Sample analyzer and magnetic bead reagent mixing method

Abstract

A sample analyzer and a magnetic bead reagent mixing method, the sample analyzer comprises an ultrasonic device, a controller, a reagent bearing mechanism and a reagent dispensing mechanism; the controller is used for controlling the ultrasonic device to emit ultrasonic waves to the unpretreated magnetic bead reagent. Since the sample analyzer is provided with the ultrasonic device, the ultrasonic device is used for emitting ultrasonic waves to the unpretreated magnetic bead reagent, and the ultrasonic waves can uniformly disperse the magnetic beads in the unpretreated magnetic bead reagent, so that the subsequent reagent needle can suck the magnetic bead reagent with uniform magnetic bead distribution, thereby ensuring the accuracy of detection. The ultrasonic device on the sample analyzer can perform ultrasonic mixing operation on the unpretreated magnetic bead reagent, so that the magnetic bead reagent does not need to be pretreated by shaking before being put on the machine. The doctor can directly put the magnetic bead reagent on the machine after getting it, which is convenient for the doctor's operation and can improve the detection efficiency.

Description

Technical Field

[0001] This invention relates to in vitro testing equipment, specifically to a sample analyzer and a method for mixing magnetic beads and reagents. Background Technology

[0002] Immunoassay analyzers are highly sensitive and specific analytical instruments commonly used in clinical laboratories to detect various analytical indicators in blood, urine, or other body fluids. Traditional immunoassay analyzers operate on various principles, including chemiluminescence and electrochemiluminescence. Taking a heterogeneous chemiluminescence immunoassay analyzer as an example, its main working principle is as follows: When a component in a sample needs to be measured, the corresponding antibody / antigen is coated onto magnetic beads to form magnetic bead reagents, and a specific marker is labeled onto the antibody to form a labeled reagent. During the test, the sample to be tested is mixed with the magnetic bead reagent, labeled reagent, and other reagents to form a reaction solution, which is then incubated under certain conditions to form a reaction complex. Then, using magnetic separation technology, unbound markers, other reagents, and sample components are removed from the reaction system. Finally, a substrate is added, and the substrate reacts with the labeled reagent on the reaction complex to emit light, which is then detected by photoluminescence.

[0003] In immunochromatographic analyzers, magnetic beads are prone to settling at the bottom under static storage conditions. The density of these beads at the bottom is significantly higher than that at the top, resulting in an uneven distribution between the beads and the reagent solution. When a portion of the reagent is drawn for immunoassay under these conditions, the density of the drawn beads can be too high or too low, leading to results that deviate from the true values. To address this issue, the traditional method is to manually shake the instrument before loading the magnetic beads. While this adds some mixing, it necessitates additional pretreatment of the reagents before loading, reducing overall testing efficiency, and the mixing effect of manual shaking is not ideal. Summary of the Invention

[0004] One embodiment provides a sample analyzer, comprising:

[0005] An ultrasonic device used to generate ultrasonic vibrations to form ultrasonic waves;

[0006] A controller, connected to the ultrasonic device, is used to control the ultrasonic device to emit ultrasonic waves into the untreated magnetic bead reagent;

[0007] A reagent carrier mechanism for holding a reagent container containing magnetic beads; and

[0008] The reagent dispensing mechanism is used to draw ultrasonically operated magnetic bead reagent from the reagent carrying mechanism and discharge the ultrasonically operated magnetic bead reagent into a receiving cup.

[0009] In one embodiment, the untreated magnetic bead reagent is a magnetic bead reagent that has not undergone any manual or automatic mixing process before entering the sample analyzer.

[0010] In one embodiment, the untreated magnetic bead reagent includes magnetic bead reagent with a magnetic bead density at the bottom of the reagent container that is greater than that at the top.

[0011] In one embodiment, the reagent carrier is used to carry a reagent container containing untreated magnetic bead reagent, and the ultrasonic device is used to perform ultrasonic operation on the untreated magnetic bead reagent located on the reagent carrier.

[0012] In one embodiment, the sample analyzer further includes a reagent buffer mechanism and a reagent transfer mechanism. The reagent buffer mechanism is used to temporarily store a reagent container containing untreated magnetic bead reagents. The ultrasonic device is used to perform ultrasonic operation on the untreated magnetic bead reagents located on the reagent buffer mechanism. The reagent transfer mechanism is used to transfer the ultrasonically operated magnetic bead reagents on the reagent buffer mechanism to the reagent carrier mechanism.

[0013] In one embodiment, the controller is used to acquire test parameters and, based on the test parameters, match one of a set of preset ultrasonic modes to perform ultrasonic operation on the untreated magnetic bead reagent.

[0014] In one embodiment, the multiple ultrasound modes have different ultrasound intensities and / or ultrasound durations.

[0015] In one embodiment, the ultrasonic device includes an ultrasonic transducer, a transmission element, and a moving device. The ultrasonic transducer is used to generate ultrasonic vibrations. The transmission element has a first end and a second end. The first end of the transmission element is connected to the ultrasonic transducer, and the outer diameter of the second end of the transmission element is smaller than the inner diameter of the reagent container. The moving device is connected to the ultrasonic transducer and is used to drive the ultrasonic transducer and the transmission element to move relative to the reagent container. The second end of the transmission element can be inserted into untreated magnetic bead reagents inside the reagent container to transmit the ultrasonic vibrations generated by the ultrasonic transducer to the untreated magnetic bead reagents inside the reagent container.

[0016] In one embodiment, the ultrasonic device includes an ultrasonic transducer and a transmission element. The ultrasonic transducer is used to generate ultrasonic vibrations. The transmission element has a first end and a second end. The first end of the transmission element is connected to the ultrasonic transducer. The second end of the transmission element is used to abut against the outer wall of a reagent container. The portion of the outer wall of the reagent container that contacts the transmission element is the portion surrounding the untreated magnetic bead reagent, so as to transmit the ultrasonic vibrations generated by the ultrasonic transducer to the untreated magnetic bead reagent inside the reagent container.

[0017] In one embodiment, the transfer member is a solid structure, and the outer diameter of the transfer member gradually decreases or decreases in a stepwise manner from the first end to the second end.

[0018] In one embodiment, the sample analyzer further includes a sample carrying mechanism, a sample dispensing mechanism, a reaction mechanism, a magnetic separation mechanism, and a measuring mechanism. The sample carrying mechanism is used to carry the sample, the sample dispensing mechanism is used to draw the sample from the sample carrying mechanism and discharge the sample into a container, the reaction mechanism is used to provide an incubation site for the reaction solution in the container, the reaction solution includes the sample and ultrasonically operated magnetic bead reagent, the magnetic separation mechanism is used to inject a cleaning solution into the incubated reaction solution to perform a magnetic separation operation, and the measuring mechanism is used to perform photometric measurement on the reaction solution containing the substrate.

[0019] In one embodiment, the ultrasonic device is further used to perform ultrasonic operations on at least one of the following: a sample, a reaction solution to be incubated, a reaction solution after incubation, a reaction solution with injected washing solution, and a reaction solution with injected substrate.

[0020] One embodiment provides a method for mixing magnetic bead reagents, comprising the following steps:

[0021] Load the reagent container containing the untreated magnetic bead reagent onto the sample analyzer;

[0022] An ultrasonic device emits ultrasonic waves into untreated magnetic bead reagents;

[0023] The reagent dispensing mechanism draws up the ultrasonically operated magnetic bead reagent and injects it into the receiving cup.

[0024] In one embodiment, the untreated magnetic bead reagent is a magnetic bead reagent that has not undergone any manual or automatic mixing process before entering the sample analyzer.

[0025] In one embodiment, the untreated magnetic bead reagent includes magnetic bead reagent with a magnetic bead density at the bottom of the reagent container that is greater than that at the top.

[0026] In one embodiment, the step of loading the reagent container containing untreated magnetic bead reagent onto the sample analyzer specifically involves loading the reagent container containing untreated magnetic bead reagent onto the reagent carrier mechanism.

[0027] The step of the ultrasonic device emitting ultrasonic waves into the untreated magnetic bead reagent specifically involves the ultrasonic device performing an ultrasonic operation on the untreated magnetic bead reagent located on the reagent carrier mechanism.

