Reagent strip and sample analyzer

Abstract

A reagent strip and a sample analyzer. The reagent strip comprises a capture rod and a reagent strip body, the reagent strip body comprises a capture rod cavity, a sample cavity, a reagent cavity, and a first accommodating portion, the sample cavity is used for accommodating a sample, a dry reagent used for sample testing is encapsulated in the reagent cavity, the dry reagent is exposed to the environment of the reagent cavity, and the capture rod is placed in the capture rod cavity; and the first accommodating portion is filled with a first drying substance, and the first accommodating portion is in communication with the reagent cavity, so that the first drying substance absorbs moisture in the reagent cavity. The reagent strip contains the first drying substance in the first accommodating portion, and the first drying substance absorbs moisture in the reagent cavity, so as to keep the reagent cavity dry, thereby helping to keep the dry reagent dry, improving the long-term stability of the dry reagent, reducing the risk of dry reagent failure due to moisture absorption, and reducing the sealing performance requirements of the reagent strip.

Description

A reagent strip and sample analyzer Technical Field

[0001] This application relates to the field of in vitro diagnostic technology, and more particularly to a reagent strip and a sample analyzer. Background Technology

[0002] In related technologies, the reagent strips of sample analyzers use dry reagents instead of liquid reagents. Dry reagents can improve reagent stability to a certain extent; however, dry reagents are relatively easy to absorb water. During long-term storage of dry reagents, the humidity in the exposed environment needs to be strictly controlled, otherwise the dry reagents face the risk of water absorption and failure in high humidity environments. Summary of the Invention

[0003] Existing technologies typically use well-sealed outer packaging materials to encapsulate test strips. However, when the outer packaging of the test strips is opened and multiple test strips are loaded into a sample analyzer, the applicant's research has revealed that the stability of the dry reagent in the test strips needs improvement when the test strips remain inside the sample analyzer for an extended period. Therefore, this application aims to provide a test strip and a sample analyzer for improving the stability of the dry reagent in test strips after the outer packaging has been removed.

[0004] This application provides a reagent strip, comprising:

[0005] Capture stick;

[0006] The reagent strip body has multiple chambers with a top side opening. The multiple chambers include a capture rod chamber, a sample chamber, and a reagent chamber. The reagent strip body also includes a first receiving part. The sample chamber is used to contain a sample. The reagent chamber contains a dry reagent for sample detection. The dry reagent is exposed to the environment of the reagent chamber. The capture rod is placed in the capture rod chamber.

[0007] The first container contains a first drying substance, and the first container is connected to the reagent chamber so that the first drying substance can absorb moisture in the reagent chamber.

[0008] The reagent strip of this application embodiment, by filling the first receiving part with a first desiccant, absorbs the moisture in the reagent chamber by means of the first desiccant, thereby helping to keep the reagent chamber dry, which in turn helps to keep the dry reagent dry, improves the long-term stability of the dry reagent, reduces the risk of the dry reagent failing due to water absorption, and reduces the sealing performance requirements of the reagent strip.

[0009] In some embodiments, the reagent chamber is also used to hold a reconstituted solution, wherein the dry reagent can be mixed with the reconstituted solution to form a liquid reagent;

[0010] When the capture rod is inserted into the liquid reagent in the reagent chamber, the dry substance does not come into contact with the liquid reagent.

[0011] In some embodiments, the first receiving portion is also in communication with the capture rod cavity, and the drying material can also absorb moisture in the capture rod cavity, thereby keeping the capture rod dry.

[0012] In some embodiments, the reagent strip body further includes a second containment portion containing a second drying substance, the second containment portion being in communication with the capture rod cavity, so that the second drying substance in the second containment portion absorbs moisture in the capture rod cavity.

[0013] In some embodiments, the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right sides, the top side of the first receiving portion has a first opening, the top side of the reagent chamber has a second opening, and the first opening and the second opening are sealed by a sealing membrane.

[0014] In some embodiments, the reagent strip body, with multiple chambers opening on the top side, is sealed by a sealing film, wherein the sealing film forms part of the outer surface of the reagent strip; and / or, the sealing film comprises a water-resistant heat-sealing aluminum film.

[0015] In some embodiments, the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right sides. The cavity wall of the reagent chamber includes a cavity side wall and a cavity bottom wall. The cavity bottom wall faces the opening of the reagent chamber. The cavity side wall is provided with one or more through holes, and the one or more through holes connect the first receiving portion and the reagent chamber.

[0016] In some embodiments, the first receiving portion and the reagent chamber are arranged adjacent to each other, the first receiving portion is detachably covering and exposing the reagent chamber, and after the first receiving portion is removed to expose the reagent chamber, the reagent chamber is also used to hold a reconstituted solution, and the dry reagent can be mixed with the reconstituted solution to form a liquid reagent.

[0017] In some embodiments, the first receiving portion is located within the reagent chamber and is detachably connected to the reagent chamber. The dry reagent is located in the space below the first receiving portion. After the first receiving portion is removed from the reagent chamber, the reagent chamber is also used to hold a reconstituted solution, and the dry reagent can be mixed with the reconstituted solution to form a liquid reagent. Alternatively, the reagent strip body includes a container, which is disposed within the reagent chamber. The dry reagent is disposed within the container. The cavity wall of the reagent chamber and the outer surface of the container constitute the first receiving portion. The container is also used to hold a reconstituted solution, and the dry reagent can be mixed with the reconstituted solution in the container to form a liquid reagent.

[0018] In some embodiments, the reagent chamber is also used to hold a reconstituted solution, and the dry reagent can be mixed with the reconstituted solution to form a liquid reagent;

[0019] When the capture rod is inserted into the liquid reagent in the reagent chamber, the first dry substance does not come into contact with the liquid reagent.

[0020] In some embodiments, the drying material comprises one or more drying particles, the first receiving portion and the reagent chamber are connected through one or more through holes, the size of the through holes and the size of the drying particles satisfying that the one or more drying structures cannot pass through the through holes; preferably, the drying particles comprise drying balls.

[0021] In some embodiments, the dry reagent includes lyophilized reagent and / or air-dried reagent; and / or, the surface of the capture rod is coated with a first antibody reagent, the dry reagent containing a second antibody reagent linked to a marker.

[0022] In some embodiments, the drying substance is selected from at least one of: silica desiccant, molecular sieve desiccant, activated carbon desiccant, fiber desiccant, and activated alumina.

[0023] This application provides a reagent strip, comprising:

[0024] Capture stick;

[0025] The reagent strip body has multiple chambers with a top side opening. The multiple chambers include a capture rod chamber, a sample chamber, and a reagent chamber. The sample chamber is used to contain a sample. The reagent chamber contains a dry reagent for sample detection. The dry reagent is exposed to the environment of the reagent chamber. The capture rod is placed in the capture rod chamber.

[0026] The reagent strip is also encapsulated with a desiccant that can absorb moisture in the reagent chamber.

[0027] The reagent strip of this application embodiment uses a desiccant to absorb moisture in the reagent chamber, thereby helping to keep the reagent chamber dry, which in turn helps to keep the dry reagent dry, improves the long-term stability of the dry reagent, reduces the risk of the dry reagent failing due to water absorption, and reduces the sealing performance requirements of the reagent strip.

