Transfusion compatibility detection quality control product kit
By designing a simple transfusion compatibility testing quality control kit, which includes quality control tubes simulating different blood types and quality control plasma with specific antibody combinations, the problems of complex structure, large number of sample tubes, and unstable detection in existing technologies are solved, achieving simple, comprehensive, and sensitive quality control results.
Patent Information
- Application Number
- CN202423260920.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-30
- Publication Date
- 2026-01-27
- Estimated Expiration
- 2034-12-30
AI Technical Summary
Existing transfusion compatibility testing internal quality control kits have complex structures and require a large number of sample tubes, making it impossible to fully cover all quality control items, and the test results are not sensitive or stable enough.
A simple quality control kit is designed, containing three control tubes that simulate different blood types. The kit uses red blood cells from healthy blood donors and control plasma with specific antibody combinations, covering ABO forward and reverse typing, RhD typing, Rh typing, antibody screening, and crossmatching. The control plasma components include glucose, phosphate buffer, antibiotics, IgG humanized anti-D monoclonal antibody, and IgM mouse anti-A/B monoclonal antibody.
It achieves comprehensive coverage of quality control items, reduces the number of sample tubes, simplifies operation, provides sensitive and stable test results, and is applicable to a variety of methodologies.
Smart Images

Figure CN223841920U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of transfusion compatibility testing technology, and in particular to a transfusion compatibility testing quality control kit. Background Technology
[0002] Currently, there are no commercially available internal quality control products for transfusion compatibility testing with SFDA approval numbers in China. Among known foreign products of the same type, only internal quality control products for ABO and RhD blood typing and irregular antibody screening are available, but no internal quality control products for crossmatch testing are available. Only a few transfusion compatibility testing laboratories in China have conducted some internal quality control work.
[0003] Internal quality control items for transfusion compatibility testing include ABO forward and reverse typing, RhD typing, Rh typing, antibody screening, and crossmatching. Existing internal quality control kits for transfusion compatibility testing contain a large number of control tubes and cannot fully cover all quality control items.
[0004] Based on the above-mentioned technical problems, those skilled in the art urgently need to develop a transfusion compatibility testing quality control kit that is simple in structure, requires few sample tubes, is easy to operate, comprehensively covers quality control items, and has sensitive and stable test results. Utility Model Content
[0005] The purpose of this invention is to provide a transfusion compatibility testing quality control kit that is simple in structure, requires few sample tubes, is easy to operate, comprehensively covers quality control items, and has sensitive and stable test results.
[0006] To achieve the above objectives, this utility model provides the following technical solution:
[0007] This invention relates to a transfusion compatibility testing quality control kit, comprising a box body and a lid. The box body has openings on both sides and is foldable. The openings on both sides are opened or closed by the lid. The kit also includes:
[0008] Three fixing holes provided in the box body; and
[0009] The first, second, and third quality control tubes are respectively placed in the three fixing holes, and each of the three quality control tubes contains quality control red blood cells and quality control plasma.
[0010] Furthermore, the quality control red blood cells are derived from healthy blood donors and have a concentration of 15% to 20% in the quality control plasma;
[0011] The quality control plasma includes glucose, phosphate buffer, antibiotics, humanized anti-D monoclonal antibody IgG, mouse anti-A IgM, and anti-B monoclonal antibody IgM.
[0012] The transfusion compatibility testing quality control kit provided by this utility model, as described above, has the following beneficial effects:
[0013] The transfusion compatibility testing quality control kit of this invention has a simple structure, requires few sample tubes, is easy to operate, comprehensively covers quality control items, is applicable to multiple methodologies, and provides sensitive and stable test results. Attached Figure Description
[0014] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this utility model. For those skilled in the art, other drawings can be obtained based on these drawings.
[0015] Figure 1 A schematic diagram of the internal structure of a transfusion compatibility testing quality control kit provided in this embodiment of the present invention;
[0016] Figure 2 This is a schematic diagram of the quality control tube in a transfusion compatibility testing quality control kit provided in an embodiment of the present invention.
