Sample analyzer and sample testing method

Abstract

The present application relates to a sample analyzer and a sample testing method. The method comprises: providing a sample solution under test containing a target analyte; providing a reagent strip which comprises a capture rod slot, a first reagent well, a second reagent well and a third reagent well, and presetting a capture rod in the capture rod slot, a marker-containing labeling reagent in the first reagent well, an elution reagent in the second reagent well, and a signal triggering reagent in the third reagent well; using the sample solution under test, the labeling reagent, and the signal triggering reagent to prepare a solution under test: removing the capture rod from the capture rod slot; using the capture rod to capture the target analyte or capture the target analyte and the marker; immersing the capture rod into the elution reagent in the second reagent well, so as to elute the target analyte and / or the marker from the capture rod to obtain an eluent; removing the capture rod from the second reagent well; and using at least the eluent and the signal triggering reagent to prepare the solution under test; and testing the solution under test so as to obtain the content of the target analyte.

Description

Sample analyzers and sample testing methods

[0001] This application claims priority to PCT International Patent Application No. PCT / CN2024 / 143357, filed on December 27, 2024, entitled “A Reagent Strip and Sample Analyzer”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of in vitro diagnostic technology, and more particularly to the field of point-of-care testing (POCT) in vitro diagnostic technology. Specifically, this application relates to a sample analyzer and a sample detection method. Background Technology

[0003] In the field of medical testing, the detection of specific proteins, peptides, and small molecules in blood can reflect the physiological or pathological state of the human body, thereby providing a basis for clinical diagnosis and forming the foundation of evidence-based medicine.

[0004] With increasing demands for testing speed in clinical settings, especially in emergency rooms and intensive care units, there is growing attention on the development of POCT (point-of-care testing). POCT refers to a testing method that utilizes portable analytical instruments and reagents to quickly obtain test results at the sampling site.

[0005] In recent years, direct testing of whole blood in POCT devices to avoid time-consuming sample pretreatment has become a trend in the field of rapid testing.

[0006] When testing whole blood, it is crucial to avoid interference from blood cells in the biochemical reactions. Whole blood contains various cell types, including red blood cells, white blood cells, and platelets. Red blood cells, for example, comprise approximately 50% of the total blood volume. During the reaction, a large number of red blood cells suspended in the reaction solution can hinder the biochemical reactions of the analytes. Furthermore, red blood cells are prone to rupture under high pressure and vigorous fluid movement, releasing their contents into the reaction solution, which can interfere with the biochemical binding of the analytes.

[0007] Currently, the industry employs the following methods and technologies to prevent blood cells from affecting the response:

[0008] 1. Filter whole blood, and the filtered plasma participates in the reaction. For example, using filter cartridges or multilayer membranes, this method is simple, easy to implement, and inexpensive. However, this type of filter material will trap or absorb some of the filtered plasma, resulting in a low conversion rate from whole blood to plasma. It is suitable for qualitative or semi-quantitative chromatographic test strips, but not for automated liquid phase reaction instruments that require precise quantification.

[0009] 2. Reagent design is used to prevent blood cells from rupturing in the reaction solution. This method is widely used in magnetic particle chemiluminescence immunoassay analyzers in the POCT field. However, while this method ensures the integrity of blood cells, the cells remain suspended in the reaction solution, and their diameter is much larger than that of the magnetic particles. During the immunobinding process, the blood cells, due to their size, prevent the analyte from binding to the capture antibodies or antigens on the surface of the magnetic beads; during the magnetic separation and washing process, the blood cells hinder the movement of the magnetic particles in the magnetic field, resulting in the loss of the magnetic particles. Furthermore, the surface of the blood cell membrane is rich in antigens and antibodies, which can easily bind non-specifically to the magnetic beads or labeled antibodies in the reaction system, causing deviations in the detection results.

[0010] This shows that the detection accuracy of automated liquid-phase reaction instruments that require precise quantification still needs to be improved. Summary of the Invention

[0011] Based on this, the objective of this application is to propose a POCT detection technology that uses a rod-type solid support to capture target analytes. This technology can remove the solid rod from the measurement path before measuring the solution to be tested, thus avoiding the solid rod from affecting the measurement and improving detection accuracy.

[0012] To achieve the above objectives, the first aspect of this application proposes a sample analyzer, comprising:

[0013] A reagent strip storage area is provided for placing at least one reagent strip. The reagent strip includes a capture rod hole and multiple reagent holes, including a first reagent hole, a second reagent hole, and a third reagent hole. A capture rod coated with a capture substance is pre-placed in the capture rod hole. A labeling reagent with a marker is pre-placed in the first reagent hole. An elution reagent is pre-placed in the second reagent hole. A signal induction reagent is pre-placed in the third reagent hole.

[0014] The preparation apparatus is configured to prepare a test solution using a sample solution containing the target analyte, the labeling reagent, the elution reagent, and the signal heuristic reagent;

[0015] The testing facility is equipped with a method for testing the solution to be tested to obtain the content of the target analyte; and

[0016] A controller is configured to be electrically connected to the preparation mechanism and the detection mechanism, so as to control the preparation mechanism to prepare the test solution and control the detection mechanism to detect the test solution;

[0017] The controller is configured to: control the preparation mechanism to remove the capture rod from the capture rod orifice; control the preparation mechanism to capture the target analyte or the target analyte and the marker using the capture rod; control the preparation mechanism to immerse the capture rod in the elution reagent in the second reagent orifice so as to elute the target analyte and / or the marker captured by the capture rod from the capture rod using the elution reagent to obtain an eluent; control the preparation mechanism to remove the capture rod from the second reagent orifice after elution; and then control the preparation mechanism to prepare the test solution using at least the eluent and the signal heuristic reagent, and control the detection mechanism to detect the test solution to obtain the content of the target analyte.

[0018] To achieve the above objectives, a second aspect of this application proposes a sample detection method, comprising:

[0019] Provide the test sample solution containing the target analyte;

[0020] A reagent strip is provided, the reagent strip including a capture rod orifice and a plurality of reagent orifices, the plurality of reagent orifices including a first reagent orifice, a second reagent orifice and a third reagent orifice, wherein a capture rod coated with a capture substance is pre-placed in the capture rod orifice, a labeling reagent with a marker is pre-placed in the first reagent orifice, an elution reagent is pre-placed in the second reagent orifice, and a signal induction reagent is pre-placed in the third reagent orifice.

[0021] A test solution is prepared using the sample solution, the labeling reagent, and the signal heuristic reagent. During preparation, the capture rod is removed from its orifice and used to capture the target analyte or the target analyte and the label. The capture rod is then immersed in the elution reagent in the second reagent well to elute the target analyte and / or the label captured by the capture rod, yielding an eluent. After elution, the capture rod is removed from the second reagent well. The test solution is then prepared using at least the eluent and the signal heuristic reagent.

[0022] The solution to be tested is analyzed to obtain the content of the target analyte.

[0023] In the technical solutions proposed in this application, the captured target analytes and / or labels are eluted from the capture rod using an elution reagent to obtain an eluent containing the target analytes and / or labels. The test solution is then prepared using the eluent and a signal heuristic reagent. After the captured target analytes and / or labels are eluted from the capture rod, the capture rod is no longer involved in subsequent processes, avoiding any adverse effects of the capture rod on the detection of the test solution and thus improving detection accuracy. In particular, in the case of solid-phase rod immunoassay, the solid-phase rod and the capture rod are not present in the photometric collection optical path, thus eliminating the adverse effects of the capture rod on photometric measurements, especially on photometric repeatability. Attached Figure Description

[0024] Figures 1 to 3 show schematic diagrams of the structure of a sample analyzer according to some embodiments of this application;

[0025] Figure 4 shows a schematic diagram of the structure of a capture rod according to some embodiments of this application;

[0026] Figure 5 shows a schematic diagram of the structure of a capture rod according to some other embodiments of this application;

[0027] Figure 6 shows a schematic diagram of the structure of a reagent strip according to some embodiments of this application;

[0028] Figure 7 shows a schematic diagram of the structure of a reagent strip according to some other embodiments of this application;

[0029] Figure 8 illustrates a schematic diagram of the binding process of a target analyte with a labeling reagent according to some embodiments of this application;

[0030] Figure 9 shows a schematic diagram of the elution step, chemiluminescence reaction step, and measurement step according to some embodiments of this application;

[0031] Figure 10 shows a schematic diagram of the eccentric rotation path of the capture rod according to some embodiments of this application;

[0032] Figure 11 shows a schematic diagram of a capture rod with an eccentric structure according to some embodiments of this application;

[0033] Figure 12 shows a schematic diagram of a clamping part with an eccentric structure according to some embodiments of the present application;

[0034] Figure 13 shows a schematic diagram of the cleaning steps according to some embodiments of this application;

[0035] Figure 14 shows a schematic diagram of the structure of a reagent strip according to some other embodiments of this application;

[0036] Figure 15 shows a schematic diagram of the working process of a sample analyzer according to some embodiments of this application;

[0037] Figure 16 shows a schematic diagram of the structure of a reagent strip according to some embodiments of this application;

[0038] Figure 17 illustrates a schematic diagram of the working process of a sample analyzer according to other embodiments of this application; and

[0039] Figure 18 shows a schematic flowchart of a sample detection method according to some embodiments of this application. Detailed Implementation

[0040] The embodiments of this application will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0041] It should be noted that the terms "first, second, and third" used in the embodiments of this application are merely to distinguish similar objects and do not represent a specific order of objects. It can be understood that "first, second, and third" can be interchanged in a specific order or sequence where permitted.

[0042] It will be understood by those skilled in the art that, unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0043] In related technologies, POCT immunoassay devices use probes or solid-phase rods to capture target analytes. After the reaction is complete, either the luminescence signal on the probe is measured, or the test solution is photometrically measured while the probe is immersed in the test solution.

[0044] The applicant found that when the probe is present in the photometric path, that is, when the probe participates in the photometric process, it may lead to inaccurate detection results, especially adversely affecting photometric repeatability.

[0045] Therefore, this application proposes that, in a solid-phase rod immunoassay, the target analyte and / or label in the sample solution to be tested is eluted from the solid rod into the aqueous phase using an elution reagent, and then the signal generated in the aqueous phase is measured.

[0046] Referring first to Figures 1 to 3, which show schematic diagrams of the structure of a sample analyzer according to some embodiments of this application.

[0047] In the embodiments of this application, whole blood samples and an immunoassay analyzer are mainly used as examples for description.

[0048] Of course, the embodiments of this application are not limited to this. The sample fluid to be tested may include, but is not limited to, at least one of the following: blood, ascites, sputum, and other bodily fluids. The sample analyzer is used, for example, to detect specific proteins, peptides, small molecules, etc., in the bodily fluids. The sample analyzer may include, but is not limited to, at least one of the following: a biochemical analyzer, an electrolyte analyzer, an immunoassay analyzer, a coagulation analyzer, and a urine analyzer; for example, the sample analyzer may be a biochemical analyzer, which may include at least one of an immunoassay module, a coagulation analysis module, and a urine analysis module.

[0049] As shown in Figures 1 to 3, the sample analyzer, especially the POCT immunoassay analyzer, proposed in the embodiments of this application includes a reagent strip storage area 110, a preparation mechanism 130, a detection mechanism 140, and a controller 150.

[0050] According to an embodiment of this application, the reagent strip storage area 110 is provided for placing at least one reagent strip 120. The reagent strip 120 includes a trapping rod 121 and a reagent strip body, on which trapping rod holes 122 and multiple reagent holes are formed. Here, the reagent strip 120 is used to pre-load the trapping rod 121 and various reagents, providing materials and a space for the desired reaction. The reagent holes are pre-loaded with various reagents required for the reaction, including labeling reagents, signal-inducing reagents, etc. The reagents in the reagent holes can be liquid or dry reagents.

