CN117949356A - Quality control product for detecting blood sedimentation instrument and preparation method thereof - Google Patents
Quality control product for detecting blood sedimentation instrument and preparation method thereof Download PDFInfo
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- 238000003908 quality control method Methods 0.000 title claims abstract description 185
- 238000004062 sedimentation Methods 0.000 title claims abstract description 133
- 210000004369 blood Anatomy 0.000 title claims abstract description 91
- 239000008280 blood Substances 0.000 title claims abstract description 91
- 238000002360 preparation method Methods 0.000 title abstract description 17
- 239000000243 solution Substances 0.000 claims abstract description 171
- 210000003743 erythrocyte Anatomy 0.000 claims abstract description 165
- 229920000642 polymer Polymers 0.000 claims abstract description 70
- 238000001514 detection method Methods 0.000 claims abstract description 48
- 239000003761 preservation solution Substances 0.000 claims abstract description 38
- 241001465754 Metazoa Species 0.000 claims abstract description 25
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 21
- 239000008103 glucose Substances 0.000 claims abstract description 21
- 239000000126 substance Substances 0.000 claims abstract description 20
- 239000001509 sodium citrate Substances 0.000 claims description 32
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical group O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 32
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims description 26
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 22
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 22
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 21
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 21
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 21
- 229920002401 polyacrylamide Polymers 0.000 claims description 17
- 239000000230 xanthan gum Substances 0.000 claims description 15
- 229920001285 xanthan gum Polymers 0.000 claims description 15
- 235000010493 xanthan gum Nutrition 0.000 claims description 15
- 229940082509 xanthan gum Drugs 0.000 claims description 15
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical group OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 11
- 238000005259 measurement Methods 0.000 claims description 11
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 8
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 8
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 8
- 238000004939 coking Methods 0.000 claims description 5
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical group CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims 4
- 239000000834 fixative Substances 0.000 claims 1
- 239000003153 chemical reaction reagent Substances 0.000 abstract description 2
- 239000000047 product Substances 0.000 description 94
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 42
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 27
- 238000000034 method Methods 0.000 description 26
- 239000002504 physiological saline solution Substances 0.000 description 24
- 238000005406 washing Methods 0.000 description 24
- 239000011780 sodium chloride Substances 0.000 description 20
- 238000005303 weighing Methods 0.000 description 20
- 239000008213 purified water Substances 0.000 description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 12
- 230000000694 effects Effects 0.000 description 12
- 238000002474 experimental method Methods 0.000 description 9
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 8
- 235000019799 monosodium phosphate Nutrition 0.000 description 8
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 8
- 239000006228 supernatant Substances 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- DGLRDKLJZLEJCY-UHFFFAOYSA-L disodium hydrogenphosphate dodecahydrate Chemical compound O.O.O.O.O.O.O.O.O.O.O.O.[Na+].[Na+].OP([O-])([O-])=O DGLRDKLJZLEJCY-UHFFFAOYSA-L 0.000 description 6
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 6
- 235000019796 monopotassium phosphate Nutrition 0.000 description 6
- 239000001103 potassium chloride Substances 0.000 description 6
- 235000011164 potassium chloride Nutrition 0.000 description 6
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 6
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 6
- 210000004027 cell Anatomy 0.000 description 5
- 238000011282 treatment Methods 0.000 description 5
- 239000000463 material Substances 0.000 description 4
- 238000012544 monitoring process Methods 0.000 description 4
- 238000005457 optimization Methods 0.000 description 4
- 229910019142 PO4 Inorganic materials 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 3
- 239000010452 phosphate Substances 0.000 description 3
- 206010018910 Haemolysis Diseases 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000008588 hemolysis Effects 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 239000003112 inhibitor Substances 0.000 description 2
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- 239000007788 liquid Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229930024421 Adenine Natural products 0.000 description 1
- GFFGJBXGBJISGV-UHFFFAOYSA-N Adenine Chemical compound NC1=NC=NC2=C1N=CN2 GFFGJBXGBJISGV-UHFFFAOYSA-N 0.000 description 1
- GAWIXWVDTYZWAW-UHFFFAOYSA-N C[CH]O Chemical group C[CH]O GAWIXWVDTYZWAW-UHFFFAOYSA-N 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 102000006395 Globulins Human genes 0.000 description 1
- 108010044091 Globulins Proteins 0.000 description 1
- 208000037581 Persistent Infection Diseases 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- WJEIYVAPNMUNIU-UHFFFAOYSA-N [Na].OC(O)=O Chemical compound [Na].OC(O)=O WJEIYVAPNMUNIU-UHFFFAOYSA-N 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 229960000643 adenine Drugs 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 210000004102 animal cell Anatomy 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 229910021538 borax Inorganic materials 0.000 description 1
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 1
- 239000004327 boric acid Substances 0.000 description 1
- 244000309466 calf Species 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 238000007675 cardiac surgery Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000003759 clinical diagnosis Methods 0.000 description 1
- 208000018631 connective tissue disease Diseases 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 230000008034 disappearance Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 229920006158 high molecular weight polymer Polymers 0.000 description 1
- 230000036210 malignancy Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
- 238000001959 radiotherapy Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000011775 sodium fluoride Substances 0.000 description 1
- 235000013024 sodium fluoride Nutrition 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/04—Investigating sedimentation of particle suspensions
- G01N15/05—Investigating sedimentation of particle suspensions in blood
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Analytical Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Physics & Mathematics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention belongs to the technical field of detection reagents, and particularly relates to a quality control product for detecting a blood sedimentation instrument and a preparation method thereof. Quality control article is used in blood sedimentation appearance detection, its characterized in that includes: animal erythrocytes, erythrocyte preservation solution, high molecular polymer solution and glucose scorch preventing substance. The detectable sedimentation rate of the quality control product for detecting the blood sedimentation instrument is 1mm/h-60mm/h; compared with the non-human nature control product in the prior art, the sedimentation rate detection range is larger, and the application range is wider.
Description
Technical Field
The invention belongs to the technical field of detection reagents, and particularly relates to a quality control product for detecting a blood sedimentation instrument and a preparation method thereof.