[0028] In one embodiment, the step of loading the reagent container containing untreated magnetic bead reagent onto the sample analyzer specifically involves loading the reagent container containing untreated magnetic bead reagent onto the reagent buffer mechanism.

[0029] The step described above involves the ultrasonic device emitting ultrasonic waves into the untreated magnetic bead reagent. Specifically, the ultrasonic device performs an ultrasonic operation on the untreated magnetic bead reagent located on the reagent buffer mechanism.

[0030] Between the step of the ultrasonic device emitting ultrasonic waves into the untreated magnetic bead reagent and the step of the reagent dispensing mechanism drawing up the ultrasonically operated magnetic bead reagent and injecting the ultrasonically operated magnetic bead reagent into the receiving cup, the method further includes the following steps:

[0031] The reagent transfer mechanism transfers the reagent container containing ultrasonically operated magnetic bead reagents to the reagent carrier mechanism.

[0032] In one embodiment, the ultrasonic operation of the ultrasonic device is controlled by the following steps:

[0033] Obtain test project parameters;

[0034] Based on the test parameters, one ultrasonic mode is selected from a variety of preset ultrasonic modes to perform ultrasonic operation on the untreated magnetic bead reagent.

[0035] In one embodiment, the multiple ultrasound modes have different ultrasound intensities and / or ultrasound durations.

[0036] According to the sample analyzer and magnetic bead reagent mixing method of the above embodiments, the sample analyzer is equipped with an ultrasonic device. This ultrasonic device emits ultrasonic waves into the untreated magnetic bead reagent, which uniformly disperses the magnetic beads within the untreated reagent. This ensures that the reagent needle can then pick up the uniformly distributed magnetic beads, thereby guaranteeing the accuracy of the detection. The ultrasonic device on this sample analyzer performs ultrasonic mixing on the untreated magnetic bead reagent, eliminating the need for pretreatment such as shaking before use. Doctors can directly use the reagent after receiving it, simplifying the doctor's operation and improving detection efficiency. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of the structure of an immunoluminescence analyzer in one embodiment;

[0038] Figure 2 This is a structural block diagram of the control section of an immunoluminescence analyzer in one embodiment;

[0039] Figure 3 This is a schematic diagram of the reagent carrier mechanism in one embodiment;

[0040] Figure 4 This is a schematic diagram of the reagent carrier mechanism in one embodiment;

[0041] Figure 5 This is a schematic diagram of the structure of a vortex mixing device in one embodiment;

[0042] Figure 6 This is a schematic diagram of the structure of a contact ultrasound device in one embodiment;

[0043] Figure 7 This is a structural view of the transfer element in one embodiment;

[0044] Figure 8 This is a structural view of the transfer element in one embodiment;

[0045] Figure 9 This is a schematic diagram of a mobile device in one embodiment;

[0046] Figure 10 This is a schematic diagram of an ultrasonic device in one embodiment;

[0047] Figure 11 This is a schematic diagram of the structure of a non-contact ultrasonic device in one embodiment;

[0048] Figure 12 This is a schematic diagram of the structure of a non-contact ultrasonic device in one embodiment;

[0049] Figure 13 This is a side view of the clamping device in one embodiment;

[0050] Figure 14 This is a top view of the clamping device in one embodiment;

[0051] Figure 15 This is a flowchart of a method for mixing magnetic bead reagents in one embodiment;

[0052] Figure 16 This is a timing diagram of a sample analysis method in one embodiment;

[0053] Figure 17 This is a flowchart of a sample analysis method in one embodiment;

[0054] Figure 18 This is a flowchart of a method for mixing magnetic bead reagents in one embodiment;

[0055] Figure 19 This is a flowchart of a sample analysis method in one embodiment. Detailed Implementation

[0056] 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 overwhelming 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.

[0057] 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 order of the steps or actions in the method description can be changed or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for clearly describing a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0058] 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. Unless otherwise specified, the terms "connection" and "linkage" used in this application include both direct and indirect connections (linkages).

[0059] For chemiluminescence immunoassay analyzers, a one-step test in this invention refers to a test that requires only one incubation step. Conversely, a multi-step test refers to a test that requires multiple incubation steps. For example, a two-step test requires two incubation steps: first, the reagents for the first incubation step are added to the sample, then the first incubation is performed. After the first incubation time is reached, the reagents for the second incubation step are added, and the second incubation is performed. After the second incubation time is reached, magnetic separation is performed, and then the measurement is taken. Generally, for a multi-step test, magnetic separation is required after the final incubation step before measurement can be performed. However, whether magnetic separation is required after other incubation steps in a multi-step test, except for the final incubation step, depends on factors such as the type of test. For example, a two-step test project can be called a two-step two-separation test project if magnetic separation is required after incubation in the first step, and a two-step one-separation test project if magnetic separation is not required after incubation in the first step.

[0060] In one-step or multi-step testing projects, the type of reagents required for each incubation step or each incubation can be one or more, depending on factors such as the type of testing project. When one or more steps in a one-step or multi-step testing project require the addition of multiple types of reagents during incubation, such a testing project can be called a multi-component testing project.

[0061] In one embodiment, a sample analyzer is provided, which includes an ultrasonic device to ultrasonically mix untreated magnetic bead reagents, thereby improving the accuracy of the test results. After the magnetic bead reagents have been left to stand for a period of time, the magnetic beads will sink to the bottom of the reagent container under their own weight, resulting in a higher density of magnetic beads at the bottom than at the top. Untreated magnetic bead reagents refer to reagents that have not undergone any manual or automatic mixing before being used in the analyzer, and the magnetic beads in untreated reagents are generally in an unevenly distributed state.

[0062] Please refer to Figure 1 and Figure 2 This sample analyzer can be a biochemical analyzer or an immunoassay analyzer. The immunoassay analyzer mainly includes an ultrasonic device 10, a sample carrying mechanism 21, a sample dispensing mechanism 22, a reagent carrying mechanism 31, a reagent dispensing mechanism 32, a reaction mechanism 40, a magnetic separation mechanism 50, and a controller 60. The sample carrying mechanism 21, sample dispensing mechanism 22, reagent carrying mechanism 31, reagent dispensing mechanism 32, reaction mechanism 40, magnetic separation mechanism 50, and ultrasonic device 10 are all mounted on a base 100. The controller 60 is mounted on the main unit of the base 100, or it can be mounted on the base 100 itself. The biochemical analyzer does not include the aforementioned magnetic separation mechanism.

[0063] The immunoluminescence analyzer also includes a cup-loading mechanism 71, a cup-throwing position 72, a first transfer mechanism 81, a second transfer mechanism 82, and a measurement mechanism 90, all mounted on the base 100.

[0064] The reaction mechanism 40 is located in the middle, and the reagent carrying mechanism 31, magnetic separation mechanism 50, ultrasonic device 10, cup-raising mechanism 71, cup-throwing position 72 and measuring mechanism 90 are respectively located around the reaction mechanism 40.

[0065] The cup-loading mechanism 71 is used to store new, unused containers 103, also known as reaction cups. The cup-loading mechanism 71 also has a cup-moving function, which can move the containers 103 from the storage position to the position to be grasped.

[0066] The first transfer mechanism 81 is a cup-grabbing mechanism. The first transfer mechanism 81 is used to transfer the new container cup 103 on the upper cup mechanism 71 to the sample feeding position 101 near the reaction mechanism 40, and to transfer the container cup 103 on the sample feeding position 101 into the reaction mechanism 40.

[0067] The cup-discarding position 72 is located near the first transfer mechanism 81, and the cup-discarding position 72 is used to collect the used container cup 103. The first transfer mechanism 81 is also used to transfer the container cup 103 after it has been tested on the reaction mechanism 40 to the cup-discarding position 72.

[0068] The sample carrier 21 is used to carry samples. In some examples, the sample carrier 21 may include a sample delivery module (SDM); in other examples, the sample carrier 21 may also be a sample tray, which includes multiple sample positions for placing sample tubes, and the sample tray can be rotated to the corresponding position, such as the position for the sample dispensing mechanism 22 to pick up the sample, by rotating its tray structure.

[0069] The sample dispensing mechanism 22 includes a sampling needle, a moving mechanism, and a driving pump. The moving mechanism drives the sampling needle to move between the sample carrying mechanism 21 and the sample dispensing position 101, and the driving pump provides power for the sampling needle to aspirate and dispense samples. The sample dispensing mechanism 22 is used to aspirate the sample from the sample tube on the sample carrying mechanism 21 and to dispense the aspirated sample into the receiving cup 103 on the sample dispensing position 101.

