Sample analyzer and sample analysis method

Abstract

A sample analyzer and a sample analysis method, comprising a magnetic separation mechanism, a determination mechanism, an ultrasonic device and a controller, the magnetic separation mechanism comprising a cleaning liquid dispensing structure, a magnetic attraction structure and a liquid suction structure, the cleaning liquid dispensing structure being used for injecting cleaning liquid into the reaction liquid in the containing cup, the magnetic attraction structure being used for performing magnetic attraction operation on the reaction liquid, and the liquid suction structure being used for performing liquid suction operation; the controller is used for controlling the ultrasonic device to emit ultrasonic waves into the reaction liquid with the injected cleaning liquid. Since in the magnetic separation process, the controller is used for controlling the ultrasonic device to emit ultrasonic waves into the reaction liquid with the injected cleaning liquid, the ultrasonic waves can uniformly disperse the reaction complex and other substances, so that in the subsequent magnetic adsorption process, the substances not combined with the magnetic beads can be prevented from being tangled on the reaction complex and being magnetically attracted, thereby the substrate can be prevented from marking the substances not combined with the magnetic beads, the accuracy of substrate marking is improved, and finally the detection accuracy is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to an in-vitro detection device, in particular to a sample analyzer and a sample analysis method. BACKGROUND

[0002] An immunoassay analyzer is a kind of analyzer with high sensitivity and high specificity, which is often used to detect various analysis indexes of blood, urine or other body fluids in a clinical laboratory. There are various working principles for traditional immunoassay analyzers, including chemiluminescence method, electrochemiluminescence method, etc. Taking a heterogeneous chemiluminescence immunoassay analyzer as an example, its main working principle is as follows: when a certain component in a sample needs to be measured, a corresponding antibody / antigen can be coated on a magnetic bead to form a magnetic bead reagent, and a specific marker can be labeled on the antibody to form a labeled reagent. During the test, the sample to be tested, the magnetic bead reagent, the labeled reagent and other reagents are mixed together to form a reaction solution, and are incubated under certain conditions to form a reaction complex. Then, through a washing and separation technique, the unbound labeled reagent and other reagents and sample components in the reaction system are removed, and finally a substrate is added. The substrate reacts with the labeled reagent on the reaction complex to emit light, and then the detection result is obtained through light measurement.

[0003] Among them, the washing and separation technique is an important test step, and a washing liquid needs to be added to the reaction solution to achieve the purpose of separation. However, the traditional analyzer is difficult to fully mix the washing liquid and the reaction liquid, which leads to poor washing and separation effect, and further leads to low accuracy of the final detection result. SUMMARY

[0004] In one embodiment, a sample analyzer is provided, comprising:

[0005] A magnetic separation mechanism, comprising a washing liquid dispensing structure, a magnetic attraction structure and a liquid suction structure, the washing liquid dispensing structure is used to inject a washing liquid into a reaction solution in a containing cup, the magnetic attraction structure is used to perform a magnetic attraction operation on the reaction solution, and the liquid suction structure is used to perform a liquid suction operation;

[0006] A measurement mechanism for measuring the reaction solution;

[0007] An ultrasonic device for generating ultrasonic vibration to form ultrasonic waves; and

[0008] A controller connected to the ultrasonic device, the controller being configured to control the ultrasonic device to emit ultrasonic waves into the reaction solution into which the washing liquid is injected.

[0009] In one embodiment, the magnetic separation mechanism is configured to perform a multi-stage magnetic separation operation on the reaction solution. During each stage of the magnetic separation operation, the controller is configured to control the ultrasonic device to perform an ultrasonic mixing operation on the reaction solution into which the washing liquid is injected.

[0010] In one embodiment, the sample analyzer further comprises a vortex mixing device configured to perform a vortex mixing operation on the reaction solution injected with the washing solution.

[0011] The magnetic separation mechanism is configured to perform a multi-stage magnetic separation operation on the reaction solution, and the controller is configured to control the ultrasonic device to perform an ultrasonic mixing operation on the reaction solution injected with the washing solution during a part of the stages of the multi-stage magnetic separation operation, and to control the vortex mixing device to perform a vortex mixing operation on the reaction solution injected with the washing solution during the remaining stages of the multi-stage magnetic separation operation.

[0012] In one embodiment, the sample analyzer further comprises a vortex mixing device configured to perform a vortex mixing operation on the reaction solution injected with the washing solution.

[0013] The magnetic separation mechanism is configured to perform a multi-stage magnetic separation operation on the reaction solution, and the controller is configured to control one of the ultrasonic device and the vortex mixing device to perform a mixing operation on the reaction solution injected with the washing solution according to the test item during each stage of the magnetic separation operation.

[0014] In one embodiment, the controller is configured to obtain a test item parameter, and to match an ultrasonic mode from a plurality of preset ultrasonic modes to perform an ultrasonic mixing operation on the reaction solution injected with the washing solution according to the test item parameter.

[0015] In one embodiment, the plurality of ultrasonic modes respectively have different ultrasonic intensities and / or ultrasonic action times.

[0016] In one embodiment, the ultrasonic device comprises an ultrasonic transducer configured to generate ultrasonic vibrations, a transmission member having a first end and a second end, the first end of the transmission member being connected to the ultrasonic transducer, the second end of the transmission member having an outer diameter smaller than an inner diameter of the holding cup, and a moving device connected to the ultrasonic transducer, the moving device being configured to drive the ultrasonic transducer and the transmission member to move relative to the holding cup, the second end of the transmission member being capable of being inserted into the reaction solution in the holding cup to transmit the ultrasonic vibrations generated by the ultrasonic transducer to the reaction solution in the holding cup.

