Chemiluminescence immunoassay analyzer and magnetic bead solution mixing method thereof

Abstract

The application relates to the technical field of in-vitro diagnosis equipment, in particular to a chemiluminescence immunoassay analyzer and a magnetic bead solution mixing method thereof. When the mixing operation is performed, first, a reagent container to be mixed is moved to a reagent position, so that a reagent needle of a reagent dispensing mechanism sucks the reagent to be mixed in the reagent container, then, the reagent to be mixed is subjected to one or more mixing operations. One mixing operation specifically comprises the following steps: first, the reagent needle is moved to a preset liquid suction position below the liquid surface of the reagent to be mixed to suck the reagent, then, the reagent needle is moved to a preset liquid discharge position to discharge the sucked reagent, and at the same time of discharging, horizontal relative motion is generated between the reagent needle and the reagent container. The above scheme of the application realizes effective superposition of dynamic impact and static shearing by adopting a fluid dynamic intervention mechanism of up-suction and down-discharge and combining a multi-dimensional collaborative disturbance strategy, and generates a more optimal collaborative chaotic mixing effect.

Description

Technical Field

[0001] This invention relates to the field of in vitro diagnostic equipment technology, specifically to a chemiluminescence immunoassay analyzer and a method for mixing magnetic bead solutions. Background Technology

[0002] Chemiluminescence immunoassay is an indispensable high-sensitivity detection technique in modern medical testing. One of its core processes is ensuring that the magnetic microparticles (magnetic beads) involved in the reaction are fully and uniformly suspended in the reagent solution. Any stubborn agglomeration of settled magnetic beads may lead to inaccurate sample volume and incomplete reaction, ultimately directly affecting the accuracy and repeatability of the test results.

[0003] Currently, most automated analyzers use a mechanical mixing scheme: the reagent container is placed on a rotatable reagent disk, which is driven by a motor to revolve. The revolve motion is converted into the rotation of the magnetic bead cavity inside the reagent container by a gear coupling transmission mechanism. A fixed periodic mixing action is used to stir and shear the magnetic bead solution with the help of the protrusions or stirring ribs inside the magnetic bead cavity to achieve mixing.

[0004] However, with the increasing number of detection items and the growing complexity of magnetic beads (variing particle size, concentration, coating material, and buffer composition), this traditional mixing method, with its fixed and singular approach and lack of adaptability, has revealed its inherent limitations: the fluid shear force it generates is limited, and its effective range is macroscopic. It often struggles to effectively disperse tightly aggregated and randomly distributed bottom magnetic beads after long periods of settling, typically requiring manual mixing or prolonged in-system mixing within the analyzer to achieve basic homogeneity. This leads to uneven magnetic bead concentration and an increased coefficient of variation (CV) for multiple sample additions, becoming a core bottleneck in improving instrument throughput and accuracy. Summary of the Invention

[0005] The present invention provides a chemiluminescence immunoassay analyzer and a method for mixing magnetic bead solutions, which effectively solves the problem of difficulty in effectively mixing magnetic bead agglomerates after long-term standing in existing magnetic bead mixing operations.

[0006] According to the first aspect, one embodiment provides a method for mixing a magnetic bead solution in a chemiluminescence immunoassay analyzer, comprising: Move the reagent container to be mixed to the reagent position so that the reagent dispensing mechanism can draw the reagent to be mixed from the reagent container. The reagent to be mixed is subjected to one or more mixing operations, wherein one mixing operation includes: moving the reagent needle to a preset aspiration position below the liquid surface of the reagent to be mixed to aspirate the reagent; moving the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, controlling the reagent needle and / or the reagent container to generate horizontal relative movement between the reagent needle and the reagent container.

[0007] In one feasible implementation, the method further includes: Obtain reagent information from the container containing the reagent to be mixed; the container contains the reagent to be mixed; the reagent information includes one or more of the following: test item, magnetic bead type, magnetic bead concentration, and settling time. The mixing parameters are determined based on the reagent information; the mixing parameters include multiple parameters such as the number of mixing operations, the dispensing speed, the amplitude of horizontal relative movement, the frequency of horizontal relative movement, the aspiration position, the dispensing position, and the aspiration-dispensing volume. The step of performing one or more mixing operations on the reagent to be mixed includes: performing one or more mixing operations on the reagent to be mixed according to the determined mixing parameters.

