CN104965092A - Preparation method of metal element whole blood control material - Google Patents
Preparation method of metal element whole blood control material Download PDFInfo
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- CN104965092A CN104965092A CN201510300359.5A CN201510300359A CN104965092A CN 104965092 A CN104965092 A CN 104965092A CN 201510300359 A CN201510300359 A CN 201510300359A CN 104965092 A CN104965092 A CN 104965092A
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
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Abstract
The invention provides a preparation method of a metal element whole blood control material. The preparation method comprises A, collecting cattle whole blood, B, detecting metal element concentrations of the cattle whole blood, wherein the metal elements comprise magnesium, iron, copper, zinc, lead, manganese and calcium, C, adding metal elements into the cattle whole blood to adjust cattle whole blood metal element concentrations to desired concentrations, D, carrying out centrifugation or filtration to remove fiber precipitates, and E, adding an antiseptic into the cattle whole blood and carrying out gentle mixing to obtain a uniform mixture. The preparation method belongs to the technical field of medical examination, is simple, and has a low cost. Through the preparation method, the metal element whole blood control material with stability, uniformity and matrix effects satisfying requirements is obtained and satisfies clinical and daily detection requirements on a metal element whole blood control material.
Description
Technical field
The invention belongs to technical field of medical examination, particularly relate to a kind of preparation method of metallic element Whole blood control.
Background technology
Along with the further investigation of metallic element and health relation, the Accurate Determining of in-vivo metal constituent content seems more and more important.Quality-control product is specifically designed to Internal Quality Control, stable, approximate with testing sample material, is the important foundation ensureing Accurate Determining, thus also increases gradually the be correlated with demand of quality-control product of metallic element.
At present, metallic element quality-control product is almost monopolized by external imported product, valuable product.Therefore, stability, homogeneity and matrix effect all satisfactory metallic element quality-control product preparation method is researched and developed significant.
Summary of the invention
For solving problems of the prior art, the invention provides a kind of preparation method of metallic element Whole blood control, preparation method is simple, cost is low, pass through the method, the all satisfactory metallic element Whole blood control of stability, homogeneity and matrix effect can be obtained, thus meet clinical and routine testing to the demand of metallic element Whole blood control.
Object of the present invention will be further described in detail below reflect and description.
The invention provides a kind of preparation method of metallic element Whole blood control, comprise the steps:
A) ox whole blood is collected; Collect ox whole blood without obvious haemolysis, jaundice, piarhemia or pollution, also without other infectiousness indexs;
B) measure the concentration of metallic element in ox whole blood, described metallic element comprises magnesium, iron, copper, zinc, lead, manganese and calcium;
C) in conjunction with the background values in ox whole blood, according to the medical science decision level concentration of each metallic element, metallic element material is added, by the concentration adjustment of metallic element in ox whole blood to aimed concn;
D) fibrillar precipitate is removed in centrifugal or filtration;
E) add antiseptic, mix gently, to obtain final product.
Preferably, described step C) in, adopt a small amount of mode repeatedly to add metallic element material, described metallic element material comprises metallic element standard substance and/or slaine.Adopt a small amount of mode repeatedly to add, avoid the quick agglutinating reaction adding a large amount of metallic elements and blood.Adopt commercial metals elemental standards material as metallic element material by the concentration adjustment of metallic element in ox whole blood to aimed concn time, directly add after calculating according to product description.
Magnesium single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW(E) 080126; Iron single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW 08616; Copper single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW 08615; Zinc single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW 08620; Plumbous single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW 08619; Manganese single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW(E) 080157; Calcium single element standard substance is purchased from China National Measuring Science Research Inst., and article No. is GBW(E) 080118.
Preferably, described slaine need dissolve with the ultrapure water of be less than ox volume of whole blood 1%.
Preferably, described metallic element material comprises magnesium nitrate, iron chloride, copper single element standard substance, zinc single element standard substance, plumbous single element standard substance, manganese single element standard substance and calcium single element standard substance.
Preferably, preparation method provided by the invention comprises the steps:
A) ox whole blood is collected;
B) concentration of metallic element in ox whole blood is measured; Assay method can adopt existing common detection methods, as atomic absorption spectrography (AAS) (AAS) and/or inductively coupled plasma mass spectrometry (ICP-MS);
C) add metallic element material, mix gently, adopt clean gauze to filter, by the concentration adjustment of metallic element in ox whole blood to aimed concn;
D) fibrillar precipitate is removed in centrifugal or filtration;
E) add antiseptic, mix gently, to obtain final product.
By adding metallic element material, can by the concentration adjustment of metallic element to aimed concn.The metallic element added may form insoluble metallic salt with the protein bound in ox whole blood and precipitate, and therefore needs to remove precipitation and continues a small amount of interpolation metallic element material repeatedly according to testing result.In order to remove precipitation, first the present inventor contemplates centrifugal mode, but still cannot realize effective separation of precipitation by the trial of different centrifugal condition, and does not affect other compositions.The present inventor is through lot of experiments exploration discovery: use the method for clean filtered through gauze can solve this problem, convenient and swift, and does not affect other compositions.