[0017] In one embodiment, the ultrasonic device is installed in the magnetic separation mechanism, and the ultrasonic device comprises an ultrasonic transducer configured to generate ultrasonic vibrations, and a transmission member having a first end and a second end, the first end of the transmission member being connected to the ultrasonic transducer, the second end of the transmission member being configured to abut against an outer wall of a holding cup in the magnetic separation mechanism, the part of the outer wall of the holding cup in contact with the transmission member being a part surrounding the reaction solution, so as to transmit the ultrasonic vibrations generated by the ultrasonic transducer to the reaction solution in the holding cup.

[0018] In one embodiment, the transmission member is a solid structure, and the outer diameter of the transmission member gradually decreases or stepwise decreases from the first end to the second end.

[0019] In one embodiment, the ultrasonic device is further configured to perform ultrasonic mixing on at least one of the sample, the reagent, the reaction solution to be incubated, and the incubated reaction solution.

[0020] In one embodiment, the sample analyzer further comprises a sample carrying mechanism, a reagent carrying mechanism, a sample dispensing mechanism, and a reagent dispensing mechanism; the sample carrying mechanism is configured to carry the sample, the reagent carrying mechanism is configured to carry the reagent, the sample dispensing mechanism is configured to suck the sample from the sample carrying mechanism and discharge the sample into the holding cup, and the reagent dispensing mechanism is configured to suck the reagent from the reagent carrying mechanism and discharge the reagent into the holding cup; the reaction mechanism is configured to provide an incubation site for the reaction solution in the holding cup, and the reaction solution is formed by mixing the sample and the reagent.

[0021] In one embodiment, a sample analysis method is provided, comprising the following steps: corresponding modification

[0022] The magnetic separation mechanism performs magnetic separation on the incubated reaction solution;

[0023] The measurement mechanism performs optical measurement on the reaction solution;

[0024] In one embodiment, the magnetic separation mechanism performs magnetic separation on the incubated reaction solution, and the method comprises the following steps:

[0025] The cleaning liquid dispensing structure injects cleaning liquid into the reaction solution in the holding cup;

[0026] The ultrasonic device emits ultrasonic waves to the reaction solution into which the cleaning liquid is injected;

[0027] The magnetic attraction structure performs magnetic attraction on the reaction solution after ultrasonic treatment;

[0028] The liquid suction structure sucks the liquid after magnetic attraction.

[0029] In one embodiment, the magnetic separation mechanism performs multi-stage magnetic separation on the incubated reaction solution, and in each stage of the magnetic separation operation, the ultrasonic device performs ultrasonic mixing on the reaction solution into which the cleaning liquid is injected.

[0030] In one embodiment, the magnetic separation mechanism performs multi-stage magnetic separation on the reaction solution, and in some stages of the magnetic separation operation, the ultrasonic device performs ultrasonic mixing on the reaction solution into which the cleaning liquid is injected; in the remaining stages of the magnetic separation operation, the vortex mixing device performs vortex mixing on the reaction solution into which the cleaning liquid is injected.

[0031] In one embodiment, the ultrasonic mixing operation of the ultrasonic device is controlled by the following steps:

[0032] According to the test item, a corresponding test item parameter is obtained;

[0033] According to the test item parameter, an ultrasonic mode is matched from a plurality of preset ultrasonic modes to perform an ultrasonic mixing operation on the reaction solution.

[0034] In one embodiment, the plurality of ultrasonic modes have different ultrasonic intensities and / or ultrasonic action times, respectively.

[0035] In one embodiment, before the magnetic separation mechanism performs a magnetic separation operation on the incubated reaction solution, the following steps are further included:

[0036] The sample dispensing mechanism and the reagent dispensing mechanism respectively inject a sample and a reagent into the holding cup to form a reaction solution;

[0037] The reaction solution is incubated in the reaction mechanism.

[0038] In one embodiment, the following steps are included:

[0039] The magnetic separation mechanism performs a magnetic separation operation on the incubated reaction solution;

[0040] The measurement mechanism performs optical measurement on the reaction solution;

[0041] In one embodiment, the magnetic separation mechanism performs a magnetic separation operation on the incubated reaction solution, specifically including the following steps:

[0042] The cleaning solution dispensing structure injects a cleaning solution into the reaction solution in the holding cup;

[0043] According to the test item, one of the ultrasonic device and the vortex mixing device is controlled to perform a mixing operation on the reaction solution to which the cleaning solution is injected;

[0044] The magnetic attraction structure performs a magnetic attraction operation on the ultrasonic reaction solution;

[0045] The liquid suction structure sucks the liquid after the magnetic attraction operation.

[0046] In one embodiment, the step of controlling one of the ultrasonic device and the vortex mixing device to perform a mixing operation on the reaction solution to which the cleaning solution is injected according to the test item specifically includes the following steps:

[0047] According to the test item, a corresponding test item parameter is obtained;

[0048] According to the test item parameter, a mixing mode is matched from a plurality of preset mixing modes;

[0049] According to the matched mixing mode, the corresponding ultrasonic device or vortex mixing device is controlled to perform mixing operation on the reaction solution injected with the cleaning solution.

[0050] In one embodiment, before the magnetic separation mechanism performs the magnetic separation operation on the incubated reaction solution, the method further comprises the following steps:

[0051] The sample dispensing mechanism and the reagent dispensing mechanism inject the sample and the reagent into the container cup respectively to form the reaction solution.

[0052] The reaction solution is incubated in the reaction mechanism.

