CN103926400A - Test strip for specifically measuring IgM, IgG and IgA blood group antibodies - Google Patents
Test strip for specifically measuring IgM, IgG and IgA blood group antibodies Download PDFInfo
- Publication number
- CN103926400A CN103926400A CN201410135589.6A CN201410135589A CN103926400A CN 103926400 A CN103926400 A CN 103926400A CN 201410135589 A CN201410135589 A CN 201410135589A CN 103926400 A CN103926400 A CN 103926400A
- Authority
- CN
- China
- Prior art keywords
- antibody
- sample
- blood group
- filter membrane
- igg
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
Abstract
The invention belongs to the field of biological medicines and discloses an immunochromatography test paper technology, which is used for specifically measuring the negative, positive and titer of IgM, IgG and IgA blood group antibodies in blood or body fluid or tissue fluid or secretion of people. The technology comprises the following steps: (1) preparing a sample filter membrane and a sample pad; (2) preparing a tracer and a tracing pad; (3) preparing a fiber membrane detection area and a quality control area; (4) labeling a test strip; (5) assembling the test strip; (6) injecting a sample and detecting; and (7) reading a result. The test strip can be used for measuring IgM anti-A and anti-B antibody titer, monitoring implantation of bone marrow transplantation and measuring the titer of immune IgG anti-A and anti-B antibodies of individuals, particularly prenatal pregnant women and newborns, the reverse typing of blood groups can be accurately judged by specifically measuring the IgM anti-A and anti-B antibodies, and the reverse typing of the blood group of an individual can be judged through saliva without blood sampling by specifically measuring IgA anti-A and anti-B antibodies in secretion.
Description
Technical field
The invention belongs to biomedicine field, a kind of method that adopts immune chromatography test paper technology specific assay IgM and IgG and the anti-A of IgA and anti-blood group antibody B and tire is disclosed, can be used for measuring the anti-A of IgM and the implantation of anti-B antibody titer monitoring bone-marrow transplantation, measure tiring of individual particularly pregnant woman antenatal and the anti-A of neonatal immunity IgG and anti-B antibody, the anti-A of specific assay IgM and anti-B antibody can accurately judge the reverse type of blood group, the anti-A of IgA in specific assay juice and anti-B antibody can be without blood sampling by the reverse types of the individual blood group of the judgements such as saliva.
Background technology
Immune chromatography test paper technology from eighties of last century the eighties so far, various infectious disease agents have been widely used in, antibody, hormone, enzyme, the detection of tumor markers and medicine, basic main points and the method for operating of this technology, extensively be disclosed in domestic and international textbook, document, the media such as network or carrier, its ultimate principle is, when sample joins behind sample area, prolong test strips while migrating to spike pad, the tested factor and tracer in sample are combined into " compound ", and continue to prolong test strips and migrate to detection zone, the specificity junction mixture that is embedded in detection zone is caught, tracer demonstrates band with color, unnecessary or other " compound " continues to migrate to Quality Control district, form Quality Control band with the specificity junction mixture of embedding, prompting detects effectively, finally according to detection zone, whether there is band or band color, the tested factor negative of interpretation or the positive or semidefinite value or quantitative values.
Retrieval Chinese patent, there are numerous patents all to adopt immune chromatography test paper technology to set up specific detection method, the immune chromatography test paper technology that these patents adopt is basically identical, difference is, or the sample the detecting factors different or that detect objects different or that detect are different, also or to detect the factor all identical with testing goal, but the mode detecting is different, if any employing dual-antigen sandwich method, the use double antibody sandwich method having etc.
About abo blood group, its assay method comprises positive definite method and instead determines method, and positive definite is A, the Blood group antigen B of measuring on red blood cell, is instead anti-A, anti-blood group antibody B in mensuration serum surely, and blood group antibody comprises IgM class and IgG class and IgA antibody-like.At present blood group determination is the most all to adopt agglutination, and its principle is to utilize blood group antigens and antibody response to cause that macroscopic red cell agglutination carrys out judged result, regularly positive, uses the anti-A of IgM or anti-B reagent to detect the red cell antigens of sample; Regularly anti-, use the red blood cell reagent of known A or Type B to measure the IgM blood group antibody in sample serum.The agglutination time is fast, cost is low, accuracy rate is high, is the standard method of bracket for blood grouping, still, if agglutination does not carry out special processing to sample in advance, still can not directly measure blood group antibody, can not the different classes of blood group antibody of specific assay, more can not measure its antibody titer.
In Chinese patent, there are a plurality of patents to adopt immunity layer test paper technology to measure abo blood group, if application for a patent for invention number 02159979.3, utility application numbers 200920041078.2, utility application 200920041080.X and utility application numbers 200720079592.6 is to measure the erythrocytic blood group antigens of sample, the i.e. positive definite form of blood group; Above-mentioned utility model patent 200720079592.6 and application for a patent for invention numbers 200910158167 and application number 201310394101.7 are blood group antibodies of measuring in sample serum, be the reverse type of blood group, and be all to use " tunica fibrosa carrier carries out antigen-antibody reaction " to complete mensuration.
These are measured in the patent of blood group antibody, application for a patent for invention numbers 201310394101.7 is to adopt " colour developing of tunica fibrosa carrier+enzyme linked immunological enzyme " method, utility application numbers 200720079592.6 and application for a patent for invention numbers 200910158167 are the methods that adopts " colour developing of tunica fibrosa carrier+immunochromatography trace particle ", but they are all mixing blood group antibodies of measuring in human serum, can not specific detection IgM or IgG class or IgA class blood group antibody, more can not measure tiring of antibody.