[0051] It should be understood that if the reagent in the reagent well is packaged as a liquid reagent, the liquid reagent in the reagent well can be used directly. If the reagent in the reagent well is packaged as a dry reagent, a reconstitution solution needs to be added to the reagent well first to mix with the dry reagent in the reagent well to obtain a liquid reagent before using the liquid reagent. The reagent strip 120 has at least a first reagent well 123, a second reagent well 124, and a third reagent well 125. A capture rod 121 coated with a capture agent is pre-placed in the capture rod well 122. This capture agent is used to capture the target analyte in the sample solution to be tested. A labeled reagent with a marker is pre-placed, i.e., pre-packaged, in the first reagent well 123. This labeled reagent can bind to the target analyte. An elution reagent is pre-placed, i.e. pre-encapsulated, in the second reagent well 124. This elution reagent is used to elute the target analyte captured by the capture rod 121 from the capture rod 121, or to elute the labeled reagent in connection with the target analyte captured by the capture rod 121 from the capture rod 121. A signal-inducing reagent is pre-placed, i.e. pre-encapsulated, in the third reagent well 125. This signal-inducing reagent is capable of chemically reacting with the labeled reagent, particularly by chemiluminescence.

[0052] It should be noted that the binding can be physical adsorption or biochemical reaction, such as the binding of antibody and antigen.

[0053] The embodiments of this application are applicable to both direct and indirect chemiluminescence systems. Therefore, in some embodiments, the label is a direct luminescent reagent, preferably an acridinium ester, the signal heuristic reagent is an excitation solution capable of stimulating the direct luminescent reagent to emit light, and the elution reagent is a pre-excitation solution. In other alternative embodiments, the label is an enzyme label, and the signal heuristic reagent is a substrate solution that emits light under the catalysis of the enzyme label.

[0054] In some embodiments, the pre-activation solution can be a strong acid, such as hydrochloric acid, sulfuric acid, nitric acid, etc., and the activation solution can be a strong base, such as sodium hydroxide, etc.

[0055] In some embodiments, the capture rod 121 is made of plastic, such as a polymer like polyethylene, polypropylene, or polystyrene, preferably polystyrene.

[0056] In some embodiments, as shown in Figures 4 and 5, the capture rod 121 includes a clamping section 1211, a positioning section 1212, and a capture section 1213 arranged sequentially in the axial direction. The clamping section 1211 is used for clamping by the preparation mechanism 130. The capture section 1213 is at least partially covered with the captured object, and the capture section 1213 is connected to the bottom side of the positioning section 1212. The positioning section 1212 is used to openably close the capture rod hole, thereby enclosing the capture section 1213 in the capture rod hole 122. That is, the capture rod 121 and the capture rod hole 122 are tightly pressed together to create a closed space, which is used to protect the capture section 1213 from the influence of the external environment in the closed space when not in use.

[0057] Preferably, the clamping section 1211, the positioning section 1212, and the capturing section 1213 are integrally formed.

[0058] In some embodiments, the diameter of the capture section 1213 is, for example, in the range of 2 to 8 mm, and the length of the capture rod 121 is, for example, in the range of 5 to 50 mm.

[0059] For further details regarding the structure of the capture rod, please refer to the applicant’s international patent application PCT / CN2023 / 101938 filed on June 21, 2023, and Chinese patent application 202411981912.5 filed on December 27, 2024, the entire disclosure of which is incorporated herein by reference.

[0060] In some embodiments, the target analyte is the antigen to be tested, and the labeling reagent is a labeled antibody that is specifically capable of binding to the target analyte. Here, the capture substance is a capture antibody (also known as fully coated) that is specifically capable of binding to the target analyte, as shown in Figure 4, or the capture substance is a first ligand substance that is capable of binding to a second ligand substance coupled to the capture antibody (also known as partially coated), as shown in Figure 5.

[0061] In other embodiments, the target analyte is the antibody to be tested, and the labeling reagent is a labeled antigen that is specifically capable of binding to the target analyte. Here, the capture substance is a capture antigen that is specifically capable of binding to the target analyte, as shown in FIG4, or the capture substance is a first ligand substance that is capable of binding to a second ligand substance coupled to the capture antigen, as shown in FIG5.

[0062] Furthermore, the first ligand can be streptavidin and the second ligand can be biotin.

[0063] In some embodiments, as shown in Figures 1 to 3, the test strip 120 may further include a sample well 126 for holding the sample solution to be tested. Preferably, the sample well 126 is also used to hold a pretreatment solution, or is preferably pre-placed, i.e., pre-encapsulated, in the sample well 126 for pretreatment of the sample solution to be tested. For example, for thyroid function tests or hepatitis B tests, the pretreatment solution includes a sample lysis buffer for separating the target analyte, such as the antigen or antibody to be tested. As another example, the pretreatment solution may include a diluent for pre-dilution of the sample solution to be tested, particularly whole blood samples.

[0064] In some embodiments, as shown in Figures 1 to 3, the reagent strip 120 may also include a measuring hole 127 separate from the capture rod hole 122, in which no liquid is pre-placed, i.e., the measuring hole is empty when not in use, and in particular, pre-sealed.

[0065] In some embodiments, as shown in FIG6, the plurality of reagent wells of reagent strip 120 may further include at least one fourth reagent well 128, in which a cleaning solution is pre-placed for washing away unbound material on the capture rod. In particular, the cleaning solution is used for cleaning the capture rod after it has reacted with the target analyte and the labeling reagent. During the cleaning process, specific binding complexes retained on the capture rod are washed away, while non-specific bindings are removed.

[0066] Preferably, the reagent strip 120 includes at least two fourth reagent holes 128, such as two, three or four fourth reagent holes 128, in order to thoroughly wash away unbound material on the capture rod.

[0067] In some embodiments, as shown in FIG6, the labeling reagent is pre-encapsulated in the first reagent well 123 in the form of a liquid reagent.

[0068] In some embodiments, as shown in FIG7, the labeling reagent is pre-encapsulated in the first reagent well 123 in the form of a dry reagent. A dry reagent is a non-liquid reagent, as opposed to a liquid reagent. For example, a dry reagent can be a lyophilized reagent, especially a lyophilized bulb reagent, or an air-dried reagent, or a dry reagent obtained by other methods of removing moisture. Compared to a liquid reagent, a dry reagent can improve reagent stability to a certain extent. In this case, when using the dry reagent in the first reagent well 123, a reconstitution solution needs to be added to the first reagent well 123 to mix with the dry reagent in the first reagent well 123 to obtain a liquid labeling reagent. Preferably, as shown in FIG7, the reagent strip 120 further includes a fifth reagent well 129, in which a reconstitution solution is pre-placed, i.e., pre-encapsulated, for mixing with the dry reagent in the first reagent well 123 to obtain a liquid labeling reagent.

[0069] In some embodiments, if the labeling reagent is pre-encapsulated in the first reagent hole 123 in the form of a dry reagent, the reagent strip body may further include a desiccant container pre-encapsulated in the desiccant container, and the desiccant container is connected to the first reagent hole 123 so that the desiccant can absorb moisture in the first reagent hole 123. For example, the desiccant container and the first reagent hole 123 are arranged adjacent to each other on the left and right sides, and one or more through holes are provided on the sidewall of the first reagent hole 123, the one or more through holes connecting the desiccant container and the first reagent hole 123.

[0070] For example, the desiccant container is located outside the first reagent hole 123. The desiccant container and the first reagent hole 123 are arranged adjacent to each other along the length of the reagent strip. A through hole is provided on the side wall of the first reagent hole 123. The desiccant particles are contained in the desiccant container and cannot pass through the through hole. The opening on the top side of the desiccant container and the opening on the top side of the first reagent hole 123 are sealed by the same sealing membrane.

[0071] In some embodiments, when the capture rod is partially coated, the plurality of reagent wells of the reagent strip 120 may also include a sixth reagent well (not shown), in which a capture antigen or capture antibody coupled with a second ligand substance is pre-placed, i.e. pre-encapsulated.

[0072] It is understood that when reagent strip 120 is not in use, all reagent wells pre-filled with reagents are sealed.

[0073] For example, as shown in Figures 1, 2, 6, and 7, all reagent wells pre-filled with reagents are sealed by a sealing film 101, which forms part of the outer surface of the reagent strip. The sealing film 101 may include a water-resistant heat-sealed aluminum film. When using the reagent strip, the sealing film needs to be punctured by the preparation mechanism 130 to draw liquid from or add liquid to the corresponding reagent well.

[0074] Furthermore, when the reagent strip 120 is not in use, as shown in Figures 6 and 7, the sample well 126 is also sealed, preferably by the sealing film 101.

[0075] Alternatively or additionally, when the reagent strip 120 is not in use, as shown in FIG6, the measuring port 127 is also sealed, preferably by a sealing film 101. Preferably, the sealed measuring port is empty.

[0076] In other embodiments, all reagent wells pre-filled with reagents can also be sealed by other means, such as by using a sealing cap.

[0077] In some embodiments, the individual holes of the reagent strip may have a circular or rectangular, especially square, cross-section. For example, the capture rod hole, the second reagent hole, the third reagent hole, and optionally the sample hole and the measurement hole have a circular cross-section, while the first reagent hole and optionally the fourth reagent hole have a rectangular, especially square, cross-section. However, the embodiments of this application are not limited to this; for example, all the holes of the reagent strip may have a circular or rectangular, especially square, cross-section.

[0078] In some embodiments, the reagent strip 120 may be made of a polymer such as polyethylene, polypropylene, or polystyrene.

[0079] In some embodiments, the reagent strip storage area 110 is configured to hold a plurality of reagent strips 120, each reagent strip 120 for one sample solution to be tested. At least two of the plurality of reagent strips correspond to different detection items or the same detection item. That is, one reagent strip 120 is used for one detection item of one sample solution to be tested.

[0080] In some embodiments, the sample analyzer may also include a reagent strip scheduling mechanism, or a reagent strip scheduling mechanism may be provided in the reagent strip storage area 110, which is configured to schedule the reagent strips to be used to the corresponding working positions so that the preparation mechanism 130 and the detection mechanism 140 can perform corresponding operations on them.

[0081] According to an embodiment of this application, the preparation mechanism 130 is configured to prepare a test solution using a sample solution containing a target analyte, a labeling reagent in a first reagent well 123, an elution reagent in a second reagent well 124, and a signal heuristic reagent in a third reagent well 125.

[0082] In a preferred embodiment, during the preparation of the test solution, the labeling reagent binds to the target analyte, and the signal-inspired reagent reacts with the label to generate a light signal whose intensity is related to the concentration of the target analyte in the sample. Here, the binding of the labeling reagent to the target analyte and / or the chemiluminescent reaction of the signal-inspired reagent with the label occurs in at least one well of the reagent strip. For example, the binding of the labeling reagent to the target analyte occurs in the first reagent well 123. As another example, the chemiluminescent reaction of the signal-inspired reagent with the label occurs in the capture rod well 122, the second reagent well 124, or the third reagent well 125, or the measurement wells described below.

[0083] In some embodiments, as shown in FIG1, the preparation mechanism 130 includes a motion device 131 for removing the capture rod 121 from the capture rod hole 122 and driving the removed capture rod 121 to move relative to the reagent strip 120. The motion device 131 may include a clamping part 1311, an opening and closing drive part 1312, a first horizontal drive part (not shown), and a first vertical drive part 1313. The clamping part 1311 includes grippers for clamping the capture rod 121, especially its clamping section 1211. The opening and closing drive part 1312 is used to drive the grippers of the clamping part 1311 to open and close so as to grasp the capture rod 121. The first horizontal drive part, such as a first horizontal drive motor, is used to drive the clamping part 1311 to move relative to the reagent strip 120 horizontally so that the capture rod 121 clamped by the clamping part 1311 is positioned above the corresponding hole of the reagent strip 120. The first vertical drive unit 1313, such as the first vertical drive motor, is used to drive the clamping unit 1311 to move vertically relative to the reagent strip 120, so that the capture rod 121 held by the clamping unit 1311 can enter and exit the corresponding hole of the reagent strip 120 in the vertical direction.

