A sample analysis device and a sample detection method

CN115541538BActive Publication Date: 2026-10-27SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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Patent Information

Application Number
CN202110728093.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-06-29
Publication Date
2026-10-27
Estimated Expiration
2041-06-29

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Abstract

A sample analysis device and a sample detection method, control the detection of specific proteins in a reaction cell; obtain the type of specific proteins detected in the reaction cell; after the measurement is completed, according to the type of specific proteins, the reaction cell is cleaned. The present application proposes a new cleaning scheme, which uses different cleaning parameters to clean the reaction cell according to different specific proteins or the strength of the protein micelle adhesion of different specific proteins.
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Description

Technical Field

[0001] This invention relates to a sample analysis device and a sample detection method. Background Technology

[0002] Sample analysis devices, or in vitro diagnostic equipment, are instruments that obtain clinical diagnostic information by testing human samples (such as blood, body fluids, and tissues) outside the human body.

[0003] To avoid inaccurate test results due to cross-contamination between samples, it is usually necessary to clean the relevant components in the sample analysis device.

[0004] Let's take the detection of a specific protein as an example.

[0005] Specific proteins refer to certain special types of proteins present in human plasma, including C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen. These specific proteins can reflect the body's inflammatory status and postoperative recovery status, and therefore have important clinical significance.

[0006] The concentration of specific proteins in blood can be detected using immunoturbidimetric inhibition immunoassay. Specifically, immunoturbidimetry is a method for dynamically measuring antigen-antibody binding; it is divided into immunotransmission turbidimetry and immunoscattering turbidimetry. Antibody-antigen complexes scatter and block light. Therefore, the amount of antibody-antigen complexes is proportional to the change in the intensity of transmitted or scattered light. When the amount of antibody is constant, the change in light intensity is also proportional to the antigen content. Therefore, under certain conditions, by detecting the change in the intensity of transmitted or scattered light and the calibration curve, the concentration or content of the antigen, i.e., the specific protein, in the sample can be determined.

[0007] A process could be like this:

[0008] Please refer to Figure 1 The sample and hemolysin are added to the reaction chamber. After the sample dissolves and incubates, a latex reagent containing a specific protein is added. This latex reagent is a suspension composed of nanoscale latex particles (antibodies). Under certain conditions, these latex particles can bind to surrounding specific proteins (antigens), forming larger microclusters. As the latex particles continuously bind to the specific protein, the volume of the resulting microclusters increases. When irradiated with light of a specific wavelength, the scattering signal gradually increases, while the transmission signal gradually decreases. By monitoring the rate of change in the scattering or transmission signal and through certain calculations, the content of the specific protein in the original sample can be obtained.

[0009] As can be seen, the determination of a specific protein is essentially a process in which the specific protein antigen and latex particle antibody continuously combine to form larger microclusters (let's call them protein microclusters). These protein microclusters are very prone to adhering to the reaction chamber wall during the formation process. If they are not cleaned in time, they will cause many adverse effects. Therefore, after each sample or project is tested, the reaction chamber and other components need to be cleaned.

[0010] How to perform specific cleaning is a question that people in this field have always been concerned about and researching. Summary of the Invention

[0011] To address issues such as cleaning reaction tanks, this invention proposes a novel cleaning solution.

[0012] According to a first aspect, one embodiment provides a sample analysis device, including a sampling unit, a reagent supply unit, a reaction unit, a detection unit, a cleaning assembly, and a controller;

[0013] The sampling unit is used to acquire a sample and then deliver the sample to the reaction unit;

[0014] The reagent supply unit is used to store reagents and supply reagents to the reaction unit;

[0015] The reaction unit includes at least a reusable reaction chamber; the reusable reaction chamber is capable of preparing at least a first type of specific protein sample and a second type of specific protein sample; the first type of specific protein sample is prepared by the reusable reaction chamber by receiving a sample delivered by the sampling unit and a first type of reagent supplied by the reagent supply unit, and is used for the determination of a first type of specific protein detection item; the second type of specific protein sample is prepared by the reusable reaction chamber by receiving a sample delivered by the sampling unit and a second type of reagent supplied by the reagent supply unit, and is used for the determination of a second type of specific protein detection item;

[0016] The detection unit includes a specific protein detection unit, which can be used to detect the first type of specific protein sample and the second type of specific protein sample to obtain the detection results of the first type of specific protein and the detection results of the second type of specific protein.

[0017] The cleaning assembly is used at least for cleaning the reusable reaction tank; the cleaning assembly has at least a post-detection cleaning mode, the post-detection cleaning mode has at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than the cleaning force of the second cleaning parameter;

[0018] After each test item of the reusable reaction tank is completed, the controller controls the cleaning assembly to execute the post-test cleaning mode to clean the reusable reaction tank; wherein:

[0019] The controller acquires the detection items of the reusable reaction tank; when the detection item of the reusable reaction tank is the first type of specific protein detection item, after the detection item is measured, the controller controls the cleaning component to execute the post-detection cleaning mode according to the first cleaning parameters to clean the reusable reaction tank; when the detection item of the reusable reaction tank is the second type of specific protein detection item, after the detection item is measured, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameters to clean the reusable reaction tank.

[0020] In one embodiment, the cleaning component further has a cleaning mode after project switching, the cleaning mode after project switching has a third cleaning parameter, and the cleaning force of the third cleaning parameter is stronger than the cleaning force of the second cleaning parameter.

[0021] The controller determines whether to control the cleaning component to execute the cleaning mode after the item switching to clean the reusable reaction tank based on the currently completed test items and the next test items to be tested in the reusable reaction tank.

[0022] When the currently completed test item in the reusable reaction tank is a second type of specific protein test item, and the next test item to be tested is a first type of specific protein test item, then after the currently completed test item and before the next test item is tested, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameters and the post-item switching cleaning mode according to the third cleaning parameters to clean the reusable reaction tank; or...

[0023] When the currently completed test item in the reusable reaction tank is the second type of specific protein test item, and the next test item to be tested is the first type of specific protein test item, then after the currently completed test item and before the next test item to be tested, the controller controls the cleaning component not to execute the post-test cleaning mode, but to execute the post-item switching cleaning mode according to the third cleaning parameter to clean the reusable reaction tank.

[0024] In one embodiment, the cleaning component further includes a pre-detection cleaning mode, which has a fourth cleaning parameter, the cleaning force of which is stronger than that of the second cleaning parameter; preferably, the cleaning force of the fourth cleaning parameter is stronger than that of the first cleaning parameter, and / or, the cleaning force of the fourth cleaning parameter is stronger than that of the third cleaning parameter.

[0025] Before the test items of the reusable reaction cell are measured, the controller obtains the blank voltage of the reusable reaction cell. When the blank voltage is outside the preset range, the controller controls the cleaning component to perform the pre-test cleaning mode according to the fourth cleaning parameter to clean the reusable reaction cell so that the blank voltage is within the preset range.