[0053] According to the sample analyzer and the sample analysis method, the ultrasonic device is arranged in the sample analyzer, and the controller is configured to control the ultrasonic device to emit ultrasonic waves to the reaction solution injected with the cleaning solution. The ultrasonic waves can uniformly disperse the reaction complex and other substances, so that in the subsequent magnetic adsorption process, the substances not combined with the magnetic beads can be prevented from being tangled on the reaction complex and being magnetically adsorbed, thereby preventing the substrate from labeling the substances not combined with the magnetic beads, improving the accuracy of substrate labeling, and ultimately improving the accuracy of detection. BRIEF DESCRIPTION OF DRAWINGS

[0054] Figure 1 FIG. 1 is a structural schematic diagram of an immuno-luminescence analyzer according to one embodiment;

[0055] Figure 2 FIG. 5 is a structural block diagram of a control part of the immuno-luminescence analyzer according to one embodiment;

[0056] Figure 3 FIG. 7 is a structural block diagram of a magnetic separation mechanism according to one embodiment;

[0057] Figure 4 FIG. 9 is a structural schematic diagram of a vortex mixing device according to one embodiment;

[0058] Figure 5 FIG. 11 is a structural schematic diagram of a contact type ultrasonic device according to one embodiment;

[0059] Figure 6 FIG. 13 is a structural view of a transmission member according to one embodiment;

[0060] Figure 7 FIG. 15 is a structural view of a transmission member according to one embodiment;

[0061] Figure 8 FIG. 17 is a schematic diagram of a moving device according to one embodiment;

[0062] Figure 9 FIG. 19 is a schematic diagram of ultrasonic mixing according to one embodiment;

[0063] Figure 10FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0064] Figure 11 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0065] Figure 12 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0066] Figure 13 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0067] Figure 14 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0068] Figure 15 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0069] Figure 16 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0070] Figure 17 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0071] Figure 18 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0072] Figure 19 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment;

[0073] Figure 20 FIG. 1 is a schematic diagram of a structure of a non-contact ultrasonic device according to an embodiment; DETAILED DESCRIPTION

[0074] The application will be further described in details with reference to the drawings. In the following embodiments, many details are described for the purpose of making the application better understood. However, one skilled in the art can easily recognize that some features can be omitted in different cases, or can be replaced by other elements, materials, methods. In some cases, some operations related to the application are not shown or described in the specification, in order to avoid the core of the application being overwhelmed by too much description, and it is not necessary to describe these related operations in detail for one skilled in the art according to the description in the specification and general technical knowledge in the art.

[0075] In addition, features described in the specification, operations or characteristics can be combined in any appropriate manner to form various embodiments. Meanwhile, the steps or actions in the method description can also be sequentially changed or adjusted in a manner that can be apparent to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment, and do not mean that the sequence is necessary, unless otherwise stated that a certain sequence must be followed.

[0076] The serial numbers of components in this paper, such as "first", "second", etc., are only used to distinguish the described objects, and do not have any order or technical meaning. The "connection" and "coupling" in this application include direct and indirect connection (coupling) unless otherwise specified.

[0077] For the immunoassay analyzer, the one-step test item in the present application refers to that only one incubation is needed for a test item; correspondingly, the multi-step test item refers to that multiple incubations are needed for a test item, for example, a two-step test item refers to that two incubations are needed for the test item, the reagent needed for the first incubation is added to the sample first, then the first incubation is performed, after the first incubation time is reached, the reagent needed for the second incubation is added, then the second incubation is performed, after the second incubation time is reached, magnetic separation is performed once, and then determination is performed. Generally speaking, for a multi-step test item, magnetic separation needs to be performed after the last incubation is completed, and then determination can be performed; and in a multi-step test item, whether magnetic separation needs to be performed after other incubations is completed depends on factors such as the type of the test item. For example, for a two-step test item, if magnetic separation needs to be performed after the first incubation, the two-step test item can be referred to as a two-step two-separation test item, and if magnetic separation does not need to be performed after the first incubation, the two-step test item can be referred to as a two-step one-separation test item.

[0078] In a one-step test item or a multi-step test item, the type of reagent needed for each incubation or each incubation can be one or multiple, which is determined according to factors such as the type of the test item; when the type of reagent needed for incubation in one step or multiple steps in a one-step test item or a multi-step test item is multiple, the test item can be referred to as a multi-component test item.

[0079] In an embodiment, a sample analyzer is provided, and the sample analyzer is provided with an ultrasonic device, which is used to mix the reaction liquid injected with the cleaning liquid by ultrasonic mixing to improve the accuracy of the test item.

[0080] Please refer to Figure 1 and Figure 2The sample analyzer is an immunoluminometer, which mainly comprises an ultrasonic device 10, a sample bearing mechanism 21, a sample dispensing mechanism 22, a reagent bearing mechanism 31, a reagent dispensing mechanism 32, a reaction mechanism 40, a magnetic separation mechanism 50 and a controller 60. The sample bearing mechanism 21, the sample dispensing mechanism 22, the reagent bearing mechanism 31, the reagent dispensing mechanism 32, the reaction mechanism 40 and the magnetic separation mechanism 50 are all mounted on a base 100, the controller 60 is mounted on a main machine of the base 100, the ultrasonic device 10 is mounted in the magnetic separation mechanism 50, and the controller 60 can also be mounted on the base 100.

[0081] The immunoluminometer further comprises a cup loading mechanism 71, a cup throwing position 72, a first transfer mechanism 81, a second transfer mechanism 82 and a measuring mechanism 90, which are all mounted on the base 100.

[0082] The reaction mechanism 40 is arranged in the middle, and the reagent bearing mechanism 31, the magnetic separation mechanism 50, the ultrasonic device 10, the cup loading mechanism 71, the cup throwing position 72 and the measuring mechanism 90 are arranged around the reaction mechanism 40.

[0083] The cup loading mechanism 71 is used to store unused new containing cups 103, which are also called reaction cups. The cup loading mechanism 71 itself also has a cup transferring function, which can transfer the containing cups 103 from the storage position to the position to be grabbed.

[0084] The first transfer mechanism 81 is a cup grabbing mechanism, which is used to transfer the new containing cups 103 on the cup loading mechanism 71 to the sample adding position 101 close to the reaction mechanism 40, and to transfer the containing cups 103 on the sample adding position 101 into the reaction mechanism 40.

