CN109541240A - A kind of directly anti-detectability verification method and its detection kit - Google Patents
A kind of directly anti-detectability verification method and its detection kit Download PDFInfo
- Publication number
- CN109541240A CN109541240A CN201811360625.3A CN201811360625A CN109541240A CN 109541240 A CN109541240 A CN 109541240A CN 201811360625 A CN201811360625 A CN 201811360625A CN 109541240 A CN109541240 A CN 109541240A
- Authority
- CN
- China
- Prior art keywords
- positive
- straight anti
- red blood
- blood cell
- detectability
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
-
- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
Abstract
The present invention relates to blood testing fields, specifically disclose a kind of directly anti-detectability verification method and its detection kit.The described method includes: a) by difference, directly anti-positive proficiency testing products or the straight anti-positive proficiency testing product of mixed agglutination and specification consign to subject to evaluator；B) subject receives proficiency testing product and specification, is detected using antiglobulin method, records the material used, method and as a result, feed back to evaluator in the form of receipt together with testing result；C) evaluator's comprehensive analysis feedback as a result, accurate evaluation participate in subject straight anti-detectability.Proficiency testing product of the invention, it can be used for verifying or assessing immunohematology laboratory or the direct anti-globulin technique detectability of professional technician, or whether verifying specialized laboratory meets quality requirement in terms of straight anti-detectability, provides effective assessment tool.
Description
Technical field
The present invention relates to blood testing fields, specifically, being a kind of straight anti-detectability verification method and its detection examination
Agent box.
Background technique
Antihuman globulin test is also known as Coombs ' test, is the common method for checking incomplete antibody, is that diagnosis itself is exempted from
The most important test of epidemic disease hemolytic anemia.It is generally divided into straightway testing (directly reaction) and indirect test (indirect reaction).
The purpose of antihuman globulin test (direct method) is the incomplete antibody for checking erythrocyte surface, and antihuman globulin test is (indirectly
Method) purpose be to check in serum with the presence or absence of free incomplete antibody.Surface with corresponding antigens red blood cell with it is endless
Whole antibody is known as sensitized erythrocyte after combining, and the sensitized erythrocyte of mistake washed with brine is not aggregated in brine media,
It is then aggregated after anti-humanglobulin serum is added, i.e. antihuman globulin straightway testing is positive for this, indicates to have on red blood cell corresponding
Antibody exists；Red blood cell is not aggregated as negative reaction, indicates do not have corresponding antibodies presence on red blood cell.Immunohematology is related real
Test the ability that room or professional technician should have enough detections in direct anti-globulin technique context of detection, with meet it is clinical or
The demand of scientific research.Current existing similar quality-control product is " the external quality assurance product " that industry, tissue or laboratory are provided, or indoor
Quality-control product.These quality-control products are made of straight anti-positive and negative sample, the detection by laboratory to positive and negative sample, assessment
The accuracy of laboratory directly anti-experiment.The method belongs to qualitative detection, can not accurate evaluation laboratory straight anti-detectability.
" China's blood transfusion magazine " the 4th phase of volume 28 in April, 2015, " base's Blood Transfusion Dept. makes Internal Quality Control by oneself to the paper published
The method and possibility research of product ", makes independent blood plasma and red blood cell quality-control product by oneself, strong through affinity, antibody titer detection, agglutination
After the verifying such as degree and stability, according to the Internal Quality Control mode of designed, designed, abo blood group identification, RhD blood group is carried out, intersects and matches
The test such as blood test and irregular antibody screening, the results showed that homemade Internal Quality Control product, validity, specificity, stability
And reliability, meet the basic demand in " ISO15189 medical laboratory accreditation criterion " to IQC, it is poor can effectively to control blood transfusion
The generation of wrong accident." clinical blood transfusion and inspection " the 4th phase of volume 18 of in August, 2016, the paper published " blood transfusion compatibility sensing chamber
The self-control of interior quality-control product and Application research " makes Internal Quality Control product by oneself using the existing blood sample resource of Blood Transfusion Dept., specifically choose A, B,
O, each 10 parts of AB type blood sample are centrifuged after homotype mixing, and separated plasma is spare；After packed red cells brine with