Literature search, there is not yet both at home and abroad at present and adopts immune chromatography test paper technology, and specific assay IgM or IgG class or IgA class blood group antibody and the report of tiring thereof, also have no existing commercial reagents box, also do not retrieve relevant Chinese patent.
The application adopts immune chromatography test paper technology equally, but specific assay IgM or IgG or IgA blood group antibody and tire.During specific assay IgM, can be used for blood group anti-fixed, will synchronize with agglutination (agglutination is measured IgM antibody), get rid of the interference of the antibody such as IgG, reduce HOOK effect, can greatly improve the Stability and veracity of measurement result; During specific assay IgM antibody titer, can monitor the whether success of implantation of bone-marrow transplantation, will be the simplest and the most directly prove, the scientific research of the medical science that also can be used for transfusing blood; During specific assay IgG blood group antibody, can measure tiring or sxemiquantitative or quantitative values of IgG antibody, can be used for the mensuration of individual particularly pregnant woman and the anti-A of neonatal immunity or anti-B antibody titer, prevention abo blood group neonatal hemolytic disease (HDN); When the anti-A of IgA in specific assay juice and anti-B antibody, can measure by juices such as salivas the reverse type of individual blood group, without sample of blood, drawn, also without saliva is carried out to special processing, can make blood group determination enter that family tests oneself or oneself measures (DIY), and the non-secretory individuality that saliva was surveyed blood group approximately 20% in the past cannot detect.Meanwhile, the immune chromatography test paper technology of the application's design, does not need people's blood sample to carry out serum separation, does not need the necessary equipment such as hydro-extractor of agglutination, operates relatively simple, time saving and energy saving accurate yet.
Summary of the invention
A kind of immune chromatography test paper method that the present invention relates to specific assay blood group antibody and tire, it is characterized in that, can the anti-A of specific assay IgM and the tiring of the tiring of the tiring of anti-blood group antibody B, the anti-A of specific assay IgG and anti-blood group antibody B, the anti-A of specific assay IgA and anti-blood group antibody B, the anti-A of specific assay IgM and anti-blood group antibody B, the anti-A of specific assay IgG and anti-blood group antibody B, the anti-A of specific assay IgA and anti-blood group antibody B.
The main contents of method for making of the present invention and detection method comprise: the making of (1) sample filter membrane and sample pad; (2) making of tracer and spike pad; (3) preparation in tunica fibrosa detection zone and Quality Control district; (4) mark of test strips; (5) assembling of test strips; (6) application of sample detects; (7) result interpretation.Concrete method for making and concrete detection method are as follows.
1. the making of sample filter membrane and sample pad: the area of sample filter membrane and sample pad is 1 square millimeter to 1 square metre, sample filter membrane comprises 2 kinds, the first is sample " visible component filter membrane ", mainly to stop the red blood cell that may contain in sample and the visible component of other large volume, the aperture of filter membrane is less than 6 to 8 microns, material is polyester film or glass film or tunica fibrosa, the number of plies is 1 to 100 layer, according to the difference of the difference of sample and sample pad material, " visible component filter membrane " can be used also and can not use, the second sample filter membrane is sample " specific component filter membrane ", filter membrane is nitrocellulose membrane or acidifying tunica fibrosa or pure tunica fibrosa or nylon membrane, the anti-human IgM antibody of embedding and (or) anti-human IgG antibody and (or) Anti-Human IgA antibody and (or) specific antibody agglutinin and (or) anti-A and (or) anti-B and (or) anti-AB antibody and (or) Staphylococal Protein A and (or) B antigen and (or) AB antigen and (or) albumin A and (or) Protein G on film, filter membrane can be 1 to 100 layer, under different objects, " specific component filter membrane " can be used also and can not use, the function of described " visible component filter membrane " can be realized by " specific component filter membrane ", sample pad at least comprises application of sample pad (8) and (or) visible component filter membrane (7) and (or) specific component filter membrane (5) and (or) hydrophilic layer (6), the material of described application of sample pad is polyester film or glass film or hemofiltration film, and when using hemofiltration film, the function of sample " visible component filter membrane " can be substituted by hemofiltration film, described hydrophilic layer is hydrophilic paper or water wetted material.
2. the making of tracer and spike pad: tracer comprises trace particle bond and trace particle, trace particle is collaurum or electroselenium or CI or latex or gelatin or magnetic bead or magnetic-particle or fluorescein or fluorescent microsphere or quantum dot or nm of gold or lanthanide series or organic nano particle or nano magnetic material or carbon nano-tube, trace particle bond is anti-human IgM antibody and (or) anti-human IgG antibody and (or) Anti-Human IgA antibody and (or) specific antibody agglutinin and (or) anti-A and (or) anti-B and (or) anti-AB antibody and (or) Staphylococal Protein A and (or) B antigen and (or) AB antigen and (or) albumin A and (or) Protein G, after trace particle bond mark trace particle, it is tracer, polyester film or glass film are spike pad after containing tracer, the area of spike pad is 1 square millimeter to 1 square metre.
