CN210534163U - Novel micro-column gel anti-human globulin detection tube - Google Patents
Novel micro-column gel anti-human globulin detection tube Download PDFInfo
- Publication number
- CN210534163U CN210534163U CN201921263877.4U CN201921263877U CN210534163U CN 210534163 U CN210534163 U CN 210534163U CN 201921263877 U CN201921263877 U CN 201921263877U CN 210534163 U CN210534163 U CN 210534163U
- Authority
- CN
- China
- Prior art keywords
- tube
- detection tube
- detection
- red blood
- plasma
- 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.)
- Active
Links
Images
Landscapes
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The utility model belongs to the technical field of medical appliances, and discloses a novel micro-column gel anti-human globulin detection tube which is provided with an empty sleeve; the detection tube is sleeved inside the hollow sleeve; the red blood cell filtering membrane is integrally arranged on one side of the upper end of the detection tube and is communicated with the empty sleeve; the pipe cover is sleeved at an opening at the upper end of the hollow sleeve. A tube cover is correspondingly arranged above the detection tube, and low-ion solution is placed in the tube cover. The space between the empty sleeve and the detection tube is empty and is used for storing separated plasma and cell density gradient centrifugal separation liquid; adding cell density gradient centrifugal separation liquid into the reaction hole above the gel, wherein the liquid can separate blood plasma from red blood cells in the centrifugal process; a red blood cell filtering membrane is added on the side wall of the inner tube and is used for keeping red blood cells in the detection tube when plasma is centrifugally separated; a tube cap was added containing 50 microliters of low ion solution for resuspending red blood cells upon secondary centrifugation. Meanwhile, the added pipe cover also ensures that liquid does not splash in the centrifugal process.
Description
Technical Field
The utility model belongs to the technical field of medical instrument, especially, relate to a novel anti-human globulin test tube of little post gel.
Background
Among the existing blood transfusion testing techniques, the most widely used mainstream technique is the micropore gel technique. The anti-human globulin detection card in the detection technology is used in various blood serological tests such as cross matching, irregular antibody screening, blood grouping and the like.
Currently, the conventional technology commonly used in the industry is the anti-human globulin test card (microcolumn gel technology) commonly used in clinical blood transfusion test technology, which is a rapid detection method for agglutination reaction of incomplete antibodies (i.e., IgG type anti-erythrocyte antibodies) in blood plasma to be tested and erythrocytes in a gel medium containing anti-human globulin antibodies (i.e., anti-human IgG antibodies). In the detection process, firstly, the blood plasma to be detected of a patient and standard red blood cells (or red blood cells of a blood donor) in a reagent are added into a detection card, the blood plasma to be detected and the standard red blood cells are incubated under the condition of 37 ℃ (if the blood plasma to be detected contains IgG type anti-red blood cell antibodies, the IgG type anti-red blood cell antibodies can be combined with the red blood cells to form sensitized red blood cells), then, in the centrifugation process, all the components enter the gel together, the sensitized red blood cells are combined with anti-human globulin antibodies in the gel to form agglutinated red blood cells, the agglutinated red blood cells cannot be completely settled to the bottom of the gel due to the fact that the volume of the agglutinated red blood cells is larger than that of a hole sieve in the gel, agglutinated particles which are visible to the. If the plasma to be tested does not contain IgG type anti-erythrocyte antibodies, sensitized erythrocytes are not formed, and agglutination is not formed, and after centrifugation, unagglutinated erythrocytes can pass through the hole sieve in the gel and deposit on the bottom of the gel (this is a negative result).
