Hct measuring assembly and chemiluminescence immunoassay analyzer

CN224695760UActive Publication Date: 2026-08-28NANJING VAZYME MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202522000778.9
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2025-09-17
Publication Date
2026-08-28
Estimated Expiration
2035-09-17

AI Technical Summary

Technical Problem

[0002]血细胞分析仪和发光化学分析仪是检验科最常规的两种检测设备,当患者需要检测血细胞和化学发光相关测试时,通常需要使用这两种不同的仪器,这样不仅增加了检验科医生的工作量,还可能因为不同仪器之间的差异性,导致测试结果存在偏差

Benefits of technology

[0022] The chemiluminescence immunoassay section of this application, including its modules, structures, and inter-module control operations, can all be implemented using existing technologies.

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Abstract

The application belongs to the technical field of detection instruments, and discloses a HCT measurement assembly and a chemiluminescence immunoassay analyzer. The HCT measurement assembly comprises a reaction pool, an optical measurement module, a diluent module, a mixing module, a waste liquid barrel and a control module. The optical measurement module is assembled on the periphery of the reaction pool and directly performs optical detection on the diluted whole blood sample in the reaction pool. The diluent module comprises a diluent barrel, and the diluent barrel is connected to the reaction pool. The control module controls the operation of the optical measurement module, the diluent module and the mixing module respectively. The chemiluminescence immunoassay analyzer of the application adds the HCT measurement assembly of blood cells, is compatible with blood cell testing and chemical testing, greatly reduces the workload of the clinical laboratory and the cost, and can avoid the result deviation caused by different instruments.
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Description

Technical Field

[0001] This application pertains to the field of testing instrument technology, and in particular relates to an HCT measurement component and a chemiluminescence immunoassay analyzer. Background Technology

[0002] Hematology analyzers and chemiluminescence analyzers are the two most common testing devices in laboratory departments. When patients require hematology and chemiluminescence-related tests, these two different instruments are usually needed. This not only increases the workload of laboratory physicians but can also lead to inaccurate test results due to differences between the instruments. This is especially true for whole blood samples. The hematologic tract computed tomography (HCT) value of a whole blood sample refers to the percentage of red blood cells in the blood volume, reflecting blood viscosity and the degree of red blood cell concentration. In some cases, changes in the HCT value can affect the chemiluminescence results of certain whole blood tests (such as PCT), particularly when the analyte is present in red blood cells. Changes in red blood cell concentration can affect the total sample volume and the dilution of the analyte.

[0003] Therefore, integrating an HCT detection module, by calculating HCT values, can determine the content of certain proteins or enzymes in the blood, and can provide support for chemiluminescence testing of some whole blood items (such as PCT). Utility Model Content

[0004] Purpose of the utility model: In view of the technical problems existing in the prior art, this application provides an HCT measurement component and a chemiluminescence immunoassay analyzer.

[0005] Technical solution: This application provides an HCT measurement component, including a reaction cell, an optical measurement module, a diluent module, a mixing module, a waste liquid tank, and a control module;

[0006] The optical measurement module is mounted on the periphery of the reaction cell and directly performs optical detection on the diluted whole blood sample in the reaction cell.

[0007] The diluent module includes a diluent tank, which is connected to the reaction tank;

[0008] The mixing module includes an isolation chamber and a pressure chamber that are sequentially connected to the reaction tank, and the outlet of the isolation chamber is connected to a waste liquid tank.

[0009] The control module controls the operation of the optical measurement module, diluent module, and mixing module respectively.

[0010] As one technical solution, the diluent in the diluent tank is delivered to the reaction tank through a syringe and a three-way valve; the isolation chamber is connected to the pressure chamber through a two-way valve, and the pressure chamber is also connected in sequence to a vacuum pump and a filter; the outlet of the isolation chamber is connected to the waste liquid tank through a waste liquid pump.