CPDA Precerving liquid mixed in equal amounts is spare；1~2 part of sample of ABO homotype Rh (D) negative blood, after confirmed is chosen, is maintained with CPDA
Liquid mixed in equal amounts is spare；The anti-D serum of IgG uses commercial reagents.The red blood cell and blood plasma of various blood are advised according to standard operation
Cheng Jinhang serology verification test meets serological reaction pattern, and Quality Control red blood cell and standard serum the intensity of agglutination reach 4+, matter
It controls blood plasma and corresponding erythrocyte agglutination intensity is 2+, Fang Zuowei Internal Quality Control product use.Internal Quality Control product are for monitoring blood transfusion phase
The accuracy of capacitive testing result, the results showed that the Internal Quality Control product of preparation are qualified, are able to satisfy 4~6 weeks and use.Patent document
CN107576807A, publication date 2018.01.12 disclose a kind of Blood grouping reagent quality-control product and preparation method thereof and in blood
Application in type detection, the quality-control product include 6 bottles of ABO, RhD Blood grouping quality-control products, 5 bottles of cross matching quality-control products and 4 bottles
Irregular antibodies screening quality-control product, 6 bottles of ABO, RhD Blood grouping quality-control product are respectively as follows: A1 type RhD (+) red blood cell, Type B
RhD (+) red blood cell, A serum, B serum, O-shaped RhD (+) red blood cell and each 1 bottle of RhD (-) red blood cell；5 bottles of cross matching matter
Control product are respectively the AB serum of AB type (+) red blood cell, O-shaped RhD (+) red blood cell, RhD (-) red blood cell, O serum, the anti-D of type containing IgG
Each 1 bottle；4 bottles of Irregular antibodies screening quality-control products are respectively each 2 bottles of AB serum of O serum and the anti-D of type containing IgG.The blood
Type detection reagent quality-control product is used to ensure accuracy, specificity, affinity, the stability of Blood grouping, avoids in detection process
Testing result is set to be affected because detection itself is unqualified.However the above quality-control product is not used to the straight of assessment laboratory
Anti- detectability.In the prior art, it about straight anti-detectability verification method of the invention and its detection kit, yet there are no
Report.
Summary of the invention
The first purpose of this invention is aiming at the shortcomings in the prior art, to provide a kind of straight anti-detectability authentication
Method.
Second object of the present invention is aiming at the shortcomings in the prior art, to provide a kind of straight anti-detectability verifying reagent
Box.
To realize above-mentioned first purpose, the technical solution adopted by the present invention is that:
A kind of straight anti-detectability verification method, comprising the following steps:
A) evaluator is by different straight anti-positive proficiency testing products or the straight anti-positive proficiency testing products of mixed agglutination, and
Specification consigns to subject；The different straight anti-positive proficiency testing products are one group by the red thin of different straight anti-positive intensity
Born of the same parents' test sample and straight anti-negative red blood cell test sample form, and the straight anti-positive intensity refers in sample on single red blood cell
IgG antibody quantity, the IgG antibody quantitative range on single red blood cell is 4-560；The straight anti-positive ability of mixed agglutination
Verifying product is one group of red blood cell test specimens mixed with straight anti-negative red blood cell according to different proportion by straight anti-positive red blood cell
Product, the proportional region are 0.2-8%；The specification describes the operating method of verifying product；
B) subject receives proficiency testing product and specification, is detected using antiglobulin method, records the material used
Material and as a result, feeds back to evaluator together with testing result at method in the form of receipt；
C) evaluator analyzes the result of feedback；In different straight anti-positive proficiency testing products, with red blood cell test sample
In IgG antibody quantity on the average single red blood cell that detects as proficiency testing index；It is tested in different straight anti-positive abilities
It demonstrate,proves in product, detects that straight anti-positive red blood cell accounts for the percentage of total cell as proficiency testing index to test in red blood cell；
Reagent manufacturer used is included in assessment factor when subject is detected, and by analyzing subject's testing result, accurate evaluation is participated in
The straight anti-detectability of subject.
In above-mentioned straight anti-detectability verification method, as an optimal technical scheme, the different straight anti-positive energy
It further include straight anti-negative red blood cell test sample in power verifying product, as negative test sample detection positive findings occurs by conduct
Deduction item reduces the assessment result of subject's detectability.
