Reagent strip and sample analyzer

Abstract

A reagent strip and a sample analyzer. The reagent strip comprises: a capture rod, which is coated with a capture agent used for capturing a target analyte in a sample solution to be tested; a label chamber, in which a labeling reagent carrying a label is pre-encapsulated, wherein the labeling reagent can bind to the target analyte; a substrate chamber, in which a signal-generating reagent is pre-encapsulated, wherein the signal-generating reagent can undergo a chemiluminescent reaction with the label to obtain a solution to be tested; and a measurement chamber, in which no liquid is pre-placed, wherein the measurement chamber is used for accommodating at least part of the solution to be tested, such that the solution to be tested in the measurement chamber can be tested by means of an optical signal generated by the chemiluminescent reaction. The test strip and the sample analyzer can improve the testing accuracy.

Description

reagent strips and sample analyzers

[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 test strip and a sample analyzer. 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 related technologies, reagent strips for chemiluminescence-based point-of-care testing (POCT) immunoassay devices include a transparent substrate well at the bottom, in which a substrate solution is pre-encapsulated. The photometric device of the POCT immunoassay device measures the test solution in the substrate well through this transparent bottom. In other words, the substrate well is used not only to contain the substrate solution but also to contain the final test solution for detection by the photometric device. However, this adversely affects the detection accuracy of the photometric device. Summary of the Invention

[0006] Based on this, the objective of this application is to propose a new reagent strip and a sample analyzer that uses the reagent strip, which can improve detection accuracy.

[0007] To achieve the above objectives, the first aspect of this application proposes a reagent strip, comprising:

[0008] A capture rod, said capture rod being coated with a capture agent for capturing the target analyte in the sample solution to be tested;

[0009] The label well contains a labeling reagent pre-encapsulated with a label, the labeling reagent being capable of binding to the target analyte;

[0010] A substrate well, in which a signal-inducing reagent is pre-encapsulated, the signal-inducing reagent reacting with the labeled substance to obtain a test solution; and

[0011] A measuring orifice, in which no liquid is pre-placed and which is used to contain at least a portion of the solution to be tested, thereby enabling the detection of the light signal generated by the chemiluminescence reaction of the solution to be tested in the measuring orifice.

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

[0013] A reagent strip storage area is configured to store at least one reagent strip, the reagent strip including a capture rod, a marker well, a substrate well, and a measurement well; the capture rod is coated with a capture substance, the marker well is pre-encapsulated with a marker reagent, the substrate well is pre-encapsulated with a signal-inducing reagent, and no liquid is pre-placed in the measurement well; wherein, a first segment of the capture rod coated with the capture substance is pre-encapsulated in the measurement well, or the reagent strip further includes a capture rod well independent of the measurement well and the first segment of the capture rod coated with the capture substance is pre-encapsulated in the capture rod well;

[0014] The preparation apparatus is configured to prepare a test solution using a sample solution containing a target analyte, the labeling reagent, and the signal heuristic reagent. During the preparation process, the labeling reagent can bind to the target analyte, and the signal heuristic reagent can undergo a chemiluminescent reaction with the labeling reagent.

[0015] The testing apparatus is configured to detect the light signal generated by the chemiluminescence reaction of the test solution to obtain the content of the target analyte; and

[0016] The controller is configured to be electrically connected to the preparation mechanism and the detection mechanism and is configured to:

[0017] The preparation mechanism is controlled to remove the capture rod from the measuring orifice or the capture rod orifice, and the preparation mechanism is controlled to prepare a conjugate of the labeling reagent and the target analyte using the capture rod;

[0018] The preparation mechanism is controlled to prepare the test solution in the measurement well using at least the portion of the conjugate containing the marker and the signal heuristic reagent, or the preparation mechanism is controlled to transfer at least a portion of the test solution into the measurement well after preparing the test solution using at least the portion of the conjugate containing the marker and the signal heuristic reagent; and

[0019] The detection mechanism is controlled to detect the solution to be tested in the measuring hole.

[0020] In the technical solutions proposed in this application, the reagent strip is used in solid-phase rod-type chemiluminescent immunoassay. The reagent strip includes a capture rod and independent label wells, substrate wells, and measurement wells. The label wells are pre-encapsulated with a labeled reagent, and the substrate wells are pre-encapsulated with a signal-inducing reagent. No liquid is pre-placed in the measurement wells. When using the reagent strip, the measurement wells are used to contain at least a portion of the test solution, enabling the detection of the light signal generated by the chemiluminescent reaction of the test solution in the measurement wells. Through the design of this reagent strip, the amount of liquid transferred is controlled throughout the solid-phase rod-type chemiluminescent immunoassay process, resulting in good detection repeatability and high detection accuracy. Attached Figure Description

[0021] Figure 1 shows a schematic diagram of the structure of the reagent strip according to the first embodiment of this application;

[0022] Figure 2 shows a schematic diagram of the structure of the reagent strip according to a second embodiment of this application;

[0023] Figure 3 shows a schematic diagram of the structure of a capture rod according to some embodiments of this application;

[0024] Figure 4 shows a schematic diagram of the structure of a capture rod according to some other embodiments of this application;

[0025] Figure 5 shows a schematic diagram of the reagent strip according to a third embodiment of this application;

[0026] Figure 6 shows a schematic diagram of the structure of the capture rod according to some other embodiments of this application;

[0027] Figure 7 shows a schematic diagram of the structure of the reagent strip according to the fourth embodiment of this application;

[0028] Figure 8 shows a schematic diagram of the structure of the reagent strip according to the fifth embodiment of this application;

[0029] Figure 9 shows a schematic diagram of the reagent strip according to the sixth embodiment of this application;

[0030] Figures 10 to 12 show schematic diagrams of the structure of a sample analyzer according to some embodiments of this application;

[0031] Figure 13 illustrates a schematic diagram of the process of binding a target analyte with a labeling reagent according to some embodiments of this application;

[0032] Figure 14 shows a schematic diagram of the elution step, chemiluminescence reaction step, and measurement step according to some embodiments of this application;

[0033] Figure 15 shows a schematic diagram of the eccentric rotation path of the capture rod according to some embodiments of this application;

[0034] Figure 16 shows a schematic diagram of a capture rod with an eccentric structure according to some embodiments of this application;

[0035] Figure 17 shows a schematic diagram of a clamping part with an eccentric structure according to some embodiments of this application;

[0036] Figure 18 shows a schematic diagram of the cleaning steps according to some embodiments of this application;

[0037] Figure 19 shows a schematic diagram of the structure of the reagent strip according to the seventh embodiment of this application; and

[0038] Figure 20 shows a schematic diagram of the workflow of a sample analyzer according to some embodiments of this application. Detailed Implementation

[0039] 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.

[0040] 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.

[0041] 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.

[0042] This application provides a reagent strip with an independent measurement well for solid-phase rod chemiluminescence immunoassay and a POCT immunoassay analyzer using the reagent strip. The measurement well is not pre-filled with any liquid, that is, there is no liquid in the measurement well when the reagent strip is not in use.

[0043] As shown in Figure 1, the reagent strip 100 proposed in this embodiment includes a capture rod 110 and a reagent strip body. The capture rod is coated with a capture agent for capturing the target analyte in the sample solution to be tested. Multiple reagent wells are formed on the reagent strip body. Here, the reagent strip 100 is used to pre-load the capture rod 110 and various reagents, providing materials and a space for the required reaction. The reagent wells are pre-loaded with various reagents required for the reaction, including labeling reagents, signal heuristic reagents, etc. The reagents in the wells can be liquid or dry reagents.

[0044] 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.

[0045] The reagent strip 100 has multiple reagent wells, including a label well 120, a substrate well 130, and a measurement well 140. The label well 120 contains a pre-encapsulated labeled reagent that binds to the target analyte. The substrate well 130 contains a pre-encapsulated signal-inducing reagent that reacts with the label to produce a chemiluminescent solution. The measurement well 140 contains no pre-placed liquid and is used to hold at least a portion of the test solution, enabling the detection of the light signal generated by the chemiluminescent reaction of the test solution in the measurement well.

[0046] It should be noted that the binding can be physical adsorption or biochemical reaction, such as the binding of antibody and antigen.

[0047] In some embodiments, the measuring aperture 140 is configured to be at least partially translucent, particularly at least partially transparent, so as to enable the detection of light signals transmitted through the translucent portion of the measuring aperture 140. For example, the translucent portion of the measuring aperture 140 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 140.

[0048] In some embodiments, as shown in FIG1, the capture rod 110 is pre-placed in the measurement port 140, specifically the first rod segment 111 of the capture rod 110, which is covered with the capture material, is pre-encapsulated in the measurement port 140. That is, when the test strip is not in use, the capture rod 110 is placed in the measurement port 140, and when the test strip is used, the capture rod 110 needs to be removed from the measurement port 140, which is then used to contain at least a portion of the test solution.