Background
Blood sedimentation (erythrocyte sedimentation rate, ESR), refers to the distance (mm) over which red blood cells settle within a certain time, by placing anticoagulated blood in a specific blood sedimentation tube. Blood sedimentation is increased in various acute or chronic infections, malignant tumors, tissue degeneration or necrosis diseases, connective tissue diseases, anaemia and the like, especially in malignant tumors, the higher the malignancy degree is, the faster the growth is, the more obvious the blood sedimentation height is, so the expected result of blood sedimentation parameters is directly related to clinical diagnosis, treatment and monitoring.
Currently, the instruments used to monitor blood sedimentation to assist patients in clinical assessment are typically blood sedimentation meters, such as fully automated dynamic blood sedimentation analyzers, which can be widely used for condition monitoring in cardiac surgery, organ transplantation, tumor and radiation therapy by monitoring blood sedimentation. Along with the continuous expansion of blood sedimentation instrument detection projects to various fields of disease diagnosis and treatment, the quality control in a detection chamber of a detection instrument is also important, and the quality control product is generally used for detecting the expected result, repeatability and stability of the blood sedimentation instrument in the prior art, so that the quality of the blood sedimentation instrument is controlled. Quality control products for monitoring the quality of a blood sedimentation instrument can be prepared by taking humanized blood as a raw material, but the humanized blood has higher potential infectivity, the difficulty of preparing the quality control products by the humanized blood is increased, and the inspection workers can face infection risks.
In order to solve the above problems, the quality control product may be prepared by replacing human blood with human-like erythrocytes, but the detection range of the existing quality control product prepared by replacing human blood with human-like erythrocytes is narrow. For example, the erythrocyte sedimentation rate of a normal adult man is 0-15mm/h, and that of an adult woman is 0-20mm/h, then the detection instrument needs to be within and out of the range to still be able to perform normal detection; thus, if the detection range of the quality control product is narrower, the quality control of the detection instrument in a wider detection range of the sedimentation rate cannot be performed. For example, the prior patent CN105158129a discloses a standard of erythrocyte sedimentation rate and a preparation method thereof, the standard of erythrocyte sedimentation rate comprises human-like erythrocytes, a cell activity protective agent (solution a) and a cell activity preservative (solution B) which are placed in a welsh blood sedimentation tube; the composition ratio of the cell activity protection liquid (A liquid) is 15-25g/L of glucose, 2-6g/L of boric acid, 1-2g/L of sodium borate, 3-5g/L of adenine and 1-2g/L of sodium fluoride; the cell activity preservation solution (B solution) comprises the following components in percentage by weight: 36g/L of disodium hydrogen phosphate, 31g/L of sodium dihydrogen carbonate, 25% of glutaraldehyde, 3g/L of propylene glycol and 0.9g/L of calf serum; the erythrocyte sedimentation rate standard has a narrow sedimentation rate range capable of being detected, and can not meet the wide detection range of blood sedimentation.
Therefore, it is necessary to develop a quality control for blood sedimentation meter detection suitable for a wide blood sedimentation detection range.
Disclosure of Invention
In view of the above problems, one of the objects of the present invention is to provide a quality control product for detecting a blood sedimentation apparatus, wherein animal cells are used to replace humanized erythrocytes, and quality control products with different quality control levels can be obtained by selecting high molecular polymers with different molecular weights, and the quality control level can be in the range of 1mm/h to 60 mm/h.
In order to achieve the above purpose, the present invention may adopt the following technical scheme:
A quality control product for blood sedimentation meter detection, comprising: animal erythrocytes, erythrocyte preservation solution, high molecular polymer solution and glucose scorch preventing substance.
The second purpose of the invention is to provide a preparation method of the quality control product for blood sedimentation instrument detection, wherein the preparation method is obtained by mixing raw materials, and the preparation method is simple and has no harsh condition.
In order to achieve the above purpose, the present invention may adopt the following technical scheme:
The preparation method of the quality control product for detecting the blood sedimentation instrument comprises the following steps: mixing animal red blood cells, red blood cell preservation solution, high polymer solution and glucose scorch preventing substance to obtain quality control product for blood sedimentation instrument detection.
The beneficial effects of the invention at least comprise: the detectable sedimentation rate of the quality control product for detecting the blood sedimentation instrument is 1mm/h-60mm/h; compared with the non-human nature control product in the prior art, the sedimentation rate detection range is larger, and the application range is wider; the preparation method is simple and the conditions are not harsh.
Detailed Description
The examples are presented for better illustration of the invention, but the invention is not limited to the examples. Those skilled in the art will appreciate that various modifications and adaptations of the embodiments described above are possible in light of the above teachings and are intended to be within the scope of the invention.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. Unless the context clearly differs, singular forms of expression include plural forms of expression. As used herein, it is understood that terms such as "comprising," "having," "including," and the like are intended to indicate the presence of features, numbers, operations, materials, or combinations. The terms of the present invention are disclosed in the specification and are not intended to exclude the possibility that one or more other features, numbers, operations, materials or combinations thereof may be present or may be added. As used herein, "/" may be interpreted as "and" or "as appropriate.
In the present invention, the term "level I" means that the erythrocyte sedimentation rate is 0 to 20mm/h; the term "level II" refers to a erythrocyte sedimentation rate of > 20mm/h; the term "mass concentration" refers to the solute mass occupying the mass of the total solution, for example, a sodium citrate solution having a mass concentration of 3% -4% refers to sodium citrate having a mass occupying 3% -4% of the sodium citrate solution.
The embodiment of the invention provides a quality control product for detecting a blood sedimentation instrument, which comprises the following components: animal erythrocytes, erythrocyte preservation solution, high molecular polymer solution and glucose scorch preventing substance.
In the invention, animal red blood cells are used for replacing human whole blood samples, so that the risk of infection of an inspection worker is reduced, and the animal blood is low in price relative to human blood, simple and easy to obtain. And animal erythrocytes better mimic the sedimentation rate of human erythrocytes than pure chemical quality controls.
In the invention, the quality control level of the quality control product is regulated and controlled by the high molecular polymer, and the quality control products of the level I and the level II can be regulated and controlled by selecting the high molecular polymers with different molecular weights and different types, so that different detection ranges of the blood sedimentation instrument are met. Specifically, the high molecular polymer simulates the effects of fibrinogen and alpha 1, alpha 2 globulins in whole blood by creating a "rouleaux" effect that increases erythrocyte aggregation and thus promotes erythrocyte sedimentation. The high molecular weight polymer in the present invention is known in the art and has no specific meaning.