3. the preparation in tunica fibrosa detection zone and Quality Control district: the area of 1 tunica fibrosa is 1 square millimeter to 1 square metre, 1 tunica fibrosa detection zone or be called detection line or T district or T line, the detection thing of embedding specificity blood group antibody, tunica fibrosa is nitrocellulose membrane or acidifying tunica fibrosa or pure tunica fibrosa or nylon membrane, the detection thing of described blood group antibody is the reactant of Staphylococal Protein A or B antigen or AB antigen or anti-A or anti-B or anti-AB antibody or agglutinin or albumen or tracer, on same 1 tunica fibrosa, 1 to 100 anti-A detection line and (or) 1 to 100 anti-B detection line can be set, the width of every detection line is 0.001 millimeter to 50 centimetres, length is 0.001 millimeter to 50 centimetres, the coated concentration of the detection thing of every detection line is the saturation concentration of the adhesion of specific blood group antibody of tiring, 1 tunica fibrosa Quality Control district or claim nature controlling line or C district or C line, the anti-antibody that embedding can be combined with tracer or agglutinin or albumen, 1 tunica fibrosa can arrange detection zone and Quality Control district simultaneously, and when 1 tunica fibrosa is embedded with 1 or many detection lines, nature controlling line can be set up also and can not set up, 1 tunica fibrosa can arrange the detection line that 1 specific antibodies is tired, and also the detection line that a plurality of specific antibodies are tired can be set, the detection line that different antibodies is tired can be arranged on 1 tunica fibrosa, also can be arranged on a plurality of different tunica fibrosas, now, can use water wetted material to make them arranged together.
4. the mark of test strips: its method be in test strips back up pad between the anti-A of mark and (or) anti-B antibody titer 1:1 to 1:16384 any one or more, mark can be other numeral or symbol or the word that represents described antibody and described antibody titer, and mark also can directly be marked on tunica fibrosa or be marked at other position of test strips.
5. the assembling of test strips: one or more test strips at least comprise one or more back up pads (1) and (or) tunica fibrosa (2) and (or) absorption pad (3) and (or) spike pad (4) and (or) specific component filter membrane (5) and (or) hydrophilic layer (6) and (or) visible component filter membrane (7) and (or) application of sample pad (8); The area of test strips is 1 square millimeter to 1 square metre; Each test strips can be used separately, also can 2 to 1000 test strips fit together use, and each test strips is used the independently independent application of sample of sample pad to detect, and also can a plurality of test strips share the application of sample detection together of 1 sample pad; One or more test strips can have one or more back up pads (1); One or more test strips can comprise one or more tunica fibrosas (2), and tunica fibrosa can be used in cutting, also can separate subregion by the mode of blocking-up liquid migration and use.
6. application of sample detects: its mode is, is loaded onto in the sample pad described in claims 1 and claims 2 sample is manual by particular device application of sample or by automation equipment; Described sample can dilute use or pre-service is used or do not dilute and use or not pre-service use, places after several seconds or tens of minutes after application of sample, if when reacting appears in the nature controlling line being provided with, starts sentence read result; Described sample comprises people's blood sample, body fluid, juice, tissue fluid, whole blood, serum, blood plasma, finger blood, saliva, urine; Each application of sample amount detecting is 1 microlitre to 10000 microlitre.
7. result interpretation: its content comprises, the tiring or tiring of the feminine gender of semidefinite value or quantitative values, the anti-A of IgG and (or) the anti-B antibody of IgG and positive findings, the anti-A of IgG and (or) the anti-B antibody of IgG or tiring or the reverse type of semidefinite value or quantitative values, abo blood group of the feminine gender of semidefinite value or quantitative values, the anti-A of IgA and (or) the anti-B antibody of IgG and positive findings, the anti-A of IgA and (or) the anti-B antibody of IgG of the anti-A of IgM of the determined sample of interpretation and (or) the feminine gender of the anti-B antibody of IgM and positive findings, the anti-A of IgM and (or) the anti-B antibody of IgM; Interpretation can have or not according to color or depth interpretation by naked eyes, also can use commercialization or homemade test strips instrument device, excitation source, optical filter, CCD scanning, optical fiber technology, opacimeter, color identification and other automatic intopretoscope interpretation testing result or provide inferred results by equipment.Following table several possible testing results of giving an example.
| Anti-A antibody: the highest positive is tired | Anti-B antibody: the highest positive is tired | Result: antibody isotype need comprehensively judge according to different test design |
| 1:64 is positive | 1:512 is positive | The anti-A 1:64 that tires; The anti-B 1:512 that tires |
| 1:512 is positive | 1:64 is positive | The anti-A 1:512 that tires; The anti-B 1:64 that tires |
| 1:512 is positive | 1:512 is positive | The anti-A 1:512 that tires; The anti-B 1:512 that tires |
| 1:64 is positive | 1:64 is positive | The anti-A 1:64 that tires; The anti-B 1:64 that tires |
8. " specific component filter membrane " (5) described in, its repertoire or its partial function can be realized according to the antibody of the embedding described in claims 2 " specific component filter membrane " or agglutinin or material by the detection zone of tunica fibrosa (2) and the part for tunica fibrosa between application of sample pad (8) or a part of embedding of other material.
9. the embedding thing in " sample filter membrane " and " tracer " and " detection zone " and " Quality Control district " described in, can be according to the ultimate principle of immunochromatography technique because using different detection modes to change, described detection mode comprises double antibody sandwich method, dual-antigen sandwich method, indirect method, fluorescent marker method, competition law, sizing technique, semiquantitative method, prize law and back flow of sample method; Use different detection modes, can specific assay IgM and (or) IgG and (or) IgA blood group antibody, also can measure the mixing blood group antibody of IgM and (or) IgG and (or) IgA, can specific assay IgM and (or) the tiring of IgG and (or) IgA blood group antibody, also can measure tiring of IgM and (or) IgG and (or) IgA mixing blood group antibody, can be for qualitative analysis blood group antibody negative or positive and for judging the reverse type of the blood group of determined sample.