[0028] In some implementations, the capture rod cavity and the reagent cavity are connected, and the drying substance can also absorb moisture in the capture rod cavity.

[0029] In some embodiments, the capture rod cavity is in communication with the reagent cavity, and the dried substance is contained in the capture rod cavity; and / or, the dried substance is contained in the reagent cavity.

[0030] In some embodiments, the reagent strip body includes a first receiving portion, which communicates with the reagent chamber, and the dried substance is contained in the first receiving portion.

[0031] In some embodiments, the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right sides, the top side of the first receiving portion has a first opening, the top side of the reagent chamber has a second opening, and the first opening and the second opening are sealed by a sealing membrane.

[0032] In some embodiments, the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right sides. The cavity wall of the reagent chamber includes a cavity side wall and a cavity bottom wall. The cavity bottom wall faces the opening of the reagent chamber. The cavity side wall is provided with one or more through holes, and the one or more through holes connect the first receiving portion and the reagent chamber.

[0033] The dried material comprises one or more dried particles, and the size of the through hole and the size of the dried particles satisfy the condition that the one or more dried particles cannot pass through the through hole.

[0034] In some embodiments, the reagent chamber is also used to hold a reconstituted solution, the dry reagent being able to mix with the reconstituted solution to form a liquid reagent, and the dry substance not coming into contact with the liquid reagent when the capture rod is inserted into the reagent chamber.

[0035] This application provides a sample analyzer, including:

[0036] The sample analysis module and the reagent strips described in any embodiment of this application,

[0037] The sample analysis module includes:

[0038] A reagent strip storage area, wherein at least one of the reagent strips can be placed;

[0039] A sample dispensing mechanism for dispensing samples into the sample chamber of the reagent strip;

[0040] A retrieving mechanism is used to drive the reagent strip body to move relative to the capture rod;

[0041] A reagent dispensing mechanism is used to dispense the reconstituted solution into the reagent chamber of the reagent strip, so that the dry reagent and the reconstituted solution are mixed to obtain a liquid reagent;

[0042] Testing institutions are used to test analytes prepared from samples.

[0043] The controller is configured to control the reagent dispensing mechanism to dispense the reconstituted solution into the reagent chamber of the reagent strip, and to control the retrieving mechanism to remove the capture rod from the capture rod chamber and place it in the sample in the sample chamber so that the capture rod captures the target substance in the sample. It is also configured to control the retrieving mechanism to remove the capture rod from the sample chamber and place it in the liquid reagent in the reagent chamber to react and obtain the analyte; and to control the detection mechanism to detect the analyte.

[0044] The sample analyzer of this application embodiment contains dry reagents and desiccant sealed in the reagent strips. The desiccant is used to keep the dry reagents dry, which makes the dry reagents more stable. Even if the reagent strips are stored in the reagent storage area for a long time (e.g., 1 to 2 months), the reagents can still maintain their stability. Attached Figure Description

[0045] Figure 1 is a schematic diagram of the reagent strip body according to the first embodiment of this application;

[0046] Figure 2 is a schematic diagram of the cooperation between the reagent strip and the dispensing mechanism shown in Figure 1. The dispensing mechanism places the capturing rod in the reagent chamber. The opening of the reagent chamber shows the sealing membrane, while the other cavities do not show the sealing membrane.

[0047] Figure 3 is a partially enlarged schematic diagram of the structure shown in Figure 1;

[0048] Figure 4 is a schematic diagram of the structure shown in Figure 3 from another perspective;

[0049] Figure 5 is a simplified schematic diagram of a partial cross-section of the reagent chamber and the first receiving part in Figure 4;

[0050] Figure 6 is a schematic diagram of the reagent strip according to the second embodiment of this application, wherein the capture rod is omitted;

[0051] Figure 7 is a partial structural schematic diagram of the reagent strip according to the third embodiment of this application;

[0052] Figure 8 is a partial structural schematic diagram of the reagent strip according to the fourth embodiment of this application;

[0053] Figure 9 is a partial structural schematic diagram of the reagent strip according to the fifth embodiment of this application;

[0054] Figure 10 is a partial structural schematic diagram of the reagent strip according to the sixth embodiment of this application. Detailed Implementation

[0055] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0056] The specific technical features described in the specific embodiments can be combined in any suitable manner without contradiction. For example, different combinations of specific technical features can form different embodiments and technical solutions. To avoid unnecessary repetition, the various possible combinations of the specific technical features in this invention will not be described separately.

[0057] In the following description, the terms "first," "second," etc., are used merely to distinguish different objects and do not indicate that the objects have the sameness or relationship. It should be understood that the directional descriptions "above," "below," "outside," and "inside" refer to the orientation under normal use conditions, while "left" and "right" refer to the left and right directions shown in the corresponding diagrams, which may or may not be the left and right directions under normal use conditions.

[0058] It should be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. "A plurality of" means two or more.

[0059] This application provides a reagent strip 100, which can be used in a sample analyzer.

[0060] Please refer to Figure 2. The reagent strip 100 includes a reagent strip body 12 and a capture rod 11.

[0061] Please refer to Figures 1 and 2. The reagent strip body 12 is provided with multiple chambers with top openings, including a capture rod chamber 12A, a sample chamber 12B, and a reagent chamber 12C.

[0062] For example, the reagent strip body 12 is generally elongated, and the aforementioned chambers are arranged along the extending direction of the reagent strip body 12.

[0063] The sample cavity 12B is used to contain the sample. It should be noted that there can be one or more sample cavities 12B.

[0064] For example, the sample analyzer includes a sample dispensing mechanism for dispensing samples into the sample chamber 12B.

[0065] In this application embodiment, the sample includes, but is not limited to, at least one of the following: blood, ascites, sputum, and other bodily fluids, but is not limited to these. The sample analyzer is used, for example, to detect specific proteins, peptides, small molecules, etc., in bodily fluids. The detection results 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. The sample analyzer includes, but is not limited to, at least one of the following: biochemical analyzer, electrolyte analyzer, immunoassay analyzer, coagulation analyzer, and urine analyzer; for example, the sample analyzer can be a biochemical analyzer, which may include at least one of an immunoassay module, a coagulation analysis module, and a urine analysis module.

[0066] In this embodiment, whole blood samples and an immunoassay analyzer are used as examples for illustration.

[0067] The reagent chamber 12C contains a dry reagent 16 for sample testing, which is exposed to the environment of the reagent chamber 12C. That is to say, the reagent chamber 12C, where the dry reagent 16 is located, is a closed chamber and is not the same as the atmospheric environment. Therefore, moisture from the atmospheric environment usually does not enter the reagent chamber 12C.

[0068] The number of reagent chambers 12C can be one or more. It should be noted that when there are multiple reagent chambers 12C, some reagent chambers 12C may contain the dry reagent 16 for sample detection, while the remaining reagent chambers 12C are reserved empty cavities. Alternatively, all reagent chambers 12C may contain the dry reagent 16 for sample detection. Among the multiple reagent chambers 12C containing the dry reagent 16, the dry reagent 16 in different reagent chambers 12C can be the same or different; there is no restriction on this.