[0008] In one feasible implementation, controlling the reagent needle and / or the reagent container to generate a horizontal relative movement between the reagent needle and the reagent container includes: Control the reagent needle to reciprocate horizontally within the reagent container or control the reagent needle to oscillate within the reagent container; or, Control the reagent container to reciprocate horizontally; or, The reagent needle is controlled to reciprocate horizontally within the reagent container, or the reagent needle is controlled to swing within the reagent container, and the reagent container is also controlled to reciprocate horizontally.

[0009] In one feasible implementation, determining the mixing parameters based on the reagent information includes: Determine the test items for the reagent to be mixed in the container; Based on the reagent characteristics and settling time in the test items, a target mixing parameter is determined from a set of preset mixing parameters with different weights. The reagent characteristics include the type and concentration of magnetic beads. The higher the concentration of magnetic beads, the greater the weight of the determined target mixing parameter. And / or, the longer the settling time, the greater the weight of the determined target mixing parameter. The mixing intensity of the mixing operation corresponding to the mixing parameter with the greater weight is greater.

[0010] In one feasible implementation, before moving the reagent needle to a preset aspiration position below the surface of the reagent liquid to be mixed to draw the reagent, the method further includes: The reagent needle is controlled to draw in a preset volume of isolation air.

[0011] In one feasible implementation, moving the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, controlling the reagent needle and / or the reagent container to generate a horizontal relative movement between the reagent needle and the reagent container, includes: According to the discharge position in the mixing parameters, the reagent needle is moved to a discharge position below the aspiration position, and the reagent of the aspiration-discharge volume is discharged according to the discharge rate in the mixing parameters. During the process of discharging the reagent of the aspirated-expelled volume, the reagent needle and / or the reagent container are controlled to generate horizontal relative motion between the reagent needle and the reagent container according to the amplitude and frequency of the horizontal relative motion in the mixing parameters.

[0012] In one feasible implementation, after moving the reagent container to be mixed to the reagent position, the method further includes: The container of the reagent to be mixed is controlled to rotate at a preset rotation speed; After controlling the reagent needle and / or the reagent container to generate a horizontal relative movement between the reagent needle and the reagent container, the method further includes: The reagent needle is moved to a cleaning device for cleaning.

[0013] According to a second aspect, one embodiment provides a chemiluminescence immunoassay analyzer, comprising: A reagent tray is used to hold multiple reagent containers, which are moved to reagent positions by rotation; each reagent container is arranged circumferentially on the reagent tray; each reagent container contains a reagent. A reagent dispensing mechanism includes a reagent needle for drawing up and dispensing reagents. Processor, used for: The reagent tray is controlled to move the reagent container to be mixed to the reagent position; The reagent needle of the reagent dispensing mechanism is controlled to draw the reagent to be mixed from the reagent container at the reagent position; The reagent to be mixed is subjected to one or more mixing operations, wherein one mixing operation includes: controlling the reagent dispensing mechanism to move the reagent needle to a preset aspiration position below the liquid surface of the reagent to be mixed to aspirate the reagent; controlling the reagent dispensing mechanism to move the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, controlling the reagent dispensing mechanism and / or the reagent tray to generate horizontal relative movement between the reagent needle and the reagent container.

[0014] According to a third aspect, one embodiment provides a chemiluminescence immunoassay analyzer, comprising: A reagent tray is used to hold multiple reagent containers, which are moved to reagent positions by rotation; each reagent container is arranged circumferentially on the reagent tray; each reagent container contains a reagent. A reagent dispensing mechanism includes a reagent needle for drawing up and dispensing reagents. Memory, used to store programs; A processor for executing the program to implement the method described above.

[0015] According to a fourth aspect, one embodiment provides a computer-readable storage medium storing a computer program that can be executed by a processor to implement the method described above.

[0016] According to the above embodiment of a chemiluminescence immunoassay analyzer and its magnetic bead solution mixing method, during the mixing operation, the reagent container to be mixed is first moved to the reagent position so that the reagent dispensing mechanism can draw the reagent to be mixed from the reagent container. Then, the reagent to be mixed is mixed once or multiple times. Specifically, one mixing operation includes: first, moving the reagent needle to a preset aspiration position below the surface of the reagent to be mixed to draw the reagent; then, moving the reagent needle to a preset discharge position to discharge the drawn reagent; and simultaneously, controlling the reagent needle or reagent container to create a horizontal relative movement between the reagent needle and the reagent container. The above-described scheme of this application employs a hydrodynamic intervention mechanism of upward suction and downward flushing. First, it draws up the clear liquid on the surface of the liquid to avoid the aspiration of precipitates and agglomerates. Then, it precisely probes down to a position very close to the bottom of the cavity and discharges the liquid at high speed, forming a directional impact jet on the agglomerated magnetic beads at the bottom. Combined with a multi-dimensional synergistic perturbation strategy, it drives the reagent needle or reagent container to perform small-amplitude horizontal oscillations, which expands the impact jet from a static point action to a dynamic surface sweep. Furthermore, the reagent needle generates additional fluid shear force in the cavity of the reagent container. This shearing action and the jet impact force generated by the discharge form a combined force, acting together on the magnetic bead agglomerates. This achieves an effective superposition of dynamic impact and static shear, resulting in a better synergistic chaotic mixing effect. Attached Figure Description