[0084] As one implementation, the first horizontal drive unit can be used to drive the clamping unit 1311 to move horizontally, so that the clamping unit 1311 can move the clamped capture rod 121 to above the corresponding hole of the reagent strip 120.

[0085] In some other implementations, the first horizontal drive unit can drive the reagent strip 120 to move horizontally, so that the corresponding hole of the reagent strip 120 can move to below the capture rod 121 held by the clamping unit 1311.

[0086] As one implementation, as shown in Figure 1, the first vertical drive unit 1313 can be used to drive the clamping unit 1311 to move vertically, so that the clamping unit 1311 can drive the clamped capture rod 121 to enter and exit the corresponding hole of the reagent strip 120 in the vertical direction.

[0087] As in some other implementations not shown, the first vertical drive unit can also be used to drive the reagent strip 120 to move vertically, so that the capture rod 121 held by the clamping unit 1311 can enter and exit the corresponding hole of the reagent strip 120 in the vertical direction.

[0088] In some embodiments, the motion device 131 may further include a rotation drive unit 1314, such as a rotation drive motor, for driving the clamping unit 1311 to rotate, so that the clamping unit 1311 can drive the clamped capture rod 121 to rotate in the corresponding hole of the reagent strip 120.

[0089] In some embodiments, as shown in FIG2, the preparation mechanism 130 includes a dispensing device 132 for transferring liquid during the preparation of the test solution, for example for transferring the test sample solution to the first reagent well 123.

[0090] In some implementations, the dispensing device 132 may include a dispensing tube 1321, a dispensing pump 1322, and a dispensing drive unit 1323. The dispensing tube 1321 is configured as a dispensing needle or can be connected to a pipette tip 1324 to draw or discharge liquid to be transferred. The dispensing pump 1322 is used to provide negative or positive pressure to the dispensing tube 1321 to draw or discharge liquid to be transferred. The dispensing drive unit 1323 is used to drive the dispensing pump 1322 to provide negative or positive pressure.

[0091] In some examples, the reagent strip 120 may also encapsulate a pipette tip 1324, for example, the reagent strip 120 may also include a pipette tip orifice in which the pipette tip 1324 is pre-positioned. The dispensing tube 1321 of the dispensing device 132 may be connected to the pipette tip 1324 in the reagent strip 120, through which the liquid to be transferred is drawn and added to the corresponding orifice of the reagent strip 120. After the pipetting operation is completed, the pipette tip 1324 can be unloaded into the pipette tip orifice. For example, different pipette tips may be used when transferring different liquids.

[0092] Of course, this is not the only possibility. For example, in other examples, the dispensing device 132 can draw up the liquid to be transferred through the dispensing needle and add the drawn liquid into the corresponding hole of the reagent strip 120, after which the dispensing needle can be cleaned. For example, the dispensing needle can be cleaned after transferring one liquid so that it can be used to transfer another liquid in the future.

[0093] Furthermore, in the embodiment shown in FIG2, the dispensing device 132 may further include a second vertical drive unit 1325 for driving the dispensing tube 1321 to move vertically, so that the dispensing tube 1321 can enter and exit the corresponding hole of the reagent strip 120 in the vertical direction, so as to draw liquid from the hole or discharge the drawn liquid into the hole.

[0094] In some embodiments, the first horizontal drive unit can drive the reagent strip 120 to move horizontally, so that the corresponding hole of the reagent strip 120 can move to below the capture rod 121 held by the clamping unit 1311 or to below the dispensing tube 1321.

[0095] In some embodiments, the preparation mechanism 130 includes a membrane-breaking device (not shown) or the dispensing device 132 integrates a membrane-breaking structure for piercing the sealing membrane 101 when using the reagent strip, or the preparation mechanism 130 includes a cap-opening device (not shown) for opening the sealing cap of the reagent strip.

[0096] According to an embodiment of this application, the detection mechanism 140 is configured to detect the test solution prepared by the preparation mechanism 130 in order to obtain the content of the target analyte.

[0097] In some embodiments, the detection unit 140 is configured to perform photodetection on the test solution to obtain the light signal generated by the test solution after luminescence, preferably chemiluminescence, and to determine the content of the target analyte based on the intensity of the light signal. Preferably, the intensity of the light signal is positively correlated with the content of the target analyte.

[0098] As one implementation, as shown in Figure 3, the detection mechanism 140 includes a photometer 141, such as a photomultiplier tube, which is configured to detect the number of photons generated by the emission of light from the solution to be tested, so as to determine the content of the target analyte based on the number of photons.

[0099] Furthermore, an optical lens 142 is provided before the photometer 141, and the photons generated by the emission of the solution to be tested enter the photometer 141 through the optical lens 142.

[0100] Furthermore, the testing mechanism 140 also includes a darkroom 143, in which a photometer 141 and an optical lens 142 are arranged. The darkroom 143 has an openable and closable door 144, through which the reagent strip 120 can be fed into the darkroom 143 to complete photometric measurement.

[0101] According to an embodiment of this application, the controller 150 is configured to be electrically connected to the preparation mechanism 130 and the detection mechanism 140, so as to control the preparation mechanism 130 to prepare the solution to be tested and control the detection mechanism 140 to detect the solution to be tested.

[0102] As some implementations, controller 150 may include: one or more processors; and one or more computer-readable memories coupled to the one or more processors, the computer-readable memories being configured to store a series of computer-executable instructions, wherein, when executed by the one or more processors, the one or more processors cause the one or more processors to perform some steps of the preparation and detection of the test solution, which are further described below.

[0103] In some examples, the processor in the embodiments of this application may include, but is not limited to, a central processing unit (CPU), a micro controller unit (MCU), a field-programmable gate array (FPGA), a digital signal processor (DSP), or other devices used to interpret computer instructions and process data in computer software.

[0104] In some examples, the memory in the embodiments of this application may be volatile memory or non-volatile memory, or both. Non-volatile memory may be read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), ferromagnetic random access memory (FRAM), flash memory, magnetic surface memory, optical disc, or compact disc read-only memory (CD-ROM); magnetic surface memory may be disk storage or magnetic tape storage. Volatile memory may be random access memory (RAM), which is used as an external cache. By way of example, but not limitation, many forms of RAM are available, such as Static Random Access Memory (SRAM), Synchronous Static Random Access Memory (SSRAM), Dynamic Random Access Memory (DRAM), Synchronous Dynamic Random Access Memory (SDRAM), Double Data Rate Synchronous Dynamic Random Access Memory (DDRSDRAM), Enhanced Synchronous Dynamic Random Access Memory (ESDRAM), SyncLink Dynamic Random Access Memory (SLDRAM), and Direct Rambus Random Access Memory (DRRAM).The memories described in the embodiments of this application are intended to include, but are not limited to, these and any other suitable types of memories.

[0105] Furthermore, the controller 150 may also include a communication interface that communicates with the processor and a computer-readable storage medium via a bus. The communication interface can be an interface using any known communication protocol. The communication interface can communicate with the outside world via a network, and the controller can transmit data with any device connected through the communication interface using a specific communication protocol.

[0106] According to an embodiment of this application, the controller 150 is configured to: control the preparation mechanism 130, particularly its motion device 131, to remove the capture rod 121 from the capture rod hole 122; control the preparation mechanism 130 to capture the target analyte using the removed capture rod 121 or to capture both the target analyte and the marker using the removed capture rod 121; and control the preparation mechanism 130 to immerse the captured capture rod 121 into the elution reagent in the second reagent hole 123, particularly ensuring that the capture section 1213 of the capture rod 121 is completely submerged in the elution reagent, so as to use the elution reagent to capture the target analyte. The target analyte and / or marker captured by the capture rod 121 are eluted from the capture rod 121 to obtain an eluent; after elution, the control preparation mechanism 130 removes the capture rod 121 from the second reagent well 123; then, the control preparation mechanism 130 prepares a test solution using at least the eluent and the signal-inducing reagent in the third reagent well 124; and the control detection mechanism 140 detects the test solution to obtain the content of the target analyte, especially after the test solution has been prepared, the control detection mechanism 140 detects the test solution without the capture rod 121 being immersed in the test solution.

[0107] Therefore, after eluting the target analyte and / or label from the capture rod 121 to obtain the eluent, the eluent and signal heuristic reagent can be quantitatively aspirated to prepare the test solution, making the detection more accurate. Moreover, since the capture rod can be removed from the test solution during detection, it avoids interfering with the detection of the detection mechanism 140.

[0108] The following describes some implementation schemes for the controller 150 to control the preparation mechanism 130 to prepare the test solution and the detection mechanism 140 to detect the test solution, taking into account the different structures of the capture rod and the reagent strip.

[0109] As described above, this application proposes two elution schemes: the first elution scheme is to elute the target substance from the capture rod; the second elution scheme is to elute the marker in the labeling reagent that is bound to the target substance captured by the capture rod.

[0110] In the first elution scheme, the controller 150 is configured to, when the preparation mechanism 130 prepares the test solution, immerse the capture rod 121 into the test sample solution, particularly to completely or partially immerse the capture section of the capture rod 121 into the test sample solution, so as to capture the target analyte in the test sample solution using the capture rod 121; immerse the capture rod 121 into the elution reagent in the second reagent well 124 so as to elute the target analyte captured by the capture rod 121 from the capture rod 121 to obtain the eluent; and prepare the test solution using the eluent in the second reagent well 124, the labeling reagent in the first reagent well 123, and the signal heuristic reagent in the third reagent well 125.

[0111] It should be understood that if the labeled reagent is pre-packaged in the first reagent well 123 in liquid form, the controller 150 can control the preparation mechanism 130 to directly prepare the test solution using the liquid labeled reagent in the first reagent well 123. However, if the labeled reagent is pre-packaged in the first reagent well 123 in dry form, when using the dry reagent in the first reagent well 123, a reconstitution solution is first added to the first reagent well 123, for example, by drawing the reconstitution solution from the fifth reagent well 129 and discharging it into the first reagent well 123, thus converting the dry reagent in the first reagent well 123 into a liquid labeled reagent; then the controller 150 can control the preparation mechanism 130 to prepare the test solution using the liquid labeled reagent in the first reagent well 123. This also applies to elution reagents and signal heuristic reagents.

[0112] In some embodiments, when the test strip 120 includes a sample well 126, the controller 150 controls the preparation mechanism 130 to immerse the capture rod 121 into the test sample solution. This may include: controlling the preparation mechanism 130, for example, controlling the dispensing device 132 to transfer (e.g., from the sample container) the test sample solution (e.g., raw or pretreated whole blood) into the sample well 126 for pretreatment, such as pre-dilution, of the test sample solution in the sample well 126; and controlling the preparation mechanism 130, for example, controlling the motion device 131 to move the capture rod 121 into the sample well 126 until the capture rod 121 is immersed in the test sample solution in the sample well 126.

[0113] In other embodiments, the test strip 120 may also be without the sample well 126, and the test sample solution may be pretreated in a sample container separate from the test strip. The controller 150 may control the preparation mechanism 130 to immerse the capture rod 121 into the test sample solution in the sample container.

[0114] In some embodiments, when the capture rod 121 is fully coated, i.e., when the capture rod 121 is coated with capture antibody or capture antigen, the controller 150 controls the preparation mechanism 130 to immerse the capture rod 121 into the sample solution to be tested. This may include controlling the preparation mechanism 130 to directly immerse the captured rod 121 into the sample solution to be tested after removing it from the capture rod orifice 122, particularly directly into the sample solution to be tested in the sample orifice 126.

[0115] In other embodiments, when the capture rod 121 is partially coated, i.e., when the capture rod 121 is coated with the first ligand substance, the controller 150 is configured to, when controlling the preparation mechanism 130 to prepare the test solution:

[0116] The control preparation mechanism 130, especially its motion device 131, immerses the capture rod 121 into the capture antibody or capture antigen coupled with the second ligand substance, so that the second ligand substance coupled to the capture antibody or capture antigen binds to the first ligand substance coated on the capture rod.

