CN107576807A - A kind of Blood grouping quality-control product and preparation method thereof and the application in Blood grouping - Google Patents
A kind of Blood grouping quality-control product and preparation method thereof and the application in Blood grouping Download PDFInfo
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Abstract
The present invention provides a kind of Blood grouping reagent quality-control product and preparation method thereof and the application in Blood grouping, the Blood grouping reagent quality-control product includes 6 bottles of ABO, RhD Blood grouping quality-control products, 5 bottles of cross matching quality-control products and 4 bottles of Irregular antibodies screening quality-control products, the Blood grouping reagent quality-control product of the present invention can ensure the accuracy of Blood grouping, specificity, affinity, stability, avoid making testing result be affected because detection itself is unqualified in detection process, determined for abo blood group, cross matching, the accurate of Irregular antibodies screening is created conditions.
Description
Technical field
The invention belongs to transfusion testing technical field, is related to a kind of Blood grouping quality-control product and preparation method thereof and in blood group
Application in detection.
Background technology
ABO blood group system is first blood group system that the mankind have found, and clinically one of most important blood group system.
Clinical blood transfusion is diagnosis and treatment disease in modern medicine, saves the important medical procedure of life.Meanwhile blood transfusion may cause
A variety of adverse reactions, patient vitals are directly injured, it is careless slightly that irreparable error may occur.To ensure blood transfusion
Safety, it is very important using specificity, the experimental technique of high sensitivity from reliable experimental method.
Early in 1907, Hoktoen just first proposed importance of the typing of blood to treatment of blood transfusion, Ottenberg etc.
In the concept that 1908 further provide for cipient blood cross matching, depth of the typing of blood to clinical blood transfusion is more emphasized
Remote meaning.The incompatible blood transfusion of abo blood group, will almost occur hemolytic blood transfusion reaction symptom without exception：Diffusivity is intravascular solidifying
Blood, renal failure are so that death.Therefore, the accurately sizing of abo blood group is most important.Nineteen ninety, Lapierre have delivered micro-column gel
Immunization experiment technology, this is the milestone of human erythrocyte's typology development.U.S.'s transfusion science meeting《Blood transfusion technical manual》12nd
Version rises for (1996) has just been included in the technology in the routine techniques of erythrocyte blood type detection.Nowadays, in advanced country in the world,
Hemagglutination test of the new technology just in Replacing for many years, apply in the routine clinical inspection work of erythrocyte blood type serology.
According to Ministry of Public Health's relevant regulations, related blood grouping reagent reagent is both needed to the indoor quality control tested.
Ministry of Public Health's issuing and implementation《Clinical laboratory test capacity management method》Article 25 clear stipulaties：" medical treatment
Clinical labororatory of mechanism should take corrective action, and record in detail." hospital's Blood Transfusion Dept. (or blood bank) and Blood Transfusion Services blood
Type Reference Lab belongs to clinical labororatory's category, and the blood transfusion compatibility detection project carried out must also carry out strict interior
Quality control (IQC).
Have Diana, DiaMed, Johnson ＆ Johnson abroad；Existing Changchun Bo Xun Biotechnology Co., Ltd of the country, river
The manufacturer production Blood grouping product such as Yin Libo medical biotechnologies Co., Ltd, Zhongshan Shengke Agent Apparatus Co., Ltd..
The abo blood group sizing detection card clinically used at present carries out blood group determination, and cross matching is carried out with antihuman globulin detection card
Tested with Irregular antibodies screening.In actual use, abo blood group used sizing detection card and antihuman globulin detection
Card needs the product with correlation to carry out Quality Control in itself to reagent card.
In this area, it is expected that developing a kind of detected to abo blood group sizing detection card and antihuman globulin blocks progress Quality Control
Method, to avoid causing result of determination wrong feelings occur because reagent card has problem in itself in use in reagent card
The generation of condition.
The content of the invention
It is an object of the invention to provide a kind of Blood grouping reagent quality-control product and preparation method thereof and in Blood grouping
Application, Blood grouping reagent quality-control product of the present invention can ensure the accuracy of Blood grouping, and can avoid examining
Because detection reagent is made testing result be affected by polluting or quality problems being present in itself during survey.
