Fully automatic thromboelastography instrument quality control product and its preparation method and application method

Abstract

The present application relates to the field of coagulation detection quality control, and specifically discloses a fully automatic thrombelastograph quality control product and its preparation method and application method. The fully automatic thrombelastograph quality control product includes a quality control product L1, and the quality control product L1 includes the following raw materials: 60-120 parts by weight of casein; 60-120 parts by weight of whey protein; and 1000-1200 parts by weight of water. The present application also discloses a method for preparing a fully automatic thrombelastograph quality control product, comprising the following steps: Preparation of quality control product L1: Accurately weigh each raw material, mix, and adjust the pH value of the mixture to 7.0-7.3 to obtain quality control product L1. The quality control product L1 made from whey protein, casein and water in the present application can complete the detection of the accuracy of the fully automatic thrombelastograph without using human or animal blood, thereby improving biosafety.

Description

Technical Field

[0001] The present application relates to the field of coagulation detection quality control, and more specifically, to a fully automatic thrombelastography quality control product and a preparation method and an application method thereof. Background Art

[0002] Thromboelastography monitors various indicators in the coagulation process. It can be used to individualize the management of the patient's coagulation status and predict the risk of thrombosis and bleeding. It can be used to guide the use of anticoagulants, antiplatelets and other drugs and clinical blood transfusions.

[0003] The main parameters involved in the thromboelastogram are R value, K value, Angle value and MA value. Among them, the R value is the time from the beginning of coagulation to the beginning of fibrin formation, which represents the time required for the full activation of coagulation factors such as thrombin and the generation of fibrin, and represents the function of the coagulation factor; the K value is the time required from the end of the R time (the beginning of blood clot formation) to the amplitude of the tracing reaching 20mm, reflecting the joint effect of fibrin and platelets when the blood clot begins to form, and represents the rate of blood clot formation; the Angle value also reflects the joint effect of fibrin and platelets when the blood clot begins to form. When the state is severely hypocoagulable, the blood clot amplitude cannot reach 20mm, and the K value cannot be measured. At this time, using the Angle value will be more valuable for reference; the MA value reflects the aggregation function of platelets and reflects the maximum strength or hardness of the blood clot.

[0004] Thromboelastograms are generated using a thrombelastograph, which requires testing and calibration with quality control products before use. Currently, commonly used quality control products are whole blood quality control products, which are derived from whole blood or plasma. However, whole blood or plasma may pose risks of biological contamination and infectious diseases. Furthermore, strict national regulations on blood products have made blood procurement increasingly difficult and their prices are gradually increasing. Therefore, the development of biosafe and affordable quality control products is a pressing issue. Summary of the Invention

[0005] In order to improve the biological safety of quality control products, the present application provides a fully automatic thrombelastography quality control product and its preparation method and application method.

[0006] In the first aspect, the automatic thromboelastography quality control product provided in the present application adopts the following technical solution: including quality control product L1, and the quality control product L1 includes the following raw materials: 80-120 parts by weight of casein; 80-120 parts by weight of whey protein; and 1000-1200 parts by weight of water.

[0007] By adopting the above technical solution, whey protein has the characteristics of high purity and rich amino acid content, and has a high similarity with the components of blood; casein has a large molecular weight, is relatively dense, is easy to coagulate, and can be easily measured for various indicators during the coagulation process. The quality control product L1 prepared from a mixed aqueous solution of casein and whey protein can denature from a liquid to a gel state like blood. Therefore, by testing the quality control product L1, the detection accuracy of the fully automatic thromboelastograph can be tested. At the same time, the concentration of the quality control product L1 is similar to that of human blood. The quality control product L1 made from whey protein, casein and water can complete the accuracy test of the fully automatic thromboelastograph without using human or animal blood, thereby improving biological safety.

[0008] In a specific embodiment, a quality control product L2 is further included, and the quality control product L2 includes the following raw materials: 60-120 parts by weight of casein; 60-120 parts by weight of whey protein; 1000-1200 parts by weight of water. The raw material ratio of the quality control product L2 is different from that of the quality control product L1.

[0009] By adopting the above technical solution, the components of quality control product L2 and quality control product L1 are set to different ratios. During the test, both quality control product L1 and quality control product L2 are tested, so that two sets of test data can be tested, reducing the possibility of errors in the test results of a single fully automatic thrombelastography quality control product and improving the accuracy of the test.