[0117] The preparation mechanism 130, especially its motion device 131, immerses a capture rod bound with capture antibody or capture antigen into the sample solution to be tested, so as to capture the antigen or antibody to be tested in the sample solution using the capture antibody or capture antigen on the capture rod.

[0118] The preparation mechanism 130, especially its motion device 131, immerses the capture rod containing the antigen or antibody to be tested into the elution reagent in the second reagent well, so that the antigen or antibody to be tested captured by the capture rod is eluted from the capture rod by the elution reagent to obtain the eluent.

[0119] The preparation mechanism 130 prepares the test solution using the eluent in the second reagent well 124, the labeling reagent in the first reagent well 123, and the signal-inducing reagent in the third reagent well 125.

[0120] For example, if the test strip 120 also includes the sample well 126 and the sixth test well as described above, the controller 150 controls the preparation mechanism 130, in particular its motion device 131, to immerse the capture rod 121 coated with the first ligand substance into the capture antibody or capture antigen coupled with the second ligand substance in the sixth test well; controls the preparation mechanism 130, for example, controls the dispensing device 132 to transfer the test sample solution, for example, whole blood sample (e.g., from the sample container) into the sample well 126 so as to pre-treat, for example, pre-dilute the test sample solution in the sample well 126; then controls the preparation mechanism 130, in particular its motion device 131, to immerse the capture rod 121 bound with the capture antibody or capture antigen into the test sample solution in the sample well 120 so as to capture the test antigen or test antibody in the test sample solution using the capture antibody or capture antigen on the capture rod.

[0121] Here, the elution reagent is specifically used to elute the capture antibody or capture antigen on the capture rod 121, thereby eluting the test antigen bound to the capture antibody or the test antibody bound to the capture antigen.

[0122] In some embodiments, the control preparation mechanism 130 prepares the test solution using the eluent in the second reagent well 124, the labeling reagent in the first reagent well 123, and the signal-inducing reagent in the third reagent well 125. This may include: the control preparation mechanism 130, and in particular its dispensing device 132, preparing the test solution in at least one of the first reagent well 123, the second reagent well 124, the third reagent well 125, the measuring well 127, and the capture rod well 122.

[0123] For example, the controller 150 can control the preparation mechanism 130 to transfer at least a portion of the eluent in the second reagent well 124 to the first reagent well 123 so that the eluent mixes with the labeling reagent in the first reagent well to obtain a mixture containing the target analyte and the labeling reagent. Then, the controller 150 controls the preparation mechanism 130 to prepare the test solution using the mixture in the first reagent well and the signal-inspired reagent in the third reagent well 125.

[0124] In the second elution scheme, the controller 150 is configured to, when the preparation mechanism 130 prepares the test solution, sequentially immerse the capture rod 121 in the test sample solution and the labeling reagent (especially to completely or partially immerse the capture section of the capture rod 121 in the test sample solution and the labeling reagent) or immerse the capture rod 121 in the mixture of the test sample solution and the labeling reagent (especially to completely or partially immerse the capture section of the capture rod 121 in the mixture), so as to capture the target analyte in the test sample solution using the capture rod 121 and bind the captured target analyte to the labeling reagent; the preparation mechanism 130 immerses the capture rod 121 containing the target analyte and the labeling reagent in the elution reagent in the second reagent well 124, so as to elute at least the labeling reagent from the capture rod 121 to obtain the eluent; the preparation mechanism 130 prepares the test solution using the eluent and the signal heuristic reagent.

[0125] It should be understood that if the labeled reagent is pre-packaged in the first reagent well 123 in the form of a liquid reagent, the controller 150 can control the preparation mechanism 130 to directly immerse the capture rod 121 into the liquid labeled reagent, or the controller 150 can directly control the preparation mechanism 130 to mix the sample solution to be tested with the liquid labeled reagent. However, if the labeled reagent is pre-packaged in the first reagent well 123 in the form of a dry reagent, when using the dry reagent in the first reagent well 123, a reconstitution solution is first added to the first reagent well 123, for example, by drawing the reconstitution solution from the fifth reagent well 129 and discharging it into the first reagent well 123, thus converting the dry reagent in the first reagent well 123 into a liquid labeled reagent; then the controller 150 can control the preparation mechanism 130 to immerse the capture rod 121 into the liquid labeled reagent, or the controller 150 can control the preparation mechanism 130 to mix the sample solution to be tested with the liquid labeled reagent.

[0126] This also applies to elution reagents and signal heuristic reagents. For example, if the elution reagent is pre-packaged in the second reagent well 124 as a liquid reagent, the controller 150 can control the preparation mechanism 130 to directly immerse the capture rod 121 into the liquid elution reagent. If the elution reagent is pre-packaged in the second reagent well 124 as a dry reagent, when using the dry reagent in the second reagent well 124, a reconstitution solution is first added to the second reagent well 124 to convert the dry reagent in the second reagent well 124 into a liquid elution reagent; then the controller 150 can control the preparation mechanism 130 to immerse the capture rod 121 into the liquid elution reagent.

[0127] Here, the elution reagent is used to elute at least the labeled portion of the complex obtained by binding the target analyte and the labeling reagent on the capture rod from the capture rod.

[0128] In some embodiments, when the reagent strip 120 further includes a sample well 126, the control preparation mechanism 130 may use the capture rod 121 to capture the target analyte or use the capture rod 121 to capture the target analyte and the labeling reagent, or the control preparation mechanism 130 may immerse the capture rod 121 sequentially into the sample solution to be tested and the labeling reagent, which may include:

[0129] The preparation mechanism 130, especially its dispensing device 132, controls the transfer of the test sample solution, such as raw test whole blood or pretreated (e.g., pre-diluted) test whole blood, into the sample well 126.

[0130] The preparation mechanism 130, especially its motion device 131, immerses the capture rod 121 into the sample liquid to be tested in the sample well 126 so that the capture rod 121 captures the target analyte in the sample liquid to be tested.

[0131] The preparation mechanism 130, especially its motion device 131, removes the capture rod 121 from the sample hole 126;

[0132] The control preparation mechanism 130, especially its motion device 131, immerses the capture rod 121 into the labeled reagent in the first reagent well 123 so that the labeled reagent binds to the target analyte captured by the capture rod 121, thereby forming a specifically bound complex, especially an immune complex, on the capture rod, consisting of the captured analyte, the target analyte, and the labeled reagent, as shown in Figure 8.

[0133] It should be understood that if the labeling reagent is pre-packaged in the first reagent well 123 in the form of a liquid reagent, the controller 150 can control the preparation mechanism 130 to directly immerse the capture rod 121 into the liquid labeling reagent in the first reagent well 123. If the labeling reagent is pre-packaged in the first reagent well 123 in the form of a dry reagent, controlling the preparation mechanism 130 to immerse the capture rod 121 into the labeling reagent in the first reagent well 123 includes: controlling the preparation mechanism 130 to add a reconstituted solution to the first reagent well 123, for example, drawing the reconstituted solution from the fifth reagent well 129 and discharging it into the first reagent well 123, thus converting the dry reagent in the first reagent well 123 into a liquid labeling reagent; and then controlling the preparation mechanism 130 to immerse the capture rod 121 into the liquid labeling reagent.

[0134] In other embodiments, the reagent strip 120 may include a sample well 126 or may not have a sample well 126. Here, the control preparation mechanism 130 uses the capture rod 121 to capture the target analyte, or uses the capture rod 121 to capture the target analyte and the label, or the control preparation mechanism 130 immerses the capture rod 121 in a mixture of the sample solution and the labeling reagent, which may include:

[0135] The control preparation mechanism 130, especially its dispensing device 132, transfers the test sample liquid, such as pretreated test whole blood, to the first reagent well 123, for example, from the sample well 126 or other sample container to the first reagent well 123, so that the target analyte in the test sample liquid binds with the labeling reagent to obtain a mixture in the first reagent well 123;

[0136] The preparation mechanism 130, especially its motion device 131, immerses the capture rod 121 into the mixture in the first reagent well 123 so that the capture rod 121 captures the target analyte in the mixture that is bound to the labeled reagent, so that the capture analyte, the target analyte, and the labeled reagent form a specifically bound complex, especially an immune complex, on the capture rod, as shown in Figure 8.

[0137] It should be understood that if the labeled reagent is pre-packaged in the first reagent well 123 in the form of a liquid reagent, the controller 150 can control the preparation mechanism 130 to directly transfer the sample solution to be tested into the first reagent well 123. However, if the labeled reagent is pre-packaged in the first reagent well 123 in the form of a dry reagent, the controller 150 controls the preparation mechanism 130 to add a reconstitution solution to the first reagent well 123 before controlling the preparation mechanism 130 to transfer the sample solution to be tested into the first reagent well 123, for example, by drawing a reconstitution solution from the fifth reagent well 129 and discharging it into the first reagent well 123, so that the dry reagent in the first reagent well 123 is converted into a liquid labeled reagent.

[0138] In some embodiments, the controller 150 is configured to: control the preparation mechanism 130, particularly its motion device 131, to immerse the capture rod 121 into the liquid in the sample well 126 and / or the first reagent well 123 only once when the preparation mechanism 130 is preparing the test solution. For example, the controller 150 controls the preparation mechanism 130, particularly its motion device 131, to immerse the capture rod 121 into the test sample solution in the sample well 126 only once and to immerse the capture rod 121 into the labeling reagent in the first reagent well 123 only once, or the controller 150 controls the preparation mechanism 130, particularly its motion device 131, to immerse the capture rod 121 into the mixture in the first reagent well 123 only once. This saves reaction time and avoids amplification errors.

[0139] In some embodiments, when the capture rod 121 is fully covered, controlling the preparation mechanism 130 to immerse the capture rod 121 into the sample solution to be tested, especially into the sample solution to be tested in the sample well 126, may include: after the preparation mechanism 130 removes the capture rod 121 from the capture rod well 122, it directly immerses the removed capture rod 121 into the sample solution to be tested, especially directly into the sample solution to be tested in the sample well 126.

[0140] In other embodiments, when the capture rod 121 is partially coated, before the control preparation mechanism 130 immerses the capture rod 121 sequentially into the test sample solution and the labeling reagent, or before the control preparation mechanism 130 immerses the capture rod 121 into the mixture of the test sample solution and the labeling reagent, the controller 150 is configured to control the preparation mechanism 130, in particular its motion device 131, to immerse the removed capture rod 121 into a capture antibody or capture antigen coupled with a second ligand substance, for example, into a capture antibody or capture antigen coupled with a second ligand substance in the sixth reagent well, after removing the capture rod 121 from the capture rod orifice 122, so that the second ligand substance coupled to the capture antibody or capture antigen binds to the first ligand substance coated on the capture rod.

[0141] In other embodiments, when the capture rod 121 is partially coated, before the control preparation mechanism 130 immerses the capture rod 121 sequentially into the test sample solution and the labeled reagent, or before the control preparation mechanism 130 immerses the capture rod 121 into the mixture of the test sample solution and the labeled reagent, the controller 150 is configured to control the preparation mechanism 130, especially its dispensing device 320, to transfer the test sample solution and the capture antibody or capture antigen coupled with the second ligand substance into the first reagent well 123, so that the test antigen in the test sample solution and the capture antibody or capture antigen coupled with the second ligand substance can be transferred to the first reagent well 123 respectively. The capture antibody and the labeled antibody of the second ligand substance undergo an immune reaction to form an immune complex of "capture antibody-test antigen-labeled antibody", or so that the test antibody, the capture antigen coupled with the second ligand substance and the labeled antigen in the test sample solution undergo an immune reaction to form an immune complex of "capture antigen-test antibody-labeled antigen"; then the preparation mechanism 130, especially its motion device, is controlled to immerse the taken-out capture rod 121 into the mixture containing the immune complex in the first reagent well 123 so that the capture rod 121 captures the immune complex.

[0142] As previously stated, the sample analyzer according to the embodiments of this application is applicable to both direct chemiluminescence systems and indirect chemiluminescence systems.