[0069] Dry reagent 16 is in contrast to liquid reagent. Dry reagent 16 refers to non-liquid reagent. For example, dry reagent 16 can be lyophilized reagent, air-dried reagent, or dry reagent 16 obtained by other methods of removing moisture.

[0070] Compared to liquid reagents, dry reagent 16 can improve reagent stability to some extent.

[0071] For example, the sample analyzer includes a reagent dispensing mechanism for dispensing a reconstituted solution into the reagent chamber 12C to mix the dry reagent 16 and the reconstituted solution to obtain a liquid reagent.

[0072] For example, please refer to Figures 1 and 2. The above-mentioned multiple cavities also include a photometry cavity 12D. The sample analyzer includes a detection mechanism, which detects the test product prepared based on the sample in the photometry cavity 12D to obtain the sample detection result.

[0073] The capture rod cavity 12A is used to place the capture rod 11 (see Figure 2). That is, the reagent strip 100 provided in this embodiment of the application is prefabricated with the capture rod 11. In other words, when the reagent strip 100 is manufactured and shipped as a finished product, the reagent strip 100 is equipped with the capture rod 11, and the capture rod 11 is placed in the capture rod cavity 12A.

[0074] For example, the surface of the capture rod 11 is coated with a layer containing a first substance to be bound and / or a substance capable of binding the first substance to be bound. The first substance to be bound can bind to a target substance in the sample. It should be noted that the binding can be physical adsorption or biochemical reaction, such as the binding of an antibody to an antigen.

[0075] For example, if the first substance to be bound is an antigen, after the capture rod 11 is inserted into the sample in the sample chamber 12B, it can capture the target substance in the sample, such as an antibody; or if the first substance to be bound is an antibody, after the capture rod 11 is inserted into the sample in the sample chamber 12B, the capture rod 11 can capture the target substance in the sample, such as an antigen.

[0076] In some embodiments, the dry reagent 16 contains a second substance to be bound. When the capture rod 11 is removed from the sample in the sample chamber 12B and placed in the liquid reagent obtained by reconstitution, the target substance captured by the capture rod 11 binds with the second substance to be bound in the reagent to form the test product.

[0077] For example, the surface of the capture rod 11 is coated with a first antibody substance, and the dry reagent 16 contains a second antibody reagent linked to a label. Preferably, the second antibody reagent may be selected from alkaline phosphatase-labeled, fluorescently labeled, horseradish peroxidase (HRP)-labeled, or acrid ester-labeled second antibody reagents.

[0078] For example, the first substance to be bound can be coated onto the surface of the capture rod 11 by adsorption or covalent binding. Taking an antibody as the first substance to be bound, the process of forming a coating layer on the surface of the capture rod 11 is as follows:

[0079] 1. Coating: Immerse the capture rod 11 in the "avidin-carbonic acid buffer solution" to coat it with avidin, and incubate overnight at 4°C.

[0080] 2. Sealing: Remove the capture rod 11 from the coating system solution and wash it 3 times with the cleaning solution; add the sealing solution and incubate at 37°C.

[0081] 3. Drying: Remove the capture rod 11 from the sealing liquid, absorb the moisture, and dry at 37°C.

[0082] 4. Capture antibody incubation: Immerse capture rod 11 in “capture antibody-biotin” working solution; incubate at 37°C for 2 hours; then remove capture rod 11 from the “capture antibody-biotin” working solution.

[0083] Exemplarily, the trapping rod 11 is a structure made of a non-metallic material. Preferably, the non-metallic material is selected from polymers and silica, and the polymer is selected from at least one of the following: polyethylene, polypropylene, and polystyrene, so that a coating layer is formed on the surface of the trapping rod 11.

[0084] Please refer to Figures 3, 4, 5, and 7. The reagent strip body 12 also includes a first receiving portion 12F. The first receiving portion 12F contains a first desiccant 13, meaning that the first receiving portion 12F serves as a support structure for carrying and containing the first desiccant 13. The first receiving portion 12F is connected to the reagent chamber 12C, so that the first desiccant 13 absorbs moisture from the reagent chamber 12C, thereby keeping the dry reagent 16 dry. In other words, the reagent strip 100 is pre-formed with the first desiccant 13, and the first desiccant 13 is also in a closed environment, i.e., not in contact with the atmospheric environment.

[0085] Desiccant refers to a substance that can absorb moisture and keep its surrounding environment dry through its own water absorption capacity. It should be noted that the water absorption performance of the first desiccant 13 is better than that of the desiccant 16.

[0086] It should be noted that dry reagent 16 is relatively easy to absorb water. During long-term storage of dry reagent 16, the humidity in the exposed environment needs to be strictly controlled. Otherwise, dry reagent 16 faces the risk of water absorption failure in high humidity environments.

[0087] In related technologies, dry reagents are encapsulated in reagent chambers, and one or more reagent strips are placed in the same outer packaging box. The environment inside the outer packaging box is kept dry by sealing the box and placing a desiccant inside. However, after the user unpacks the outer packaging box, the reagent strips are exposed to the atmospheric environment. For example, after the reagent strips are installed in the machine, they may not be used for a long period of time. In this case, the stability of the dry reagents depends on the sealing level of the reagent strips themselves, and the sealing performance of the reagent strips is greatly challenged.

[0088] The reagent strip 100 of this application embodiment, by loading a first desiccant 13 in the first receiving part 12F, absorbs the moisture in the reagent chamber 12C by means of the first desiccant 13, thereby helping to keep the reagent chamber 12C dry, and further helping to keep the dry reagent 16 dry, improving the long-term stability of the dry reagent 16, reducing the risk of the dry reagent 16 failing due to water absorption, and reducing the sealing performance requirements of the reagent strip 100.

[0089] The applicant conducted a series of experiments on the embodiments and comparative examples of this application under the same conditions of 37°C and 90% humidity. The reagent strips 100 of the embodiments and comparative examples have the same structure, and the dry reagent 16 used in both embodiments and comparative examples is the same, both being lyophilized reagents of the same composition. The only difference is that the embodiments of this application include a silica desiccant ball (i.e., the first desiccant 13), while the comparative examples do not. The applicant unexpectedly discovered that the lyophilized reagent 16 in the reagent chamber 12C of the embodiments of this application did not collapse after one month. However, the lyophilized reagent 16 in the comparative examples collapsed after 5-10 days (possibly due to water absorption; the lyophilized reagent 16 softens and collapses after absorbing moisture). By adding a first receiving portion 12F to the reagent strip and placing a small amount of desiccant, the in-system stability of the reagent strip after removing the outer packaging can be significantly improved.

[0090] The specific type of the first drying substance 13 is not limited. For example, in some embodiments, the first drying substance 13 is selected from at least one of the following: silica desiccant, molecular sieve desiccant, activated carbon desiccant, fiber desiccant, and activated alumina.

[0091] The form of the first dry substance 13 is not limited; for example, it can be in the form of powder, granules, blocks, rods, etc.

[0092] In some embodiments, the multiple cavities may further include a cleaning chamber containing a cleaning solution. After the capture rod is removed from the sample in the sample chamber and / or the liquid reagent in the reagent chamber, the capture rod 11 enters the cleaning solution in the cleaning chamber for cleaning to remove interfering substances from the capture rod 11.