[0026] According to a second aspect, one embodiment provides a sample analysis apparatus, including a sampling unit, a reagent supply unit, a reaction unit, a detection unit, a cleaning assembly, and a controller;

[0027] The sampling unit is used to acquire a sample and then deliver the sample to the reaction unit;

[0028] The reagent supply unit is used to store reagents and supply reagents to the reaction unit;

[0029] The reaction unit includes at least a first type of reaction tank and a second type of reaction tank; the first type of reaction tank is used to receive the sample delivered by the sampling unit and the first type of reagent supplied by the reagent supply unit to prepare a first type of specific protein sample for measuring a first type of specific protein detection item; the second type of reaction tank is used to receive the sample delivered by the sampling unit and the second type of reagent supplied by the reagent supply unit to prepare a second type of specific protein sample for measuring a second type of specific protein detection item.

[0030] The detection unit includes a first-type specific protein detection unit and a second-type specific protein detection unit; the first-type specific protein detection unit is used to detect the first-type specific protein sample to obtain the detection result of the first-type specific protein; the second-type specific protein detection unit is used to detect the second-type specific protein sample to obtain the detection result of the second-type specific protein.

[0031] The cleaning assembly is used to clean the first type of reaction tank and the second type of reaction tank; the cleaning assembly has at least a post-detection cleaning mode, the post-detection cleaning mode has at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than the cleaning force of the second cleaning parameter.

[0032] After each test item measurement in the first type of reaction tank is completed, the controller controls the cleaning component to execute the post-test cleaning mode according to the first cleaning parameters to clean the first type of reaction tank; after each test item measurement in the second type of reaction tank is completed, the controller controls the cleaning component to execute the post-test cleaning mode according to the second cleaning parameters to clean the second type of reaction tank.

[0033] In one embodiment, the cleaning component further includes a pre-detection cleaning mode, which has a fourth cleaning parameter. The cleaning force of the fourth cleaning parameter is stronger than that of the second cleaning parameter. Preferably, the cleaning force of the fourth cleaning parameter is stronger than that of the first cleaning parameter.

[0034] Before the detection of the first type of reaction cell, the controller acquires the blank voltage of the first type of reaction cell. When the blank voltage is outside the preset range, the controller controls the cleaning component to execute the pre-detection cleaning mode according to the fourth cleaning parameter to clean the first type of reaction cell, so that the blank voltage is within the preset range; and / or,

[0035] Before the second type of reaction cell test item is measured, the controller obtains the blank voltage of the second type of reaction cell. When the blank voltage is outside the preset range, the controller controls the cleaning component to execute the pre-test cleaning mode according to the fourth cleaning parameter to clean the second type of reaction cell, so that the blank voltage is within the preset range.

[0036] In one embodiment, the first cleaning parameter and the second cleaning parameter include at least different cleaning durations, different types of cleaning agents, and / or different concentrations of cleaning agents.

[0037] In one embodiment, the cleaning duration of the first cleaning parameter is greater than the cleaning duration of the second cleaning parameter; and / or, the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and / or, the cleaning agent concentration of the first cleaning parameter is greater than the cleaning agent concentration of the second cleaning parameter.

[0038] In one embodiment, the first type of specific protein includes at least C-reactive protein, and the second type of specific protein includes at least serum amyloid protein.

[0039] In one embodiment, the cleaning agent includes at least a hemolytic agent.

[0040] In one embodiment, the first type of reagent includes a hemolytic agent; the second type of reagent includes a hemolytic agent; and the hemolytic agents included in the first type of reagent and the second type of reagent are of the same kind.

[0041] In one embodiment, the reaction unit further includes a blood routine reaction unit, and the detection unit further includes a blood routine detection unit;

[0042] The blood routine reaction unit is used to receive the sample delivered by the sampling unit and the third type of reagent supplied by the reagent supply unit to prepare blood routine test samples for determining blood routine test items;

[0043] The complete blood count (CBC) unit includes one or more of the following: a DIFF unit, an RBC unit, an HGB unit, an NRBC unit, and a RET unit. The DIFF unit is used to detect the four differential white blood cell counts; the HGB unit is used to detect hemoglobin concentration; the RBC unit is used to detect red blood cell count and / or platelet count; the RET unit is used to detect reticulocyte count; and the NRBC unit is used to detect nucleated red blood cell count, white blood cell count, and basophil count.

[0044] In one embodiment, the third type of reagent includes at least a hemolytic agent; the cleaning assembly uses the hemolytic agent from the third type of reagent for cleaning.

[0045] According to a third aspect, one embodiment provides a sample detection method applied to a sample analysis device capable of determining multiple specific proteins, the sample detection method comprising:

[0046] The detection of any one of the various specific proteins is controlled within the reaction chamber;

[0047] To obtain the types of specific proteins currently being tested in the reaction vessel;

[0048] Obtain the cleaning parameters corresponding to the specific protein being detected; among the multiple specific proteins, at least two specific proteins have different cleaning parameters, and different cleaning parameters correspond to different cleaning intensities;

[0049] After the measurement is completed, the reaction tank is cleaned according to the obtained cleaning parameters.

[0050] In one embodiment, the cleaning parameters include cleaning duration, type of cleaning agent, and / or concentration of cleaning agent.

[0051] In one embodiment, the sample detection method further includes:

[0052] Obtain the specific protein types that have been detected in the reaction chamber and the next specific protein types to be detected;

[0053] Obtain the cleaning parameters corresponding to the specific protein type to be detected next;

[0054] If the cleaning intensity of the cleaning parameters corresponding to the currently detected specific protein type is weaker than the cleaning intensity of the cleaning parameters corresponding to the next specific protein type to be detected, then the reaction tank is controlled to be cleaned additionally. Alternatively, the cleaning parameters corresponding to the currently detected specific protein type are adjusted so that the cleaning intensity is greater than or equal to the cleaning intensity of the cleaning parameters corresponding to the next specific protein type to be detected, and the reaction tank is cleaned according to the adjusted cleaning parameters.

[0055] In one embodiment, the plurality of specific proteins includes at least two of C-reactive protein, serum amyloid protein, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

[0056] According to a fourth aspect, one embodiment provides a computer-readable storage medium including a program that can be executed by a processor to perform the methods as described in any of the embodiments herein.

[0057] Based on the sample analysis apparatus and sample detection method of the above embodiments, as well as the computer-readable storage medium, a new cleaning scheme is proposed. For different specific proteins, or according to the strength of protein cluster adhesion of different specific proteins, different cleaning parameters are used to perform cleaning of the reaction cell. Attached Figure Description

[0058] Figure 1 This is a schematic diagram illustrating the determination of a specific protein in one embodiment;

[0059] Figure 2 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0060] Figure 3 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0061] Figure 4 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0062] Figure 5 This is a schematic diagram of the structure of a cleaning assembly according to one embodiment;

[0063] Figure 6 A flowchart of a sample detection method according to one embodiment;

[0064] Figure 7 This is a flowchart illustrating the process of cleaning the reaction tank according to the type of the specific protein after the determination is completed, as described in one embodiment.