[0143] As some implementations, the sample analyzer according to the embodiments of this application is based on a direct chemiluminescence system, that is, the label is a direct luminescent reagent, preferably acridinium ester, the eluent is a pre-excitation solution, and the signal heuristic reagent is an excitation solution that excites the direct luminescent reagent to emit light. Here, the controller 150 is configured to: control the preparation mechanism 130 to capture the target analyte and the direct luminescent reagent using the retrieved capture rod; control the preparation mechanism 130 to immerse the captured capture rod 121 into the pre-excitation solution in the second reagent well 124, especially to completely immerse the capture section 1213 of the capture rod 121 in the pre-excitation solution, so as to elute at least the direct luminescent reagent from the capture rod into the pre-excitation solution to obtain an eluent, as shown in FIG9; then control the preparation mechanism 130 to prepare the test solution using the eluent in the second reagent well 124 and the excitation solution in the third reagent well 125.

[0144] Optionally, the controller 150 can control the preparation mechanism 130, especially its motion device 131, to immerse the captured rod 121, which has completed its capture, into the pre-excitation liquid in the second reagent hole 124 for 10 to 100 seconds. At this time, the captured rod 121 can be statically immersed in the pre-excitation liquid.

[0145] In some examples, the preparation mechanism 130 prepares the test solution using the eluent in the second reagent well 124 and the excitation solution in the third reagent well 125. This may include: the preparation mechanism 130, especially its dispensing device 132, transferring at least a portion of the excitation solution in the third reagent well 125 to the second reagent well 124, or the preparation mechanism 130, especially its dispensing device 132, transferring at least a portion of the eluent in the second reagent well 124 to the third reagent well 125 containing the excitation solution, so that the eluent and the excitation solution mix and undergo a chemiluminescent reaction to prepare the test solution.

[0146] At this time, the controller 150 can control the detection mechanism 140 to perform photometric measurement on the solution to be tested in the second reagent well 124 or the third reagent well 125.

[0147] Preferably, the second reagent aperture 124 or the third reagent aperture 125 is configured to be at least partially translucent, particularly at least partially transparent, so that the detection mechanism 140 can detect the light signal transmitted through the translucent portion of the second reagent aperture 124 or the third reagent aperture 125. For example, the translucent portion of the second reagent aperture 124 or the third reagent aperture 125 can be the bottom or a portion of the sidewall directly adjacent to the bottom, which preferably extends over the entire height of the second reagent aperture 124 or the third reagent aperture 125.

[0148] In other examples, as shown in Figure 9, when the reagent strip 120 also includes a measuring orifice 127, the control preparation mechanism 130 may prepare the test solution using the eluent in the second reagent orifice 124 and the excitation liquid in the third reagent orifice 125. This may include the control preparation mechanism 130, and in particular its dispensing device 132, transferring at least a portion of the eluent in the second reagent orifice 124 and at least a portion of the excitation liquid in the third reagent orifice 125 into the measuring orifice 127, particularly by transferring the eluent first and then the excitation liquid, so that the eluent and the excitation liquid mix and undergo a chemiluminescent reaction to prepare the test solution.

[0149] Preferably, the measuring aperture 127 is configured to be at least partially translucent, particularly at least partially transparent, so that the detection mechanism 140 can detect the light signal transmitted through the translucent portion of the measuring aperture 127. For example, the translucent portion of the measuring aperture 127 may be the bottom or a portion of the sidewall directly adjacent to the bottom, which preferably extends over the entire height of the measuring aperture 127.

[0150] In some other examples, reagent strip 120 does not have a separate measuring hole 127, but since the capture rod 121 has been removed from the capture rod hole 122, the capture rod hole 122 can be used as a measuring hole. Here, the control preparation mechanism 130 prepares the test solution using the eluent in the second reagent hole 124 and the excitation liquid in the third reagent hole 125, which may include: the control preparation mechanism 130, in particular its dispensing device 132, transferring at least a portion of the eluent in the second reagent hole 124 and at least a portion of the excitation liquid in the third reagent hole 125 into the capture rod hole 122, in particular transferring the eluent first and then the excitation liquid, so that the eluent and the excitation liquid mix to undergo a chemiluminescent reaction to prepare the test solution.

[0151] Preferably, the capture rod aperture 122 is configured to be at least partially translucent, particularly at least partially transparent, so that the detection mechanism 140 can detect the light signal transmitted through the translucent portion of the capture rod aperture 122. For example, the translucent portion of the capture rod aperture 122 may be the bottom or a portion of the sidewall directly adjacent to the bottom, which preferably extends over the entire height of the capture rod aperture 122.

[0152] Since a light signal is generated the instant the excitation liquid and the pre-excitation liquid come into contact, the detection mechanism 140 needs to be ready for photometry, i.e., turned on, before the excitation liquid and the pre-excitation liquid come into contact, because the luminescence time of acridine ester is extremely short, only about 1 second. In other words, the detection mechanism 140 starts collecting the generated light signal the instant the excitation liquid and the pre-excitation liquid come into contact.

[0153] For example, as shown in Figure 3, after the preparation mechanism 130, particularly its dispensing device 132, transfers at least a portion of the eluent from the second reagent well 124 to the measuring well 127, the reagent strip 120 is fed into the darkroom 143 through the movable door 144, and then the movable door 144 is closed. The dispensing device 132 of the preparation mechanism 130 also includes a pipette pump disposed within the darkroom 143, which transfers at least a portion of the excitation solution from the third reagent well 125 to the measuring well 127, while photometry is performed by the photometer 141.

[0154] In a specific illustrative process, controller 150 is configured to control preparation mechanism 130 to prepare the test solution:

[0155] The preparation mechanism 130, especially its dispensing device 132, transfers the sample solution to be tested into the first reagent well 123 so that the target analyte in the sample solution to be tested combines with the labeling reagent with the direct luminescent reagent to obtain a mixture.

[0156] The preparation mechanism 130, especially its motion device 131, immerses the capture rod 121, for example, fully or partially immerses its capture section into the mixture in the first reagent well 123, so that the capture rod captures the target analyte in the mixture that is bound to the labeled reagent.

[0157] The preparation mechanism 130, especially its motion device 131, removes the capture rod 121 from the first reagent orifice 123;

[0158] The preparation mechanism 130, especially its motion device 131, immerses the capture rod 121, especially its capture section, into the pre-excitation liquid in the second reagent hole 124, so as to elute at least the direct luminescent reagent from the capture rod 121 into the pre-excitation liquid to obtain an eluent.

[0159] The preparation mechanism 130, especially its motion device 131, removes the capture rod 121 from the second reagent orifice 124;

[0160] The preparation mechanism 130, especially its dispensing device 132, prepares the test solution using an eluent and an activation solution.

[0161] As some other implementations, the sample analyzer according to the embodiments of this application is based on an indirect chemiluminescence system, that is, the label is an enzyme label, and the signal heuristic reagent is a substrate solution that emits light under the catalysis of the enzyme label. Here, the controller 150 is configured to: control the preparation mechanism 130 to capture the target analyte and the enzyme label using the retrieved capture rod; control the preparation mechanism 130 to immerse the captured capture rod 121 into the elution reagent in the second reagent well 124, especially to completely immerse the capture section 1213 of the capture rod 121 into the elution reagent, so as to elute at least the enzyme label from the capture rod into the elution reagent to obtain an eluent; then control the preparation mechanism 130 to prepare the test solution using the eluent in the second reagent well 124 and the substrate solution in the third reagent well 125.

[0162] In some embodiments, the controller 150 is further configured to control the preparation mechanism 130 to drive the capture rod 121 to rotate in the liquid in the corresponding hole after the preparation mechanism 130 has immersed the capture rod 121 into the liquid in the sample well or reagent well and before the capture rod 121 has been removed.

[0163] In particular, the preparation mechanism 130 is controlled to drive the capture rod 121 to rotate in the liquid in the corresponding hole so that the capture rod 121 does not contact the inner wall of the hole when rotating in the liquid, thus avoiding damage to the capture section.

[0164] In some examples, the controller 150 is also configured to: after the preparation mechanism 130 has immersed the capture rod 121 into the liquid in the sample well 126, i.e., the sample solution to be tested, and before it has been removed, drive the capture rod 121 to rotate, preferably eccentrically rotate, in the liquid in the sample well 126. This enables the capture rod 121 to fully capture the target analyte in the sample solution to be tested.

[0165] Alternatively or additionally, the controller 150 is further configured to: after the preparation mechanism 130 immerses the capture rod 121 in the liquid (e.g., labeled reagent or a mixture of labeled reagent and sample solution) in the first reagent well 123 and before removing it, drive the capture rod 121 to rotate, preferably eccentrically rotate, in the liquid in the first reagent well 123, for example, at a speed of 1 to 50 rpm for 1 to 30 minutes. This promotes the immunoreaction between the target analyte and the labeled reagent, and improves the efficiency of the immunoreaction.

[0166] Alternatively or additionally, the controller 150 is also configured to: after the preparation mechanism 130 has immersed the capture rod 121 into the elution reagent in the second reagent well 124 and before it has been removed, drive the capture rod 121 to rotate, preferably eccentrically rotate, in the liquid in the second reagent well 124, i.e., the elution solution. This enhances the elution effect.

[0167] In the embodiments of this application, eccentric rotation means that the rotation axis of the capture rod 121 is at least deviated from the central axis of the capture section 1213 of the capture rod 121, or in other words, the rotation axis of the capture rod 121 is parallel to but does not coincide with the central axis of the capture section 1213 of the capture rod 121.

[0168] In some embodiments, as shown in FIG1, the motion device 131 includes a rotation drive 1314 for driving the clamping part 1311 to rotate, such that the clamping part 1311 can drive the clamped capture rod 121 to rotate around the rotation axis in the corresponding hole of the reagent strip 120, especially to rotate eccentrically, as shown in FIG10.

[0169] For example, the clamping part 1311 includes a gripper section (i.e., a gripper) and a rotary drive section arranged adjacent to each other in the axial direction. The gripper section is used to clamp the clamping section 1211 of the capture rod 121. One end of the rotary drive section is connected to the gripper section and the other end is connected to the rotary drive part 1314, such as a rotary motor.

[0170] In some examples, as shown in FIG11, the capture rod 121 includes an eccentric structure, that is, the central axis of the capture section is offset from the central axis of the clamping section, i.e., the central axis of the capture section does not coincide with the central axis of the clamping section. Here, the central axis of the gripper section of the clamping part 1311 is preferably coaxial with the central axis of the rotary drive section. When the gripper section clamps the capture rod 121, the central axis of the clamping section 1211 is coaxial with the central axis of the gripper section, and the rotary drive part 1314 drives the clamping part 1311 to rotate about the central axis of the rotary drive section, thereby causing at least the capture section of the capture rod 121 to rotate eccentrically in the hole.

[0171] In other examples, as shown in Figure 12, the clamping part 1311 includes an eccentric structure, that is, the central axis of the rotary drive section is offset from the central axis of the gripper section, i.e., the central axis of the rotary drive section does not coincide with the central axis of the gripper section. Here, the central axis of the capture section of the capture rod 121 is preferably coaxial with the central axis of the clamping section. When the gripper section clamps the capture rod 121, the central axis of the gripper section is coaxial with the central axis of the capture section, and the rotary drive part 1314 drives the clamping part 1311 to rotate around the central axis of the rotary drive section, thereby causing at least the capture section of the capture rod 121 to rotate eccentrically in the hole.

[0172] In some embodiments, the distance between the central axis of the capture section and the axis of rotation in the radial direction of the corresponding hole is greater than or equal to 0.1 mm and less than or equal to 3 mm.

[0173] In some embodiments, as shown in FIG13, where the reagent holes of reagent strip 120 also include at least one fourth reagent hole 128 pre-filled with cleaning solution, controller 150 is further configured to, before elution, control preparation mechanism 130, in particular to immerse motion device 131 in the cleaning solution in the fourth reagent hole 128, in particular to completely immerse its capture section 1213 in the cleaning solution in the fourth reagent hole, and control preparation mechanism 130 to drive capture rod to rotate, preferably eccentrically rotate, in the cleaning solution in the fourth reagent hole, for example, at a speed of 5 to 50 rpm for 1 to 60 seconds, so as to wash away unbound material on capture rod.

