CN102338800A - Antibody screening erythrocyte kit - Google Patents
Antibody screening erythrocyte kit Download PDFInfo
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- CN102338800A CN102338800A CN201110136059XA CN201110136059A CN102338800A CN 102338800 A CN102338800 A CN 102338800A CN 201110136059X A CN201110136059X A CN 201110136059XA CN 201110136059 A CN201110136059 A CN 201110136059A CN 102338800 A CN102338800 A CN 102338800A
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Abstract
The antibody screening erythrocyte kid is composed of reagents and a box. The reagents comprise a screening cell No. 1 reagent, a screening cell No. 2 reagent and a screening cell No. 3 reagent. The main components of the reagents comprise three kind of O-type erythrocyte with known antigen phenotype, glucose, citric acid, antibiotics and so on. The antibody screening erythrocyte kit of the invention can provide effective support for screening of clinical irregular antibodies, so as to reduce the risk of blood transfusion and enhance the safety of blood transfusion.
Description
Technical field:
The present invention relates to biochemical field, be mainly used in the examination of blood group irregular antibody.
Background technology:
The antibody screening red corpuscle reagent box is used for the examination of blood group irregular antibody.So-called irregular antibody is meant the antibody beyond anti-A and the anti-B.Clinically, to blood transfusion history, pregnant history being arranged or need receiving repeatedly blood donor in a short time; And it is out of style that cross matching takes place in the match process, must carry out antibody examination test.For some healthy blood donor, have objection or suspect and also can carry out antibody examination test when irregular antibody is arranged in that blood typing takes place.This product is not used in the examination of blood source, only is used for clinical examination.
According to the person's of being studied the difference and the difference of test method sensitivity, the individuality of nearly 0.3%-2% has allo-antibody among the crowd.The approach of immunity possibly be conceived, and blood transfusion is transplanted, or injected immunogenic material.
Irregular antibody regular meeting causes the illnesss such as generation, hemolytic blood transfusion reaction or the erythrocytic rapid loss of infusion of neonatal hemolytic disease.The clinical meaning that antibody has of different qualities is different also.Some antibody can just destroy ill-matched infusion red blood cell in several hours even several minutes fully, and some antibody then possibly need a couple of days or can not produce conspicuousness to the infusion red blood cell to destroy.
In order to prevent the generation of all kinds of transfusion reactions or neonatal hemolytic disease, the examination of be correlated with blood donor and sufferer being carried out irregular antibody is very important.
The 17 regulation of Ministry of Public Health's " clinical blood transfusion technical manual ": all scenario that meets must be done the antibody screening test by " national clinical examination working specification " relevant regulations: cross matching is out of style; To blood transfusion history, pregnant history being arranged or need receiving repeatedly blood donor in a short time.
Summary of the invention:
The purpose of this invention is to provide a kind of antibody screening red corpuscle reagent box, for the examination of clinical irregular antibody provides effective support.
This antibody screening red corpuscle reagent box of the present invention is made up of reagent and box body, and each one of cell, II number screening of I number screening cell, III number screening cell reagent is housed in every box.Its principal ingredient is by 3 the phenotypic O type of known antigens red blood cells, glucose, citric acid, compositions such as microbiotic.
Product performance index of the present invention is following:
Outward appearance: I, II, III antibody screening red blood cell should be the red cell suspension that cerise does not have grumeleuse.Behind the standing demix, supernatant is transparency liquid, no haemolysis.
Hemolysis rate: answer≤3.0%.
Specificity: I, II, the expressed antigen of III antibody screening cell is consistent with the antigen that the red cell antigens general layout table that provides with reagent is indicated.
The research of antibody screening red corpuscle reagent box and production work require to improve constantly along with the needs of clinical position.In the period of nearly two, it is distinctive that our company mainly is devoted to the examination Chinese population, and crowd's proportion is lower and have the raw material of the blood group antigens of clinical meaning as the antibody screening red corpuscle reagent box.And optimize the epitope pattern of 3 cells in the antibody screening cell reagent box, be convenient to the testing result that clinical user judges antibody screening.Through continuous effort, our product can be guaranteed in 3 red blood cells, to include 15 kinds of conventional blood group antigens, also contains 3 kinds of distinctive rare blood type antigens of Chinese population simultaneously as far as possible.
2010, our company with public praise on antibody screening red corpuscle reagent box of producing and the market preferably import reagent be sent to this city 3 tame medical institutions and carry out the detection and the comparison of clinical sample.In amounting to 1100 routine test specimens, detect antibody positive sample 105 examples altogether, negative sample 995 examples.Through the antibody design test, confirm 18 kinds of antibody types, the clinical samples of wherein rare antibody type is totally 8 examples.Compare with the antibody qualification result, the susceptibility of our company's reagent is 100%, and specificity is 99.90%, and accuracy is 99.91%.And, more be better than import reagent aspect the rare antibody of detection.