However, due to the presence of various endogenous interference factors in human plasma samples, such as: rheumatoid factor, autoantibody, immunoglobulin, etc., and the detection process of the existing anti-human globulin detection card only needs one step of sample adding and completes all detection reactions simultaneously, and the formed sensitized erythrocyte can not be separated from the endogenous interference factors in the blood plasma, so the detection result of the existing detection technology can be influenced by the endogenous interference factors in the human blood plasma sample, and the detection result is wrong. In addition, nonspecific immunoglobulin g (IgG) other than IgG-type anti-erythrocyte antibodies contained in a human plasma sample may not only interfere with the reaction between sensitized erythrocytes (to which IgG-type anti-erythrocyte antibodies are bound on erythrocytes) and anti-human globulin antibodies contained in the gel, but also may consume such antibodies by binding to the anti-human globulin antibodies in the gel, resulting in a decrease in the anti-human globulin antibodies bound to the sensitized erythrocytes, thereby causing false negatives or false decreases in the results. Since the occurrence of the above interference phenomena can cause the error of the blood transfusion detection result, thereby affecting the diagnosis and treatment of the patient and the life safety, a new anti-human globulin detection card is urgently needed to solve the problem.
In summary, the problems of the prior art are as follows: the existing detection card cannot separate endogenous interference factors in a plasma sample in the detection process, and the detection result is influenced by the endogenous interference factors in the human plasma sample, so that the detection result is wrong, and diagnosis and treatment are influenced.
The difficulty in solving the technical problems is as follows:
the existing anti-human globulin detection card is a rapid detection method, and operation steps are required to be reduced as much as possible in the detection process, so that sample adding and detection are completed in one step in the prior art. However, the actual detection process of the anti-human globulin test card is divided into two steps: the first step is that anti erythrocyte antibody in the blood plasma to be measured of the patient is combined with erythrocyte to form sensitized erythrocyte; the second step is the binding of the sensitized erythrocytes with the anti-human globulin antibody in the test card, forming visible agglutination of the erythrocytes. Since the two-step reaction is a test performed after one-step sample application, and the patient's plasma (including endogenous interference factors in the plasma) is not separated from the sensitized red blood cells in the second step reaction, the interference factors in the plasma interfere with the second step reaction, resulting in erroneous results.
In addition, the existing anti-human globulin test card is a micro-scale test method, and the sample adding amount of blood plasma and red blood cells to be tested in the test process is not more than 50 microliters, so that if a traditional test tube method is adopted to separately carry out two-step reactions, the operation process is complex, the test time is long, the sample adding amount can be greatly increased (at least 200 microliters), the test result is relatively easily influenced by human factors, the standardization and the automation are not easy, and the clinical application of the traditional test tube method is limited by the above steps.
The significance of solving the technical problems is as follows:
the safety of blood transfusion is related to the life safety of patients, the current guarantee of the safety of blood transfusion is based on the development of various blood transfusion test technologies, and the accuracy of results is more concerned due to the wide application of the microcolumn gel technology in blood transfusion test. The interference of endogenous interference factors in the plasma to be tested against the results of the human globulin test card (microcolumn gel technology) is the focus of research in recent years, and various interference factors are discovered in the process, such as: rheumatoid factors, autoantibodies, immune globulin and the like can generate bidirectional interference on the detection result of the prior art, so that the result is false negative or false positive. Therefore, the blood transfusion detection result is wrong, the blood product which should not be transfused is wrongly transfused to the patient, and the life safety of the patient cannot be ensured. Therefore, the improvement of the detection card can remove the interference factors in the blood plasma to be detected to a certain extent, so that the interference factors do not interfere with the result in the reaction process, thereby ensuring the accuracy of the blood transfusion detection result.
SUMMERY OF THE UTILITY MODEL
To the problems existing in the prior art, the utility model provides a novel micro-column gel anti-human globulin test tube.
The utility model is realized in such a way that the antiglobulin detection tube is provided with an empty sleeve;
the detection tube is sleeved in the hollow sleeve, the middle of the inner tube and the outer tube is hollow, and the detection tube can contain 200-300 microliter of liquid; this is provided for storing the separated plasma and cell density gradient centrifugation liquid when red blood cells are separated from the plasma and cell density gradient centrifugation liquid.
The red blood cell filtering membrane is integrally arranged on the side wall of the upper end of the detection tube and is communicated with the empty sleeve;
the erythrocyte filtering membrane is used for separating plasma and cell density gradient centrifugation liquid into an empty sleeve and keeping erythrocytes in the detection tube when the plasma and the cell density gradient centrifugation liquid are centrifugally separated.