[0017] Explanation of reference numerals in the attached figures:
[0018] 1. Box body; 2. Box lid; 3. First quality control tube; 4. Second quality control tube; 5. Third quality control tube; 101. Fixing hole. Detailed Implementation
[0019] To enable those skilled in the art to better understand the technical solution of this utility model, the present utility model will be further described in detail below with reference to the accompanying drawings.
[0020] See Figures 1-2 As shown;
[0021] This invention relates to a transfusion compatibility testing quality control kit, which includes a box body 1 and a box lid 2. The box body 1 has openings on both sides and is foldable. The openings on both sides are opened or closed by the box lid 2. The kit also includes:
[0022] Three fixing holes 101 are provided in the box body 1; and
[0023] The first quality control tube 3, the second quality control tube 4, and the third quality control tube 5 are respectively placed in the three fixing holes 101. Each of the three quality control tubes contains quality control red blood cells and quality control plasma.
[0024] As a further description of this embodiment, the quality control red blood cells are derived from healthy blood donors and have a concentration of 15% to 20% in the quality control plasma;
[0025] Quality control plasma includes glucose, phosphate buffer, antibiotics, humanized anti-D monoclonal antibody IgG, murine anti-A IgM, and anti-B monoclonal antibody IgM.
[0026] The specific components are as follows:
[0027] The first quality control tube 3 simulates A1 type R1R1 (CCDee) whole blood, with red blood cells containing A1, C, D, and e antigens, and the quality control plasma contains mouse-derived anti-B (IgM) monoclonal antibody;
[0028] The second quality control tube 4 simulates type B R2R2 (ccDEE) whole blood, with red blood cells containing B, c, D, and E antigens, and the quality control plasma contains mouse-derived anti-A (IgM) monoclonal antibody.
[0029] The third quality control tube 5 simulates A1 or B type RhD negative whole blood. When the red blood cell antigen is A1 RhD negative, the quality control plasma contains murine anti-B (IgM) monoclonal antibody and humanized anti-D (IgG) irregular antibody; when the red blood cell antigen is B RhD negative, the quality control plasma contains murine anti-A (IgM) monoclonal antibody and humanized anti-D (IgG) irregular antibody.
[0030] Specifically, for items requiring quality control, refer to the table below to select the corresponding quality control components:
[0031] Quality control items First Quality Control Second quality control Third Quality Control ABO forward and reverse shaping √ √ RhD finalization √ √ √ Rh(C, c, E, e) classification √ √ Antibody screening √ √ √ cross-match √(Blood Donor) √(Blood Donor) √(Recipient)
[0032] In the table above: blank components for the corresponding test items represent those that are not applicable, and "√" represents those that are applicable; for RhD typing and antibody screening, except for the third quality control tube 5 which is mandatory, the first quality control tube 3 and the second quality control tube 4 can be selected or either one can be selected for testing.
[0033] The transfusion compatibility testing quality control kit provided by this utility model, as described above, has the following beneficial effects:
[0034] The transfusion compatibility testing quality control kit of this invention has a simple structure, requires few sample tubes, is easy to operate, comprehensively covers quality control items, is applicable to multiple methodologies, and provides sensitive and stable test results.
[0035] The foregoing description only illustrates certain exemplary embodiments of the present invention. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the above drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.
Claims
1. A transfusion compatibility testing quality control kit, comprising a box body (1) and a box lid (2), wherein the box body (1) has openings on both sides and is foldable, and the openings on both sides are opened or closed by the box lid (2), characterized in that, The kit also includes: Three fixing holes (101) are provided in the box body (1); and The first quality control tube (3), the second quality control tube (4), and the third quality control tube (5) are respectively placed in the three fixing holes (101), and each of the three quality control tubes contains quality control red blood cells and quality control plasma.
2. The transfusion compatibility testing quality control kit according to claim 1, characterized in that, The quality control red blood cells are derived from healthy blood donors and have a concentration of 15% to 20% in the quality control plasma; The quality control plasma includes glucose, phosphate buffer, antibiotics, humanized anti-D monoclonal antibody IgG, mouse anti-A IgM, and anti-B monoclonal antibody IgM.