[0049] In some embodiments, as shown in FIG2, the reagent strip 100 further includes a capture rod hole 150 separate from the measuring hole 140, in which a capture rod 110 is placed, and in particular, a first rod segment 111 of the capture rod 110 coated with the capture material is pre-encapsulated in the capture rod hole 150. In this case, the measuring hole 140 is preferably empty when not in use, and in particular pre-sealed.

[0050] In some embodiments, the target analyte is the test antigen, and the labeling reagent is a labeled antibody that specifically binds to the target analyte. Here, the capture agent is a capture antibody (also known as fully coated) that specifically binds to the test antigen, as shown in Figure 3. Alternatively, the capture agent is a first ligand substance that can bind to a second ligand substance coupled to the capture antibody (also known as partially coated), wherein the capture antibody specifically binds to the test antigen, as shown in Figure 4.

[0051] In other embodiments, the target analyte is the antibody to be tested, and the labeling reagent is a labeled antigen that specifically binds to the antibody to be tested. Here, the capture substance is a capture antigen that specifically binds to the target analyte, as shown in Figure 3. Alternatively, the capture substance is a first ligand that binds to a second ligand coupled to the capture antigen, wherein the capture antigen specifically binds to the antibody to be tested, as shown in Figure 4.

[0052] Furthermore, the first ligand can be streptavidin and the second ligand can be biotin.

[0053] Furthermore, in the case of partial coating of the capture rod, as shown in Figure 5, the multiple reagent wells of the reagent strip 100 may also include capture reagent wells 160, in which capture antibodies or capture antigens coupled with a second ligand substance are pre-encapsulated.

[0054] In some embodiments, the capture rod 110 is made of plastic, such as a polymer like polyethylene, polypropylene, or polystyrene, preferably polystyrene.

[0055] In some embodiments, as shown in FIG6, the capture rod 110 includes an interconnected rod-shaped body and a closed structure 112. The rod-shaped body includes a first rod segment 111 connected to the bottom side of the closed structure. The closed structure 112 is used to openably and closably close the measuring hole 140 or the capture rod hole 150, thereby enclosing the first rod segment 111 in the measuring hole 140 or the capture rod hole 150. That is, the capture rod 110 and the measuring hole 140 or the capture rod hole 150 are tightly pressed together to create a closed space, which is used to protect the first rod segment 111 from the influence of the external environment in the closed space when not in use.

[0056] The preferred design integrates the rod-shaped main body and the closed structure into a single molded structure.

[0057] As shown in Figure 6, one of the hole walls of the measuring hole 140 or the capture rod hole 150 and the closing structure 112 is provided with a positioning recess 100B, and the other is provided with a positioning protrusion 100A. The opening of the positioning recess 100B faces or is away from the rod-shaped body. The positioning recess 100B and the positioning protrusion 100A are fitted together to position the capture rod 110 on the reagent strip body and to place the first rod segment 111 suspended in the measuring hole 140 or the capture rod hole 150.

[0058] The opening of the aforementioned positioning recess 100B faces or faces away from the rod-shaped body. The positioning recess 100B and the positioning protrusion 100A are engaged in the following situations: When the positioning recess 100B is disposed on the wall of the measuring hole 140 or the capturing rod hole 150, the opening of the positioning recess 100B faces the rod-shaped body, and the positioning protrusion 100A is disposed on the closed structure 112. When the positioning recess 100B is disposed on the closed structure 112, the opening of the positioning recess 100B faces away from the rod-shaped body, and the positioning protrusion 100A is disposed on the wall of the measuring hole 140 or the capturing rod hole 150, with the positioning protrusion 100A facing the rod-shaped body.

[0059] The aforementioned engagement of the positioning recess 100B and positioning protrusion 100A means that the positioning protrusion 100A passes through the opening of the positioning recess 100B and extends into the positioning recess 100B. In this way, the positioning recess 100B and the positioning protrusion 100A form a positioning fit in the extension direction of the rod-shaped body, making it difficult for the two to move relative to each other in the extension direction of the rod-shaped body. This achieves the positioning fit between the closed structure 112 and the hole wall of the measuring hole 140 or the capturing rod hole 150 in the extension direction of the rod-shaped body, thereby positioning the capturing rod 110 on the reagent strip body.

[0060] The first rod segment 111 is suspended in the measuring hole 140 or the capture rod hole 150, which means that the first rod segment 111 does not contact the hole wall of the measuring hole 140 or the capture rod hole 150. In this way, the probability of the first rod segment 111 rubbing against the hole wall of the measuring hole 140 or the capture rod hole 150 can be reduced.

[0061] Therefore, by using the structure of the capture rod 110 itself to close the measurement hole 140 or the capture rod hole 150, and by using the engagement of the positioning recess 100B and the positioning protrusion 100A, the capture rod 110 can be positioned. Thus, there is no need to configure an additional outer cover for the reagent strip body to position the capture rod 110. The structure is simple and the operation is convenient.

[0062] Preferably, the positioning recess and positioning protrusion are sealed together to achieve a seal between the closed structure and the wall of the measuring hole 140 or the capture rod hole 150.

[0063] In some embodiments, as shown in FIG6, the reagent strip may further include a seal 122, wherein the sealing structure and the orifice wall of the measuring hole 140 or the capture rod hole 150 are sealed to the seal 122 to achieve a seal between the sealing structure and the orifice wall of the capture rod hole.

[0064] Preferably, the seal and the wall of the measuring hole 140 or the capture rod hole 150 are integrally formed, or the seal and the sealing structure are integrally formed.

[0065] Furthermore, as shown in Figure 6, the rod-shaped body may also include a second rod segment 113 connected to the top side of the closed structure 112. The outer periphery of the second rod segment 113 is provided with a gripping engagement structure 1131 for the gripping part to grasp. Due to the force applied by the gripping part, the gripping engagement structure 1131 makes it less likely for the two to slip in the direction of the applied force, thereby improving the gripping reliability.

[0066] In some embodiments, the gripping and engaging structure 1131 includes a protruding structure that protrudes from the outer peripheral surface of the second rod segment 113. The specific shape of the protruding structure is not limited; for example, it may be an annular shoulder surrounding the outer peripheral surface of the second rod segment 113. The protruding structure may also consist of multiple protrusions arranged at circumferential intervals along the second rod segment 113.

[0067] In other embodiments, the gripping engagement structure 1131 includes one or more slots recessed into the outer peripheral surface of the second rod segment 113.

[0068] In some embodiments, the diameter of the first rod segment 111 is, for example, in the range of 2 to 8 mm, and the length of the capture rod 110 is, for example, in the range of 5 to 50 mm.

[0069] 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.

[0070] In some embodiments, as shown in FIG7, the test strip 100 may further include a sample well 170 for containing the sample solution to be tested. Preferably, the sample well 170 is also used to place a pretreatment solution or is preferably pre-encapsulated in the sample well 170 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, especially whole blood samples.

[0071] In some embodiments, as shown in FIG7, the reagent wells of reagent strip 100 may further include cleaning wells 180, in which cleaning fluid is pre-encapsulated for washing away unbound material on the capture rod. In particular, the cleaning fluid is used to clean the capture rod after it has reacted with the target analyte and the labeled reagent. During the cleaning process, specific binding complexes are retained on the capture rod, while non-specific bindings are washed away.

[0072] Preferably, the reagent strip 100 includes at least two cleaning holes 180, such as two, three or four cleaning holes 180, to thoroughly wash away unbound material on the capture rod.

[0073] In some embodiments, the cleaning fluid is a general cleaning fluid, including a buffer solution and a surfactant.

[0074] In some embodiments, as shown in Figures 1, 2, 5 and 7, the labeling reagent is pre-encapsulated in the labeling orifice 120 in the form of a liquid reagent.

[0075] In some embodiments, as shown in FIG8, the labeling reagent is pre-encapsulated in the label well 120 in the form of a dry reagent. A dry reagent, as opposed to a liquid reagent, refers to a non-liquid reagent; for example, it can be a lyophilized reagent, an air-dried reagent, or a dry reagent obtained by other methods of moisture removal. Compared to liquid reagents, dry reagents can improve reagent stability to a certain extent. In this case, when using the dry reagent in the label well 120, a reconstitution solution needs to be added to the label well 120 to mix with the dry reagent in the label well 120 to obtain a liquid labeling reagent.

[0076] In some embodiments, if the labeling reagent is pre-encapsulated in the labeling hole 120 in the form of a dry reagent, the reagent strip body may further include a desiccant container in which a desiccant is pre-encapsulated, and the desiccant container communicates with the labeling hole 120 so that the desiccant can absorb moisture in the labeling hole 120. For example, the desiccant container and the labeling hole 120 are arranged adjacent to each other, and one or more through holes are provided on the sidewall of the labeling hole 120, the one or more through holes communicating with the desiccant container and the labeling hole 120.

[0077] For example, the desiccant container is located outside the marker hole 120. The first container and the marker hole 120 are arranged adjacent to each other along the length of the reagent strip. A through hole is provided on the sidewall of the marker hole 120. The desiccant particles are contained in the first 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 marker hole 120 are sealed by the same sealing membrane.