[0017] Figure 1 This is a flowchart of a method for mixing magnetic bead solutions in a chemiluminescence immunoassay analyzer provided in this embodiment; Figure 2 This is a flowchart of a single mixing operation provided in this embodiment; Figure 3 This is another flowchart illustrating a method for mixing magnetic bead solutions in a chemiluminescence immunoassay analyzer, as provided in this embodiment. Figure 4 This is a flowchart for determining mixing parameters based on reagent information, provided in this embodiment. Figure 5 This is a structural block diagram of a chemiluminescence immunoassay analyzer provided in this embodiment; Figure 6 This is a structural block diagram of another chemiluminescence immunoassay analyzer provided in this embodiment.

[0018] Reference numerals: 10, reagent tray; 20, reagent dispensing mechanism; 30, processor; 40, memory. Detailed Implementation

[0019] 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.

[0020] 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.

[0021] 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).

[0022] Traditional mechanical mixing techniques rely on the revolution of the reagent disk and the rotation of the magnetic bead cavity, using protrusions within the cavity to mechanically agitate the solution. However, this technique has the following inherent drawbacks: First, the mixing intensity is insufficient. The fluid shear force generated by mechanical mixing with a fixed transmission ratio is limited and cannot effectively break up stubborn magnetic bead agglomerates formed after long-term standing. Its effective range is macroscopic, making it difficult to effectively disturb the tightly bonded magnetic bead agglomerates at the bottom.

[0023] Secondly, it has poor adaptability. The mixing parameters (such as rotation speed and number of rotations) are fixed and cannot be dynamically adjusted according to the physical characteristics (particle size, concentration, coating type) of different magnetic beads, and it lacks adaptability to diverse reagents.

[0024] Secondly, there is an efficiency bottleneck. For severely agglomerated magnetic beads, an excessively long mixing time is often required to achieve basic uniformity, which severely restricts the improvement of instrument detection throughput and becomes a bottleneck in system performance.

[0025] In view of this, the inventors of this application propose a method for mixing magnetic bead solutions in a chemiluminescence immunoassay analyzer, the specific implementation of which is shown below.

[0026] refer to Figure 1 This embodiment provides a method for mixing magnetic bead solutions in a chemiluminescence immunoassay analyzer, which specifically includes the following steps: Step 100: Move the reagent container to be mixed to the reagent position so that the reagent dispensing mechanism can draw the reagent to be mixed from the reagent container.

[0027] Specifically, in practical applications, the reagent container to be mixed is placed in a reagent tray. Multiple reagent containers can be placed circumferentially in the tray. When mixing is required, the reagent tray is rotated to move the target container to the designated position, allowing the reagent dispensing mechanism's needle to draw the reagent from the container. Moving the target container to the designated position means placing it vertically below the working position of the reagent needle to facilitate subsequent mixing. The reagent dispensing mechanism, in addition to the reagent needle, includes tubing and a pump. The pump draws the reagent, and the needle stores the drawn reagent in the tubing.

[0028] Step 200: Perform one or more mixing operations on the reagent to be mixed.

[0029] like Figure 2As shown, one mixing operation includes: step 210: moving the reagent needle to a preset aspiration position below the surface of the reagent to be mixed to aspirate the reagent; step 220: moving the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent; and step 230: during the discharge of the aspirated reagent, controlling the reagent needle and / or reagent container to generate horizontal relative movement between the reagent needle and the reagent container.

[0030] In practical applications, specifically during the mixing operation, the reagent needle is first inserted into a preset aspiration position below the reagent liquid surface using the liquid level detection function. For example, the supernatant is aspirated at a depth of 5 mm below the liquid surface, and the aspirated liquid volume can be 100-300 microliters. It should be noted that the liquid level detection function specifically detects changes in the physical or chemical properties of the liquid-gas interface through a sensor, converting these changes into measurable electrical or optical signals to ultimately determine the liquid level position. There are various ways to determine the specific depth of the reagent needle tip below the liquid surface. In this embodiment, a capacitive liquid level detection function can be used to determine the specific depth of the reagent needle tip below the liquid surface, that is, by measuring the change in capacitance between the liquid and the electrode to reflect the liquid level depth. Alternatively, it can be achieved by mechanically controlling the descent height of the reagent needle; this embodiment does not require further explanation in this regard.