[0010] In a specific embodiment, the raw materials of the quality control product L1 and the quality control product L2 also include 10-20 parts by weight of a preservative.

[0011] In a specific embodiment, the preservative is sodium benzoate.

[0012] By adopting the above technical solution, casein and whey protein are both protein products that are easily decomposed by bacteria and deteriorate after long-term storage, which may lead to deviations in test results. The addition of preservatives can inhibit the survival and reproduction of bacteria, thereby ensuring that quality control products L1 and L2 can maintain high test accuracy even when stored for a long time. Sodium benzoate is easily soluble in water and has a bactericidal effect, and is highly compatible with quality control products L1 and L2.

[0013] In a second aspect, the present application provides a method for preparing a quality control product for a fully automatic thrombelastography instrument, comprising the following steps:

[0014] Preparation of quality control product L1: Accurately weigh each raw material, mix and stir to dissolve, and adjust the pH value of the mixture to 7.0-7.3 to obtain quality control product L1.

[0015] By adopting the above technical solution, the raw materials can be mixed with water, and when the pH value is 7.0-7.3, both casein and whey protein can maintain high activity.

[0016] In a specific embodiment, tris(hydroxymethyl)aminomethane hydrochloride is used to adjust the pH.

[0017] On the third aspect, the present application provides an application method of a fully automatic thrombelastograph quality control product. Multiple copies of the fully automatic thrombelastograph quality control product are taken, and the multiple copies of the automatic thrombelastograph quality control product are mixed with a coagulant at different times and added to the fully automatic thrombelastograph for quality control testing. The initial test results and subsequent test results are obtained according to the sequence of the quality control tests. The accuracy of the fully automatic thrombelastograph is judged by comparing the subsequent test results with the initial test results.

[0018] By adopting the above technical solution, the fully automatic thromboelastograph first tests the newly prepared quality control product L1 to obtain the initial R value, K value, Angle value and MA value; during subsequent use, the stored quality control product L1 is tested to obtain subsequent R value, K value, Angle value and MA value, and the accuracy of the fully automatic thromboelastograph is tested by comparing the initial R value, K value and Angle value.

[0019] In a specific embodiment, water, gluconic acid and glutaraldehyde are weighed and mixed in a weight ratio of 100:(12-14):(9-10), and then stirred and dissolved to prepare a coagulant.

[0020] By adopting the above technical solution, a coagulant is added to the quality control product L1 or the quality control product L2. The coagulant in this application uses acidic gluconic acid, which can create an acidic environment; at the same time, glutaraldehyde can cross-link with casein and whey protein. The acidic environment and cross-linking can denature casein and whey protein, thereby coagulating into a gel, which facilitates the measurement of the coagulation process.

[0021] In summary, this application has the following beneficial effects:

[0022] 1. Since this application uses casein and whey protein added to water as quality control products, whey protein has high-quality and rich amino acid content and has a high similarity with blood; casein has a large molecular weight, which has the effect of improving the stability of the quality control product, and the casein coagulation process is more obvious and easy to detect. Whey protein and casein are used in combination in a certain proportion to achieve the effect of detecting the accuracy of the fully automatic thromboelastogram. This application does not need to use blood as a raw material, thereby improving biological safety.

[0023] 2. In this application, it is preferred to use quality control products L1 and L2 to test the same fully automatic thromboelastograph. The component ratios of quality control products L1 and L2 are different, and there are differences in the gel formation process, which reduces the impact of randomness when testing a quality control product of a fully automatic thromboelastograph, so as to achieve a more accurate test of the fully automatic thromboelastograph.

[0024] 3. The application method of the present application is to store the quality control product in a cold storage and compare it with the initial test result to determine whether the accuracy of the fully automatic thromboelastography instrument has changed, which greatly reduces the comparison variables and makes the test results more accurate. DETAILED DESCRIPTION

[0025] Preparation example of coagulant

[0026] Preparation Example 1

[0027] Use a beaker to measure 1000 mL of water. Use a balance to weigh 120 g of gluconic acid and 90 g of glutaraldehyde. Add to the water and stir thoroughly to prepare the coagulant for the quality control product. The CAS number for gluconic acid is 526-95-4, and the CAS number for glutaraldehyde is 111-30-8.