In above-mentioned straight anti-detectability verification method, as an optimal technical scheme, the mixed agglutination directly anti-sun
Further include straight anti-negative red blood cell test sample in sexuality verifying product, is incited somebody to action as positive findings occurs in negative test sample detection
As deduction item, the assessment result of subject's detectability is reduced.
In above-mentioned straight anti-detectability verification method, as an optimal technical scheme, the different straight anti-positive energy
Power verifying product the preparation method is as follows: straight anti-negative red blood cell is mixed with the IgG blood group antibody of various concentration, be prepared into 3
The test red blood cell of~12 differences directly anti-intensity, by a series of test red blood cells of different straight anti-positive intensity and straight anti-feminine gender
Red blood cell is tested as different straight anti-positive proficiency testing products；IgG antibody quantity on the single red blood cell is 4,17,
70,140 or 560.
In above-mentioned straight anti-detectability verification method, as an optimal technical scheme, the mixed agglutination directly anti-sun
Sexuality verifying product mixes the preparation method is as follows: straight anti-positive red blood cell is pressed different proportion with straight anti-negative red blood cell,
Be made a series of straight anti-positive proficiency testing sample of mixed agglutination of determinations directly anti-yin-yang sex ratio, which is 0.2,0.5,
0.8,2,5 or 8%.
In above-mentioned straight anti-detectability verification method, as an optimal technical scheme, the straight anti-positive ability is tested
Demonstrate,proving the IgG antibody quantity in product on straight anti-positive red blood cell is 4,17,70,140 and 560, the mixed agglutination directly anti-sun
It is 0.2,0.5,0.8,2,5 and 8% that straight anti-positive red blood cell, which accounts for total cell percentage, in sexuality verifying product.
To realize above-mentioned second purpose, the technical solution adopted by the present invention is that:
A kind of straight anti-detectability verifying kit, include: (1) detectability verifying product includes different straight anti-positives
Proficiency testing product or the straight anti-positive proficiency testing product of mixed agglutination；The different straight anti-positive proficiency testing products are one group
It is made of the red blood cell test sample and straight anti-negative red blood cell test sample of different straight anti-positive intensity, the straight anti-positive is strong
Degree refers to the IgG antibody quantity in sample on single red blood cell, and the IgG antibody quantitative range on single red blood cell is 4-560；
The straight anti-positive proficiency testing product of mixed agglutination be one group by straight anti-positive red blood cell and straight anti-negative red blood cell according to not
The red blood cell test sample mixed in proportion, the proportional region are 0.2-8%；(2) specification: the specification describes institute
State the operating method or detectability appraisal procedure of detectability verifying product.
In above-mentioned straight anti-detectability verifying kit, as an optimal technical scheme, detectability appraisal procedure:
In different straight anti-positive proficiency testing products, with the IgG being averaged on single red blood cell detected in red blood cell test sample
Antibody levels are as proficiency testing index；In different straight anti-positive proficiency testing products, detected directly with testing in red blood cell
Anti-positive red blood cell accounts for the percentage of total cell as proficiency testing index；Reagent manufacturer used is included in when subject is detected
Assessment factor, by analyzing subject's testing result, accurate evaluation participates in the straight anti-detectability of subject.
In the present invention, the straight anti-detectability is embodied in two aspects, one is for disease (such as autoimmune disease
Disease) or treatment (such as drug-induced straight anti-positive) factor formed the straight anti-positive of red blood cell detectability；The second is for
The straight anti-positive of some red blood cells caused by the factors such as blood transfusion, i.e., the detectability of so-called " mixed agglutination " straight anti-positive.For standard
Really the ability of assessment these two aspects, the present invention use controllable method, prepare with can quantitative description, have different straight anti-
The proficiency testing product of positive strength, to simulate the former, and by specific straight anti-positive cell and straight anti-negative cells by certain ratio
Example mixing, is prepared into the test article of mixed agglutination positive, to simulate the verifying of the latter progress laboratory directly anti-detectability.
The invention has the advantages that:
1, present inventor is after extensive and in-depth study, it is understood that current existing similar quality-control product product or matter
Prosecutor method is not used to Objective corroboration or assesses immunohematology laboratory or the direct anti-ball egg of professional technician
White experiment (straight anti-) detectability, can not also verify whether laboratory conforms to quality requirements in terms of straight anti-detectability.