[0031] After the reagent needle tip is inserted into a preset aspiration position below the reagent liquid surface to draw up the reagent, the needle tip is further inserted downwards to move it to a preset discharge position below the aspiration position, where the supernatant drawn into the needle is discharged. This achieves a hydrodynamic intervention mechanism of upward aspiration and downward flushing. Simultaneously, while discharging the supernatant, a stepper motor controls the reagent dispensing mechanism to make the reagent needle oscillate slightly within the reagent container, or a stepper motor controls the reagent disk to reciprocate slightly in a horizontal plane. This simultaneous discharge and oscillation creates a sweeping and shearing fluid effect, expanding the impact jet from a static point action to a dynamic surface sweep, ensuring comprehensive coverage of any agglomerates at any location on the bottom of the reagent container.

[0032] Furthermore, in practical applications, the number of mixing operations required can be determined based on the information of the reagent to be mixed in the reagent container.

[0033] Furthermore, refer to Figure 3 The method for mixing the magnetic bead solution in this embodiment also includes: Step 300: Obtain the reagent information of the container to be mixed; the container contains the reagent to be mixed; the reagent information includes one or more of the following: test item, magnetic bead type, magnetic bead concentration, and settling time. Step 400: Determine the mixing parameters based on the reagent information; the mixing parameters include multiple parameters such as the number of mixing operations, the dispensing speed, the amplitude of horizontal relative motion, the frequency of horizontal relative motion, the aspiration position, the dispensing position, and the aspiration-dispensing volume. Perform one or more mixing operations on the reagent to be mixed, including: Step 500: Perform one or more mixing operations on the reagent to be mixed according to the determined mixing parameters.

[0034] In practical applications, the mixing parameters used vary depending on the physical characteristics of the reagents to be mixed, such as magnetic bead size, magnetic bead concentration, and settling time. Specifically, firstly, the reagent information of the container to be mixed needs to be obtained, including the test items, magnetic bead type, magnetic bead concentration, and settling time. Then, the corresponding mixing parameters are determined based on the specific reagent information. The entire process is driven by an intelligent control system. Mixing parameters such as aspiration-discharge volume, discharge speed, mixing cycles, and movement trajectory can be adaptively matched and optimized according to the physical characteristics of different magnetic bead solutions (i.e., reagents to be mixed), such as particle size, concentration, and settling time, thereby achieving a leap from "general mixing" to "precise customized mixing." Ultimately, this solution seamlessly integrates and deeply collaborates with the mechanical mixing process, forming a complete, system-level solution. Without increasing any hardware costs, it maximizes and enhances the potential of existing equipment platforms through cutting-edge control algorithm innovation.

[0035] Furthermore, refer to Figure 4 The mixing parameters are determined based on the reagent information, specifically including: Step 410: Determine the test items for the reagents to be mixed in the container; Step 420: Based on the reagent characteristics and settling time in the test item, determine the target mixing parameter from a set of preset mixing parameters with different weights; the reagent characteristics include the type and concentration of magnetic beads; the higher the concentration of magnetic beads, the greater the weight of the determined target mixing parameter; and / or, the longer the settling time, the greater the weight of the determined target mixing parameter; the greater the weight of the mixing parameter, the greater the mixing intensity of the mixing operation.

[0036] The system internally stores a magnetic bead characteristic database and automatically matches the optimal mixing parameters by recognizing the reagent kit barcode. The database contains physical characteristic parameters of magnetic beads for different items and batches, enabling automatic adaptation of mixing parameters. Specifically, during actual operation, the reagent container to be mixed will have label information. The control system will scan and recognize the label information on the reagent container to obtain the reagent information of the reagent to be mixed in that container. After determining the test item of the current reagent container to be mixed, the control system will determine the target mixing parameter from a set of preset mixing parameters with different weights based on the magnetic bead concentration and the settling time of the magnetic beads in the test item.