[0078] In some preferred embodiments, as shown in FIG9, the labeling reagent is pre-encapsulated in the label well 120 in the form of lyophilized ball reagent.

[0079] In some embodiments, as shown in Figures 8 and 9, the reagent wells of the reagent strip 100 further include a reconstitution well 190, in which a reconstitution solution is pre-encapsulated. This reconstitution solution is used to mix with the dry reagent in the marker well 120 to obtain a liquid marker reagent.

[0080] In some embodiments, as shown in Figures 8 and 9, the plurality of reagent wells of reagent strip 100 may further include elution wells 102, in which elution reagent is pre-encapsulated for eluting target analytes captured by capture rod 110 from capture rod 110, or for eluting markers in a labeling reagent bound to the target analytes captured by capture rod 110 from capture rod 110.

[0081] 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 capable of luminescence under the catalysis of the enzyme label.

[0082] 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.

[0083] It is understood that, in the unused state of reagent strip 100, all reagent wells pre-packaged with reagents are sealed, that is, the marker well 120, substrate well 130, capture reagent well 160 (if present), washing well 180 (if present), reconstitution well 190 (if present), and elution well 102 (if present) of reagent strip 100 are all sealed.

[0084] For example, as shown in Figures 1, 2, 5, and 7-9, all reagent wells pre-packaged 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-sealing aluminum film. When using the reagent strip, the sealing film needs to be punctured to allow liquid to be drawn from or added to the corresponding reagent well.

[0085] Furthermore, when the reagent strip 100 is not in use, as shown in FIG7, the sample well 170 is also sealed, preferably by the sealing film 101.

[0086] Alternatively or additionally, when the reagent strip 100 is in an unused state, as shown in Figures 2, 5, and 7-9, the measuring port 140 is also sealed, preferably by a sealing membrane 101. Preferably, the sealed measuring port 140 is empty.

[0087] In other embodiments, all reagent wells pre-encapsulated with reagents may also be sealed by other means, such as by using a sealing cap.

[0088] In some embodiments, the individual holes of the reagent strip may have a circular or rectangular, especially square, cross-section. For example, the substrate hole and measuring hole may have a circular cross-section, while the marker hole may have a rectangular, especially square, cross-section. However, the embodiments of this application are not limited to this; for example, all holes of the reagent strip may have a circular or rectangular, especially square, cross-section.

[0089] In some embodiments, the reagent strip 100 may be made of a polymer such as polyethylene, polypropylene, or polystyrene.

[0090] This application also provides a sample analyzer, particularly a POCT immunoassay analyzer. As shown in Figures 10 to 12, the sample analyzer includes a reagent strip storage area 200, a preparation mechanism 300, a detection mechanism 400, and a controller 500.

[0091] In this application, whole blood samples are used as an example for description. However, this application is 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.

[0092] According to an embodiment of this application, the reagent strip storage area 200 is configured to hold at least one reagent strip 100. The reagent strip 100 includes a capture rod 110 and a reagent strip body, on which a marker hole 120, a substrate hole 130, and a measurement hole 140 are formed. The capture rod 110 is coated with a capture substance, a marker reagent with a marker is pre-encapsulated in the marker hole 120, a signal-inducing reagent is pre-encapsulated in the substrate hole 130, and no liquid is pre-placed in the measurement hole 140. In some examples, a first segment 111 of the capture rod 110 coated with the capture substance is pre-encapsulated in the measurement hole 140. In other examples, as shown in Figures 10 and 11, the reagent strip also includes a capture rod hole 150 independent of the measurement hole 140, and the first segment 111 of the capture rod coated with the capture substance 110 is pre-encapsulated in the capture rod hole 150.

[0093] Further embodiments and advantages of reagent strip 100 can be found in the above description and will not be repeated here.

[0094] In some embodiments, the test strip storage area 200 is configured to hold a plurality of test strips 100, each test strip 100 for one sample solution to be tested. At least two of the plurality of test strips correspond to different detection items or the same detection item. That is, one test strip 100 is used for one detection item of one sample solution to be tested.

[0095] 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 200, which is configured to schedule the reagent strips to be used to the corresponding work positions so that the preparation mechanism 300 and the detection mechanism 400 can perform corresponding operations on them.

[0096] According to an embodiment of this application, the preparation mechanism 300 is configured to prepare a test solution using a sample solution containing a target analyte, a labeling reagent in the label well 120, and a signal-inducing reagent in the substrate well 130. During the preparation process, the labeling reagent can bind to the target analyte, and the signal-inducing reagent can undergo a chemiluminescent reaction with the label to generate a light signal. The intensity of this light signal is related to the concentration of the target analyte in the sample.

[0097] Here, the binding of the labeled reagent to the target analyte and / or the chemiluminescent reaction of the signal-inspired reagent with the labeled reagent occurs in at least one well in the reagent strip. For example, the binding of the labeled reagent to the target analyte occurs in the labeled well 120. As another example, the chemiluminescent reaction of the signal-inspired reagent with the labeled reagent occurs in the capture rod well 150, the substrate well 130, or the measurement well 140, preferably in the measurement well 140.

[0098] In some embodiments, as shown in FIG10, the preparation mechanism 300 includes a motion device 310 for removing the capture rod 110 from the capture rod hole 150 and driving the removed capture rod 110 to move relative to the reagent strip 100. The motion device 310 may include a clamping part 311, an opening and closing drive part 312, a first horizontal drive part (not shown), and a first vertical drive part 313. The clamping part 311 includes grippers for clamping the capture rod 110, especially its second rod segment 112. The opening and closing drive part 312 is used to drive the grippers of the clamping part 311 to open and close so as to grasp the capture rod 110. The first horizontal drive part, such as a first horizontal drive motor, is used to drive the clamping part 311 to move relative to the reagent strip 100 horizontally so that the capture rod 110 clamped by the clamping part 311 is positioned above the corresponding hole of the reagent strip 100. The first vertical drive unit 313, such as the first vertical drive motor, is used to drive the clamping unit 311 to move vertically relative to the reagent strip 100 so that the capture rod 110 held by the clamping unit 311 can enter and exit the corresponding hole of the reagent strip 100 in the vertical direction.

[0099] As one implementation, the first horizontal drive unit can be used to drive the clamping unit 311 to move horizontally, so that the clamping unit 311 can move the clamped capture rod 110 above the corresponding hole of the reagent strip 100.

[0100] In some other implementations, the first horizontal drive unit can drive the reagent strip 100 to move horizontally, so that the corresponding hole of the reagent strip 100 can move to below the capture rod 110 held by the clamping unit 311.

[0101] As one implementation, as shown in Figure 10, the first vertical drive unit 313 can be used to drive the clamping unit 311 to move vertically, so that the clamping unit 311 can drive the clamped capture rod 110 to enter and exit the corresponding hole of the reagent strip 100 in the vertical direction.

[0102] As in some other implementations not shown, the first vertical drive unit can also be used to drive the reagent strip 100 to move vertically, so that the capture rod 110 held by the clamping unit 311 can enter and exit the corresponding hole of the reagent strip 100 in the vertical direction.

[0103] In some embodiments, the motion device 310 may further include a rotation drive 314, such as a rotation drive motor, for driving the clamping part 311 to rotate, so that the clamping part 311 can drive the clamped capture rod 110 to rotate in the corresponding hole of the reagent strip 100.

[0104] In some embodiments, as shown in FIG11, the preparation mechanism 300 includes a dispensing device 320 for transferring liquid during the preparation of the test solution, for example for transferring the test sample liquid to the marker well 120.

[0105] As some implementations, the dispensing device 320 may include a dispensing tube 321, a dispensing pump 322, and a dispensing drive unit 323. The dispensing tube 321 is configured as a dispensing needle or can be connected to a pipette tip 324 to draw or discharge liquid to be transferred. The dispensing pump 322 is used to provide negative or positive pressure to the dispensing tube 321 to draw or discharge liquid to be transferred. The dispensing drive unit 323 is used to drive the dispensing pump 322 to provide negative or positive pressure.

[0106] In some examples, the reagent strip 100 may also encapsulate a pipette tip 324, for example, the reagent strip 100 may also include a pipette tip orifice in which a pipette tip 324 is pre-positioned. The dispensing tube 321 of the dispensing device 320 may be connected to the pipette tip 324 in the reagent strip 100, through which the liquid to be transferred is drawn and added to the corresponding orifice of the reagent strip 100. After the pipetting operation is completed, the pipette tip 324 can be unloaded into the pipette tip orifice. For example, different pipette tips may be used when transferring different liquids.

[0107] Of course, this is not the only possibility. For example, in other examples, the dispensing device 320 can draw the liquid to be transferred through the dispensing needle and add the drawn liquid into the corresponding hole of the reagent strip 100, after which the dispensing needle is cleaned. For example, the dispensing needle is cleaned after transferring one liquid so that it can be used to transfer another liquid in the future.