[0065] Figure 8 This is a flowchart of a sample detection method according to one embodiment. Detailed Implementation

[0066] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0067] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0068] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0069] As mentioned in the background section, protein microparticles are very easy to adhere to the reaction chamber wall during the formation process. If they are not cleaned in time, they will cause many adverse effects. For example, they will carry contaminants, which will affect the detection results of the next sample. Furthermore, protein microparticles adhering to the reaction chamber wall will reduce the light transmittance of the reaction chamber, and the corresponding scattering or transmission signals will also change, directly affecting the detection results of the sample or project.

[0070] Therefore, after the sample or project is completed, the reaction tank and other components (such as related pipelines) need to be cleaned to restore them to their initial state to avoid affecting the test results of the next sample.

[0071] Currently, for instruments capable of measuring multiple specific proteins, the same cleaning strategy and fixed parameters are used to clean the reaction chamber and other components after each reaction and measurement.

[0072] The applicant discovered that different specific proteins, due to differences in their physicochemical properties and corresponding latex reagents, produce protein clusters with varying degrees of adhesion, ranging from strong to weak. For example, the applicant's research found that C-reactive protein (CRP) clusters exhibit stronger adhesion than serum amyloid (SAA) clusters. However, existing assays targeting different specific proteins use the same washing method. This one-size-fits-all approach is either only effective for weakly adhesive proteins, with negligible results for strongly adhesive proteins, or effective for strongly adhesive proteins but with a lengthy washing process, low efficiency, and high reagent consumption. Therefore, the applicant conceived a method to use different washing methods for different specific proteins, or to divide specific proteins into at least two groups based on the adhesion of their protein clusters, and then use different washing methods for different groups of specific proteins after detection, such as different washing durations, types, or concentrations of washing agents.

[0073] Therefore, this invention designs a specific intelligent cleaning scheme for proteins. For different specific proteins, or according to the strength of protein cluster adhesion of different specific proteins, different cleaning methods are used for different specific proteins. For example, for strongly adhesive proteins, a high-intensity cleaning method is used after the measurement to ensure the cleaning effect of the sample pool. For weakly adhesive proteins, a low-intensity cleaning method is used after the measurement to save cleaning time and reagents.

[0074] Please refer to Figure 2 Some embodiments of the present invention disclose a sample analysis device, which may include a sampling unit 10, a reagent supply unit 20, a reaction unit 30, a detection unit 40, a cleaning assembly 50, and a controller 60. The components are described in detail below.

[0075] The sampling unit 10 is used to acquire a sample and deliver it to the reaction unit 30. For example, the sampling unit 10 may include a sampling needle for drawing a sample from a sample tube located at the aspiration position and delivering the drawn sample to the reaction unit 30.

[0076] In this invention, the term "sample" generally refers to a blood sample, particularly a whole blood sample. In this document, the sample is typically derived from peripheral or venous blood samples from mammals, particularly from human blood samples. The sample has undergone necessary processing prior to the immune response, including but not limited to anticoagulation treatment.

[0077] The reagent supply unit 20 is used to store reagents and supply reagents to the reaction unit 30. For example, the reagent supply unit 20 can supply first-class reagents and second-class reagents to the reaction unit 30.

[0078] In some embodiments, the first type of reagent may include a hemolytic agent, and the first type of reagent may also include a latex reagent. In some embodiments, the second type of reagent may include a hemolytic agent, and the second type of reagent may also include a latex reagent. In some embodiments, the hemolytic agents included in the first type of reagent and the second type of reagent may be the same type of hemolytic agent.

[0079] The first type of reagent and the second type of reagent include at least the same type of hemolytic agent.

[0080] The reaction section 30 will now be explained.

[0081] Please refer to Figure 3 From a functional perspective, the reaction section 30 may include any one or more of the following: a first-type specific protein reaction section 31, a second-type specific protein reaction section 33, and a blood routine reaction section 35.

[0082] The first-type specific protein reaction unit 31 receives the sample delivered by the sampling unit 10 and the first-type reagent supplied by the reagent supply unit 20 to prepare a first-type specific protein sample, which is used for the determination of a first-type specific protein detection item. The second-type specific protein reaction unit 33 receives the sample delivered by the sampling unit 10 and the second-type reagent supplied by the reagent supply unit 20 to prepare a second-type specific protein sample, which is used for the determination of a second-type specific protein detection item.

[0083] The blood routine reaction unit 35 is used to receive the sample delivered by the sampling unit 10 and the third-class reagent supplied by the reagent supply unit 20 to prepare a blood routine sample for determining blood routine test items. In some embodiments, the third-class reagent may include at least a hemolytic agent. In some embodiments, the third-class reagent may also include a fluorescent agent.

[0084] From a structural perspective, the reaction unit 30 may include one or more reaction chambers for receiving samples and reagents delivered by the sampling unit 10 and the reagent supply unit 20 to prepare corresponding samples. For example, in some embodiments, the reaction unit 30 includes a reaction chamber for receiving samples delivered by the sampling unit 10 and first-type reagents supplied by the reagent supply unit 20 to prepare a first-type specific protein sample for measuring a first-type specific protein detection item. In other embodiments, the reaction unit 30 includes a reaction chamber for receiving samples delivered by the sampling unit 10 and second-type reagents supplied by the reagent supply unit 20 to prepare a second-type specific protein sample for measuring a second-type specific protein detection item. In yet another embodiment, the reaction unit 30 includes a reaction chamber for receiving samples delivered by the sampling unit 10 and third-type reagents supplied by the reagent supply unit 20 to prepare a blood routine test sample for measuring a blood routine test item.

[0085] When designing a sample analysis device, a first type of reaction cell and a second type of reaction cell can be designed. The first type of reaction cell is used to receive the sample delivered by the sampling unit 10 and the first type of reagent supplied by the reagent supply unit 20 to prepare a first type of specific protein sample for measuring a first type of specific protein detection item. The second type of reaction cell is used to receive the sample delivered by the sampling unit 10 and the second type of reagent supplied by the reagent supply unit 20 to prepare a second type of specific protein sample for measuring a second type of specific protein detection item.

[0086] When designing the sample analysis device, a reusable reaction cell can also be designed. The reusable reaction cell can be used to prepare at least a first type of specific protein sample and a second type of specific protein sample. In other words, the first type of specific protein sample is prepared by the reusable reaction cell by receiving the sample delivered by the sampling unit 10 and the first type of reagent supplied by the reagent supply unit 20, and is used for the determination of the first type of specific protein detection item; the second type of specific protein sample is prepared by the reusable reaction cell by receiving the sample delivered by the sampling unit 10 and the second type of reagent supplied by the reagent supply unit 20, and is used for the determination of the second type of specific protein detection item.

[0087] Regardless of whether it is a Class I reaction cell, a Class II reaction cell, or a reusable reaction cell, in some cases they are also used to prepare blood routine samples.