Principle of work of the present invention is to express following antigen: D, C, E, c, e, Jk with the antibody screening red blood cell
a, Jk
b, M, N, S, s, Mur, Fy
a, Di
a, Le
a, Le
b, P
1Antibody screening test is to let serum or the blood plasma examined react with the antibody screening red blood cell, with discovery blood group irregular antibody.
The present invention and prior art contrast, and its technology has certain primacy.Antigenic type of the present invention is abundant, contains the distinctive private antigen of Chinese population, and the epitope pattern of its 3 reagent red blood cells is optimized, and more helps the interpretation of Clinical detection personnel to the result.Its cell-preservation liquid can effectively keep cell viability through studying for many years and using, and keeps antigen active.
The main gordian technique of the present invention is following:
The examination of private antigen and affirmation work, rare blood type antigen blood donor's recruitment become the large-scale production of antibody screening red corpuscle reagent box and maintain market the key of supply.Because the examination of private antigen need be used more import antibody reagent, costs an arm and a leg large usage quantity.Carry out related work and must expend more resource and cost.Simultaneously, rare blood type blood person's recruitment becomes the constantly clinical key point of supply of this reagent more.Only have huge, young blood donor troop, could guarantee clinical agent delivery.
Major technique characteristics of the present invention and index of correlation are following:
The extensive examination of rare blood type antigen: in O type blood blood donor, to Mur antigen, Dia antigen and S antigen carry out examination, guarantee the homozygosity proportioning of other antigens simultaneously.According to the frequency of various red cell antigenses, in 3 O type blood, it is eligible proportioning to go out, and the cover screening red corpuscle reagent box through optimizing, and its ratio is about 4%.
Embodiment:
Sample requires as follows:
According to the blood sample acquisition step in the clinical blood transfusion technical manual, gather patient or blood donor, receptor's blood, separate obtaining blood plasma or serum.Sample 2-8 ℃ preservation to be checked.Serum and blood plasma all can use, and serum more is superior to blood plasma.The blood sample inability to recognize and treat BIAC and BEN aspects of disease treatment of haemolysis and serious piarhemia or pollution is used for the antibody screening test.
The method of inspection is following:
This kit does not have specific (special) requirements to detecting with method, all can adopt like salt water test method, cohesion amine method, antiglobulin method etc., can select by the serology behavior and the breadboard condition of antibody.But some method of inspection can be destroyed (or weakening) some antigen, please according to the prompting of each reagent instructions or according to the immunohematology working specification, careful selection check method is in order to avoid omission antibody.
1. salt water law
1.1 get 3 of small test tubes, add 2 of examinee's serum or blood plasma (100 μ l) respectively;
1.2 add I, II, III antibody screening red blood cell reagent each 1 (50 μ l) then respectively;
1.3 mixing, with 1000g (3400rpm) centrifugal 15 seconds, visual inspection aggegation situation.
2. condense the amine method
2.1 get 3 of small test tubes, add 2 of examinee's serum or blood plasma (100 μ l) respectively;
2.2 add I, II, III antibody screening red blood cell reagent each 1 (50 μ l) then respectively;
2.3 mixing is operated by the instructions that used cohesion amine producer provides.
2.4 jog is observed the aggegation situation after finally adding resuspended liquid.
3. antiglobulin method
3.1 get 3 of small test tubes, add 2 of examinee's serum or blood plasma (100 μ l) respectively;
3.2 add I, II, III number screening red blood cell reagent each 1 (50 μ l) then respectively;
3.3 the rearmounted 37 ℃ of water-baths of mixing 30 minutes, with physiological saline washing 3 times, centrifugal 1 minute of 1000g (3400rpm), last button is done;
Add 1 of antihuman globulin reagent (50 μ l), with 1000g (3400rpm) centrifugal 15 seconds, the situation of visual inspection aggegation immediately.
Being explained as follows of assay of the present invention:
Aggegation takes place in any time of antigen-antibody reaction in positive reaction: I, II, III antibody screening cell, or salt solution and amplified medium stage of reaction generation hemolytic reaction, can think positive findings.
Negative reaction: haemolysis or agglutinating reaction do not take place in whole testing process, can think seized serum sample do not contain with antibody screening cellular expression antigen accordingly can detected antibody.
The limitation of the method for inspection of the present invention is following:
1. scenario possibly cause the false positive or the false negative of testing result:
A) sample to be checked has bacterial contamination or patient with after some chemical agent treatment, and is influential to detecting;
B) incubation time, temperature are not enough, and centrifugal force is not enough, and cell washing is incomplete;
C) sample storage to be checked is improper;
D) sample to be checked contains autoantibody or cold antibody.(own control is done in suggestion simultaneously)
E) antigenicity of some red cell antigens can weaken in time, and is lower if the irregular antibody of sample to be checked is tired, might detect less than.Suggestion detects with fresh antibody screening cell.