[0108] Furthermore, in the embodiment shown in FIG2, the dispensing device 320 may further include a second vertical drive unit 325 for driving the dispensing tube 321 to move vertically, so that the dispensing tube 321 can enter and exit the corresponding hole of the reagent strip 100 in the vertical direction, so as to draw liquid from the hole or discharge the drawn liquid into the hole.

[0109] In some embodiments, the first horizontal drive unit can drive the reagent strip 100 to move horizontally, so that the corresponding hole of the reagent strip 100 can move to below the capture rod 110 held by the clamping unit 311 or to below the dispensing tube 321.

[0110] In some embodiments, the preparation mechanism 300 includes a membrane-breaking device (not shown) or the dispensing device 320 integrates a membrane-breaking structure for piercing the sealing membrane 101 when using the reagent strip, or the preparation mechanism 300 includes a cap-opening device (not shown) for opening the sealing cap of the reagent strip.

[0111] According to an embodiment of this application, the detection unit 400 is configured to detect the light signal generated by the chemiluminescence reaction of the test solution prepared by the preparation unit 300, in order to obtain the content of the target analyte, i.e., to determine the content of the target analyte based on the intensity of the light signal. Here, the intensity of the light signal is positively correlated with the content of the target analyte.

[0112] As one implementation, as shown in Figure 12, the detection mechanism 400 includes a photometer 410, 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.

[0113] Furthermore, an optical lens 420 is provided before the photometer 410, and the photons generated by the emission of the solution to be tested enter the photometer 410 through the optical lens 420.

[0114] Furthermore, the testing apparatus 400 also includes a darkroom 430, in which a photometer 410 and an optical lens 420 are arranged. The darkroom 430 has an openable door 440, through which the reagent strip 100 can be fed into the darkroom 430 to complete photometry within the darkroom 430.

[0115] According to an embodiment of this application, the controller 500 is configured to be electrically connected to the preparation mechanism 300 and the detection mechanism 400 so as to control the preparation mechanism 300 to prepare the test solution and control the detection mechanism 400 to detect the test solution.

[0116] As some implementations, controller 500 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 test solution preparation and detection, which are further described below.

[0117] 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.

[0118] 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.

[0119] Furthermore, the controller 500 may also include a communication interface that communicates with the processor and 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.

[0120] According to an embodiment of this application, the controller 500 is configured to: control the preparation mechanism 300, particularly its motion device 310, to remove the capture rod 110 from the measurement hole 140 or the capture rod hole 150; control the preparation mechanism 300 to prepare a conjugate of a labeled reagent and a target analyte using the capture rod 110; control the preparation mechanism 300 to prepare a test solution in the measurement hole 140 using at least the labeled portion of the conjugate and a signal heuristic reagent, or control the preparation mechanism 300 to transfer at least a portion of the test solution to the measurement hole 140 after preparing the test solution using at least the labeled portion of the conjugate and a signal heuristic reagent; and control the detection mechanism 400 to detect the test solution in the measurement hole 140.

[0121] In some embodiments, the reagent strip 100 may further include a sample well 170 for holding the sample solution to be tested, preferably pre-encapsulated with a pretreatment solution in the sample well. Here, the control preparation mechanism 300 for preparing the combination of the labeled reagent and the target analyte using a capture rod may include:

[0122] The preparation mechanism 300, and in particular its dispensing device 320, controls the transfer (e.g., from the sample container) of the test sample solution (e.g., raw test whole blood or pretreated test whole blood) into the sample well 170, for example, to pretreat, e.g., pre-dilute the test sample solution in the sample well 170.

[0123] The preparation mechanism 300, especially the motion control device 310, immerses the capture rod 110 into the sample liquid to be tested in the sample well 170, especially by completely or partially immersing the first section 111 of the capture rod 110 into the sample liquid to be tested, so that the capture rod 110 captures the target analyte in the sample liquid to be tested.

[0124] The preparation mechanism 300, and especially its motion control device 310, removes the capture rod 110 from the sample orifice 170; and

[0125] The preparation mechanism 300, and especially its motion control device 310, immerses the capture rod 110 into the labeling reagent in the labeling orifice 120, and in particular, completely or partially immerses the first segment 111 of the capture rod 110 into the labeling reagent, so that the labeling reagent and the captured target analyte form a complex on the capture rod, so that the captured analyte, the target analyte, and the labeling reagent form a specifically bound complex, especially an immune complex, on the capture rod, as shown in Figure 13.

[0126] It should be understood that if the labeling reagent is pre-encapsulated in the labeling well 120 as a liquid reagent, the controller 500 can control the preparation mechanism 300 to directly immerse the capture rod 110 into the liquid labeling reagent. However, if the labeling reagent is pre-encapsulated in the labeling well 120 as a dry reagent, when using the dry reagent in the labeling well 120, the controller 500 first controls the preparation mechanism 300 to add a reconstitution solution to the labeling well 120, for example, by drawing a reconstitution solution from the reconstitution solution well 190 and discharging it into the labeling well 120, thus converting the dry reagent in the labeling well 120 into a liquid labeling reagent; then, the controller 500 can control the preparation mechanism 300 to immerse the capture rod 110 into the liquid labeling reagent. This also applies to signal-inspired reagents.

[0127] In other embodiments, the reagent strip 100 may include a sample well 170 or may not have a sample well 170. Here, the control preparation mechanism 400, by means of the capture rod 110, prepares the combination of the labeled reagent and the target analyte, which may include:

[0128] The preparation mechanism 300, particularly its dispensing device 320, controls the transfer of the test sample solution, such as pretreated whole blood, to the labeling well 120, for example, from the sample well 170 or other sample container, so that the labeling reagent binds to the target analyte in the test sample solution, resulting in a mixture containing the binder in the labeling well 120; and

[0129] The preparation mechanism 300, especially the motion control device 310, immerses the capture rod 110 into the mixture in the labeling well 120 so that the capture rod 110 captures the target analyte in the conjugate, thereby attaching the conjugate to the capture rod 110, so that the capture analyte, the target analyte, and the labeling reagent form a specifically bound complex, especially an immune complex, on the capture rod, as shown in Figure 13.

[0130] It should be understood that if the labeled reagent is pre-encapsulated in the labeled well 120 in liquid form, the controller 500 can control the preparation mechanism 300 to directly transfer the sample solution to be tested into the labeled well 120. However, if the labeled reagent is pre-encapsulated in the labeled well 120 in dry form, the controller 500 controls the preparation mechanism 300 to add a reconstitution solution to the labeled well 120 before controlling the preparation mechanism 300 to transfer the sample solution to be tested into the labeled well 120, for example, by drawing a reconstitution solution from the reconstitution solution well 190 and discharging it into the labeled well 120, thereby converting the dry reagent in the labeled well 120 into a liquid labeled reagent.

[0131] In some embodiments, the controller 500 is configured to control the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod 110 in the liquid in the sample well 170 and / or the marker well 120 only once. For example, the controller 500 controls the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod 110 in the sample solution in the sample well 170 only once and to immerse the capture rod 110 in the labeling reagent in the marker well 120 only once, or the controller 500 controls the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod 110 in the mixture in the marker well 120 only once.

[0132] In some embodiments, the target analyte is a test antigen, the labeling reagent is a labeled antibody with a label that specifically binds to the test antigen, and the capture substance is a capture antibody that specifically binds to the test antigen; or the target analyte is a test antibody, the labeling reagent is a labeled antigen with a label that specifically binds to the test antibody, and the capture substance is a capture antigen that specifically binds to the test antibody. That is, the capture rod 110 is completely coated. Here, the preparation mechanism 300, by means of the capture rod 110, prepares the conjugate of the labeling reagent and the target analyte, which may include:

[0133] The preparation mechanism 300, especially its motion device 310, is controlled to sequentially immerse the capture rod 110 in the sample solution to be tested and the labeling reagent (for example, the motion device 310 is controlled to immerse the capture rod 110 in the sample solution to be tested in the sample well 170, then the motion device 310 is controlled to remove the capture rod 110 from the sample well 170, and then the motion device 310 is controlled to immerse the capture rod 110 in the labeling reagent in the labeling well 120) or the preparation mechanism 300, especially its motion device 310, is controlled to capture the rod 110. The sample is immersed in a mixture of the test sample solution and the labeling reagent (e.g., the dispensing device 320 transfers the test sample solution into the labeling well 120, and then the motion device 310 immerses the capture rod 110 into the mixture in the labeling well 120), so that the target analyte is captured by the capture antibody or capture antigen on the capture rod 110 and the labeling reagent forms a conjugate with the captured target analyte on the capture rod, so that the capture, the target analyte, and the labeling reagent form a specifically bound immune complex on the capture rod, as shown in Figure 13.

[0134] In other embodiments, the capture rod 110 is partially coated. The target analyte is the test antigen, the labeling reagent is a labeled antibody with a label that specifically binds to the test antigen, and the capture substance is a first ligand that binds to a second ligand coupled to the capture antibody, wherein the capture antibody specifically binds to the test antigen; or the target analyte is the test antibody, the labeling reagent is a labeled antigen with a label that specifically binds to the test antibody, and the capture substance is a first ligand that binds to a second ligand coupled to the capture antigen, wherein the capture antigen specifically binds to the test antibody.

