Gel suspension buffer, gel solution, test card and use thereof

Abstract

The present invention relates to the field of medical device technology, and more particularly to a gel suspension buffer, a gel solution, a test card, and uses thereof. The gel suspension buffer comprises: 0.5-5 g / L potassium dihydrogen phosphate, 0.5-5 g / L disodium hydrogen phosphate, 0.5-5 g / L sodium chloride, 10-50 g / L polyethylene glycol, 10-50 g / L polyvinyl pyrrolidone, 10-50 g / L dextran reagent, and the remainder solvent. Using the gel suspension buffer provided by the present invention to prepare a test card has the advantages of low production cost, high detection time, high sensitivity, and high accuracy.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a gel suspension buffer, a gel solution, a test card and uses thereof. Background Art

[0002] The antiglobulin test, also known as the Coombs' test, was invented by British immunologist Coombs et al. in 1945 to detect antibodies on the surface of red blood cells. The antiglobulin test uses antiglobulin antibodies as anti-antibodies, which bind to specific antibodies (such as incomplete IgG antibodies and / or C3d complement) bound to red blood cell surface antigens, thereby causing the sensitized red blood cells to agglutinate.

[0003] Microcolumn gel technology was invented by Yves Lapierre in 1984, and the patented product was commercialized by Swiss company Diamé in 1988. Its principle is that free red blood cells can pass through a colloidal medium composed of gel particles that act as a molecular sieve, while aggregated red blood cells cannot, thus separating red blood cells in different states.

[0004] The Microcolumn Gel Broad-Spectrum Anti-Human Globulin Reagent Test Card is a novel product that combines microcolumn gel technology with the anti-human globulin test method and has been widely used in recent years. In the microcolumn gel medium, red blood cells sensitized with incomplete IgG antibodies and / or complement undergo agglutination reaction under the action of anti-human globulin polyclonal antibodies and anti-C3d antibodies, forming red blood cell immune complexes. Under a certain centrifugal force, these complexes cannot pass through the gel gaps and settle on the surface or within the gel. Red blood cells that are not sensitized with incomplete IgG antibodies and / or complement cannot form red blood cell immune complexes. Under a certain centrifugal force, free red blood cells can pass through the gel gaps and settle to the bottom of the microcolumn cavity.

[0005] Compared to traditional test tube-based anti-human globulin assays, the Microcolumn Gel Broad-Spectrum Anti-Human Globulin Reagent Test Card omits tedious washing and negative control procedures. Furthermore, the card offers advantages such as small sample volume, ease of operation, minimal human interference, ease of standardized and automated operation, easy interpretation of results, and convenient storage and review, making it suitable for large-scale specimen testing. Currently, the Microcolumn Gel Broad-Spectrum Anti-Human Globulin Reagent Test Card has been widely used in blood typing, irregular antibody screening, cross-matching, and direct anti-human globulin detection and identification.

[0006] However, in the process of realizing the present invention, the inventors found that the test card in the prior art had a high production cost due to the use of multi-specific anti-human globulin reagents; moreover, the test card performed anti-human globulin testing in a low-ion environment, and the red blood cell antigen and serum needed to be incubated at 37°C for 15 to 30 minutes, which took a long time to detect; in addition, the test card had poor stability, which made the detection sensitivity easily affected by external factors. Summary of the Invention

[0007] Therefore, the technical problem to be solved by the present invention is to overcome the defects of the anti-human globulin test card in the prior art, such as high production cost, long detection time and easily affected sensitivity, thereby providing a gel suspension buffer, a gel solution and a test card and their uses.

[0008] To this end, the present invention provides a gel suspension buffer comprising:

[0009] Potassium dihydrogen phosphate 0.5-5g / L, disodium hydrogen phosphate 0.5-5g / L, sodium chloride 0.5-5g / L, polyethylene glycol 10-50g / L, polyvinyl pyrrolidone 10-50g / L, dextran reagent 10-50g / L and the remainder of the solvent.