F) some method of inspection can be destroyed (or weakening) some antigen, please according to the prompting of each reagent instructions or according to the blood bank procedure rules, careful selection check method is in order to avoid omission antibody.
2. antibody screening is tested to differ and is detected the antibody that all have clinical meaning surely; The antibody of some low frequency antigens or the antibody of dosage effect; Maybe be by omission; At this moment need select antigenicity antibody screening cell more complete and that specificity is more responsive to test, or conduct a survey with more high sensitive technology.
3. use micro-column gel agglutination assay to carry out the antibody screening test, should carry out the adjustment of cell concentration or other test conditions according to the requirement of employed micro-column gel instructions.This antibody screening red corpuscle reagent box is not to using micro-column gel agglutination assay to describe.
Freezing serum or the plasma sample of melting again, its antibody titer and antibody characteristic possibly be affected, and may produce incorrect result with this screening cell effect, should careful use.
Claims (5)
1. antibody screening red corpuscle reagent box: be made up of box body and reagent, reagent is arranged in the box body, and reagent is made up of I type reagent, II type reagent and III type reagent; Described I type reagent by alserver's solution and I type packed red cells form, described II type reagent is made up of alserver's solution and II type packed red cells, described III type reagent is made up of alserver's solution and III type packed red cells, it is characterized in that: described red blood cell alarm liquid is made up of glucose, citric acid trisodium, citric acid, sodium dihydrogen phosphate, disodium ethylene diamine tetraacetate, nucleotide and microbiotic; Wherein, described glucose accounts for the big 1.7-2.1% of mass percent of described alserver's solution, and the mass percent that described citric acid trisodium accounts for described alserver's solution is 2.0-2.2%; The mass percent that described citric acid accounts for described alserver's solution is 0.030-0.040%; The mass percent that described sodium dihydrogen phosphate accounts for described alserver's solution is 0.20-0.30%, and the mass percent that described disodium ethylene diamine tetraacetate accounts for described alserver's solution is 0.08-0.12%, and the mass percent that described microbiotic accounts for described alserver's solution is 0.040-0.045%; The mass percent that described microbiotic accounts for described alserver's solution is 0.001-0.002%; Surplus is a distilled water, and described I type packed red cells prepares through following method: at first with the I type blood of at least three person-portions slurry of dehematizing, mix then; Use an amount of physiological sodium chloride solution Washed Red Blood Cells at least twice then; Use an amount of alserver's solution Washed Red Blood Cells more respectively at least once, centrifugal 3-5 degree centigrade of washing, 3000-4000 rev/min 10-20 minute; After for the last time centrifugal; 3000-4000 rev/min 15-25 minute, abandon serum, deposition is the I packed red cells; The preparation method of described II type packed red cells is with the preparation method of described I type packed red cells; The preparation method of described II type packed red cells is with the preparation method of described I type packed red cells, and the preparation method of described III type packed red cells is with the preparation method of described I type packed red cells, in described I type reagent; The concentration that described I type packed red cells accounts for described I type reagent is 2-5%; Surplus is described alserver's solution, and in described II type reagent, the concentration that described II type packed red cells accounts for described I type reagent is 2-5%; Surplus is described alserver's solution; In described III type reagent, the concentration that described III type packed red cells accounts for described I type reagent is 2-5%, and surplus is described alserver's solution.
2. antibody screening red corpuscle reagent box as claimed in claim 1; It is characterized in that: the mass percent of the described alserver's solution of described glucose is 1.9%; The mass percent that described citric acid trisodium accounts for described alserver's solution is 2.1%; The mass percent that described citric acid accounts for described alserver's solution is 0.035%; The mass percent that described sodium dihydrogen phosphate accounts for described alserver's solution is 0.25%, and the mass percent that described disodium ethylene diamine tetraacetate accounts for described alserver's solution is 0.1%, and the mass percent that described nucleotide accounts for described alserver's solution is 0.0043%; The mass percent that described microbiotic accounts for described alserver's solution is 0.0015%, and surplus is a distilled water.
3. antibody screening red corpuscle reagent box as claimed in claim 1 is characterized in that: described I type packed red cells prepares through following method, at first with the I type blood of at least three person-portions slurry of dehematizing; Mix then, use an amount of physiological sodium chloride solution Washed Red Blood Cells three times then, use an amount of alserver's solution Washed Red Blood Cells more respectively once; Centrifugal 4 degrees centigrade of washings; 3500 rev/mins 15 minutes, last centrifugal after, 3500 rev/mins 20 minutes; Abandon serum, deposition is packed red cells.