[0037] Among these factors, the higher the concentration of magnetic beads and the longer the settling time, the greater the weight of the determined target mixing parameter. The weight of the mixing parameter corresponds to the mixing intensity during the mixing operation; the greater the weight of the mixing parameter, the greater the mixing intensity of the mixing operation. Specifically, the weight of the mixing parameter (W) total It consists of two parts: type-based weights and state-dynamic weights. The relationship between the weights of the three is expressed as: W total = W type + W state The weights of the mixing parameters determine the final mixing intensity (such as the number of aspiration / expulsion cycles, drainage rate, etc.); W type Type-based weight: Determined by the inherent physical and chemical properties of the magnetic beads within the reagent bead cavity, reflecting their inherent tendency to settle and aggregate; this is the static basic value. W state The dynamic weight is determined by the real-time state of the magnetic bead solution, mainly including the settling time (T), which is a dynamically adjusted value.

[0038] Mapping between weights and mixing intensity: Each set of mixing parameters built into the system (parameter schemes one to five below) corresponds to a weight range. The system calculates W... total The system intelligently uses the appropriate parameter set based on its weight range, or performs linear interpolation fine-tuning based on this range. Higher weights result in greater mixing intensity. Table 1 below shows examples of the system's built-in mixing parameters and their corresponding weights: Magnetic bead type classification Key feature descriptions (particle size, density, surface modification, etc.) Inherent tendency to reunite <![CDATA[Base weight (W type )]]> Class I: Highly Sensitive Small particle size (<1μm), density close to that of solution, and surface precisely coated with monoclonal antibodies, etc. Easily inactivated due to excessive shearing. Low 10% Category II: Standard General Type The particles have a moderate size (1-3 μm) and density, and their surfaces are modified with conventional proteins or carboxyl groups. They exhibit a balance between sedimentation and aggregation. middle 20% Category III: Easily Aggregates The particles are relatively large (>3μm) or have high density, strong hydrophobic surface, or are multi-layered. They tend to form compact aggregates after standing. high 30% Table 1 For example, this embodiment also provides multiple customizable mixing parameter schemes based on actual experimental data to adapt to magnetic bead reagents with different characteristics, as shown in Table 2 below: Parameter scheme Number of mixing cycles (number of inhalations and exhalations) Drainage rate (μL / s) Horizontal (circumferential) swing amplitude (mm) Horizontal (circumferential) oscillation frequency (Hz) Drainage depth: from the bottom of the cavity (mm) Volume of liquid aspirated and expelled in a single instance (μL) Parameter 1 5 100-110 4 1 8 100 Parameter 2 8 100-110 5 1 8 100 Parameter 3 10 150-160 5 2 5 150 Parameter 4 15 150-160 5 2 3 250 Parameter 5 25 300-310 8 3 3 300 Table 2 Furthermore, the reagent needle is moved to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, the reagent needle and / or reagent container are controlled to generate horizontal relative movement between the reagent needle and the reagent container, including: Move the reagent needle to the discharge position below the aspiration position according to the discharge position in the mixing parameters, and discharge the reagent of the aspiration-expulsion volume according to the discharge rate in the mixing parameters; During the process of discharging the reagent volume from the aspiration to the effluent, the reagent needle and / or reagent container are controlled to generate horizontal relative motion between the reagent needle and the reagent container according to the amplitude and frequency of the horizontal relative motion in the mixing parameters.

[0039] Taking parameter 1 in Table 2 above as an example: The reagent tray is rotated to bring the target reagent container to the working position (i.e., the reagent position). Then, the system reads the markings on the reagent container and retrieves the corresponding mixing parameters from the database (6 aspiration / expulsion cycles, dispensing rate of 180 μL / s, etc.). The reagent needle is moved to 5 mm below the liquid surface to aspirate 100 μL of supernatant. Afterward, the reagent needle descends to 4 mm from the bottom of the reagent container and dispenses at a rate of 100 μL / s, while simultaneously performing a horizontal oscillation (amplitude 4 mm, frequency 1 Hz). This completes one mixing operation. The above steps are repeated until the required number of mixing cycles is reached. The reagent needle then enters the cleaning process, followed by subsequent mechanical mixing or sample dispensing. This innovative design achieves intelligent, efficient, and precise magnetic bead mixing, providing a complete technical path to solve the long-standing problem of magnetic bead mixing.

[0040] In some embodiments, controlling the reagent needle and / or reagent container to create a horizontal relative movement between the reagent needle and the reagent container specifically includes: Control the reagent needle to move horizontally back and forth within the reagent container, or control the reagent needle to swing within the reagent container; or, Control the reagent container to move back and forth horizontally; or, The reagent needle can be controlled to move back and forth horizontally within the reagent container, or to swing within the reagent container, and the reagent container can also be controlled to move back and forth horizontally.

