CN113243360A - Plasma preservation solution and application thereof - Google Patents
Plasma preservation solution and application thereof Download PDFInfo
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- CN113243360A CN113243360A CN202110764707.XA CN202110764707A CN113243360A CN 113243360 A CN113243360 A CN 113243360A CN 202110764707 A CN202110764707 A CN 202110764707A CN 113243360 A CN113243360 A CN 113243360A
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- plasma
- preservation solution
- quality control
- detection
- sodium
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- 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
- G01N33/80—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types or red blood cells
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- 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
Abstract
Disclosed is a plasma preservation solution, which comprises 5g/L glucose, 0.55g/L citric acid, 8g/L sodium citrate, 1.6g/L sodium chloride, 0.56g/L disodium hydrogen phosphate, 0.5g/L sodium dihydrogen phosphate, 10g/L bovine serum albumin, 10g/L mannitol, 10g/L trehalose, 1g/L sodium azide and 10-100 mg/L beta-cyclodextrin. The plasma preservation solution provided by the invention can be used for preserving plasma at the temperature of 2-8 ℃ for a long time, and is convenient to be used as a plasma quality control product for ABO blood group reverse typing detection so as to confirm the accuracy of the detection result of the ABO blood group reverse typing blood group identification test.
Description
Technical Field
The present invention relates to a plasma preservation solution, in particular to a plasma preservation solution capable of prolonging the storage life of plasma at refrigeration temperature. The invention also relates to application of the plasma preservation solution.
Background
The quality control is used for testing the analysis performance of the detection method, judging the quality of the whole detection result according to the result of a quality control product, and prompting or warning operators to detect possible problems of a reagent or a detection system. Annex 5.1.4 quality control requirements of blood station technical operating procedures (version 2019) issued by the national health agency: "an effective quality control procedure should be established. Ensure that the quality control reagents of the known antigen and the known antibody react correctly in a routine parallel test, otherwise, the test must be repeated ". The transfusion compatibility detection items mainly comprise ABO and Rh (D) blood grouping tests, irregular antibody screening tests and cross matching tests, and detection results are influenced by various factors, such as reagent quality, instrument performance, test environment, operation normative and the like. The Indoor Quality Control (IQC) can timely find errors possibly existing in each link of the test, and is an important measure for ensuring the accuracy of the detection result.
The method for long-term storage of plasma is mainly freezing at low temperature (-20 deg.C or lower). The method has the defects that the method is used as a quality control product for carrying out blood type reverse typing detection, and has various inconveniences, such as that the melting is required before each use, and the repeated freezing and thawing can possibly cause the change of the properties of the components.
At present, no plasma quality control product which can be stably stored for a long time at the common refrigeration temperature is available.
Disclosure of Invention
In one aspect, provided herein is a plasma preservation solution comprising 5g/L glucose, 0.55g/L citric acid, 8g/L sodium citrate, 1.6g/L sodium chloride, 0.56g/L disodium hydrogen phosphate, 0.5g/L sodium dihydrogen phosphate, 10g/L bovine serum albumin, 10g/L mannitol, 10g/L trehalose, 1g/L sodium azide and 10 to 100mg/L beta-cyclodextrin.
In some embodiments, the concentration of the beta-cyclodextrin is 50 mg/L.
In another aspect, provided herein is a method for preserving plasma, comprising mixing the above-described plasma preservation solution with plasma and preserving at 2-8 ℃.
In some embodiments, the plasma preservation solution is mixed with plasma in a 1: 9 volume ratio.
In another aspect, provided herein is a method for preparing a plasma quality control product for blood group reverse typing, which comprises mixing the above-mentioned plasma preservation solution with plasma.
In some embodiments, the plasma preservation solution is mixed with plasma in a 1: 9 volume ratio.
In another aspect, provided herein is a plasma quality control prepared by the above method.
In another aspect, provided herein is a use of the above plasma quality control product for ABO blood group retrotyping.