And the pipe cover is sleeved at the opening at the upper end of the detection pipe.
The tube cover is added to ensure that no liquid splashes occur during centrifugation.
Furthermore, a hollow layer is arranged between the detection pipe and the hollow sleeve, and the volume of the hollow layer is 200-300 microliters. The volume is set to 200-300 microliter, so that the highest liquid level of the total amount of liquid stored each time is not higher than the detection tube, and the liquid is prevented from being blocked when the result is read.
Further, the outside cover of empty sleeve pipe is equipped with centrifugal fixing clip, the lower extreme of centrifugal fixing clip is pasted and is had the label.
The centrifugal fixing clamps are arranged on the two sides outside the empty sleeve, so that the effect of fixing the detection tube is achieved when the detection tube is placed in the special centrifuge, the detection tube is prevented from rotating in the vertical centrifugation process, and plasma and cell density gradient centrifugal separation liquid can smoothly enter the empty sleeve through the erythrocyte filtering membrane along the direction of the centrifugal force in the vertical centrifugation process.
Further, a layer of aluminum foil paper is sealed at the pipe orifice of the detection pipe. The aluminum foil paper is used for realizing the sealed package of the detection tube.
Furthermore, the tube cover contains 50 microliter of low-ion solution, and the contained low-ion solution can resuspend the red blood cells in the detection tube in the secondary centrifugation process and provide a proper reaction environment in the process of the reaction of the sensitized red blood cells and the anti-human globulin in the gel so as to improve the combination sensitivity of the sensitized red blood cells and the anti-human globulin and improve the detection sensitivity.
The gel is filled in the detection tube, an air column is arranged above the gel, and the cell density gradient centrifugal separation liquid is arranged above the air column.
Further, the cell density gradient centrifugation liquid is a liquid obtained by separating red blood cells from plasma components after incubation of red blood cells with plasma is completed, and the liquid in the detection tube above the gel can be separated into a plasma layer, a cell density gradient centrifugation liquid layer, and a red blood cell layer from the top to the bottom by centrifugation (centrifugal force of × 700 g).
Drawings
Fig. 1 is a schematic structural diagram of a novel micro-column gel anti-human globulin detection tube provided by the embodiment of the present invention.
In the figure: 1. a low-ion solution; 2. a tube cover; 3. a red blood cell filtration membrane; 4. gelling; 5. an empty cannula; 6. An air column; 7. centrifuging the separation solution by cell density gradient; 8. a detection tube; 9. centrifuging and fixing the card; 10. a label; 11. aluminum foil paper.
Fig. 2 is a schematic view of an installation structure of an aluminum foil sealing strip provided by an embodiment of the present invention.
Detailed Description
In order to further understand the contents, features and effects of the present invention, the following embodiments are illustrated and described in detail with reference to the accompanying drawings.
The structure of the present invention will be described in detail with reference to fig. 1 to 2.
Example (b):
the red blood cell filtering membrane 3 is thermally bonded on the upper portion of the right side of the detection tube 8, the gel 4 is arranged at the lower end of the inner side of the detection tube 8, the air column 6 is arranged above the gel 4, the cell density gradient centrifugal separation liquid 7 is arranged above the air column 6, the tube cover 2 is correspondingly arranged above the detection tube 8, and the low-ion solution 1 is placed inside the tube cover 2. The outer part of the detection tube 8 is thermally bonded with a hollow sleeve 5. The centrifugal fixing clamp 9 is flat and is made of polyethylene materials, and because the detection switch has strict direction setting during centrifugation, the centrifugal fixing clamp 9 is arranged for fixing the detection tube 8 during centrifugation, so that the detection tube cannot rotate randomly during centrifugation. In addition, a label 10 for writing is attached to a lower margin of the centrifugal fixing clip 9. Before the detection tube 8 is used without being unsealed, a layer of aluminum foil paper 11 is arranged to seal the tube opening of the detection tube 8.