[0041] Specifically, horizontal relative movement between the reagent needle and the reagent container can be achieved in the following three ways: The first method: Specifically, the reagent needle of the reagent dispensing mechanism can be controlled by controlling a stepper motor to make a small horizontal reciprocating movement or a small oscillation within the reagent container.

[0042] The second method: Specifically, a stepper motor can be controlled to move the reagent tray holding the reagent container back and forth in the horizontal direction, thereby realizing the reciprocating movement of the reagent container in the horizontal direction.

[0043] The third method involves controlling the first stepper motor to control the reagent needle of the reagent dispensing mechanism to move back and forth in the horizontal direction within the reagent container in a small amplitude, or to control the reagent needle to swing in the horizontal direction in a small amplitude within the reagent container. At the same time, the second stepper motor is controlled to control the reagent tray holding the reagent container to move back and forth in the horizontal direction, thereby achieving horizontal relative movement between the reagent needle and the reagent container.

[0044] The range of motion in the three methods described above can be a fixed range or determined based on specific mixing parameters. The specific range depends on the actual situation, and this embodiment does not make too many requirements.

[0045] In some embodiments, before moving the reagent needle to a preset aspiration position below the surface of the reagent to be mixed to draw the reagent, the method further includes: controlling the reagent needle to draw a preset volume of isolation air.

[0046] In practice, before drawing the reagent to be mixed using the reagent needle, it is necessary to first draw a small amount of air to prevent the solution in the magnetic bead chamber from mixing with the cleaning agent used for cleaning in the reagent needle. This would prevent contamination or abnormal dilution of the solution in the magnetic bead chamber. Drawing a small amount of air provides a certain degree of isolation during both liquid aspiration and dispensing. This isolation air can be drawn before each liquid aspiration, or it can be drawn once before the mixing operation, eliminating the need for further air aspiration during subsequent mixing operations.

[0047] In some embodiments, after moving the reagent container to be mixed to the reagent position, the method further includes: Control the container of reagents to be mixed to rotate at a preset speed; After controlling the reagent needle and / or reagent container to create a horizontal relative movement between the reagent needle and the reagent container, the process also includes: Move the reagent needle to the cleaning device for cleaning.

[0048] Specifically, in practical applications, a rotating device can be installed at the bottom of the cavity in the reagent tray where the reagent container is placed. This rotating device can drive the reagent container to rotate on its own. During the mixing operation, the reagent container can also be controlled to rotate at a preset speed, which can further increase the mixing intensity.

[0049] After the mixing operation of the current reagent container is completed, that is, after the agglomerates in the current reagent container are broken up, before the mixing operation of the next reagent container, the reagent needle needs to be cleaned. Specifically, the reagent needle of the reagent dispensing mechanism is moved to the cleaning device by controlling the stepper motor to perform the cleaning operation, so as to avoid cross-contamination.

[0050] refer to Figure 5 This embodiment provides a chemiluminescence immunoassay analyzer, comprising: The reagent tray 10 is used to hold multiple reagent containers and moves the reagent containers to the reagent position by rotating it; each reagent container is arranged circumferentially on the reagent tray 10; the reagent containers contain reagents. The reagent dispensing mechanism 20 includes a reagent needle for drawing up and dispensing reagents. Processor 30, used for: The control reagent tray 10 moves the reagent container to be mixed to the reagent position; The reagent needle of the control reagent dispensing mechanism 20 draws the reagent to be mixed from the reagent container at the reagent position; The reagent to be mixed is subjected to one or more mixing operations. One mixing operation includes: controlling the reagent dispensing mechanism 20 to move the reagent needle to a preset aspiration position below the liquid surface of the reagent to be mixed to aspirate the reagent; controlling the reagent dispensing mechanism 20 to move the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, controlling the reagent dispensing mechanism 20 and / or the reagent tray 10 to generate horizontal relative movement between the reagent needle and the reagent container.

[0051] In practical applications, the reagent tray 10 carries multiple reagent containers, and the reagent tray 10 is rotated to drive the reagent containers to rotate circumferentially. The reagent containers can be reagent kits, which hold the reagents. During mixing, the reagent tray 10 is rotated to move the reagent kit to be mixed to a position directly below the reagent needle of the reagent dispensing mechanism 20, allowing the reagent needle to draw up the reagent. Then, using the liquid level detection function, the needle tip is inserted into a preset aspiration position below the liquid surface to draw up the reagent, for example, at a depth of 5 mm below the liquid surface to draw up the supernatant. The volume of liquid drawn can be 100-300 microliters. It should be noted that the liquid level detection function specifically uses a sensor to detect changes in the physical or chemical properties of the liquid-gas interface, converting these changes into measurable electrical or optical signals to ultimately determine the liquid level position. There are several ways to determine the exact depth of the reagent needle tip below the liquid surface. In this embodiment, a capacitive liquid level detection function can be used to determine the exact depth of the reagent needle tip below the liquid surface, that is, by measuring the change in capacitance between the liquid and the electrode to reflect the liquid level depth. Of course, it can also be achieved by mechanically controlling the descent height of the reagent needle, but this embodiment does not require further explanation.

