CN211905398U - IgG blood group antibody titer rapid detection test strip - Google Patents
IgG blood group antibody titer rapid detection test strip Download PDFInfo
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- CN211905398U CN211905398U CN202020411859.2U CN202020411859U CN211905398U CN 211905398 U CN211905398 U CN 211905398U CN 202020411859 U CN202020411859 U CN 202020411859U CN 211905398 U CN211905398 U CN 211905398U
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Abstract
The utility model discloses a test strip for rapidly detecting the titer of IgG blood group antibody, which comprises a sample adding part, a reaction part and a water absorbing part which are contacted and arranged from the upstream to the downstream in sequence; the sample adding part is sequentially provided with a washing sample adding area, a red blood cell sample adding area and a sample adding area from upstream to downstream; the reaction part is provided with at least one detection point and a control point, wherein the at least one detection point is coated and solidified with an anti-human IgG antibody, and the control point is coated and solidified with an anti-RBC antibody. When the utility model is used, only one-step method is needed to be adopted to add the sample, the red blood cells and the flushing fluid, and the result can be obtained after 3-5 minutes.
Description
Technical Field
The utility model particularly relates to a IgG blood group antibody titer short-term test examination strip.
Background
Hemolytic disease of the newborn (HDN) of the pediatrics is one of the most common acute hemolytic diseases, which means that blood types of mothers and infants are incompatible, fetal red blood cells stimulate the mothers, immune blood group antibodies are formed in pregnant mothers, mainly IgG type antibodies are used as main antibodies, the IgG antibodies can enter the fetuses through placentas to destroy the fetal red blood cells to cause HDN, serious patients can also have abortion, premature birth, dead fetus, hemolytic jaundice and severe anemia, and can develop into jaundice with jaundice, early death of infants or irreversible neurological sequelae left on survivors, and great pain is brought to the sick infants and families. The most common neonatal hemolytic disease with ABO blood group incompatibility found in the human blood group system so far is Rh blood group system, and HDN caused by other blood group systems is less common.
The pregnant woman prenatal needs to monitor the serum IgG antibody titer, particularly IgG anti-A (B) and IgG anti-D, in a recommended scheme of a neonatal Hemolytic Disease (HDN) immunohematology test published by the Chinese physician association, and the possibility of causing HDN is shown when the IgG anti-A (B) titer is more than or equal to 64 and the anti-D titer is more than or equal to 16, and the recommended scheme can be used as a prenatal routine detection project for observing the change of the titer, predicting the possibility of generating the neonatal hemolytic disease and related hazards and providing basis for next medical behaviors and decisions.
Currently, the prenatal IgG antibody detection in clinical laboratories adopts an anti-human globulin test determination method, and the basic processes are as follows: 1) removal of IgM antibodies in the sample: incubating maternal serum (plasma) to be detected with a certain amount of dimercaptoethanol (2-Me) or Dithiothreitol (DTT) for 1-2 hours at 37 ℃ and shaking occasionally to inactivate IgM antibodies, 2) diluting a sample in a multiple ratio, and 3) sensitizing with standard blood group red blood cells: mixing the diluted sample with A-type, B-type and D-type erythrocyte suspensions with certain concentrations in a multiple ratio, incubating at 37 ℃ for 0.5-1 hour to ensure that IgG antibodies are fully sensitized with standard erythrocytes, and 4) removing excessive IgG antibodies: washing sensitized erythrocytes with physiological saline for 3 times, 5) detection of anti-human globulin: the washed erythrocytes were mixed with a certain amount of anti-human globulin antibody (anti-human IgG antibody) and centrifuged for 5-10 minutes, and finally the agglutination assay was observed with a microscope. Because the determination process is too complex, a microcolumn gel card method is basically adopted in large hospitals, the steps of washing erythrocytes and interpreting results by a microscope can be omitted, but the whole process still consumes long time, and the steps are complicated and high in cost. Significant time and effort is consumed by the inspector, and errors or misalignments often occur.