Present invention firstly provides a kind of straight anti-detectability verification methods, by the different straight anti-positive proficiency testing products of preparation, and
" mixed agglutination " straight anti-positive proficiency testing product is prepared, it not only can be to disease (such as autoimmune disease) or treatment (such as medicine
Straight anti-positive caused by object) detectability of the straight anti-positive of red blood cell that is formed of factor, it can also be blood transfusion etc. caused by factors
The detectability of the straight anti-positive of the straight anti-positive of dividend cell, i.e. " mixed agglutination ".
2, in different straight anti-positive proficiency testing products, by a series of IgG class blood group antibody of determining concentration, to ginseng
Try the straight anti-positive of laboratory testing ability carry out relative quantification assessment, and can between the testing result of not homogeneous into
Row compares, to find the variation of straight anti-detectability.
3, in " mixed agglutination " straight anti-positive proficiency testing product, pass through a series of determinations directly anti-yin-yang sex ratio
" mixed agglutination " straight anti-detectability verification sample, can accurate evaluation participate in the experiment laboratory to " mixed agglutination " straight anti-positive sample
Detectability.
4, proficiency testing product of the invention can be used for verifying or assessing immunohematology laboratory and (be engaged in red blood cell blood
The laboratory of type detection) or professional technician direct anti-globulin technique (straight anti-) detectability.Or verifying is special
Whether industry laboratory meets quality requirement in terms of straight anti-detectability, provides effective assessment tool.
Detailed description of the invention
Attached drawing 1: the laboratory quantity of the straight anti-cell detection of varying strength.Wherein, average in abscissa numerical value representative sample
IgG antibody quantity on single red blood cell.
Attached drawing 2: different type laboratory directly anti-detectability.Wherein, average single red in abscissa numerical value representative sample
IgG antibody quantity on cell.
Attached drawing 3: different vendor detects the percentage of various concentration.
Attached drawing 4: the laboratory quantity of the straight anti-cell detection of various concentration.Wherein, directly resist in abscissa numerical value representative sample
Positive cell percentage.
Attached drawing 5: the straight anti-detectability distribution in all kinds of laboratories.Wherein, straight anti-positive in abscissa numerical value representative sample
Cell percentage.
Attached drawing 6: the straight anti-detectability distribution based on different vendor's reagent.Wherein, straight in abscissa numerical value representative sample
Anti-positive cell percentage.
Attached drawing 7: the flow chart of straight anti-detectability verification method of the invention.
Specific embodiment
The invention will be further elucidated with reference to specific embodiments.It should be understood that these embodiments are merely to illustrate this hair
It is bright rather than limit the scope of the invention.In addition, it should also be understood that, after having read the content of the invention recorded, art technology
Personnel can make various changes or modifications the present invention, and such equivalent forms equally fall within the application the appended claims and limited
Fixed range.
Embodiment 1
1. the preparation of different straight anti-positive proficiency testing products: mixed using straight anti-negative, fresh, more person-portion, determine it is dense
A series of IgG class blood group antibody of determining concentration is added in the red blood cell of degree, is prepared into the test of 3~12 differences directly anti-intensity
Red blood cell.Since the concentration of red blood cell is it is known that the amount of IgG antibody be added can be obtained varying strength and directly resist it is known that by calculating
IgG antibody quantity in positive sample, on average each red blood cell.By the test articles of known straight anti-positive intensity a series of and
The proficiency testing product that several straight anti-negative " distracters " are combined into, can ability to the straight anti-positive of laboratory testing of participating in the experiment into
The assessment of row relative quantification, and can be compared between the testing result of not homogeneous, to find straight anti-detectability
Variation.
The preparation of " 2. mixed agglutination " straight anti-positive proficiency testing product: prepare and specific directly resist according to the method in above-mentioned 1
The red blood cell of positive strength is mixed with the red blood cell of straight anti-feminine gender by the different proportion drafted, a series of determinations directly anti-yin is made
The straight anti-detectability verification sample of " mixed agglutination " of positive ratio, wherein may make comprising the straight anti-negative red blood cell of certain amount
For yin control.By analyzing the testing result in laboratory of participating in the experiment, can accurate evaluation participate in the experiment laboratory to " mixed agglutination " straight anti-sun
The detectability of property sample.
3. nearly 200 laboratories have carried out research on probation to the present invention at home, from the interpretation of result of feedback, this method
Laboratory can effectively be assessed to the detectability of straight anti-positive sample.