In some embodiments, the plasma is human plasma.
The plasma preservation solution provided by the invention can be used for preserving plasma at the temperature of 2-8 ℃ for a long time, and is convenient to be used as a plasma quality control product for ABO blood group reverse typing detection so as to confirm the accuracy of the detection result of the ABO blood group reverse typing blood group identification test.
Detailed Description
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.
"plasma preservation solution" refers to a solution for mixing with plasma to change the plasma preservation conditions or extend the plasma preservation period. For example, in some embodiments of the invention, the plasma preservation solution is mixed with the plasma such that the plasma can be preserved for 6 months at refrigerated temperatures. During this time, the ability of the preserved plasma to undergo agglutination reactions with the corresponding erythrocytes is substantially unchanged.
The "plasma quality control substance" refers to a standard substance for blood type reverse typing detection, which is known to have an agglutination reaction with red blood cells of a specific blood type (or after being diluted by a specific multiple). The quality of the reagent, the performance of the instrument, the testing environment, the operation normalization and the like in the detection process can be judged according to the agglutination reaction result.
By using the plasma preservation solution provided by the invention, the plasma can be used as a quality control product for long-term preservation, the blood type detection operation is simplified, and the standardization of the blood type detection is facilitated.
The invention is further illustrated by the following specific examples.
Plasma treatment
Thawing frozen A type plasma (plasma collecting time is no more than 1 year) purchased from blood center in Tianjin city in water bath at 37 deg.C, subpackaging, centrifuging at 3000r/min for 5min in centrifuge, and collecting supernatant.
Example 1 preparation of plasma storage solution
5 groups of plasma storage solutions were prepared from water for injection as follows.
(1) Experimental group 1: 5g/L glucose, 0.55g/L citric acid, 8g/L sodium citrate, 1.6g/L sodium chloride, 0.56g/L disodium hydrogen phosphate, 0.5g/L sodium dihydrogen phosphate, 10g/L bovine serum albumin, 10g/L mannitol, 10g/L trehalose, 1g/L sodium azide and 1mg/L beta-cyclodextrin.
(2) Experimental group 2: the concentration of beta-cyclodextrin was changed to 10mg/L, and the concentrations of other components were tested in test group 1.
(3) Experimental group 3: the concentration of beta-cyclodextrin was changed to 50mg/L, and the concentrations of other components were determined in experiment group 1.
(4) Experimental group 4: the concentration of beta-cyclodextrin was changed to 100mg/L, and the concentrations of other components were tested in test group 1.
(5) Experimental group 5: the concentration of beta-cyclodextrin was changed to 150mg/L, and the concentrations of other components were tested in test group 1.
EXAMPLE 2 preparation of ABO blood group reverse typing plasma quality control substance
The blood plasma treated by the above-described plasma treatment method (i.e., supernatant after centrifugation) was aspirated to 9mL and added to a blood collection tube containing no anticoagulant, which had been filled with 1mL of the plasma preservation solution prepared in example 1, to obtain ABO blood group reverse typing plasma quality control products prepared from various plasma preservation solutions. For each plasma preservation solution, two tubes of ABO blood type reverse typing plasma quality control products are prepared respectively, one tube is used for detection, and the other tube is used for standing observation. All are stored under refrigeration at 2-8 ℃.
For convenience of explanation, the plasma quality control products prepared from the storage solutions of experimental groups 1 to 5 in example 1 are referred to as "# 1" to "# 5" correspondingly.
Example 3 specificity and antibody titer detection of each plasma quality control product
The method for detecting the specificity and the antibody titer of each plasma quality control product adopts a test tube method, and references are made to the clinical blood transfusion detection operating protocol. And (3) determining the specificity and the antibody titer of the A-type quality control product stored in each preservation solution, and comparing with the A-type serum quality control product in the commercially available ABO and RhD blood type detection quality control products. The adopted commercially available ABO and RhD blood type detection quality control products are purchased from Changchun Boxun Biotechnology Limited liability company, and have the specifications as follows: 6 bottles/boxes (cargo number: BX7001), and the label is annotated with the standard and stored at the temperature of 2-8 ℃ for 90 days.