[0052] After the reagent needle tip is inserted into a preset aspiration position below the reagent liquid surface to draw up the reagent, the needle tip is further inserted downwards to move it to a preset discharge position below the aspiration position, thus discharging the supernatant drawn into the needle. This achieves a hydrodynamic intervention mechanism of upward aspiration and downward flushing. Simultaneously, while discharging the supernatant, a stepper motor controls the reagent dispensing mechanism 20 to make the reagent needle oscillate slightly within the reagent container, or a stepper motor controls the reagent disk 10 to perform slight reciprocating motion in the horizontal plane. By simultaneously discharging and oscillating, a sweeping and shearing fluid effect is created, expanding the impact jet from a static point action to a dynamic surface sweep, ensuring comprehensive coverage of any agglomerates at any location on the bottom of the reagent container.

[0053] Furthermore, in practical applications, the number of mixing operations required can be determined based on the information of the reagent to be mixed in the reagent container.

[0054] refer to Figure 6 This embodiment provides a chemiluminescence immunoassay analyzer, comprising: The reagent tray 10 is used to hold multiple reagent containers and moves the reagent containers to the reagent position by rotating it; each reagent container is arranged circumferentially on the reagent tray 10; the reagent containers contain reagents. The reagent dispensing mechanism 20 includes a reagent needle for drawing up and dispensing reagents. Memory 40 is used to store programs; Processor 30 is used to execute the program to implement the method described above.

[0055] Specifically, in practical applications, the reagent tray 10 carries multiple reagent containers, and by controlling the rotation of the reagent tray 10, the reagent containers are rotated circumferentially. The reagent containers can be reagent kits, which hold the reagents. During the mixing operation, the reagent tray 10 is rotated to move the reagent kit to be mixed to a position directly below the reagent needle of the reagent dispensing mechanism 20, so that the reagent needle can draw up the reagent to be mixed. Furthermore, the method executed by the processor 30 has been described in detail in the above-described magnetic bead solution mixing method embodiment, and will not be repeated here.

[0056] This embodiment provides a computer-readable storage medium storing a computer program that can be executed by a processor to implement the method described above. Since the above embodiments have already described in detail a method for mixing magnetic bead solutions in a chemiluminescence immunoassay analyzer, this embodiment will not repeat that description further.

[0057] Those skilled in the art will understand that all or part of the functions of the various methods in the above embodiments can be implemented by hardware or by computer programs. When all or part of the functions in the above embodiments are implemented by computer programs, the program can be stored in a computer-readable storage medium, which may include: read-only memory, random access memory, disk, optical disk, hard disk, etc., and the program is executed by a computer to achieve the above functions. For example, the program can be stored in the memory of a device, and when the program in the memory is executed by the processor, all or part of the above functions can be achieved. In addition, when all or part of the functions in the above embodiments are implemented by computer programs, the program can also be stored in a server, another computer, disk, optical disk, flash drive, or external hard drive, etc., and can be downloaded or copied to the memory of a local device, or the system of the local device can be updated. When the program in the memory is executed by the processor, all or part of the functions in the above embodiments can be achieved.

[0058] 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 method for mixing magnetic bead solutions in a chemiluminescence immunoassay analyzer, characterized in that, include: Move the reagent container to be mixed to the reagent position so that the reagent dispensing mechanism can draw the reagent to be mixed from the reagent container. The reagent to be mixed is subjected to one or more mixing operations, wherein one mixing operation includes: moving the reagent needle to a preset liquid aspiration position below the liquid surface of the reagent to be mixed to aspirate the reagent; The reagent needle is moved to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, the reagent needle and / or the reagent container are controlled to generate a horizontal relative movement between the reagent needle and the reagent container.