10. the blood group described in and blood group antibody, is characterized in that, blood group comprises A, B, O and the AB type of abo blood group, and wherein A type comprises A, A1 and A2 type, and AB type comprises AB, A1B and A2B type; Described blood group antibody comprises anti-A and anti-B antibody, and wherein anti-A antibody comprises anti-A and anti-A1 antibody; The classification of described blood group antibody comprises IgG and IgM and IgA antibody.
Staphylococal Protein A described in 11. and B antigen and AB antigen, be the body fluid blood group substance of the erythrocyte membrane antigen that extracts or extraction or manually synthetic carbohydrate antigen or glycoprotein or glycolipid, and Staphylococal Protein A comprises Staphylococal Protein A and A1 antigen.
Accompanying drawing explanation
Fig. 1 is composition and the antigen-antibody embedding of the specific assay blood group antibody test strips of tiring and detects schematic diagram.1. back up pad; 2. tunica fibrosa; 3. absorption pad; 4. spike pad; 5. specific component filter membrane; 6. hydrophilic layer; 7. visible component filter membrane; 8. application of sample pad; 9. the factor to be measured; 10. tracer; 11. factor reactants to be measured; 12. tracer reactants; 64,128,256,512 and 1024 be respectively detection zone, numeral represents respectively the 1:64 that tires, 1:128,1:256,1:512 and the 1:1024 of specific antibody; C represents Quality Control district.
Embodiment
Embodiment 1: a kind of immuno-chromatographic test paper strip method of measuring pregnancy serum or the anti-A of blood plasma and anti-B antibody titer, key step is as follows.
1. the making of sample filter membrane: comprise a kind " specific component filter membrane ", select nitrocellulose membrane, the anti-human IgM antibody of saturated embedding.
2. the making of tracer and spike pad: tracer comprises trace particle bond and trace particle, and trace particle is selected collaurum, trace particle bond is goat-anti-human IgG antibody, and tracer scattered adsorption is lyophilized into spike pad in fiberglass packing.
3. the preparation in tunica fibrosa detection zone and Quality Control district: tunica fibrosa is selected nitrocellulose membrane, is used 2 tunica fibrosas, establishes 4 of detection lines for 1, respectively embedding blood group antigens A; Another 1 tunica fibrosa is established 4 detection lines equally, respectively embedding blood group antigens B; Anti-goat-anti-the human IgG antibody of the equal embedding in Quality Control district.
4. the mark of test strips: the position of the corresponding tunica fibrosa detection line of test strips back up pad is mark 1:64,1:128,1:256,1:512 respectively.
5. the assembling of test strips: minute 2 test strips, each test strips is all assembled by accompanying drawing, then parallel 1 integral body, the middle distance that keeps 1 millimeter, 2 shared 1 sample pad of test strips of fixedly becoming.
6. application of sample detects: pregnancy serum or blood plasma, use 64 times of normal saline dilutions, and then 1 or 50 microlitre application of samples are in sample pad.
While there is bands visible in 7.Dai Quality Control district, according to the form below sentence read result (giving an example).
| Anti-A: the highest positive is tired | Anti-B: the highest positive is tired | Result: IgG antibody-like is tired | Result is inferred |
| 1:64 is positive | 1:512 is positive | Anti-A 1:64, anti-B 1:512 | Anti-B raises |
| 1:512 is positive | 1:512 is positive | Anti-A 1:512, anti-B 1:512 | Anti-A, B raises |
| 1:512 is positive | 1:64 is negative | Anti-A 1:512, anti-B is less than 1:64 | Anti-A raises |
Embodiment 2: a kind of immuno-chromatographic test paper strip assay method that uses finger hematometry IgM class abo antibody, key step is as follows.
1. the making of sample filter membrane: comprise 2 kinds, the first is " visible component filter membrane ", is used glass film, and in prevention sample, red blood cell and leucocyte enter detection zone; The second is " specific component filter membrane ", selects nitrocellulose membrane, embedding albumin A.
2. the making of tracer and spike pad: tracer comprises trace particle bond and trace particle, and trace particle is selected collaurum, trace particle bond is the anti-A of mouse source IgM and anti-B antibody, and tracer scattered adsorption is lyophilized into spike pad in fiberglass packing.
3. the preparation in tunica fibrosa detection zone and Quality Control district: tunica fibrosa is selected nitrocellulose membrane, 2 of detection lines, respectively embedding blood group antigens A and B; 1 of nature controlling line, the anti-mouse IgM of embedding antibody.
4. the assembling of test strips: test strips is pressed accompanying drawing assembling.
5. application of sample detects: sample is used finger blood, 1 or 50 microlitres, and directly application of sample is in sample pad.
While there is bands visible in 6.Dai Quality Control district, according to the form below sentence read result (giving an example).
| Anti-A | Anti-B | Result | Reverse type |
| Positive | Negative | There is the anti-A antibody of IgM, without the anti-B antibody of IgM | Type B |
| Positive | Positive | There are the anti-A antibody of IgM and the anti-B antibody of IgM | O type |
| Negative | Positive | Without the anti-A antibody of IgM, there is the anti-B antibody of IgM | A type |
| Negative | Negative | Without the anti-A antibody of IgM with without the anti-B antibody of IgM | AB type |
Embodiment 3: a kind of immuno-chromatographic test paper strip method of using saliva to measure abo blood group reverse type, key step is as follows.