It should be understood that animal erythrocytes are known in the art, and pig erythrocytes are generally selected, so that materials are easy to obtain and sources are wide; in addition, red blood cell preservation solutions, polymer solutions, and glucose scorch inhibitors are all known materials in the art.
In some embodiments, the mass concentration of the polymer in the polymer solution may be preferably 1% to 2%. It should be noted that, the concentration of different high molecular polymers has different effects on the quality control product obtained by preparation, for example, when the high molecular polymer selects xanthan gum, the quality of the quality control product of the prepared level I is better than that of other quality concentrations when the quality concentration is 1% -2.5%; for example, when the high molecular polymer selects polyvinylpyrrolidone (average molecular weight 1300000) and the mass concentration is 1% -2%, the quality of the quality control of the prepared level II is superior to that of other mass concentrations; for example, when the high polymer is polyvinyl alcohol (the average molecular weight is 40000) and the mass concentration is 1% -4%, the quality of the prepared level I quality control product is superior to other concentrations; for another example, when the high molecular polymer selects ethyl cellulose, the quality of the prepared level II quality control is better than that of other quality concentrations when the quality concentration is 0.5% -2%; for another example, when the high molecular polymer is polyacrylamide (average molecular weight is 100000), the quality of the prepared level II quality control product is better than other quality concentrations when the quality concentration is 0.5% -2%.
In some embodiments, the polymer in the polymer solution may include one or more of polyvinylpyrrolidone, polyacrylamide, polyvinyl alcohol, xanthan gum, or hydroxyethyl cellulose. The polymer in the present invention may be any polymer known to those skilled in the art, and the polymer described above is preferable.
In some embodiments, the high molecular polymer in the high molecular polymer solution is selected according to different quality control levels of the quality control product from any one of the following (a) to (e): (a) Preparing a quality control product with a quality control level I, and selecting polyvinylpyrrolidone with a molecular weight less than or equal to 60000; preparing a quality control product with a quality control level II, and selecting polyvinylpyrrolidone with a molecular weight of more than 1000000; (b) Preparing a quality control product with a quality control level II, and selecting polyacrylamide with a molecular weight of more than or equal to 1000000; (c) Preparing a quality control product with a quality control level I, and selecting polyvinyl alcohol with a molecular weight less than or equal to 40000; preparing a quality control product with a quality control level II, and selecting polyvinyl alcohol with a molecular weight of more than or equal to 72000; (d) preparing a quality control product with a quality control level I, and selecting xanthan gum; (e) Preparing a quality control product with a quality control level II, and selecting hydroxyethyl cellulose.
It is to be noted that polyvinylpyrrolidone having a molecular weight of 60000 or less and polyvinylpyrrolidone having a molecular weight of more than 1000000 are conventional substances in the prior art; likewise, polyacrylamides having a molecular weight greater than 1000000 are conventional in the art.
In the present invention, the quality control level of the quality control product is controlled by different high molecular polymers and different molecular weights, and in particular, different types and different molecular weights of the quality control product as described above can be preferable. The quality control product prepared from the high molecular polymers with different types and different molecular weights has good stability at the level I and the level II, and has higher accuracy compared with a manual method.
In some embodiments, the glucose scorch inhibitor may be selected from sodium citrate solution or EDTA solution. The anti-glucose-coking substance is a substance capable of preventing glucose from coking, preferably a sodium citrate solution or an EDTA solution, and when the two different solutions are selected, the mass concentration and the volume of other substances in the quality control substance are different; for example, when a sodium citrate solution is selected, the mass concentration of the sodium citrate solution can be 3% -4%, and at this time, the volume ratio of the animal red blood cells, the red blood cell preservation solution, the high polymer solution and the sodium citrate solution can be (10-20): (30-40): (40-50): (8-12), preferably 10:40:50:10, 15:35:50:10 or 20:30:50:10; the quality control quality prepared by the proportion is stable and high in accuracy; for example, when the EDTA solution is selected, the concentration of the EDTA solution can be 20% -40%, and at this time, the ratio of the animal red blood cells, the red blood cell preservation solution, the high polymer solution and the EDTA solution is (10-20): (30-40): (40-50): (0.3-0.7), preferably 15:35:50:0.5, the quality of the quality control prepared at the ratio is the most stable and the accuracy is the highest. In addition, it should be noted that the mass concentration of the sodium citrate solution may be 3% -4%, such as 3.2%, 3.5% or 4%, preferably 3.5%, and at this ratio, the quality control product prepared has the best stability and highest accuracy; the concentration of EDTA solution can be 20% -40%, such as 25%, 30% or 35%, etc., preferably 30%, and the quality control product prepared by the ratio has the best stability and highest accuracy.
In some embodiments, the method for preparing the erythrocyte preservation solution includes: weighing 2-3g of sodium citrate, 0.1-0.5g of citric acid, 7-9g of glucose, 4-5g of sodium chloride and 0.5-2g of sodium dihydrogen phosphate, and adding purified water to prepare 1L solution; preferably, 2.3g of sodium citrate, 0.2g of citric acid, 8.31g of glucose, 4g of sodium chloride and 1.09g of sodium dihydrogen phosphate are weighed and purified water is added to prepare a 1L solution.
It should also be noted that the above-mentioned red blood cell preservation solution has the following functions: sodium citrate: anticoagulation, preventing hemolysis; citric acid: avoiding the glucose in the preservation solution from coking in the disinfection; glucose: is a necessary nutrition for erythrocyte metabolism, and can prolong erythrocyte preservation time and prevent hemolysis; and slow down the disappearance of organic phosphorus in the cells, prevent the storage damage of red blood cells; phosphate: the pH of the preservation solution is improved, and the storage period of the red blood cells is prolonged. Phosphate is adopted to improve the pH of the preservation solution, the buffer capacity of the phosphate is strong, the pH is less affected by temperature, and the reaction of saccharide substances is not easy to occur.