[0011] Another aspect of this application provides a chemiluminescence immunoassay analyzer, including a chemiluminescence immunoassay measurement component and an HCT measurement component;

[0012] The chemiluminescence immunoassay assembly includes a sample addition mechanism, a reagent addition mechanism, an incubation mechanism, a magnetic separation and cleaning mechanism, a reagent storage mechanism, a sample injection mechanism, a photoelectric detection mechanism, a mixing mechanism, a reaction cup handling mechanism, and a cup gripping mechanism.

[0013] The reagent storage mechanism is arranged on one side of the analyzer, the sample injection mechanism is located on the proximal side of the reagent storage mechanism, and the incubation mechanism and the magnetic separation and cleaning mechanism are arranged sequentially on the inward side of the reagent storage mechanism. The reaction cup sorting mechanism is arranged on the proximal side of the magnetic separation and cleaning mechanism.

[0014] The sample addition mechanism is located between the sample injection mechanism and the incubation mechanism, and is used to add the sample to the incubation mechanism; the reagent addition mechanism is located between the reagent storage mechanism and the incubation mechanism, and is used to add the reagent to the incubation mechanism.

[0015] The cup-gripping mechanism is located between the magnetic separation and cleaning mechanism and the incubation mechanism. The photoelectric detection mechanism and the mixing mechanism are both located between the reaction cup sorting mechanism and the incubation mechanism, and are within the stroke range of the cup-gripping mechanism.

[0016] The HCT measurement component includes a reaction chamber located within the travel range of the sample dispensing mechanism, facilitating the addition of whole blood samples to the reaction chamber.

[0017] As a technical solution, the reaction cell is located between the sample injection mechanism and the sample addition mechanism.

[0018] As a technical solution, the sample addition mechanism, reagent addition mechanism, incubation mechanism, magnetic separation and cleaning mechanism, reagent storage mechanism, sample injection mechanism, photoelectric detection mechanism, mixing mechanism, reaction cup sorting mechanism, cup gripping mechanism, and reaction cell are all arranged in the same plane of the frame.

[0019] As a technical solution, the HCT measurement component includes a reaction cell and an optical measurement module. The optical measurement module is assembled around the reaction cell and directly performs optical detection on the diluted whole blood sample in the reaction cell.

[0020] As a technical solution, the HCT measurement component includes a reaction tank, an optical measurement module, a diluent module, a mixing module, a waste liquid tank, and a control module; the diluent module includes a diluent tank connected to the reaction tank; the mixing module includes an isolation chamber and a pressure chamber connected to the reaction tank in sequence; the outlet of the isolation chamber is connected to the waste liquid tank; the control module controls the operation of the optical measurement module, the diluent module, and the mixing module respectively.

[0021] As one technical solution, the diluent in the diluent tank is delivered to the reaction tank through a syringe and a three-way valve; the isolation chamber is connected to the pressure chamber through a two-way valve, and the pressure chamber is also connected in sequence to a vacuum pump and a filter; the outlet of the isolation chamber is connected to the waste liquid tank through a waste liquid pump.

[0022] The chemiluminescence immunoassay section of this application, including its modules, structures, and inter-module control operations, can all be implemented using existing technologies.

[0023] Beneficial Effects: Compared to existing technologies, the HCT measurement component of this application uses optical principles to detect the proportion of red blood cells in the blood, thereby calculating the HCT value. The method is simple, easy to operate, and the results are reliable. This application's chemiluminescence immunoassay analyzer incorporates an HCT measurement component for blood cells, making it compatible with both blood cell and chemical tests. This significantly reduces the workload and costs of laboratory departments and hospitals, and avoids result discrepancies caused by different instruments. Even when HCT measurement is not required, the chemiluminescence immunoassay component can be used alone to perform chemiluminescence-related tests on other samples. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the HCT measurement components and their operating principle;

[0025] Figure 2 This is a schematic diagram of the reaction cell and optical measurement module.

[0026] Figure 3 This is a schematic diagram of a chemiluminescence immunoassay analyzer.

[0027] Figure 4 This is a flowchart of the whole blood analysis method for chemiluminescence immunoassay analyzer.