[0174] Especially after the capture rod 121 is immersed in the liquid (e.g., liquid labeled reagent or a mixture of labeled reagent and sample solution) in the first reagent well 123, a specific complex (i.e., a complex of capture analyte-labeled reagent) binds to the capture segment of the capture rod 121 before elution. Simultaneously, some non-specifically bound substances, such as labeled reagents that do not form a complex (e.g., labeled antibodies or labeled antigens), also adhere to it. Therefore, it is preferable to wash the capture rod with the bound complex before elution to remove the non-specific binding substances.

[0175] Here, the control preparation mechanism 130 drives the capture rod to rotate, particularly eccentrically rotate, in the cleaning solution of the fourth reagent well 128. The shear force of the cleaning solution flowing over the surface of the capture rod removes non-specifically adsorbed substances. Simultaneously, this shear force is insufficient to cleave specifically bound complexes, thus significantly reducing background noise and improving the signal-to-noise ratio.

[0176] In some embodiments, when the reagent strip 120 includes a plurality of fourth reagent holes 128, the controller 150 controls the preparation mechanism 130, in particular the motion device 131, to sequentially immerse the capture rod 121 into the cleaning solution in each of the fourth reagent holes 128 and rotate it.

[0177] In some embodiments, the cleaning fluid is a general cleaning fluid, including a buffer solution and a surfactant.

[0178] In some embodiments, where the reagent strip 120 also includes a measurement well 127 independent of the capture rod well 122, the control preparation mechanism 130 prepares the test solution using at least the eluent and the signal heuristic reagent, including: the control preparation mechanism 120 preparing the test solution in the measurement well 127 using at least the eluent and the signal heuristic reagent, or the control preparation mechanism 130 transferring at least a portion of the test solution to the measurement well 127 after preparing the test solution using at least the eluent and the signal heuristic reagent. At this time, the control detection mechanism 140 detects the test solution, including: the control detection mechanism 140 detecting the test solution in the measurement well 127 to obtain the content of the target analyte.

[0179] In some alternative embodiments, the control preparation mechanism 130 prepares the test solution using at least the eluent and the signal heuristic reagent, including: the control preparation mechanism 120 prepares the test solution in the capture rod well 122 using at least the eluent and the signal heuristic reagent, or the control preparation mechanism 130 transfers at least a portion of the test solution to the capture rod well 122 after preparing the test solution using at least the eluent and the signal heuristic reagent. In this case, the control detection mechanism 140 detects the test solution, including: the control detection mechanism 140 detects the test solution in the capture rod well 122 to obtain the content of the target analyte.

[0180] In some alternative embodiments, the sample analyzer further includes a measurement area configured to hold at least one measurement container for receiving at least a portion of the test solution. The control preparation mechanism 130 prepares the test solution using at least an eluent and a signal heuristic reagent, including: the control preparation mechanism 120 preparing the test solution in the measurement container using at least an eluent and a signal heuristic reagent, or the control preparation mechanism 130 transferring at least a portion of the test solution to the measurement container after preparing the test solution using at least an eluent and a signal heuristic reagent. At this time, the control detection mechanism 140 detects the test solution, including: the control detection mechanism 140 detecting the test solution in the measurement container to obtain the content of the target analyte.

[0181] For example, the measuring container is constructed as a separate measuring cup.

[0182] The following describes a specific workflow of a sample analyzer based on a direct chemiluminescence system according to an embodiment of this application, with reference to Figures 14 and 15. Figure 14 shows a schematic side and top view of a reagent strip 120, which includes the aforementioned capture rod well 122, first reagent well 123, second reagent well 124, third reagent well 125, four fourth reagent wells 128, sample well 126, and measurement well 127. The capture rod 121 is coated with a capture antibody, and the labeling reagent is a labeled antibody.

[0183] As shown in Figure 15, the controller 150 is configured to execute steps 1 through 7. In step 1, the controller 150 controls the dispensing device 132 to add the whole blood to be tested into the sample well 126, for example, controlling the dispensing device 132 to quantitatively aspirate the whole blood to be tested from a test tube containing the whole blood to be tested and dispense it into the sample well 126. The sample well can be empty or pre-loaded with sample diluent. In step 2, the controller 150 controls the dispensing device 132 to transfer the whole blood to be tested or diluted whole blood to be tested from the sample well to the first reagent well 123 (if the labeled antibody is pre-packaged in the first reagent well 123 in the form of dry reagent, a reconstitution solution is added to the first reagent well 123 beforehand, for example, a reconstitution solution is aspirated from the fifth reagent well 129 and dispensed into the first reagent well 123, so that the dry reagent in the first reagent well 123 is converted into liquid labeled antibody) and optionally mixes it so that the antigen to be tested reacts fully with the labeled antibody in the first reagent well 123. In step 3, the controller 150 controls the motion device 131 to remove the capture rod 121 from the capture rod hole 122 and immerse the removed capture rod 121 in the liquid in the first reagent hole 123, rotating it in the liquid in the first reagent hole 123 to capture the antibody, the test antigen, and the labeled antibody to undergo an immune reaction, forming an immune complex on the capture rod 121. In step 4, the controller 150 controls the motion device 131 to remove the capture rod from the first reagent hole 123 and immerse it sequentially in the washing solution in each of the four fourth reagent holes 128, rotating the capture rod in the washing solution in each of the fourth reagent holes 128 to wash away unbound material on the capture rod. In step 5, the controller 150 controls the motion device 131 to remove the capture rod from the last fourth reagent hole and immerse it in the pre-excitation solution in the second reagent hole 124 to elute the direct luminescent label into the pre-excitation solution. In step 6, the controller 150 controls the dispensing device 132 to transfer at least a portion of the pre-excitation liquid containing the direct luminescent marker from the second reagent well 124 to the empty measuring well 127. In step 7, the controller 150 controls the dispensing device 132 to transfer at least a portion of the excitation liquid from the third reagent well 125 to the measuring well 127 containing the pre-excitation liquid, while simultaneously controlling the detection mechanism 140 to perform photometric measurement on the test solution in the measuring well 127.

[0184] The following describes another specific workflow of a sample analyzer based on a direct chemiluminescence system according to an embodiment of this application, with reference to Figures 16 and 17. Figure 16 shows a schematic side and top view of a reagent strip 120, which includes the aforementioned capture rod hole 122, first reagent hole 123, second reagent hole 124, third reagent hole 125, four fourth reagent holes 128, and sample hole 126. The capture rod 121 is coated with a capture antibody, and the labeling reagent is a labeled antibody. A pre-reserved hole is also provided in the reagent strip 120 of Figure 16. It is understood that a pre-reserved hole may not be provided. Here, the second reagent hole 124 is configured to be at least partially translucent, particularly at least partially transparent, so that the detection mechanism 140 can detect the light signal transmitted through the translucent portion of the second reagent hole 124. For example, the translucent portion of the second reagent hole 124 is a partial sidewall directly adjacent to the bottom, which preferably extends over the entire height of the second reagent hole 124.

[0185] As shown in Figure 16, the controller 150 is configured to execute steps 1 through 6. In step 1, the controller 150 controls the dispensing device 132 to add the whole blood to be tested into the sample well 126, for example, controlling the dispensing device 132 to quantitatively aspirate the whole blood to be tested from a test tube containing the whole blood to be tested and dispense it into the sample well 126. The sample well can be empty or pre-loaded with sample diluent. In step 2, the controller 150 controls the dispensing device 132 to transfer the whole blood to be tested or diluted whole blood to be tested from the sample well to the first reagent well 123 (if the labeled antibody is pre-packaged in the first reagent well 123 in the form of dry reagent, a reconstitution solution is added to the first reagent well 123 beforehand, for example, a reconstitution solution is aspirated from the fifth reagent well 129 and dispensed into the first reagent well 123, so that the dry reagent in the first reagent well 123 is converted into liquid labeled antibody) and optionally mixes it so that the antigen to be tested reacts fully with the labeled antibody in the first reagent well 123. In step 3, the controller 150 controls the motion device 131 to remove the capture rod 121 from the capture rod hole 122 and immerse the removed capture rod 121 in the liquid in the first reagent hole 123, rotating it in the liquid in the first reagent hole 123 to capture the antibody, the test antigen, and the labeled antibody to undergo an immune reaction, forming an immune complex on the capture rod 121. In step 4, the controller 150 controls the motion device 131 to remove the capture rod from the first reagent hole 123 and immerse it sequentially in the washing solution in each of the four fourth reagent holes 128, rotating the capture rod in the washing solution in each of the fourth reagent holes 128 to wash away unbound material on the capture rod. In step 5, the controller 150 controls the motion device 131 to remove the capture rod from the last fourth reagent hole and immerse it in the pre-excitation solution in the second reagent hole 124 to elute the direct luminescent label into the pre-excitation solution. In step 6, the controller 150 controls the dispensing device 132 to transfer at least a portion of the excitation liquid in the third reagent well 125 to the second reagent well 124, so that the excitation liquid mixes with the pre-excitation liquid containing the direct luminescent marker in the second reagent well 124 to obtain the test solution. Simultaneously, the controller controls the detection mechanism 140 to perform photometric measurement on the test solution in the second reagent well 124. As shown in Figure 18, this application embodiment also proposes a sample detection method 200, including steps S210 to S140.

[0186] In step S210, a test sample solution containing the target analyte is provided. The target analyte is, for example, a test antigen or a test antibody.

[0187] In step S220, a reagent strip 120 is provided, which includes a capture rod orifice 122 and a plurality of reagent orifices. The plurality of reagent orifices include a first reagent orifice 123, a second reagent orifice 124, and a third reagent orifice 125. A capture rod 121 coated with a capture substance is pre-placed in the capture rod orifice 122, a labeling reagent with a marker is pre-placed in the first reagent orifice 123, an elution reagent is pre-placed in the second reagent orifice 124, and a signal induction reagent is pre-placed in the third reagent orifice 125.

[0188] In step S230, a test solution is prepared using the sample solution, labeling reagent, and signal heuristic reagent. Specifically, the following steps are performed when preparing the test solution: the capture rod 121 is removed from the capture rod orifice 122, and the target analyte or the target analyte and label are captured using the capture rod 121; the capture rod 121 is immersed in the elution reagent in the second reagent orifice 124 to elute the target analyte and / or label captured by the capture rod from the capture rod, obtaining an eluent; after elution, the capture rod 121 is removed from the second reagent orifice 122; then, the test solution is prepared using at least the eluent and the signal heuristic reagent.

[0189] In step S240, the test solution is analyzed to obtain the content of the target analyte.

[0190] In some embodiments, step S240 may include: performing photodetection on the test solution to obtain the light signal generated by the test solution after luminescence, preferably chemiluminescence, and determining the content of the target analyte based on the intensity of the light signal. Preferably, the intensity of the light signal and the content of the target analyte are positively correlated.

[0191] Furthermore, step S240 may include: detecting the number of photons generated by the emission of light from the solution to be tested, so as to determine the content of the target analyte based on the number of photons.

[0192] In some embodiments, the reagent strip 120 may further include a sample well 126 for holding the sample solution to be tested, preferably with a pre-treatment solution pre-placed in the sample well 126. Here, step S230, capturing the target analyte or capturing the target analyte and the marker using the capture rod, may include: transferring the sample solution to be tested into the sample well 126; immersing the capture rod 121 into the sample solution to be tested in the sample well 126 so that the capture rod captures the target analyte in the sample solution to be tested, preferably immersing the capture rod 121 into the sample solution to be tested in the sample well 126 only once; removing the capture rod 121 from the sample well 126; immersing the capture rod 121 into the marker reagent in the first reagent well 123 so that the marker reagent binds to the target analyte captured by the capture rod, preferably immersing the capture rod into the marker reagent in the first reagent well only once.