Another embodiment of the present invention provides a method for preparing the quality control product for detecting a blood sedimentation apparatus, including: mixing animal red blood cells, red blood cell preservation solution, high polymer solution and glucose scorch preventing substance to obtain quality control product for blood sedimentation instrument detection.
In some embodiments, in the preparation method described above, the animal red blood cells are fixed using a red blood cell fixing solution prior to mixing; the erythrocyte fixing solution is prepared by using PBS solution to prepare glutaraldehyde solution with the mass concentration of 1% -5%. Glutaraldehyde is used to fix red blood cells, and the red blood cells can be stored only after fixation, and if the concentration is higher than 5%, the red blood cells are broken, and if the concentration is lower than 1%, the fixing effect on the red blood cells is not good, preferably 2%, and the fixing effect is the best at the concentration.
In some embodiments, the fixed time may be 0.5h-3h, such as 1h, 1.5h, 2h, or 2.5 h. It should be noted that, the fixing time is less than 0.5h, the red blood cells will fail to fix, so that the quality control product cannot be prepared later, in addition, the optimal fixing time of different quality control products is different, but after 3h, the fixing effects of all quality control products are not much different, so the fixing time can be selected to be 0.5h-3h.
In some embodiments, the volume ratio of animal red blood cells, PBS solution, and 1% -5% glutaraldehyde solution is 12:13:25. The volume ratio of animal erythrocytes, PBS solution and 1% -5% glutaraldehyde solution has an influence on the fixing effect of erythrocytes, and the ratio is preferable, and the fixing effect of erythrocytes is the best at the ratio.
In some embodiments, after the fixation, the supernatant is discarded, and the lower layer is washed with PBS solution to obtain animal red blood cells, wherein the ratio of PBS solution to lower layer is 35:15.
In some embodiments, the animal red blood cells are washed with normal saline before mixing, and then with PBS solution. In some embodiments, the method includes separating animal blood containing sodium citrate anticoagulant to obtain red blood cells, cleaning the red blood cells with glutaraldehyde, normal saline and PBS, fixing, adding red blood cell preservation solution into the cleaned red blood cells, adding a proper amount of high polymer solution, and mixing to obtain the quality control product.
For a better understanding of the present invention, the content of the present invention is further elucidated below in connection with the specific examples, but the content of the present invention is not limited to the examples below.
Example 1 level I blood sedimentation instrument quality control
(1) Washing of erythrocytes: weighing 0.2g of potassium chloride, 8g of sodium chloride, 0.2g of monopotassium phosphate and 2.89g of disodium hydrogen phosphate dodecahydrate, and adding purified water to prepare a 1LPBS solution; weighing sodium chloride to prepare physiological saline with the mass fraction of 0.9%; washing the pig red blood cells with 0.9% physiological saline (the volume ratio of the 0.9% physiological saline to the pig red blood cells is 9:6) 3 times, and then washing the pig red blood cells with PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 9:6) 1 time;
(2) Fixing of erythrocytes: diluting the PBS solution prepared in the above to prepare glutaraldehyde solution with volume fraction of 2%; fixing red blood cells by using a PBS solution and a 2% glutaraldehyde solution (the volume ratio of the pig red blood cells to the PBS solution to the 2% glutaraldehyde solution is 12:13:25), and the fixing time is 1h; discarding the supernatant; washing the pig red blood cells three times by using a PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 35:15);
(3) Preparing a red blood cell preservation solution: 2.3g of sodium citrate, 0.2g of citric acid, 8.31g of glucose, 4g of sodium chloride and 1.09g of sodium dihydrogen phosphate are weighed, and purified water is added to prepare a 1L solution;
(4) Preparing a high-molecular polymer solution: weighing 10g of xanthan gum, and adding 0.9% physiological saline to prepare 1L solution;
(5) Preparing quality control level I: and mixing the fixed pig red blood cells, the red blood cell preservation solution, the high polymer solution and the 3.8% sodium citrate solution according to the volume ratio of 15:35:50:10, and uniformly mixing to obtain the level I quality control product.
The above-mentioned level I quality control was set to 10 parallel samples, and the erythrocyte sedimentation rate of the above-mentioned 10 parallel samples was measured using a manual method (also called Wick's method, which is recommended by ICSH as a standard method for measuring sedimentation), and a blood sedimentation meter having a line mark YY/T1251-2014, which was determined based on the line mark, and the measurement results are shown in Table 1.
Table 1 detection of level I quality control prepared in example 1
| Sequence number | Manual method (mm/h) | Blood sedimentation instrument (mm/h) |
| 1 | 8 | 8.7 |
| 2 | 7 | 7.7 |
| 3 | 8 | 8.1 |
| 4 | 10 | 8.1 |
| 5 | 9 | 8.4 |
| 6 | 9 | 7.7 |
| 7 | 9 | 7.8 |
| 8 | 10 | 7.0 |
| 9 | 8 | 5.8 |
| 10 | 9 | 7.1 |
As can be seen from the above Table 1, the sedimentation rate of the quality control product detected by the manual method is not very different from the sedimentation rate of the quality control product detected by the blood sedimentation instrument, which indicates that the quality control product prepared by the embodiment of the invention has high accuracy; and the sedimentation rate values among 10 groups are not greatly different and are relatively stable, which indicates that the quality control product prepared by the embodiment of the invention has good stability.
Example 2 quality control product of horizontal I blood sedimentation instrument
(1) Washing of erythrocytes: weighing 0.2g of potassium chloride, 8g of sodium chloride, 0.2g of monopotassium phosphate and 2.89g of disodium hydrogen phosphate dodecahydrate, and adding purified water to prepare a 1LPBS solution; weighing sodium chloride to prepare physiological saline with the mass fraction of 0.9%; washing the pig red blood cells with 0.9% physiological saline (the ratio of the 0.9% physiological saline to the pig red blood cells is 9:6) 3 times, and then washing the pig red blood cells with PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 9:6) 1 time;
(2) Fixing of erythrocytes: preparing a 3% glutaraldehyde solution by using a PBS solution; fixing red blood cells by using a PBS solution and a 3% glutaraldehyde solution (the volume ratio of the pig red blood cells to the PBS solution to the 3% glutaraldehyde solution is 12:13:25), and the fixing time is 2 hours; discarding the supernatant; washing the pig red blood cells three times by using a PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 35:15);
(3) Preparing a red blood cell preservation solution: 1.8g of sodium citrate, 0.4g of citric acid, 8.4g of glucose, 5g of sodium chloride and 1g of sodium dihydrogen phosphate are weighed, and purified water is added to prepare a 1L solution;
(4) Preparing a high-molecular polymer solution: weighing 20g of polyvinyl alcohol (average molecular weight is 40000), and adding physiological saline with mass fraction of 0.9% to prepare 1L solution;
(5) Preparing a horizontal I quality control product: and mixing the red blood cells, the red blood cell preservation solution, the high polymer solution and the 30% EDTA solution according to the volume ratio of 15:35:50:0.5, and uniformly mixing to obtain the quality control level I.