[0088] The above are some explanations of the reaction section 30.

[0089] The testing section 40 is used to test the sample to obtain test results.

[0090] In some embodiments, the detection unit 40 includes a routine blood count detection unit 41 and / or a specific protein detection unit 43, which will be described in detail below.

[0091] The complete blood count (CBC) testing unit 41 is used to test a CBC sample to obtain CBC results. CBC results may include, but are not limited to, one or more of the following: white blood cell count, white blood cell differential (three-part, four-part, or five-part), red blood cell count, reticulocyte count, nucleated red blood cell count, platelet count, and hemoglobin concentration. Therefore, in some embodiments, the CBC testing unit 41 may be one or more of the following: a DIFF testing unit, an RBC testing unit, an HGB testing unit, an NRBC testing unit, and a RET testing unit; the DIFF testing unit is used to detect four-part white blood cell differential, the HGB testing unit is used to detect hemoglobin concentration, the RBC testing unit is used to detect red blood cell count and / or platelet count; the RET testing unit is used to detect reticulocyte count, and the NRBC testing unit is used to detect nucleated red blood cell count, white blood cell count, and basophil count.

[0092] The specific protein detection unit 43 can be used to detect a specific protein sample to obtain a corresponding detection result, i.e., the concentration of the specific protein. For example, the specific protein detection unit 43 can be used to detect a first type of specific protein sample and a second type of specific protein sample to obtain detection results for the first type of specific protein and the second type of specific protein. For some specific embodiments, please refer to... Figure 4 The specific protein detection unit 43 includes a first type specific protein detection unit 44 and a second type specific protein detection unit 45. The first type specific protein detection unit 44 is used to detect a first type specific protein sample to obtain the detection result of the first type specific protein; the second type specific protein detection unit 45 is used to detect a second type specific protein sample to obtain the detection result of the second type specific protein.

[0093] In some embodiments, the specific protein detection unit 43, the first type of specific protein detection unit 44, and the second type of specific protein detection unit 45 can be implemented by a photometer, which can specifically be a turbidimeter and / or a turbidimeter.

[0094] The cleaning component 50 is used at least for cleaning reaction tanks. For example, the cleaning component 50 cleans a reusable reaction tank. Another example is the cleaning component 50 cleaning a type I reaction tank. Yet another example is the cleaning component 50 cleaning a type II reaction tank.

[0095] In some embodiments, please refer to Figure 5 In the diagram, 39 represents a reaction tank, which can be a reusable reaction tank, a type I reaction tank, or a type II reaction tank. The reaction tank 39 is equipped with a waste liquid discharge port 39a and a first cleaning port 39b. The waste liquid discharge port 39a is used to discharge waste liquid, such as samples after testing or waste liquid generated during cleaning. Specifically, a waste liquid channel 38a and a waste liquid driving component 38 can be introduced; one end of the waste liquid channel 38a is connected to the waste liquid discharge port 39a of the reaction tank 39, and the other end is connected to the waste liquid driving component 38; the waste liquid driving component 38 is used to discharge the liquid in the reaction tank 39 through the waste liquid channel 38a. For example, the waste liquid driving component 38 may include a pressure source to provide negative pressure, allowing the waste liquid in the reaction tank 39 to flow into the waste liquid channel 38a through the waste liquid discharge port 39a and then be discharged. In some examples, the waste liquid discharge port 39a or the waste liquid channel 38a can be controllably opened and closed, for example, through a solenoid valve. In some examples, the waste liquid discharge port 39a is located at the bottom of the reaction tank 39.

[0096] In some embodiments, the cleaning assembly 50 is used to rinse the reaction tank with a cleaning agent. In some embodiments, the cleaning assembly 50 includes a cleaning agent supply component 51. The cleaning agent supply component 51 includes a cleaning agent supply channel 51a connected to a first cleaning port 39b of the reaction tank 39, and the cleaning agent supply component 51 is used to supply cleaning agent to the reaction tank 39 through the cleaning agent supply channel 51a. In some examples, the first cleaning port 39b is located on the side wall of the reaction tank 39. In the specific cleaning process, the cleaning agent supply component 51 uses, for example, positive pressure to add cleaning agent into the reaction tank 39 through the first cleaning port 39b to rinse the tank walls and other areas, and discharges the waste liquid through the waste liquid discharge port 39a. This rinsing action can be repeated several times to achieve a better rinsing effect.

[0097] The cleaning unit 50 can be used to rinse and / or soak the reaction tank with a cleaning agent. The cleaning agent can be a hemolysin, such as the hemolysin in the reusable reagent supply unit 20.

[0098] The above is a description of the sample analysis device of this application. The following section explains how to specifically clean the reaction tank.

[0099] Let's take a reusable reaction tank as an example.

[0100] In some embodiments, the cleaning component 50 has at least a post-detection cleaning mode, which has at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning intensity of the first cleaning parameter and the cleaning intensity of the second cleaning parameter are different, for example, the cleaning intensity of the first cleaning parameter is stronger than that of the second cleaning parameter. In some embodiments, the first cleaning parameter and the second cleaning parameter include at least different cleaning durations, different types of cleaning agents, and / or different concentrations of cleaning agents.

[0101] After each test item in the reusable reaction tank is completed (e.g., after the test item for the first or second type of specific protein is completed), the controller 60 controls the cleaning component 50 to execute a post-test cleaning mode to clean the reusable reaction tank. In some specific embodiments, the controller 60 acquires the test items of the reusable reaction tank; when the test item in the reusable reaction tank is a first type of specific protein test item, after the test item is completed, the controller 60 controls the cleaning component 50 to execute a post-test cleaning mode according to a first cleaning parameter to clean the reusable reaction tank; when the test item in the reusable reaction tank is a second type of specific protein test item, after the test item is completed, the controller 60 controls the cleaning component 50 to execute a post-test cleaning mode according to a second cleaning parameter to clean the reusable reaction tank.

[0102] For example, if the viscosity of protein clusters of a specific type of protein is greater than that of protein clusters of a specific type of protein, then in this case, the cleaning power of the first cleaning parameter is stronger than that of the second cleaning parameter. Specifically, the cleaning time of the first cleaning parameter is greater than the cleaning time of the second cleaning parameter; and / or, the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and / or, the cleaning agent concentration of the first cleaning parameter is greater than the cleaning agent concentration of the second cleaning parameter.

[0103] In some embodiments, the cleaning agent in the first cleaning parameter and the cleaning agent in the second cleaning parameter can both be LH hemolysin. In some embodiments, the cleaning agent in the first cleaning parameter is LN hemolysin, and the cleaning agent in the second cleaning parameter is LH hemolysin.