[0093] In some embodiments, reagent chamber 12C is also used to hold a reconstituted solution, and the dry reagent 16 can be mixed with the reconstituted solution to form a liquid reagent. When the capture rod 11 is inserted into the liquid reagent in reagent chamber 12C, the first dry substance 13 does not come into contact with the liquid reagent.

[0094] When reagent strip 100 is used on the sample analyzer, the reconstitution solution needs to be dispensed into reagent chamber 12C first, so that the dry reagent 16 dissolves in the reconstitution solution, thus forming a liquid reagent. After the capture rod 11 is inserted into the liquid reagent in reagent chamber 12C, the liquid level in reagent chamber 12C will rise. That is to say, even when the capture rod 11 is inserted into the liquid reagent in reagent chamber 12C, the first dry substance 13 will not come into contact with the liquid reagent, and the first dry substance 13 will not mix into the liquid reagent. In this way, the probability of the first dry substance 13 contaminating the reagent can be reduced, thereby reducing the impact of the first dry substance 13 on the sample detection results.

[0095] Of course, the first dry substance 13 does not come into contact with the dry reagent 16.

[0096] In some embodiments, the first receiving portion 12F is also connected to the capturing rod cavity 12A, and the first drying substance 13 can also absorb moisture in the capturing rod cavity 12A, thereby keeping the capturing rod 11 dry. In this embodiment, the first drying substance 13 can absorb moisture from both the reagent cavity 12C and the capturing rod cavity 12A, thus reusing the first drying substance 13 in the first receiving portion 12F, which is beneficial for making the reagent strip 100 structure compact. For example, when the distance between the capturing rod cavity 12A and the reagent cavity 12C is far, one or more connecting gas paths can be provided on the reagent strip body 12, and the capturing rod cavity 12A and the reagent cavity 12C are connected through the connecting gas paths, while the first receiving portion and the first drying substance 13 can be provided on the connecting gas paths.

[0097] In other embodiments, the reagent strip body 12 further includes a second receiving portion containing a second drying substance. The second receiving portion is in communication with the capture rod cavity 12A, so that the second drying substance in the second receiving portion absorbs moisture in the capture rod cavity 12A, thereby keeping the capture rod 11 dry. In this embodiment, a second receiving portion and a second drying substance are additionally provided for the capture rod cavity 12A to keep the capture rod cavity 12A dry.

[0098] It should be noted that the type of the first dry substance 13 in the first container 12F and the type of the second dry substance 13 in the second container can be the same or different.

[0099] In some embodiments, referring to Figure 5, the first receiving portion 12F and the reagent cavity 12C are arranged adjacent to each other. The top side of the first receiving portion 12F has a first opening, and the top side of the reagent cavity 12C has a second opening. The first and second openings are sealed by a sealing membrane 15. The adjacent arrangement of the first and second openings facilitates the sealing operation using the sealing membrane 15. Furthermore, it also facilitates demolding when the reagent strip body 12 is manufactured using an injection molding process.

[0100] Specifically, during the assembly process, the dry reagent 16 is placed into the reagent chamber 12C through the second opening, the dry substance 13 is placed into the first receiving part 12F through the first opening, and the first opening and the second opening are sealed with a sealing membrane 15.

[0101] In this embodiment, the left-right direction refers to any direction within a plane perpendicular to the vertical direction. For example, it can be parallel to the length of the reagent strip or the width of the reagent strip. Preferably, the left-right direction is parallel to the length of the reagent strip.

[0102] In some embodiments, please refer to Figures 3 and 4, two non-communicating first receiving portions 12F are provided between two adjacent reagent chambers 12C. One first receiving portion 12F is connected to one of the reagent chambers 12C, and the other first receiving portion 12F is connected to the other reagent chamber 12C. The two first receiving portions 12F are arranged approximately along the width direction of the reagent body 12, which helps to reduce the length of the reagent strip.

[0103] For example, the sealing film 15 constitutes part of the outer surface of the reagent strip 100. That is, after sealing with the sealing film 15, there is no need for protective measures such as a protective cover on the outer layer of the sealing film 15. When the reagent strip 100 is loaded into the sample analyzer for use, the sealing film 15 needs to be damaged, for example, by using an additional membrane-breaking structure to puncture the sealing film 15, or the reagent dispensing mechanism itself has a structure for puncturing the sealing film 15.

[0104] The specific type of sealing membrane 15 is not limited. For example, in some embodiments, the sealing membrane 15 includes a water-resistant heat-sealing aluminum membrane. The water-resistant heat-sealing aluminum membrane has good waterproof performance and can effectively prevent moisture from entering the reagent chamber 12C and the first receiving portion 12F.

[0105] For example, the water-resistant heat-sealing aluminum film includes an outer barrier layer, a permeation barrier layer, and a heat-sealing layer.

[0106] The outer barrier layer can be made of nylon or polyethylene terephthalate. It provides protection against external impacts and scratches, while also offering good insulation and heat resistance.

[0107] The barrier layer is mainly composed of aluminum foil and is used to prevent the intrusion of moisture and oxygen. It has high barrier properties and ensures the stability of the packaging interior (e.g., reagent chamber 12C and first containment 12F).

[0108] The heat-sealing layer can be made of cast polypropylene and its main function is to prevent external substances from contacting the aluminum foil and to ensure good heat-sealing performance and sealing.

[0109] Of course, in addition to the water-resistant heat-sealing aluminum film mentioned above, the sealing film 15 can also be other types of film, as long as it meets the requirements of waterproof and sealing performance.

[0110] In some embodiments, there are multiple reagent chambers 12C, at least one of which is pre-filled with dry reagent, while the remaining reagent chambers 12C may be reserved chambers without dry reagent. In summary, no liquid is pre-filled in the reagent chambers 12C.

[0111] Exemplarily, multiple reagent chambers 12C are arranged adjacent to each other and sealed by the same sealing film. The remaining cavities (such as sample chambers, cleaning chambers described below, substrate wells, etc.) are arranged adjacent to each other and sealed by another sealing film. That is to say, during the sealing process, dry reagents can be first placed into the reagent chambers 12C, and all the reagent chambers can be sealed with a sealing film. Then, substrate liquid, cleaning liquid, etc. are placed into the remaining cavities, and then sealed with another sealing film. In this way, the influence of the liquid on the dry reagents can be minimized.

[0112] Exemplarily, referring to FIGS. 3, 4 and 5, the first accommodating portion 12F and the reagent chamber 12C are arranged adjacent to each other. Referring to FIG. 5, the chamber wall of the reagent chamber 12C includes a chamber side wall 12C1 and a chamber bottom wall 12C2. The chamber bottom wall 12C2 faces the opening of the reagent chamber 12C. One or more through holes 12H are provided on the chamber side wall 12C1, and the one or more through holes 12H connect the first accommodating portion 12F and the reagent chamber 12C. The through hole 12H provided on the chamber side wall 12C1. The position of the through hole 12H can be relatively high. When the reconstitution solution is quantitatively injected into the reagent chamber 12C, the reconstitution solution is not likely to enter the through hole 12H. The first accommodating portion 12F and the through hole 12H do not affect the liquid level of the liquid reagent in the reagent chamber 12C, and thus do not affect the contact area between the capture rod 11 and the liquid reagent; on the other hand, the dry matter 13 is not easily mixed into the liquid reagent, reducing the influence of the dry matter 13 on the sample test result. <000023​​​​​​​​​​​​​In some embodiments, both the dried granules and the dried reagent 16 are spherical in shape, so that they can be granulated using the same granulator, which helps to reduce production costs.