[0070] The reaction mechanism 40 is used to provide an incubation site for the reaction liquid. The reaction mechanism 40 can be a reaction plate, which is arranged in a disc shape and has one or more placement positions for placing reaction cups. The reaction plate can rotate and drive the reaction cups in its placement positions to rotate, which is used to manage the reaction cups and incubate the reaction liquid in the reaction cups within the reaction plate.

[0071] The magnetic separation mechanism 50 includes a cleaning fluid dispensing structure, a magnetic attraction structure, a liquid absorption structure, and a substrate dispensing mechanism. The cleaning fluid dispensing structure is used to add cleaning fluid to the incubated reaction solution, and the cleaning fluid is used to separate free substances in the incubated reaction solution. The magnetic attraction structure is used to perform a magnetic attraction operation on the reaction solution to which the cleaning fluid has been added, and the magnetic attraction structure is used to adsorb the reaction complex bound to the magnetic beads. The liquid absorption structure is used to discharge other components except for the reaction complex bound to the magnetic beads from the receiving cup 103. The substrate dispensing mechanism is used to add substrate to the reaction solution in the receiving cup 103, and the substrate reacts with the reaction complex in the reaction solution, and the substrate luminescently marks the reaction complex.

[0072] There are two magnetic separation mechanisms 50, which can work independently to improve the efficiency of the test.

[0073] A mixing position 102 is provided near the reaction mechanism 40 and the magnetic separation mechanism 50. Both the mixing position 102 and the sample addition position 101 are provided with cup holders for placing the container cup 103. The second transfer mechanism 82 is used to transfer the container cup 103 between the reaction mechanism 40, the magnetic separation mechanism 50 and the mixing position 102.

[0074] The measuring mechanism 90 is used to perform photometric measurements on the incubated reaction solution to obtain the sample's reaction data. For example, the measuring mechanism 90 detects the luminescence intensity of the reaction solution to be tested and calculates the concentration of the analyte in the sample through a calibration curve.

[0075] The base 100 is also equipped with a cleaning mechanism and a waste liquid aspiration mechanism. The cleaning mechanism is used to clean the sampling needle and reagent needle, and the waste liquid aspiration mechanism is used to aspirate the reaction liquid after detection.

[0076] Please refer to Figure 1 and Figure 3 The reagent carrier 31 is used to carry untreated magnetic bead reagents. In one embodiment, the reagent carrier 31 can be a reagent tray with a disc-shaped structure and multiple positions for carrying reagent containers. The reagent carrier 31 can rotate and drive the reagent containers it carries to rotate, for rotating the reagent containers to a specific position, such as the position where the reagent is drawn up by the reagent dispensing mechanism 32. The number of reagent carriers 31 can be one or more.

[0077] The ultrasonic device 10 is positioned close to the reagent carrier 31. The ultrasonic device 10 is used to perform ultrasonic mixing on the untreated magnetic bead reagent in the reagent container 105 located on the reagent carrier 31. The ultrasonic device 10 is used to emit ultrasonic waves into the untreated magnetic bead reagent in the reagent container 105. The ultrasonic waves uniformly disperse the magnetic beads in the untreated magnetic bead reagent, so that the magnetic beads in the magnetic bead reagent are evenly distributed in the reagent container 105.

[0078] The reagent dispensing mechanism 32 includes a reagent needle, a moving mechanism, and a driving pump. The moving mechanism drives the reagent needle to move between the reagent carrying mechanism 31 and the reaction mechanism 40, and the driving pump provides power to the reagent needle for aspirating and dispensing reagents. The reagent dispensing mechanism 32 is used to aspirate untreated magnetic bead reagent from the reagent tube on the reagent carrying mechanism 31 and to add the aspirated untreated magnetic bead reagent to the sample-containing container 103 on the reaction mechanism 40. The sample and reagent in the container 103 mix and react to form a reaction solution.

[0079] Please refer to Figure 4In one embodiment, a reagent buffer mechanism 33 and a reagent transfer mechanism 34 are further provided on the rack 100. The reagent buffer mechanism 33 is located close to the reagent carrying mechanism 31 and has multiple placement positions for holding reagent containers 105 containing untreated magnetic bead reagents. When the throughput of magnetic bead reagents is greater than the consumption throughput of magnetic bead reagents on the reagent carrying mechanism 31, the reagent buffer mechanism 33 is used to buffer excess reagent containers 105 containing untreated magnetic bead reagents, ensuring that the reagent dispensing mechanism 32 continuously and uninterruptedly dispenses magnetic bead reagents to improve detection efficiency.

[0080] The structure of the reagent transfer mechanism 34 is the same as or similar to that of the first transfer mechanism 81 and the second transfer mechanism 82. The reagent transfer mechanism 34 is installed between the reagent buffer mechanism 33 and the reagent carrier mechanism 31. The reagent transfer mechanism 34 is used to transfer the reagent container 10 containing untreated magnetic bead reagents on the reagent buffer mechanism 33 into the reagent carrier mechanism 31.

[0081] The ultrasonic device 10 is positioned close to the reagent buffer mechanism 33. The ultrasonic device 10 is used to perform ultrasonic mixing on the untreated magnetic bead reagent in the reagent container 105 located on the reagent buffer mechanism 33. The ultrasonic device 10 is used to emit ultrasonic waves into the untreated magnetic bead reagent in the reagent container 105. The ultrasonic waves uniformly disperse the magnetic beads in the untreated magnetic bead reagent, so that the magnetic beads in the untreated magnetic bead reagent are evenly distributed in the reagent container 105.

[0082] In one embodiment, multiple ultrasonic devices 10 are provided, one of which is located near the mixing position 102. The second transfer mechanism 82 is used to transfer the container 103 containing the reaction liquid to be incubated from the reaction mechanism 40 to the mixing position 102. The ultrasonic device 10 is used to perform ultrasonic mixing operation on the reaction liquid on the mixing position 102.

[0083] The second transfer mechanism 82 is also used to transfer the container 103 containing the incubated reaction liquid from the reaction mechanism 40 to the mixing position 102, and the ultrasonic device 10 is also used to perform ultrasonic mixing operation on the incubated reaction liquid on the mixing position 102.

[0084] The second transfer mechanism 82 is also used to transfer the reaction liquid container 103 containing the injected substrate from the magnetic separation mechanism 50 to the mixing position 102, and the ultrasonic device 10 is also used to perform ultrasonic mixing operation on the reaction liquid containing the substrate on the mixing position 102.

[0085] In one embodiment, multiple ultrasonic devices 10 are provided, one of which is located near the sample application position 101. The ultrasonic device 10 is used to perform ultrasonic mixing operation on the sample application position 101.

[0086] In one embodiment, multiple ultrasonic devices 10 are provided, one of which is located near the magnetic separation mechanism 50, or one ultrasonic device 10 is installed inside the magnetic separation mechanism 50. The ultrasonic devices 10 are used to perform ultrasonic mixing on the reaction liquid injected with cleaning fluid inside the magnetic separation mechanism 50.

[0087] In one embodiment, at least two mixing positions 102 are provided to increase the placement of the container cups 103. One ultrasonic device 10 corresponds to at least two mixing positions 102. That is, one ultrasonic device 10 can ultrasonically mix the reaction liquid 104 in multiple container cups 103 respectively. During the ultrasonic mixing process, the container cups 103 on other mixing positions 102 can be transferred or otherwise operated. The container cups 103 on multiple mixing positions 102 are alternately mixed to improve detection efficiency.

[0088] In one embodiment, the ultrasonic device 10 may also be configured in a one-to-one correspondence with the mixing position 102.