The specific detection method is briefly described as follows. Taking 6 test tubes, sequentially marking as 1, 2, 3, 4 and 5 and a commercial control, adding 100 mu L of quality control products with corresponding numbers into each test tube, then adding 100 mu L A cells (Tianjin blood center) into each test tube, uniformly mixing, incubating for 15min at room temperature, centrifuging for 10 s at 3000r/min, and then judging the result.
The interpretation criteria of the results in the specificity and antibody titer tests are shown in Table 1.
TABLE 1 agglutination strength interpretation criteria
The results of the specific detection are shown in Table 2.
TABLE 2 detection results of specificity of each quality control substance
As shown in Table 2, the control specificities of #1 to #4 and the commercial control were all negative results and the specificities thereof were acceptable, while #5 was 1+ positive results and the specificities thereof were not acceptable, so #5 was eliminated and the antibody titer detection was not performed.
The antibody titer detection method is briefly described below. 8 tubes were removed and labeled sequentially: 1:2, 1:4, 1:8, 1:16, 1:32, 1:64, 1:128, 1:256, then 100 μ L of sodium chloride injection is added to each tube, 100 μ L of plasma quality control is added to the 1 st tube, mixed, moved 100 μ L to the 2 nd tube, and so on to the 8 th tube, and finally 100 μ L is discarded, so that the dilution of the #1 quality control from the 1 st tube to the 8 th tube is 1:2, 1:4, 1:8, 1:16, 1:32, 1:64, 1:128, 1:256, respectively, then 100 μ L B cells (Tianjin blood center) are added to the tube corresponding to each dilution, mixed, incubated at room temperature for 15min, centrifuged at 3000r/min for 10 seconds, and the titer of the antibody is determined by the reciprocal of the dilution that appears to be 1+ agglutination strength (e.g. 32, instead of 1/32 or 1: 32). If agglutination still remains in the tube with the highest dilution, indicating that the end point of the reaction has not been reached, the dilution should be continued and detected.
According to the determination method, the antibody titer detection is carried out on the plasma quality control product and the commercial control serum quality control product which are preserved for different time and have negative specificity. The results are shown in Table 3.
TABLE 3 preservation of the results of the detection of the antibody titer of each quality control product at different times
As shown in Table 3, the antibody titers #1 to #4 and the commercial control were substantially constant over a period of time, and gradually decreased over this period of time.
The time period during which the antibody titer is unchanged is defined as the storage period of each quality control product, the storage period of #1 and the commercial control is 4 months, and the storage period of #2 to #4 is 6 months.
From the results of combining the specificity of plasma quality control and the antibody titer, the preservation effect of #2 to #4 is the best, and the preservation effect is as long as 6 months.
It should be noted that, since there is no plasma quality control for blood type detection on the market, we use serum quality control as a control in the examples. As will be appreciated by those skilled in the art, plasma components are more complex and more difficult to store for long periods of time than serum. But because the plasma is easier to purchase and has low cost, the plasma has obvious economic advantages as a quality control product.
While the composition of the plasma preservation solution is described herein to give a specific concentration or concentration range, and in the examples to give a specific mixing ratio of the plasma preservation solution to the plasma of 1: 9, it will be understood by those skilled in the art that the volume ratio may vary within a certain range (e.g., at least 1:8 to 1: 10), and accordingly, the concentration or concentration range of the plasma preservation solution may vary with the variation of the volume ratio, and such varied plasma preservation solutions are also within the scope of the present invention.
