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Quality control material and calibration material for verifying hematology analyzer and preparation method thereof

A blood cell analyzer and quality control product technology, applied in the field of quality control products and calibration products, can solve the problems of inability to guarantee cell activity and integrity, monotonous function of formula components, simple manufacturing process, etc.

Active Publication Date: 2013-08-28
ZHONGSHAN TAOLUE BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is complicated in technology, which makes it difficult to manufacture quality control products or calibration products. In addition, the effect of formula components is slightly monotonous. For example, after adding anticoagulant to monkey whole blood plasma, although it can ensure blood It does not coagulate and hemolyzes, but if the blood is not processed in time, it will also quickly hemolyze and then fail; in addition, the manufacturing process is also slightly simple and rough. After adding the stabilizer, such a process cannot guarantee the cell viability and integrity. The cells may coagulate or hemolyze before adding the stabilizer, so that the blood can no longer be used. Therefore, the calibrator and quality control prepared by this process method The qualification rate of the product is low, which greatly increases the production cost, and the activity stability is poor, and the aging time is short

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment one, the preparation process of quality control product is:

[0057] 1) Preparation of cell treatment solution: 5g of NaH2PO4, 3g of 2-hydroxypropane-1,2,3-tricarboxylate, 4g of 3-hydroxy-3-carboxyglutaric acid, 1g by weight or volume NH4Cl, 20g of C6H12O6, 10g of C6H14O6, 0.5g of C5H5N5, 0.05ml of C5H8O2, 0.05ml of (CH2O)n, 0.5g of NaN3, 9g of sodium chloride and 1000ml of pure water, then mix and stir evenly, After filtering and sterilizing, it is ready for use;

[0058] 2) Pretreatment of blood collection: collect 1000ml of monkey blood into a sterilized glass container, immediately add 200ml (that is, at a ratio of 1:5) of cell treatment solution to it, mix well, cover and seal, and let stand for 1 hour ;

[0059] 3) Cell solidification treatment: Take the above-mentioned monkey blood pretreatment product, fully mix, centrifuge, and separate to obtain the first supernatant, take out all of it and discard it, and add an equal volume to the discarded supe...

Embodiment 2

[0064] Embodiment two, the preparation process of quality control product is:

[0065] 1) Preparation of cell treatment solution: Take 10g of NaH2PO4, 6g of 2-hydroxypropane-1,2,3-tricarboxylate, 10g of 3-hydroxy-3-carboxyglutaric acid, 3g by weight or volume NH4Cl, 50g of C6H12O6, 50g of C6H14O6, 5g of C5H5N5, 1ml of C5H8O2, 1ml of (CH2O)n, 1.5g of NaN3, 1g of sodium chloride and 1000ml of pure water, then mix and stir evenly, filter, ready for use after sterilization;

[0066] 2) Pretreatment of blood collection: collect 1000ml of monkey blood into a sterilized glass container, add 400ml (that is, at a ratio of 1:2.5) of cell treatment solution to it immediately, mix well, cover and seal, and let stand for 3 hours ;

[0067] 3) Cell solidification treatment: Take the above-mentioned monkey blood pretreatment product, fully mix, centrifuge, and separate to obtain the first supernatant, take out all of it and discard it, and add an equal volume to the discarded supernatant a...

Embodiment 3

[0073] Embodiment three, the preparation process of quality control product is:

[0074] 1) Preparation of cell treatment solution: Take 7.5g of NaH2PO4, 4.5g of 2-hydroxypropane-1,2,3-tricarboxylate and 7g of 3-hydroxy-3-carboxyglutaric acid by weight or volume , 2g of NH4Cl, 35g of C6H12O6, 30g of C6H14O6, 2.75g of C5H5N5, 0.52ml of C5H8O2, 0.52ml of (CH2O)n, 1g of NaN3, 5g of sodium chloride and 1000ml of pure water, then mix and stir evenly , after being filtered and sterilized for later use;

[0075] 2) Pretreatment of blood collection: collect 750ml of monkey blood into a sterilized glass container, immediately add 200ml (that is, at a ratio of 1:3.75) of cell treatment solution to it, mix well, cover and seal, and let stand for 2.5 hours ;

[0076] 3) Cell solidification treatment: Take the above-mentioned monkey blood pretreatment product, fully mix, centrifuge, and separate to obtain the first supernatant, take out all of it and discard it, and add an equal volume t...

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Abstract

The invention discloses a quality control material and a calibration material for verifying hematology analyzer. Various liquids are integrated; a cell treating liquid integrates the functions of anti-coagulation, blood cell preservation and cell solidification stabilization; secondly, a manufacturing process is optimized, and pre-treatment is carried out immediately once blood is sampled, so that on one hand, the blood is prevented from coagulation and hemolysis, and on the other hand the immobilization of the blood cells is ultimately realized, and at the same time the activity of fresh blood is not lost; and by utilizing the process, not only the freshness of the blood cells is determined, but also the aging of the blood cells alive is determined, subsequently, by utilizing a centrifugation and separation technique, expected blood cells are extracted, and finally cell simulants of different concentrations are added so as to synthesize a complete standard substance; such process is low in production cost, the produced calibration material and the quality control material are high in yield; and the synthesized calibration material and the quality control material are stable in activity and longer in aging.

Description

【Technical field】 [0001] The invention relates to a quality control product and a calibrator used in calibrating a blood cell analyzer. 【Background technique】 [0002] The existing quality control products and calibration products used to check the precision, stability and accuracy of blood cell analyzers mainly rely on human blood and pig blood, etc., but human blood or its products are restricted by the country’s prohibition of sales as commodities. However, pig blood is quite different from human blood cells. Although the cost is low, the effect is far from that of human blood. In addition, there are also some blood cell analysis instrument manufacturers that provide supporting quality control products and calibration products, but they are expensive, and they are limited by transportation conditions and supply chains when importing quality control products and calibration products, so they produce domestically produced products. The cheap and high-quality quality contro...

Claims

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Application Information

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IPC IPC(8): G01N33/48G01N1/28
Inventor 欧明坤张剑洪
Owner ZHONGSHAN TAOLUE BIOLOGICAL TECH
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