[0118] In some embodiments, the volume of the first receiving portion 12F can be adapted to the volume of the drying granules, so that placing one drying granule in the first receiving portion 12F is sufficient to meet the drying requirements. Of course, two or more drying granules can also be placed in the first receiving portion 12F.

[0119] The dimensions of the through-hole 12H and the drying particles satisfy the condition that one or more drying particles cannot pass through the through-hole 12H. Thus, by controlling the size of the through-hole 12H, the drying particles are prevented from entering the reagent chamber 12C. For example, when the through-hole 12H is circular and the drying particles are spherical, the inner diameter of the through-hole 12H is smaller than the outer diameter of the drying particles. For example, when the through-hole 12H is rectangular and the drying particles are spherical, the length of the shorter side of the through-hole 12H is smaller than the outer diameter of the drying particles.

[0120] In some implementations, as shown in Figure 6, when the reagent strip is not in use, the first receiving portion 12F is located above the reagent chamber 12C, arranged vertically adjacent to the reagent chamber, and covers the opening of the reagent chamber. The first receiving portion 12F is not higher than the height of the reagent strip, facilitating the sealing of all chambers of the reagent strip with a single sealing film. When in use, the first receiving portion 12F is removed, exposing the reagent chamber to hold the reconstituted solution.

[0121] In some implementations, referring to Figure 10, the first receiving portion 12F is located in the reagent chamber 12C, and the first receiving portion 12F and the reagent chamber 12C are detachably connected. The dry reagent 16 is located in the space below the first receiving portion 12F. Thus, the first receiving portion 12F does not need to increase the external size of the reagent strip; it can be placed into the reagent chamber 12C based on an existing reagent strip. After the first receiving portion 12F is removed from the reagent chamber 12C, the reagent chamber 12C is also used to hold the reconstitution solution, and the dry reagent 16 can be mixed with the reconstitution solution to form a liquid reagent. During the use of the reagent strip 100 in the sample analyzer, before injecting the reconstitution solution into the reagent chamber 12C, the first receiving portion 12F is removed from the reagent chamber 12C, and then the reconstitution solution is injected into the reagent chamber 12C.

[0122] It should be noted that in some embodiments, the opening of the reagent chamber 12C can also be sealed by the sealing film 15, that is, the first receiving portion 12F, the first dry substance 13, and the dry reagent 16 are all encapsulated in the reagent chamber 12C. In other embodiments, the opening of the reagent chamber 12C can be sealed by the first receiving portion 12F. In some embodiments, referring to FIG7, the first receiving portion 12F and the reagent chamber 12C are arranged adjacent to each other vertically, that is, the first receiving portion 12F is located outside the reagent chamber 12C and above the opening of the reagent chamber 12C. The first receiving portion 12F can detachably cover and expose the reagent chamber 12C. After the first receiving portion 12F is removed to expose the reagent chamber 12C, the reagent chamber 12C is also used to hold the reconstitution solution, and the dry reagent can be mixed with the reconstitution solution to form a liquid reagent. In this embodiment, when the reagent strip is used, the first receiving portion 12F is removed first, and the reagent chamber 12C is exposed to the surrounding environment, and then the reagent chamber 12C is injected with the reconstitution solution. In this embodiment, the opening of the reagent chamber 12C can be sealed by the contact surface between the edge of the first receiving portion 12F and the edge of the reagent chamber 12C. In other embodiments, referring to FIG9, the reagent strip also includes a container 18, which is disposed within the reagent chamber 12C, and the dried reagent 16 is disposed within the container 18. The cavity wall of the reagent chamber 12C and the outer surface of the container 18 constitute the first receiving portion 12F, that is, the first dried substance 13 is located within the space enclosed by the cavity wall of the reagent chamber 12C and the outer surface of the container 18. In this embodiment, the first dried substance 13 is located within the reagent chamber 12C. The container 18 is also used to hold the reconstitution solution, and the dried reagent 16 can mix with the reconstitution solution in the container 18 to form a liquid reagent. That is, the reconstitution solution will not flow out of the container 18, so that even if the dried substance 13 is located below the container 18, it will not come into contact with the reconstitution solution.

[0123] This application provides a reagent strip 100, which can be used in a sample analyzer.

[0124] Please refer to Figure 2. The reagent strip 100 includes a reagent strip body 12 and a capture rod 11.

[0125] The reagent chamber 12C encapsulates dry reagent 16 for sample detection, which is exposed to the environment of the reagent chamber 12C. That is, the reagent chamber 12C containing the dry reagent 16 is a closed chamber, separate from the atmospheric environment; therefore, moisture from the atmosphere will not enter the reagent chamber 12C. There can be one or multiple reagent chambers 12C. It should be noted that when there are multiple reagent chambers 12C, some reagent chambers 12C may contain reagents for sample detection, while the remaining reagent chambers 12C are reserved cavities. Alternatively, all reagent chambers 12C may contain reagents for sample detection. Among the multiple reagent chambers 12C containing reagents, the reagents in different reagent chambers 12C can be the same or different; there is no restriction on this.

[0126] Dry reagent 16 is in contrast to liquid reagent. Dry reagent 16 refers to non-liquid reagent. For example, dry reagent 16 can be lyophilized reagent, air-dried reagent, or dry reagent obtained by other methods of removing moisture.

[0127] Compared to liquid reagents, dry reagent 16 can improve reagent stability to some extent.

[0128] For example, please refer to Figures 1, 2, and 6. The multiple cavities mentioned above also include a photometry cavity 12D. The sample analyzer includes a detection mechanism, which detects the test product prepared based on the sample in the photometry cavity 12D to obtain the sample detection result.

[0129] The reagent strip 100 also encapsulates a desiccant 13 (which can be understood as the first desiccant in the above embodiments). The desiccant 13 keeps the dry reagent 16 dry by absorbing moisture in the reagent chamber 12C. In other words, the desiccant 13 is encapsulated in the reagent strip 100 and does not come into contact with the atmospheric environment. By absorbing moisture in the reagent chamber 12C, the desiccant 13 helps to keep the reagent chamber 12C dry, which in turn helps to keep the dry reagent 16 dry, improves the long-term stability of the dry reagent 16, reduces the risk of the dry reagent 16 failing due to water absorption, and also reduces the sealing performance requirements of the reagent strip 100.

[0130] The type and form of the dried substance 13 can be referred to in any of the above embodiments, and will not be repeated here.

[0131] In some embodiments, the capture rod cavity 12A and the reagent cavity 12C are connected, and the drying material 13 can also keep the capture rod 11 dry by absorbing moisture in the capture rod cavity 12A. This allows the drying material 13 to be reused, which is beneficial for making the reagent strip 100 structurally compact.

[0132] The location of dry substance 13 is not limited.