[0193] In some alternative embodiments, step S230, capturing the target analyte or capturing the target analyte and the labeling reagent using a capture rod, may include: transferring the sample solution to be tested into the first reagent well 123 so that the target analyte in the sample solution binds to the labeling reagent to obtain a mixture; immersing the capture rod 121 into the mixture in the first reagent well 123 so that the capture rod captures the target analyte bound to the labeling reagent in the mixture, preferably immersing the capture rod 121 into the mixture in the first reagent well 123 only once.

[0194] In some embodiments, in method 200, a direct luminescent reagent, preferably acridinium ester, is used as the label, a pre-excitation solution is used as the elution reagent, and an excitation solution that excites the direct luminescent reagent is used as the signal heuristic reagent. Here, step S230 includes: transferring the sample solution to be tested into the first reagent well 123 so that the target analyte in the sample solution binds to the labeling reagent to obtain a mixture; immersing the capture rod 121 into the mixture in the first reagent well 123 so that the capture rod 121 captures the target analyte bound to the labeling reagent in the mixture; removing the capture rod 121 from the first reagent well 123; immersing the capture rod 121 into the pre-excitation solution in the second reagent well 124 so that at least the direct luminescent reagent is eluted from the capture rod 121 into the pre-excitation solution to obtain an eluent; removing the capture rod 121 from the second reagent well 124; and preparing the test solution using the eluent and the excitation solution. Step S240 includes: after preparing the test solution, detecting the test solution without immersing the capture rod in the test solution.

[0195] In some embodiments, step S230 includes: immersing the capture rod 121 into the sample solution to capture the target analyte in the sample solution; immersing the capture rod 121 into the elution reagent in the second reagent well 124 to elute the target analyte captured by the capture rod from the capture rod to obtain an eluent; and preparing a test solution using the eluent, a labeling reagent, and a signal heuristic reagent.

[0196] In some alternative embodiments, step S230 includes: immersing the capture rod 121 sequentially into the sample solution to be tested and the labeling reagent, or immersing the capture rod 121 into a mixture of the sample solution to be tested and the labeling reagent, so as to capture the target analyte in the sample solution to be tested using the capture rod and the captured target analyte binds to the labeling reagent; immersing the capture rod into the elution reagent of the second reagent well 124 so as to elute at least the label from the capture rod using the elution reagent to obtain an eluent; and preparing the test solution using the eluent and a signal heuristic reagent.

[0197] In some embodiments, step S230 includes: after immersing the capture rod 121 in the liquid of the sample well 126 and before removing it, rotating, preferably eccentrically rotating, the capture rod 121 in the liquid of the sample well 126.

[0198] Alternatively or additionally, step S230 includes: after immersing the capture rod 121 in the liquid in the first reagent orifice 123 and before removing it, rotating, preferably eccentrically rotating, the capture rod 121 in the liquid in the first reagent orifice 123.

[0199] Alternatively or additionally, step S230 includes: after immersing the capture rod 121 in the elution reagent in the second reagent well 124 and before removing it, rotating, preferably eccentrically rotating, the capture rod 121 in the liquid in the second reagent well 124.

[0200] In some embodiments, the reagent strip 120 further includes at least one fourth reagent hole 128 in which cleaning solution is pre-placed. Here, step S230 includes: before elution, immersing the capture rod 121 in the cleaning solution of the fourth reagent hole 128 and rotating, preferably eccentrically rotating, the capture rod 121 in the cleaning solution of the fourth reagent hole 128 to wash away unbound material on the capture rod.

[0201] In some embodiments, the reagent strip 120 further includes a measurement well 127 separate from the capture rod well, in which no liquid is pre-placed. Here, in step S230, preparing the test solution using at least the eluent and the signal heuristic reagent includes: preparing the test solution in the measurement well 127 using at least the eluent and the signal heuristic reagent, or transferring at least a portion of the test solution to the measurement well 127 after preparing the test solution using at least the eluent and the signal heuristic reagent. Accordingly, step S240 includes: detecting the test solution in the measurement well 127.

[0202] In some embodiments, in step S230, preparing the test solution using at least the eluent and the signal heuristic reagent includes: preparing the test solution in the capture rod well 122 using at least the eluent and the signal heuristic reagent, or transferring at least a portion of the test solution to the capture rod well 122 after preparing the test solution using at least the eluent and the signal heuristic reagent. Accordingly, step S240 includes: detecting the test solution in the capture rod well 122.

[0203] The method 200 proposed in this application embodiment can be implemented, in particular, by the sample analyzer described above.

[0204] All features or combinations of features mentioned above in the specification, drawings, and claims may be used in any combination or individually, provided they are meaningful within the scope of this application and do not contradict each other. The advantages and features described in the sample analyzer provided in the embodiments of this application are applicable in a corresponding manner to the sample detection method provided in the embodiments of this application, and vice versa.

[0205] The above description is merely a preferred embodiment of this application and does not limit the patent scope of this application. All equivalent modifications made based on the inventive concept of this application and the contents of the specification and drawings of this application, or direct / indirect applications in other related technical fields, are included within the patent protection scope of this application.

Claims

1. A sample analyzer, comprising: A reagent strip storage area is provided for placing at least one reagent strip. The reagent strip includes a capture rod hole and multiple reagent holes, including a first reagent hole, a second reagent hole, and a third reagent hole. A capture rod coated with a capture substance is pre-placed in the capture rod hole. A labeling reagent with a marker is pre-placed in the first reagent hole. An elution reagent is pre-placed in the second reagent hole. A signal induction reagent is pre-placed in the third reagent hole. The preparation apparatus is configured to prepare a test solution using a sample solution containing the target analyte, the labeling reagent, the elution reagent, and the signal heuristic reagent; A testing facility is configured to test the solution to be tested in order to obtain the content of the target analyte; and A controller is configured to be electrically connected to the preparation mechanism and the detection mechanism, so as to control the preparation mechanism to prepare the test solution and control the detection mechanism to detect the test solution; The controller is configured to: control the preparation mechanism to remove the capture rod from the capture rod orifice; control the preparation mechanism to capture the target analyte or the target analyte and the marker using the capture rod; control the preparation mechanism to immerse the capture rod in the elution reagent in the second reagent orifice so as to elute the target analyte and / or the marker captured by the capture rod from the capture rod using the elution reagent to obtain an eluent; control the preparation mechanism to remove the capture rod from the second reagent orifice after elution; and then control the preparation mechanism to prepare the test solution using at least the eluent and the signal heuristic reagent, and control the detection mechanism to detect the test solution to obtain the content of the target analyte.

2. The sample analyzer of claim 1, wherein, The detection mechanism is configured to perform photodetection on the test solution to obtain the light signal generated by the test solution after luminescence, preferably chemiluminescence, and to determine the content of the target analyte based on the intensity of the light signal; Preferably, the intensity of the optical signal is positively correlated with the content of the target analyte; Preferably, the detection mechanism includes a photometer configured to detect the number of photons generated by the emission of light from the solution to be tested, so as to determine the content of the target analyte based on the number of photons.

3. The sample analyzer of claim 1 or 2, wherein, The reagent strip also includes a sample well for placing the sample solution to be tested, preferably with a pretreatment solution placed in the sample well beforehand. The control of the preparation mechanism to capture the target analyte using the capture rod or to capture the target analyte and the marker using the capture rod includes: The preparation mechanism is controlled to transfer the sample solution to be tested into the sample well; The preparation mechanism is controlled to immerse the capture rod into the sample solution to be tested in the sample well, so that the capture rod captures the target analyte in the sample solution to be tested; The preparation mechanism is controlled to remove the capture rod from the sample well; The preparation mechanism is controlled to immerse the capture rod into the labeled reagent in the first reagent well, so that the labeled reagent binds to the target analyte captured by the capture rod.

4. The sample analyzer of claim 1 or 2, wherein, The control of the preparation mechanism to capture the target analyte using the capture rod or to capture the target analyte and the marker using the capture rod includes: The preparation mechanism is controlled to transfer the test sample solution into the first reagent well, so that the target analyte in the test sample solution binds with the labeling reagent to obtain a mixture; The preparation mechanism is controlled to immerse the capture rod into the mixture in the first reagent well, so that the capture rod captures the target analyte in the mixture that is bound to the labeled reagent.

5. The sample analyzer of claim 3 or 4, wherein, The controller is configured to, when controlling the preparation mechanism to prepare the test solution: The preparation mechanism is controlled to immerse the capture rod into the liquid in the sample well and / or the first reagent well only once.

6. The sample analyzer of any one of claims 1 to 5, wherein, The controller is configured to: After the test solution is prepared, the detection mechanism is controlled to detect the test solution without the capture rod being immersed in the test solution.

7. The sample analyzer of any one of claims 1 to 6, wherein, The label is a direct luminescent reagent, preferably an acridinium ester; the elution reagent is a pre-excitation solution; and the signal heuristic reagent is an excitation solution that excites the direct luminescent reagent to emit light. The controller is configured to: The preparation mechanism is controlled to capture the target analyte and the direct luminescent reagent using the capture rod; The preparation mechanism is controlled to immerse the capture rod into the pre-excitation solution in the second reagent well, so as to elute at least the direct luminescent reagent from the capture rod into the pre-excitation solution to obtain the eluent; The preparation mechanism is controlled to prepare the test solution using the eluent and the activation solution.

8. The sample analyzer of claim 7, wherein, The method of controlling the preparation mechanism to prepare the test solution using the eluent and the activation solution includes: controlling the preparation mechanism to transfer at least a portion of the activation solution in the third reagent well to the second reagent well, or controlling the preparation mechanism to transfer at least a portion of the eluent in the second reagent well to the third reagent well containing the activation solution, thereby mixing the eluent and the activation solution to prepare the test solution; or... The reagent strip also includes a measuring orifice in which no liquid is pre-placed. The control of the preparation mechanism to prepare the test solution using the eluent and the activation solution includes: controlling the preparation mechanism to transfer at least a portion of the eluent in the second reagent orifice and at least a portion of the activation solution in the third reagent orifice to the measuring orifice, so that the eluent and the activation solution are mixed to prepare the test solution.

9. The sample analyzer of claim 7, wherein, The controller is configured to, when controlling the preparation mechanism to prepare the test solution: The preparation mechanism is controlled to transfer the sample solution to be tested into the first reagent well, so that the target analyte in the sample solution to be tested combines with the labeling reagent with the direct luminescent reagent to obtain a mixture; The preparation mechanism is controlled to immerse the capture rod into the mixture in the first reagent well, so that the capture rod captures the target analyte in the mixture that is bound to the labeled reagent; The preparation mechanism is controlled to remove the capture rod from the first reagent orifice; The preparation mechanism is controlled to immerse the capture rod into the pre-excitation solution in the second reagent well, so as to elute at least the direct luminescent reagent from the capture rod into the pre-excitation solution to obtain the eluent; The preparation mechanism is controlled to remove the capture rod from the second reagent orifice; The preparation mechanism is controlled to prepare the test solution using the eluent and the activation solution.

10. The sample analyzer of any one of claims 1 to 6, wherein, The controller is configured to, when controlling the preparation mechanism to prepare the test solution: The preparation mechanism is controlled to immerse the capture rod into the sample solution to be tested, so as to capture the target analyte in the sample solution using the capture rod; The preparation mechanism is controlled to immerse the capture rod into the elution reagent in the second reagent well so as to elute the target analyte captured by the capture rod from the capture rod to obtain the eluent; The preparation mechanism is controlled to prepare the test solution using the eluent, the labeling reagent, and the signal heuristic reagent.