[0089] Please refer to Figure 5 In one embodiment, a vortex mixing device 200 is also installed at the mixing position 102. The vortex mixing device 200 includes a drive motor 201, a transmission belt 202, an eccentric shaft 203, and a mounting base 204. The drive motor 201 is fixedly installed on the mounting base 204, with the output shaft of the drive motor 201 facing downwards. The eccentric shaft 203 is rotatably installed on the mounting base 204 through bearings. The eccentric shaft 203 is vertically arranged and has a first segment and a second segment that are not collinear. The first segment is located at the lower position, and the second segment is located at the upper position. Both the first segment and the second segment of the eccentric shaft 203 are parallel to the output shaft of the drive motor 201. Pullers are mounted on the output shaft of the drive motor 201 and the first section of the eccentric shaft 203, respectively. A transmission belt 202 connects the drive motor 201 and the pulleys of the eccentric shaft 203. The drive motor 201 drives the eccentric shaft 203 to rotate via the transmission belt 202. A cup holder 205 for placing the container cup 103 is mounted on the eccentric shaft 203. Thus, the eccentric shaft 203 can drive the container cup 103 located on the cup holder 205 to rotate eccentrically, performing a vortex mixing operation on the reaction liquid inside the container cup 103. The drive motor 201 is connected to a controller 60, which controls the output power and output duration of the drive motor 201 to achieve various vortex mixing modes with different intensities and durations.

[0090] In this embodiment, the controller 60 is connected to the ultrasonic device 10, the sample dispensing mechanism 22, the reagent dispensing mechanism 32, the reaction mechanism 40, the magnetic separation mechanism 50, the first transfer mechanism 81, and the second transfer mechanism 82, respectively. The controller 60 is used to control the test sequence of the entire sample analyzer.

[0091] When the controller 60 controls the ultrasound device 10, the controller 60 acquires the test items input or selected by the doctor, acquires the test item parameters corresponding to the test items, and matches one ultrasound mode from multiple ultrasound modes according to the test item parameters to perform ultrasound mixing operation on the untreated magnetic bead reagent.

[0092] Different ultrasound modes have different ultrasound mixing intensities or different ultrasound mixing times. The mixing intensity is controlled by the input power and can be set to at least three ultrasound mixing intensities: strong, medium, and weak. It can also be set to at least two ultrasound mixing times: 1 second and 2 seconds.

[0093] Ultrasonic mixing modes include at least the following:

[0094] The first mixing mode uses ultrasonic device 10 to perform ultrasonic mixing operation, with medium ultrasonic mixing intensity and 1 second ultrasonic mixing time.

[0095] The second mixing mode uses ultrasonic device 10 to perform ultrasonic mixing operation, with weak ultrasonic mixing intensity and ultrasonic mixing time of 2s.

[0096] In the third mixing mode, ultrasonic device 10 is used to perform ultrasonic mixing operation, the ultrasonic mixing intensity is strong, and the ultrasonic mixing time is 1 second.

[0097] Test parameters include numbers, letters, or a combination of both. For example, the test parameter for TNI (troponin) is 2, and the test parameters for E2 (estradiol) include 0 and 1. The controller 60 pre-stores test parameters corresponding to different test items, and each test parameter corresponds to a mixing mode. For example, test parameter 0 corresponds to the first mixing mode. When the controller 60 obtains a test parameter of 0, it drives the ultrasonic device 10 to perform ultrasonic mixing of the untreated magnetic bead reagent at a medium intensity for 1 second. Test parameter 1 corresponds to the second mixing mode. When the controller 60 obtains a test parameter of 1, it drives the ultrasonic device 10 to perform ultrasonic mixing of the untreated magnetic bead reagent at a weak intensity for 2 seconds. Test parameter 2 corresponds to the third mixing mode. When the controller 60 obtains a test parameter of mode 2, it drives the ultrasonic device 10 to perform ultrasonic mixing of the untreated magnetic bead reagent at a strong intensity for 1 second.

[0098] Different ultrasonic mixing modes can be set according to specific test items, so that the ultrasonic device 10 can effectively ultrasonically mix the untreated magnetic bead reagent in different test items.

[0099] Please refer to Figure 6In this embodiment, the ultrasound device 10 is an independent device, that is, the ultrasound device 10 can operate independently. For example, the ultrasound device 10 can operate independently of the sample dispensing mechanism 22, and the ultrasound device 10 can operate synchronously or asynchronously with other mechanisms to improve the efficiency of project testing.

[0100] The ultrasonic device 10 is a contact ultrasonic device. The ultrasonic device 10 includes an ultrasonic transducer 11, a transmission element 12, and a moving device 13. The ultrasonic transducer 11 includes a backing layer, a piezoelectric layer, and a matching layer connected in sequence. The piezoelectric layer is a piezoelectric crystal. Under the action of the driving electrical signal, the piezoelectric crystal generates compression and expansion in the thickness direction through the inverse piezoelectric effect. The frequency of this deformation reaches the ultrasonic frequency, forming ultrasonic vibration.

[0101] Please refer to Figure 6 and Figure 7 The transmission element 12 is a solid rod-shaped structure with a first end and a second end, the first end being the upper end and the second end being the lower end. The first end of the transmission element 12 has an external thread, and the lower end of the ultrasonic transducer 11 has an internal thread. The transmission element 12 is installed at the lower end of the ultrasonic transducer 11 by a threaded connection. The transmission element 12 can also be connected to the ultrasonic transducer 11 by snap-fit ​​or other methods. The transmission element 12 is a resonant rod and is connected to the matching layer of the ultrasonic transducer 11. The transmission element 12 is used to transmit ultrasonic vibrations. Compared with the hollow transmission element 12, the solid transmission element 12 is more conducive to the propagation of axial vibration. Furthermore, when the outer diameter of the transmission element 12 decreases along the direction of ultrasonic vibration transmission, the solid transmission element 12 is more conducive to energy convergence, thereby achieving a better ultrasonic mixing effect.

[0102] The outer diameter of the transmission element 12 gradually decreases or decreases in a stepwise manner from the first end to the second end. The transmission element 12 has the function of concentrating energy. When the ultrasonic vibration is transmitted from the first end to the second end, the axial cross-sectional area of ​​the second end is smaller than that of the first end. The ultrasonic vibration is more concentrated at the second end relative to the first end, which amplifies the amplitude of the emitted ultrasonic vibration at the second end of the transmission element 12 relative to the first end, thereby increasing the emitted ultrasonic energy.

[0103] Specifically, the transfer member 12 includes a first end 121, an intermediate section 122, and a second end 123. The first end 121 is a threaded connection end, and the second end 123 is a needle-shaped structure. The outer diameter of the second end 123 is smaller than the inner diameter of the receiving cup 103, allowing the second end 123 of the transfer member 12 to be inserted into the receiving cup 103. The intermediate section 122 has a trumpet-shaped structure. The end of the intermediate section 122 connected to the first end 121 is the large end of the trumpet, and the end of the intermediate section 122 connected to the second end 123 is the small end of the trumpet. The axial diameter of the intermediate section 122 gradually decreases from the large end to the small end of the trumpet.

[0104] The intermediate section 122 can also be composed of one or a conical rod, or any combination of both. Please refer to [reference needed]. Figure 8 The intermediate section 122 of structure a includes two cylindrical rods of different diameters; the intermediate section 122 of structure b includes four cylindrical rods of different diameters; the intermediate section 122 of structure c includes one conical rod; and the intermediate section 122 of structure d includes two cylindrical rods of different diameters and one conical rod. All five structures of the transmission component 12 described above are structures that gradually decrease in size or decrease in a stepped manner from the first end to the second end, which can amplify the amplitude.

[0105] Please refer to Figure 9 The mobile device 13 includes a mounting base 131, a swing arm assembly 132, a first moving assembly 133, and a second moving assembly 134.

[0106] The swing arm assembly 132 includes a swing arm 1321 and a lifting rod 1322. The lifting rod 1322 is vertically, liftably, and rotatably mounted on the mounting base 131. The swing arm 1321 is horizontally positioned, with one end connected to the lifting rod 1322. The ultrasonic transducer 11 is mounted on the end of the swing arm 1321 away from the lifting rod 1322. The swing arm assembly 132 is used to drive the ultrasonic transducer 11 and the transmission element 12 to move vertically and horizontally. In one embodiment, the swing arm 1321 and the lifting rod 1322 may also be an integrated structure.

[0107] The first moving component 133 is a lifting component, which includes a lifting motor 1331 and a lifting transmission component 1332. The lifting motor 1331 is mounted on the mounting base 131. The lifting transmission component 1332 includes a transmission wheel, a transmission belt, a gear, and a rack. The rack is vertically mounted on the lifting rod 1322, and the gear is rotatably mounted on the mounting base 131. The gear meshes with the rack. The lifting motor 1331 is connected to the gear through the transmission wheel and the transmission belt, and the lifting motor 1331 drives the lifting rod 1322 to move up and down through the gear and rack. In one embodiment, the first moving component 133 is a linear motor, and the output shaft of the linear motor is directly connected to the lifting rod 1322, which can also drive the lifting rod 1322 to move up and down.