[0104] In some embodiments, the cleaning component 50 further has a post-project switching cleaning mode, wherein the post-project switching cleaning mode has a third cleaning parameter, the third cleaning parameter having a stronger cleaning force than the second cleaning parameter. The controller 60 determines whether to control the cleaning component 50 to execute the post-detection cleaning mode to clean the reusable reaction tank based on the currently completed detection item and the next detection item to be detected. In some embodiments, when the currently completed detection item of the reusable reaction tank is the second type of specific protein detection item and the next detection item to be detected is the first type of specific protein detection item, then after the currently completed detection item and before the next detection item is detected, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameter and the post-detection cleaning mode according to the third cleaning parameter to clean the reusable reaction tank. Alternatively, when the currently completed detection item of the reusable reaction tank is the second type of specific protein detection item and the next detection item to be detected is the first type of specific protein detection item, then after the currently completed detection item and before the next detection item is detected, the controller controls the cleaning component not to execute the post-detection cleaning mode but to execute the post-detection cleaning mode according to the third cleaning parameter to clean the reusable reaction tank.

[0105] For example, taking the case where the viscosity of protein clusters of the first type of specific protein is greater than that of the second type of specific protein, when the currently completed test item in the reusable reaction chamber is the detection item of the second type of specific protein, and the next test item to be detected is the detection item of the first type of specific protein, the controller 60 controls the cleaning component 50 to execute the post-test item switching cleaning mode to clean the reusable reaction chamber. In some specific embodiments, the controller 60 may control the cleaning component 50 to execute the post-test item switching cleaning mode to perform additional cleaning on the reusable reaction chamber. That is, when the currently completed test item is the detection item of the second type of specific protein, and the next test item to be detected is the detection item of the first type of specific protein, then after the second type of specific protein test item is completed and before the first type of specific protein test item is measured, the controller 60 controls the cleaning component 50 to perform two cleaning operations: one is the post-test cleaning mode, and the other is the post-test item switching cleaning mode. The order of these two cleaning operations can be adjusted.

[0106] For example, in some embodiments, the controller 60 controls the cleaning component 50 to execute a post-item switching cleaning mode instead of a post-detection cleaning mode to clean the reusable reaction tank. That is, if the currently completed test item is a second-type specific protein detection item, and the next test item is a first-type specific protein detection item, then the cleaning component 50 would normally execute the post-detection cleaning mode after the second-type specific protein detection item is completed and before the first-type specific protein detection item is measured. However, the controller 60 controls the cleaning component 50 to execute the post-item switching cleaning mode instead of the original post-detection cleaning mode. In some embodiments, the cleaning intensity of the post-item switching cleaning mode is stronger than the cleaning intensity of the first cleaning parameter in the post-detection cleaning mode.

[0107] In some embodiments, the cleaning component 50 further includes a pre-detection cleaning mode, which has a fourth cleaning parameter. The cleaning force of the fourth cleaning parameter is stronger than that of the second cleaning parameter. In some embodiments, the cleaning force of the fourth cleaning parameter is stronger than that of the first cleaning parameter. In some embodiments, the cleaning force of the fourth cleaning parameter is stronger than that of the third cleaning parameter. The pre-detection cleaning mode is related to the blank voltage. For example, the blank voltage (the signal detection voltage value when the tank is filled with a specific liquid, generally using a diluent) can be collected at a specified time point during the measurement process. Specifically, the blank voltage value can be read before each test item is measured. Of course, the blank voltage value can also be read after the reusable reaction tank has been used for a predetermined period of time, or after the reusable reaction tank has measured a predetermined number of test items. When the blank voltage is outside the preset range, it indicates that the contamination level of the tank has reached a certain level, and continued use may have a certain impact on the measured value. At this time, the reusable reaction tank can be subjected to the pre-detection cleaning mode.

[0108] Therefore, in some embodiments, the controller 60 acquires the blank voltage of the reusable reaction tank. When the blank voltage is outside the preset range, the cleaning component 50 is controlled to execute a pre-detection cleaning mode according to the fourth cleaning parameter to clean the reusable reaction tank, so that the blank voltage is within the preset range. The blank voltage is the voltage obtained by the controller 70 through irradiation of the specific liquid in the reusable reaction tank when it contains a specific liquid, sensing transmitted or scattered light and converting it into voltage. For blank voltage acquired using the scattering principle, the preset range is greater than a set voltage; for blank voltage acquired using the transmission principle, the preset range is less than a set voltage. In some embodiments, the specific liquid is a cleaning agent or diluent.

[0109] In some embodiments, the cleaning component 50 may use a hemolysin, such as LN hemolysin, when performing a pre-detection cleaning mode.

[0110] The above are some instructions for cleaning reusable reaction tanks.

[0111] The cleaning of the first and second type of reaction tanks will be explained below.

[0112] In some embodiments, the cleaning component 50 has at least a post-detection cleaning mode, which has at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning intensity of the first cleaning parameter and the cleaning intensity of the second cleaning parameter are different, for example, the cleaning intensity of the first cleaning parameter is stronger than that of the second cleaning parameter. In some embodiments, the first cleaning parameter and the second cleaning parameter include at least different cleaning durations, different types of cleaning agents, and / or different concentrations of cleaning agents.

[0113] After each measurement of a test item (e.g., a specific protein test item) in the first type of reaction tank is completed, the controller 60 controls the cleaning component 50 to execute a post-detection cleaning mode according to the first cleaning parameters to clean the first type of reaction tank; similarly, after each measurement of a test item (e.g., a specific protein test item) in the second type of reaction tank is completed, the controller 60 controls the cleaning component 50 to execute a post-detection cleaning mode according to the second cleaning parameters to clean the second type of reaction tank.

[0114] For example, if the viscosity of protein clusters of a specific type of protein is greater than that of protein clusters of a specific type of protein, then in this case, the cleaning power of the first cleaning parameter is stronger than that of the second cleaning parameter. Specifically, the cleaning time of the first cleaning parameter is greater than the cleaning time of the second cleaning parameter; and / or, the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and / or, the cleaning agent concentration of the first cleaning parameter is greater than the cleaning agent concentration of the second cleaning parameter.

[0115] In some embodiments, the cleaning agent in the first cleaning parameter and the cleaning agent in the second cleaning parameter can both be LH hemolysin. In some embodiments, the cleaning agent in the first cleaning parameter is LN hemolysin, and the cleaning agent in the second cleaning parameter is LH hemolysin.

[0116] In some embodiments, the cleaning component 50 further includes a pre-detection cleaning mode, which has a fourth cleaning parameter. The cleaning power of the fourth cleaning parameter is stronger than that of the second cleaning parameter. In some embodiments, the cleaning power of the fourth cleaning parameter is stronger than that of the first cleaning parameter. The pre-detection cleaning mode is related to the blank voltage. For example, the blank voltage (the signal detection voltage value when the tank is filled with a specific liquid, generally using a diluent) can be collected at a specified time point during the measurement process. Specifically, the blank voltage value can be read before each test item is measured. Alternatively, the blank voltage value can be read after the reaction tank has been used for a predetermined period of time, or after the reaction tank has been measured for a predetermined number of test items. When the blank voltage is outside the preset range, it indicates that the contamination level of the tank has reached a certain level, and continued use may have a certain impact on the measured value. In this case, the pre-detection cleaning mode can be applied to the reusable reaction tank.