[0135] As one implementation, with the capture rod 110 partially coated, controlling the preparation mechanism 300 to prepare the conjugate of the labeled reagent and the target analyte using the capture rod 110 may include:

[0136] The preparation mechanism 300, particularly its motion control device 310, immerses the capture rod 110 into the capture antibody or capture antigen coupled with the second ligand substance, so that the capture antibody or capture antigen coupled with the second ligand substance is attached to the capture rod; and

[0137] The preparation mechanism 300, especially the motion control device 310, immerses the capture rod connected to the capture antibody or capture antigen into the test sample solution and the labeling reagent in sequence, or the preparation mechanism 300, especially the motion control device 310, immerses the capture rod connected to the capture antibody or capture antigen into the mixture of the test sample solution and the labeling reagent, so that the capture antibody or capture antigen of the capture rod captures the target analyte in the test sample solution and the labeling reagent forms a conjugate with the captured target analyte on the capture rod.

[0138] For example, if the reagent strip 100 includes the aforementioned capture reagent well 160, then the control preparation mechanism 300 may immerse the capture rod 110 into the capture antibody or capture antigen coupled with the second ligand substance in the capture reagent well 160 after removing the capture rod 110 from the measuring well 140 or the capture rod well 150.

[0139] As other implementations, in the case where the capture rod 110 is partially coated, the preparation mechanism 300 may prepare a conjugate of the labeled reagent and the target analyte using the capture rod 110, which may also include:

[0140] The preparation mechanism 300, and especially its motion control device 310, immerses the capture rod 110 in a mixture of capture antibody or capture antigen coupled with a second ligand substance, the sample solution to be tested, and the labeling reagent, so as to capture the conjugate formed by the capture antibody or capture antigen coupled with the second ligand substance, the sample solution to be tested, and the labeling reagent using the first ligand substance on the capture rod 110.

[0141] For example, when the capture rod 110 is partially coated, the controller 500 controls the preparation mechanism 300, especially its dispensing device 320, to transfer the test sample solution and the capture antibody or capture antigen coupled with the second ligand substance to the label well 120, so that the test antigen, the capture antibody coupled with the second ligand substance, and the label antibody in the test sample solution can react immunely 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 label antigen in the test sample solution can react immunely to form an immune complex of "capture antigen-test antibody-labeled antigen". Then, the preparation mechanism 300, especially its motion device, is controlled to immerse the removed capture rod 110 into the mixture containing the immune complex in the label well 120 so that the capture rod 110 can capture the immune complex.

[0142] In some embodiments, after a conjugate is formed or attached to the capture rod 100, the controller 500 can control the preparation mechanism 300 to elute at least the marker in the conjugate from the capture rod 110 using an elution reagent, such as the elution reagent in the elution well 102, to form an eluent. Then, the controller 500 controls the preparation mechanism 300 to prepare a test solution using the eluent and a signal heuristic reagent. That is, preparing a test solution using at least the marker-containing portion of the conjugate and a signal heuristic reagent includes: controlling the preparation mechanism 300 to elute at least the marker from the capture rod with the conjugate attached using an elution reagent to obtain an eluent; and controlling the preparation mechanism 300 to prepare a test solution using the eluent and a signal heuristic reagent.

[0143] For example, the controller 500 is configured to control the preparation mechanism 300, particularly its motion device 310, to remove the capture rod 110 from the measuring orifice 140 or the capture rod orifice 150; to control the preparation mechanism 300 to capture the target analyte and the marker using the removed capture rod 110; and to control the preparation mechanism 300 to immerse the captured capture rod 110 in the elution reagent in the elution orifice 102, particularly ensuring that the first segment 111 of the capture rod 110 is completely submerged in the elution reagent, so as to use the elution reagent to remove at least the marker. The analyte is eluted from the capture rod 110 to obtain an eluent; after elution, the control preparation mechanism 300 removes the capture rod 110 from the elution well 102; then, the control preparation mechanism 300 prepares the test solution using at least the eluent and the signal heuristic reagent in the substrate well 130; and the control detection mechanism 400 detects the test solution to obtain the content of the target analyte, especially after the test solution is prepared, the control detection mechanism 400 detects the test solution without immersing the capture rod 110 in the test solution.

[0144] Here, the elution reagent is used to elute at least a portion of the labeled portion of the conjugate obtained by binding the target analyte and the labeled reagent on the capture rod from the capture rod.

[0145] Therefore, after eluting at least the marker from the capture rod 110 to obtain the eluent, the eluent and signal heuristic reagent can be quantitatively aspirated to prepare the test solution, making the detection more accurate. Furthermore, since the capture rod can be removed from the test solution during detection, it avoids interfering with the detection of the detection mechanism 400.

[0146] In some embodiments, the sample analyzer is based on a direct chemiluminescence system, i.e., the marker is a direct luminescent reagent, preferably acridinium ester, the signal heuristic reagent is an excitation liquid that can excite the direct luminescent reagent to emit light, and the reagent strip also includes a pre-excitation well, i.e., an elution well 102, pre-encapsulated with a pre-excitation liquid (i.e., an elution reagent).

[0147] As one implementation, as shown in Figure 14, the control preparation mechanism 300 prepares the test solution in the measurement well 140 using at least the labeled portion of the conjugate and a signal-inducing reagent. This includes: controlling the preparation mechanism 300, and in particular controlling its motion device 310, to immerse the capture rod 110 connected to the conjugate into the pre-excitation liquid in the pre-excitation well, i.e., the elution well 102, especially to completely immerse the first rod segment 111 of the capture rod 110 in the pre-excitation liquid, so as to elute at least the labeled portion of the conjugate from the capture rod 110 into the pre-excitation liquid, thereby obtaining an eluent; controlling the preparation mechanism 300, and in particular controlling its dispensing device 320, to transfer at least a portion of the eluent in the elution well 102 into the measurement well 140; and controlling the preparation mechanism 300 to transfer at least a portion of the excitation liquid in the substrate well 130 into the measurement well 140, thereby preparing the test solution in the measurement well 140.

[0148] Optionally, the controller 500 can control the preparation mechanism 300, especially its motion device 310, to immerse the captured rod 110, which has completed capture, into the pre-excitation liquid in the elution well 102 for 10 to 100 seconds. At this time, the captured rod 110 can be statically immersed in the pre-excitation liquid.

[0149] In a specific illustrative process, controller 500 is configured as follows:

[0150] The preparation mechanism 300, especially its dispensing device 320, transfers the sample solution to be tested into the label well 120 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.

[0151] The preparation mechanism 300, especially its motion device 310, immerses the capture rod 110, for example, fully or partially immerses its first rod segment into the mixture in the marker orifice 120, so that the capture rod captures the target analyte in the mixture that is bound to the labeling reagent.

[0152] The control preparation mechanism 300, especially its motion device 310, removes the capture rod 110 from the marker hole 120;

[0153] The preparation mechanism 300, especially its motion device 310, immerses the capture rod 110, especially its first rod segment, into the pre-excitation liquid in the elution well 102, so as to elute at least the direct luminescent reagent from the capture rod 110 into the pre-excitation liquid to obtain the eluent.

[0154] The control mechanism 300, especially its motion device 310, removes the capture rod 110 from the elution port 102; and

[0155] The preparation mechanism 300, and especially its dispensing device 320, controls the transfer of at least a portion of the eluent in the elution well 102 and at least a portion of the excitation liquid in the substrate well 130 into the measurement well 140 to prepare the test solution in the measurement well 140.

[0156] Since a light signal is generated the instant the excitation liquid and the pre-excitation liquid come into contact, the detection mechanism 400 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 400 begins to collect the generated light signal the instant the excitation liquid and the pre-excitation liquid come into contact.

[0157] For example, as shown in Figure 12, after the preparation mechanism 300, particularly its dispensing device 320, transfers at least a portion of the eluent from the elution well 102 to the measurement well 140, the reagent strip 100 is fed into the darkroom 430 through the movable door 440, and then the movable door 440 is closed. The dispensing device 320 of the preparation mechanism 300 also includes a pipette pump disposed within the darkroom 430, which transfers at least a portion of the excitation solution from the substrate well 130 to the measurement well 140, while photometry is performed by the photometer 410.

[0158] In some other implementations, the control preparation mechanism 300 uses at least the labeled portion of the conjugate and a signal-inducing reagent to prepare a test solution in the measurement well 140, including: the control preparation mechanism 300, in particular its motion control device 310, drives the capture rod 110 connected to the conjugate into the empty measurement well 140; then the control preparation mechanism 300, in particular its dispensing device 320, successively transfers at least a portion of the pre-excitation liquid in the elution well 102 and at least a portion of the excitation liquid in the substrate well 130 into the measurement well 140 to prepare the test solution in the measurement well 140.