[0085] The cup throwing position 72 is located in the moving range of the first transfer mechanism 81, and is connected with a recycling box. The cup throwing position 72 is used to recycle the used containing cups 103. The first transfer mechanism 81 is also used to transfer the containing cups 103 after detection on the reaction mechanism 40 to the cup throwing position 72.

[0086] The sample bearing mechanism 21 is used to bear samples. In some examples, the sample bearing mechanism 21 can comprise a sample delivery module (SDM). In other examples, the sample bearing mechanism 21 can also be a sample disc, which comprises a plurality of sample positions where sample tubes can be placed. The sample disc can be rotated to schedule the samples to the corresponding positions, such as the positions where the sample dispensing mechanism 22 can suck the samples.

[0087] The sample dispensing mechanism 22 includes a sample needle, a moving mechanism for driving the sample needle to move in two or three dimensions between the sample carrying mechanism 21 and the sample loading site 101, and a driving pump for providing power for the sample needle to suck and spit the sample. The sample dispensing mechanism 22 is used to suck the sample in the sample tube on the sample carrying mechanism 21 and to dispense the sucked sample into the sample cup 103 on the sample loading site 101.

[0088] The reagent carrying mechanism 31 is used to carry reagents. In an embodiment, the reagent carrying mechanism 31 can be a reagent disk arranged in a disk structure and having a plurality of positions for carrying reagent containers. The reagent carrying mechanism 31 can rotate and drive the reagent containers carried thereby to rotate to a specific position, for example, a position for the reagent dispensing mechanism 32 to suck reagents. The number of reagent carrying mechanisms 31 can be one or more.

[0089] The reagent dispensing mechanism 32 includes a reagent needle, a moving mechanism for driving the reagent needle to move in two or three dimensions between the reagent carrying mechanism 31 and the reaction mechanism 40, and a driving pump for providing power for the reagent needle to suck and spit reagents. The reagent dispensing mechanism 32 is used to suck the reagent in the reagent tube on the reagent carrying mechanism 31 and to dispense the sucked reagent into the sample cup 103 on the reaction mechanism 40, so that the sample in the sample cup 103 and the reagent are mixed to form a reaction liquid.

[0090] The reaction mechanism 40 is used to provide a place for the reaction liquid to be incubated. The reaction mechanism 40 can be a reaction disk arranged in a disk structure and having one or more positions for placing reaction cups. The reaction disk can rotate and drive the reaction cups in the positions to rotate, so as to schedule the reaction cups in the reaction disk and incubate the reaction liquid in the reaction cups.

[0091] Please refer to Figure 3 The magnetic separation mechanism 50 includes a washing liquid dispensing mechanism 51, a magnetic attraction structure 52, a liquid sucking structure 53, and a substrate dispensing mechanism 54.

[0092] The washing liquid dispensing mechanism 51 is used to suck the washing liquid from the washing liquid carrying mechanism and to dispense the sucked washing liquid into the sample cup 103 containing the incubated reaction liquid in the magnetic separation mechanism 50. The washing liquid is used to separate free substances in the incubated reaction liquid.

[0093] The magnetic attraction structure 52 is used to form a magnetic field. The sample cup 103 is located in the magnetic field formed by the magnetic attraction structure 52. The magnetic attraction structure 52 can attract the reaction complex combined with the magnetic beads in the reaction liquid.

[0094] The liquid suction structure 53 is used to discharge other components in the containing cup 103 except the reaction complex combined with the magnetic beads, so that only the reaction complex combined with the magnetic beads is reserved in the reaction liquid.

[0095] The substrate dispensing mechanism 54 is used to suck the substrate from the substrate carrying mechanism and inject the substrate into the reaction liquid in the containing cup 103, the substrate reacts with the reaction complex in the reaction liquid, and the substrate labels the reaction complex by luminescence.

[0096] The magnetic separation mechanism 50 is provided with two, and the two magnetic separation mechanisms 50 can work independently to improve the efficiency of the test.

[0097] The second transfer mechanism 82 is installed between the reaction mechanism 40 and the magnetic separation mechanism 50, and is provided with a mixing position 102 near the reaction mechanism 40 and the magnetic separation mechanism 50, the mixing position 102 and the sample adding position 101 are both provided with a cup seat for placing the containing cup 103, and the second transfer mechanism 82 is used to transfer the containing cup 103 between the reaction mechanism 40, the magnetic separation mechanism 50 and the mixing position 102.

[0098] The measuring mechanism 90 is used to perform light measurement on the reaction liquid after incubation to obtain the reaction data of the sample. For example, the measuring mechanism 90 detects the luminescence intensity of the reaction liquid to be measured, and calculates the concentration of the component to be measured in the sample through a calibration curve.

[0099] The machine base 100 is also provided with a cleaning mechanism and a waste liquid suction mechanism, the cleaning mechanism is used to clean the sampling needle and the reagent needle, and the waste liquid suction mechanism is used to suck the reaction liquid after detection.

[0100] The ultrasonic device 10 is installed in the magnetic separation mechanism 50, and the ultrasonic device 10 is used to perform ultrasonic mixing operation on the reaction liquid injected with cleaning liquid. The ultrasonic device 10 can also be installed outside the magnetic separation mechanism 50, and the ultrasonic device 10 moves into the magnetic separation mechanism 50 to perform ultrasonic mixing operation on the reaction liquid injected with cleaning liquid in the containing cup 103.