[0117] Therefore, in some embodiments, the controller 60 acquires the blank voltage of the first type of reaction tank. When the blank voltage is outside the preset range, the cleaning component 50 is controlled to execute the pre-detection cleaning mode according to the fourth cleaning parameter to clean the first type of reaction tank, so that the blank voltage is within the preset range. The blank voltage is the voltage obtained by the controller 70 through controlling the irradiation of the specific liquid in the first type of reaction tank when it contains a specific liquid, sensing transmitted or scattered light and converting it into voltage. For blank voltage acquired using the scattering principle, the preset range is greater than a set voltage; for blank voltage acquired using the transmission principle, the preset range is less than a set voltage. In some embodiments, the specific liquid is a cleaning agent or diluent. Similarly, the controller 60 acquires the blank voltage of the second type of reaction tank. When the blank voltage is outside the preset range, the controller 70 controls the cleaning component 50 to execute the pre-detection cleaning mode to clean the second type of reaction tank, so that the blank voltage is within the preset range. The blank voltage is the voltage obtained by the controller 70 controlling the irradiation of the specific liquid in the second type of reaction tank when the tank contains a specific liquid, sensing the transmitted or scattered light and converting it into voltage. For blank voltage acquired using the scattering principle, the preset range is greater than a set voltage. For blank voltage acquired using the transmission principle, the preset range is less than a set voltage.

[0118] In some embodiments, the cleaning component 50 may use a hemolysin, such as LN hemolysin, when performing a pre-detection cleaning mode.

[0119] The above are some instructions on cleaning the first and second type of reaction tanks.

[0120] It should be noted that if the liquid pipelines connected to the reaction tank also need to be cleaned during the cleaning process of the reaction tank, the liquid pipelines can be cleaned by suctioning and spitting out the cleaning agent remaining in the reaction tank once or multiple times.

[0121] Some embodiments of the present invention also disclose a sample detection method, which is applied to a sample analysis device, which can be any of the sample analysis devices described in this embodiment. In one embodiment, the sample analysis device involved in the sample detection method can be used to determine a variety of specific proteins, such as CPR and SAA. Please refer to... Figure 6 Some embodiments of the sample detection method include the following steps:

[0122] Step 100: Control the detection of any one of the multiple specific proteins in the reaction tank.

[0123] In some embodiments, the plurality of specific proteins includes at least two of C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

[0124] Step 110: Obtain the type of the specific protein currently being tested in the reaction chamber.

[0125] Step 120: After the determination is completed, the reaction chamber is cleaned according to the type of the specific protein. In some embodiments, please refer to... Figure 7 Step 120 includes the following steps:

[0126] Step 121: Obtain the cleaning parameters corresponding to the specific protein being tested; among the multiple specific proteins, at least two specific proteins have different cleaning parameters, and different cleaning parameters correspond to different cleaning intensities;

[0127] Step 123: Clean the reaction tank according to the obtained cleaning parameters.

[0128] In some embodiments, the cleaning parameters include cleaning duration, cleaning agent type, and / or cleaning agent concentration. For example, when the specific protein is CPR, the obtained parameter is the first cleaning parameter; when the specific protein is SAA, the obtained parameter is the second cleaning parameter. The cleaning power of the first cleaning parameter is stronger than that of the second cleaning parameter. Specifically, the cleaning duration of the first cleaning parameter is longer than that of the second cleaning parameter; and / or, the cleaning intensity of the cleaning agent type in the first cleaning parameter is greater than that of the cleaning agent type in the second cleaning parameter; and / or, the cleaning agent concentration of the first cleaning parameter is greater than that of the second cleaning parameter.

[0129] Please refer to Figure 8 In some embodiments, the sample detection method further includes the following steps:

[0130] Step 200: Before the assay begins, obtain the specific protein types that have been detected in the reaction chamber and the next specific protein types to be detected;

[0131] Step 210: Obtain the cleaning parameters corresponding to the specific protein type to be detected next;

[0132] Step 220: If the cleaning intensity of the cleaning parameter corresponding to the currently detected specific protein type is weaker than the cleaning intensity of the cleaning parameter corresponding to the next specific protein type to be detected, then control the reaction cell to perform additional cleaning, or adjust the cleaning parameter corresponding to the currently detected specific protein type so that the cleaning intensity is greater than or equal to the cleaning intensity of the cleaning parameter corresponding to the next specific protein type to be detected, and clean the reaction cell according to the adjusted cleaning parameter.

[0133] For example, if the viscosity of the protein flocs of a specific protein species that has been detected is less than that of the protein flocs of the next specific protein species to be detected, then step 210 controls the reaction cell to be cleaned additionally or the cleaning parameters are adjusted to increase the cleaning intensity.

[0134] Additional cleaning refers to cleaning the reaction chamber after the current detection is completed, based on the cleaning parameters corresponding to the specific protein type detected. Since the viscosity of the protein flocs of the currently detected specific protein type is less than that of the protein flocs of the next specific protein type to be detected, the reaction chamber is then cleaned additionally. Understandably, the order of this additional cleaning can be before the original cleaning of the reaction chamber based on the cleaning parameters corresponding to the currently detected specific protein type.

[0135] Adjusting the cleaning parameters corresponding to the currently detected specific protein type to make the cleaning intensity greater than or equal to the cleaning intensity of the cleaning parameters corresponding to the next specific protein type to be detected, and then cleaning the reaction cell according to the adjusted cleaning parameters, means that before detecting the current specific protein and performing the next specific protein determination, there was originally a cleaning parameter corresponding to the currently detected specific protein type. However, because the viscosity of the protein flocs of the currently detected specific protein type is less than that of the protein flocs of the next specific protein type to be detected, the cleaning parameters are adjusted. For example, the cleaning intensity of the adjusted cleaning parameters is stronger, for example, at least not weaker than the cleaning intensity of the cleaning parameters corresponding to the next specific protein type to be detected, and then the reaction cell is cleaned according to the adjusted cleaning parameters.

[0136] In some embodiments, the sample detection method may include collecting blank voltage (the signal detection voltage value when the tank is filled with a specific liquid, generally a diluent) at a specified time point during the measurement process; specifically, for example, the blank voltage value may be read before each test item is measured; of course, the blank voltage value may also be read after the reaction tank has been used for a predetermined period of time, or after the reaction tank has been measured for a predetermined number of test items, etc. When the blank voltage is outside the preset range, it indicates that the contamination level of the tank has reached a certain level, and continued use may have a certain impact on the measured value. At this time, the reusable reaction tank can be cleaned before testing. Therefore, in some embodiments, the sample detection method may include: acquiring the blank voltage of the reaction tank, and when the blank voltage is outside the preset range, cleaning the reaction tank to bring the blank voltage within the preset range.

[0137] This invention designs a smart cleaning method for specific proteins, which can improve the cleaning efficiency for the determination of specific proteins. While ensuring effective cleaning for different specific proteins, it saves cleaning time and reagents and improves cleaning efficiency.