In the prior art, an immunochromatographic test strip for measuring IgG anti-A and anti-B blood group antibodies of a pregnant woman or human blood group reverse typing aims at quickly measuring the human blood IgG anti-A and anti-B antibodies, replaces the traditional measuring mode of IgM antibody inactivation, anti-human globulin test and observation agglutination, simplifies the operation steps and shortens the time consumption. However, there still exist many problems and disadvantages, for example, 1) the manufacturing process is complex, the artificial blood group antigen needs to be prepared, the labeling of the tracer particles is needed, 2) the process is not mature, the artificial blood group antigen is only a theoretical concept, the actual application of the artificial blood group antigen is almost zero, the specificity, the affinity and the stability cannot be studied, 3) the result is difficult to be judged, the result judgment area has 3 to 100 lines including various coating lines in the blocking area, the detection area and the quality control area, 4) the operation is still inconvenient, when the blocking area is not set, the traditional chemical method needs to be adopted to inactivate the IgM antibody in advance, the treated sample is determined, 5) the detection time is longer, ten minutes is needed, because the test strip is based on the traditional low-aperture nitrocellulose membrane chromatographic strip, and the result judgment area on the nitrocellulose membrane is long, the sample passing time is long, and the time for the substance marked by the tracer particles needs to be released, 6) the detection antibody is limited in kind, and only IgG class anti-A and anti-B antibodies can be measured, but not IgG anti-D.
SUMMERY OF THE UTILITY MODEL
The utility model aims to overcome the prior art defect, provide a IgG blood group antibody titer short-term test examination strip.
The technical scheme of the utility model as follows:
a IgG blood group antibody titer rapid detection test strip is characterized in that: comprises a sample adding part, a reaction part and a water absorbing part which are sequentially arranged in a contact way from upstream to downstream; the sample adding part is sequentially provided with a washing sample adding area, a red blood cell sample adding area and a sample adding area from upstream to downstream; the reaction part is provided with at least one detection point and a control point, wherein the at least one detection point is coated and solidified with an anti-human IgG antibody, and the control point is coated and solidified with an anti-RBC antibody;
the anti-human IgG antibody can be specifically and immunologically combined with a corresponding IgG blood group antibody in the sample driven by the flushing fluid, and the IgG blood group antibody can be combined with red blood cells in a standard red blood cell suspension driven by the flushing fluid to form an anti-human IgG antibody/IgG blood group antibody/red blood cell compound and is gathered at a detection point; the anti-RBC antibody can bind to red blood cells in a quasi-red blood cell suspension carried by the wash fluid, so that the red blood cells are gathered at the control point.
The utility model has the advantages that:
1. the utility model discloses well sample is under capillary action, the reaction portion of flowing through earlier, IgG blood group antibody in the sample and the anti-human IgG antibody specificity immunological binding of the solid phase of peridium in advance, and the IgM blood group antibody in the sample directly flows through the reaction portion and gets into the water absorption portion, the red blood cell of back process is held back by IgG blood group antibody again and is formed anti-human IgG antibody/IgG blood group antibody/red blood cell complex and the gathering color development, can effectively eliminate IgM blood group antibody interference in the sample, need not chemical inactivation IgM antibody in advance, it is safe nontoxic odorless (dimercaptoethanol and dithiothreitol are all poisonous smelly).
2. When the utility model is used, only one-step method is needed to be adopted to add the sample, the red blood cells and the flushing fluid, and the result can be obtained after 3-5 minutes.
3. The utility model discloses directly use the erythrocyte as the indicator, the red colour of erythrocyte is more bright-coloured as the pilot color, judges better, according to selecting for use different standard blood group erythrocyte, the utility model discloses can detect all kinds of blood group system IgG antibodies, not only can detect IgG anti-A (B), can also detect IgG anti-D, and other blood group system IgG antibodies.
4. The detection test strip of the utility model has the advantages of convenient carrying, room temperature preservation (2-30 ℃), long effective period (24 months), no auxiliary equipment and extremely small required sample volume (5-10 muL).