[0159] In some other implementations, after the preparation mechanism 300 prepares the test solution using at least the labeled portion of the conjugate and a signal heuristic reagent, it transfers at least a portion of the test solution to the measurement well 140. This includes: the preparation mechanism 300 immersing a capture rod attached to the conjugate into a pre-excitation solution in a pre-excitation well, i.e., an elution well 102, to elute at least the labeled portion of the conjugate from the capture rod into the pre-excitation solution, obtaining an eluent; the preparation mechanism 300 transferring at least a portion of the eluent to a substrate well 130 or transferring at least a portion of the excitation solution in the substrate well 130 to a pre-excitation well, i.e., an elution well 102, to prepare the test solution; and the preparation mechanism 300 transferring at least a portion of the test solution to the measurement well 140.

[0160] In some embodiments, the reagent strip 100 does not have an elution well 102; instead, the sample analyzer also includes a reagent container for containing elution reagents, which is independent of the reagent strip 100. In this case, the controller 500 controls the preparation mechanism 300 to draw pre-excitation liquid from the reagent container and use the drawn pre-excitation liquid to elute at least the marker from the capture rod into the pre-excitation liquid, obtaining an eluent.

[0161] In some alternative embodiments, the sample analyzer is based on an indirect chemiluminescence system, i.e., 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 500 is configured to: control the preparation mechanism 300 to capture the target analyte and the enzyme label using the retrieved capture rod; control the preparation mechanism 300 to immerse the captured capture rod 110 into the elution reagent in the elution well 102, especially to completely immerse the first segment 111 of the capture rod 110 into the elution reagent, so as to elute at least the enzyme label from the capture rod into the elution reagent, obtaining an eluent; then control the preparation mechanism 300 to prepare the test solution using the eluent in the elution well 102 and the substrate solution in the substrate well 130.

[0162] In other embodiments, after a conjugate is formed or attached to the capture rod 100, the controller 500 can control the preparation mechanism 300 to prepare the test solution using the capture rod 110 with the conjugate attached and the signal heuristic reagent.

[0163] For example, in an indirect chemiluminescence system, after the preparation mechanism 300 prepares the test solution using at least the labeled portion of the conjugate and a signal-inducing reagent, it transfers at least a portion of the test solution into the measurement well. This includes: the preparation mechanism 300 immersing the capture rod 110 connected to the conjugate into the substrate liquid in the substrate well 130 to prepare the test solution, and the preparation mechanism 300 transferring at least a portion of the test solution in the substrate well into the measurement well 140.

[0164] In other alternative embodiments, the target analyte may be captured first using the capture rod 110, and then eluted with an elution reagent to obtain an eluent. The eluent and a labeling reagent are then used to obtain a conjugate. In other words, the preparation mechanism 300 prepares the conjugate of the labeling reagent and the target analyte using the capture rod 110, including:

[0165] The control preparation mechanism 300 immerses the capture rod 110 into the sample solution to be tested, especially by completely or partially immersing the first section of the capture rod 110 into the sample solution to be tested, so as to capture the target analyte in the sample solution using the capture rod 110.

[0166] The control preparation mechanism uses elution reagents to elute the target analyte captured by the capture rod 110 from the capture rod, obtaining an eluent; and

[0167] The control preparation mechanism mixes the labeling reagent with the eluent, so that the labeling reagent forms a complex with the target analyte in the eluent.

[0168] Therefore, after eluting the target analyte from the capture rod 110 to obtain the eluent, the eluent and signal heuristic reagent can be quantitatively aspirated to prepare the test solution, making the detection more accurate. Furthermore, since the capture rod can be removed from the test solution during detection, it avoids interfering with the detection mechanism 400.

[0169] In some embodiments, when the test strip 100 includes a sample well 170, the controller 500 controls the preparation mechanism 300 to immerse the capture rod 110 into the sample solution to be tested. This may include: controlling the preparation mechanism 300, for example, controlling the dispensing device 320 to transfer (e.g., from the sample container) the sample solution to be tested (e.g., raw whole blood or pretreated whole blood) into the sample well 170 so as to pretreat, for example, the sample solution to be tested in the sample well 170; and controlling the preparation mechanism 300, for example, controlling the motion device 310 to move the capture rod 110 into the sample well 170 until the capture rod 110 is immersed in the sample solution to be tested in the sample well 170.

[0170] In other embodiments, the test strip 100 may also be without the sample well 170, and the test sample solution may be pretreated in a sample container separate from the test strip. The controller 500 may control the preparation mechanism 300 to immerse the capture rod 110 into the test sample solution in the sample container.

[0171] In some embodiments, when the capture rod 110 is fully coated, i.e., when the capture rod 110 is coated with capture antibody or capture antigen, the controller 500 controls the preparation mechanism 300 to immerse the capture rod 110 into the sample solution to be tested. This may include controlling the preparation mechanism 300 to directly immerse the captured rod 110 into the sample solution to be tested after removing it from the capture rod hole 150 after the measurement hole 140, particularly directly into the sample solution to be tested in the sample hole 170.

[0172] In other embodiments, when the capture rod 110 is partially coated, i.e., the controller 500 controls the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod 131 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; then, the controller 500 controls the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod bound with the 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.

[0173] For example, if the test strip 100 also includes the sample well 170 and the capture reagent well as described above, the controller 500 controls the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod 110 coated with the first ligand substance into the capture antibody or capture antigen coupled with the second ligand substance in the capture reagent well; controls the preparation mechanism 300, for example, controls the dispensing device 320 to transfer the test sample solution, for example, whole blood sample (e.g., from the sample container) into the sample well 170 so as to pre-treat, for example, pre-dilute the test sample solution in the sample well 170; then controls the preparation mechanism 300, in particular its motion device 310, to immerse the capture rod 110 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.

[0174] Here, the elution reagent is specifically used to elute the capture antibody or capture antigen on the capture rod 110, thereby eluting the test antigen bound to the capture antibody or the test antibody bound to the capture antigen.

[0175] In some embodiments, the controller 500 is further configured to control the preparation mechanism 300 to drive the capture rod 110 to rotate in the liquid in the corresponding well after the preparation mechanism 300 has immersed the capture rod 110 into the liquid in the sample well or reagent well and before the capture rod 110 has been removed.

[0176] In particular, the preparation mechanism 300 is controlled to drive the capture rod 110 to rotate in the liquid in the corresponding hole so that the capture rod 110 does not contact the inner wall of the hole when rotating in the liquid, thus avoiding damage to the first rod segment.

[0177] In some examples, the controller 500 is also configured to: after the preparation mechanism 300 immerses the capture rod 110 in the liquid in the sample well 170, i.e., the sample solution to be tested, and before removing it, drive the capture rod 110 to rotate, preferably eccentrically rotate, in the liquid in the sample well 170. This enables the capture rod 110 to fully capture the target analyte in the sample solution to be tested.

[0178] Alternatively or additionally, the controller 500 is also configured to: after the preparation mechanism 300 has immersed the capture rod 110 into the labeling reagent or mixture in the labeling well 120 and before removing it, drive the capture rod 100 to rotate, preferably eccentrically rotate, in the labeling reagent or mixture in the labeling well 120, for example, at a speed of 1 to 50 rpm for 1 to 30 minutes, so that the labeling reagent forms a conjugate with the captured target analyte on the capture rod, or so that the capture rod captures the target analyte in the conjugate, thereby attaching the conjugate to the capture rod. This promotes the immune reaction between the target analyte and the labeling reagent, improving the efficiency of the immune reaction.

[0179] Alternatively or additionally, the controller 500 is also configured to: after the control preparation mechanism 300 immerses the capture rod 110 in the elution reagent in the elution well 102 and before removing it, drive the capture rod 110 to rotate, preferably eccentrically rotate, in the liquid, i.e., the elution solution, in the elution well 102. This enhances the elution effect.

[0180] In the embodiments of this application, eccentric rotation means that the rotation axis of the capture rod 110 is at least deviated from the central axis of the first segment 111 of the capture rod 110, or in other words, the rotation axis of the capture rod 110 is parallel to but does not coincide with the central axis of the first segment 111 of the capture rod 110.

[0181] In some embodiments, as shown in FIG10, the motion device 310 includes a rotation drive 314 for driving the clamping part 311 to rotate, such that the clamping part 311 can drive the clamped capture rod 110 to rotate around the rotation axis in the corresponding hole of the reagent strip 100, especially to rotate eccentrically, as shown in FIG15.

[0182] For example, the clamping part 311 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 grip the second rod section 113 of the capture rod 110. One end of the rotary drive section is connected to the gripper section and the other end is connected to the rotary drive part 314, such as a rotary motor.