To use following technical scheme up to this purpose, the present invention：
On the one hand, the present invention provides a kind of Blood grouping reagent quality-control product, the Blood grouping quality-control product include 6 bottles of ABO,
RhD Blood groupings quality-control product, 5 bottles of cross matching quality-control products and 4 bottles of Irregular antibodies screening quality-control products, 6 bottles of ABO, RhD blood
Type detects quality-control product：A1 types RhD (+) red blood cell (sample 1), Type B RhD (+) red blood cell (sample 2), A serum (samples
3), B serum (sample 4), O-shaped RhD (+) red blood cell (sample 5) and each 1 bottle of RhD (-) red blood cell (sample 6)；5 bottles of intersections
Match quality-control product is respectively AB types (+) red blood cell (sample 1), O-shaped RhD (+) red blood cell (sample 2), RhD (-) red blood cell (sample
3), each 1 bottle of the anti-D of O serum (sample 4), type containing IgG AB serum (sample 5)；4 bottles of Irregular antibodies screenings quality-control product point
Not Wei O serum (sample 1) and the anti-D of type containing IgG each 2 bottles of AB serum (sample 2).
Preferably, the red blood cell is maintained in alserver's solution, and the alserver's solution includes Hepes10-
20g/L (such as 13g/L, 15g/L, 17g/L, 19g/L or 20g/L), NaCl 3-9g/L (such as 4g/L, 6g/L, 8g/L or 9g/
L), D-Glucose 10-20g/L (such as 13g/L, 15g/L, 17g/L, 19g/L or 20g/L), adenine 0.1-1g/L (such as
0.1g/L, 0.3g/L, 0.5g/L, 0.8g/L or 1g/L), inosine 1-5g/L (such as 1g/L, 2g/L, 3g/L, 4g/L or 5g/L),
Sodium citrate 1-10g/L (such as 2g/L, 4g/L, 6g/L, 8g/L or 9g/L), chloramphenicol 0.1-1g/L (such as 0.3g/L,
0.5g/L, 0.7g/L or 0.9g/L), neomycin 0.1-1g/L (such as 0.1g/L, 0.3g/L, 0.5g/L, 0.8g/L or 1g/L),
Gentamicin 0.1-1g/L (such as 0.1g/L, 0.3g/L, 0.5g/L, 0.8g/L or 1g/L), pH=6.8-7.4 (such as 6.8,
6.9th, 7.0,7.1,7.2,7.3 or 7.4).
In the present invention, the red blood cell is maintained in the red cell preservation system of standardization, can be maintained with the long period
The performance of red blood cell, and have developed the buffer system with very strong buffer capacity.Formed using hydrogen ion buffer HEPES
Buffer system, the long period constant pH scopes can be controlled, cytotoxic is acted on, pH is maintained 6.8-7.4 for a long time
In the range of.Red blood cell is set to be chronically in suitable pH environment.With effective low salt concn system.Using D-Glucose,
Adenine, inosine and sodium citrate can further maintain pH stability and can to red blood cell as the additive for preserving liquid
Play a good protection, maintain the biological property of red blood cell well.
In the Blood grouping reagent quality-control product of the present invention, there is outstanding protective system.Using chloramphenicol, neomycin,
Gentamicin is broad-spectrum antibiotic as preservative, wherein chloramphenicol, and neomycin belongs to aminoglycoside with gentamicin and resisted
Raw element, it is all effective to Gram-positive and negative bacterium.The compound use of three kinds of antibiotic, make the protection liquid that there is more preferable anti-corrosion
Ability, while avoid because chemical substance addition causes the change of pH value of solution.
Preferably, A1 types RhD (+) red blood cell, Type B RhD (+) red blood cell, O-shaped RhD (+) red blood cell, AB types (+) are red
Cell, RhD (-) red blood cell are by taking A1 type RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+), RhD (-) respectively
Packed red cells, it is diluted to the red blood cell reagent that concentration is 0.8% with above-mentioned alserver's solution and obtains.
Preferably, the A serum moderate resistance B potency ＞ 128.
Preferably, the B serum moderate resistance A potency ＞ 128.
Preferably, the O serum moderate resistance A potency ＞ 128, anti-B potency ＞ 128.
Preferably, the anti-D potency ＞ 128 of IgG types in the anti-D of the type containing IgG AB serum.
In the present invention, to ensure the quality of corresponding quality-control product, also need to carry out red blood cell raw material in preparation process
Screening.Need to block the accuracy, specificity, parent to red blood cell by abo blood group qualitative detection card and antihuman globulin detection
Detected with power, stability and hemolytic.Choose raw material of the superior red blood cell of properties as Quality Control red blood cell.This hair
In bright, packed red cells is diluted with alserver's solution when preparing red blood cell, can directly be diluted to aimed concn.Once
Property operation, contaminated probability in red blood cell preparation process can be reduced, and gimmick is gentle, the physics damage to red blood cell can be avoided
Wound.
In the present invention, to ensure the quality of quality controlled serum, the antibody being added in serum is screened, makes anti-A
Potency ＞ 128, anti-B potency ＞ 128, the anti-D potency ＞ 128 of IgG types.