5. The utility model discloses sensitivity is high and the specificity is good, detects 1-2 gradients than the anti-human globulin of current gold standard product and detects microcolumn gel card sensitivity to the red blood cell that can adopt is the standard red blood cell on the market of national registration, the artificially synthesized antigen of non-passing national authentication.
Drawings
Fig. 1 is an exploded view of a part of a three-dimensional structure according to embodiment 1 of the present invention.
Fig. 2 is a schematic structural diagram of an upper housing according to embodiment 1 of the present invention.
Detailed Description
The technical solution of the present invention will be further illustrated and described below with reference to the accompanying drawings by means of specific embodiments.
In a preferred embodiment of the present invention, the device further comprises a first sealing tape, a second sealing tape and a third sealing tape, wherein the first sealing tape is adhered between the flushing sample adding region and the red blood cell sample adding region, the second sealing tape is adhered between the red blood cell sample adding region and the sample adding region, and the third sealing tape is adhered to the boundary portion covering the sample adding portion and the reaction portion.
Further preferably, the first to third sealing tapes are PP tape, PE tape, ABS tape or PET tape with adhesive.
In a preferred embodiment of the present invention, the sample adding part covers the reaction part at a contact position of the sample adding part and the reaction part.
In a preferred embodiment of the present invention, the water-absorbing part is covered on the reaction part at a contact part of the water-absorbing part and the reaction part.
In a preferred embodiment of the present invention, the sample adding device further comprises a substrate and an upper cover, wherein the sample adding part, the reaction part and the water absorbing part are all disposed on the substrate, and the upper cover is disposed on the substrate and covers the sample adding part, the reaction part and the water absorbing part. Preferably, the substrate is made of polyester, and the upper cover is made of at least one of PS, ABS and PET.
Preferably, the upper cover is provided with a flushing liquid adding hole, a red blood cell adding hole, a sample adding hole and an observation window which are sequentially corresponding to the flushing sample adding area, the red blood cell sample adding area, the sample adding area and the reaction part.
In a preferred embodiment of the present invention, the material of the sample adding part is porous polymer material (preferably glass fiber) with water conductivity and hydrophilicity, and the material of the water absorbing part is cotton pulp paper.
In a preferred embodiment of the present invention, the material of the reaction portion is a nitrocellulose membrane, a cellulose acetate membrane, a polyethylene membrane, or a nylon membrane.
More preferably, the reaction part is made of a backing nitrocellulose membrane having a capillary flow rate of 40 to 90sec/4cm width.
Example 1
As shown in fig. 1 and 2, a rapid test strip for IgG blood group antibody titer comprises a sample addition part 11, a reaction part 12, and a water absorption part 13, which are sequentially arranged in contact from upstream to downstream, and further comprises a first sealing tape 110, a second sealing tape 120, and a third sealing tape 130; the sample addition part 11 is made of a porous polymer material (preferably glass fiber) having water conductivity and hydrophilicity, the water absorption part 13 is made of cotton pulp paper, the reaction part 12 is made of a nitrocellulose membrane, a cellulose acetate membrane, a polyethylene membrane or a nylon membrane, and more preferably a backed nitrocellulose membrane having a capillary flow rate of 40 to 90sec/4cm width.
The sample addition part 11 is covered on the reaction part 12 at the contact part of the sample addition part 11 and the reaction part 12, and the water absorption part 13 is covered on the reaction part 12 at the contact part of the water absorption part 13 and the reaction part 12; the first to third sealing tapes 130 are PP tapes, PE tapes, ABS tapes or PET tapes with adhesive.
The sample addition part 11 is provided with a washing sample addition region 111, a red blood cell sample addition region 112 and a sample addition region 113 in order from upstream to downstream, a first seal tape 110 is stuck between the washing sample addition region 111 and the red blood cell sample addition region 112, a second seal tape 120 is stuck between the red blood cell sample addition region 112 and the sample addition region 113, and a third seal tape 130 is stuck to cover the boundary between the sample addition part 11 and the reaction part 12.
