterase, 20 - 150 U / L γ-glutamyl transferase, 100 - 460 U / L lactate dehydrogenase, 40 - 400 U / L amylase, 20 - 250 U / L pancreatic amylase, 60 - 550 μmol / L creatinine, 3 - 25 mmol / L urea, 120 - 520 μmol / L uric acid, 0.5 - 3 mmol / L triglyceride, 2 - 10 mmol / L total cholesterol, 0.5 - 2 mmol / L high density lipoprotein cholesterol, 1 - 5 mmol / L low density lipoprotein cholesterol, 1 - 3 g / L apolipoprotein A1, 0.2 - 1.5 g / L apolipoprotein B, 20 - 250 U / L lipase, 80 - 480 U / L creatine kinase, 100 - 480 U / L α-hydroxybutyric dehydrogenase, 3 - 20 mmol / L glucose, 0.5 - 10 mmol / L lactate, 10 - 40 mmol / L bicarbonate, 20 - 50 μmol / L unsaturated iron binding capacity, 2 - 10 mmol / L potassium, 100 - 180 mmol / L sodium, 80 - 150 mmol / L chloride, 1 - 5 mmol / L calcium, 0.2 - 1.8 mmol / L magnesium, 0.5 - 3 mmol / L inorganic phosphorus, 10 - 20 μmol / L copper, 10 - 40 μmol / L iron, 30 - 50 μmol / L zinc, 0.5 - 2.5 mmol / L lithium, 150 - 380 mg / L prealbumin, 0.5 - 1.5 g / L α1-acid glycoprotein, 0.5 - 2 g / L α1-antitrypsin, 1.5 - 3.5 g / L transferrin, 1 - 2 mg / L β2-microglobulin, 2 - 40 mg / L C-reactive protein, 1 - 3 g / L complement C3, 0.1 - 0.5 g / L complement C4, 1 - 5 g / L immunoglobulin A, 5 - 15 g / L immunoglobulin G, 0.5 - 1.5 g / L immunoglobulin M, 90 - 180 IU / mL antistreptolysin O, 2 - 50 IU / mL rheumatoid factor, 10 - 80 U / L mitochondrial isoenzyme of aspartate aminotransferase, 30 - 70 U / L glutathione reductase, 5 - 20 U / L 5'-nucleotidase, 180 - 450 μmol / L glycated albumin, 1 - 5 mmol / L glycated serum protein, 0.1 - 1.5 mmol / L small dense low density lipoprotein cholesterol, 50 - 250 mg / L lipoprotein a, 0.5 - 5 mg / dL apolipoprotein E, 35 - 65 mg / L retinol binding protein, 0.1 - 0.8 mg / L cystatin C, 5 - 20 U / L creatine kinase isoenzyme, 10 - 20 μmol / L homocysteine, 15 - 40 μg / mL glycocholic acid, 15 - 30 U / L leucine aminopeptidase, 0.5 - 2 mmol / L free fatty acid.

9. A method for preparing a biochemical multi - analyte liquid quality control product for 67 analytes according to any one of claims 1 - 8, characterized in that: Including the following steps: S1. Using human serum negative for infectious diseases as a matrix, adding non-analytes, and stirring evenly to obtain a matrix solution; S2. Adjusting the pH of the matrix solution to 6.0 - 8.0; S3. Filtering the matrix solution with adjusted pH through a 0.2 μm filter membrane; S4. Adding each analyte to the filtered matrix solution while stirring to obtain a quality control product; S5. Sub-packaging the quality control product; S6. Freezing the sub-packaged quality control product at a temperature condition of -20°C to -80°C to obtain a biochemical multi-item liquid quality control product of 67 analytes in a frozen liquid form; Steps S1 - S5 are all operated in an environment below 4°C.