[0183] In some examples, as shown in Figure 16, the capture rod 110 includes an eccentric structure, meaning that the central axis of the first rod segment is offset from the central axis of the second rod segment, i.e., the central axes of the first and second rod segments do not coincide. Here, the central axis of the gripper section of the clamping part 311 is preferably coaxial with the central axis of the rotary drive section. When the gripper section clamps the capture rod 110, the central axis of the second rod segment 113 is coaxial with the central axis of the gripper section, and the rotary drive part 314 drives the clamping part 311 to rotate around the central axis of the rotary drive section, thereby causing at least the first rod segment of the capture rod 110 to rotate eccentrically within the hole.

[0184] In other examples, as shown in FIG17, the clamping part 311 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 first segment of the capture rod 110 is preferably coaxial with the central axis of the second segment. When the gripper section clamps the capture rod 110, the central axis of the gripper section is coaxial with the central axis of the first segment, and the rotary drive part 314 drives the clamping part 311 to rotate around the central axis of the rotary drive section, thereby causing at least the first segment of the capture rod 110 to rotate eccentrically in the hole.

[0185] In some embodiments, the distance between the central axis of the first rod segment 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.

[0186] In some embodiments, as shown in FIG18, where the reagent holes of the reagent strip 100 also include at least one cleaning hole 180 pre-filled with cleaning solution, the control preparation mechanism 300 prepares the conjugate of the labeled reagent and the target analyte by means of the capture rod 110, and further includes: the control preparation mechanism 300 immersing the capture rod 110 with the conjugate attached into, in particular, completely immersing its first rod segment 111 into the cleaning solution in the cleaning hole 180, and the control preparation mechanism 300 driving the capture rod 110 to rotate in the cleaning solution in the cleaning hole 180, preferably eccentrically, for example, at a speed of 5 to 50 rpm for 1 to 60 seconds, so as to wash away the unbound material on the capture rod.

[0187] Especially after the capture rod 110 is immersed in the liquid (e.g., liquid labeling reagent or a mixture of labeling reagent and test sample solution) in the labeling well 120, a specific complex (i.e., a complex of capture-target analyte-labeling reagent) binds to the first segment of the capture rod 110. Simultaneously, some non-specifically bound substances, such as labeling reagents that do not form a complex (e.g., labeled antibodies or labeled antigens), also adhere. Therefore, it is preferable to wash the capture rod with the bound complex before elution to remove the non-specific binding substances.

[0188] Here, the control preparation mechanism 300 drives the capture rod 110 to rotate, particularly eccentrically rotate, in the cleaning fluid of the cleaning hole 180. The shear force of the cleaning fluid 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.

[0189] In some embodiments, when the reagent strip 100 includes a plurality of cleaning holes 180, the controller 500 controls the preparation mechanism 300, in particular the motion device 310, to sequentially immerse the capture rod 110 into the cleaning liquid in each cleaning hole 180 and rotate it.

[0190] 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 19 and 20. Figure 19 shows a schematic side and top view of a reagent strip 100, which includes the aforementioned capture rod well 150, label well 120, elution well 102, substrate well 130, four washing wells 180, sample well 170, and measurement well 140. The capture rod 110 is coated with a capture antibody, and the labeling reagent is a labeled antibody.

[0191] As shown in Figure 15, the controller 500 is configured to execute steps 1 through 7. In step 1, the controller 500 controls the dispensing device 320 to add the whole blood to be tested into the sample well 170. For example, the controller 500 controls the dispensing device 320 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 170. The sample well can be empty or pre-loaded with sample diluent. In step 2, the controller 500 controls the dispensing device 320 to transfer the whole blood to be tested or diluted whole blood to be tested from the sample well to the labeling well 120 and optionally mix it so that the antigen to be tested reacts sufficiently with the labeled antibody in the labeling well 120. In step 3, the controller 500 controls the motion device 310 to remove the capture rod 110 from the capture rod hole 150 and immerse the removed capture rod 110 in the liquid in the label hole 120, causing it to rotate in the liquid in the label hole 120, thereby capturing the antibody, the test antigen, and the labeled antibody to undergo an immune reaction, forming an immune complex on the capture rod 110. In step 4, the controller 500 controls the motion device 310 to remove the capture rod from the label hole 120 and immerse it sequentially in the washing solution in the four washing holes 180, causing the capture rod to rotate in the washing solution in each washing hole 180 to wash away unbound material on the capture rod. In step 5, the controller 500 controls the motion device 310 to remove the capture rod from the last washing hole and immerse it in the pre-excitation solution in the elution hole 128 to elute the direct luminescent label into the pre-excitation solution. In step 6, the controller 500 controls the dispensing device 320 to transfer at least partially of the pre-excitation liquid containing the direct luminescent marker in the elution well 102 into the empty measurement well 140. In step 7, the controller 500 controls the dispensing device 320 to transfer the excitation liquid in the substrate well 130 into the measurement well 140 containing the pre-excitation liquid, while simultaneously controlling the detection mechanism 400 to perform photometric measurement on the test solution in the measurement well 140.

[0192] 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 reagent strips provided in the embodiments of this application are applicable in a corresponding manner to the sample analyzer provided in the embodiments of this application, and vice versa.

[0193] 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 reagent strip, characterized in that, include: A capture rod, said capture rod being coated with a capture agent for capturing the target analyte in the sample solution to be tested; The label well contains a labeling reagent pre-encapsulated with a label, the labeling reagent being capable of binding to the target analyte; The substrate wells are pre-encapsulated with a signal-inducing reagent, which can react with the label to produce a chemiluminescent reaction to obtain the test solution. and A measuring orifice, in which no liquid is pre-placed and which is used to contain at least a portion of the solution to be tested, thereby enabling the detection of the light signal generated by the chemiluminescence reaction of the solution to be tested in the measuring orifice.

2. The reagent strip according to claim 1, characterized in that, The first rod segment containing the captured material is pre-encapsulated in the measuring hole.

3. The reagent strip according to claim 1, characterized in that, The reagent strip also includes a capture rod orifice independent of the measurement orifice, and the first rod segment of the capture rod, which is covered with the captured material, is pre-encapsulated in the capture rod orifice.

4. The reagent strip according to any one of claims 1-3, characterized in that, The target analyte is the antigen to be tested, the labeling reagent is a labeled antibody that is specifically bound to the antigen to be tested, and the capture agent is a capture antibody that is specifically bound to the antigen to be tested. or The target analyte is the antibody to be tested, the labeling reagent is a labeled antigen that is specifically bound to the antibody to be tested, and the capture substance is a capture antigen that is specifically bound to the antibody to be tested.

5. The reagent strip according to any one of claims 1-3, characterized in that, The target analyte is the test antigen, the labeling reagent is a labeled antibody that specifically binds to the test antigen, and the capture substance is a first ligand substance that can bind to a second ligand substance coupled to the capture antibody, wherein the capture antibody specifically binds to the test antigen; or The target analyte is the antibody to be tested, the labeling reagent is a labeled antigen that is specifically bound to the antibody to be tested, and the capture substance is a first ligand substance that can bind to a second ligand substance coupled to the capture antigen, wherein the capture antigen can specifically bind to the antibody to be tested. Preferably, the first ligand is streptavidin and the second ligand is biotin.

6. The reagent strip according to claim 5, characterized in that, The reagent strip also includes a capture reagent well in which the capture antibody or the capture antigen, coupled with the second ligand substance, is pre-encapsulated.

7. The reagent strip according to any one of claims 2 to 6, characterized in that, The capture rod includes a rod-shaped body and a closed structure connected to each other. The rod-shaped body includes a first rod segment connected to the bottom side of the closed structure. The closed structure is used to openably and close the measuring hole or the capture rod hole, thereby enabling the first rod segment to be closed in the measuring hole or the capture rod hole. Preferably, the rod-shaped main body and the closed structure are integrally formed.

8. The reagent strip according to any one of claims 1 to 7, characterized in that, The capture rod is made of plastic, preferably polystyrene.

9. The reagent strip according to any one of claims 1 to 8, characterized in that, The reagent strip also includes a cleaning hole, in which a cleaning solution is pre-encapsulated. The cleaning solution is used to wash away unbound material on the capture rod.

10. The reagent strip according to any one of claims 1 to 9, characterized in that, The labeling reagent is pre-encapsulated in the label well in the form of a dry reagent, preferably a lyophilized reagent, and more preferably a lyophilized sphere reagent.

11. The reagent strip according to any one of claims 1 to 10, characterized in that, The reagent strip also includes a sample well for containing the sample solution to be tested. Preferably, the sample well is pre-encapsulated with a pretreatment solution for pre-treating the sample solution to be tested.

12. The reagent strip according to any one of claims 1 to 11, characterized in that, The measuring orifice is sealed in the reagent strip, preferably the sealed measuring orifice is empty.