The reaction part 12 is provided with at least one detection spot 121 and a control spot 122, wherein the at least one detection spot 121 is coated and immobilized with an anti-human IgG antibody, and the control spot 122 is coated and immobilized with an anti-RBC antibody. Preferably, the detection spots 121 and the control spots 122 are arranged in a straight line along the width direction of the test strip 1 to avoid interference in the capillary flow direction.
The test strip 1 further comprises a substrate 17 and an upper cover 18, wherein the sample addition part 11, the reaction part 12 and the water absorption part 13 are all disposed on the substrate 17, and the upper cover 18 is disposed on the substrate 17 and covers the sample addition part 11, the reaction part 12 and the water absorption part 13. The upper cover 18 is provided with a washing solution adding hole 181, a red blood cell adding hole 182, a sample adding hole 183 and an observation window 184 which correspond to the washing sample adding region 111, the red blood cell sample adding region 112, the sample adding region 113 and the reaction part 12 in sequence. Preferably, the substrate 17 is made of polyester, and the upper cover 18 is made of at least one of PS, ABS and PET.
The anti-human IgG antibody can be specifically and immunologically combined with a corresponding IgG blood group antibody in the sample driven by the flushing fluid, and the IgG blood group antibody is combined with red blood cells in a standard red blood cell suspension driven by the flushing fluid to form an anti-human IgG antibody/IgG blood group antibody/red blood cell compound and is gathered at the detection point 121; the anti-RBC antibodies bind red blood cells in the standard red blood cell suspension carried by the wash fluid, and cause the red blood cells to aggregate at the control site 122.
The detection test strip 1 has a simple structure, three layers are overlapped, and three sealing tapes are used for separating all functional regions, so that a sample, red blood cells and flushing fluid sequentially flow through the reaction part 12; the ferrule is designed, the interface is simple, only at least one detection point 121 and one control point 122 are provided, the result interpretation is easy, complex tracer particle preparation and marking processes are not required, and erythrocyte antigen extraction and preparation are not required.
Example 2
The IgG anti-A (B) and anti-D in the serum (plasma) of the pregnant woman are identified by using the IgG blood group antibody titer rapid detection strip of example 1, and the method specifically comprises the following steps:
(1) sample adding: adding 5 mu L of pregnant woman serum (serum) to be detected into sample adding hole 183;
(2) adding a standard red blood cell suspension: add 5 μ LAB & RhD type 10% (v/v) erythrocyte suspension to the Add erythrocyte well 182;
(3) adding a flushing liquid: adding 100 μ L of washing solution into the hole 181 for adding washing solution;
(4) and (4) interpretation of results: after 3min, the detection spot 121 and the control spot 122 are red, and the positive reaction is shown, which indicates that the pregnant woman serum (plasma) contains one, two or three of IgG anti-A, anti-B or anti-D. If only the control spot 122 is red, the detection spot 121 is not colored, and the reaction is negative, which indicates that the pregnant woman has no IgG anti-A, anti-B and anti-D in the serum (plasma).
Example 3
The IgG anti-A (B) titer in the serum (plasma) of the pregnant woman is identified by using the IgG blood group antibody titer rapid detection test strip of example 1, which comprises the following steps:
(1) sample dilution: diluting the serum (plasma) of the pregnant woman to be detected into a mixture with a ratio of 1: 32 and 1: 64. 1: 128. 1: 256, etc.;
(2) sample adding: adding 5 μ L of diluted sample to sample well 183;
(3) adding standard red blood cells: adding 5 μ la (b) type 10% (v/v) red blood cell suspension to the red blood cell addition well 182;
(4) adding a flushing liquid: adding 100 μ L of washing solution into the hole 181 for adding washing solution;
(5) and (4) interpretation of results: after 3 minutes, the test spot 121 and the control spot 122 are red and positive, and the reciprocal of the highest dilution of the positive result is the titer of the tested sample IgG anti-A (B).