2. The method for mixing magnetic bead solution as described in claim 1, characterized in that, The method further includes: Obtain reagent information from the container containing the reagent to be mixed; the container contains the reagent to be mixed; the reagent information includes one or more of the following: test item, magnetic bead type, magnetic bead concentration, and settling time. The mixing parameters are determined based on the reagent information; the mixing parameters include multiple parameters such as the number of mixing operations, the dispensing speed, the amplitude of horizontal relative movement, the frequency of horizontal relative movement, the aspiration position, the dispensing position, and the aspiration-dispensing volume. The step of performing one or more mixing operations on the reagent to be mixed includes: performing one or more mixing operations on the reagent to be mixed according to the determined mixing parameters.

3. The method for mixing magnetic bead solution as described in claim 1, characterized in that, The control of the reagent needle and / or the reagent container to generate a horizontal relative movement between the reagent needle and the reagent container includes: Control the reagent needle to reciprocate horizontally within the reagent container or control the reagent needle to oscillate within the reagent container; or, Control the reagent container to reciprocate horizontally; or, The reagent needle is controlled to reciprocate horizontally within the reagent container, or the reagent needle is controlled to swing within the reagent container, and the reagent container is also controlled to reciprocate horizontally.

4. The method for mixing magnetic bead solution as described in claim 2, characterized in that, The step of determining the mixing parameters based on the reagent information includes: Determine the test items for the reagent to be mixed in the container; Based on the reagent characteristics and settling time in the test items, a target mixing parameter is determined from a set of preset mixing parameters with different weights. The reagent characteristics include the type and concentration of magnetic beads. The higher the concentration of magnetic beads, the greater the weight of the determined target mixing parameter. And / or, the longer the settling time, the greater the weight of the determined target mixing parameter. The mixing intensity of the mixing operation corresponding to the mixing parameter with the greater weight is greater.

5. The method for mixing magnetic bead solution as described in claim 2, characterized in that, Before moving the reagent needle to a preset aspiration position below the surface of the reagent liquid to be mixed to draw the reagent, the method further includes: The reagent needle is controlled to draw in a preset volume of isolation air.

6. The method for mixing magnetic bead solution as described in claim 2, characterized in that, The step of moving the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, controlling the reagent needle and / or the reagent container to generate horizontal relative movement between the reagent needle and the reagent container, includes: According to the discharge position in the mixing parameters, the reagent needle is moved to a discharge position below the aspiration position, and the reagent of the aspiration-discharge volume is discharged according to the discharge rate in the mixing parameters. During the process of discharging the reagent of the aspirated-expelled volume, the reagent needle and / or the reagent container are controlled to generate horizontal relative motion between the reagent needle and the reagent container according to the amplitude and frequency of the horizontal relative motion in the mixing parameters.

7. The method for mixing magnetic bead solution as described in claim 1, characterized in that, After moving the reagent container to be mixed to the reagent position, the process further includes: The container of the reagent to be mixed is controlled to rotate at a preset rotation speed; After controlling the reagent needle and / or the reagent container to generate a horizontal relative movement between the reagent needle and the reagent container, the method further includes: The reagent needle is moved to a cleaning device for cleaning.

8. A chemiluminescence immunoassay analyzer, characterized in that, include: A reagent tray is used to hold multiple reagent containers, which are moved to reagent positions by rotation; each reagent container is arranged circumferentially on the reagent tray; each reagent container contains a reagent. A reagent dispensing mechanism includes a reagent needle for drawing up and dispensing reagents. Processor, used for: The reagent tray is controlled to move the reagent container to be mixed to the reagent position; The reagent needle of the reagent dispensing mechanism is controlled to draw the reagent to be mixed from the reagent container at the reagent position; The reagent to be mixed is subjected to one or more mixing operations, wherein one mixing operation includes: controlling the reagent dispensing mechanism to move the reagent needle to a preset aspiration position below the liquid surface of the reagent to be mixed to aspirate the reagent; controlling the reagent dispensing mechanism to move the reagent needle to a preset discharge position below the aspiration position to discharge the aspirated reagent, and during the discharge of the aspirated reagent, controlling the reagent dispensing mechanism and / or the reagent tray to generate horizontal relative movement between the reagent needle and the reagent container.

9. A chemiluminescence immunoassay analyzer, characterized in that, include: A reagent tray is used to hold multiple reagent containers, and the reagent containers are moved to the reagent positions by rotating the tray; the reagent containers are arranged circumferentially on the reagent tray. The reagent container contains reagents; A reagent dispensing mechanism includes a reagent needle for drawing up and dispensing reagents. Memory, used to store programs; A processor for executing the program to implement the method as described in any one of claims 1-7.

10. A computer-readable storage medium, characterized in that, The medium stores a computer program that can be executed by a processor to implement the method as described in any one of claims 1-7.

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