Preferably, described clean gauze is cleaning sterile close hole gauze.
Preferably, described antiseptic adopts Proclin 300 antiseptic, and addition is 0.02 ~ 0.05% of ox volume of whole blood.
Compared with prior art, the invention has the beneficial effects as follows: preparation method provided by the invention is simple, cost is low, pass through the method, the all satisfactory metallic element Whole blood control of stability, homogeneity and matrix effect can be obtained, thus meet clinical and routine testing to the demand of metallic element Whole blood control.The metallic element Whole blood control adopting preparation method provided by the invention to obtain can preserve more than 18 months under the condition of-20 DEG C, can preserve more than 2 weeks under the condition of 2 ~ 8 DEG C, the homogeneity after taking out normal temperature redissolution from-20 DEG C of conditions, stability, matrix effect can meet quality-control product requirement.
Accompanying drawing explanation
Fig. 1 is ferro element matrix effect testing result schematic diagram.
Embodiment
Below by specific embodiment, the present invention is described in further detail.
the preparation of embodiment one metallic element Whole blood control
Collect ox whole blood, measure the concentration of metallic element in ox whole blood, described metallic element comprises magnesium, iron, copper, zinc, lead, manganese and calcium; According to testing result, add magnesium nitrate, iron chloride, copper single element standard substance, zinc single element standard substance, plumbous single element standard substance, manganese single element standard substance and calcium single element standard substance, by the concentration adjustment of metallic element in ox whole blood to aimed concn; Centrifugal segregation fibrillar precipitate; Add Proclin 300 antiseptic, addition is 0.03% of ox volume of whole blood, mixes gently, to obtain final product.
the preparation of embodiment two metallic element Whole blood control
Collect ox whole blood, measure the concentration of metallic element in ox whole blood, described metallic element comprises magnesium, iron, copper, zinc, lead, manganese and calcium; According to testing result, add magnesium single element standard substance, iron chloride, copper single element standard substance, zinc single element standard substance, plumbous single element standard substance, manganese single element standard substance and calcium single element standard substance, by the concentration adjustment of metallic element in ox whole blood to aimed concn; Filter and remove fibrillar precipitate; Add Proclin 300 antiseptic, addition is 0.02% of ox volume of whole blood, mixes gently, to obtain final product.
the blank background of embodiment three metallic element detects
In Example one and embodiment two metallic element Whole blood control preparation process, to used container containing, filter the blank background that gauze bag, antiseptic etc. carry out metallic element and detect.
Result: container containing used in embodiment one and embodiment two metallic element Whole blood control preparation process, filter gauze bag, antiseptic etc. and all meet the requirements.
the bacteriostatic test of embodiment four metallic element Whole blood control
The metallic element Whole blood control that Example one is obtained, get 1mL respectively with aseptic straw and be inoculated in 2 pieces of sterilizing plates, autoclaved nutrient agar 15mL is added in plate, pour into while shake up, treat agar solidification, be placed in 36 DEG C of incubators and cultivate 48h, calculate the average colony number of 2 pieces of plates.
Result: clump count is 0.
the matrix effect of embodiment five metallic element Whole blood control
Each project to be checked prepares 20 routine samples, the whole range of linearity of CONCENTRATION DISTRIBUTION, use comparative approach (atom absorption method) respectively and treat that detecting method (ICP-MS method) measures, use U.S. clinical Laboratory Standard association (CLSI) EP14-A to assess.
Result: metallic element Whole blood control is compared with human whole blood sample, and matrix effect can be ignored.For ferro element, result as shown in Figure 1.
the homogeneity of embodiment six metallic element Whole blood control and stability
Metallic element Whole blood control obtained for embodiment one is implemented packing, randomly draws 10 parts, to every part of quality-control product replicate determination 2 times, carry out variance analysis.Result: variance yields is less than 3.02, the metallic element Whole blood control that the present invention obtains has good homogeneity.
Metallic element Whole blood control obtained for embodiment one is implemented packing, preserves, every 60 days, adopt the result of 3 days under the condition of-20 DEG C, every day, to quality-control product Parallel testing 2 times, carries out paired-samples T-test analysis.Result: T value is less than 2.23, preserves and still meets related request after 18 months, and the metallic element Whole blood control that the present invention obtains has good stability.
Above content is in conjunction with concrete preferred implementation further description made for the present invention, can not assert that specific embodiment of the invention is confined to these explanations.For general technical staff of the technical field of the invention, without departing from the inventive concept of the premise, some simple deduction or replace can also be made, all should be considered as belonging to protection scope of the present invention.
Claims (7)
1. a preparation method for metallic element Whole blood control, is characterized in that: comprise the steps:
A) ox whole blood is collected;
B) measure the concentration of metallic element in ox whole blood, described metallic element comprises magnesium, iron, copper, zinc, lead, manganese and calcium;
C) metallic element material is added, by the concentration adjustment of metallic element in ox whole blood to aimed concn;
D) fibrillar precipitate is removed in centrifugal or filtration;
E) add antiseptic, mix gently, to obtain final product.