Example 4
The IgG blood group antibody titer rapid detection test strip of the embodiment 1 is used for identifying the IgG anti-D titer in the serum (plasma) of the pregnant woman, and the method specifically comprises the following steps:
(1) sample dilution: diluting the serum (plasma) of pregnant woman to be detected into 1: 8, 1: 16, 1: 32, 1: 64 and the like by using normal saline or 10mM PBS in a multiple ratio;
(2) sample adding: adding 5 μ L of diluted sample to sample well 183;
(3) adding standard red blood cells: add 5. mu. L O & RhD type 10% (v/v) erythrocyte suspension to the Add erythrocyte well 182;
(4) adding a flushing liquid: adding 100 μ L of washing solution into the hole 181 for adding washing solution;
(5) and (4) interpretation of results: after 3 minutes, the test spot 121 and the control spot 122 are judged to be red, the test is positive reaction, and the reciprocal of the highest dilution of the positive result is the titer of the IgG anti-D of the tested sample.
The above description is only a preferred embodiment of the present invention, and therefore the scope of the present invention should not be limited by this description, and all equivalent changes and modifications made within the scope and the specification of the present invention should be covered by the present invention.
Claims (6)
1. A IgG blood group antibody titer rapid detection test strip is characterized in that: comprises a sample adding part, a reaction part and a water absorbing part which are sequentially arranged in a contact way from upstream to downstream; the sample adding part is sequentially provided with a washing sample adding area, a red blood cell sample adding area and a sample adding area from upstream to downstream; the reaction part is provided with at least one detection point and a control point, wherein the at least one detection point is coated and solidified with an anti-human IgG antibody, and the control point is coated and solidified with an anti-RBC antibody;
the anti-human IgG antibody can be specifically and immunologically combined with a corresponding IgG blood group antibody in the sample driven by the flushing fluid, and the IgG blood group antibody can be combined with red blood cells in a standard red blood cell suspension driven by the flushing fluid to form an anti-human IgG antibody/IgG blood group antibody/red blood cell compound and is gathered at a detection point; the anti-RBC antibody can bind to red blood cells in a quasi-red blood cell suspension carried by the wash fluid, so that the red blood cells are gathered at the control point.
2. The rapid test strip for IgG blood group antibody titer according to claim 1, wherein: the device also comprises a first sealing strip, a second sealing strip and a third sealing strip, wherein the first sealing strip is stuck between the flushing sample adding area and the red blood cell sample adding area, the second sealing strip is stuck between the red blood cell sample adding area and the sample adding area, and the third sealing strip is stuck to cover the junction of the sample adding part and the reaction part.
3. The rapid test strip for IgG blood group antibody titer according to claim 1, wherein: the sample adding part covers the reaction part at the contact position of the sample adding part and the reaction part.
4. The rapid test strip for IgG blood group antibody titer according to claim 1, wherein: the water absorption part covers the reaction part at the contact part of the water absorption part and the reaction part.
5. The rapid test strip for IgG blood group antibody titer according to claim 1, wherein: the sample adding part, the reaction part and the water absorbing part are all arranged on the substrate, and the upper cover is arranged on the substrate and covers the sample adding part, the reaction part and the water absorbing part.
6. The rapid test strip for IgG blood group antibody titer according to claim 5, wherein: the upper cover is provided with a flushing liquid adding hole, a red blood cell adding hole, a sample adding hole and an observation window which sequentially correspond to the flushing sample adding area, the red blood cell sample adding area, the sample adding area and the reaction part.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111458524A (en) * | 2020-03-26 | 2020-07-28 | 英科新创(厦门)科技股份有限公司 | IgG blood group antibody titer rapid detection kit |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111458524A (en) * | 2020-03-26 | 2020-07-28 | 英科新创(厦门)科技股份有限公司 | IgG blood group antibody titer rapid detection kit |
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