On the other hand, the invention provides the preparation method of Blood grouping reagent quality-control product as described above, the preparation
Method comprises the following steps：
(1) preparation of alserver's solution：Each composition of alserver's solution is mixed, and adjusts pH=6.8-
7.4 (preferably 7.4) obtain alserver's solution,
(2) preparation of red blood cell reagent：Take respectively A1 type RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+),
RhD (-) packed red cells, the red blood cell reagent of concentration 0.5-1% (preferably 0.8%) is diluted to above-mentioned alserver's solution；
(3) A serum, B serum, O serum and the anti-D of type containing IgG AB serum are prepared；
(4) dispense：Preparation-obtained reagent is dispensed to 6 bottles of ABO, RhD Blood grouping quality-control products, 5 bottles of cross matchings
In quality-control product and 4 bottles of Irregular antibodies screening quality-control products, the Blood grouping reagent quality-control product is obtained.
As optimal technical scheme, the preparation method of the Blood grouping reagent quality-control product specifically includes following steps：
(1) preparation of alserver's solution：
By Hepes 10-20g, NaCl 3-9g add ultra-pure water 1L, fully mix, and pH=6.8-7.4 is adjusted with NaOH,
Add D-Glucose 10-20g/L, adenine 0.1-1g/L, inosine 1-5g/L, sodium citrate 1-10g/L, chloramphenicol 0.1-1g/
L, neomycin 0.1-1g/L, gentamicin 0.1-1g/L, fully mix, 0.22 μm of filtering with microporous membrane.
(2) preparation of red blood cell reagent：Take respectively A1 type RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+),
RhD (-) packed red cells, it is diluted to the red blood cell reagent that concentration is 0.8% with above-mentioned alserver's solution and produces.
(3) preparation of serum：
A serum：Anti- B is added in AB serum, makes anti-B potency ＞ 128；
B serum：Anti- A is added in AB serum, makes anti-A potency ＞ 128；
O serum：Anti- A and anti-B are added in AB serum, make anti-A potency ＞ 128, anti-B potency ＞ 128；
The anti-D of type containing IgG AB serum：The anti-D of IgG types is added in AB serum, makes the anti-D potency ＞ 128 of IgG types.
(4) dispense：
The packing standard of reagent is as follows：
ABO, RhD Blood grouping quality-control product (micro-column gel agglutination assay)
Sample 1：2mL/ bottle × 1 bottle；Sample 2：2mL/ bottle × 1 bottle；Sample 3：2mL/ bottle × 1 bottle
Sample 4：2mL/ bottle × 1 bottle；Sample 5：2mL/ bottle × 1 bottle；Sample 6：1mL/ bottle × 1 bottle
Cross matching quality-control product (micro-column gel agglutination assay)
Sample 1：2mL/ bottle × 1 bottle；Sample 2：1mL/ bottle × 1 bottle；Sample 3：1mL/ bottle × 1 bottle, sample 4：2mL/ bottle × 1
Bottle；Sample 5：2mL/ bottle × 1 bottle
Irregular antibodies screening quality-control product (micro-column gel agglutination assay)
Sample 1：2mL/ bottle × 2 bottle
Sample 2：2mL/ bottle × 2 bottle
Dispensed according to above-mentioned packing standard with electronic liquid-transfering gun.
On the other hand, the application the invention provides Blood grouping reagent quality-control product as described above in Blood grouping.
The Blood grouping reagent quality-control product being made up of three special quality control product that the present invention researches and develops can be to abo blood group qualitative detection card
And antihuman globulin detection card etc. detection reagent carry out Quality Control, be screened out underproof detection reagent, avoid in detection process because
For detection reagent by pollution or quality problems in itself be present makes testing result be affected.
Compared with prior art, the invention has the advantages that：
(1) ABO, RhD Blood grouping quality-control product (micro-column gel agglutination assay) of the invention, cross matching quality-control product (micro-column gel
Method) and the function admirable such as the accuracy of Irregular antibodies screening quality-control product (micro-column gel agglutination assay), specificity, affinity, stability.
Can detection reagent carry out Quality Control, be screened out underproof detection reagent, avoid in detection process because detection itself is unqualified and
Testing result is set to be affected.
(2) alserver's solution of design can maintain stable pH value, and and can protects the biological of red blood cell well
Can, prevent red blood cell to be infected by bacterial and fail.It is positive caused by red blood cell to be not less than 3 during the use of quality-control product
+, the term of validity is preserved typically under the conditions of 2~8 DEG C not less than three months.