[0010] In the gel suspension buffer, the sodium chloride content is 0.5 g / L-5 g / L, for example, 0.5 g / L, 1 g / L, 1.5 g / L, 2 g / L, 2.5 g / L, 3 g / L, 3.5 g / L, 4 g / L, 4.5 g / L or 5 g / L; the polyethylene glycol content is 10 g / L-50 g / L, for example, 10 g / L, 15 g / L, 20 g / L, 25 g / L, 30 g / L, 35 g / L, 40 g / L, 45 g / L or The content of polyvinyl pyrrolidone is 10g / L-50g / L, for example, 10g / L, 15g / L, 20g / L, 25g / L, 30g / L, 35g / L, 40g / L, 45g / L or 50g / L; the content of dextran reagent is 10g / L-50g / L, for example, 10g / L, 15g / L, 20g / L, 25g / L, 30g / L, 35g / L, 40g / L, 45g / L or 50g / L.

[0011] Optionally, the polyethylene glycol can be selected from at least one of PEG4000, PEG6000, PEG8000 and PEG20000; the polyvinyl pyrrolidone can be selected from at least one of PVP10, PVP30, PVP40, PVP60 and PVP90; the molecular weight of the dextran reagent can be Mr6000, Mr40000, Mr70000, Mr100000 or Mr450000-650000. In actual use, dextran with different molecular weights can be selected according to performance requirements.

[0012] Optionally, the gel suspension buffer comprises: 1-2 g / L potassium dihydrogen phosphate, 3-5 g / L disodium hydrogen phosphate, 1-5 g / L sodium chloride, 10-20 g / L polyethylene glycol, 10-20 g / L polyvinyl pyrrolidone, 10-30 g / L dextran reagent, and the remainder of solvent;

[0013] Optionally, the gel suspension buffer comprises: 1.4 g / L potassium dihydrogen phosphate, 4.2 g / L disodium hydrogen phosphate, 3 g / L sodium chloride, 10 g / L polyethylene glycol, 10 g / L polyvinyl pyrrolidone, 20 g / L dextran reagent and the remainder of the solvent.

[0014] Optionally, the gel suspension buffer further contains 0.1 to 2 g / L of sodium azide, such as 0.1 g / L, 0.5 g / L, 1 g / L, 1.5 g / L or 2 g / L, preferably 1 g / L;

[0015] Optionally, the gel suspension buffer further contains 0.01-2 g / L of tartrazine and 0.01-2 g / L of methylene blue, for example, 0.01 g / L, 0.05 g / L, 0.1 g / L, 1.5 g / L or 2 g / L of tartrazine, and 0.01 g / L, 0.05 g / L, 0.1 g / L, 1.5 g / L or 2 g / L of methylene blue, preferably 0.1 g / L of tartrazine and 0.1 g / L of methylene blue.

[0016] Optionally, the pH of the gel suspension buffer is 6.8 to 7.4, such as 6.8, 6.9, 7.0, 7.1, 7.2, 7.3 or 7.4, preferably 7.2.

[0017] Optionally, the solvent is water.

[0018] The present invention also provides a gel solution, which comprises the gel suspension buffer described in any one of the above items and a gel, wherein the volume ratio of the gel suspension buffer to the gel is (20-50): (50-80), for example, 50:50, 45:55, 40:60, 35:65, 30:70, 25:75 or 20:80.

[0019] Optionally, the volume ratio of the gel suspension buffer to the gel is (35-45):(55-65); preferably, the volume ratio of the gel suspension buffer to the gel is 40:60.

[0020] Optionally, the gel is selected from any one of Sephadex G10, Sephadex G25, Sephadex G50 and Sephadex G100.

[0021] Optionally, the preparation process of the gel solution includes:

[0022] The gel raw material was swelled with pure water overnight, and the supernatant was removed after centrifugation the next day. The gel was washed with purified water 2 to 3 times, the supernatant was discarded, and the gel was washed with an equal amount of the gel suspension buffer 2 to 3 times, the supernatant was discarded, and the gel suspension buffer was directly added at one time.

[0023] The present invention also provides a test card comprising a micro-column tube filled with any of the above-mentioned gel solutions.

[0024] Optionally, the number of the microcolumn tubes is 6 to 8, for example Figure 1 6 as shown, or as Figure 2 8 shown; each microcolumn tube is filled with 20 to 50 μl of the gel solution, for example, 20 μl, 25 μl, 30 μl, 35 μl, 40 μl, 45 μl or 50 μl, preferably 30 μl;

[0025] Optionally, the test card is obtained by filling and centrifuging at a centrifugal speed of 1000 to 5000 rpm, preferably 4000 rpm. Centrifugation is performed to remove bubbles in the gel solution to prevent bubbles from affecting the test results.