1. the making of sample filter membrane: without above-mentioned " visible component filter membrane " and " specific component filter membrane ".
2. the making of tracer and spike pad: tracer comprises trace particle bond and trace particle, and trace particle is selected collaurum, trace particle bond is mouse Anti-Human IgA antibody, and tracer scattered adsorption is lyophilized into spike pad in fiberglass packing.
3. the preparation in tunica fibrosa detection zone and Quality Control district: tunica fibrosa is selected nitrocellulose membrane, establishes 2 and detects wire embedding blood group antigens A and B respectively, the anti-mouse Anti-Human of Quality Control district embedding IgA antibody.
4. the assembling of test strips: test strips is pressed accompanying drawing assembling.
5. application of sample detects: 1 of saliva or 50 microlitres after saliva or dilution, directly application of sample is in sample area.
While there is bands visible in 6.Dai Quality Control district, according to the form below sentence read result.
| Anti-A | Anti-B | Result | Reverse type |
| Positive | Negative | There is the anti-A antibody of IgA, without the anti-B antibody of IgA | Type B |
| Positive | Positive | There is the anti-A antibody of IgA and have the anti-B antibody of IgA | O type |
| Negative | Positive | Without the anti-A antibody of IgA, there is the anti-B antibody of IgA | A type |
| Negative | Negative | Without the anti-A antibody of IgA with without the anti-B antibody of IgA | AB type |
Claims (12)
1. a specific assay blood group antibody and the immune chromatography test paper method of tiring thereof, it is characterized in that, can the anti-A of specific assay IgM and the tiring of the tiring of the tiring of anti-blood group antibody B, the anti-A of specific assay IgG and anti-blood group antibody B, the anti-A of specific assay IgA and anti-blood group antibody B, the anti-A of specific assay IgM and anti-blood group antibody B, the anti-A of specific assay IgG and anti-blood group antibody B, the anti-A of specific assay IgA and anti-blood group antibody B, it is made and detection method comprises: the making of (1) sample filter membrane and sample pad; (2) making of tracer and spike pad; (3) preparation in tunica fibrosa detection zone and Quality Control district; (4) mark of test strips; (5) assembling of test strips; (6) application of sample detects; (7) result interpretation.
2. according to sample filter membrane and sample pad described in claims 1, it is characterized in that, area is 1 square millimeter to 1 square metre, sample filter membrane comprises 2 kinds, the first is sample " visible component filter membrane ", mainly to stop the red blood cell that may contain in sample and the visible component of other large volume, the aperture of filter membrane is less than 6 to 8 microns, material is polyester film or glass film or tunica fibrosa, the number of plies is 1 to 100 layer, according to the difference of the difference of sample and sample pad material, " visible component filter membrane " can be used also and can not use, the second sample filter membrane is sample " specific component filter membrane ", filter membrane is nitrocellulose membrane or acidifying tunica fibrosa or pure tunica fibrosa or nylon membrane, the anti-human IgM antibody of embedding and (or) anti-human IgG antibody and (or) Anti-Human IgA antibody and (or) specific antibody agglutinin and (or) anti-A and (or) anti-B and (or) anti-AB antibody and (or) Staphylococal Protein A and (or) B antigen and (or) AB antigen and (or) albumin A and (or) Protein G on film, filter membrane can be 1 to 100 layer, under different objects, " specific component filter membrane " can be used also and can not use, the function of described " visible component filter membrane " can be realized by " specific component filter membrane ", sample pad at least comprises application of sample pad (8) and (or) visible component filter membrane (7) and (or) specific component filter membrane (5) and (or) hydrophilic layer (6), the material of described application of sample pad is polyester film or glass film or hemofiltration film, and when using hemofiltration film, the function of sample " visible component filter membrane " can be substituted by hemofiltration film, described hydrophilic layer is hydrophilic paper or water wetted material.
3. according to the tracer described in claims 1 and spike pad, it is characterized in that, tracer comprises trace particle bond and trace particle, trace particle is collaurum or electroselenium or CI or latex or gelatin or magnetic bead or magnetic-particle or fluorescein or fluorescent microsphere or quantum dot or nm of gold or lanthanide series or organic nano particle or nano magnetic material or carbon nano-tube, trace particle bond is anti-human IgM antibody and (or) anti-human IgG antibody and (or) Anti-Human IgA antibody and (or) specific antibody agglutinin and (or) anti-A and (or) anti-B and (or) anti-AB antibody and (or) Staphylococal Protein A and (or) B antigen and (or) AB antigen and (or) albumin A and (or) Protein G, after trace particle bond mark trace particle, it is tracer, polyester film or glass film are spike pad after containing tracer, the area of spike pad is 1 square millimeter to 1 square metre.