(3) the invention provides exist including abo blood group determination experiment, cross matching experiment, Irregular antibodies screening experiment
The indoor quality control product of the experiment of interior standardization.Each hospital and Blood Transfusion Services can be directly at production suppliers
The quality-control product consistent to standard, created conditions for abo blood group measure, cross matching, the accurate of Irregular antibodies screening.
Brief description of the drawings
Fig. 1 is result schematic diagram when carrying out Blood grouping in the embodiment of the present invention 2 using Blood grouping reagent quality-control product.
Embodiment
Technical scheme is further illustrated below by embodiment.Those skilled in the art should be bright
, the embodiment be only to aid in understand the present invention, be not construed as to the present invention concrete restriction.
Embodiment 1
Step 1: the preparation of alserver's solution
By Hepes 15g/L, NaCl 9g/L add ultra-pure water 1L, fully mix, and PH=7.0 ± 0.1 is adjusted with NaOH,
Add D-Glucose 20g/L, adenine 0.1g/L, inosine 1g/L, sodium citrate 5g/L, chloramphenicol 0.1g/L, neomycin 0.2g/
L, gentamicin 1g/L, fully mix, 0.22 μm of filtering with microporous membrane.
Step 2: the preparation of red blood cell reagent
A is taken respectively1Type RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+), RhD (-) packed red cells, are used
State alserver's solution be diluted to concentration be 0.8% red blood cell reagent produce.
Step 3: the preparation of different antibodies type serum
A serum:Anti- B is added in AB serum, makes anti-B potency ＞ 128；
B serum：Anti- A is added in AB serum, makes anti-A potency ＞ 128；
O serum:Anti- A and anti-B are added in AB serum, make anti-A potency ＞ 128, anti-B potency ＞ 128；
The anti-D of type containing IgG AB serum：The anti-D of IgG types is added in AB serum, makes the anti-D potency ＞ 128 of IgG types.
Step 4: packing
The packing standard of reagent is as follows：
Sample 1：2mL/ bottle × 1 bottle；Sample 2：2mL/ bottle × 1 bottle；Sample 3：2mL/ bottle × 1 bottle
Sample 4：2mL/ bottle × 1 bottle；Sample 5：2mL/ bottle × 1 bottle；Sample 6：1mL/ bottle × 1 bottle
Cross matching quality-control product (micro-column gel agglutination assay)
Sample 1：2mL/ bottle × 1 bottle；Sample 2：1mL/ bottle × 1 bottle；Sample 3：1mL/ bottle × 1 bottle, sample 4：2mL/ bottle × 1
Bottle；Sample 5：2mL/ bottle × 1 bottle
Irregular antibodies screening quality-control product (micro-column gel agglutination assay)
Sample 1：2mL/ bottle × 2 bottle
Sample 2：2mL/ bottle × 2 bottle
Dispensed according to above-mentioned packing standard with electronic liquid-transfering gun.
Step 5: semi-finished product determine
It is required that red blood cell antibody generation >=3+ corresponding with gel tube positive reaction, i.e. red blood cell concentrate on gel
Upper surface, linear type.Antibody corresponding with not containing or without antibody gel tube produces negative reaction, i.e. red blood cell can be with
Micro-pipe bottom is all reached by gel, is deposited on micro-pipe bottom, negative reaction is presented.
Step 6：Food preservation test
Above-mentioned three special quality controls product preserve more than 3 months, and during preserving herein, three special quality control product have following testing result：
(1) outward appearance：Red blood cell is without haemolysis, erythrocyte sedimentation and bottom of bottle after standing, and supernatant is preserves liquid, achromaticity and clarification；Blood
Limpid clear free from admixture.
(2) sensitivity：Red blood cell antibody generation >=3+ corresponding with gel tube positive reaction, i.e. red blood cell concentrate on
The upper surface of gel, linear type.
(3) it is specific：Red blood cell produces positive reaction in the micro-column gel pipe containing corresponding antibodies, with corresponding antibodies,
I.e. red blood cell concentrates on the upper surface of gel, linear type.Antibody corresponding with not containing or without antibody gel tube produces
Negative reaction, i.e. red blood cell all can reach micro-pipe bottom by gel, be deposited on micro-pipe bottom, and negative reaction is presented.
(4) hemolytic：Determine the content of hemoglobin to dissociate in alserver's solution supernatant, hemolysis rate≤5% measured.