[0133] For example, in some embodiments, the trapping rod cavity 12A is connected to the reagent cavity 12C, and the dried material 13 is contained in the trapping rod cavity 12A. Since the trapping rod cavity 12A is connected to the reagent cavity 12C, the dried material 13 can absorb moisture from the reagent cavity 12C even while it is in the trapping rod cavity 12A. In this embodiment, the dried material 13 reuses the trapping rod cavity 12A, and the reagent strip 100 does not need to allocate additional space for the dried material 13, which is beneficial for the compact structure of the reagent strip 100.

[0134] In some embodiments, the dried substance 13 is housed in the reagent chamber 12C. In this embodiment, the dried substance 13 reuses the reagent chamber 12C, and the reagent strip 100 does not need to allocate additional space for the dried substance 13, which is beneficial for the compact structure of the reagent strip 100. It should be noted that when the dried substance 13 is in contact with the dry reagent 16, or when the dried substance 13 is in contact with the reconstitution solution, the dried substance 13 cannot participate in the reaction of the sample and reagents, so as to minimize the impact on the sample detection results.

[0135] In some embodiments, please refer to Figures 3 to 5, the reagent strip body 12 includes a first receiving portion 12F, which is in communication with the reagent chamber 12C, and the dried substance 13 is contained in the first receiving portion 12F.

[0136] Of course, in the embodiment where the dry substance 13 is contained in the reagent chamber 12C, the dry substance 13 may also never come into contact with the dry reagent 16 or the reconstituted solution.

[0137] For example, the dried substance 13 is placed in the first receiving portion 12F in the above embodiment, and the first receiving portion 12F is detachably disposed in the reagent chamber 12C. When the reagent strip 100 is installed in the sample analyzer for use, before injecting the reconstituted solution into the reagent chamber 12C, the first receiving portion 12F is removed from the reagent chamber 12C, and then the reconstituted solution is injected into the reagent chamber 12C.

[0138] It should be noted that in some embodiments, the opening of the reagent chamber 12C can also be sealed by the sealing film 15, that is, both the first receiving portion 12F and the dry reagent 16 are encapsulated in the reagent chamber 12C. In other embodiments, the opening of the reagent chamber 12C can be sealed by the first receiving portion 12F.

[0139] In some embodiments, referring to Figures 3 to 5, the reagent strip body 12 includes a first receiving portion 12F, which is located outside the capture rod cavity 12A and outside the reagent cavity 12C, and is in communication with the reagent cavity 12C. That is, the dried substance 13 does not occupy the space of either the reagent cavity 12C or the capture rod cavity 12A.

[0140] In some embodiments, the first accommodating portion 12F and the reagent chamber 12C are arranged adjacent to each other left and right. The top side of the first accommodating portion 12F has a first opening, and the top side of the reagent chamber 12C has a second opening. The first opening and the second opening are sealed by a sealing film 15. The adjacent arrangement of the first opening and the second opening is beneficial to the sealing operation using the sealing film 15.

[0141] In some embodiments, the sealing film 15 forms part of the outer appearance surface of the reagent strip 100. That is to say, after being sealed by the sealing film 15, there is no need to provide protective measures such as a protective outer cover on the outer layer of the sealing film 15. When the reagent strip 100 is loaded into the sample analyzer for use, the sealing film 15 needs to be damaged. For example, an additional film-breaking structure is used to pierce the sealing film 15, or the reagent dispensing mechanism itself has a structure for piercing the sealing film 15.

[0142] The type of the sealing film 15 can be the type of the sealing film 15 in any of the above embodiments, which will not be elaborated here. Exemplarily, referring to FIG. 5, the first accommodating portion 12F and the reagent chamber 12C are arranged adjacent to each other left and right. The chamber wall of the reagent chamber 12C includes a chamber side wall 12C1 and a chamber bottom wall 12C2. The chamber bottom wall 12C2 faces the opening of the reagent chamber 12C. One or more through holes 12H are provided on the chamber side wall 12C1. The one or more through holes 12H communicate the first accommodating portion 12F and the reagent chamber 12C. The through holes 12H provided on the chamber side wall 12C1 can be relatively high in position. After the reconstitution solution is quantitatively injected into the reagent chamber 12C, the reconstitution solution is not likely to enter the through holes 12H. The first accommodating portion 12F and the through holes 12H do not affect the liquid level of the liquid reagent in the reagent chamber 12C, and thus do not affect the contact area between the capture rod 11 and the liquid reagent. On the other hand, the dry matter 13 is not easily mixed into the liquid reagent, reducing the influence of the dry reagent on the sample detection result.

[0143] The dry matter 13 includes one or more dry particles. The size of the through holes 12H and the size of the dry particles satisfy that the one or more dry particles cannot pass through the through holes 12H. Thus, by controlling the size of the through holes 12H, the dry particles are prevented from entering the reagent chamber 12C.

[0144] In some embodiments, referring to FIG. 5, the lowest position h2 of the one or more through holes 12H is not lower than 2 / 3 of the depth h1 of the reagent chamber 12C. That is, h1*1 / 3≤h2<h1. Thus, the lowest position of the through holes 12H is relatively high and is not likely to contact the liquid reagent.

[0145] In some implementations, reagent chamber 12C is also used to hold a reconstitution solution. The dry reagent 16 can be mixed with the reconstitution solution to form a liquid reagent. When the capture rod 11 is inserted into the liquid reagent in reagent chamber 12C, the dried substance 13 does not come into contact with the liquid reagent. When the reagent strip 100 is used on a sample analyzer, the reconstitution solution needs to be dispensed into reagent chamber 12C first, allowing the dry reagent 16 to dissolve in the reconstitution solution, thus forming a liquid reagent. After the capture rod 11 is inserted into the liquid reagent in reagent chamber 12C, the liquid level in reagent chamber 12C will rise. That is, even when the capture rod 11 is inserted into the liquid reagent in reagent chamber 12C, the dried substance 13 will not come into contact with the liquid reagent, and the dried substance 13 will not mix into the liquid reagent. Thus, the probability of contamination of the reagent by the dried substance 13 can be reduced.

[0146] Other structures in this embodiment can refer to the reagent strip 100 in any of the above embodiments, and will not be described again here.

[0147] The following is a brief description of six exemplary embodiments of this application with reference to the accompanying drawings. It should be understood that these six embodiments are only some embodiments of this application, and not an exhaustive list of embodiments.

[0148] First Embodiment

[0149] Please refer to Figure 5. In this embodiment, the first receiving portion 12F is located outside the reagent chamber 12C. The first receiving portion 12F and the reagent chamber 12C are arranged adjacent to each other in the length direction of the reagent strip. A through hole 12H is provided on the side wall 12C1 of the reagent chamber 12C. The dried granules are contained in the first receiving portion 12F and cannot pass through the through hole 12H.

[0150] The opening on the top side of the first receiving part 12F and the opening on the top side of the reagent chamber 12C are sealed by the same sealing membrane 15.

[0151] When the reconstituted solution is dispensed into reagent chamber 12C, it mixes with dry reagent 16 to form liquid reagent. When the capture rod 11 is inserted into reagent chamber 12C, the liquid level will be lower than the lowest position of the through hole 12H, so that the liquid reagent will not pass through the through hole 12H and will not come into contact with the dry particles.