[0028] In the diagram, the components are: 1. Sample addition mechanism; 2. Reagent addition mechanism; 3. Incubation mechanism; 4. Magnetic separation and cleaning mechanism; 5. Reagent storage mechanism; 6. Sample injection mechanism; 7. Photoelectric detection mechanism; 8. Mixing mechanism; 9. Reaction cup handling mechanism; 10. Cup gripping mechanism; 11. HCT measurement component; 31. Syringe; 32. Three-way valve; 33. Reaction cell; 34. Isolation chamber; 35. Two-way valve; 36. Vacuum pump; 37. Filter; 38. Pressure chamber; 39. Waste liquid pump; 40. Optical measurement module; 41. Waste liquid tank; 42. Diluent tank; 43. Support frame. Detailed Implementation

[0029] The technical solution of this application will be described in detail below with reference to specific embodiments and accompanying drawings.

[0030] Example 1

[0031] like Figure 1The HCT measurement assembly shown includes a reaction cell 33, an optical measurement module 40, a diluent module, a mixing module, a waste liquid tank 41, and a control module (not shown in the figure). The optical measurement module 40 is assembled around the reaction cell 33 and directly performs optical detection on the diluted whole blood sample in the reaction cell 33. The diluent module includes a diluent tank 42, which is connected to the reaction cell 33. The mixing module includes an isolation chamber 34 and a pressure chamber 38 connected to the reaction cell 33 in sequence, and the outlet of the isolation chamber 34 is connected to the waste liquid tank 41. The control module controls the operation of the optical measurement module 40, the diluent module, and the mixing module respectively.

[0032] In this embodiment, the diluent in the diluent tank 42 is delivered to the reaction tank 33 through the syringe 31 and the three-way valve 32; the isolation chamber 34 is connected to the pressure chamber 38 through the two-way valve 35, and the pressure chamber 38 is also connected in sequence to the vacuum pump 36 and the filter 37; the outlet of the isolation chamber 34 is connected to the waste liquid tank 41 through the waste liquid pump 39.

[0033] Combination Figure 2 The reaction tank 33 is installed by a support frame 43. An optical measurement module 40 is set around the reaction tank 33. Specifically, the optical measurement module 40 is a pair of UV LED lights. The bottom outlet of the reaction tank 33 is connected to the inlet at the top of the isolation chamber 34 through a liquid pipe. The isolation chamber 34 is connected to the pressure chamber 38 through a connecting valve 35.

[0034] The HCT measurement using this HCT measurement component includes the following steps: First, the control module controls the 5ml syringe 31 and the three-way valve 32 to add the diluent from the diluent tank 42 into the reaction tank 33. Then, a whole blood sample is drawn and added to the reaction tank 33 to dilute the whole blood sample. The control module controls the vacuum pump 36 in advance to establish positive pressure in the pressure chamber 38. By controlling the repeated switching of the two-way valve 35, air is vented into the isolation chamber 34 to mix the diluted whole blood sample in the reaction tank 33. Then, the optical measurement module 40 fixed on the reaction tank 33 is used to detect the HCT value of the diluted whole blood sample. The value is then multiplied by the corresponding dilution factor to obtain the HCT value of the whole blood sample. Finally, the waste liquid after the test is completed is discharged to the external waste liquid tank 41 through the waste liquid pump 39.

[0035] Example 2

[0036] like Figure 3The chemiluminescence immunoassay analyzer shown includes a chemiluminescence immunoassay measurement component and an HCT measurement component. The chemiluminescence immunoassay measurement component includes a sample loading mechanism 1, a reagent loading mechanism 2, an incubation mechanism 3, a magnetic separation and cleaning mechanism 4, a reagent storage mechanism 5, a sample injection mechanism 6, a photoelectric detection mechanism 7, a mixing mechanism 8, a reaction cup handling mechanism 9, and a cup gripping mechanism 10. The reagent storage mechanism 5 is located on one side of the analyzer, and the sample injection mechanism 6 is located near the proximal end of the reagent storage mechanism 5. The incubation mechanism 3 and the magnetic separation and cleaning mechanism 4 are sequentially distributed inwards from the reagent storage mechanism 5. A reaction cup arrangement mechanism 9 is arranged near the cleaning mechanism 4 and the magnetic separation cleaning mechanism 4. A sample addition mechanism 1 is arranged between the sample injection mechanism 6 and the incubation mechanism 3 to add samples to the incubation mechanism 3. A reagent addition mechanism 2 is arranged between the reagent storage mechanism 5 and the incubation mechanism 3 to add reagents to the incubation mechanism 3. A cup gripper mechanism 10 is arranged between the magnetic separation cleaning mechanism 4 and the incubation mechanism 3. A photoelectric detection mechanism 7 and a mixing mechanism 8 are both arranged between the reaction cup arrangement mechanism 9 and the incubation mechanism 3 and are within the stroke range of the cup gripper mechanism 10.