Embodiment 2：
A. the application method of ABO, RhD Blood grouping quality-control product (micro-column gel agglutination assay)：
1.ABO, RhD Blood grouping quality-control product (micro-column gel agglutination assay) include 6 bottles of reagents altogether：A1Type RhD (+) red blood cell (sample
This 1), Type B RhD (+) red blood cell (sample 2), A serum (sample 3), B serum (sample 4), O-shaped RhD (+) red blood cell
Each 1 bottle of (sample 5) and RhD (-) red blood cell (sample 6)；
2.ABO, RhD Blood grouping quality-control product (micro-column gel agglutination assay) concrete operation step is as follows：
(1) 4 micro-column gel cards to be checked are taken.Sample 1 is separately added into 1~4 hole of the 1st card, each 1 drop (50 μ l)；
Sample 3 is added into each 1 drop (50 μ l) in Ac, Bc hole of the 1st micro-column gel card, adds 0.8%A in index aperture respectively1、B
Each 1 drop (50 μ l) of normal erythrocytes.
(2) sample 2 is separately added into 1~4 hole of the 2nd card, each 1 drop (50 μ l)；Sample 4 is added into the 2nd microtrabeculae
Each 1 drop (50 μ l), adds 0.8%A in index aperture respectively in Ac, Bc hole of gel cards1, B standard red blood cell it is each 1 drop (50 μ
l)；
(3) sample 5 is added in 1~4 hole of the 3rd card, sample 6 added in 3~4 holes of the 4th card.
(4) centrifuged with the special centrifugal machine of the reagent card, result of determination.Experimental result should meet standard as shown below, no
Then think that blood type card has problem in itself.
Note：A1 types RhD (+) red blood cell：With anti-A, anti-D the intensity of agglutination >=3+；Type B RhD (+) red blood cell：With anti-B,
Anti-D the intensity of agglutination >=3+；O-shaped RhD (+) red blood cell：With anti-D the intensity of agglutination >=3+；A serum：It is red thin with human blood type B
Extracellular antigen the intensity of agglutination >=3+；B serum：With A type human red cell agglutination of antigen intensity >=3+.
B. the application method of the cross matching quality-control product (micro-column gel agglutination assay)：
1. cross matching quality-control product (micro-column gel agglutination assay) includes 5 bottles of reagents altogether：Respectively AB types (+) red blood cell (sample 1),
O-shaped RhD (+) red blood cell (sample 2), RhD (-) red blood cell (sample 3), O serum (sample 4), the anti-D of type containing IgG AB serum (samples
This 5) each 1 bottle；
Cross matching quality-control product 2. (micro-column gel agglutination assay) concrete operation step is as follows：
(1) cross matching experiment is according to 1 (sample 4+ samples 1) of combination, 2 (sample 4+ samples 2) of combination, 3 (sample 5+ of combination
Sample 1), combination 4 (sample 5+ samples 3) sample-adding
(2) reagent card after being loaded, is placed in 37 DEG C and is incubated 15 minutes.
(3) centrifuged 5 minutes using special centrifugal machine, take out visual results.Experimental result should meet mark as shown below
Standard, otherwise it is assumed that blood type card has problem in itself.
| Sample combines | Testing result |
| Combination 1:Sample 4+ samples 1 | + |
| Combination 2:Sample 4+ samples 2 | - |
| Combination 3:Sample 5+ samples 1 | + |
| Combination 4:Sample 5+ samples 3 | - |
C. the application method of the Irregular antibodies screening quality-control product (micro-column gel agglutination assay)：
1. Irregular antibodies screening quality-control product (micro-column gel agglutination assay) includes 4 bottles of reagents altogether：Respectively O serum (sample 1) and
Each 2 bottles of the anti-D of type containing IgG AB serum (sample 2).
Irregular antibodies screening quality-control product 2. (micro-column gel agglutination assay) concrete operation step is as follows：
(1) by the red blood cell of irregular antibody detection reagent according to I, II, III order be added to antihuman globulin detection card 1~
In 3 pipes and 4~6 pipes, 50 μ l/ pipes.
(2) sample 1 is added in preceding 3 pipe respectively, rear 3 pipe adds the μ l/ of sample 2,50 pipes.
(3) will detect in 37 DEG C of couveuses of holding 15 minutes.
(4) centrifuged 5 minutes using special centrifugal machine at once, naked eyes result of determination.
Note：A1 types RhD (+) red blood cell and O serum agglutinations intensity >=3+；Type B RhD (+) red blood cell and O serum agglutination intensity
≥3+；O-shaped RhD (+) red blood cell and AB serum (anti-D of type containing IgG) (indirect antihuman globulin test (IAT)) the intensity of agglutination
≥3+。
Positive cutoff value, as shown in Figure 1：
4+ red blood cells gel separation media upper surface aggegation, and formed an endless belt；
Most of red blood cell of 3+ generation aggegations rests on the top half of gel separation media；
The red cell distribution of aggegation occurs for 2+ in whole gel separation media, and a small amount of red blood cell is arranged at the bottom of microtrabeculae；
The red blood cell of 1+ major part aggegations rests on the latter half of gel separation media, and the bottom of microtrabeculae has more red
Cell；
- it is negative reaction, all red blood cells both pass through the gap of gel, are formed in the bottom of microtrabeculae one smooth red thin
Born of the same parents' accumulation zone.Haemolysis：There is transparent red in hole in gel microtrabeculae.