The tube cover 2 contains 50 microliter of low ion solution 1, the low ion solution 1 is LISS liquid, the cell density gradient centrifugal separation liquid 7 is Ficoll liquid, and the main component is synthesized sucrose polymer.
The utility model discloses a theory of operation: adding the cell density gradient centrifugal separation liquid 7 into a detection tube 8, adding the plasma and the red blood cells to be detected into the detection tube 8, and incubating the plasma and the red blood cells to be detected for 15 minutes at 37 ℃ above the cell density gradient centrifugal separation liquid 7; after incubation, placing the detection tube 8 in a special centrifuge, horizontally centrifuging for 1 minute (the centrifugal force is multiplied by 700g) to separate red blood cells from plasma, wherein the upper layer is the plasma, the middle layer is a cell density gradient centrifugal separation liquid 7, and the lower layer is the red blood cells; then vertically centrifuging for 1 minute (the centrifugal force is multiplied by 700g), throwing the plasma and the cell density gradient centrifugal separation liquid 7 into an empty sleeve 5 in the middle of the inner tube and the outer tube through a red blood cell filtering membrane 3; the tube cap 2 is closed and centrifuged horizontally for 9 minutes again (centrifugal force. times.900 g), during which the low-ion solution 1 in the tube cap 2 enters the test tube 8 to resuspend the red blood cells and bring the red blood cell suspension into the gel 4 to react with the antihuman globulin.
The centrifugal force of x 700g ensures that the erythrocytes are not broken during the centrifugation, and the centrifugation for 1 minute is to ensure that the erythrocytes and the plasma can be completely separated, and simultaneously, the cell density gradient centrifugation liquid 7 can not enter the gel 4 (if the cell density gradient centrifugation liquid 7 enters the gel 4, the molecular sieve in the gel 4 is blocked, so that the unsensitized erythrocytes can not be deposited at the bottom of the gel 4, thereby causing the occurrence of false positive).
The utility model discloses the result comparison of improved method and current method has been simulated step by step, and under rheumatoid factor interference condition, false negative appears in the result of current method pipe, and the result of improved method pipe can be clearly distinguished and is regarded as positive. Under the condition of immunoglobulin interference, 1 tube is a control tube, and 2 tubes are simulated interference tubes added with immunoglobulin G (IgG) with the concentration of 50g/L, and the result is not changed (namely, no interference occurs) after the detection is carried out by the improved method.
Furthermore, the utility model discloses enlarged simulation experiment sample number and further verified above-mentioned experiment. In 96 prepared rheumatoid factor interference simulation samples (rheumatoid factors with the concentration of 500-12000 IU/mL are added in plasma), 49 results in the detection results of the existing anti-human globulin detection card have false negative, but the improved method only has the false negativeThe 17 results showed interference, and the two results were statistically different, x223.642, p is 0.000 < 0.005. The utility model discloses under rheumatoid factor's interference condition, the interference killing feature is showing the promotion than current method.
Among 28 cases of IgG interference simulation samples (IgG added in plasma at a concentration of 100G/L), 18 cases of the test results using the existing anti-human globulin test card showed false negatives, while only 5 cases of the test results in the improved method showed interference, and the two results were statistically significantly different, x212.469, p is 0.000 < 0.005. The utility model discloses under immunoglobulin G's interference condition, the interference killing feature also has showing the promotion than current method.
The two groups of simulation interference experiments compare the interference resistance of the improved method with that of the prior art to two main endogenous interference factors (rheumatoid factors and IgG) in blood plasma to be detected of a patient. By adopting statistical comparison analysis, the improved method can obviously reduce the interference of the two endogenous interference factors on the result.
The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention in any way, and all the modifications and equivalents of the technical spirit of the present invention to any simple modifications of the above embodiments are within the scope of the technical solution of the present invention.