[0037] The HCT measurement assembly is the same as in Example 1. The reaction cell 33 is located between the sample injection mechanism 6 and the sample addition mechanism 1. The sample addition machine 1, reagent addition mechanism 2, incubation mechanism 3, magnetic separation and cleaning mechanism 4, reagent storage mechanism 5, sample injection mechanism 6, photoelectric detection mechanism 7, mixing mechanism 8, reaction cup sorting mechanism 9, cup gripping mechanism 10, and reaction cell 33 are all located in the same plane of the frame.

[0038] The operating steps for testing whole blood using the HCT measurement component and chemiluminescence immunoassay analyzer include:

[0039] (1) After the whole blood sample is placed in the sample injection mechanism 6 and transported to the sampling position, the control module first controls the 5ml syringe 31 and the three-way valve 32 to add the diluent in the diluent tank 42 to the reaction tank 33. Then, the sample addition mechanism 1 is controlled to draw up the whole blood sample and add it to the reaction tank 33 to dilute the whole blood sample. The control module controls the air pump 36 in advance to establish positive pressure in the pressure chamber 38. By controlling the repeated switching of the two-way valve 35, air is vented to the isolation chamber 34 to mix the diluted whole blood sample in the reaction tank 33. Then, the optical measurement module 40 fixed on the reaction tank 33 is used to detect the HCT value of the diluted whole blood sample. Then, the corresponding dilution factor is multiplied to obtain the HCT value of the whole blood sample. Finally, the waste liquid after the test is completed is discharged to the external waste liquid tank 41 through the waste liquid pump 39.

[0040] (2) Control the sample feeding mechanism 1 to draw whole blood samples and perform chemiluminescence tests on some whole blood items.

[0041] Specifically, the procedure for whole blood testing and analysis using this chemiluminescence immunoassay analyzer is as follows: Figure 4 As shown, it includes two steps:

[0042] S11: Obtain the HCT value of whole blood samples through the HCT measurement component;

[0043] S12: The chemiluminescence immunoassay analyzer combines the HCT value of whole blood samples to perform chemiluminescence tests on some whole blood items and obtain the analysis results.

[0044] Taking the whole blood PCT test as an example, the procalcitonin (PCT) in whole blood samples is calculated using the following formula, with the unit being mg / L.

[0045] PCT1 = PCT2 / (100 - HCT) * 100

[0046] Wherein, PCT1 is the corrected PCT concentration; PCT2 is the PCT concentration obtained from chemiluminescence assay; and HCT is the hematocrit value obtained from HCT measurement unit.

Claims

1. An HCT measurement component, characterized in that, It includes a reaction tank (33), an optical measurement module, a diluent module, a mixing module, a waste liquid tank (41), and a control module; The optical measurement module is mounted on the periphery of the reaction cell (33) and can directly perform optical detection on the diluted whole blood sample in the reaction cell (33); The diluent module includes a diluent tank (42), which is connected to the reaction tank (33); The mixing module includes an isolation chamber (34) and a pressure chamber (38) that are connected in sequence to the reaction tank (33), and the outlet of the isolation chamber (34) is connected to the waste liquid tank (41); The control module controls the operation of the optical measurement module, diluent module, and mixing module respectively.