4. antibody screening red corpuscle reagent box as claimed in claim 1 is characterized in that: described II type packed red cells prepares through following method, at first with the II type blood of at least three person-portions slurry of dehematizing; Mix then, use an amount of physiological sodium chloride solution Washed Red Blood Cells three times then, use an amount of alserver's solution Washed Red Blood Cells more respectively once; Centrifugal 4 degrees centigrade of washings; 3500 rev/mins 20 minutes, abandon serum, deposition is packed red cells.
5. antibody screening red corpuscle reagent box as claimed in claim 1 is characterized in that: described III type packed red cells prepares through following method, at first with the III type blood of at least three person-portions slurry of dehematizing; Mix then, use an amount of physiological sodium chloride solution Washed Red Blood Cells three times then, use an amount of alserver's solution Washed Red Blood Cells more respectively once; Centrifugal 4 degrees centigrade of washings; 3500 rev/mins 15 minutes, last centrifugal after, 3500 rev/mins 20 minutes; Abandon serum, deposition is packed red cells.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110136059XA CN102338800A (en) | 2011-05-25 | 2011-05-25 | Antibody screening erythrocyte kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110136059XA CN102338800A (en) | 2011-05-25 | 2011-05-25 | Antibody screening erythrocyte kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102338800A true CN102338800A (en) | 2012-02-01 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201110136059XA Pending CN102338800A (en) | 2011-05-25 | 2011-05-25 | Antibody screening erythrocyte kit |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110736832A (en) * | 2019-12-18 | 2020-01-31 | 首都医科大学附属北京友谊医院 | Composition for identifying spectrum cells by antibodies |
| CN112684192A (en) * | 2020-12-25 | 2021-04-20 | 天津市宝坻区人民医院 | New application of ammonium bradykinin in ABO blood group reverse typing kit |
| CN113341163A (en) * | 2021-06-03 | 2021-09-03 | 上海市血液中心 | D-rare blood type screening reagent and application thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59218958A (en) * | 1983-05-27 | 1984-12-10 | Ishizu Seiyaku Kk | Reagent for detecting irregular antibody |
| CN1501084A (en) * | 2002-11-14 | 2004-06-02 | 北京市红十字血液中心 | Reagent red blood cell |
| CN101109756A (en) * | 2007-08-20 | 2008-01-23 | 陕西省血液中心 | Reagent kit used for detecting irregular antibody in blood serum and preparing method thereof |
| CN101178410A (en) * | 2006-11-07 | 2008-05-14 | 上海血液生物医药有限责任公司 | Red corpuscle reagent box for reverse typing used for detecting human ABO blood type |
| CN101387648A (en) * | 2008-10-24 | 2009-03-18 | 李勇 | Erythrocyte membrane antigen magnetic ball kit and applications on blood group antibody detection |
-
2011
- 2011-05-25 CN CN201110136059XA patent/CN102338800A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59218958A (en) * | 1983-05-27 | 1984-12-10 | Ishizu Seiyaku Kk | Reagent for detecting irregular antibody |
| CN1501084A (en) * | 2002-11-14 | 2004-06-02 | 北京市红十字血液中心 | Reagent red blood cell |
| CN101178410A (en) * | 2006-11-07 | 2008-05-14 | 上海血液生物医药有限责任公司 | Red corpuscle reagent box for reverse typing used for detecting human ABO blood type |
| CN101109756A (en) * | 2007-08-20 | 2008-01-23 | 陕西省血液中心 | Reagent kit used for detecting irregular antibody in blood serum and preparing method thereof |
| CN101387648A (en) * | 2008-10-24 | 2009-03-18 | 李勇 | Erythrocyte membrane antigen magnetic ball kit and applications on blood group antibody detection |
Non-Patent Citations (2)
| Title |
|---|
| 杨玉发，邹翠贤，邓爱玲: "红细胞谱细胞的建立和保存的初步研究", 《现代检验医学杂志》, vol. 18, no. 1, 28 February 2003 (2003-02-28), pages 19 - 20 * |
| 罗广平，肖露露，赵阳: "红细胞谱细胞的建立及临床应用", 《实用医学杂志》, vol. 18, no. 12, 31 December 2002 (2002-12-31), pages 1324 - 1325 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110736832A (en) * | 2019-12-18 | 2020-01-31 | 首都医科大学附属北京友谊医院 | Composition for identifying spectrum cells by antibodies |
| CN112684192A (en) * | 2020-12-25 | 2021-04-20 | 天津市宝坻区人民医院 | New application of ammonium bradykinin in ABO blood group reverse typing kit |
| CN113341163A (en) * | 2021-06-03 | 2021-09-03 | 上海市血液中心 | D-rare blood type screening reagent and application thereof |
| CN113341163B (en) * | 2021-06-03 | 2024-01-19 | 上海市血液中心 | -D-rare blood group screening reagent and application thereof |
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Application publication date: 20120201 |