[0101] Please refer to Figure 4In the embodiment, the vortex mixing device 200 is also installed at the mixing site 102. The vortex mixing device 200 includes a driving motor 201, a transmission belt 202, an eccentric rotating shaft 203, and a mounting seat 204. The driving motor 201 is fixedly installed on the mounting seat 204, and the output shaft of the driving motor 201 is downwardly arranged. The eccentric rotating shaft 203 is rotatably installed on the mounting seat 204 through a bearing, and is vertically arranged. The eccentric rotating shaft 203 has a first segment and a second segment which are not collinear. The first segment is located at a lower position, and the second segment is located at an upper position. The first segment and the second segment of the eccentric rotating shaft 203 are parallel to the output shaft of the driving motor 201. Pulleys are respectively installed on the output shaft of the driving motor 201 and the first segment of the eccentric rotating shaft 203. The transmission belt 202 is connected to the pulleys of the driving motor 201 and the eccentric rotating shaft 203. The driving motor 201 drives the eccentric rotating shaft 203 to rotate through the transmission belt 202. A cup seat 205 for placing the containing cup 103 is installed on the eccentric rotating shaft 203. Thus, the containing cup 103 located on the cup seat 205 can be driven by the eccentric rotating shaft 203 to rotate eccentrically, so as to perform a vortex mixing operation on the reaction liquid in the containing cup 103. The driving motor 201 is connected to the controller 60. The controller 60 controls the output power and the output time length of the driving motor 201, so as to realize multiple vortex mixing modes with different intensities and time lengths.

[0102] In the embodiment, the magnetic separation mechanism 50 is used to perform multiple-stage magnetic separation operations on the incubated reaction liquid. During each stage of the magnetic separation operation, the controller 60 controls the ultrasonic device 10 to perform an ultrasonic mixing operation on the reaction liquid into which the cleaning liquid is injected, so as to separate the reaction complex from other substances.

[0103] In one embodiment, the vortex mixing device 200 described above is also installed in the magnetic separation mechanism 50. The vortex mixing device 200 is used to perform a vortex mixing operation on the reaction liquid into which the cleaning liquid is injected in the containing cup 103 in the magnetic separation mechanism 50. The magnetic separation mechanism 50 is used to perform multiple-stage magnetic separation operations on the incubated reaction liquid. During some stages of the multiple-stage magnetic separation operations, the controller 60 controls the ultrasonic device 10 to perform an ultrasonic mixing operation on the reaction liquid into which the cleaning liquid is injected, so as to separate the reaction complex from other substances. During the remaining stages of the multiple-stage magnetic separation operations, the controller 60 controls the vortex mixing device 200 to perform a vortex mixing operation on the reaction liquid into which the cleaning liquid is injected. The ultrasonic device 10 and the vortex mixing device 200 perform mixing operations on the multiple-stage magnetic separation operations which are set in advance. For example, the multiple-stage magnetic separation operations include first-stage, second-stage, third-stage, and fourth-stage magnetic separation operations. The ultrasonic device 10 performs an ultrasonic mixing operation on the reaction liquid into which the cleaning liquid is injected during the first-stage and third-stage magnetic separation operations. The vortex mixing device 200 performs a vortex mixing operation on the reaction liquid into which the cleaning liquid is injected during the second-stage and fourth-stage magnetic separation operations.

[0104] In one embodiment, the magnetic separation mechanism 50 is configured to perform multi-stage magnetic separation operation on the incubated reaction solution, and during each stage of the magnetic separation operation, the controller 60 controls one of the ultrasonic device 10 and the vortex mixing device 200 to perform mixing operation on the reaction solution with the washing liquid added therein. In one embodiment, the ultrasonic device 10 and the vortex mixing device 200 are configured to perform mixing operation during any stage of the multi-stage magnetic separation operation, for example, the multi-stage magnetic separation operation includes first, second, third and fourth stages of magnetic separation operation, and one of the ultrasonic device 10 and the vortex mixing device 200 is selected to perform mixing operation during the first, second and fourth stages of magnetic separation operation.

[0105] In one embodiment, the ultrasonic device 10 and the vortex mixing device 200 are installed in the magnetic separation mechanism 50, and according to different test items, the reaction solution with the washing liquid added therein can be mixed by ultrasonic mixing or vortex mixing during the multi-stage magnetic separation operation, so that the reaction solution with the washing liquid added therein can be effectively mixed.

[0106] In one embodiment, the test method includes multi-stage magnetic separation operation, and the controller 60 pre-stores ultrasonic modes including one or both of the ultrasonic device 10 and the vortex mixing device 200 performing mixing operation.

[0107] When the controller 60 controls the ultrasonic device 10, the controller 60 obtains the test item input or selected by the doctor, obtains the test item parameters corresponding to the test item, and matches one mixing mode from a plurality of mixing modes according to the test item parameters to perform mixing operation on the reaction solution.

[0108] Different mixing modes have different mixing intensities or different mixing times, and the mixing intensity is controlled by input power, and at least three mixing intensities including strong, medium and weak can be set, and at least two ultrasonic mixing times including 1s and 2s can be set.

[0109] The mixing modes include at least the following:

[0110] The first mixing mode is used for the first stage of magnetic separation operation, and the ultrasonic device 10 is used to perform ultrasonic mixing operation, the ultrasonic mixing intensity is medium, and the ultrasonic mixing time is 1s;

[0111] The second mixing mode is used for the first stage of magnetic separation operation, and the ultrasonic device 10 is used to perform ultrasonic mixing operation, the ultrasonic mixing intensity is weak, and the ultrasonic mixing time is 2s;

[0112] The third mixing mode is for four-stage magnetic separation operation. In the first and second stage magnetic separation operation, the ultrasonic device 10 is used to perform ultrasonic mixing operation with medium intensity and 1s time. In the third and fourth stage magnetic separation operation, the vortex mixing device 200 is used to perform vortex mixing operation with strong intensity and 2s time.

[0113] The fourth mixing mode is for four-stage magnetic separation operation. In the first and third stage magnetic separation operation, the ultrasonic device 10 is used to perform ultrasonic mixing operation with medium intensity and 1s time. In the second and fourth stage magnetic separation operation, the vortex mixing device 200 is used to perform vortex mixing operation with strong intensity and 2s time.