4. according to the tunica fibrosa detection zone described in claims 1 and Quality Control district, it is characterized in that, the area of 1 tunica fibrosa is 1 square millimeter to 1 square metre, 1 tunica fibrosa detection zone or be called detection line or T district or T line, the detection thing of embedding specificity blood group antibody, tunica fibrosa is nitrocellulose membrane or acidifying tunica fibrosa or pure tunica fibrosa or nylon membrane, the detection thing of blood group antibody is the reactant of Staphylococal Protein A or B antigen or AB antigen or anti-A or anti-B or anti-AB antibody or agglutinin or albumen or tracer, on same 1 tunica fibrosa, 1 to 100 anti-A detection line and (or) 1 to 100 anti-B detection line can be set, the width of every detection line is 0.001 millimeter to 50 centimetres, length is 0.001 millimeter to 50 centimetres, 1 tunica fibrosa Quality Control district or claim nature controlling line or C district or C line, the anti-antibody that embedding can be combined with tracer or agglutinin or albumen, 1 tunica fibrosa can arrange detection zone and Quality Control district simultaneously, and when 1 tunica fibrosa is embedded with 1 or many detection lines, nature controlling line can be set up also and can not set up, 1 tunica fibrosa can arrange the detection line that 1 specific antibodies is tired, and also the detection line that a plurality of specific antibodies are tired can be set, the detection line that different antibodies is tired can be arranged on 1 tunica fibrosa, also can be arranged on a plurality of different tunica fibrosas, now, can use water wetted material to make them arranged together.
5. according to the mark of the test strips described in claims 1, its method is, in test strips back up pad between the anti-A of mark and (or) anti-B antibody titer 1:1 to 1:16384 any one or more, mark can be other numeral or symbol or the word that represents described antibody and described antibody titer, and mark also can directly be marked on tunica fibrosa or be marked at other position of test strips.
6. according to the assembling of the test strips described in claims 1, it is characterized in that, one or more test strips at least comprise one or more back up pads (1) and (or) tunica fibrosa (2) and (or) absorption pad (3) and (or) spike pad (4) and (or) specific component filter membrane (5) and (or) hydrophilic layer (6) and (or) visible component filter membrane (7) and (or) application of sample pad (8); The area of test strips is 1 square millimeter to 1 square metre; Each test strips can be used separately, also can 2 to 1000 test strips fit together use, and each test strips is used the independently independent application of sample of sample pad to detect, and also can a plurality of test strips share the application of sample detection together of 1 sample pad; One or more test strips can have one or more back up pads (1); One or more test strips can comprise one or more tunica fibrosas (2), and tunica fibrosa can be used in cutting, also can separate subregion by the mode of blocking-up liquid migration and use.
7. according to application of sample described in claims 1 and claims 6, detect, its mode is, is loaded onto in the sample pad described in claims 1 and claims 2 sample is manual by particular device application of sample or by automation equipment; Described sample can dilute use or pre-service is used or do not dilute and use or not pre-service use, places after several seconds or tens of minutes after application of sample, if when reacting appears in the nature controlling line being provided with, starts sentence read result; Described sample comprises people's blood sample, body fluid, juice, tissue fluid, whole blood, serum, blood plasma, finger blood, saliva, urine; Each application of sample amount detecting is 1 microlitre to 10000 microlitre.
8. according to the result interpretation described in claims 1, its content comprises, the anti-A of IgM of the determined sample of interpretation and (or) feminine gender and the positive findings of the anti-B antibody of IgM, tiring or semidefinite value or quantitative values of the anti-A of IgM and (or) the anti-B antibody of IgM, feminine gender and the positive findings of the anti-A of IgG and (or) the anti-B antibody of IgG, tiring or semidefinite value or quantitative values of the anti-A of IgG and (or) the anti-B antibody of IgG, feminine gender and the positive findings of the anti-A of IgA and (or) the anti-B antibody of IgG, tiring or semidefinite value or quantitative values of the anti-A of IgA and (or) the anti-B antibody of IgG, the reverse type of abo blood group, interpretation can have or not according to color or depth interpretation by naked eyes, also can use commercialization or homemade test strips instrument device, excitation source, optical filter, CCD scanning, optical fiber technology, opacimeter, color identification and other automatic intopretoscope interpretation testing result or provide inferred results by equipment.
9. according to " specific component filter membrane " (5) described in claims 2, its repertoire or its partial function can be realized according to the antibody of the embedding described in claims 2 " specific component filter membrane " or agglutinin or material by the detection zone of tunica fibrosa (2) and the part for tunica fibrosa between application of sample pad (8) or a part of embedding of other material.
10. according to " sample filter membrane " and " tracer " and " detection zone " described in claims 2 and claims 3 and claims 4 and the embedding thing in " Quality Control district ", can be according to the ultimate principle of immunochromatography technique because using different detection modes to change, described detection mode comprises double antibody sandwich method, dual-antigen sandwich method, indirect method, fluorescent marker method, competition law, sizing technique, semiquantitative method, prize law and back flow of sample method; Use different detection modes, can specific assay IgM and (or) IgG and (or) IgA blood group antibody, also can measure the mixing blood group antibody of IgM and (or) IgG and (or) IgA, can specific assay IgM and (or) the tiring of IgG and (or) IgA blood group antibody, also can measure tiring of IgM and (or) IgG and (or) IgA mixing blood group antibody, can be for qualitative analysis blood group antibody negative or positive and for judging the reverse type of the blood group of determined sample.
11. according to blood group and blood group antibody described in claims 1 and claims 2 and claims 3 and claims 4 and claims 5 and claims 8, it is characterized in that, blood group comprises A, B, O and the AB type of abo blood group, wherein A type comprises A, A1 and A2 type, and AB type comprises AB, A1B and A2B type; Described blood group antibody comprises anti-A and anti-B antibody, and wherein anti-A antibody comprises anti-A and anti-A1 antibody; The classification of described blood group antibody comprises IgG and IgM and IgA antibody.