Embodiment 3
The Quality Control effect of the quality-control product is verified in the present embodiment
ABO, RhD Blood grouping quality-control product are shaped to abo blood group detects the Quality Control effect test of card：
1.ABO blood typings detect card antibody titer determination test：
A. 4 abo blood group sizing detection cards are taken, now the 1st hole moderate resistance A potency ＞ 128.To in the hole 1 of 1-4 cards
Anti- A carries out doubling dilution, makes anti-A potency ＜ 32.By operating procedure in example 2 to 1-4.With the special centrifugal machine of the reagent card
Centrifugation, result of determination are as a result as shown in the table：
B. 4 abo blood group sizing detection cards are taken, now the 2nd hole moderate resistance B potency ＞ 128.To in the hole 1 of 1-4 cards
Anti- B carries out doubling dilution, makes anti-B potency ＜ 32.By operating procedure in embodiment 2 to 1-4.With the special centrifugation of the reagent card
Machine centrifuges, and result of determination is as a result as shown in the table：
C. 4 abo blood group sizing detection cards are taken, now the 3rd hole moderate resistance D potency ＞ 128.To in the hole 1 of 1-4 cards
Anti- D carries out doubling dilution, makes anti-D potency ＜ 32.By operating procedure in example 2 to 1-4.With the special centrifugal machine of the reagent card
Centrifugation, result of determination are as a result as shown in the table：
2.ABO blood typings detect card antigen gel post test for contamination：
A. 4 abo blood group sizing detection cards are taken, the 1st hole moderate resistance A gel columns of 1-4 cards is polluted by anti-B, by example 2
Middle operating procedure is loaded to 1-4 cards.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
B. 4 abo blood group sizing detection cards are taken, make the 1st hole moderate resistance A gel column quilts of 1-4 cards
Anti- D pollutions, are loaded by operating procedure in example 2 to 1-4 cards.Centrifuged with the special centrifugal machine of the reagent card,
Result of determination, it is as a result as shown in the table：
C. 4 abo blood group sizing detection cards are taken, the 2nd hole moderate resistance B gel columns of 1-4 cards is polluted by anti-A, by example 2
Middle operating procedure is loaded to 1-4 cards.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
D. 4 abo blood group sizing detection cards are taken, the 2nd hole moderate resistance B gel columns of 1-4 cards is polluted by anti-D, by example 2
Middle operating procedure is loaded to 1-4 cards.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
E. 4 abo blood group sizing detection cards are taken, the 3rd hole moderate resistance D gel columns of 1-4 cards is polluted by anti-A, by example 2
Middle operating procedure is loaded to 1-4 cards.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
F. 4 abo blood group sizing detection cards are taken, the 3rd hole moderate resistance D gel columns of 1-4 cards is polluted by anti-B, by example 2
Middle operating procedure is loaded to 1-4 cards.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
G. 4 abo blood group sizing detection cards are taken, negative gel column in the 4th hole of 1-4 cards is polluted by anti-A, by example
Operating procedure is loaded to 1-4 cards in 2.Centrifuged with the special centrifugal machine of the reagent card, result of determination, as a result such as following table institute
Show：
H. 4 abo blood group sizing detection cards are taken, negative gel column in the 4th hole of 1-4 cards is polluted by anti-B, by example
Operating procedure is loaded to 1-4 cards in 2.Centrifuged with the special centrifugal machine of the reagent card, result of determination, as a result such as following table institute
Show：
I. 4 abo blood group sizing detection cards are taken, negative gel column in the 4th hole of 1-4 cards is polluted by anti-D, by example
Operating procedure is loaded to 1-4 cards in 2.Centrifuged with the special centrifugal machine of the reagent card, result of determination, as a result such as following table institute
Show：
Summarize：Result above shows that contaminated abo blood group sizing detection card and the reaction result of Quality Control do not meet example
Reaction result in 2, show that corresponding abo blood group sizing detection card has problem in itself.Therefore, the present invention design ABO,
RhD Blood groupings quality-control product (micro-column gel agglutination assay) can play role of inspection to the quality of abo blood group sizing detection card.