4. the straight anti-cell detectability verification sample application example of varying strength: using the anti-D sensitization RhD of various concentration IgG
Positive red blood cell prepares direct anti-globulin technique (straight anti-experiment) detection sample.This purpose Key for Reference is each red blood cell
In conjunction with the quantity of IgG antibody.One shares 5 samples as the positive in 8 samples, and 3 samples are feminine gender.As shown in Figure 1, generation respectively
The each erythrocyte surface of table averagely has 560,140,70,17 and 4 IgG anti-Ds." 0 " of abscissa represents negative control, should
Item occurs positive being false positive.IgG antibody number on above-mentioned each red blood cell is after comparing with international standard substance, according to each
On red blood cell obtained from the ng/ml numerical value conversion of antibody.
Testing result shows, the straight anti-detectability limiting value in most of laboratories it is average " 70 IgG antibody molecules/
Red blood cell " is horizontal.Although thering are 4 unit detectabilities to reach " 4 IgG/ red blood cells " level, in view of there is 7 laboratories
There is false positive report, so a possibility that result that can not exclude this 4 laboratories is false positive.It is detailed in Fig. 1.Inhomogeneity
The reagent of type laboratory and different reagent manufacturers also has a significant effect (Fig. 2, Fig. 3) to detection.
5. mixing the positive straight anti-detectability test application example in the visual field: this straight anti-detectability test sample granting
Effectively 143, test paper is recycled in 190 laboratories.Wherein Blood Center 15, center blood station 20, front three general hospital 88,
20, other hospitals.It is red that this direct anti-globulin technique (straight anti-experiment) has used the anti-D sensitization RhD of IgG that straight anti-positive is made
Cell, the mode mixed under the conditions of various concentration with non-sensitized erythrocyte, i.e. mixing visual field mode are detected.Why make
With this kind of sample, in the blood sample for allowing for immune hemolysis patient, it may appear that the straight anti-phenomenon in the mixing visual field positive.This
Purpose Key for Reference is the percentage that straight anti-positive accounts for total cell.It detects that mixed straight anti-positive red cell proportion is lower, says
Bright detection method is more sensitive.One shares 6 samples as the positive in 8 samples.
This testing result, most of laboratory can detect that be mixed with 2%~5% straight anti-positive sample, it is different real
The capacity variance for testing room is larger, and detection limits differ 40 times or more.Influence of the reagent of different manufacturers to detection is also bigger,
It can be seen that using single factory reagent, in straight anti-context of detection, there may be problem (Fig. 4-6).
Embodiment 2
It is the flow chart of straight anti-detectability verification method of the invention referring to Fig. 7, Fig. 7.The following steps are included:
1, different straight anti-positive proficiency testing products or the straight anti-positive proficiency testing product of mixed agglutination are prepared first.
The different straight anti-positive proficiency testing product preparation methods are as follows: mixed using straight anti-negative, fresh, more person-portion
The red blood cell of concentration is closed, determined, a series of IgG class blood group antibody of determining concentration is added, 3~12 differences is prepared into and directly resists by force
The test red blood cell of degree determines average single in each blood group antibody according to the concentration of red blood cell and the amount of IgG antibody be added
IgG antibody quantity on a red blood cell, a series of test red blood cell of above-mentioned different straight anti-positive intensity and straight anti-feminine gender is " dry
Disturb item " red blood cell is tested as different straight anti-positive proficiency testing products.IgG antibody quantity on single red blood cell for example can be with
It is 0-560, the IgG antibody quantity on the preferred single red blood cell for example can be 4,17,70,140 or 560.
The straight anti-positive proficiency testing product preparation method of mixed agglutination is as follows: preparing according to the method described above specific straight anti-
The red blood cell of positive strength is mixed with the red blood cell of straight anti-feminine gender by the different proportion drafted, a series of determinations directly anti-yin is made
The straight anti-positive proficiency testing sample of " mixed agglutination " of positive ratio.The ratio for example can be 0-8%, the preferred percentage
Ratio can be 0.2,0.5,0.8,2,5 or 8%.Intensity described in the range of choice and 1 of the specific straight anti-positive intensity
Range is identical.