10 Parallel samples were set for the above-mentioned level I quality control, and erythrocyte sedimentation rate of the above-mentioned 10 parallel samples was measured using a manual detection method and a blood sedimentation instrument, and the measurement results are shown in Table 2.
Table 2 detection of level I quality control prepared in example 2
| Sequence number | Manual method (mm/h) | Blood sedimentation instrument (mm/h) |
| 1 | 3 | 3 |
| 2 | 3 | 5 |
| 3 | 3 | 3 |
| 4 | 3 | 4 |
| 5 | 3 | 4 |
| 6 | 4 | 5 |
| 7 | 3 | 4 |
| 8 | 3 | 3 |
| 9 | 4 | 5 |
| 10 | 5 | 3 |
As can be seen from the above Table 2, the sedimentation rate of the quality control product detected by the manual method is not very different from the sedimentation rate of the quality control product detected by the blood sedimentation instrument, which indicates that the quality control product prepared by the embodiment of the invention has high accuracy; and the sedimentation rate values among 10 groups are not greatly different and are relatively stable, which indicates that the quality control product prepared by the embodiment of the invention has good stability.
Example 3 quality control product of level II blood sedimentation instrument
(1) Washing of erythrocytes: weighing 0.2g of potassium chloride, 8g of sodium chloride, 0.2g of monopotassium phosphate and 2.89g of disodium hydrogen phosphate dodecahydrate, and adding purified water to prepare a 1LPBS solution; weighing sodium chloride to prepare 0.9% physiological saline; washing the pig red blood cells 3 times with 0.9% physiological saline (the ratio of the 0.9% physiological saline to the pig red blood cells is 9:6), and then washing the pig red blood cells 1 time with PBS solution (the ratio of the PBS solution to the pig red blood cells is 9:6);
(2) Fixing of erythrocytes: preparing 4% glutaraldehyde solution by using PBS solution; fixing red blood cells by using a PBS solution and a 4% glutaraldehyde solution (the volume ratio of the pig red blood cells to the PBS solution to the 4% glutaraldehyde solution is 12:13:25), and the fixing time is 2 hours; discarding the supernatant; washing the pig red blood cells three times by using a PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 35:15);
(3) Preparing a red blood cell preservation solution: 2.1g of sodium citrate, 1g of citric acid, 8.22g of glucose, 4.5g of sodium chloride and 1.94g of sodium dihydrogen phosphate are weighed, and purified water is added to prepare a 1L solution;
(4) Preparing a high-molecular polymer solution: 15g of polyvinylpyrrolidone (average molecular weight: about 1300000) was weighed, and 1L of a solution was prepared by adding 0.9% by mass of physiological saline;
(5) Preparing a level II quality control product: and mixing the fixed pig red blood cells, the red blood cell preservation solution, the high polymer solution and the 3.8% sodium citrate solution according to the volume ratio of 15:35:50:10, and uniformly mixing to obtain the level II quality control product.
10 Parallel samples were set for the level II quality control, and the erythrocyte sedimentation rate of the 10 parallel samples was measured using a manual detection method and a blood sedimentation instrument, and the measurement results are shown in Table 3.
TABLE 3 detection of level II quality control prepared in EXAMPLE 3
| Sequence number | Manual method (mm/h) | Blood sedimentation instrument (mm/h) |
| 1 | 25 | 26.5 |
| 2 | 26 | 24.3 |
| 3 | 26 | 26.1 |
| 4 | 26 | 24.7 |
| 5 | 27 | 25.3 |
| 6 | 28 | 22.7 |
| 7 | 27 | 24.8 |
| 8 | 25 | 26.3 |
| 9 | 29 | 28.5 |
| 10 | 27 | 23.6 |
As can be seen from the above Table 3, the sedimentation rate of the quality control product detected by the manual method is not very different from the sedimentation rate of the quality control product detected by the blood sedimentation instrument, which indicates that the quality control product prepared by the embodiment of the invention has high accuracy; and the sedimentation rate values among 10 groups are not greatly different and are relatively stable, which indicates that the quality control product prepared by the embodiment of the invention has good stability.
Example 4 quality control product of level II blood sedimentation instrument
(1) Washing of erythrocytes: weighing 0.2g of potassium chloride, 8g of sodium chloride, 0.2g of monopotassium phosphate and 2.89g of disodium hydrogen phosphate dodecahydrate, and adding purified water to prepare a 1LPBS solution; weighing sodium chloride to prepare physiological saline with the mass fraction of 0.9%; washing the pig red blood cells with 0.9% physiological saline (the volume ratio of the 0.9% physiological saline to the pig red blood cells is 9:6) 3 times, and then washing the pig red blood cells with PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 9:6) 1 time;
(2) Fixing of erythrocytes: preparing a 3% glutaraldehyde solution by using a PBS solution; fixing red blood cells by using a PBS solution and a 3% glutaraldehyde solution (the volume ratio of the PBS solution to the 3% glutaraldehyde solution is 12:13:25), and the fixing time is 2.5h; discarding the supernatant; washing the pig red blood cells three times by using a PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 35:15);
(3) Preparing a red blood cell preservation solution: weighing 2g of sodium citrate, 0.2g of citric acid, 8g of glucose, 5.32g of sodium chloride and 0.94g of sodium dihydrogen phosphate, and adding purified water to prepare 1L of red blood cell preservation solution;
(4) Preparing a high-molecular polymer solution: weighing 18g of hydroxyethyl cellulose, and adding 0.9% physiological saline to prepare 1L of high polymer solution;
(5) Level II quality control level II formulation: and mixing the erythrocytes, the erythrocyte preservation solution, the high polymer solution and the 3.8% sodium citrate solution according to the volume ratio of 15:35:50:10 after the fixation treatment, and uniformly mixing to obtain the quality control level II.