[0152] Of course, in other embodiments, the dried granules can be removed from the opening on the top side of the first receiving part 12F before the rehydration solution is injected, so there is no requirement for the height of the through hole 12H.

[0153] Second Embodiment

[0154] Referring to Figure 6, in this embodiment, the first receiving portion 12F is located inside the reagent chamber 12C and is detachably disposed at the opening of the reagent chamber 12C. Before dispensing the reconstituted solution, the first receiving portion 12F can be removed from the reagent chamber 12C.

[0155] Third Embodiment

[0156] Referring to Figure 7, in this embodiment, the first receiving portion 12F and the reagent chamber 12C are arranged adjacent to each other vertically. The first receiving portion 12F detachably covers and exposes the reagent chamber 12C. Before injecting the reconstituted solution into the reagent chamber 12C, the first receiving portion 12F is removed, and then the reconstituted solution is injected into the reagent chamber 12C.

[0157] Fourth embodiment

[0158] Referring to Figure 8, in this embodiment, both the dried substance 13 and the dry reagent 16 are disposed in the reagent chamber 12C, and the dried substance 13 and the dry reagent 16 can be in contact with each other. In this embodiment, it can be understood that the first receiving part 12F is not provided.

[0159] In this embodiment, the dried substance 13 can be removed from the reagent chamber 12C before dispensing the reconstitution solution. Alternatively, the dried substance 13 can also be dissolved in the reconstitution solution, as long as the composition of the dried substance 13 does not substantially affect the reaction of the sample and reagents.

[0160] Fifth embodiment

[0161] Referring to Figure 9, in this embodiment, the reagent strip includes a container 18 disposed within the reagent chamber 12C. A dry reagent 16 is disposed within the container 18, and a dried substance 13 is located in the space between the cavity wall of the reagent chamber 12C and the outer surface of the container 18. The container 18 also serves to hold the reconstitution solution, allowing the dry reagent 16 to mix with the reconstitution solution in the container 18 to form a liquid reagent. In other words, the reconstitution solution will not flow out of the container 18, thus ensuring that the dried substance 13, even if located below the container 18, will not come into contact with the reconstitution solution.

[0162] Sixth Embodiment

[0163] Please refer to Figure 10. In this embodiment, it is similar to the second embodiment described above, except that the shape of the first receiving portion 12F is different. In this embodiment, the first receiving portion 12F is roughly cup-shaped and can extend deep into the reagent chamber 12C. The first receiving portion 12F can be removed before dispensing the reconstituted solution.

[0164] This application provides a sample analyzer, including a sample analysis module and a reagent strip 100 in any embodiment of this application.

[0165] The sample analysis module includes a reagent strip storage area, a sample dispensing mechanism, a reagent dispensing mechanism, a retrieval mechanism 200, and a testing mechanism.

[0166] The reagent strip storage area can hold at least one reagent strip 100.

[0167] The sample dispensing mechanism is used to dispense the sample into the sample chamber 12B of the reagent strip 100.

[0168] The retrieving mechanism 200 is used to drive the reagent strip body to move relative to the capture rod 11. That is, the reagent strip body 12 can move while the capture rod 11 remains stationary; or the reagent strip body 12 can remain stationary while the capture rod 11 moves. As long as the reagent strip body 12 and the capture rod 11 move relative to each other, the capture rod 11 can be separated from the reagent strip body 12, or the capture rod 11 can be placed into the capture rod cavity 12A of the reagent strip body.

[0169] The reagent dispensing mechanism is used to dispense the reconstituted solution into the reagent chamber 12C of the reagent strip 100 so that the dry reagent 16 is mixed with the reconstituted solution to obtain a liquid reagent.

[0170] Testing agencies use these instruments to detect analytes prepared from samples. For example, they can excite the analyte, such as a marker bound to a target substance, to emit light, and detect parameters such as the intensity of the light emission; based on the test results, the concentration of the target substance in the sample can be determined, for example.

[0171] The controller is used to control the reagent dispensing mechanism to dispense the reconstituted solution into the reagent chamber 12C of the reagent strip 100, and to control the retrieving mechanism 200 to remove the capture rod 11 from the capture rod chamber 12A and place it in the sample chamber 12B so that the capture rod 11 captures the target substance in the sample. It is also used to control the retrieving mechanism 200 to remove the capture rod 11 from the sample chamber 12B and place it in the liquid reagent in the reagent chamber 12C to react and obtain the test product; and to control the detection mechanism to detect the test product.

[0172] In another embodiment, the test strip also has substrate wells pre-filled with substrate solution, which reacts with the substance bound from the capture rod to obtain the analyte. The substrate solution may include substances capable of exciting the luminescence of a labeled substance, such as hydrogen peroxide, or substrates containing enzyme-catalyzed luminescence from a labeled substance (such as alkaline phosphatase), such as AMPPD (1,2-dioxane derivative). The detection mechanism can detect changes in the luminescence signal generated on the capture rod, changes in the luminescence signal after the eluent eluted from the capture rod and the substrate solution are mixed, or changes in the luminescence signal of the substrate solution triggered by contact between the capture rod and the substrate solution.

[0173] In some embodiments, the aforementioned plurality of cavities further include a reaction well, and the reagent dispensing mechanism is further configured to aspirate the substrate liquid from the substrate well and discharge at least a portion of the substrate liquid into the reaction well. The controller is further configured to control the retrieving mechanism to insert the capture rod into the reaction well.

[0174] In some embodiments, the reagent dispensing mechanism for dispensing the reconstituted solution and the reagent dispensing mechanism for dispensing the substrate solution described above can share the same fluid path and electromechanical structure. For example, the reconstituted solution can be drawn and dispensed using a reagent needle, and after cleaning the reagent needle, the substrate solution can be drawn and dispensed using the reagent needle. In other embodiments, the reagent strip 100 further includes one or more pipette tips, and the multiple cavities also include pipette tip cavities, in which pipette tips are pre-positioned. The reagent dispensing mechanism can be connected to the pipette tip in the reagent strip, through which the reconstituted solution is drawn and dispensed, and then the pipette tip can be unloaded into the pipette tip cavity. When it is necessary to dispense the substrate solution, the reagent dispensing mechanism can be connected to another pipette tip in the reagent strip, through which the substrate solution is drawn and dispensed, and then the pipette tip can be unloaded into the corresponding pipette tip cavity.

[0175] In some sample analyzers, the reagent dispensing mechanism can be used to aspirate reagents and dispense them into reaction cups. The sample dispensing mechanism then dispenses the sample into the reaction cups, and the detection mechanism analyzes the reaction solution containing the sample and reagents in the reaction cups. When reagent strips are loaded into this type of sample analyzer, the reagent dispensing mechanism is also suitable for dispensing reconstituted solutions into the reagent chamber.

[0176] The sample analyzer of this application embodiment contains dry reagent 16 and desiccant 13 sealed in the reagent strip 100. The desiccant 13 is used to keep the dry reagent 16 dry, which makes the dry reagent 16 more stable. Even if the reagent strip 100 is stored in the reagent storage area for a long time (e.g., 1 to 2 months), the stability of the reagent can still be maintained.