2. the preparation method of metallic element Whole blood control according to claim 1, it is characterized in that: described step C) in, adopt a small amount of mode repeatedly to add metallic element material, described metallic element material comprises metallic element standard substance and/or slaine.
3. the preparation method of metallic element Whole blood control according to claim 2, is characterized in that: described slaine need dissolve with the ultrapure water of be less than ox volume of whole blood 1%.
4. the preparation method of metallic element Whole blood control according to claim 2, is characterized in that: described metallic element material comprises magnesium nitrate, manganese single element standard substance, iron chloride, copper single element standard substance, zinc single element standard substance, plumbous single element standard substance and calcium single element standard substance.
5. the preparation method of metallic element Whole blood control according to claim 1, is characterized in that: comprise the steps:
A) ox whole blood is collected;
B) concentration of metallic element in ox whole blood is measured;
C) add metallic element material, mix gently, adopt clean gauze to filter, by the concentration adjustment of metallic element in ox whole blood to aimed concn;
D) fibrillar precipitate is removed in centrifugal or filtration;
E) add antiseptic, mix gently, to obtain final product.
6. the preparation method of metallic element Whole blood control according to claim 5, is characterized in that: described clean gauze is cleaning sterile close hole gauze.
7. the preparation method of metallic element Whole blood control according to claim 1, is characterized in that: described antiseptic adopts Proclin 300 antiseptic, and addition is 0.02 ~ 0.05% of ox volume of whole blood.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106370872A (en) * | 2016-08-30 | 2017-02-01 | 广州金域医学检验中心有限公司 | Method for adding high-concentration metallic elements in bovine whole blood and bovine whole blood quality control serum |
| RU2629605C1 (en) * | 2016-11-08 | 2017-08-30 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Новосибирский государственный аграрный университет" | Method for lead level determination in cattle muscular tissue |
| CN107677530A (en) * | 2017-09-30 | 2018-02-09 | 汇智泰康生物技术(北京)有限公司 | The preparation method of five kinds of metallic element standard substances in ox blood |
| CN108333175A (en) * | 2018-01-18 | 2018-07-27 | 青岛汉唐生物科技有限公司 | A kind of total cholesterol detection method |
| CN109142742A (en) * | 2018-07-19 | 2019-01-04 | 江苏浩欧博生物医药股份有限公司 | A kind of allergenic specific IgE antibody quality-control product and preparation method thereof |
| CN112903798A (en) * | 2021-01-21 | 2021-06-04 | 山东英盛生物技术有限公司 | Preparation method of serum quality control product for element detection |
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| CN101701962A (en) * | 2009-11-19 | 2010-05-05 | 首都医科大学附属北京朝阳医院 | Serum magnesium standard substance |
| CN101930009A (en) * | 2009-11-19 | 2010-12-29 | 首都医科大学附属北京朝阳医院 | Serum calcium standard substance |
| CN104535382A (en) * | 2014-12-04 | 2015-04-22 | 国家电网公司 | Pretreatment method for measuring lead in blood by graphite furnace atomic absorption process |
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2015
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| CN101701962A (en) * | 2009-11-19 | 2010-05-05 | 首都医科大学附属北京朝阳医院 | Serum magnesium standard substance |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106370872A (en) * | 2016-08-30 | 2017-02-01 | 广州金域医学检验中心有限公司 | Method for adding high-concentration metallic elements in bovine whole blood and bovine whole blood quality control serum |
| CN106370872B (en) * | 2016-08-30 | 2018-04-13 | 广州金域医学检验中心有限公司 | A kind of method and ox Whole blood control of ox whole blood addition high concentration metallic element |
| RU2629605C1 (en) * | 2016-11-08 | 2017-08-30 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Новосибирский государственный аграрный университет" | Method for lead level determination in cattle muscular tissue |
| CN107677530A (en) * | 2017-09-30 | 2018-02-09 | 汇智泰康生物技术(北京)有限公司 | The preparation method of five kinds of metallic element standard substances in ox blood |
| CN108333175A (en) * | 2018-01-18 | 2018-07-27 | 青岛汉唐生物科技有限公司 | A kind of total cholesterol detection method |
| CN109142742A (en) * | 2018-07-19 | 2019-01-04 | 江苏浩欧博生物医药股份有限公司 | A kind of allergenic specific IgE antibody quality-control product and preparation method thereof |
| CN112903798A (en) * | 2021-01-21 | 2021-06-04 | 山东英盛生物技术有限公司 | Preparation method of serum quality control product for element detection |
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Address after: 510700 No. 10, helix 3 Road, International Biological Island, Huangpu District, Guangzhou City, Guangdong Province Patentee after: GUANGZHOU KINGMED CENTER FOR CLINICAL LABORATORY Address before: 510330 Guangdong Guangzhou Haizhuqu District Xingang East Road 2429, 3rd floor. Patentee before: GUANGZHOU KINGMED CENTER FOR CLINICAL LABORATORY |