10 Parallel samples were set for the level II quality control, and the erythrocyte sedimentation rate of the 10 parallel samples was measured using a manual detection method and a blood sedimentation instrument, and the measurement results are shown in Table 4.
TABLE 4 detection of level II quality control prepared in EXAMPLE 4
| Sequence number | Manual method (mm/h) | Blood sedimentation instrument (mm/h) |
| 1 | 22 | 21 |
| 2 | 23 | 22 |
| 3 | 23 | 21 |
| 4 | 23 | 21 |
| 5 | 22 | 22 |
| 6 | 24 | 21 |
| 7 | 23 | 22 |
| 8 | 24 | 21 |
| 9 | 24 | 21 |
| 10 | 24 | 21 |
As can be seen from the above Table 4, the sedimentation rate of the quality control product detected by the manual method is not very different from the sedimentation rate of the quality control product detected by the blood sedimentation instrument, which indicates that the quality control product prepared by the embodiment of the invention has high accuracy; and the sedimentation rate values among 10 groups are not greatly different and are relatively stable, which indicates that the quality control product prepared by the embodiment of the invention has good stability.
Example 5 quality control product of level II blood sedimentation instrument
(1) Washing of erythrocytes: weighing 0.2g of potassium chloride, 8g of sodium chloride, 0.2g of monopotassium phosphate and 2.89g of disodium hydrogen phosphate dodecahydrate, and adding purified water to prepare a 1LPBS solution; weighing sodium chloride to prepare physiological saline with the mass fraction of 0.9%; washing the pig red blood cells with 0.9% physiological saline (the volume ratio of the 0.9% physiological saline to the pig red blood cells is 9:6) 3 times, and then washing the pig red blood cells with PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 9:6) 1 time;
(2) Fixing of erythrocytes: preparing 2.3% glutaraldehyde solution by using PBS solution; fixing red blood cells by using a PBS solution and a 2.3% glutaraldehyde solution (the volume ratio of the pig red blood cells to the PBS solution to the 3% glutaraldehyde solution is 12:13:25), and the fixing time is 3h; discarding the supernatant; washing the pig red blood cells three times by using a PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 35:15);
(3) Preparing a red blood cell preservation solution: weighing 2g of sodium citrate, 0.2g of citric acid, 8g of glucose, 5.32g of sodium chloride and 0.94g of sodium dihydrogen phosphate, and adding purified water to prepare 1L of red blood cell preservation solution;
(4) Preparing a high-molecular polymer solution: 16g of polyacrylamide (average molecular weight 1000000) was weighed, and 1L of a polymer solution was prepared by adding 0.9% physiological saline;
(5) Level II quality control level II formulation: and mixing the erythrocytes, the erythrocyte preservation solution, the high polymer solution and the 3.8% sodium citrate solution according to the volume ratio of 15:35:50:10 after the fixation treatment, and uniformly mixing to obtain the quality control level II.
10 Parallel samples were set for the level II quality control, and the erythrocyte sedimentation rate of the 10 parallel samples was measured using a manual detection method and a blood sedimentation instrument, and the measurement results are shown in Table 5.
TABLE 5 detection of level II quality control prepared in EXAMPLE 5
| Sequence number | Manual method (mm/h) | Blood sedimentation instrument (mm/h) |
| 1 | 50 | 52 |
| 2 | 49 | 52 |
| 3 | 47 | 52 |
| 4 | 48 | 53 |
| 5 | 49 | 48 |
| 6 | 47 | 49 |
| 7 | 52 | 52 |
| 8 | 47 | 53 |
| 9 | 50 | 49 |
| 10 | 48 | 48 |
As can be seen from the above Table 5, the sedimentation rate of the quality control product detected by the manual method is not very different from the sedimentation rate of the quality control product detected by the blood sedimentation instrument, which indicates that the quality control product prepared by the embodiment of the invention has high accuracy; and the sedimentation rate values among 10 groups are not greatly different and are relatively stable, which indicates that the quality control product prepared by the embodiment of the invention has good stability.
Example 6 preparation of quality control substances from polymers of different Mass concentration
(1) Xanthan gum mass concentration optimization
The xanthan gum of example 1 was set to different mass concentrations (0.5%, 1%, 2.5% and 5%), and the other steps were the same as in example 1, with 5 sets of parallel experiments per sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 6.
Table 6 detection of level I quality control prepared with different concentrations of xanthan gum
From table 6 above, it can be seen that when the mass concentration of xanthan gum is 1% -2.5%, the sedimentation value of the prepared level I quality control product in the level I stage is relatively obvious, which is beneficial to reading, and the result is relatively stable, so that 1% -2.5% is preferable in the invention.
(2) Polyvinylpyrrolidone concentration optimization
The xanthan gum of example 1 was replaced with polyvinylpyrrolidone (average molecular weight 1300000) and formulated into solutions of different mass concentrations (0.5%, 1%, 2%, 3% and 4%), the other steps being the same as in example 1, 5 sets of parallel experiments were set up per sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 7.
TABLE 7 detection of level II quality control prepared with polyvinylpyrrolidone at different concentrations
From the above table 7, it can be seen that when the mass concentration of polyvinylpyrrolidone is 1% -2%, the sedimentation rate of the prepared quality control product ranges from level II, and the sedimentation rate is relatively stable, which is beneficial to reading, so that 1% -2% is preferable in the present invention.
(3) Polyvinyl alcohol concentration optimization
The xanthan gum of example 1 was replaced with polyvinyl alcohol (average molecular weight 40000) and formulated as a solution of different mass concentration (1%, 2%, 3%, 4%, 5% and 10%), the other steps being the same as example 1, 5 sets of parallel experiments were set up for each sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 8.
TABLE 8 detection of level I quality control prepared with different concentrations of polyvinyl alcohol
As can be seen from Table 8 above, the quality of the level I quality control product prepared is best when the mass concentration of polyvinyl alcohol is 1% -4%, so that 1% -4% is preferred in the present invention.