[0138] This document describes various exemplary embodiments with reference to them. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope of this document. For example, various operational steps and components for performing operational steps can be implemented in different ways depending on the specific application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps can be deleted, modified, or combined with other steps).

[0139] In the above embodiments, implementation can be achieved, in whole or in part, by software, hardware, firmware, or any combination thereof. Furthermore, as those skilled in the art will understand, the principles herein can be reflected in a computer program product on a computer-readable storage medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions can be loaded onto a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to form a machine, such that instructions executing on the computer or other programmable data processing apparatus can generate means for implementing a specified function. These computer program instructions can also be stored in a computer-readable storage medium that can instruct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium can form an article of manufacture including means for implementing the specified function. The computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to perform a series of operational steps on the computer or other programmable apparatus to produce a computer-implemented process, such that instructions executing on the computer or other programmable apparatus can provide steps for implementing the specified function.

[0140] While the principles herein have been illustrated in various embodiments, numerous modifications to the structures, arrangements, proportions, elements, materials, and components, particularly suited to specific environments and operational requirements, may be used without departing from the principles and scope of this disclosure. These modifications and other alterations or alterations will be included within the scope of this document.

[0141] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, article, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.

[0142] Those skilled in the art will understand that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined only by the claims.

Claims

1. A sample analysis device, characterized in that, It includes a sampling unit, a reagent supply unit, a reaction unit, a detection unit, a cleaning assembly, and a controller; The sampling unit is used to acquire a sample and then deliver the sample to the reaction unit; The reagent supply unit is used to store reagents and supply reagents to the reaction unit; The reaction unit includes at least a reusable reaction chamber; the reusable reaction chamber is capable of preparing at least a first type of specific protein sample and a second type of specific protein sample; the first type of specific protein sample is prepared by the reusable reaction chamber by receiving a sample delivered by the sampling unit and a first type of reagent supplied by the reagent supply unit, and is used for the determination of a first type of specific protein detection item; the second type of specific protein sample is prepared by the reusable reaction chamber by receiving a sample delivered by the sampling unit and a second type of reagent supplied by the reagent supply unit, and is used for the determination of a second type of specific protein detection item; The detection unit includes a specific protein detection unit, which can be used to detect the first type of specific protein sample and the second type of specific protein sample to obtain the detection results of the first type of specific protein and the detection results of the second type of specific protein. The cleaning assembly is used at least for cleaning the reusable reaction tank; the cleaning assembly has at least a post-detection cleaning mode, the post-detection cleaning mode has at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than the cleaning force of the second cleaning parameter; After each test item of the reusable reaction tank is completed, the controller controls the cleaning assembly to execute the post-test cleaning mode to clean the reusable reaction tank; wherein: The controller acquires the detection items of the reusable reaction tank; when the detection item of the reusable reaction tank is the first type of specific protein detection item, after the detection item is measured, the controller controls the cleaning component to execute the post-detection cleaning mode according to the first cleaning parameters to clean the reusable reaction tank; when the detection item of the reusable reaction tank is the second type of specific protein detection item, after the detection item is measured, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameters to clean the reusable reaction tank.

2. The sample analysis apparatus as described in claim 1, characterized in that, The cleaning component also has a cleaning mode after project switching, and the cleaning mode after project switching has a third cleaning parameter, the cleaning force of the third cleaning parameter being stronger than the cleaning force of the second cleaning parameter. The controller determines whether to control the cleaning component to execute the cleaning mode after the item switching to clean the reusable reaction tank based on the currently completed test items and the next test items to be tested in the reusable reaction tank. When the currently completed test item in the reusable reaction tank is a second type of specific protein test item, and the next test item to be tested is a first type of specific protein test item, then after the currently completed test item and before the next test item is tested, the controller controls the cleaning component to execute the post-detection cleaning mode according to the second cleaning parameters and the post-item switching cleaning mode according to the third cleaning parameters to clean the reusable reaction tank; or... When the currently completed test item in the reusable reaction tank is the second type of specific protein test item, and the next test item to be tested is the first type of specific protein test item, then after the currently completed test item and before the next test item to be tested, the controller controls the cleaning component not to execute the post-test cleaning mode, but to execute the post-item switching cleaning mode according to the third cleaning parameter to clean the reusable reaction tank.

3. The sample analysis device as described in claim 2, characterized in that, The cleaning component also has a pre-detection cleaning mode, which has a fourth cleaning parameter, wherein the cleaning force of the fourth cleaning parameter is stronger than that of the second cleaning parameter; or, the cleaning force of the fourth cleaning parameter is stronger than that of the first cleaning parameter; or, the cleaning force of the fourth cleaning parameter is stronger than that of the third cleaning parameter. Before the test items of the reusable reaction cell are measured, the controller obtains the blank voltage of the reusable reaction cell. When the blank voltage is outside the preset range, the controller controls the cleaning component to perform the pre-test cleaning mode according to the fourth cleaning parameter to clean the reusable reaction cell so that the blank voltage is within the preset range.

4. The sample analysis apparatus as described in claim 1, characterized in that, The first cleaning parameter and the second cleaning parameter include at least different cleaning times, different types of cleaning agents, and / or different concentrations of cleaning agents.

5. The sample analysis apparatus as described in claim 1, characterized in that, The cleaning duration of the first cleaning parameter is greater than the cleaning duration of the second cleaning parameter; and / or, the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and / or, the cleaning agent concentration of the first cleaning parameter is greater than the cleaning agent concentration of the second cleaning parameter.

6. The sample analysis apparatus as described in claim 1, characterized in that, The first type of specific protein includes at least C-reactive protein, and the second type of specific protein includes at least serum amyloid protein.

7. The sample analysis apparatus as described in claim 4 or 5, characterized in that, The cleaning agent includes at least a hemolytic agent.

8. The sample analysis apparatus as described in claim 1, characterized in that, The first type of reagent and the second type of reagent include at least the same type of hemolytic agent.

9. The sample analysis device according to claim 1, 2, 3, 4, 5, 6 or 8, wherein the reaction unit further includes a routine blood test reaction unit, and the detection unit further includes a routine blood test detection unit; The blood routine reaction unit is used to receive the sample delivered by the sampling unit and the third type of reagent supplied by the reagent supply unit to prepare blood routine test samples for determining blood routine test items; The complete blood count (CBC) unit includes one or more of the following: a DIFF unit, an RBC unit, an HGB unit, an NRBC unit, and a RET unit. The DIFF unit is used to detect the four differential white blood cell counts; the HGB unit is used to detect hemoglobin concentration; the RBC unit is used to detect red blood cell count and / or platelet count; the RET unit is used to detect reticulocyte count; and the NRBC unit is used to detect nucleated red blood cell count, white blood cell count, and basophil count.