[0177] In the description of this application, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the embodiments of this application. In this application, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Furthermore, without contradiction, those skilled in the art can combine different embodiments or examples described in this application, as well as features of different embodiments or examples.

[0178] The above description is merely a preferred embodiment of this application and is not intended to limit the application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A reagent strip, comprising: Capture stick; The reagent strip body has multiple chambers with a top side opening. The multiple chambers include a capture rod chamber, a sample chamber, and a reagent chamber. The reagent strip body also includes a first receiving part. The sample chamber is used to contain a sample. The reagent chamber contains a dry reagent for sample detection. The dry reagent is exposed to the environment of the reagent chamber. The capture rod is placed in the capture rod chamber. The first container contains a first drying substance, and the first container is connected to the reagent chamber so that the first drying substance can absorb moisture in the reagent chamber.

2. The reagent strip according to claim 1, wherein the first receiving portion is further connected to the capture rod cavity, so that the first drying substance can also absorb moisture in the capture rod cavity.

3. The reagent strip according to claim 1, wherein the reagent strip body further comprises a second receiving portion, the second receiving portion being filled with a second drying substance, the second receiving portion being in communication with the capture rod cavity, so that the second drying substance can absorb moisture in the capture rod cavity.

4. The reagent strip according to any one of claims 1-3, wherein the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right, the top side of the first receiving portion has a first opening, the top side of the reagent chamber has a second opening, and the first opening and the second opening are sealed by a sealing film.

5. The reagent strip according to any one of claims 1-4, wherein the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right, the cavity wall of the reagent chamber includes a cavity side wall and a cavity bottom wall, the cavity bottom wall faces the opening of the reagent chamber, and the cavity side wall is provided with one or more through holes, the one or more through holes communicating with the first receiving portion and the reagent chamber.

6. The reagent strip according to any one of claims 1-3, wherein the first receiving portion and the reagent chamber are arranged adjacent to each other vertically, the first receiving portion detachably covers and exposes the reagent chamber, and after the first receiving portion is removed to expose the reagent chamber, the reagent chamber is also used to hold a reconstituted solution, wherein the dry reagent can be mixed with the reconstituted solution to form a liquid reagent.

7. The reagent strip according to any one of claims 1-3, wherein the first receiving portion is located within the reagent chamber and is detachably connected to the reagent chamber, the dry reagent is located in the space below the first receiving portion, and after the first receiving portion is removed from the reagent chamber, the reagent chamber is further used to hold a reconstituted solution, and the dry reagent can be mixed with the reconstituted solution to form a liquid reagent; or, the reagent strip body includes a container, the container is disposed within the reagent chamber, the dry reagent is disposed within the container, the cavity wall of the reagent chamber and the outer surface of the container constitute the first receiving portion, the container is further used to hold a reconstituted solution, and the dry reagent can be mixed with the reconstituted solution in the container to form a liquid reagent.

8. The reagent strip according to any one of claims 1-7, wherein the reagent strip body, with a plurality of chambers opening on the top side, is sealed by a sealing membrane, wherein, The sealing film forms part of the outer surface of the reagent strip, and / or the sealing film includes a water-resistant heat-sealing aluminum film.

9. The reagent strip according to any one of claims 1-8, The reagent chamber is also used to hold the reconstituted solution, and the dry reagent can be mixed with the reconstituted solution to form a liquid reagent. When the capture rod is inserted into the liquid reagent in the reagent chamber, the first dry substance does not come into contact with the liquid reagent.

10. The reagent strip according to any one of claims 1-9, wherein the first drying substance comprises one or more drying particles, the first receiving portion and the reagent chamber are connected through one or more through holes, the size of the through holes and the size of the drying particles satisfying that a single drying particle cannot pass through the through hole; preferably, the drying particles comprise drying balls.

11. The reagent strip according to any one of claims 1-10, wherein the dry reagent comprises lyophilized reagent and / or air-dried reagent; And / or, the surface of the capture rod is coated with a first antibody, and the dry reagent contains a second antibody reagent linked to a marker.

12. The reagent strip according to any one of claims 1-11, wherein the first drying substance is selected from at least one of: silica desiccant, molecular sieve desiccant, activated carbon desiccant, fiber desiccant, and activated alumina.

13. A reagent strip, comprising: Capture stick; The reagent strip body has multiple chambers with a top side opening. The multiple chambers include a capture rod chamber, a sample chamber, and a reagent chamber. The sample chamber is used to contain a sample. The reagent chamber contains a dry reagent for sample detection. The dry reagent is exposed to the environment of the reagent chamber. The capture rod is placed in the capture rod chamber. The reagent strip is also encapsulated with a desiccant that can absorb moisture in the reagent chamber.

14. The reagent strip according to claim 13, wherein the capture rod cavity and the reagent cavity are connected, and the drying substance can also absorb moisture in the capture rod cavity.

15. The reagent strip according to claim 13, The capture rod cavity is connected to the reagent cavity, and the dried substance is contained in the capture rod cavity; and / or, the dried substance is contained in the reagent cavity.

16. The reagent strip according to claim 13, wherein the reagent strip body includes a first receiving portion, the first receiving portion being in communication with the reagent chamber, and the dried substance being contained in the first receiving portion.

17. The reagent strip according to claim 16, wherein the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right, the top side of the first receiving portion has a first opening, the top side of the reagent chamber has a second opening, and the first opening and the second opening are sealed by a sealing film.

18. The reagent strip according to claim 16, wherein the first receiving portion and the reagent chamber are arranged adjacent to each other on the left and right, the cavity wall of the reagent chamber includes a cavity side wall and a cavity bottom wall, the cavity bottom wall faces the opening of the reagent chamber, and the cavity side wall is provided with one or more through holes, the one or more through holes communicating with the first receiving portion and the reagent chamber; The dried material comprises one or more dried particles, and the size of the through hole and the size of the dried particles satisfy the condition that the one or more dried particles cannot pass through the through hole.

19. The reagent strip according to any one of claims 13-18, wherein the reagent chamber is further configured to hold a reconstituted solution, the dry reagent being capable of mixing with the reconstituted solution to form a liquid reagent, and the dry substance not coming into contact with the liquid reagent when the capture rod is inserted into the reagent chamber.

20. A sample analyzer, comprising: The sample analysis module and the reagent strip according to any one of claims 1-19 The sample analysis module includes: A reagent strip storage area, wherein at least one of the reagent strips can be placed; A sample dispensing mechanism for dispensing samples into the sample chamber of the reagent strip; A retrieving mechanism is used to drive the relative movement between the reagent strip body and the capture rod; A reagent dispensing mechanism is used to dispense the reconstituted solution into the reagent chamber of the reagent strip, so that the dry reagent and the reconstituted solution are mixed to obtain a liquid reagent; Testing institutions are used to test analytes prepared from samples. The controller is configured to control the reagent dispensing mechanism to dispense the reconstituted solution into the reagent chamber of the reagent strip, and to control the retrieving mechanism to remove the capture rod from the capture rod chamber and place it in the sample in the sample chamber so that the capture rod captures the target substance in the sample. It is also configured to control the retrieving mechanism to remove the capture rod from the sample chamber and place it in the liquid reagent in the reagent chamber to react and obtain the analyte; and to control the detection mechanism to detect the analyte.

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