(4) Hydroxyethyl fiber concentration screening
The xanthan gum of example 1 was replaced with hydroxyethyl cellulose and made into solutions of different mass concentrations (0.5%, 1%, 2%, 3% and 6%), the other steps being the same as example 1, 5 sets of parallel experiments were set up per sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 9.
TABLE 9 detection of level II quality control prepared with different concentrations of hydroxyethylcellulose
From table 9 above, it can be seen that most of the test values meet the level II values when the mass concentration of hydroxyethyl cellulose is 0.5% -2%, and the data are relatively stable and favorable for reading, so that 0.5% -2% is preferred in the present invention.
(5) Polyacrylamide concentration optimization
The xanthan gum of example 1 was replaced with polyacrylamide (average molecular weight 100000) and formulated into solutions of different mass concentrations (0.5%, 1%, 2% and 5%), the other steps being the same as in example 1, with 5 sets of parallel experiments per sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 10.
Table 10 detection of level II quality control prepared with different concentrations of polyacrylamide
As can be seen from the above Table 10, when the concentration of polyacrylamide is 0.5% -2%, the quality of the prepared level II quality control product is best, and the blood sedimentation rate can be detected to be more than 50mm/h, and can be detected to be more than 52 mm/h.
Example 7 preparation of quality control substances from Polymer having different molecular weight
(1) Different molecular weights of polyvinyl alcohol
The polyvinyl alcohol of example 2 was set to a different molecular weight (average molecular weights 40000, 72000 and 200000), and the other steps were the same as in example 2, and 5 sets of parallel experiments were set for each sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 11.
TABLE 11 different molecular weight polyvinyl alcohol test
As can be seen from the above Table 11, the blood sedimentation rate of the quality control product prepared from the polyvinyl alcohol with the molecular weight of 40000 is 3mm/h-5mm/h, which belongs to the level I quality control product; the blood sedimentation rate of the quality control product prepared from the polyvinyl alcohol with the molecular weight of 72000 is 48mm/h-50mm/h, and the quality control product belongs to a level II quality control product; the blood sedimentation rate of the quality control product prepared from the polyvinyl alcohol with the molecular weight of 200000 is 56mm/h-58mm/h, belonging to the level II quality control product; and the blood sedimentation rate detection at different levels is relatively stable; it shows that the polyvinyl alcohol with different molecular weights can prepare quality control products with different blood sedimentation rates.
(2) Polyvinylpyrrolidone of different molecular weights
The polyvinylpyrrolidone of example 3 was set to a different molecular weight (average molecular weights 58000 and 1300000), and the other steps were the same as in example 3, and 5 sets of parallel experiments were set for each sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 12.
TABLE 12 different molecular weight polyvinylpyrrolidone test
As can be seen from the above Table 12, the blood sedimentation rate of the quality control product prepared from polyvinylpyrrolidone (average molecular weight 58000) is 8-10 mm/h, which belongs to the level I quality control product; the blood sedimentation rate of the quality control product prepared from polyvinylpyrrolidone (average molecular weight 1300000) is 25-27 mm/h, belonging to the level II quality control product; and the detection of the blood sedimentation rate of the two levels is relatively stable; the polyvinylpyrrolidone with different molecular weights can be used for preparing quality control products with different blood sedimentation rates.
(3) Polyacrylamide of different molecular weights
The polyacrylamide of example 5 was set to a different molecular weight (average molecular weights 1000000, 5000000 and 7000000) and the other steps were the same as in example 5, with 5 sets of parallel experiments per sample; the sedimentation rate of the quality control was measured by a manual method, and the results are shown in table 13.
TABLE 13 Polyacrylamide test of different molecular weights
As can be seen from Table 13 above, the sedimentation rate of the quality control product prepared from polyacrylamide with an average molecular weight of 1000000 is 47mm/h to 51mm/h, which belongs to the level II quality control product, and the sedimentation rate of the quality control product prepared from polyacrylamide with an average molecular weight of 5000000 is 39mm/h to 42mm/h, which also belongs to the level II quality control product; and the blood sedimentation rate is relatively stable, which indicates that polyacrylamide with different molecular weights can be used for preparing quality control products with different blood sedimentation rates.
Example 8 preparation of quality control product without Polymer addition
Pig erythrocytes, erythrocyte preservation solution and 3.8% sodium citrate solution in example 1 were mixed in a ratio of 15:35:10 (without adding polymer solution), and 10 sets of parallel experiments were set up for each sample in the same manner as in example 1; sedimentation rate of the quality control was measured using a manual method and a blood sedimentation meter, and the results are shown in table 14 below.
Table 14 preparation of quality control product without Polymer addition
| Sequence number | Manual method (mm/h) | Blood sedimentation instrument (mm/h) |
| 1 | 2 | 0 |
| 2 | 3 | 2 |
| 3 | 1 | 0 |
| 4 | 2 | 1 |
| 5 | 2 | 0 |
| 6 | 2 | 2 |
| 7 | 2 | 2 |
| 8 | 3 | 3 |
| 9 | 3 | 2 |
| 10 | 1 | 1 |
As can be seen from Table 14 above, without the addition of polymer, the test range was between 1 and 3, and when the manual test value was 1, the upper hemocytometer test result was probably 0, the quality control of the hemocytometer could not be performed, while the sedimentation range could be changed by adding different polymer.
EXAMPLE 9 different erythrocyte ratios
(1) Washing of erythrocytes: weighing 0.2g of potassium chloride, 8g of sodium chloride, 0.2g of monopotassium phosphate and 2.89g of disodium hydrogen phosphate dodecahydrate, and adding purified water to prepare a 1LPBS solution; weighing sodium chloride to prepare physiological saline with the mass of 0.9%; washing the pig red blood cells with 0.9% physiological saline (the volume ratio of the 0.9% physiological saline to the pig red blood cells is 9:6) 3 times, and then washing the pig red blood cells with PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 9:6) 1 time;
(2) Fixing of erythrocytes: preparing a 3% glutaraldehyde solution by using a PBS solution; fixing red blood cells by using a PBS solution and a 3% glutaraldehyde solution (the volume ratio of the PBS solution to the 3% glutaraldehyde solution is 12:13:25), and the fixing time is 2.5h; discarding the supernatant; washing the pig red blood cells three times by using a PBS solution (the volume ratio of the PBS solution to the pig red blood cells is 35:15);
(3) Preparing a red blood cell preservation solution: weighing 2g of sodium citrate, 0.2g of citric acid, 8g of glucose, 5.32g of sodium chloride and 0.94g of sodium dihydrogen phosphate, and adding purified water to prepare 1L of red blood cell preservation solution;
(4) Preparing a high-molecular polymer solution: weighing 15g of polyvinyl alcohol (average molecular weight is 40000), and adding 0.9% physiological saline to prepare 1L of high polymer solution;
(5) Preparation of quality control level II: mixing the erythrocytes, the erythrocyte preservation solution, the high molecular polymer solution and the 3.8% sodium citrate solution according to the proportion of 5:45:50:10, 10:40:50:10, 15:35:50:10, 20:30:50:10 and 25:25:50:10 after the fixation treatment, and obtaining five groups of quality control level II after uniform mixing.