[0114] The test item parameters include numbers, letters or a combination of both, such as the test item parameter of TNI (troponin) is 2, and the test item parameters of E2 (estradiol) include 0 and 1. The controller 60 pre-stores the test item parameters corresponding to different test items, and each test item parameter corresponds to a mixing mode. For example, the test item parameter 0 corresponds to the first mixing mode, when the controller 60 obtains the test item parameter 0, the ultrasonic device 10 is driven to perform ultrasonic mixing with medium intensity and 1s time on the reaction solution; the test item parameter 1 corresponds to the second mixing mode, when the controller 60 obtains the test item parameter 1, the ultrasonic device 10 is driven to perform ultrasonic mixing with weak intensity and 2s time on the reaction solution; the test item parameter 2 corresponds to the third mixing mode, when the controller 60 obtains the test item parameter 2, in the first and second stage magnetic separation operation, the ultrasonic device 10 is driven to perform ultrasonic mixing with strong intensity and 1s time, and in the third and fourth stage magnetic separation operation, the vortex mixing device 200 is driven to perform vortex mixing operation with strong intensity and 2s time.

[0115] Different mixing modes can be set according to specific test items, so that the ultrasonic device 10 can effectively perform ultrasonic mixing on the reaction solution in different test items.

[0116] In one embodiment, the test method process only includes one-stage magnetic separation operation, and the ultrasonic mode pre-stored by the controller 60 includes the mixing operation performed by the ultrasonic device 10. The ultrasonic mode at least includes the first mixing mode and the second mixing mode.

[0117] In the embodiment, the ultrasonic device 10 is arranged in the magnetic separation mechanism 50. During the magnetic separation process, the controller is configured to control the ultrasonic device 10 to emit ultrasonic waves to the reaction solution injected with the cleaning solution. The ultrasonic waves can uniformly disperse the reaction complex and other substances, improve the accuracy of magnetic attraction, and further improve the accuracy of detection.

[0118] Please refer to Figure 5 In the embodiment, the ultrasonic device 10 is a device independent of other mechanisms, that is, the ultrasonic device 10 can operate independently. For example, the ultrasonic device 10 can operate independently of the sample dispensing mechanism 22. The ultrasonic device 10 can operate synchronously or asynchronously with other mechanisms to improve the efficiency of project detection.

[0119] The ultrasonic device 10 is a contact type ultrasonic device. The ultrasonic device 10 includes an ultrasonic transducer 11, a transmission member 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. The piezoelectric crystal generates compression and expansion in the thickness direction through the inverse piezoelectric effect under the action of a driving electric signal. The frequency of this deformation reaches the ultrasonic frequency, forming ultrasonic vibration.

[0120] Please refer to Figure 5 and Figure 6 The transmission member 12 is a solid rod structure. The transmission member 12 has a first end and a second end, wherein the first end is the upper end and the second end is the lower end. The first end of the transmission member 12 is provided with external threads, and the lower end of the ultrasonic transducer 11 is provided with internal threads. The transmission member 12 is installed on the lower end of the ultrasonic transducer 11 by threaded connection. The transmission member 12 can also be connected to the ultrasonic transducer 11 by clamping or other methods. The transmission member 12 is a resonant rod. The transmission member 12 is connected to the matching layer of the ultrasonic transducer 11 and is used to transmit ultrasonic vibration. Compared with the hollow structure of the transmission member 12, the solid structure of the transmission member 12 is beneficial to the propagation of axial vibration. When the outer diameter of the transmission member 12 decreases along the direction of ultrasonic vibration transmission, the solid structure of the transmission member 12 is beneficial to the convergence of energy, so as to achieve better ultrasonic mixing effect.

[0121] The outer diameter of the transmission member 12 gradually decreases or decreases in steps from the first end to the second end. The transmission member 12 has the function of converging energy. When the ultrasonic vibration is transmitted from the first end to the second end, the axial cross-sectional area of the second end relative to the first end decreases. The ultrasonic vibration is more convergent at the second end relative to the first end. The second end of the transmission member 12 amplifies the amplitude of the outgoing ultrasonic vibration relative to the first end, thereby improving the outgoing ultrasonic energy.

[0122] Specifically, the transmission member 12 comprises a first end 121, an intermediate section 122 and a second end 123, wherein the first end 121 is a threaded connection end, and the second end 123 is a needle rod structure, the outer diameter of the second end 123 is smaller than the inner diameter of the accommodating cup 103, so that the second end 123 of the transmission member 12 can be inserted into the accommodating cup 103. The intermediate section 122 is a horn structure, one end of the intermediate section 122 connected with the first end 121 is a large end of the horn, and the other end of the intermediate section 122 connected with the second end 123 is a small end of the horn, and the shaft diameter of the intermediate section 122 gradually decreases from the large end of the horn to the small end of the horn.

[0123] The intermediate section 122 can also be composed of one or a combination of the cylindrical rod and the conical rod. Please refer to Figure 7 , wherein the intermediate section 122 of the a structure comprises two cylindrical rods with different diameters; the intermediate section 122 of the b structure comprises four cylindrical rods with different diameters; the intermediate section 122 of the c structure comprises a conical rod; and the intermediate section 122 of the d structure comprises two cylindrical rods with different diameters and a conical rod. The five structures of the transmission member 12 described above are gradually decreasing or stepwise decreasing structures from the first end to the second end, which can amplify the amplitude.

[0124] Please refer to Figure 8 , the moving device 13 comprises a mounting base 131, a swing arm assembly 132, a first moving assembly 133 and a second moving assembly 134.

[0125] The swing arm assembly 132 comprises a swing arm 1321 and a lifting rod 1322, the lifting rod 1322 is vertically and rotatably installed on the mounting base 131, and the swing arm 1321 is horizontally arranged, one end of the swing arm 1321 is connected to the lifting rod 1322, and the ultrasonic transducer 11 is installed on the other end of the swing arm 1321 away from the lifting rod 1322. The swing arm assembly 132 is used to drive the vertical lifting and horizontal rotation of the ultrasonic transducer 11 and the transmission member 12. In an embodiment, the swing arm 1321 and the lifting rod 1322 can also be an integrated structure.