2, evaluator is by above-mentioned different straight anti-positive proficiency testing products or the straight anti-positive proficiency testing products of mixed agglutination,
And specification consigns to subject, the specification describes the operating method of verifying product, and the operating method is existing
The direct anti-globulin technique of standard (straight anti-experiment) operating method.
3, subject receives proficiency testing product and specification, requires to carry out using standard antiglobulin method to specifications
Detection, is recorded the material used, method and as a result, is fed back to evaluator in the form of receipt together with testing result.
4, evaluator analyzes the result of feedback.In different straight anti-positive proficiency testing products, examined with testing in red blood cell
For the IgG antibody quantity on average single red blood cell measured as proficiency testing index, the quantity is smaller, represents tester and directly resists
Detectability is stronger.In different straight anti-positive proficiency testing products, straight anti-positive red blood cell is detected to test in red blood cell
The percentage of total cell is accounted for as proficiency testing index, the percentage is smaller, and directly anti-detectability is stronger by table tester.It is described by
Examination person can be unit or individual；The mode that both sides deliver can be mailing, express delivery, face to face delivery etc.；To the straight of subject
After anti-detectability comprehensive assessment, the straight anti-detectability of different subjects can also be compared, or to same subject
Multiple straight anti-detectability is compared.
Embodiment 3
A kind of straight anti-detectability verifying kit, include: (1) detectability verifying product includes different straight anti-positives
Proficiency testing product or the straight anti-positive proficiency testing product of mixed agglutination；The different straight anti-positive proficiency testing products are one group
It is made of the red blood cell test sample and straight anti-negative red blood cell test sample of different straight anti-positive intensity, the straight anti-positive is strong
Degree refers to the IgG antibody quantity in sample on single red blood cell, and the IgG antibody quantitative range on single red blood cell is 4-560；
The straight anti-positive proficiency testing product of mixed agglutination be one group by straight anti-positive red blood cell and straight anti-negative red blood cell according to not
The red blood cell test sample mixed in proportion, the proportional region are 0.2-8%；(2) specification: the specification describes institute
State the operating method or detectability appraisal procedure of detectability verifying product.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
Member, under the premise of not departing from the method for the present invention, can also make several improvement and supplement, these are improved and supplement also should be regarded as
Protection scope of the present invention.
Claims (8)
1. a kind of straight anti-detectability verification method, which comprises the following steps:
A) evaluator is by different straight anti-positive proficiency testing products or the straight anti-positive proficiency testing products of mixed agglutination, and explanation
Book consigns to subject；The different straight anti-positive proficiency testing products are that one group of red blood cell by different straight anti-positive intensity is surveyed
Test agent and straight anti-negative red blood cell test sample form, and the straight anti-positive intensity refers in sample on single red blood cell
IgG antibody quantity, the IgG antibody quantitative range on single red blood cell are 4-560；The straight anti-positive ability of mixed agglutination is tested
Card product is one group of red blood cell test sample mixed with straight anti-negative red blood cell according to different proportion by straight anti-positive red blood cell,
The proportional region is 0.2-8%；The specification describes the operating method of verifying product；
B) subject receives proficiency testing product and specification, is detected using antiglobulin method, records the material used, side
Method and as a result, feeding back to evaluator in the form of receipt together with testing result；
C) evaluator analyzes the result of feedback；In different straight anti-positive proficiency testing products, to be examined in red blood cell test sample
The IgG antibody quantity on average single red blood cell measured is as proficiency testing index；It is produced in different straight anti-positive proficiency testings
In product, detect that straight anti-positive red blood cell accounts for the percentage of total cell as proficiency testing index to test in red blood cell；It will be by
Examination person reagent manufacturer used when detecting is included in assessment factor, and by analyzing subject's testing result, accurate evaluation participates in tested
The straight anti-detectability of person.
2. straight anti-detectability verification method according to claim 1, which is characterized in that the different straight anti-positive abilities are tested
Further include straight anti-negative red blood cell test sample in card product, deduction will be used as positive findings occurs in negative test sample detection
, reduce the assessment result of subject's detectability.
3. straight anti-detectability verification method according to claim 1, which is characterized in that the straight anti-positive energy of mixed agglutination
It further include straight anti-negative red blood cell test sample in power verifying product, as negative test sample detection positive findings occurs by conduct
Deduction item reduces the assessment result of subject's detectability.