10 Parallel samples were set for each of the above level II quality control samples, and the erythrocyte sedimentation rate of the samples was measured by a manual detection method, and the measurement results are shown in Table 15.
TABLE 15 detection of level I quality control substances prepared at different erythrocyte ratios
As can be seen from table 15 above, when the volume ratio of the erythrocytes, the erythrocyte preservation solution, the high molecular polymer solution and the 3.8% sodium citrate solution is 5:45:50:10 and 25:25:50:10, sedimentation is not generated or the limit is unclear and reading is impossible, the ratio between 5:45:50:10 and 25:25:50:10, such as 10:40:50:10, 15:35:50:10 or 20:30:50:10, can be selected in the present invention.
Finally, it is noted that the above embodiments are only for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications and equivalents may be made thereto without departing from the spirit and scope of the technical solution of the present invention, which is intended to be covered by the scope of the claims of the present invention.
Claims (10)
1. A quality control product for blood sedimentation meter detection, characterized by comprising: animal erythrocytes, erythrocyte preservation solution, high molecular polymer solution and glucose scorch preventing substance.
2. The quality control product for blood sedimentation meter detection of claim 1, wherein the high molecular polymer in the high molecular polymer solution comprises one or more of polyvinylpyrrolidone, polyacrylamide, polyvinyl alcohol, xanthan gum, and hydroxyethyl cellulose.
3. The quality control for blood sedimentation meter detection according to claim 2, wherein the mass concentration of the polymer in the polymer solution is selected from any one of: (1) The high molecular polymer is xanthan gum, and the mass concentration is 1% -2.5%; (2) The high molecular polymer is polyvinylpyrrolidone with an average molecular weight of 1300000 and the mass concentration of 1-2%; (3) The high molecular polymer is selected from polyvinyl alcohol with average molecular weight of 40000 and mass concentration of 1% -4%; (4) The high molecular polymer is ethyl cellulose, and the mass concentration is 0.5% -2%; (5) The high molecular polymer is polyacrylamide with average molecular weight of 100000 and mass concentration of 0.5-2%.
4. The quality control product for blood sedimentation meter detection according to claim 2, wherein the polymer in the polymer solution is selected according to different quality control levels of the quality control product from any one of the following (a) to (e): (a) Preparing a quality control product with a quality control level I, and selecting polyvinylpyrrolidone with a molecular weight less than or equal to 60000; preparing a quality control product with a quality control level II, and selecting polyvinylpyrrolidone with a molecular weight of more than 1000000; (b) Preparing a quality control product with a quality control level II, and selecting polyvinyl alcohol with a molecular weight of more than or equal to 1000000; (c) Preparing a quality control product with a quality control level I, and selecting polyvinyl alcohol with a molecular weight less than or equal to 40000; preparing a quality control product with a quality control level II, and selecting polyvinyl alcohol with a molecular weight of more than or equal to 72000; (d) preparing a quality control product with a quality control level I, and selecting xanthan gum; (e) Preparing a quality control product with a quality control level II, and selecting hydroxyethyl cellulose.
5. The quality control for blood sedimentation measurement according to any one of claims 1 to 4, wherein the quality control for blood sedimentation measurement is selected from any one of the following (i) or (ii): (i) The anti-glucose-coking matter is sodium citrate solution with the mass concentration of 3% -4%, the volume ratio of the sodium citrate solution, animal red blood cells, red blood cell preservation solution, high polymer solution and the sodium citrate solution is (10-20): (30-40): (40-50): (8-12); (ii) The glucose-coking-preventing substance is EDTA solution with the mass concentration of 20-40%, and the proportions of animal red blood cells, red blood cell preservation solution, high polymer solution and EDTA solution are (10-20): (30-40): (40-50): (0.3-0.7).
6. The quality control for blood sedimentation measurement according to any one of claims 1 to 4, wherein the quality control for blood sedimentation measurement is selected from any one of the following (i) or (ii): (i) The glucose-scorch preventing substance is sodium citrate solution with the mass concentration of 3% -4%, and the volume ratio of the sodium citrate solution to the animal red blood cells, the red blood cell preservation solution to the high polymer solution to the sodium citrate solution is 10:40:50:10, 15:35:50:10 or 20:30:50:10; (ii) The glucose-coking preventing substance is EDTA solution with the mass concentration of 20% -40%, and the ratio of the animal red blood cells to the red blood cell preservation solution to the high polymer solution to the EDTA solution is 15:35:50:0.5.
7. The method for producing a quality control for blood sedimentation meter detection according to any one of claims 1 to 6, comprising: mixing animal red blood cells, red blood cell preservation solution, high polymer solution and glucose scorch preventing substance to obtain quality control product for blood sedimentation instrument detection.
8. The method for producing a quality control product for blood sedimentation meter detection according to claim 7, wherein, before mixing, the animal erythrocytes are fixed by using an erythrocyte fixative; the erythrocyte fixing solution is 1% -5% glutaraldehyde solution prepared by PBS solution.
9. The method for producing a quality control product for blood sedimentation meter detection according to claim 8, wherein the fixed time is 0.5h to 1.2h.
10. The method for producing a quality control for blood sedimentation measurement according to claim 8 or 9, wherein the ratio of animal erythrocytes, PBS solution and 2% glutaraldehyde solution is 12:13:25.
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