[0126] The first moving assembly 133 is a lifting assembly, which comprises a lifting motor 1331 and a lifting transmission assembly 1332. The lifting motor 1331 is installed on the mounting base 131, and the lifting transmission assembly 1332 comprises a transmission wheel, a transmission belt, a gear and a rack. The rack is vertically installed on the lifting rod 1322, the gear is rotatably installed on the mounting base 131, the gear is in meshing connection with the rack, the lifting motor 1331 is connected with 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 the rack. In an embodiment, the first moving assembly 133 is a linear motor, the output shaft of the linear motor is directly connected with the lifting rod 1322, which can also drive the lifting rod 1322 to move up and down.

[0127] The second moving assembly 134 is a rotating assembly, which comprises a rotating motor 1341 and a rotating transmission assembly 1342. The rotating motor 1341 is installed on the mounting seat 131, and the rotating transmission assembly 1342 comprises a transmission belt and a rotating gear. The transmission belt is a gear belt, and the rotating gear is sleeved on the lifting rod 1322 and connected with the lifting rod 1322 through a key. The lifting rod 1322 can move up and down relative to the rotating gear, and the rotating gear is used to drive the lifting rod 1322 to rotate. The rotating motor 1341 is connected with the rotating gear through the transmission belt, and is used to drive the lifting rod 1322 to rotate. In an embodiment, the rotating motor 1341 is connected with the lifting rod 1322 through a gear set, and can also drive the lifting rod 1322 to rotate.

[0128] In an embodiment, the moving device 13 only comprises the mounting seat 131, the swing arm assembly 132 and the 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 holding cup 103 at a specific mixing position 102.

[0129] In an embodiment, the second moving assembly 134 can also be a planar moving assembly combined by X-axis movement and Y-axis movement. The X-axis movement and the Y-axis movement are respectively realized through two motors, and the moving device 13 can also drive the transmission member 12 to move between the mixing positions 102.

[0130] Please refer to Figure 9 In the embodiment, the transmission member 12 of the ultrasonic device 10 is directly inserted into the reaction liquid 104 in the holding cup 103. The ultrasonic device 10 has a preset frequency and voltage, so that the ultrasonic vibration is mainly propagated in the axial direction. The second end face of the transmission member 12 is an emission surface of the ultrasonic wave. During the ultrasonic mixing, the second end face of the transmission member 12 emits the ultrasonic wave into the reaction liquid 104 filled with the cleaning liquid, and an ultrasonic sound field is formed in the reaction liquid 104. The reaction liquid 104 will form a violent liquid flow under the action of the ultrasonic sound field, so as to realize the mixing of the components in the reaction liquid 104.

[0131] In addition to the mixing of the reaction liquid 104 filled with the cleaning liquid realized by the vibration of the ultrasonic wave, the cavitation effect of the ultrasonic wave in the liquid can also uniformly disperse some agglomerated and adhered substances in the reaction liquid 104. When the frequency and sound pressure of the ultrasonic wave are controlled, and the amplification of the transmission member 12 is combined, the ultrasonic energy entering the reaction liquid 104 in the holding cup 103 is greater than the threshold value of the ultrasonic cavitation. Therefore, during the ultrasonic mixing process, the ultrasonic cavitation phenomenon can be generated in the reaction liquid 104. When the ultrasonic cavitation occurs, a large amount of energy is released, and a certain force is generated on some agglomerated and adhered substances in the reaction liquid 104, so that the substances are dispersed. Under the action of the ultrasonic vibration mixing, the substances can be uniformly dispersed in the reaction cup.

[0132] In one embodiment, the ultrasonic device 10 is a non-contact ultrasonic mixing device, the ultrasonic device 10 is in contact with the container cup 103, and the ultrasonic waves emitted by the ultrasonic device 10 are transmitted to the reaction solution in the container cup 103 through the container cup 103.

[0133] Please refer to Figure 10 and Figure 11 , the ultrasonic device 10 includes an ultrasonic transducer 11 and a transmission member 12. During ultrasonic mixing, the transmission member 12 abuts the outer wall of the container cup 103 with the second end, and transmits ultrasonic vibrations to the reaction solution 104 through the container cup 103. Since the transmission member 12 does not need to be inserted into the container cup 103, the axial length of the transmission member 12 is shorter than that of a contact transmission member, but also has the characteristics of gradually decreasing or stepwise decreasing from the first end to the second end to achieve amplification of the amplitude.

[0134] During ultrasonic mixing, the second end surface of the transmission member 12 of the present embodiment abuts against the outer wall of the container cup 103, and the part of the outer wall of the container cup 103 in contact with the transmission member 12 is the part surrounding the reaction solution 104, so as to transmit the ultrasonic vibrations generated by the ultrasonic transducer 11 to the liquid in the container cup 103. The part of the container cup 103 surrounding the reaction solution 104 is the bottom of the container cup 103 and the lower end sidewall connected to the bottom, so that the second end of the transmission member 12 abuts against any position of the bottom of the container cup 103 and the lower end sidewall connected to the bottom, and the ultrasonic vibrations can be transmitted to the liquid in the container cup 103.

[0135] In the present embodiment, the ultrasonic device 10 is a movable structure, and the ultrasonic device 10 further includes a moving device, the moving device includes a mounting seat and a horizontal moving assembly, the horizontal moving assembly is installed on the mounting seat, and the ultrasonic transducer is installed on the horizontal moving assembly. The horizontal moving assembly is a gas cylinder or a linear motor, and the horizontal moving assembly is used to drive the second end of the transmission member 12 to abut against or leave the outer wall of the container cup 103 on the mixing site 102.