2. Quality Control effect test of the cross matching quality-control product to antihumanglobulin cards：
Antihumanglobulin cards titration experiment：
Antibody in antihumanglobulin cards micro-column gel is diluted, makes antibody titer ＜ 32, according to the behaviour in example 2
Make method addition sample.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
| Sample combines | Testing result |
| Combination 1:Sample 4+ samples 1 | - |
| Combination 2:Sample 4+ samples 2 | - |
| Combination 3:Sample 5+ samples 1 | - |
| Combination 4:Sample 5+ samples 3 | - |
Summarize：Result above shows that the too low antihuman globulin detection card of potency and the reaction result of Quality Control do not meet reality
Reaction result in example 2, show that corresponding antihuman globulin detection card has problem in itself.Therefore, the intersection that the present invention designs
The quality that match quality-control product (micro-column gel agglutination assay) can detect card to antihuman globulin plays role of inspection.
3. Quality Control effect test of the Irregular antibodies screening quality-control product to antihumanglobulin cards：
Irregular antibody detection reagent is diluted, red blood cell concentration is less than 0.4%, according to the operation in example 2
Method adds sample.Centrifuged with the special centrifugal machine of the reagent card, result of determination is as a result as shown in the table：
Summarize：Result above shows that the reaction result of the too low irregular antibody detection reagent of concentration and Quality Control is not met
Reaction result in example 2, show that corresponding irregular antibody detection reagent has problem in itself.Therefore, the present invention designs
Irregular antibodies screening quality-control product (micro-column gel agglutination assay) can play role of inspection to the quality of irregular antibody detection reagent.
The present invention illustrates the Blood grouping reagent quality-control product of the present invention and its preparation side merely by above-described embodiment
Method and the application in Blood grouping, but the invention is not limited in above-described embodiment, that is, do not mean that the present invention has to rely on
Above-described embodiment could be implemented.Person of ordinary skill in the field is it will be clearly understood that any improvement in the present invention, to the present invention
The equivalence replacement of each raw material of product and the addition of auxiliary element, the selection of concrete mode etc., all fall within protection scope of the present invention
Within the scope of disclosure.
Claims (10)
1. a kind of Blood grouping reagent quality-control product, it is characterised in that the quality-control product includes 6 bottles of ABO, RhD Blood grouping Quality Controls
Product, 5 bottles of cross matching quality-control products and 4 bottles of Irregular antibodies screening quality-control products, 6 bottles of ABO, RhD Blood groupings quality-control product point
It is not：A1 types RhD (+) red blood cell, Type B RhD (+) red blood cell, A serum, B serum, O-shaped RhD (+) red blood cell and RhD (-) are red thin
Each 1 bottle of born of the same parents；5 bottles of cross matching quality-control products are respectively AB types (+) red blood cell, O-shaped RhD (+) red blood cell, RhD (-) red thin
Born of the same parents, O serum, the anti-D of type containing IgG each 1 bottle of AB serum；4 bottles of Irregular antibodies screening quality-control products are respectively O serum and contained
Each 2 bottles of the anti-D of IgG types AB serum.
2. Blood grouping reagent quality-control product according to claim 1, it is characterised in that the red blood cell maintains red blood cell
Preserve in liquid, the alserver's solution includes Hepes 10-20g/L, NaCl 3-9g/L, D-Glucose 10-20g/L, and gland is fast
Purine 0.1-1g/L, inosine 1-5g/L, sodium citrate 1-10g/L, chloramphenicol 0.1-1g/L, neomycin 0.1-1g/L, gentamicin
0.1-1g/L, pH=6.8-7.4.
3. Blood grouping reagent quality-control product according to claim 1 or 2, it is characterised in that the A1 types RhD (+) is red thin
Born of the same parents, Type B RhD (+) red blood cell, O-shaped RhD (+) red blood cell, AB types (+) red blood cell, RhD (-) red blood cell are by taking A1 types respectively
RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+), RhD (-) packed red cells, diluted with the alserver's solution
Obtained into the red blood cell reagent that concentration is 0.8%.
4. the Blood grouping reagent quality-control product according to any one of claim 1-3, it is characterised in that in the A serum
Anti- B potency ＞ 128.
5. the Blood grouping reagent quality-control product according to any one of claim 1-4, it is characterised in that in the B serum
Anti- A potency ＞ 128.
6. the Blood grouping reagent quality-control product according to any one of claim 1-5, it is characterised in that in the O serum
Anti- A potency ＞ 128, anti-B potency ＞ 128.
7. the Blood grouping reagent quality-control product according to any one of claim 1-6, it is characterised in that the type containing IgG
The anti-D potency ＞ 128 of IgG types in anti-D AB serum.