4. straight anti-detectability verification method according to claim 2, which is characterized in that the different straight anti-positive abilities are tested
Card product the preparation method is as follows: straight anti-negative red blood cell is mixed with the IgG blood group antibody of various concentration, be prepared into 3~12
The test red blood cell of a different straight anti-intensity, by a series of test red blood cell of different straight anti-positive intensity and straight anti-negative test
Red blood cell is as different straight anti-positive proficiency testing products；IgG antibody quantity on the single red blood cell is 4,17,70,140
Or 560.
5. straight anti-detectability verification method according to claim 3, which is characterized in that the straight anti-positive energy of mixed agglutination
Mixing the preparation method is as follows: straight anti-positive red blood cell is pressed different proportion with straight anti-negative red blood cell for power verifying product, is made
A series of straight anti-positive proficiency testing sample of mixed agglutination of determinations directly anti-yin-yang sex ratio, which is 0.2,0.5,0.8,2,
5 or 8%.
6. straight anti-detectability verification method according to claim 1, which is characterized in that the straight anti-positive proficiency testing produces
IgG antibody quantity in product on straight anti-positive red blood cell is 4,17,70,140 and 560, the straight anti-positive energy of mixed agglutination
It is 0.2,0.5,0.8,2,5 and 8% that straight anti-positive red blood cell, which accounts for total cell percentage, in power verifying product.
7. a kind of straight anti-detectability verifying kit is, characterized by comprising: (1) detectability verifies product, comprising different
Straight anti-positive proficiency testing product or the straight anti-positive proficiency testing product of mixed agglutination；The different straight anti-positive proficiency testings produce
Product are that one group of red blood cell test sample by different straight anti-positive intensity is formed with straight anti-negative red blood cell test sample, described straight
Anti-positive intensity refers to the IgG antibody quantity in sample on single red blood cell, and the IgG antibody quantitative range on single red blood cell is
4-560；The straight anti-positive proficiency testing product of mixed agglutination is one group red thin by straight anti-positive red blood cell and straight anti-feminine gender
The red blood cell test sample that born of the same parents mix according to different proportion, the proportional region are 0.2-8%；(2) specification: the specification
Describe the operating method or detectability appraisal procedure of the detectability verifying product.
8. straight anti-detectability verifies kit according to claim 7, which is characterized in that detectability appraisal procedure:
It is anti-with the IgG being averaged on single red blood cell detected in red blood cell test sample in different straight anti-positive proficiency testing products
Body quantity is as proficiency testing index；In different straight anti-positive proficiency testing products, straight resist is detected to test in red blood cell
Positive red blood cell accounts for the percentage of total cell as proficiency testing index；Reagent manufacturer used, which is included in, when subject is detected comments
Estimate factor, by analyzing subject's testing result, accurate evaluation participates in the straight anti-detectability of subject.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811360625.3A CN109541240A (en) | 2018-11-15 | 2018-11-15 | A kind of directly anti-detectability verification method and its detection kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811360625.3A CN109541240A (en) | 2018-11-15 | 2018-11-15 | A kind of directly anti-detectability verification method and its detection kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109541240A true CN109541240A (en) | 2019-03-29 |
Family
ID=65847661
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811360625.3A Pending CN109541240A (en) | 2018-11-15 | 2018-11-15 | A kind of directly anti-detectability verification method and its detection kit |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109541240A (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101718784A (en) * | 2009-11-25 | 2010-06-02 | 江阴力博医药生物技术有限公司 | Method for preparing kit for testing hemolytic disease of newborn |
| CN102183631A (en) * | 2011-02-23 | 2011-09-14 | 中国人民解放军总医院 | Indoor quality control product kit for detecting blood transfusion compatibility |