[0108] The second moving component 134 is a rotating component, comprising a rotating motor 1341 and a rotating transmission component 1342. The rotating motor 1341 is mounted on the mounting base 131. The rotating transmission component 1342 includes a transmission belt and a rotating gear. The transmission belt is a gear belt. The rotating gear is fitted onto the lifting rod 1322 and is connected to the lifting rod 1322 via a key. The lifting rod 1322 can move up and down relative to the rotating gear, and the rotating gear drives the lifting rod 1322 to rotate. The rotating motor 1341 is connected to the rotating gear via the transmission belt and drives the lifting rod 1322 to rotate. In one embodiment, the rotating motor 1341 is connected to the lifting rod 1322 via a gear set, which also drives the lifting rod 1322 to rotate.

[0109] In one embodiment, the moving device 13 includes only a mounting base 131, a swing arm assembly 132, and a first moving assembly 133. The ultrasonic device 10 has a lifting function and is used to perform a mixing operation on the reaction liquid 104 in the container cup 103 on a specific mixing position 102.

[0110] In one embodiment, the second moving component 134 may also be a planar moving component composed of X-axis movement and Y-axis movement, with the X-axis movement and Y-axis movement respectively achieved by two motors, which can also drive the transmission component 12 to move alternately between multiple mixing positions 102.

[0111] Please refer to Figure 10 In this embodiment, the transmission element 12 of the ultrasonic device 10 is directly inserted into the reaction liquid 104 of the container 103. The ultrasonic device 10 has a preset frequency and voltage, so that the ultrasonic vibration mainly propagates along the axial direction. The second end face of the transmission element 12 is the emitting surface of the ultrasonic wave. During ultrasonic mixing, the second end face of the transmission element 12 emits ultrasonic waves into the reaction liquid 104, forming an ultrasonic sound field within the reaction liquid 104. Under the action of the ultrasonic sound field, the reaction liquid 104 will form a violent liquid flow to achieve the mixing of the components in the reaction liquid 104.

[0112] Besides the vibration effect of ultrasound, which enables the mixing of reaction liquid 104, the cavitation effect generated by ultrasound in the liquid can also uniformly disperse some aggregated and adhered substances in reaction liquid 104. When the frequency and sound pressure of the ultrasound are controlled, and combined with the amplification effect of the transmission element 12, the ultrasound energy entering the reaction liquid 104 in the container 103 is greater than the threshold of ultrasound cavitation, then ultrasound cavitation can occur in reaction liquid 104 during the ultrasound mixing process. When ultrasound cavitation occurs, it releases a large amount of energy, exerting a certain force on some aggregated and adhered substances in reaction liquid 104, causing them to disperse. At the same time, under the action of ultrasound vibration mixing, these substances can be uniformly dispersed in the reaction container.

[0113] In one embodiment, the ultrasonic device 10 is a non-contact ultrasonic mixing device. The ultrasonic device 10 is in contact with the container 103, and the ultrasonic waves emitted by the ultrasonic device 10 are transmitted to the reaction liquid inside the container 103 through the container 103.

[0114] Please refer to Figure 11 and Figure 12 The ultrasonic device 10 includes an ultrasonic transducer 11 and a transmission element 12. During ultrasonic mixing, the second end of the transmission element 12 rests against the outer wall of the receiving cup 103, transmitting ultrasonic vibrations to the reaction liquid 104 through the receiving cup 103. Since the transmission element 12 does not need to be inserted into the receiving cup 103, its axial length is shorter than that of a contact-type transmission element, but it also has the characteristic of gradually decreasing or stepwise decreasing from the first end to the second end to achieve amplified amplitude.

[0115] During ultrasonic mixing, the second end face of the transfer member 12 in this embodiment abuts against the outer wall of the container 103. The portion of the outer wall of the container 103 that contacts the transfer member 12 surrounds the reaction liquid 104, thereby transmitting the ultrasonic vibration generated by the ultrasonic transducer 11 to the liquid in the container 103. The portion of the container 103 that surrounds the reaction liquid 104 is the bottom of the container 103 and the lower sidewall connected to the bottom. Therefore, the ultrasonic vibration can be transmitted to the liquid in the container 103 at any position where the second end of the transfer member 12 abuts against the bottom of the container 103 and the lower sidewall connected to the bottom.

[0116] In this embodiment, the ultrasonic device 10 is a movable structure. The ultrasonic device 10 also includes a moving device, which includes a mounting base and a horizontal moving component. The horizontal moving component is mounted on the mounting base, and the ultrasonic transducer is mounted on the horizontal moving component. The horizontal moving component is a cylinder or a linear motor. The horizontal moving component is used to drive the second end of the transmission member 12 to abut against or move away from the outer wall of the receiving cup 103 on the mixing position 102.

[0117] In one embodiment, the ultrasonic device 10 is configured as a fixed structure, and the transmission member 12 is located in a preset position, such that after the receiving cup 103 is placed on the mixing position 102, the receiving cup 103 will directly contact the second end of the transmission member 12.

[0118] In this embodiment, the sample analyzer also includes a clamping device 110, which is used to limit the radial degree of freedom of the cup 103 on the mixing position 102.

[0119] Please refer to Figure 13 and Figure 14The clamping device 110 includes two clamping assemblies arranged opposite each other. Each clamping assembly includes a clamping motor 111, a clamping cam 112, and a clamping block 113. The clamping motor 111 is mounted on the base 100, with its output shaft facing upwards and vertically arranged. The output shaft of the clamping motor 111 is connected to the clamping cam 112, which is horizontally arranged and in contact with the clamping block 113. The clamping block 113 is horizontally movable and mounted on the base 100. The two sides of the clamping block 113 are adapted to the receiving cup 103 and the clamping cam 112, respectively. If the receiving cup 103 is a circular tube, the surface of the clamping block 113 facing the receiving cup 103 is a concave arc surface; if the receiving cup 103 is a square tube, the surface of the clamping block 113 facing the receiving cup 103 is a flat surface. The protrusion of the clamping cam 112 is a convex arc surface, while the clamping block 113 facing the clamping cam 112 is a concave arc surface with a larger curvature. This allows the concave arc surface of the clamping block 113 to guide the protrusion of the clamping cam 112 to slide in and out. The clamping motor 111 drives the clamping cam 112 to rotate, so that the clamping cam 112 drives the clamping block 113 to move closer to or away from the receiving cup 103. When the protrusions of both clamping cams 112 face the receiving cup 103 and are aligned on a line, the two clamping blocks 113 clamp the receiving cup 103, restricting the radial degree of freedom of the receiving cup 103. This prevents the receiving cup 103 from shaking during ultrasonic mixing and ensures good contact between the receiving cup 103 and the transfer member 12.

[0120] In this embodiment, since the ultrasonic device 10 contacts the lower end of the receiving cup 103 to achieve ultrasonic mixing, the clamping block 113 of the clamping device 110 clamps the lower side wall of the receiving cup 103 to improve the stability of the clamping. When the transmission member 12 of the ultrasonic device 10 abuts against the lower side wall of the receiving cup 103, the transmission member 12 and the clamping block 113 are staggered on the lower side wall of the receiving cup 103.

[0121] In one embodiment, the clamping device 110 may also include a linear drive and a clamping block. The linear drive is a cylinder or a linear motor. The linear drive drives the clamping block to move closer to and away from the receiving cup 103, which can also achieve the limiting of the receiving cup 103.

[0122] This embodiment uses a non-contact ultrasonic device 10, which can also transmit ultrasonic vibrations to the reaction liquid 104 in the container 103 to form an ultrasonic sound field and ultrasonic cavitation phenomenon, so as to ultrasonically mix the reaction liquid 104 in the container 103.