8. the preparation method of the Blood grouping reagent quality-control product according to any one of claim 1-7, it is characterised in that institute
Preparation method is stated to comprise the following steps：
(1) preparation of alserver's solution：Each composition of alserver's solution is mixed, and adjusts pH=6.8-7.4, is obtained
To alserver's solution,
(2) preparation of red blood cell reagent：A1 type RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+), RhD are taken respectively
(-) packed red cells, the red blood cell reagent that concentration is 0.5%-1% is diluted to above-mentioned alserver's solution；
(3) A serum, B serum, O serum and the anti-D of type containing IgG AB serum are prepared；
(4) dispense：Preparation-obtained reagent is dispensed to 6 bottles of ABO, RhD Blood grouping quality-control products, 5 bottles of cross matching Quality Controls
In product and 4 bottles of Irregular antibodies screening quality-control products, the Blood grouping reagent quality-control product is obtained.
9. preparation method according to claim 8, it is characterised in that the preparation method comprises the following steps：
(1) preparation of alserver's solution：
By Hepes 10-20g, NaCl 3-9g add ultra-pure water 1L, fully mix, and adjust pH=6.8-7.4 with NaOH, add
D-Glucose 10-20g/L, adenine 0.1-1g/L, inosine 1-5g/L, sodium citrate 1-10g/L, chloramphenicol 0.1-1g/L, newly
Mycin 0.1-1g/L, gentamicin 0.1-1g/L, fully mix, 0.22 μm of filtering with microporous membrane；
(2) preparation of red blood cell reagent：A1 type RhD (+), Type B RhD (+), O-shaped RhD (+), AB type RhD (+), RhD are taken respectively
(-) packed red cells, it is diluted to the red blood cell reagent that concentration is 0.8% with above-mentioned alserver's solution and produces；
(3) preparation of serum：
A serum：Anti- B is added in AB serum, makes anti-B potency ＞ 128；
B serum：Anti- A is added in AB serum, makes anti-A potency ＞ 128；
O serum：Anti- A and anti-B are added in AB serum, make anti-A potency ＞ 128, anti-B potency ＞ 128；
The anti-D of type containing IgG AB serum：The anti-D of IgG types is added in AB serum, makes the anti-D potency ＞ 128 of IgG types；
(4) dispense：
The packing standard of reagent is as follows：
ABO, RhD Blood grouping quality-control product：
A1 types RhD (+) red blood cell：2mL/ bottle × 1 bottle；Type B RhD (+) red blood cell：2mL/ bottle × 1 bottle；A serum：2mL/ bottle × 1
Bottle, B serum：2mL/ bottle × 1 bottle；O-shaped RhD (+) red blood cell：2mL/ bottle × 1 bottle；RhD (-) red blood cell：1mL/ bottle × 1 bottle
Cross matching quality-control product：
AB types (+) red blood cell：2mL/ bottle × 1 bottle；O-shaped RhD (+) red blood cell：1mL/ bottle × 1 bottle；RhD (-) red blood cell：1mL/ bottles
× 1 bottle, O serum：2mL/ bottle × 1 bottle；The anti-D of type containing IgG AB serum：2mL/ bottle × 1 bottle
Irregular antibodies screening quality-control product：
O serum：2mL/ bottle × 2 bottle
The anti-D of type containing IgG AB serum：2mL/ bottle × 2 bottle.
10. application of the Blood grouping reagent quality-control product in Blood grouping according to any one of claim 1-7.
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Cited By (4)
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| CN109239364A (en) * | 2018-11-02 | 2019-01-18 | 上海市血液中心 | A kind of ABO blood type antibody titer detectability verification method, kit and system |
| CN109239365A (en) * | 2018-11-02 | 2019-01-18 | 上海市血液中心 | A kind of blood group serology the intensity of agglutination decision-making ability verification method, kit and system |
| CN109541233A (en) * | 2018-11-15 | 2019-03-29 | 上海市血液中心 | A kind of Serum Antibody Detection susceptibility proficiency testing method and its detection kit |
| CN112684191A (en) * | 2020-12-04 | 2021-04-20 | 上海润普生物技术有限公司 | ABO blood type positive and negative shaping and Rh blood type detection card and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109239364A (en) * | 2018-11-02 | 2019-01-18 | 上海市血液中心 | A kind of ABO blood type antibody titer detectability verification method, kit and system |
| CN109239365A (en) * | 2018-11-02 | 2019-01-18 | 上海市血液中心 | A kind of blood group serology the intensity of agglutination decision-making ability verification method, kit and system |
| CN109541233A (en) * | 2018-11-15 | 2019-03-29 | 上海市血液中心 | A kind of Serum Antibody Detection susceptibility proficiency testing method and its detection kit |
| CN112684191A (en) * | 2020-12-04 | 2021-04-20 | 上海润普生物技术有限公司 | ABO blood type positive and negative shaping and Rh blood type detection card and preparation method thereof |
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