[0026] The present invention also provides use of any of the above-mentioned detection cards in preparing products for irregular antibody detection, cross-matching detection or direct anti-human globulin detection.

[0027] Optionally, the use is in the preparation of D, C, E, c, e, Jk on red blood cells a 、Jk b 、M、N、s、Fy a 、Fy b ,k,Le a 、Le b , use in products for detecting irregular antibodies corresponding to the P1 antigen;

[0028] Optionally, the use is for preparing a product for detecting an IgM antigen-antibody reaction and / or an IgG antigen-antibody reaction;

[0029] Optionally, the use is in the preparation of products for neonatal sensitized red blood cell detection, neonatal hemolytic disease or maternal incomplete antibody detection, autoimmune hemolytic disease detection, and drug-induced immune hemolytic disease detection.

[0030] The technical solution of the present invention has the following advantages:

[0031] 1. The gel suspension buffer provided by the present invention contains PEG, PVP, and dextran reagents. The combined use of these three reagents can effectively reduce the filtration gap of the gel molecular sieve in the test card, so that red blood cells that react with IgG or C3d antibodies on their surface antigens can be trapped above the gel surface and in the middle of the gel column, while red blood cells that do not react with IgG or C3d antibodies on their surface antigens can completely pass through the gaps between the gel particles. Therefore, in the test card prepared using this gel suspension buffer, there is no need to use an anti-human globulin secondary antibody to aggregate sensitized red blood cells into larger immune complexes. Accordingly, the production of the test card also does not require the addition of conventional anti-human globulin reagents, thereby significantly reducing production costs.

[0032] Furthermore, the sodium chloride concentration in the gel suspension buffer is lower than the physiological concentration, which can effectively reduce the ionic strength of the gel medium, lower the Zeta potential of red blood cells, promote antigen-antibody binding, and enable antibodies that previously could not agglutinate red blood cells in saline media to agglutinate, thereby accelerating the reaction rate and shortening the incubation time required to detect most antibodies. Furthermore, the gel suspension buffer can provide a low-ion salt environment, eliminating the need for additional dilution of red blood cells with a specific low-ion salt solution, and the detection process does not require a 15-30 minute incubation period, greatly shortening the detection time.

[0033] In addition, the gel suspension buffer can provide a reaction medium suitable for the reaction between human red blood cell antigens and serum antibodies. Moreover, by adding macromolecular polymers, the suspension ability of the gel medium can be effectively improved, so that the gel is placed in a dense, stable and uniform suspension environment. This not only facilitates process filling, but also enhances the stability of the gel medium, avoiding deformation of the test results as the gel flows, thereby improving detection sensitivity and accuracy.

[0034] 2. The gel suspension buffer provided by the present invention, lemon yellow and methylene blue reagents can be mixed to form a green gel solution, which distinguishes the test card from other antibody detection gel cards; sodium azide is used as a preservative, which can effectively maintain the antibacterial effect for a long time, and at the same time has good serum antibody compatibility and will not affect the red blood cell antigen and serum antibody reaction. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0036] Figure 1 Schematic diagram of a test card with 6 microcolumns in the present invention;

[0037] Figure 2 Schematic diagram of a test card with 8 microcolumns according to the present invention. DETAILED DESCRIPTION

[0038] The following examples are provided for a better understanding of the present invention and are not intended to limit the best mode of implementation. They do not limit the content and scope of protection of the present invention. Any product identical or similar to the present invention obtained by anyone under the guidance of the present invention or by combining the features of the present invention with other prior arts shall fall within the scope of protection of the present invention.

[0039] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in this field can be used. If the manufacturer of the reagents or instruments is not specified, they are all commercially available conventional reagents.

[0040] The dextran reagent used in the examples or comparative examples of the present invention was purchased from Sigma and had a molecular weight of Mr100000.

[0041] Example 1

[0042] This embodiment provides a test card, which is prepared by the following method:

[0043] (1) Preparation of gel suspension buffer:

[0044] Take 1.4 g of potassium dihydrogen phosphate, 4.2 g of disodium hydrogen phosphate, 3 g of sodium chloride, 10 g of PEG4000, 10 g of PVP10, 20 g of dextran reagent, 1 g of sodium azide, 0.1 g of tartrazine, and 0.1 g of methylene blue, add purified water and dissolve to 1 L, adjust the pH to 7.2, to obtain gel suspension buffer;

