Multi-level quality control product and preparation method thereof, and application of multi-level quality control product in thrombelastogram detection

A technology of thromboelasticity and quality control products, applied in the direction of biological testing, material inspection products, etc., to achieve the effects of easy industrial production, simple preparation process, and sufficient sources

Pending Publication Date: 2021-08-31
重庆鼎润医疗器械有限责任公司
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Problems solved by technology

[0004] The present invention intends to provide multi-level quality control products to solve the technical problem that there are no q

Method used

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  • Multi-level quality control product and preparation method thereof, and application of multi-level quality control product in thrombelastogram detection
  • Multi-level quality control product and preparation method thereof, and application of multi-level quality control product in thrombelastogram detection
  • Multi-level quality control product and preparation method thereof, and application of multi-level quality control product in thrombelastogram detection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: Thromboelastography Quality Control Level 1 (Normal Value Quality Control)

[0040] 1. Preparation of plasma matrix solution and fibrinogen matrix solution

[0041] (1) Collection of anticoagulant pig blood: when pigs are slaughtered, fresh pig whole blood and 3.8% sodium citrate anticoagulant are mixed at a volume ratio of 9:1 to collect anticoagulant pig blood.

[0042] (2) Preparation of porcine plasma: the collected anticoagulated porcine blood was placed at room temperature for 3-6 hours, and then separated into layers. Aspirate the upper liquid, put it into a tube centrifuge for centrifugation, and set the centrifugation parameters: rotation speed 4500rpm, time 15min, temperature 4°C. After centrifugation, the supernatant was carefully sucked out, and sodium azide preservative with a final concentration of 0.02% was added to obtain pig plasma, which was frozen at -20 to -30°C (valid for 3 years). The lower layer is mainly red blood cells, which are...

Embodiment 2

[0069] Embodiment 2: Thromboelastography quality control product level 2 (high coagulation quality control product)

[0070] 1. Preparation of Thromboelastography Quality Control Level 2

[0071] (1) Take out the frozen fibrinogen matrix solution and place it in a 37±2°C water bath to thaw quickly. Add 100.0 mL of thawed fibrinogen matrix solution into a 1000 mL beaker, and then add 900 mL of plasma matrix solution to obtain solution A. In this step, the ratio of fibrinogen matrix solution to plasma matrix solution can be controlled at 5-15:82-94, so that in the subsequent adjustment process, it is easier to adjust the MA value to the range of 60.0-80.0mm .

[0072] (2) Take solution A, use thromboelastography instrument (DRNX-Ⅲ, DRNX-Ⅳ, DRNX-Ⅴ, TEG 5000, etc.) and supporting reagents (thromboelastography test (activated coagulation) reagent (coagulation method), etc ) detection, the MA value is required to be in the range of 60.0-80.0mm; when the MA value is 80.0mm, add an...

Embodiment 3

[0096] Embodiment 3: Thromboelastography quality control product level 3 (low coagulation quality control product)

[0097] 1. Preparation of Thromboelastography Quality Control Level 3

[0098] (1) Take out the frozen fibrinogen matrix solution and place it in a 37±2°C water bath to thaw quickly. Take 70.0mL of thawed fibrinogen matrix solution and add it to a 1000mL beaker, then add 200mL of plasma matrix solution and 730mL of 6% hydroxyethyl starch 130 / 0.4 saline solution (6% hydroxyethyl starch saline solution, that is, artificial plasma ), to obtain solution A'. In this operation step, the volume ratio of fibrinogen matrix solution, plasma matrix solution and 6% hydroxyethyl starch 130 / 0.4 saline solution is controlled at 2-10:18-22:67-74, all of which can be prepared to meet the requirements quality control products.

[0099] (2) Take the solution A' and test it with a thromboelastograph (such as DRNX-Ⅲ type) and supporting reagents (thromboelastography test (activate...

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Abstract

The invention relates to the technical field of quality control of blood coagulation test items, in particular to a multi-level quality control product and a preparation method thereof and application of the multi-level quality control product to thromboelastogram detection. The thrombelastogram quality control product provided by the invention has a level 1 (normal value), a level 2 (high coagulation) and a level 3 (low coagulation), covers various states such as clinical normal coagulation, high coagulation, low coagulation, small Angle and the like, simulates a clinical actual detection environment, is combined with a thrombelastogram instrument, a matched reagent and a calcium chloride solution for use, and can carry out quality control or detection system evaluation on a thromboelastogram detection system. The thrombelastogram quality control product can be applied to quality control practice operation of a thrombelastogram detection system composed of equipment and matched reagents, and the reliability of clinical sample detection results is guaranteed.

Description

technical field [0001] The invention relates to the technical field of quality control of blood coagulation test items, in particular to a multi-level quality control product, a preparation method thereof and an application in thromboelastogram detection. Background technique [0002] Thromboelastography is a dynamic process curve of blood coagulation traced by a thromboelastograph, and it is a graph that can dynamically analyze the whole process of coagulation formation and fibrinolysis. Thromboelastography was invented by Hartert in 1948 and began to be used clinically in the middle and late 1980s. It has become an important indicator for perioperative monitoring of coagulation function and has been widely used in liver transplantation, cardiac surgery, kidney transplantation, and trauma surgery. And many other fields, guiding perioperative blood transfusion, thrombolysis and anticoagulant therapy. Thromboelastography can provide more than 16 quantitative parameters. Amo...

Claims

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Application Information

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IPC IPC(8): G01N33/96G01N33/86
CPCG01N33/86G01N33/96
Inventor 陈树国张鹏飞母志芹邹忠良
Owner 重庆鼎润医疗器械有限责任公司
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