Claims (8)
1. A plasma preservation solution is characterized by comprising 5g/L of glucose, 0.55g/L of citric acid, 8g/L of sodium citrate, 1.6g/L of sodium chloride, 0.56g/L of disodium hydrogen phosphate, 0.5g/L of sodium dihydrogen phosphate, 10g/L of bovine serum albumin, 10g/L of mannitol, 10g/L of trehalose, 1g/L of sodium azide and 10-100 mg/L of beta-cyclodextrin.
2. The plasma preservation solution according to claim 1, wherein the concentration of the β -cyclodextrin is 50 mg/L.
3. A method for preserving plasma, which comprises mixing the plasma preserving fluid of claim 1 or 2 with plasma and preserving at 2-8 ℃.
4. The method of claim 3, wherein the plasma preservation solution is mixed with plasma at a 1: 9 volume ratio.
5. A method for preparing a plasma quality control product for blood group reverse typing, which comprises mixing the plasma preservation solution of claim 1 or 2 with plasma.
6. The method of claim 5, wherein the plasma preservation solution is mixed with plasma at a 1: 9 volume ratio.
7. A plasma quality control product prepared by the method of claim 5 or 6.
8. Use of the plasma quality control product of claim 7 for ABO blood group reverse typing.
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4086218A (en) * | 1975-04-11 | 1978-04-25 | Edward Shanbrom, Inc. | Method of preserving blood plasma II |
| CN102823579A (en) * | 2012-08-27 | 2012-12-19 | 杭州博拓生物技术有限公司 | Blood protective agent, preparation method thereof and application |
| CN104381245A (en) * | 2014-10-13 | 2015-03-04 | 邓杏飞 | Reagent for stabilization of blood sample cells |
| CN104634628A (en) * | 2014-12-16 | 2015-05-20 | 邓杏飞 | Blood stabilizer and application thereof |
| CN105794767A (en) * | 2016-03-17 | 2016-07-27 | 四川新健康成生物股份有限公司 | Preservative solution for storing pig whole blood and application method thereof |
| CN107467013A (en) * | 2017-09-20 | 2017-12-15 | 上海贞元诊断用品科技有限公司 | Preparation method of quality control product universal plasma matrix capable of being stored for long time |
| CN108041022A (en) * | 2017-11-29 | 2018-05-18 | 默禾医疗科技（上海）有限公司 | A kind of new plasma DNA and haemocyte preserve liquid |
-
2021
- 2021-07-07 CN CN202110764707.XA patent/CN113243360B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4086218A (en) * | 1975-04-11 | 1978-04-25 | Edward Shanbrom, Inc. | Method of preserving blood plasma II |
| CN102823579A (en) * | 2012-08-27 | 2012-12-19 | 杭州博拓生物技术有限公司 | Blood protective agent, preparation method thereof and application |
| CN104381245A (en) * | 2014-10-13 | 2015-03-04 | 邓杏飞 | Reagent for stabilization of blood sample cells |
| CN104634628A (en) * | 2014-12-16 | 2015-05-20 | 邓杏飞 | Blood stabilizer and application thereof |
| CN105794767A (en) * | 2016-03-17 | 2016-07-27 | 四川新健康成生物股份有限公司 | Preservative solution for storing pig whole blood and application method thereof |
| CN107467013A (en) * | 2017-09-20 | 2017-12-15 | 上海贞元诊断用品科技有限公司 | Preparation method of quality control product universal plasma matrix capable of being stored for long time |
| CN108041022A (en) * | 2017-11-29 | 2018-05-18 | 默禾医疗科技（上海）有限公司 | A kind of new plasma DNA and haemocyte preserve liquid |
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Address after: No. 29, Xinye 7th Street, West District, Binhai New Area Economic and Technological Development Zone, Tianjin 300462 Patentee after: Tianjin Texiang Biotechnology Co.,Ltd. Address before: No. 29, Xinye 7th Street, West District, Binhai New Area Economic and Technological Development Zone, Tianjin 300462 Patentee before: TIANJIN DEXIANG BIOTECHNOLOGY Co.,Ltd. |
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