[0045] The gel suspension buffer comprises 1.4 g / L potassium dihydrogen phosphate, 4.2 g / L disodium hydrogen phosphate, 3 g / L sodium chloride, 10 g / L PEG4000, 10 g / L PVP10, 20 g / L dextran reagent, 1 g / L sodium azide, 0.1 g / L tartrazine, and 0.1 g / L methylene blue;

[0046] (2) Preparation of dextran gel:

[0047] Take 10 g of G50 dextran powder, add 200 mL of purified water and soak it overnight to swell. After standing and settling, discard the supernatant. Repeat the soaking and washing with 200 mL of purified water three times to remove gel impurities. Then, repeat the soaking and washing with 200 mL of the gel suspension buffer prepared in step (1) three times, and discard the supernatant to obtain a dextran gel with uniform particles.

[0048] (3) Preparation of gel solution:

[0049] Take 40 mL of the gel suspension buffer prepared in step (1) and 60 mL of the dextran gel prepared in step (2), mix them, stir them evenly, and prepare to fill;

[0050] (4) Filling of test cards

[0051] The gel solution prepared in step (3) was taken and filled into test cards at 30 μl / tube. Six microcolumn tubes were filled into each test card. Immediately after filling, the test cards were centrifuged at 4000 rpm for 5 minutes to obtain the filled test cards.

[0052] (5) Sealing:

[0053] The filled test cards prepared in step (4) are placed on an aluminum film at a rate of 12 cards / mold, and heat-sealed using a blood type card sealing machine to obtain the test cards.

[0054] Example 2

[0055] This embodiment provides a test card. Unlike Example 1, the gel suspension buffer used in this test card includes 1 g / L potassium dihydrogen phosphate, 3 g / L disodium hydrogen phosphate, 1 g / L sodium chloride, 10 g / L PEG4000, 10 g / L PVP10, 10 g / L dextran reagent, 0.5 g / L sodium azide, 0.05 g / L tartrazine, and 0.05 g / L methylene blue.

[0056] Example 3

[0057] This embodiment provides a test card. Unlike Example 1, the gel suspension buffer used in this test card includes 2 g / L potassium dihydrogen phosphate, 5 g / L disodium hydrogen phosphate, 5 g / L sodium chloride, 20 g / L PEG4000, 20 g / L PVP10, 30 g / L dextran reagent, 1.5 g / L sodium azide, 0.15 g / L tartrazine, and 0.15 g / L methylene blue.

[0058] Example 4

[0059] This embodiment provides a test card. Unlike Example 1, the gel suspension buffer used in this test card includes 0.5 g / L potassium dihydrogen phosphate, 0.5 g / L disodium hydrogen phosphate, 0.5 g / L sodium chloride, 10 g / L PEG4000, 10 g / L PVP10, 10 g / L dextran reagent, 0.1 g / L sodium azide, 0.01 g / L tartrazine, and 0.01 g / L methylene blue.

[0060] Example 5

[0061] This embodiment provides a test card. Unlike Example 1, the gel suspension buffer used in this test card includes 5 g / L potassium dihydrogen phosphate, 5 g / L disodium hydrogen phosphate, 5 g / L sodium chloride, 50 g / L PEG4000, 50 g / L PVP10, 50 g / L dextran reagent, 2 g / L sodium azide, 2 g / L tartrazine, and 2 g / L methylene blue.

[0062] Example 6

[0063] This embodiment provides a test card. Different from Example 1, during the preparation of the test card, 20 mL of the gel suspension buffer prepared in step (1) and 80 mL of the dextran gel prepared in step (2) are mixed to obtain a gel solution.

[0064] Example 7

[0065] This embodiment provides a test card. Different from Example 1, during the preparation of the test card, 50 mL of the gel suspension buffer prepared in step (1) and 50 mL of the dextran gel prepared in step (2) are mixed to obtain a gel solution.

[0066] Comparative Example 1

[0067] This comparative example provides a test card. Different from Example 1, the gel suspension buffer used in the test card does not contain PEG4000.

[0068] Comparative Example 2

[0069] This comparative example provides a test card. Unlike Example 1, the gel suspension buffer used in the test card does not contain PVP10.

[0070] Comparative Example 3

[0071] This comparative example provides a test card. Different from Example 1, the gel suspension buffer used in the test card does not contain a dextran reagent.