2. The HCT measurement component according to claim 1, characterized in that, The diluent in the diluent tank (42) is delivered to the reaction tank (33) via a syringe (31) and a three-way valve (32); the isolation chamber (34) is connected to the pressure chamber (38) via a two-way valve (35), and the pressure chamber (38) is also connected in sequence to a vacuum pump (36) and a filter (37); the outlet of the isolation chamber (34) is connected to the waste liquid tank (41) via a waste liquid pump (39).

3. A chemiluminescence immunoassay analyzer, characterized in that, Includes chemiluminescence immunoassay kit and HCT measurement kit; The chemiluminescence immunoassay assembly includes a sample loading mechanism (1), a reagent loading mechanism (2), an incubation mechanism (3), a magnetic separation and cleaning mechanism (4), a reagent storage mechanism (5), a sample injection mechanism (6), a photoelectric detection mechanism (7), a mixing mechanism (8), a reaction cup handling mechanism (9), and a cup gripping mechanism (10). The reagent storage mechanism (5) is arranged on one side of the analyzer, the sample injection mechanism (6) is located on the proximal side of the reagent storage mechanism (5), the incubation mechanism (3) and the magnetic separation and cleaning mechanism (4) are arranged in sequence on the inward side of the reagent storage mechanism (5), and the reaction cup sorting mechanism (9) is arranged on the proximal side of the magnetic separation and cleaning mechanism (4). The sample addition mechanism (1) is located between the sample injection mechanism (6) and the incubation mechanism (3) and is used to add the sample to the incubation mechanism (3); the reagent addition mechanism (2) is located between the reagent storage mechanism (5) and the incubation mechanism (3) and is used to add the reagent to the incubation mechanism (3); The cup-gripping mechanism (10) is located between the magnetic separation and cleaning mechanism (4) and the incubation mechanism (3). The photoelectric detection mechanism (7) and the mixing mechanism (8) are both located between the reaction cup sorting mechanism (9) and the incubation mechanism (3), and are within the stroke range of the cup-gripping mechanism (10). The HCT measurement component includes a reaction chamber (33), which is located within the travel range of the sample dispensing mechanism (1) to facilitate the sample dispensing mechanism (1) in adding whole blood samples to the reaction chamber (33).

4. The chemiluminescence immunoassay analyzer according to claim 3, characterized in that, The reaction chamber (33) is located between the sample injection mechanism (6) and the sample addition mechanism (1).

5. The chemiluminescence immunoassay analyzer according to claim 3, characterized in that, The sample addition mechanism (1), reagent addition mechanism (2), incubation mechanism (3), magnetic separation and cleaning mechanism (4), reagent storage mechanism (5), sample injection mechanism (6), photoelectric detection mechanism (7), mixing mechanism (8), reaction cup sorting mechanism (9), cup gripping mechanism (10), and reaction cell (33) are all located on the same plane of the frame.

6. The chemiluminescence immunoassay analyzer according to claim 3, characterized in that, The HCT measurement component includes a reaction cell (33) and an optical measurement module. The optical measurement module is mounted on the periphery of the reaction cell (33) and directly performs optical detection on the diluted whole blood sample in the reaction cell (33).

7. The chemiluminescence immunoassay analyzer according to claim 3, characterized in that, The HCT measurement assembly includes a reaction tank (33), an optical measurement module, a diluent module, a mixing module, a waste liquid tank (41), and a control module. The diluent module includes a diluent tank (42) connected to the reaction tank (33). The mixing module includes an isolation chamber (34) and a pressure chamber (38) connected to the reaction tank (33) in sequence. The outlet of the isolation chamber (34) is connected to the waste liquid tank (41). The control module controls the operation of the optical measurement module, the diluent module, and the mixing module respectively.

8. The chemiluminescence immunoassay analyzer according to claim 7, characterized in that, The diluent in the diluent tank (42) is delivered to the reaction tank (33) via a syringe (31) and a three-way valve (32); the isolation chamber (34) is connected to the pressure chamber (38) via a two-way valve (35), and the pressure chamber (38) is also connected in sequence to a vacuum pump (36) and a filter (37); the outlet of the isolation chamber (34) is connected to the waste liquid tank (41) via a waste liquid pump (39).