[0123] In one embodiment, the ultrasonic device 10 and the reagent dispensing mechanism 32 are integrated into a single structure. The ultrasonic device 10 includes an ultrasonic transducer, which is mounted on the moving mechanism of the reagent dispensing mechanism 32. The ultrasonic transducer is connected to a reagent needle, and the ultrasonic vibrations generated by the ultrasonic transducer are transmitted to the reagent needle, which then emits ultrasonic waves into the untreated magnetic bead reagent. After the ultrasonic device 10 and the reagent dispensing mechanism 32 are combined, the reagent needle can not only pick up the untreated magnetic bead reagent, but also perform ultrasonic mixing on the untreated magnetic bead reagent. Specifically, the reagent needle can perform ultrasonic mixing on the untreated magnetic bead reagent in the reagent container on the reagent carrying mechanism 31 or the reagent buffer mechanism 33.

[0124] In one embodiment, a method for mixing magnetic bead reagents is provided, and this sample analysis method is performed by the sample analyzer described in the above embodiment.

[0125] Please refer to Figure 14 The magnetic bead reagent mixing method in this embodiment includes the following steps:

[0126] S101: Magnetic bead reagent loading;

[0127] The doctor places the reagent container 105 containing untreated magnetic bead reagent into the reagent carrier 31. After standing for a period of time, the magnetic beads will sink to the bottom of the reagent container under their own weight, resulting in a higher density of magnetic beads at the bottom than at the top. Untreated magnetic bead reagent refers to reagent that has not undergone any manual or automatic mixing before being used on the machine; untreated magnetic bead reagent is generally in a state of uneven distribution of magnetic beads.

[0128] S102: Ultrasonic mixing;

[0129] The ultrasonic device 10 emits ultrasonic waves into the untreated magnetic bead reagent on the reagent carrier 31 to perform ultrasonic mixing. The ultrasonic device 10 uniformly disperses the magnetic beads in the untreated magnetic bead reagent so that the subsequent reagent dispensing mechanism 32 can pick up the uniformly distributed magnetic bead reagent.

[0130] When the controller 60 controls the ultrasound device 10, the controller 60 acquires the test items input or selected by the doctor, acquires the test item parameters corresponding to the test items, and matches one ultrasound mode from multiple ultrasound modes according to the test item parameters to perform ultrasound mixing operation on the untreated magnetic bead reagent.

[0131] Different ultrasound modes have different ultrasound mixing intensities or different ultrasound mixing times. The mixing intensity is controlled by the input power and can be set to at least three ultrasound mixing intensities: strong, medium, and weak. It can also be set to at least two ultrasound mixing times: 1 second and 2 seconds.

[0132] Ultrasonic mixing modes include at least the following:

[0133] The first mixing mode uses ultrasonic device 10 to perform ultrasonic mixing operation, with medium ultrasonic mixing intensity and 1 second ultrasonic mixing time.

[0134] The second mixing mode uses ultrasonic device 10 to perform ultrasonic mixing operation, with weak ultrasonic mixing intensity and ultrasonic mixing time of 2s.

[0135] In the third mixing mode, ultrasonic device 10 is used to perform ultrasonic mixing operation, the ultrasonic mixing intensity is strong, and the ultrasonic mixing time is 1 second.

[0136] Test parameters include numbers, letters, or a combination of both. For example, the test parameter for TNI (troponin) is 2, and the test parameters for E2 (estradiol) include 0 and 1. The controller 60 pre-stores test parameters corresponding to different test items, and each test parameter corresponds to a mixing mode. For example, test parameter 0 corresponds to the first mixing mode. When the controller 60 obtains a test parameter of 0, it drives the ultrasonic device 10 to perform ultrasonic mixing of the untreated magnetic bead reagent at a medium intensity for 1 second. Test parameter 1 corresponds to the second mixing mode. When the controller 60 obtains a test parameter of 1, it drives the ultrasonic device 10 to perform ultrasonic mixing of the untreated magnetic bead reagent at a weak intensity for 2 seconds. Test parameter 2 corresponds to the third mixing mode. When the controller 60 obtains a test parameter of mode 2, it drives the ultrasonic device 10 to perform ultrasonic mixing of the untreated magnetic bead reagent at a strong intensity for 1 second.

[0137] Different ultrasonic mixing modes can be set according to specific test items, so that the ultrasonic device 10 can effectively ultrasonically mix the untreated magnetic bead reagent in different test items.

[0138] S103: Add reagent;

[0139] The first transfer mechanism 81 transfers the container 103 containing sample S from the sample dispensing position 101 to the outer ring inside the reaction mechanism 40; the reaction mechanism 40 then transfers the container 103 to the reagent dispensing position;

[0140] The reagent dispensing mechanism 32 draws ultrasonically treated magnetic bead reagent R from the reagent carrying mechanism 31 and adds the drawn ultrasonically treated magnetic bead reagent R into the container cup 103 at the sample addition position in the reaction mechanism 40.

[0141] In this embodiment, an ultrasonic mixing step is included after the magnetic bead reagent is loaded onto the instrument. This allows the untreated magnetic bead reagent to be loaded directly without prior pretreatment, achieving full automation of the detection and improving detection efficiency. Compared to traditional manual shaking and vortex mixing, ultrasonic mixing can disperse the magnetic beads in the reagent more evenly, ensuring greater accuracy in the detection.

[0142] In one embodiment, a sample analysis method is provided, which is performed by the sample analyzer described in the above embodiments. This sample analysis method includes the magnetic bead reagent mixing method described in the above embodiments.

[0143] Please refer to Figure 16 In the overall testing, the sample analyzer can support five different testing procedures depending on the different reagent items.

[0144] The first method, one-step separation: After adding sample S and reagent R respectively, perform one incubation and one magnetic separation operation, then add substrate A, incubate and measure light.

[0145] The second method is a two-step separation: After adding sample S, the first step is to add reagent R1, which can be one or more reagents. The sample and reagent R1 are mixed to form a reaction solution for the first incubation. After the first incubation, the second step is to add reagent R2, which can be one or more reagents. Reagent R2 and the reaction solution after the first incubation form a new reaction solution for the second incubation. The reaction solution after the second incubation is then subjected to magnetic separation, substrate A addition, incubation, and photometric measurement in sequence.

[0146] The third method is a two-step separation: After adding the sample, the first step is to add reagent R1. The sample and reagent R1 are mixed to form a reaction solution for the first incubation. After the first incubation, the first magnetic separation operation is performed. After the first magnetic separation operation, the second step is to add reagent R2. Reagent R2 and the reaction solution after the first magnetic separation form a new reaction solution for the second incubation. The reaction solution after the second incubation is used for the second magnetic separation operation. After the second magnetic separation operation, the reaction solution is used to add substrate A, incubate, and perform photometric measurement in sequence.

[0147] The fourth method is sample pretreatment: add sample S, then add pretreatment solution to pretreat the sample to form sample S'; add reagent R to the pretreated sample S', and then perform incubation, magnetic separation, substrate A addition, incubation and photometry in sequence.

[0148] The fifth method is sample pre-dilution: add sample S, then add diluent to dilute the sample to obtain a sample S' with a lower concentration; add reagent to the diluted sample S', and then perform incubation, magnetic separation, addition of substrate A, incubation and photometry in sequence.

[0149] In this embodiment, the sample analysis method is controlled and executed by the controller 60, and is illustrated using a one-step magnetic separation method as an example. This sample analysis method involves ultrasonically mixing the incubated reaction solution.

[0150] Please refer to Figure 17 The sample analysis method in this embodiment includes the following steps:

[0151] S201: Magnetic bead reagent loading;

[0152] The doctor places the reagent container 105 containing untreated magnetic bead reagent into the reagent carrier 31.

[0153] S202: Ultrasonic mixing;

[0154] The ultrasonic device 10 emits ultrasonic waves into the untreated magnetic bead reagent on the reagent carrier 31 to perform ultrasonic mixing. The ultrasonic device 10 uniformly disperses the magnetic beads in the untreated magnetic bead reagent so that the subsequent reagent dispensing mechanism 32 can pick up the uniformly distributed magnetic bead reagent.

[0155] The ultrasonic mixing operation is the same as in the above embodiments, but different ultrasonic modes are matched for different test items to effectively mix the magnetic bead reagents.

[0156] S203: Sample injection;

[0157] The first transfer mechanism 81 transfers the new container cup 103 on the upper cup mechanism 71 to the sample dispensing position 101;

[0158] The sample dispensing mechanism 22 picks up the sample S from the sample carrying mechanism 21 and adds the picked-up sample S into the container cup 103 on the sample dispensing position 101.