11. The sample analyzer of claim 10, wherein, The target analyte is the antigen to be tested, the labeling reagent is a labeled antibody that is specifically bound to the target analyte, and the capture substance is a first ligand substance that can bind to a second ligand substance coupled to the capture antibody. Alternatively, the target analyte is an antibody to be tested, the labeling reagent is a labeled antigen that is specifically bound to the target analyte, and the capture substance is a first ligand substance that can bind to a second ligand substance coupled to the capture antigen; preferably, the first ligand substance is streptavidin and the second ligand substance is biotin. The controller is configured to, when controlling the preparation mechanism to prepare the test solution: The preparation mechanism is controlled to immerse the capture rod into the capture antibody or the capture antigen coupled with the second ligand substance, so that the second ligand substance coupled to the capture antibody or the capture antigen binds to the first ligand substance coated on the capture rod; The preparation mechanism is controlled to immerse the capture rod, which is bound to the capture antibody or the capture antigen, into the test sample solution so as to capture the test antigen or the test antibody in the test sample solution using the capture antibody or the capture antigen on the capture rod; The preparation mechanism is controlled to immerse the capture rod, which captures the antigen or antibody to be tested, into the elution reagent in the second reagent well, so that the antigen or antibody to be tested captured by the capture rod is eluted from the capture rod by the elution reagent to obtain the eluent; The preparation mechanism is controlled to prepare the test solution using the eluent, the labeling reagent, and the signal heuristic reagent.

12. The sample analyzer of any one of claims 1 to 6, wherein, The controller is configured to, when controlling the preparation mechanism to prepare the test solution: The preparation mechanism is controlled to immerse the capture rod sequentially into the sample solution to be tested and the labeling reagent, or the preparation mechanism is controlled to immerse the capture rod into a mixture of the sample solution to be tested and the labeling reagent, so as to capture the target analyte in the sample solution to be tested using the capture rod and the captured target analyte binds to the labeling reagent; The preparation mechanism is controlled to immerse the capture rod, which contains the target analyte and the labeling reagent, into the elution reagent in the second reagent well, so that at least the labeling reagent is eluted from the capture rod to obtain the eluent. The preparation mechanism is controlled to prepare the test solution using the eluent and the signal heuristic reagent.

13. The sample analyzer according to any one of claims 1 to 12, wherein, The target analyte is the antigen to be tested, the labeling reagent is a labeled antibody that is specifically bound to the target analyte, and the capture substance is a capture antibody that is specifically bound to the target analyte or the capture substance is a first ligand substance that is bound to a second ligand substance coupled to the capture antibody. or The target analyte is the antibody to be tested, the labeling reagent is a labeled antigen that is specifically bound to the target analyte, and the capture substance is a capture antigen that is specifically bound to the target analyte or the capture substance is a first ligand substance that is bound to a second ligand substance coupled to the capture antigen. Preferably, the first ligand is streptavidin and the second ligand is biotin.

14. The sample analyzer of any one of claims 1 to 13, wherein, The capture rod is made of plastic, preferably polystyrene.

15. The sample analyzer of any one of claims 3 to 5, wherein, The controller is also configured to: After the preparation mechanism immerses the capture rod in the liquid in the sample well and before removing it, the preparation mechanism drives the capture rod to rotate, preferably eccentrically rotate, in the liquid in the sample well; and / or After the preparation mechanism immerses the capture rod in the liquid in the first reagent orifice and before removing it, the preparation mechanism is controlled to drive the capture rod to rotate, preferably eccentrically rotate, in the liquid in the first reagent orifice; and / or After the preparation mechanism immerses the capture rod in the elution reagent in the second reagent well and before removing it, the preparation mechanism drives the capture rod to rotate, preferably eccentrically rotate, in the liquid in the second reagent well.

16. The sample analyzer according to any one of claims 1 to 15, wherein, The plurality of reagent wells also includes at least one fourth reagent well, in which cleaning solution is pre-placed; The controller is also configured to, prior to the elution, control the preparation mechanism to immerse the capture rod in the cleaning solution in the fourth reagent well and control the preparation mechanism to drive the capture rod to rotate, preferably eccentrically rotate, in the cleaning solution in the fourth reagent well, so as to wash away unbound material on the capture rod.

17. The sample analyzer according to any one of claims 1 to 16, wherein, The reagent strip also includes a measuring orifice separate from the capture rod orifice, in which no liquid is pre-placed; The control of the preparation mechanism to prepare the test solution using at least the eluent and the signal heuristic reagent includes: controlling the preparation mechanism to prepare the test solution in the measurement well using at least the eluent and the signal heuristic reagent, or controlling the preparation mechanism to transfer at least a portion of the test solution into the measurement well after preparing the test solution using at least the eluent and the signal heuristic reagent; and The control of the detection mechanism to detect the test solution includes: controlling the detection mechanism to detect the test solution in the measuring orifice to obtain the content of the target analyte.

18. The sample analyzer of any one of claims 1 to 16, wherein, The control of the preparation mechanism to prepare the test solution using at least the eluent and the signal heuristic reagent includes: controlling the preparation mechanism to prepare the test solution in the capture rod well using at least the eluent and the signal heuristic reagent, or controlling the preparation mechanism to transfer at least a portion of the test solution to the capture rod well after preparing the test solution using at least the eluent and the signal heuristic reagent; and The control of the detection mechanism to detect the test solution includes: controlling the detection mechanism to detect the test solution in the capture rod orifice to obtain the content of the target analyte.

19. The sample analyzer of any one of claims 1 to 18, wherein, The reagent strip storage area is configured to hold multiple reagent strips, each reagent strip being used for one sample solution to be tested, and at least two of the multiple reagent strips corresponding to different test items or the same test item.

20. A sample detection method, comprising: Provide the test sample solution containing the target analyte; A reagent strip is provided, the reagent strip including a capture rod orifice and a plurality of reagent orifices, the plurality of reagent orifices including a first reagent orifice, a second reagent orifice and a third reagent orifice, wherein a capture rod coated with a capture substance is pre-placed in the capture rod orifice, a labeling reagent with a marker is pre-placed in the first reagent orifice, an elution reagent is pre-placed in the second reagent orifice, and a signal induction reagent is pre-placed in the third reagent orifice. A test solution is prepared using the sample solution, the labeling reagent, and the signal heuristic reagent. During preparation, the capture rod is removed from its orifice and used to capture the target analyte or the target analyte and the label. The capture rod is then immersed in the elution reagent in the second reagent well to elute the target analyte and / or the label captured by the capture rod, yielding an eluent. After elution, the capture rod is removed from the second reagent well. The test solution is then prepared using at least the eluent and the signal heuristic reagent. The solution to be tested is analyzed to obtain the content of the target analyte.

21. The method of claim 20, wherein, The method of detecting the test solution to obtain the content of the target analyte includes: performing photodetection on the test solution to obtain the light signal generated by the test solution after luminescence, preferably chemiluminescence, and determining the content of the target analyte based on the intensity of the light signal; Preferably, the intensity of the optical signal is positively correlated with the content of the target analyte; Preferably, the test solution is tested to obtain the content of the target analyte, including: detecting the number of photons generated by the emission of light from the test solution, so as to determine the content of the target analyte based on the number of photons.

22. The method of claim 20 or 21, wherein, The reagent strip further includes a sample well for holding the sample solution to be tested, preferably with a pretreatment solution pre-placed in the sample well; wherein, the step of capturing the target analyte or capturing the target analyte and the label using the capture rod includes: transferring the sample solution to be tested into the sample well; immersing the capture rod into the sample solution to be tested in the sample well so that the capture rod captures the target analyte in the sample solution to be tested, preferably immersing the capture rod into the sample solution to be tested in the sample well only once; removing the capture rod from the sample well; immersing the capture rod into the labeling reagent in the first reagent well so that the labeling reagent binds to the target analyte captured by the capture rod, preferably immersing the capture rod into the labeling reagent in the first reagent well only once; Alternatively, the method of capturing the target analyte or capturing the target analyte and the labeling reagent using the capture rod includes: transferring the test sample solution into the first reagent well so that the target analyte in the test sample solution binds to the labeling reagent to obtain a mixture; immersing the capture rod into the mixture in the first reagent well so that the capture rod captures the target analyte bound to the labeling reagent in the mixture, preferably immersing the capture rod into the mixture in the first reagent well only once.

23. The method of any one of claims 20-22, wherein, In the method, a direct luminescent reagent, preferably acridinium ester, is used as the label, a pre-excitation solution is used as the elution reagent, and an excitation solution that excites the direct luminescent reagent to emit light is used as the signal heuristic reagent. as well as The preparation of the test solution using the sample solution, the labeling reagent, and the signal heuristic reagent includes: The sample solution to be tested is transferred to the first reagent well so that the target analyte in the sample solution to be tested binds with the labeling reagent to obtain a mixture; The capture rod is immersed in the mixture in the first reagent well so that the capture rod captures the target analyte in the mixture that is bound to the labeled reagent; Remove the capture rod from the first reagent well; The capture rod is immersed in the pre-excitation solution in the second reagent well so that at least the direct luminescent reagent is eluted from the capture rod into the pre-excitation solution to obtain the eluent; Remove the capture rod from the second reagent well; The test solution is prepared using the eluent and the activation solution; The method of detecting the test solution to obtain the content of the target analyte includes: after the test solution is prepared, detecting the test solution without immersing the capture rod in the test solution.

24. The sample analyzer according to any one of claims 20 to 22, wherein, The preparation of the test solution using the sample solution, the labeling reagent, and the signal heuristic reagent includes: The capture rod is immersed in the sample solution to capture the target analyte in the sample solution. The capture rod is immersed in the elution reagent in the second reagent well so that the target analyte captured by the capture rod is eluted from the capture rod by the elution reagent to obtain the eluent. The test solution is prepared using the eluent, the labeling reagent, and the signal heuristic reagent.

25. The sample analyzer according to any one of claims 20 to 22, wherein, The preparation of the test solution using the sample solution, the labeling reagent, and the signal heuristic reagent includes: The capture rod is immersed sequentially in the sample solution to be tested and the labeling reagent, or the capture rod is immersed in a mixture of the sample solution to be tested and the labeling reagent, so as to capture the target analyte in the sample solution to be tested using the capture rod and the captured target analyte binds to the labeling reagent; The capture rod is immersed in the elution reagent in the second reagent well so that at least the marker is eluted from the capture rod using the elution reagent to obtain the eluent; The test solution is prepared using the eluent and the signal heuristic reagent.

26. The method according to claim 22, wherein, The preparation of the test solution using the sample solution, the labeling reagent, and the signal heuristic reagent includes: After immersing the capture rod in the liquid of the sample well and before removing it, the capture rod is rotated, preferably eccentrically rotated, in the liquid of the sample well; and / or After immersing the capture rod in the liquid in the first reagent well and before removing it, rotate, preferably eccentrically rotate, the capture rod in the liquid in the first reagent well; and / or After immersing the capture rod in the elution reagent in the second reagent well and before removing it, the capture rod is rotated, preferably eccentrically rotated, in the liquid in the second reagent well.

27. The method according to any one of claims 20 to 26, wherein, The plurality of reagent wells also includes at least one fourth reagent well, in which cleaning solution is pre-placed; The preparation of the test solution using the sample solution, the labeling reagent, and the signal heuristic reagent includes: Prior to elution, the capture rod is immersed in the cleaning solution of the fourth reagent well and rotated, preferably eccentrically rotated, in the cleaning solution of the fourth reagent well to wash away unbound material on the capture rod.

28. The method according to any one of claims 20 to 27, wherein, The reagent strip also includes a measuring orifice separate from the capture rod orifice, in which no liquid is pre-placed; The step of preparing the test solution using at least the eluent and the signal heuristic reagent includes: preparing the test solution in the measurement well using at least the eluent and the signal heuristic reagent, or transferring at least a portion of the test solution into the measurement well after preparing the test solution using at least the eluent and the signal heuristic reagent; and Detecting the test solution to obtain the content of the target analyte includes: detecting the test solution in the measurement well.

29. The method according to any one of claims 20 to 27, wherein, The step of preparing the test solution using at least the eluent and the signal heuristic reagent includes: preparing the test solution in the well of the capture rod using at least the eluent and the signal heuristic reagent, or transferring at least a portion of the test solution into the well of the capture rod after preparing the test solution using at least the eluent and the signal heuristic reagent; and Detecting the test solution to obtain the content of the target analyte includes: detecting the test solution in the well of the capture rod to obtain the content of the target analyte.

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