13. A sample analyzer, comprising: A reagent strip storage area is configured to store at least one reagent strip, the reagent strip including a capture rod, a marker well, a substrate well, and a measurement well; The capture rod is coated with a capture substance, a marker reagent with a marker is pre-encapsulated in the marker well, a signal-inducing reagent is pre-encapsulated in the substrate well, and no liquid is pre-placed in the measurement well; wherein, a first segment of the capture rod coated with the capture substance is pre-encapsulated in the measurement well, or the reagent strip further includes a capture rod well independent of the measurement well and the first segment of the capture rod coated with the capture substance is pre-encapsulated in the capture rod well; The preparation apparatus is configured to prepare a test solution using a sample solution containing a target analyte, the labeling reagent, and the signal heuristic reagent. During the preparation process, the labeling reagent can bind to the target analyte, and the signal heuristic reagent can undergo a chemiluminescent reaction with the labeling reagent. The testing apparatus is configured to detect the light signal generated by the chemiluminescence reaction of the test solution to obtain the content of the target analyte; and The controller is configured to be electrically connected to the preparation mechanism and the detection mechanism and is configured to: The preparation mechanism is controlled to remove the capture rod from the measuring orifice or the capture rod orifice, and the preparation mechanism is controlled to prepare a conjugate of the labeling reagent and the target analyte using the capture rod; The preparation mechanism is controlled to prepare the test solution in the measurement well using at least the portion of the conjugate containing the marker and the signal heuristic reagent, or the preparation mechanism is controlled to transfer at least a portion of the test solution into the measurement well after preparing the test solution using at least the portion of the conjugate containing the marker and the signal heuristic reagent; and The detection mechanism is controlled to detect the solution to be tested in the measuring hole.

14. The sample analyzer according to claim 13, characterized in that, The reagent strip also includes a sample well for holding the sample solution to be tested, and preferably a pre-treatment solution is pre-encapsulated in the sample well. The method of controlling the preparation mechanism to prepare the conjugate of the labeled reagent and the target analyte 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; and The preparation mechanism is controlled to immerse the capture rod into the labeling reagent in the labeling well, so that the labeling reagent and the captured target analyte form the complex on the capture rod.

15. The sample analyzer according to claim 13, wherein, The control of the preparation mechanism to prepare the conjugate of the labeled reagent and the target analyte by means of the capture rod includes: The preparation mechanism is controlled to transfer the test sample solution into the label well, so that the labeling reagent binds to the target analyte in the test sample solution to obtain a mixture containing the binder; and The preparation mechanism is controlled to immerse the capture rod into the mixture in the marker orifice so that the capture rod captures the target analyte in the conjugate, thereby attaching the conjugate to the capture rod.

16. The sample analyzer according to any one of claims 13 to 15, characterized in that, The target analyte is the antigen to be tested, the labeling reagent is a labeled antibody that is specifically bound to the antigen to be tested, and the capture agent is a capture antibody that is specifically bound to the antigen to be tested. Alternatively, the target analyte is the antibody to be tested, the labeling reagent is a labeled antigen that is specifically bound to the antibody to be tested, and the capture substance is a capture antigen that is specifically bound to the antibody to be tested; The control of the preparation mechanism to prepare the conjugate of the labeled reagent and the target analyte by means of the capture rod includes: The preparation mechanism is controlled to immerse the capture rod sequentially into the test sample solution and the labeling reagent, or the preparation mechanism is controlled to immerse the capture rod into a mixture of the test sample solution and the labeling reagent, so as to use the capture antibody or the capture antigen on the capture rod to capture the target analyte, and the labeling reagent and the captured target analyte form the conjugate on the capture rod.

17. The sample analyzer according to any one of claims 13 to 15, characterized in that, The target analyte is a test antigen, the labeling reagent is a labeled antibody that specifically binds to the test antigen, and the capture substance is a first ligand that binds to a second ligand coupled to the capture antibody, wherein the capture antibody specifically binds to the test antigen; or the target analyte is a test antibody, the labeling reagent is a labeled antigen that specifically binds to the test antibody, and the capture substance is a first ligand that binds to a second ligand coupled to the capture antigen, wherein the capture antigen specifically binds to the test antibody; preferably, the first ligand is streptavidin and the second ligand is biotin. The control of the preparation mechanism to prepare the conjugate of the labeled reagent and the target analyte by means of the capture rod includes: The preparation mechanism is controlled to immerse the capture rod in the capture antibody or the capture antigen coupled with the second ligand substance, so that the capture antibody or the capture antigen coupled with the second ligand substance is connected to the capture rod. The preparation mechanism is also controlled to immerse the capture rod connected with the capture antibody or the capture antigen sequentially into the test sample solution and the labeling reagent, or to immerse the capture rod connected with the capture antibody or the capture antigen into a mixture of the test sample solution and the labeling reagent, so that the capture antibody or the capture antigen of the capture rod captures the target analyte in the test sample solution and the labeling reagent forms a conjugate with the captured target analyte on the capture rod; or The preparation mechanism is controlled to immerse the capture rod in a mixture of the capture antibody or capture antigen coupled with the second ligand substance, the test sample solution, and the labeling reagent, so as to capture the conjugate formed by the capture antibody or capture antigen coupled with the second ligand substance, the test sample solution, and the labeling reagent using the first ligand substance on the capture rod; Preferably, the reagent strip further includes a capture reagent well in which the capture antibody or the capture antigen coupled with the second ligand substance is pre-encapsulated.

18. The sample analyzer according to claim 16 or 17, characterized in that, The marker is a direct luminescent reagent, preferably acridinium ester, and the signal heuristic reagent is an excitation liquid that can excite the direct luminescent reagent to emit light. The reagent strip also includes a pre-excitation hole pre-encapsulated with a pre-excitation liquid. The method of controlling the preparation mechanism to prepare the test solution in the measurement well using at least a portion of the conjugate containing the marker and the signal-inducing reagent includes: controlling the preparation mechanism to immerse the trapping rod connected to the conjugate into the pre-excitation liquid in the pre-excitation well to elute at least the marker in the conjugate from the trapping rod into the pre-excitation liquid to obtain an eluent; controlling the preparation mechanism to transfer at least a portion of the eluent to the measurement well; and controlling the preparation mechanism to transfer at least a portion of the excitation liquid in the substrate well to the measurement well to prepare the test solution in the measurement well; or The method of controlling the preparation mechanism to transfer at least a portion of the test solution to the measurement well after preparing the test solution using at least a portion of the conjugate containing the marker and the signal heuristic reagent includes: controlling the preparation mechanism to immerse the capture rod connected to the conjugate into the pre-excitation liquid in the pre-excitation well to elute at least the marker in the conjugate from the capture rod into the pre-excitation liquid to obtain an eluent; controlling the preparation mechanism to transfer at least a portion of the eluent to the substrate well or controlling the preparation mechanism to transfer at least a portion of the excitation liquid in the substrate well to the pre-excitation well to prepare the test solution; and controlling the preparation mechanism to transfer at least a portion of the test solution to the measurement well.

19. The sample analyzer according to claim 16 or 17, characterized in that, The label is an enzyme label, and the signal heuristic reagent is a substrate solution that can emit light under the catalysis of the enzyme label; Controlling the preparation mechanism to transfer at least a portion of the test solution into the measurement orifice after preparing the test solution using at least a portion of the conjugate containing the marker and the signal heuristic reagent includes: The preparation mechanism is controlled to immerse the capture rod, to which the conjugate is attached, into the substrate liquid in the substrate well to prepare the test solution, and the preparation mechanism is controlled to transfer at least a portion of the test solution in the substrate well to the measurement well.

20. The sample analyzer according to claim 14 or 15, characterized in that, The controller is also configured to: After the preparation mechanism immerses the capture rod in the labeling reagent or the mixture in the labeling orifice and before removing it, the preparation mechanism drives the capture rod to rotate, preferably eccentrically rotate, in the labeling reagent or the mixture in the labeling orifice so that the labeling reagent and the captured target analyte form the conjugate on the capture rod or so that the capture rod captures the target analyte in the conjugate, thereby attaching the conjugate to the capture rod.

21. The sample analyzer according to any one of claims 13 to 20, characterized in that, The reagent strip also includes a cleaning hole, in which cleaning solution is pre-encapsulated; The method of controlling the preparation mechanism to prepare the conjugate of the labeled reagent and the target analyte by means of the capture rod further includes: The preparation mechanism is controlled to immerse the capture rod connected to the binder into the cleaning fluid in the cleaning hole and to drive the capture rod to rotate, preferably eccentrically rotate, in the cleaning fluid in the cleaning hole in order to wash away the unbound material on the capture rod.

22. The sample analyzer according to any one of claims 14 to 21, characterized in that, The preparation of the test solution using at least a portion of the conjugate containing the marker and the signal heuristic reagent includes: controlling the preparation mechanism to elute at least the marker from the capture rod connected to the conjugate using an elution reagent to obtain an eluent; and controlling the preparation mechanism to prepare the test solution using the eluent and the signal heuristic reagent.

23. The sample analyzer according to claim 13, characterized in that, The control of the preparation mechanism to prepare the conjugate of the labeled reagent and the target analyte by means of the capture rod includes: 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 elute the target analyte captured by the capture rod from the capture rod using an elution reagent, to obtain an eluent; and The preparation mechanism is controlled to mix the labeling reagent with the eluent, such that the labeling reagent and the target analyte in the eluent form the conjugate.

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