[0028] Preparation Example 2

[0029] Use a beaker to measure 1000 mL of water, use a balance to weigh 140 g of gluconic acid and 10 g of glutaraldehyde, add them to the water, and stir thoroughly to obtain the coagulant of the quality control product. Example

[0030] Example 1

[0031] This embodiment discloses a fully automatic thromboelastometry instrument quality control product, including a quality control product L1, which comprises the following components: 1000 mL of water, 100 g of casein, and 100 g of whey protein. In this embodiment, the casein is purchased from Jiangsu Caiwei Biotechnology Co., Ltd., and the whey protein is purchased from Shenzhen Lefu Biotechnology Co., Ltd.

[0032] This embodiment also discloses a method for preparing the above-mentioned fully automatic thromboelastography quality control product, comprising the following steps:

[0033] Preparation of quality control product L1: Use a beaker to measure 1000 mL of water, use a balance to weigh 100 g of casein and 100 g of whey protein, add the casein and whey protein to the water, and stir to mix at room temperature for 5 minutes; add tris (hydroxymethyl)aminomethane hydrochloride) to the water to adjust the pH to 7.0, and stir for 20 minutes to obtain quality control product L1; the CAS number of tris (hydroxymethyl)aminomethane hydrochloride is 1185-53-1;

[0034] The quality control product L1 was placed in a PET bottle and refrigerated at 5°C. It should be noted that, in other embodiments, the refrigerated storage temperature may be other values ​​between 2-8°C.

[0035] This embodiment also discloses an application method of the above-mentioned fully automatic thromboelastograph quality control product, taking 10 mL of the quality control product L1 refrigerated on the 1st day, 3rd day, 10th day, 30th day, 90th day and 180th day, respectively, and mixing each quality control product L1 with 1 mL of a coagulant, the coagulant prepared in Preparation Example 1 is selected, and placed in a fully automatic thromboelastograph for quality control testing. The fully automatic thromboelastograph will automatically detect the R value, K value, Angle value and MA value on different dates according to the setting results of the detection program, and record the data.

[0036] Example 2

[0037] This embodiment discloses a quality control product for a fully automatic thrombelastography instrument. The main difference from Example 1 is that the quality control product L1 in this embodiment further includes 15 g of sodium benzoate.

[0038] The preparation method of a fully automatic thromboelastography quality control product of this embodiment is as follows: 1000 mL of water is measured, 100 g of casein, 100 g of whey protein, and 15 g of sodium benzoate are weighed, the casein, whey protein, and sodium benzoate are added to the water, and stirred at room temperature for 5 minutes;

[0039] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.2, and stirred for 20 min to obtain quality control product L1;

[0040] The quality control product L1 was placed in a PET bottle and stored at 5°C.

[0041] The application method of the fully automatic thrombelastography quality control product of this embodiment is the same as that of Example 1.

[0042] Example 3

[0043] This embodiment discloses a quality control product for a fully automatic thromboelastography instrument. The main difference from Example 1 is that the quality control product L1 in this embodiment includes 1200 mL of water, 60 g of casein, 120 g of whey protein, and 15 g of sodium benzoate.

[0044] The preparation method of a quality control product for a fully automatic thromboelastography instrument of this embodiment is as follows: Preparation of quality control product L1: Measure 1200 mL of water, weigh 60 g of casein, 120 g of whey protein, and 15 g of sodium benzoate, add the casein, whey protein, and sodium benzoate to the water, and stir and mix at room temperature for 5 minutes;

[0045] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.2, and stirred for 20 min to obtain quality control product L1;

[0046] The quality control product L1 was placed in a PET bottle and stored at 5°C.

[0047] The application method of the fully automatic thrombelastography quality control product of this embodiment is the same as that of Example 1.

[0048] Example 4

[0049] This embodiment discloses a quality control product for a fully automatic thromboelastography instrument. The main difference from Example 1 is that the quality control product L1 in this embodiment includes 1000 mL of water, 120 g of casein, 60 g of whey protein, and 15 g of sodium benzoate.

[0050] The method for preparing a quality control product for a fully automatic thromboelastography instrument of this embodiment is as follows: Preparation of quality control product L1: Measure 1000 mL of water, weigh 120 g of casein, 60 g of whey protein, and 15 g of sodium benzoate, add the casein, whey protein, and sodium benzoate to the water, and stir and mix at room temperature for 5 minutes;

[0051] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.2, and stirred for 20 min to obtain quality control product L1;

[0052] The quality control product L1 was placed in a PET bottle and stored at 5°C.

[0053] The application method of the fully automatic thrombelastography quality control product of this embodiment is the same as that of Example 1.

[0054] Example 5

[0055] This embodiment discloses a quality control product for a fully automatic thromboelastography instrument. The main difference from Example 2 is that this embodiment also includes a quality control product L2, which includes 1000 mL of water, 60 g of casein, 60 g of whey protein, and 15 g of sodium benzoate.

[0056] The preparation method of a quality control product for a fully automatic thromboelastography instrument of this embodiment is as follows: Preparation of quality control product L1: 1000 mL of water, 100 g of casein, 100 g of whey protein, and 15 g of sodium benzoate are weighed, the casein, whey protein, and sodium benzoate are added to the water, and stirred at room temperature for 5 minutes;

[0057] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.0 and stirred for 20 min to obtain quality control product L1;

[0058] Preparation of quality control product L2: Measure 1000 mL of water, weigh 60 g of casein, 60 g of whey protein, and 15 g of sodium benzoate, add casein, whey protein, and sodium benzoate to the water, and stir at room temperature for 5 minutes;

[0059] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.0, and the mixture was stirred for 20 min to obtain quality control product L2.

[0060] The quality control products L1 and L2 were packaged in PET bottles and stored at 5°C.

[0061] This embodiment also discloses a method for using the above-mentioned fully automatic thrombelastograph quality control product. 10 mL of the quality control product L1 stored refrigerated on the 1st, 3rd, 10th, 30th, 90th, and 180th day are taken, and each portion of the quality control product L1 is mixed with 1 mL of a coagulant, where the coagulant is the coagulant prepared in Preparation Example 2. The samples are then placed in the fully automatic thrombelastograph for quality control testing. The fully automatic thrombelastograph automatically detects the R value, K value, Angle value, and MA value on different days according to the test program settings and records the data.

[0062] Take 10 mL of the quality control product L2 refrigerated on the 1st day, 3rd day, 10th day, 30th day, 90th day and 180th day, mix each quality control product L2 with 1 mL of coagulant, and use the coagulant prepared in Preparation Example 2 as the coagulant, and place it in the fully automatic thromboelastograph for quality control testing. The fully automatic thromboelastograph will automatically detect the R value, K value, Angle value and MA value on different dates according to the setting results of the detection program, and record the data.

[0063] Example 6

[0064] This embodiment discloses a quality control product for a fully automatic thromboelastography instrument. The main difference from Example 2 is that this embodiment also includes a quality control product L2, which includes 1000 mL of water, 120 g of casein, 60 g of whey protein, and 20 g of sodium benzoate.

[0065] The method for preparing a quality control product for a fully automatic thromboelastography instrument of this embodiment is as follows: Preparation of quality control product L1: Measure 1000 mL of water, weigh 100 g of casein, 100 g of whey protein, and 20 g of sodium benzoate, add the casein, whey protein, and sodium benzoate to the water, and stir and mix at room temperature for 5 minutes;

[0066] Tris (hydroxymethyl)aminomethane hydrochloride) was added to water to adjust the pH to 7.3, and stirred for 20 min to obtain quality control product L1;

[0067] Preparation of quality control product L2: Measure 1000 mL of water, weigh 120 g of casein, 60 g of whey protein, and 20 g of sodium benzoate, add casein, whey protein, and sodium benzoate to the water, and stir at room temperature for 5 minutes;

[0068] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.3, and the mixture was stirred for 20 min to obtain quality control product L2.

[0069] The quality control products L1 and L2 were packaged in PET bottles and stored at 5°C.

[0070] The application method of the fully automatic thrombelastography quality control product of this embodiment is the same as that of Example 5.

[0071] Example 7

[0072] This embodiment discloses a quality control product for a fully automatic thromboelastography instrument. The main difference from Example 2 is that this embodiment also includes a quality control product L2, which includes 1000 mL of water, 60 g of casein, 120 g of whey protein, and 10 g of sodium benzoate.

[0073] The preparation method of a quality control product for a fully automatic thromboelastography instrument of this embodiment is as follows: Preparation of quality control product L1: Measure 1000 mL of water, weigh 100 g of casein, 100 g of whey protein, and 10 g of sodium benzoate, add the casein, whey protein, and sodium benzoate to the water, and stir and mix at room temperature for 5 minutes;

[0074] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.0 and stirred for 20 min to obtain quality control product L1;

[0075] Preparation of quality control product L2: Measure 1000 mL of water, weigh 60 g of casein, 120 g of whey protein, and 10 g of sodium benzoate, add casein, whey protein, and sodium benzoate to the water, and stir at room temperature for 5 minutes;

[0076] Tris(hydroxymethyl)aminomethane hydrochloride was added to water to adjust the pH to 7.2, and the mixture was stirred for 20 min to obtain quality control product L2.

[0077] The quality control products L1 and L2 were packaged in PET bottles and stored at 5°C.

[0078] The application method of the fully automatic thrombelastography quality control product of this embodiment is the same as that of Example 5.

[0079] Comparative Example 1

[0080] The main difference between Comparative Example 1 and Example 1 is that the amount of casein used in Comparative Example 1 is 30 g and the amount of whey protein used is 180 g.

[0081] Comparative Example 2

[0082] The main difference between Comparative Example 2 and Example 1 is that the amount of casein used in Comparative Example 2 is 180 g and the amount of whey protein used is 30 g.

[0083] Performance testing

[0084] The fully automatic thrombelastograph quality control samples obtained in Examples 1-7 and Comparative Examples 1-2 were prepared according to their respective application methods and placed in the ATEG-8 fully automatic thrombelastograph for quality control testing. The fully automatic thrombelastograph automatically measured the R value, K value, Angle value, and MA value on different dates according to the test program settings and recorded the data. Coagulant A was used in Examples 1-4 and Comparative Examples 1-2, and Coagulant B was used in Examples 5-7.

[0085] Results and analysis of results

[0086] Table 1: Test data of Example 1

[0087] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.3 0.72 82 56 L1 Day 3 1.3 0.72 82 56 L1 Day 10 1.3 0.72 82 56 L1 Day 30 1.3 0.72 82 55 L1 Day 90 1.3 0.73 83 54 L1 Day 180 1.4 0.73 83 53

[0088] Table 2: Test data of Example 2

[0089] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.3 0.72 82 56 L1 Day 3 1.3 0.72 82 56 L1 Day 10 1.3 0.72 82 56 L1 Day 30 1.3 0.72 82 56 L1 Day 90 1.3 0.72 82 56 L1 Day 180 1.4 0.73 83 55

[0090] Table 3: Test data of Example 3

[0091] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.2 0.69 80 42 L1 Day 3 1.2 0.69 80 42 L1 Day 10 1.2 0.69 80 42 L1 Day 30 1.2 0.7 81 42 L1 Day 90 1.3 0.71 82 41 L1 Day 180 1.3 0.71 82 40

[0092] Table 4: Test data of Example 4

[0093] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.4 0.71 80 58 L1 Day 3 1.4 0.71 80 58 L1 Day 10 1.4 0.71 80 58 L1 Day 30 1.4 0.71 80 58 L1 Day 90 1.4 0.72 81 57 L1 Day 180 1.5 0.73 81 57

[0094] Table 5: Test data of Example 5

[0095] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.3 0.72 82 56 L1 Day 3 1.3 0.72 82 56 L1 Day 10 1.3 0.72 82 56 L1 Day 30 1.3 0.72 82 56 L1 Day 90 1.3 0.72 83 56 L1 Day 180 1.4 0.73 83 55 L2 Day 1 2.5 1.3 87 33 L2 Day 3 2.5 1.3 87 33 L2 Day 10 2.5 1.3 87 33 L2 Day 30 2.5 1.4 88 33 L2 Day 90 2.6 1.4 88 33 L2 Day 180 2.6 1.4 88 32

[0096] Table 6: Test data of Example 6

[0097] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.3 0.72 82 56 L1 Day 3 1.3 0.72 82 56 L1 Day 10 1.3 0.72 82 56 L1 Day 30 1.3 0.72 82 56 L1 Day 90 1.3 0.73 83 56 L1 Day 180 1.4 0.73 83 55 L2 Day 1 1.4 1 84 57 L2 Day 3 1.4 1 84 57 L2 Day 10 1.4 1 84 57 L2 Day 30 1.4 1 84 57 L2 Day 90 1.4 1.1 85 57 L2 Day 180 1.5 1.1 85 56

[0098] Table 7: Test data of Example 7

[0099] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 1.3 0.72 82 56 L1 Day 3 1.3 0.72 82 56 L1 Day 10 1.3 0.72 82 56 L1 Day 30 1.3 0.72 82 56 L1 Day 90 1.3 0.72 82 56 L1 Day 180 1.4 0.73 83 55 L2 Day 1 1.8 1.1 85 41 L2 Day 3 1.8 1.1 85 41 L2 Day 10 1.8 1.1 85 41 L2 Day 30 1.8 1.1 85 39 L2 Day 90 1.8 1.2 85 39 L2 Day 180 1.9 1.3 86 38

[0100] Table 8: Test data of Comparative Example 1

[0101] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 2.3 1.5 82 22 L1 Day 3 2.3 1.5 82 22 L1 Day 10 2.3 1.5 82 21 L1 Day 30 2.3 1.6 82 20 L1 Day 90 2.3 1.6 83 20 L1 Day 180 2.4 1.6 83 18

[0102] Table 9: Test data of Comparative Example 2

[0103] project R(min) K(min) Angle(°) MA value (mm) L1 Day 1 0.8 0.68 67 81 L1 Day 3 0.8 0.68 67 81 L1 Day 10 0.8 0.68 67 81 L1 Day 30 0.9 0.7 68 80 L1 Day 90 1 0.71 68 80 L1 Day 180 1.2 0.72 69 78

[0104] In combination with Example 1-2 and Table 1-2, the addition of sodium benzoate can extend the shelf life of the quality control product L1. Within 180 days, the quality control product in Example 2 can maintain better coagulation effect and detection effect than the quality control product in Example 1.

[0105] In combination with Examples 1-4 and Tables 1-4, the concentration of the quality control product L1 in Examples 1-4 is close to that of human blood, and it has both stability and biosafety. When the quality control product L1 in Examples 1-4 was tested, the test results within 30 days were almost consistent with the test results on the first day, indicating that the stability of the quality control product L1 was good and it served to calibrate the accuracy of the fully automatic thromboelastography instrument. Within 30 days to 180 days, the R value, K value, Angle value, and MA value changed slightly, which had little effect on the test results. The quality control product L1 in Examples 1 to 4 still had the verification effect after 180 days.

[0106] In combination with Example 5-7 and Table 5-7, the quality control product L1 and the quality control product L2 in Example 5-7 both have good calibration effects after 180 days; two sets of quality control products are used to test the same fully automatic thromboelastograph, so that the fully automatic thromboelastograph can be tested multiple times. When quality control products L1 and quality control products L2 are used for testing, the error caused by the deterioration of a certain quality control product can be reduced.

[0107] In combination with Example 1, Table 1, Comparative Examples 1-2 and Tables 8-9, when the content of casein and whey protein is too much or too little, the test results have little reference value because they are greatly different from the R value, K value, Angle value and MA value of human blood.

[0108] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. The application method of the quality control product of the fully automatic thromboelastography instrument is characterized by: The quality control product includes quality control product L1, and the quality control product L1 includes the following raw materials: 60-120 parts by weight of casein; 60-120 parts by weight of whey protein; 1000-1200 parts by weight of water; 10-20 parts by weight of preservative; Preparation of quality control product L1: Accurately weigh all raw materials, mix and stir to dissolve, and adjust the pH of the mixture to 7.0-7.3 to obtain quality control product L1; Application method: multiple copies of the automatic thrombelastograph quality control product are taken, and the multiple copies of the automatic thrombelastograph quality control product are mixed with a coagulant at different times and added to the fully automatic thrombelastograph for quality control testing. The first test result and subsequent test results are obtained according to the order of the quality control tests. The accuracy of the fully automatic thrombelastograph is judged by comparing the subsequent test results with the first test results. Water, gluconic acid and glutaraldehyde are weighed and mixed in a weight ratio of 100:(12-14):(9-10), and then stirred and dissolved to prepare a coagulant.

2. The method for using the quality control product of the fully automatic thrombelastography instrument according to claim 1, characterized in that: The preservative is sodium benzoate.