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Preparation method of normal value quality control product for blood coagulation and platelet function analyzer

A technology for functional analysis and platelets, applied in the preparation of test samples, analytical materials, instruments, etc., can solve problems such as complex technical solutions, matrix effects, and difficult production control, and achieve simple preparation processes, good performance, and stability Good results

Pending Publication Date: 2022-05-27
南京可诺医疗技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Disadvantages of prior art 1: 1. Pig plasma is used as raw material instead of human source, and matrix effect exists
2. Only applicable to thromboelastography
[0018] Disadvantages of prior art 2: 1. Pig plasma is used as raw material instead of human source, and matrix effect exists
2. Only applicable to thromboelastography
3. The technical scheme is complicated, there are many steps, and the production control is difficult
[0022] Disadvantages of prior art 3: 1. Pig plasma is used as raw material instead of human source, and matrix effect exists
2. Only applicable to thromboelastography

Method used

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  • Preparation method of normal value quality control product for blood coagulation and platelet function analyzer
  • Preparation method of normal value quality control product for blood coagulation and platelet function analyzer
  • Preparation method of normal value quality control product for blood coagulation and platelet function analyzer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Preparation of normal value quality control product

[0048] Step 1: Using sodium citrate anticoagulant human plasma as the matrix fluid, the matrix fluid was tested with a coagulation and platelet function analyzer produced by Sienco. The whole blood coagulation activation time (ACT) was in the range of 100-240 seconds, and the coagulation rate ( CR) in the range of 10-36 with platelet function (PF) >1. Matrix fluid test results see figure 1 .

[0049]Step 2: Mix the matrix solution with pH7.2 100mM Tris hydrochloride buffer at a ratio of 9:1, stir for 10 minutes, add 1‰ sodium azide, 2% trehalose, 2% white Egg white, stir for 30 minutes, and after it is completely dissolved, divide it into 1ml / bottle, freeze-dry it with a vacuum freeze dryer, take it out, cap the bottle, etc., and store it at 2-8°C. The test results of the quality control products after lyophilization are shown in figure 2 .

Embodiment 2

[0050] The preparation of embodiment 2 normal value quality control substance

[0051] Step 1: Using sodium citrate anticoagulant human plasma as the matrix fluid, the matrix fluid was tested with a coagulation and platelet function analyzer produced by Sienco. The whole blood coagulation activation time (ACT) was in the range of 100-240 seconds, and the coagulation rate ( CR) in the range of 10-36 and platelet function (PF) image 3 . A 0.2 g / mL phosphatidylserine solution (0.2 g phosphatidylserine in 1 ml chloroform) was added to adjust PF to greater than 1. After adding phospholipid solution for adjustment, see the test results Figure 4 .

[0052] Step 2: Mix the matrix solution with pH7.2 100mM Tris hydrochloride buffer at a ratio of 9:1, stir for 10 minutes, add 1‰ sodium azide, 2% trehalose, 2% white Egg white, stir for 30 minutes, and after it is completely dissolved, divide it into 1ml / bottle, freeze-dry it with a vacuum freeze dryer, take it out, cap the bottle, e...

Embodiment 3

[0053] Example 3 Performance measurement of the quality control product prepared by the present invention

[0054] The quality control products for normal level coagulation and platelet function analyzers prepared in Examples 1 and 2 were successively investigated for bottle opening stability at 4°C, accelerated stability at 37°C and repeated freezing and thawing. The specific measurement data are shown in the following table:

[0055]

[0056]

[0057]

[0058]

[0059]

[0060] Conclusion: The normal value control products prepared in Example 1 and Example 2 are stable in nature, and can be stable for 2 days after opening at 4 °C; the relative deviations of ACT, CR and PF measured at 37 °C for 14 days are all within 15%; repeated freezing and thawing 5 times The relative deviations of the determinations were all within 15%; the coefficients of variation of the uniformity results were all less than 10%.

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Abstract

The invention discloses a preparation method of a normal value quality control product for a blood coagulation and platelet function analyzer, which comprises the following steps: taking sodium citrate anticoagulant human plasma as a matrix liquid, adding a buffering agent, a preservative and a freeze-drying protective agent, stirring until the materials are completely dissolved, and performing vacuum freeze-drying to obtain the normal value quality control product. Compared with the prior art, the quality control product for the blood coagulation and platelet function analyzer prepared by the invention can break through the bottleneck which does not exist in the market temporarily; the preparation process is simple, the performance is good, instant requirements of different customers can be met, and the method is used for quality control of laboratory detection; human whole blood can be completely replaced, waste of abnormal human plasma is avoided, and the utilization rate of the abnormal human plasma is increased.

Description

technical field [0001] The invention belongs to the technical field of quality control product preparation, and in particular relates to a preparation method of a normal value quality control product for coagulation and platelet function analyzers. Background technique [0002] After the blood vessel is damaged, tissue factor enters the blood, and the blood contacts with the subendothelial collagen to activate the exogenous and endogenous coagulation systems, respectively, and finally generate thrombin through a common pathway. Under the action of thrombin, fibrinogen changes into Into fibrin monomers, fibrin monomers repolymerize into fibrin multimers, and finally the blood becomes gelatinous. This is also known as the coagulation cascade. [0003] Routine coagulation function tests include: 4 items of coagulation (APTT, PT, TT, FIB) and platelet count (PLT). Among them, the 4 items of coagulation can only reflect the status of coagulation factors, but not the system of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96G01N1/28
CPCG01N33/96G01N1/28G01N2001/2893
Inventor 李兆学王旭东张元靖
Owner 南京可诺医疗技术有限公司
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