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Blood coagulation quality control product and preparing method thereof

A coagulation quality control and coagulation technology, applied in the field of clinical coagulation testing project quality control, can solve problems such as high price, achieve low cost of raw materials, eliminate the risk of infection with AIDS or hepatitis virus, and reduce testing costs.

Active Publication Date: 2013-06-19
SHANGHAI SUNBIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the main coagulation quality control products on the market are mostly imported products, which are expensive, and most of them are derived from human plasma
There are also foreign patents reporting the use of animal-derived plasma to prepare blood coagulation quality control substances, but it only evaluates the quality of clinical experiments for the two blood coagulation tests of PT and APTT

Method used

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  • Blood coagulation quality control product and preparing method thereof
  • Blood coagulation quality control product and preparing method thereof
  • Blood coagulation quality control product and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of coagulation quality control products by adding fibrinogen solution

[0035] 1. Preparation of coagulation quality control products

[0036] 1. Rabbit and bovine blood were collected from the carotid artery, and pig blood was collected from the anterior vena cava. Add 3.8% trisodium citrate anticoagulant to the collected blood at a ratio of 9:1 to anticoagulant. The blood added with anticoagulant was centrifuged for 30 minutes with a relative centrifugal force of 2500g, and the upper layer of plasma was carefully separated and drawn.

[0037] 2. Preparation of plasma buffer containing stabilizer: Tris 20mM / L, sodium azide 1g / L, sucrose 20g / L, aprotinin 80000KIU / L, hydrochloric acid to adjust the pH value to 7.5.

[0038] 3. Detect the PT and APTT values ​​of pig, cow and rabbit plasma, as shown in Table 1.

[0039] Table 1 Animal plasma PT and APTT values ​​(unit: second)

[0040]

[0041] 4. Mix 74ml of pig plasma, 10ml of bovine plasma, ...

Embodiment 2

[0069] Example 2 Preparation of coagulation quality control products by removing part of fibrinogen

[0070] 1. Preparation of coagulation quality control products

[0071] 1. Rabbit and bovine blood were collected from the carotid artery, and pig blood was collected from the anterior vena cava. Add 3.8% trisodium citrate anticoagulant to the collected blood at a ratio of 9:1 to the anticoagulant, centrifuge for 30 minutes at a relative centrifugal force of 2500g, and carefully separate and absorb the upper layer of plasma.

[0072] 2. Preparation of plasma buffer containing stabilizer: Tris 20mM / L, sodium azide 1g / L, sucrose 20g / L, aprotinin 80000KIU / L, hydrochloric acid to adjust the pH value to 7.5.

[0073] 3. Detect the PT and APTT values ​​of pig, cow and rabbit plasma, as shown in Table 8.

[0074] Table 8 Animal plasma PT and APTT values ​​(unit: second)

[0075]

[0076] 4. Mix 146ml of pig plasma, 34ml of bovine plasma, and 20ml of rabbit plasma, and test the P...

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Abstract

The invention relates to the field of quality control of a clinical blood coagulation inspection item, and in particular provides to a method for preparing a quality control product which can be used for simultaneously carrying out PT (Prothrombin Time), APTT (activated partial thromboplastin time) and FIB (fibrinogen) blood coagulation inspection items through animal blood plasma. The method comprises the steps of mixing the animal blood plasma according to an appropriate rate, adding or removing the FIB, adding proper amount of blood plasma buffer solution contacting a stabilizing agent so as to enable detecting results of mixed blood plasma PT, APTT and FIB to be in the range of a blood coagulation indicator of a normal person, drying and cooling, thus obtaining the product. The blood coagulation quality control product prepared by the method provided by the invention has good sensibility to variation of a detection reagent, has high stability and meets the quality control requirement of the clinical blood coagulation inspection item.

Description

technical field [0001] The invention relates to the field of quality control of clinical blood coagulation test items, in particular to a method for preparing a quality control product that can be used for PT, APTT and FIB blood coagulation test at the same time by using animal plasma and the prepared blood coagulation quality control product. Background technique [0002] Mammalian blood coagulation is a complex physiological and biochemical metabolic process. Its essence is to convert liquid fibrinogen in plasma into solid cross-linked fibrin through a series of enzymatic reactions, referred to as blood coagulation. The multiple materials that participate in each chain reaction are called blood coagulation factors, and their chemical essence, except calcium ion, the great majority is protein. The coagulation process can be divided into three basic steps: the formation of prothrombin activator, the activation of prothrombin and the generation of fibrin. According to the di...

Claims

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Application Information

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IPC IPC(8): G01N33/96
Inventor 谢永华
Owner SHANGHAI SUNBIO TECH
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