[0159] There is no necessary sequential relationship between step S103 and steps S101 and S102. Step S103 can be performed before or after steps S101 and S102, or simultaneously with steps S101 and S102.

[0160] S204: Add reagent;

[0161] The first transfer mechanism 81 transfers the container 103 containing sample S from the sample dispensing position 101 to the outer ring inside the reaction mechanism 40; the reaction mechanism 40 then transfers the container 103 to the reagent dispensing position;

[0162] The reagent dispensing mechanism 32 picks up the ultrasonicated magnetic bead reagent R from the reagent carrying mechanism 31 and adds the picked-up ultrasonicated magnetic bead reagent R into the container cup 103 at the sample addition position in the reaction mechanism 40. The sample S and magnetic bead reagent R in the container cup 103 are mixed to form a reaction solution.

[0163] S205: Vortex mixing;

[0164] The second transfer mechanism 82 transfers the container 103 containing the reaction liquid to the mixing position 102;

[0165] A vortex mixing device is used to vortex mix the reaction solution in container 103 to ensure that sample S and magnetic bead reagent R react fully.

[0166] S206: Incubation;

[0167] The second transfer mechanism 82 transfers the container 103 containing the vortex-mixed reaction liquid from the mixing position 102 back to the inner ring of the reaction mechanism 40 for incubation for a preset time.

[0168] S207: Magnetic separation;

[0169] The second transfer mechanism 82 transfers the container 103 containing the incubated reaction liquid from the reaction mechanism 40 into the magnetic separation mechanism 50.

[0170] The cleaning fluid dispensing structure of the magnetic separation mechanism 50 dispenses cleaning fluid into the container cup 103 containing the reaction fluid;

[0171] The magnetic structure uses a magnetic field to attract the reaction complex containing magnetic beads inside the container cup 103.

[0172] The liquid-absorbing structure removes other substances and liquids, except for the adsorbed reaction complex, from the container cup 103.

[0173] S208: Add substrate;

[0174] The substrate dispensing mechanism of the magnetic separation unit 50 adds substrate A to the container 103 after liquid absorption. Substrate A luminescently marks the reaction complex in the reaction solution.

[0175] S209: Incubation;

[0176] The second transfer mechanism 82 transfers the container 103 containing the reaction solution injected with substrate A from the magnetic separation mechanism 50 back to the outer ring of the reaction mechanism 40 for incubation.

[0177] S210: Optical measurement;

[0178] The reaction mechanism 40 transfers the incubated reaction solution container 103 to the detection position;

[0179] The measuring apparatus 90 detects the luminescent reactive complex within the container cup 103;

[0180] After the photometry is completed, the waste liquid suction mechanism removes the reaction liquid from the container 103;

[0181] The first transfer mechanism 81 transfers the container 103 containing the discharged reaction liquid from the reaction mechanism 40 to the cup-throwing position 72.

[0182] In this embodiment, the sample analysis method includes the magnetic bead reagent mixing method described in the above embodiments, achieving full automation of the detection and improving detection efficiency. Compared with traditional manual shaking and vortex mixing, ultrasonic mixing can disperse the magnetic beads in the reagent more evenly, thus ensuring greater detection accuracy.

[0183] In one embodiment, in step 202, the sampling needle is connected to the ultrasonic device 10, and ultrasonic waves are emitted by the sampling needle into the untreated magnetic bead reagent on the reagent carrier 31. This also enables ultrasonic mixing of the untreated magnetic bead reagent.

[0184] In one embodiment, multiple ultrasonic devices 10 are provided, and the ultrasonic devices 10 are also used to perform ultrasonic mixing operations on the reaction solution. For example, if one is located near the mixing position 102, the ultrasonic device 10 is also used to perform ultrasonic mixing operations on the reaction solution before or after incubation, and to perform ultrasonic mixing operations on the reaction solution to which the substrate has been added.

[0185] In one embodiment, a magnetic bead reagent mixing method is provided. The difference between this magnetic bead reagent mixing method and the magnetic bead reagent mixing method in the above embodiment is that: the untreated magnetic bead reagent is first placed in the reagent buffer mechanism 33, and after performing an ultrasonic mixing operation on the untreated magnetic bead reagent in the reagent buffer mechanism 33, the ultrasonically mixed magnetic bead reagent is then transferred to the reagent carrying mechanism 31.

[0186] Please refer to Figure 18 The sample analysis method in this embodiment includes the following steps:

[0187] S301: Magnetic bead reagent loading;

[0188] The doctor places the reagent container 105 containing untreated magnetic bead reagent into the reagent buffer mechanism 33.

[0189] S302: Ultrasonic mixing;

[0190] The ultrasonic device 10 emits ultrasonic waves into the untreated magnetic bead reagent in the reagent buffer mechanism 33, performing an ultrasonic mixing operation on the untreated magnetic bead reagent. The ultrasonic device 10 uniformly disperses the magnetic beads in the untreated magnetic bead reagent, so that the subsequent reagent dispensing mechanism 32 can pick up the uniformly distributed magnetic bead reagent.

[0191] The ultrasonic mixing operation is the same as in the above embodiments, but different ultrasonic modes are matched for different test items to effectively mix the magnetic bead reagents.

[0192] S303, transfer magnetic bead reagent;

[0193] The reagent transfer mechanism 34 transfers the ultrasonically purified magnetic bead reagent from the reagent buffer mechanism 33 to the reagent carrier mechanism 31.

[0194] S304: Adding reagents;

[0195] The first transfer mechanism 81 transfers the container 103 containing sample S from the sample dispensing position 101 to the outer ring inside the reaction mechanism 40; the reaction mechanism 40 then transfers the container 103 to the reagent dispensing position;

[0196] The reagent dispensing mechanism 32 draws ultrasonically treated magnetic bead reagent R from the reagent carrying mechanism 31 and adds the drawn ultrasonically treated magnetic bead reagent R into the container cup 103 at the sample addition position in the reaction mechanism 40.

[0197] In this embodiment, the untreated magnetic bead reagent is ultrasonically mixed in the reagent buffer mechanism 34, which also mixes the magnetic beads before they are added to the sample, so that the magnetic bead reagent absorbed by the reagent dispensing mechanism 32 can fully react with the sample, thereby improving the accuracy of the detection.

[0198] In one embodiment, a sample analysis method is provided, which includes the magnetic bead reagent mixing method described in the above embodiment.

[0199] Please refer to Figure 19 The sample analysis method in this embodiment includes the following steps:

[0200] S401: Magnetic bead reagent loading;

[0201] The doctor places the reagent container 105 containing untreated magnetic bead reagent into the reagent buffer mechanism 33.

[0202] S402: Ultrasonic mixing;

[0203] The ultrasonic device 10 emits ultrasonic waves into the untreated magnetic bead reagent in the reagent buffer mechanism 33, performing an ultrasonic mixing operation on the untreated magnetic bead reagent. The ultrasonic device 10 uniformly disperses the magnetic beads in the untreated magnetic bead reagent, so that the subsequent reagent dispensing mechanism 32 can pick up the uniformly distributed magnetic bead reagent.

[0204] The ultrasonic mixing operation is the same as in the above embodiments, but different ultrasonic modes are matched for different test items to effectively mix the magnetic bead reagents.

[0205] S403: Transfer magnetic bead reagent;

[0206] The reagent transfer mechanism 34 transfers the ultrasonically purified magnetic bead reagent from the reagent buffer mechanism 33 to the reagent carrier mechanism 31.

[0207] S404: Sample injection;

[0208] The first transfer mechanism 81 transfers the new container cup 103 on the upper cup mechanism 71 to the sample dispensing position 101;

[0209] The sample dispensing mechanism 22 picks up the sample S from the sample carrying mechanism 21 and adds the picked-up sample S into the container cup 103 on the sample dispensing position 101.

[0210] There is no necessary sequential relationship between step S204 and steps S201 to S203. Step S204 can be performed before or after steps S201 and S203, or step S204 can be performed simultaneously with steps S201 and S203.

[0211] S405: Adding reagents;

[0212] The first transfer mechanism 81 transfers the container 103 containing sample S from the sample dispensing position 101 to the outer ring inside the reaction mechanism 40; the reaction mechanism 40 then transfers the container 103 to the reagent dispensing position;

[0213] The reagent dispensing mechanism 32 picks up the ultrasonicated magnetic bead reagent R from the reagent carrying mechanism 31 and adds the picked-up ultrasonicated magnetic bead reagent R into the container cup 103 at the sample addition position in the reaction mechanism 40. The sample S and magnetic bead reagent R in the container cup 103 are mixed to form a reaction solution.