[0072] Experimental Example 1

[0073] Irregular antibody detection was performed using the test cards prepared in Examples 1-7 and Comparative Examples 1-3:

[0074] Mark each test card, such as Figure 1As shown. Three test subjects' serum was separated and the screening red blood cells (source: Beijing Lepu Diagnostics Technology Co., Ltd.) were prepared with physiological saline to a 0.8% red blood cell volume concentration. One drop (or 50 μL) of red blood cell suspension was added to each labeled micro-column tube. Then, one drop (or 50 μL) of serum from one test subject was immediately added to each micro-column tube. The test card was centrifuged for 5 minutes (900 rpm for 2 minutes, 2000 rpm for 3 minutes) using a dedicated centrifuge. The results were then visually observed. The results were determined using the following criteria:

[0075] 4+: Red blood cells aggregate on the upper surface of the gel separation medium and form a ring;

[0076] 3+: Most of the agglutinated red blood cells remain in the upper half of the gel separation medium;

[0077] 2+: Agglutinated red blood cells are distributed throughout the gel separation medium, with a small amount of red blood cells at the bottom of the microcolumn;

[0078] 1+: Most of the agglutinated red blood cells remain in the lower half of the gel separation medium, and there are more red blood cells at the bottom of the microcolumn;

[0079] -: Negative reaction, all red blood cells passed through the gaps in the gel and formed a flat red blood cell aggregation zone at the bottom of the microcolumn.

[0080] A clinical routine anti-human globulin test card (source: Changchun Boxun Biotechnology Co., Ltd., model: 6 wells / card) was used as a control, and the test results are shown in Table 1.

[0081] Table 1 Irregular antibody detection results

[0082]

[0083]

[0084] As can be seen from Table 1, the detection results of the test card of the present invention for irregular antibodies are consistent with those of the conventional clinical anti-human globulin test card, and the agglutination strength of the test card of the present invention is 1+ higher than the conventional result.

[0085] Experimental Example 2

[0086] A cross-matching test was performed using the test cards prepared in Examples 1-7 and Comparative Examples 1-3:

[0087] Separate the red blood cell serum from two pairs of recipients and donors; prepare a physiological saline suspension with a red blood cell volume percentage concentration of 0.8% for each pair of recipient and donor red blood cells; for each pair of recipient and donor, add one drop (or 50 microliters) of recipient serum and one drop (or 50 microliters) of donor red blood cells to the primary side tube; add one drop (or 50 microliters) of recipient red blood cells and one drop (or 50 microliters) of donor serum to the secondary side tube; immediately after adding the samples, centrifuge them in a dedicated centrifuge for 5 minutes (900 rpm for 2 minutes, 2000 rpm for 3 minutes), remove them and observe the results with the naked eye. The results are determined according to the same rules as in Experimental Example 1.

[0088] A routine clinical anti-human globulin test card (source: Changchun Boxun Biotechnology Co., Ltd., model: 6 wells / card) was used as a control. The test results are shown in Table 2.

[0089] Table 2 Cross-matching test results

[0090]

[0091]

[0092] As can be seen from Table 2, the results of the cross-matching test using the test card of the present invention are consistent with those of the conventional clinical anti-human globulin test card, and the agglutination strength of the test card of the present invention is 1+ to 2+ higher than the conventional result.

[0093] Experimental Example 3

[0094] The direct anti-human globulin test was performed using the test cards prepared in Examples 1-7 and Comparative Examples 1-3:

[0095] Mark the microtubes on the test card, such as Figure 1 As shown; the red blood cells of the two subjects to be tested were washed with normal saline and then prepared into a red blood cell normal saline suspension with a red blood cell volume percentage concentration of 0.8%; negative control red blood cells: healthy male type O red blood cells were prepared into a red blood cell normal saline suspension with a red blood cell volume percentage concentration of 0.8%; 50 μl of the 0.8% red blood cell normal saline suspension of the two subjects to be tested were added to tubes 1 and 2 respectively, and 50 μl of the negative control red blood cells were added to tube 6.

[0096] Immediately centrifuge for 5 minutes (900 rpm for 2 minutes, 2000 rpm for 3 minutes), remove the sample, and visually judge the results. The results are the same as those in Experimental Example 1. A conventional clinical anti-human globulin test card (source: Changchun Boxun Biotechnology Co., Ltd., model: 6 wells / card) was used as a control. The test results are shown in Tables 3 and 4.