Claims (5)
1. A novel micro-column gel anti-human globulin detection tube is characterized in that the novel micro-column gel anti-human globulin detection tube is provided with an empty sleeve;
the detection tube is sleeved inside the hollow sleeve;
the red blood cell filtering membrane is integrally arranged on the side wall of the upper end of the detection tube and is communicated with the empty sleeve;
and the pipe cover is sleeved at the opening at the upper end of the detection pipe.
2. The novel micro-column gel anti-human globulin test tube according to claim 1, wherein a centrifugal fixing clip is sleeved outside the hollow sleeve, and a label is adhered to the lower end of the centrifugal fixing clip.
3. The novel microcolumn gel anti-human globulin test tube according to claim 1, wherein said tube has a mouth sealed with a layer of aluminum foil paper.
4. The novel micro-column gel anti-human globulin detection tube as claimed in claim 1, wherein a hollow layer is formed between the detection tube and the empty sleeve, and the volume of the hollow layer is 200-300 μ l.
5. The novel microcolumn gel anti-human globulin detection tube according to claim 1, wherein said tube contains a gel, an air column is above said gel, and a cell density gradient centrifugation liquid is above said air column.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201921263877.4U CN210534163U (en) | 2019-08-06 | 2019-08-06 | Novel micro-column gel anti-human globulin detection tube |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201921263877.4U CN210534163U (en) | 2019-08-06 | 2019-08-06 | Novel micro-column gel anti-human globulin detection tube |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN210534163U true CN210534163U (en) | 2020-05-15 |
Family
ID=70600517
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201921263877.4U Active CN210534163U (en) | 2019-08-06 | 2019-08-06 | Novel micro-column gel anti-human globulin detection tube |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN210534163U (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024152474A1 (en) * | 2023-01-16 | 2024-07-25 | 楚天思为康基因科技(长沙)有限公司 | Method for centrifugation of cells |
-
2019
- 2019-08-06 CN CN201921263877.4U patent/CN210534163U/en active Active
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024152474A1 (en) * | 2023-01-16 | 2024-07-25 | 楚天思为康基因科技(长沙)有限公司 | Method for centrifugation of cells |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US6114179A (en) | Method and test kit for detecting antigens and/or antibodies | |
| US5460940A (en) | Method for detecting antigens and/or antibodies | |
| US4436631A (en) | Multiple particle washing system and method of use | |
| WO2018014513A1 (en) | Microfluidic reagent card and detection method and application thereof | |
| CA1313616C (en) | Lateral flow, non-bibulous membrane protocols | |
| CA1190905A (en) | Particle washing system and method of use | |
| US4943522A (en) | Lateral flow, non-bibulous membrane assay protocols | |
| US5282981A (en) | Flow restrictor-separation device | |
| US7754472B2 (en) | Device and method for detecting analytes by visualization and separation of agglutination | |
| Bromilow et al. | Evaluation of the ID‐gel test for antibody screening and identification | |
| EP2788774B1 (en) | Method and device for assaying an antigen present on erythrocytes or an antibody binding to an antigen present on erythrocytes | |
| JPS5838536A (en) | Blood collecting apparatus | |
| Rumsey et al. | New protocols in serologic testing: a review of techniques to meet today's challenges | |
| Malyska et al. | The gel test | |
| CN210534163U (en) | Novel micro-column gel anti-human globulin detection tube | |
| US5869347A (en) | Particle immunoassay using a compact matrix | |
| CN110308288B (en) | Novel blood platelet cross matching kit | |
| Freedman et al. | Random donor platelet crossmatching: comparison of four platelet antibody detection methods | |
| JPS60140155A (en) | Device for interposing separated gel between two phase in test tube | |
| AU2660500A (en) | Method for detecting antibodies or antigens and for determining blood groups | |
| WO1995030904A1 (en) | Solid-phase filtration method for antigen and antibody assays in bloodgroup serology, and test kit | |
| JP6683626B2 (en) | Device and method for detecting blood group antigens using incomplete antibodies | |
| CN207866824U (en) | A kind of the anti-of efficient detection determines card | |
| US4708850A (en) | Self-contained portable apparatus for blood typing | |
| Beck et al. | Solid-phase techniques in blood transfusion serology |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant |