Physical quality control product as well as preparation method and application thereof

A kind of quality control product and physical technology, applied in the field of clinical blood coagulation test, can solve the problems of raw material toxicity and carcinogenicity, complex preparation process, lack of stability, etc., and achieve the effect of low cost and simple preparation process

Pending Publication Date: 2022-05-27
重庆康巨全弘生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention intends to provide a physical quality control product to solve the problem of lack of detection accuracy and precision caused by the toxicity and carcinogenicity of raw materials, complex preparation process, high cost and lack of stability of physical quality control products in the prior art. The problem

Method used

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  • Physical quality control product as well as preparation method and application thereof
  • Physical quality control product as well as preparation method and application thereof
  • Physical quality control product as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Preparation of physical quality control product I

[0036] S1: Prepare the solvent: Dispense the water in 1mL / bottle and store in a sealed plastic tube at room temperature.

[0037] S2: Preparation of solute: Weigh 5 mg of agar, and place it in a plastic tube, sealed and stored at room temperature.

[0038] S3: Preparation of quality control product I: Take 1 agar prepared in S2, tap the tube wall to make the agar powder fall to the bottom, add the water prepared in S1 after opening the cap, invert the cap for 5 times, and store at 100°C Heating for 10min, then inverting it upside down 5 times, and testing immediately. If it cannot be detected immediately, it should be maintained at 100°C.

[0039] Table 1 Differences in raw materials of Examples 1 to 3 and Comparative Example 1

[0040] Example Agar / mg water / ml product Example 1 5 1 Quality Control I Example 2 7 1 Quality control product II Example 3 9 1 Quality C...

experiment example 1

[0041] Experimental Example 1: Dose-effect relationship between the concentration of agar in the quality control product and the parameters of thrombelastography

[0042] The quality control substances with agar concentration of 4-11 mg / mL were prepared as shown in Example 1, and a total of 12 groups of quality control substances (4 mg / mL, 5 mg / mL, 5.5 mg / mL, 6 mg / mL, 6.6 mg / mL) were prepared. , 7 mg / mL, 7.7 mg / mL, 8 mg / mL, 8.8 mg / mL, 9 mg / mL, 9.9 mg / mL, 11 mg / mL).

[0043] The expected results and uniformity (precision) of the quality control products were tested by thromboelastometry (American Blood Technology Company, TEG5000), as follows:

[0044] 1. Inspection steps:

[0045] A. Load the sample cup.

[0046] B. Add 340 μL of the mixed sample to the sample cup.

[0047] C. Test according to the requirements of thromboelastography until the MA (clot strength) value is determined.

[0048] 2. Expected results:

[0049] Randomly select 3 bottles of quality control produc...

experiment example 2

[0051] Experimental example 2: Detection and results of quality control products I to III and comparative example 1 in thromboelastography:

[0052] The expected results and uniformity (precision) of the quality control products were tested by thromboelastometry (American Blood Technology Company, TEG5000), as follows:

[0053] 1. Inspection steps:

[0054] A. Load the sample cup.

[0055] B. Add 340 μL of the mixed sample to the sample cup.

[0056] C. Test according to the requirements of thromboelastography until the MA (clot strength) value is determined.

[0057] 2. Expected results:

[0058] Randomly select 3 bottles of quality control products from the same batch for testing, repeat 3 times, and each measurement result should meet the requirements of R, K, Angle, and MA, which should all be within the range of label assignment.

[0059] 3. Uniformity:

[0060] Randomly select 10 bottles of quality control products from the same batch for testing, repeat 10 times, a...

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Abstract

The invention relates to the technical field of clinical blood coagulation testing, and discloses a physical quality control product as well as a preparation method and application thereof. Physical quality control products in the scheme comprise agar and water, the agar and the water are separately stored, and the quality control products are divided into a quality control product I, a quality control product II and a quality control product III according to agar solutions with different concentrations. When in use, agar and water are uniformly mixed and then heated and melted to prepare a colorless, transparent and uniformly dispersed quality control product in a solution state; the quality control product gradually forms a clot along with the cooling of the solution, the clot is described by a thrombelastogram instrument to obtain various parameters (R, K, Angle, MA and the like), and the quality of the thrombelastogram instrument is accurately evaluated by comparing the assignment range of the quality control product. The quality control product has the advantages that the raw materials are convenient to store and transport, the cost is low, the stability is good, the manufacturing process is simple, the detection result is stable and the like, different working states of the thrombelastogram can be accurately evaluated through agar solutions with different concentrations, and the quality control product is very suitable for evaluating and detecting the thrombelastogram in clinic.

Description

technical field [0001] The invention relates to the technical field of clinical blood coagulation testing, in particular to a physical quality control product and a preparation method and application thereof. Background technique [0002] Thromboelastography, invented by German Hartert in 1948, can monitor the whole process from the beginning of coagulation to clot formation and fibrinolysis completely from a blood sample. Coagulation factors, fibrin, platelet aggregation, and fibrinolysis were detected and evaluated for the overall picture of coagulation. The clinical application of thromboelastography requires good quality control in order to obtain timely, effective and accurate diagnostic results. Thromboelastography uses physical and chemical methods to detect blood coagulation status. Under the condition of 37℃, anticoagulated whole blood is swung back and forth in a cylindrical detection cup at an angle of 4°45' (frequency 0.1HZ), the blood clot is formed, retracted...

Claims

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Application Information

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IPC IPC(8): G01N1/28G01N1/38G01N1/44G01N33/48
CPCG01N1/28G01N1/38G01N1/44G01N33/48G01N2001/2893
Inventor 陈渝峰陈鑫孙文
Owner 重庆康巨全弘生物科技有限公司
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