10. The sample analysis apparatus as described in claim 9, characterized in that, The third type of reagent includes at least a hemolytic agent; the cleaning assembly uses the hemolytic agent from the third type of reagent for cleaning.

11. A sample analysis device, characterized in that, It includes a sampling unit, a reagent supply unit, a reaction unit, a detection unit, a cleaning assembly, and a controller; The sampling unit is used to acquire a sample and then deliver the sample to the reaction unit; The reagent supply unit is used to store reagents and supply reagents to the reaction unit; The reaction unit includes at least a first type of reaction tank and a second type of reaction tank; the first type of reaction tank is used to receive the sample delivered by the sampling unit and the first type of reagent supplied by the reagent supply unit to prepare a first type of specific protein sample for measuring a first type of specific protein detection item; the second type of reaction tank is used to receive the sample delivered by the sampling unit and the second type of reagent supplied by the reagent supply unit to prepare a second type of specific protein sample for measuring a second type of specific protein detection item. The detection unit includes a first-type specific protein detection unit and a second-type specific protein detection unit; the first-type specific protein detection unit is used to detect the first-type specific protein sample to obtain the detection result of the first-type specific protein; the second-type specific protein detection unit is used to detect the second-type specific protein sample to obtain the detection result of the second-type specific protein. The cleaning assembly is used to clean the first type of reaction tank and the second type of reaction tank; the cleaning assembly has at least a post-detection cleaning mode, the post-detection cleaning mode has at least a first cleaning parameter and a second cleaning parameter, wherein the cleaning force of the first cleaning parameter is stronger than the cleaning force of the second cleaning parameter. After each test item measurement in the first type of reaction tank is completed, the controller controls the cleaning component to execute the post-test cleaning mode according to the first cleaning parameters to clean the first type of reaction tank; after each test item measurement in the second type of reaction tank is completed, the controller controls the cleaning component to execute the post-test cleaning mode according to the second cleaning parameters to clean the second type of reaction tank.

12. The sample analysis apparatus as described in claim 11, characterized in that, The cleaning component further includes a pre-detection cleaning mode, which has a fourth cleaning parameter, wherein the cleaning force of the fourth cleaning parameter is stronger than that of the second cleaning parameter, or the cleaning force of the fourth cleaning parameter is stronger than that of the first cleaning parameter. Before the detection of the first type of reaction cell, the controller acquires the blank voltage of the first type of reaction cell. When the blank voltage is outside the preset range, the controller controls the cleaning component to execute the pre-detection cleaning mode according to the fourth cleaning parameter to clean the first type of reaction cell, so that the blank voltage is within the preset range; and / or, Before the second type of reaction cell test item is measured, the controller obtains the blank voltage of the second type of reaction cell. When the blank voltage is outside the preset range, the controller controls the cleaning component to execute the pre-test cleaning mode according to the fourth cleaning parameter to clean the second type of reaction cell, so that the blank voltage is within the preset range.

13. The sample analysis apparatus as described in claim 11, characterized in that, The first cleaning parameter and the second cleaning parameter include at least different cleaning times, different types of cleaning agents, and / or different concentrations of cleaning agents.

14. The sample analysis apparatus as described in claim 11, characterized in that, The cleaning duration of the first cleaning parameter is greater than the cleaning duration of the second cleaning parameter; and / or, the cleaning intensity of the cleaning agent type of the first cleaning parameter is greater than the cleaning intensity of the cleaning agent type of the second cleaning parameter; and / or, the cleaning agent concentration of the first cleaning parameter is greater than the cleaning agent concentration of the second cleaning parameter.

15. The sample analysis apparatus as described in claim 11, characterized in that, The first type of specific protein includes at least C-reactive protein, and the second type of specific protein includes at least serum amyloid protein.

16. The sample analysis apparatus as described in claim 13 or 14, characterized in that, The cleaning agent includes at least a hemolytic agent.

17. The sample analysis apparatus as described in claim 11, characterized in that, The first type of reagent and the second type of reagent include at least the same type of hemolytic agent.

18. The sample analysis apparatus as described in claim 11, 12, 13, 14, 15 or 17, characterized in that, The reaction unit also includes a routine blood test reaction unit, and the detection unit also includes a routine blood test unit; The blood routine reaction unit is used to receive the sample delivered by the sampling unit and the third type of reagent supplied by the reagent supply unit to prepare blood routine test samples for determining blood routine test items; The complete blood count (CBC) unit includes one or more of the following: a DIFF unit, an RBC unit, an HGB unit, an NRBC unit, and a RET unit. The DIFF unit is used to detect the four differential white blood cell counts; the HGB unit is used to detect hemoglobin concentration; the RBC unit is used to detect red blood cell count and / or platelet count; the RET unit is used to detect reticulocyte count; and the NRBC unit is used to detect nucleated red blood cell count, white blood cell count, and basophil count.

19. The sample analysis apparatus as described in claim 18, characterized in that, The third type of reagent includes at least a hemolytic agent; the cleaning assembly uses the hemolytic agent from the third type of reagent for cleaning.

20. A sample detection method, wherein the sample detection method is applied to a sample analysis device, the sample analysis device being capable of determining multiple specific proteins, characterized in that, The sample detection method includes: The detection of any one of the various specific proteins is controlled within the reaction chamber; To obtain the types of specific proteins currently being tested in the reaction vessel; Obtain the cleaning parameters corresponding to the specific protein being detected; among the multiple specific proteins, at least two specific proteins have different cleaning parameters, and different cleaning parameters correspond to different cleaning intensities; After the measurement is completed, the reaction tank is cleaned according to the obtained cleaning parameters.

21. The sample detection method as described in claim 20, characterized in that, The cleaning parameters include cleaning duration, type of cleaning agent, and / or concentration of cleaning agent.

22. The sample detection method as described in claim 20, characterized in that, Also includes: Obtain the specific protein types that have been detected in the reaction chamber and the next specific protein types to be detected; Obtain the cleaning parameters corresponding to the specific protein type to be detected next; If the cleaning intensity of the cleaning parameters corresponding to the currently detected specific protein type is weaker than the cleaning intensity of the cleaning parameters corresponding to the next specific protein type to be detected, then the reaction tank is controlled to be cleaned additionally. Alternatively, the cleaning parameters corresponding to the currently detected specific protein type are adjusted so that the cleaning intensity is greater than or equal to the cleaning intensity of the cleaning parameters corresponding to the next specific protein type to be detected, and the reaction tank is cleaned according to the adjusted cleaning parameters.

23. The sample detection method according to any one of claims 20 to 22, characterized in that, The specific proteins mentioned include at least two of the following: C-reactive protein, serum amyloid, procalcitonin, interleukin-6, human chorionic gonadotropin, growth hormone, luteinizing hormone, alpha-fetoprotein, and carcinoembryonic antigen.

24. A computer-readable storage medium, characterized in that, Includes a program that can be executed by a processor to implement the method as described in any one of claims 20 to 23.

Citation Information

Patent Citations

  • Sample analysis device and cleaning method thereof

    CN110749730A