12. according to Staphylococal Protein A and B antigen and AB antigen described in claims 2 and claims 3 and claims 4, for the body fluid blood group substance of the erythrocyte membrane antigen that extracts or extraction or manually synthetic carbohydrate antigen or glycoprotein or glycolipid, Staphylococal Protein A comprises Staphylococal Protein A and A1 antigen.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410135589.6A CN103926400A (en) | 2014-04-06 | 2014-04-06 | Test strip for specifically measuring IgM, IgG and IgA blood group antibodies |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410135589.6A CN103926400A (en) | 2014-04-06 | 2014-04-06 | Test strip for specifically measuring IgM, IgG and IgA blood group antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103926400A true CN103926400A (en) | 2014-07-16 |
Family
ID=51144696
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410135589.6A Pending CN103926400A (en) | 2014-04-06 | 2014-04-06 | Test strip for specifically measuring IgM, IgG and IgA blood group antibodies |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103926400A (en) |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103278637A (en) * | 2013-06-05 | 2013-09-04 | 姜竹泉 | Carbon nanotube test paper for detecting helicobacter pylori, and preparation method thereof |
| CN104764882A (en) * | 2014-08-20 | 2015-07-08 | 苏州和锐医药科技有限公司 | Preparation method and application of anti-BPI-ANCA antibody test strip |
| CN105911048A (en) * | 2016-04-08 | 2016-08-31 | 合肥工业大学 | Carbon nanotube labeled test paper, production method thereof, and rapid Hg<2+> detection method |
| CN106802351A (en) * | 2015-09-08 | 2017-06-06 | 默克专利股份有限公司 | The method that evaluation is suitable to the quality of the medium for removing anti-A or anti-B antibody |
| CN107290520A (en) * | 2017-06-14 | 2017-10-24 | 邵超鹏 | Determine the immuno-chromatographic test paper strip of the anti-A of pregnant woman IgG and anti-blood group antibody B or human blood type reverse type |
| CN108267591A (en) * | 2017-01-03 | 2018-07-10 | 普迈德（北京）科技有限公司 | A kind of immune microsphere chromatographs quick HIT antibody tests test paper |
| CN109100518A (en) * | 2018-10-17 | 2018-12-28 | 陕西医药控股医药研究院有限公司 | Bird flu, the test strips of human influenza Susceptible population and test card are quickly detected using competition law |
| CN110174511A (en) * | 2019-05-09 | 2019-08-27 | 昆明市儿童医院 | ABO Hemolysis quick detection test paper |
| CN110398590A (en) * | 2019-06-21 | 2019-11-01 | 深圳大学 | Sensing chip and application |
| CN111474352A (en) * | 2020-04-29 | 2020-07-31 | 北京乐普医疗科技有限责任公司 | Novel coronavirus COVID-2019 detection card and preparation method thereof |
| CN112763730A (en) * | 2020-12-29 | 2021-05-07 | 成都永安制药有限公司 | Colloidal gold immunochromatography trace whole blood detection test paper and detection method thereof |
| CN114660305A (en) * | 2022-03-31 | 2022-06-24 | 中国人民解放军军事科学院军事医学研究院 | Reagent for rapidly detecting blood type antibody titer, preparation method, test strip and application |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1438486A (en) * | 2002-12-31 | 2003-08-27 | 江西中德生物工程有限公司 | Method for detecting ABO blood type using immuno-chromatography, its prepared indicator paper and use |
| CN101118239A (en) * | 2007-06-14 | 2008-02-06 | 四川省迈克科技有限责任公司 | Reagent kit |
| CN101957370A (en) * | 2009-07-15 | 2011-01-26 | 英科新创(厦门)科技有限公司 | Method and detection strip for rapidly detecting human blood group antibodies |
| WO2012061317A1 (en) * | 2010-11-01 | 2012-05-10 | New York Blood Center, Inc. | Blood bank management and rapid blood type determination system |
| CN103439518A (en) * | 2013-06-07 | 2013-12-11 | 中国人民解放军南京军区南京总医院 | Blood ABD typing rapid comprehensive test card |
| WO2014025895A1 (en) * | 2012-08-08 | 2014-02-13 | Arryx, Inc. | Methods and devices for immunodiagnostic applications |
-
2014
- 2014-04-06 CN CN201410135589.6A patent/CN103926400A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1438486A (en) * | 2002-12-31 | 2003-08-27 | 江西中德生物工程有限公司 | Method for detecting ABO blood type using immuno-chromatography, its prepared indicator paper and use |
| CN101118239A (en) * | 2007-06-14 | 2008-02-06 | 四川省迈克科技有限责任公司 | Reagent kit |
| CN101957370A (en) * | 2009-07-15 | 2011-01-26 | 英科新创(厦门)科技有限公司 | Method and detection strip for rapidly detecting human blood group antibodies |
| WO2012061317A1 (en) * | 2010-11-01 | 2012-05-10 | New York Blood Center, Inc. | Blood bank management and rapid blood type determination system |
| WO2014025895A1 (en) * | 2012-08-08 | 2014-02-13 | Arryx, Inc. | Methods and devices for immunodiagnostic applications |
| CN103439518A (en) * | 2013-06-07 | 2013-12-11 | 中国人民解放军南京军区南京总医院 | Blood ABD typing rapid comprehensive test card |
Non-Patent Citations (1)
| Title |
|---|