[0214] S406: Vortex mixing;

[0215] The second transfer mechanism 82 transfers the container 103 containing the reaction liquid to the mixing position 102;

[0216] A vortex mixing device is used to vortex mix the reaction solution in container 103 to ensure that sample S and magnetic bead reagent R react fully.

[0217] S407: Incubation;

[0218] The second transfer mechanism 82 transfers the container 103 containing the vortex-mixed reaction liquid from the mixing position 102 back to the inner ring of the reaction mechanism 40 for incubation for a preset time.

[0219] S408: Magnetic separation;

[0220] The second transfer mechanism 82 transfers the container 103 containing the incubated reaction liquid from the reaction mechanism 40 into the magnetic separation mechanism 50.

[0221] The cleaning fluid dispensing structure of the magnetic separation mechanism 50 dispenses cleaning fluid into the container cup 103 containing the reaction fluid;

[0222] The magnetic structure uses a magnetic field to attract the reaction complex containing magnetic beads inside the container cup 103.

[0223] The liquid-absorbing structure removes other substances and liquids, except for the adsorbed reaction complex, from the container cup 103.

[0224] S409: Add substrate;

[0225] The substrate dispensing mechanism of the magnetic separation unit 50 adds substrate A to the container 103 after liquid absorption. Substrate A luminescently marks the reaction complex in the reaction solution.

[0226] S410: Incubation;

[0227] The second transfer mechanism 82 transfers the container 103 containing the reaction solution injected with substrate A from the magnetic separation mechanism 50 back to the outer ring of the reaction mechanism 40 for incubation.

[0228] S411: Optical measurement;

[0229] The reaction mechanism 40 transfers the incubated reaction solution container 103 to the detection position;

[0230] The measuring apparatus 90 detects the luminescent reactive complex within the container cup 103;

[0231] After the photometry is completed, the waste liquid suction mechanism removes the reaction liquid from the container 103;

[0232] The first transfer mechanism 81 transfers the container 103 containing the discharged reaction liquid from the reaction mechanism 40 to the cup-throwing position 72.

[0233] The sample analysis method in this embodiment includes the magnetic bead reagent mixing method in the above embodiment. The untreated magnetic bead reagent is ultrasonically mixed in the reagent buffer mechanism 34, which can also mix the magnetic beads before they are added to the sample, so that the magnetic bead reagent absorbed by the reagent dispensing mechanism 32 can fully react with the sample, thereby improving the accuracy of the detection.

[0234] The above examples illustrate the present invention only to aid in understanding it and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention.

Claims

1. A sample analyzer, characterized in that, include: A sample carrier mechanism, used to hold the sample; A sample dispensing mechanism is used to draw the sample from the sample carrying mechanism and dispense the sample into a receiving cup; A reagent carrier mechanism is used to hold a reagent container containing magnetic beads. A reagent dispensing mechanism is used to draw magnetic bead reagent from the reagent carrying mechanism and discharge the magnetic bead reagent into a receiving cup; A reagent buffer mechanism is used to temporarily store reagent containers containing magnetic beads. A reagent transfer mechanism is used to transfer the reagent container on the reagent buffer mechanism to the reagent carrying mechanism; An ultrasonic device is used to generate ultrasonic vibrations to form ultrasonic waves; the ultrasonic device is used to contact the outer wall of the reagent container. A controller is connected to the ultrasonic device, the reagent transfer mechanism, and the reagent dispensing mechanism. The controller is used to control the ultrasonic device to emit ultrasonic waves into the magnetic bead reagent of the reagent buffer mechanism in a non-contact manner. The controller is used to control the reagent transfer mechanism to transfer the reagent container with ultrasonically operated magnetic beads on the reagent buffer mechanism to the reagent carrying mechanism; The controller is used to control the reagent dispensing mechanism to draw ultrasonically operated magnetic bead reagent from the reagent carrying mechanism and to discharge the ultrasonically operated magnetic bead reagent into the receiving cup.

2. The sample analyzer as described in claim 1, characterized in that, The magnetic bead reagent is an untreated magnetic bead reagent, which is a magnetic bead reagent that has not undergone any manual or automatic mixing process before entering the sample analyzer.

3. The sample analyzer as described in claim 2, characterized in that, The untreated magnetic bead reagent includes magnetic bead reagents with a magnetic bead density at the bottom of the reagent container that is greater than that at the top.

4. The sample analyzer as described in claim 1, characterized in that, The reagent carrier is used to carry a reagent container containing magnetic beads, and the ultrasonic device is used to perform ultrasonic operation on the magnetic beads located on the reagent carrier.

5. The sample analyzer as described in claim 1, characterized in that, The controller is used to acquire test parameters and, based on the test parameters, select one of a variety of preset ultrasonic modes to perform ultrasonic operation on the magnetic bead reagent.

6. The sample analyzer as described in claim 5, characterized in that, The various ultrasound modes have different ultrasound intensities and / or ultrasound durations.

7. The sample analyzer as described in claim 1, characterized in that, The ultrasonic device includes an ultrasonic transducer and a transmission element. The ultrasonic transducer is used to generate ultrasonic vibrations. The transmission element has a first end and a second end. The first end of the transmission element is connected to the ultrasonic transducer. The second end of the transmission element is used to abut against the outer wall of a reagent container. The part of the outer wall of the reagent container that contacts the transmission element is the part surrounding the magnetic bead reagent, so as to transmit the ultrasonic vibrations generated by the ultrasonic transducer to the magnetic bead reagent in the reagent container.

8. The sample analyzer as described in claim 7, characterized in that, The transfer element is a solid structure, and its outer diameter gradually decreases or decreases in a stepwise manner from the first end to the second end.

9. The sample analyzer as described in claim 1, characterized in that, It also includes a reaction mechanism, a magnetic separation mechanism, and a measurement mechanism. The reaction mechanism is used to provide an incubation site for the reaction liquid in the container cup. The reaction liquid includes a sample and ultrasonically operated magnetic bead reagents. The magnetic separation mechanism is used to inject a cleaning solution into the incubated reaction liquid to perform a magnetic separation operation. The measurement mechanism is used to perform photometric measurement on the reaction liquid containing the substrate.

10. The sample analyzer as described in claim 9, characterized in that, The ultrasonic device is also used to perform ultrasonic operations on at least one of the following: a sample, a reaction solution to be incubated, a reaction solution after incubation, a reaction solution with injected cleaning solution, and a reaction solution with injected substrate.

11. A method for mixing magnetic beads as a reagent, characterized in that, Includes the following steps: A reagent container containing magnetic beads is loaded onto a reagent buffer mechanism; an ultrasonic device contacts the outer wall of the reagent container, and the ultrasonic device emits ultrasonic waves into the magnetic beads in the reagent buffer mechanism in a non-contact manner. The reagent transfer mechanism transfers the reagent container with ultrasonically operated magnetic beads from the reagent buffer mechanism to the reagent carrying mechanism; The reagent dispensing mechanism draws the ultrasonically operated magnetic bead reagent from the reagent carrying mechanism and injects the ultrasonically operated magnetic bead reagent into the receiving cup.

12. The method for mixing magnetic bead reagents as described in claim 11, characterized in that, The magnetic bead reagent is an untreated magnetic bead reagent, which is a magnetic bead reagent that has not undergone any manual or automatic mixing process before entering the sample analyzer.

13. The method for mixing magnetic bead reagents as described in claim 12, characterized in that, The untreated magnetic bead reagent includes magnetic bead reagents with a magnetic bead density at the bottom of the reagent container that is greater than that at the top.

14. The method for mixing magnetic bead reagents as described in any one of claims 11 to 13, characterized in that, The ultrasonic operation of the ultrasonic device is controlled by the following steps: Obtain test project parameters; Based on the test parameters, one ultrasonic mode is selected from a variety of preset ultrasonic modes to perform ultrasonic operation on the magnetic bead reagent.

15. The method for mixing magnetic bead reagents as described in claim 14, characterized in that, The various ultrasound modes have different ultrasound intensities and / or ultrasound durations.

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