[0097] Table 3 Comparison results of IgG-sensitized red blood cells

[0098]

[0099]

[0100] Table 4 Comparison results of C3d-sensitized red blood cells

[0101]

[0102]

[0103] As can be seen from Tables 3 and 4, the results of the direct anti-human globulin test of the test card of the present invention are consistent with those of the conventional clinical anti-human globulin test card, and the agglutination strength of the test card of the present invention is generally 1+ higher than the conventional results.

[0104] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A gel solution, characterized in that The gel solution includes a gel suspension buffer and a gel, and the volume ratio of the gel suspension buffer to the gel is (20-50): (50-80); The gel suspension buffer comprises: 0.5-5 g / L potassium dihydrogen phosphate, 0.5-5 g / L disodium hydrogen phosphate, 0.5-5 g / L sodium chloride, 10-50 g / L polyethylene glycol, 10-50 g / L polyvinyl pyrrolidone, 10-50 g / L dextran reagent, and the remainder of solvent; The preparation process of the gel solution includes: The gel raw material was swollen in pure water overnight, and the supernatant was removed after centrifugation the next day. The gel was washed with purified water 2 to 3 times, the supernatant was discarded, and the gel was washed with an equal amount of the gel suspension buffer 2 to 3 times, the supernatant was discarded, and the gel suspension buffer was directly added at one time. The gel is selected from any one of Sephadex G10, Sephadex G25, Sephadex G50 and Sephadex G100.

2. The gel solution according to claim 1, characterized in that The gel suspension buffer comprises: Potassium dihydrogen phosphate 1-2 g / L, disodium hydrogen phosphate 3-5 g / L, sodium chloride 1-5 g / L, polyethylene glycol 10-20 g / L, polyvinyl pyrrolidone 10-20 g / L, dextran reagent 10-30 g / L and the remainder of the solvent.

3. The gel solution according to claim 2, characterized in that The gel suspension buffer comprises: 1.4 g / L potassium dihydrogen phosphate, 4.2 g / L disodium hydrogen phosphate, 3 g / L sodium chloride, 10 g / L polyethylene glycol, 10 g / L polyvinyl pyrrolidone, 20 g / L dextran reagent and the remainder of solvent.

4. The gel solution according to claim 1, wherein The gel suspension buffer further contains 0.1-2 g / L of sodium azide.

5. The gel solution according to claim 4, characterized in that The gel suspension buffer further contains 1 g / L of sodium azide.

6. The gel solution according to claim 1, characterized in that The gel suspension buffer further contains 0.01-2 g / L of tartrazine and 0.01-2 g / L of methylene blue.

7. The gel solution according to claim 1, characterized in that The gel suspension buffer further contains 0.1 g / L of tartrazine and 0.1 g / L of methylene blue.

8. The gel solution according to claim 1, characterized in that The pH of the gel suspension buffer is 6.8-7.

4.

9. The gel solution according to claim 1, characterized in that The volume ratio of the gel suspension buffer to the gel is (35-45): (55-65).

10. The gel solution according to claim 9, characterized in that The volume ratio of the gel suspension buffer to the gel is 40:

60.

11. A detection card, characterized in that: The detection card comprises a micro-column tube, and the micro-column tube is filled with the gel solution according to any one of claims 1 to 10.

12. The test card according to claim 11, characterized in that: The number of the micro-column tubes is 6 to 8, and each micro-column tube is filled with 20 to 50 μl of the gel solution.

13. The detection card according to claim 12, characterized in that: Each microcolumn tube was filled with 30 μl of the gel solution.

14. The test card according to claim 11, characterized in that: The test card is obtained by filling and centrifuging, and the centrifugal speed is 1000-5000 rpm.

15. Use of the test card according to any one of claims 11 to 14 in the preparation of products for irregular antibody detection, cross-matching detection or direct anti-human globulin detection.

16. The use according to claim 15, characterized in that The use is to prepare D, C, E, c, e, Jk on red blood cells a 、Jk b 、M、N、s、Fy a 、Fy b ,k,Le a 、Le b , and its use in products for detecting irregular antibodies corresponding to P1 antigen.

17. The use according to claim 15, characterized in that The use is in the preparation of products for detecting IgM antigen-antibody reactions and / or IgG antigen-antibody reactions.

18. The use according to claim 15, characterized in that The use is in the preparation of products for detecting neonatal sensitized red blood cells, neonatal hemolytic disease or maternal incomplete antibodies, autoimmune hemolytic disease, and drug-induced immune hemolytic disease.

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