| CN102680717A (en) * | 2012-05-30 | 2012-09-19 | 江苏力通生物技术有限公司 | Internal quality control kit for detecting transfusion compatibility and production process thereof |
| US20130130280A1 (en) * | 2010-07-21 | 2013-05-23 | Diagast | Magnetic immunodiagnostic methods and kit for the demonstration of antibody/antigen complexes in erythrocyte blood grouping and phenotyping |
| US20170370951A1 (en) * | 2015-01-14 | 2017-12-28 | Bio-Rad Laboratories, Inc. | Blood analysis systems and methods |
| CN108680756A (en) * | 2018-05-21 | 2018-10-19 | 中国科学院苏州生物医学工程技术研究所 | A kind of incomplete antibody detection kit and detection method |
-
2018
- 2018-11-15 CN CN201811360625.3A patent/CN109541240A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101718784A (en) * | 2009-11-25 | 2010-06-02 | 江阴力博医药生物技术有限公司 | Method for preparing kit for testing hemolytic disease of newborn |
| US20130130280A1 (en) * | 2010-07-21 | 2013-05-23 | Diagast | Magnetic immunodiagnostic methods and kit for the demonstration of antibody/antigen complexes in erythrocyte blood grouping and phenotyping |
| CN102183631A (en) * | 2011-02-23 | 2011-09-14 | 中国人民解放军总医院 | Indoor quality control product kit for detecting blood transfusion compatibility |
| CN102680717A (en) * | 2012-05-30 | 2012-09-19 | 江苏力通生物技术有限公司 | Internal quality control kit for detecting transfusion compatibility and production process thereof |
| US20170370951A1 (en) * | 2015-01-14 | 2017-12-28 | Bio-Rad Laboratories, Inc. | Blood analysis systems and methods |
| CN108680756A (en) * | 2018-05-21 | 2018-10-19 | 中国科学院苏州生物医学工程技术研究所 | A kind of incomplete antibody detection kit and detection method |
Non-Patent Citations (2)
| Title |
|---|
| 焦芳艳等: "湖南省临床血型学EQARh弱(D)抗原检测结果分析与探讨", 《湖南师范大学学报（医学版）》 * |
| 胡丽华: "《临床输血检验》", 31 March 2010 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Beauchamp et al. | Sweat‐testing: a review of current technical requirements | |
| CN205656141U (en) | But conventional analytical equipment of simultaneous measurement CRP and blood | |
| CN108613977B (en) | N-terminal brain natriuretic peptide precursor detection kit | |
| CN112526134A (en) | Chitinase 3-like protein 1 determination kit | |
| Cui et al. | Water as a probe for serum–based diagnosis by temperature–dependent near–infrared spectroscopy | |
| CN109374902A (en) | A kind of latex enhancing Immunoturbidimetric kit of quantitative detection IgG4 and preparation method thereof | |
| CN109187955A (en) | It is a kind of for detecting the kit and its detection method of d-dimer | |
| Wang et al. | Analytical comparison between two hematological analyzer systems: Mindray BC‐5180 vs Sysmex XN‐1000 | |
| CN109061125A (en) | The method and purposes of reliability assessment are carried out to the result of the quantitative detection project of detection system | |
| Verbakel et al. | Clinical reliability of point-of-care tests to support community based acute ambulatory care | |
| CN207067137U (en) | Chemical illumination immunity analysis instrument | |
| CN109946129A (en) | Five classification cellanalyzer quality-control product preparation methods | |
| CN109541240A (en) | A kind of directly anti-detectability verification method and its detection kit | |
| Taylor et al. | Assessment of laboratory improvement by the Center for Disease Control diagnostic immunology proficiency testing program | |
| CN109239365A (en) | A kind of blood group serology the intensity of agglutination decision-making ability verification method, kit and system | |
| CN106546729B (en) | Novel process method for removing serum matrix effect in dry immunofluorescence quantitative detection | |
| CN106053782B (en) | The method for building up of brucellosis immunoprecipitation test quality control chart and application | |
| CN109541233A (en) | A kind of Serum Antibody Detection susceptibility proficiency testing method and its detection kit | |
| CN109239364A (en) | A kind of ABO blood type antibody titer detectability verification method, kit and system | |
| CN103777025B (en) | The preparation method of the critical value one-level reference material of protein microarray chip, the determination of critical value coefficient and experimental result decision method | |
| Pinkerton et al. | Proficiency testing in immunohaematology in Ontario, Canada, 1977–1979 | |
| Bandi et al. | Immunochemical methods for measurement of transferrin in serum: effects of analytical errors and inappropriate reference intervals on diagnostic utility. | |
| CN109239372A (en) | Abo blood group antigen detectability verifies product and its application | |
| CN104237526B (en) | A kind of system detecting Alzheimer disease risk | |
| Little et al. | Evaluation of solid-phase panreactivity with negative direct antiglobulin testing |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190329 |