| 黄菲等: "血清中高效价IgＭ 抗Ａ干扰IgＧ抗Ａ效价测定１例", 《临床血液杂志》, vol. 26, no. 8, 15 August 2013 (2013-08-15), pages 582 - 583 * |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103278637B (en) * | 2013-06-05 | 2015-09-30 | 姜竹泉 | A kind of carbon nano-tube Test paper detecting helicobacter pylori and preparation method thereof |
| CN103278637A (en) * | 2013-06-05 | 2013-09-04 | 姜竹泉 | Carbon nanotube test paper for detecting helicobacter pylori, and preparation method thereof |
| CN104764882A (en) * | 2014-08-20 | 2015-07-08 | 苏州和锐医药科技有限公司 | Preparation method and application of anti-BPI-ANCA antibody test strip |
| CN106802351A (en) * | 2015-09-08 | 2017-06-06 | 默克专利股份有限公司 | The method that evaluation is suitable to the quality of the medium for removing anti-A or anti-B antibody |
| CN105911048A (en) * | 2016-04-08 | 2016-08-31 | 合肥工业大学 | Carbon nanotube labeled test paper, production method thereof, and rapid Hg<2+> detection method |
| CN108267591A (en) * | 2017-01-03 | 2018-07-10 | 普迈德（北京）科技有限公司 | A kind of immune microsphere chromatographs quick HIT antibody tests test paper |
| CN107290520B (en) * | 2017-06-14 | 2019-08-02 | 邵超鹏 | Measure the immuno-chromatographic test paper strip of pregnant woman IgG anti-A and anti-blood group antibody B or human blood type reverse type |
| CN107290520A (en) * | 2017-06-14 | 2017-10-24 | 邵超鹏 | Determine the immuno-chromatographic test paper strip of the anti-A of pregnant woman IgG and anti-blood group antibody B or human blood type reverse type |
| CN109100518A (en) * | 2018-10-17 | 2018-12-28 | 陕西医药控股医药研究院有限公司 | Bird flu, the test strips of human influenza Susceptible population and test card are quickly detected using competition law |
| CN110174511A (en) * | 2019-05-09 | 2019-08-27 | 昆明市儿童医院 | ABO Hemolysis quick detection test paper |
| CN110398590A (en) * | 2019-06-21 | 2019-11-01 | 深圳大学 | Sensing chip and application |
| CN110398590B (en) * | 2019-06-21 | 2022-11-15 | 深圳大学 | Sensing chip and application |
| CN111474352A (en) * | 2020-04-29 | 2020-07-31 | 北京乐普医疗科技有限责任公司 | Novel coronavirus COVID-2019 detection card and preparation method thereof |
| CN111474352B (en) * | 2020-04-29 | 2023-12-22 | 北京乐普诊断科技股份有限公司 | Novel coronavirus COVID-2019 detection card and preparation method thereof |
| CN112763730A (en) * | 2020-12-29 | 2021-05-07 | 成都永安制药有限公司 | Colloidal gold immunochromatography trace whole blood detection test paper and detection method thereof |
| CN114660305A (en) * | 2022-03-31 | 2022-06-24 | 中国人民解放军军事科学院军事医学研究院 | Reagent for rapidly detecting blood type antibody titer, preparation method, test strip and application |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103926400A (en) | Test strip for specifically measuring IgM, IgG and IgA blood group antibodies | |
| CN104730258B (en) | A kind of Portable blood group system detectio test paper and its detection method | |
| JP7235735B2 (en) | New general-purpose inspection system for quantitative analysis | |
| AU2004256206B2 (en) | Device and method for simultaneous carrying out of blood group determination, serum cross-check and antibody detection test | |
| EP1891447B1 (en) | Two step lateral flow assay methods and devices | |
| CN202814988U (en) | Full scale high-sensitivity C-reaction protein colloidal gold test paper strip | |
| US8349618B2 (en) | Diagnostic devices | |
| KR102489679B1 (en) | Method and device for combined detection of viral and bacterial infections | |
| CN202794178U (en) | Fast quantitative immunochromatographic assay kit for procalcitonin | |
| JP5090734B2 (en) | Apparatus and method for simultaneously determining blood group antigens | |
| CN104764877A (en) | Immunity chromatography test method and test paper | |
| JP5484068B2 (en) | Method for determining small cell populations in heterogeneous cell populations | |
| CN201522494U (en) | Duplex occult blood fast diagnositic and chromatographic test paper | |
| CN202720231U (en) | Test strip for testing specimen | |
| CN106526166A (en) | Rapid detection of lean meat powder in pork | |
| CN107290520A (en) | Determine the immuno-chromatographic test paper strip of the anti-A of pregnant woman IgG and anti-blood group antibody B or human blood type reverse type | |
| CN106053824A (en) | Pancreas cancer duplex detection kit | |
| CN211905398U (en) | IgG blood group antibody titer rapid detection test strip | |
| US20210325383A1 (en) | Lateral flow assay for detecting multiple proteins of a pathogen | |
| CN103884849A (en) | Display manner of determination results of blood type and blood type antibody and manufacturing method | |
| CN210269872U (en) | Human blood group antigen detection device | |
| CN205027759U (en) | Note is inspected soon to trigeminy antibody | |
| CN204422542U (en) | Two len antibodies inspect paper slip soon | |
| CN210626494U (en) | Blood group antigen detection subassembly | |
| US20030124618A1 (en) | Device for analysing analyte compounds and use hereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20140716 |