[0136] In one embodiment, the ultrasonic device 10 is arranged as a fixed structure, and the transmission member 12 is located at a predetermined position, so that after the container cup 103 is placed on the mixing site 102, the container cup 103 will directly contact the second end of the transmission member 12.

[0137] In the present embodiment, the sample analyzer further includes a holding device 110, and the holding device 110 is used to limit the radial freedom degree of the container cup 103.

[0138] Please refer to Figure 12 and Figure 13The holding device 110 comprises two oppositely arranged clamping assemblies, each of which comprises a holding motor 111, a holding cam 112 and a holding clamp block 113. The holding motor 111 is mounted on the base 100, and the output shaft of the holding motor 111 is vertically arranged upwards. The output shaft of the holding motor 111 is in transmission connection with the holding cam 112. The holding cam 112 is horizontally arranged, and the holding cam 112 is in contact connection with the holding clamp block 113. The holding clamp block 113 is movably mounted on the base 100, and the two side surfaces of the holding clamp block 113 are respectively matched with the containing cup 103 and the holding cam 112. If the containing cup 103 is a circular tube, the surface of the holding clamp block 113 facing the containing cup 103 is a concave arc surface. If the containing cup 103 is a square tube, the surface of the holding clamp block 113 facing the containing cup 103 is a plane. The convex part of the holding cam 112 is a convex arc surface, and the surface of the holding clamp block 113 facing the holding cam 112 is a concave arc surface with greater curvature, so that the concave arc surface of the holding clamp block 113 can guide the convex part of the holding cam 112 to slide in and out. The holding motor 111 is used to drive the holding cam 112 to rotate, so that the holding cam 112 drives the holding clamp block 113 to approach or move away from the containing cup 103. When the convex parts of the two holding cams 112 are both directed towards the containing cup 103 and aligned on a line, the two holding clamp blocks 113 hold the containing cup 103, and the radial freedom degree of the containing cup 103 is limited, thereby avoiding the shaking of the containing cup 103 during the ultrasonic mixing process and ensuring the good contact between the containing cup 103 and the transmission member 12.

[0139] Since the ultrasonic device 10 realizes ultrasonic mixing by contacting the lower end of the containing cup 103, the holding clamp block 113 of the holding device 110 holds the lower end side wall of the containing cup 103, so as to improve the stability of holding. When the transmission member 12 of the ultrasonic device 10 abuts against the lower end side wall of the containing cup 103, the transmission member 12 and the holding clamp block 113 are arranged staggeredly on the lower end side wall of the containing cup 103.

[0140] The holding device 110 can also comprise a linear drive member and a holding clamp block. The linear drive member is a gas cylinder or a linear motor, and the linear drive member drives the holding clamp block to approach and move away from the containing cup 103, so as to limit the containing cup 103.

[0141] The non-contact ultrasonic device 10 can also transmit ultrasonic vibration to the reaction liquid filled with cleaning liquid in the containing cup 103 to form an ultrasonic sound field and ultrasonic cavitation phenomenon, so as to ultrasonically mix the reaction liquid filled with cleaning liquid in the containing cup 103.

[0142] In one embodiment, the ultrasonic device 10 is installed outside the magnetic separation mechanism 50, and the ultrasonic device 10 is movable to the mixing position 102 to perform ultrasonic mixing operation on the liquid in the holding cup 103. The liquid in the holding cup 103 at the mixing position 102 is a sample, a reagent, a reaction liquid to be incubated, or a reaction liquid after incubation. According to different test items, the holding cup 103 containing the sample, the reagent, the reaction liquid to be incubated, or the reaction liquid after incubation is transferred to the mixing position 102, and then the ultrasonic device 10 performs ultrasonic mixing operation on the liquid in the holding cup 103.

[0143] In one embodiment, a sample analysis method is provided, and the sample analysis method is performed by the sample analyzer in the above embodiment.

[0144] Please refer to Figure 14 In the whole machine test, according to different reagent items, the sample analyzer mainly includes the following five different test processes:

[0145] Test process one, one-step one-separation: after adding the sample S and the reagent R respectively, one incubation and one magnetic separation operation are performed, and then the substrate A is added, incubated, and light measured:

[0146] Test process two, two-step one-separation: after adding the sample S, the reagent R1 is added in the first step, the reagent R1 is one reagent or multiple reagents, the sample and the reagent R1 are mixed to form a reaction liquid for first incubation; after the first incubation, the reagent R2 is added in the second step, the reagent R2 is one reagent or multiple reagents, the reagent R2 and the reaction liquid after the first incubation form a new reaction liquid for second incubation; the reaction liquid after the second incubation is sequentially subjected to magnetic separation, addition of the substrate A, incubation, and light measurement.

[0147] Test process three, two-step two-separation: after adding the sample, the reagent R1 is added in the first step, the sample and the reagent R1 are mixed to form a reaction liquid for first incubation, and the first incubation is followed by first magnetic separation operation; after the first magnetic separation operation, the reagent R2 is added in the second step, the reagent R2 and the reaction liquid after the first magnetic separation form a new reaction liquid for second incubation; the reaction liquid after the second incubation is subjected to second magnetic separation operation; the reaction liquid after the second magnetic separation operation is sequentially subjected to addition of the substrate A, incubation, and light measurement.

[0148] Test process four, sample pretreatment: the sample S is added, and then the pretreatment reagent is added to pretreat the sample S to form a sample S'; the reagent R is added to the pretreated sample S', and then incubation, magnetic separation, addition of the substrate A, incubation, and light measurement are sequentially performed.

[0149] Test procedure five, sample pretreatment: inject sample S, then inject diluent, dilute sample S with diluent to obtain sample S' with lower concentration; inject reagent into sample S' after dilution, then perform incubation, magnetic separation, injection of substrate A, incubation and light measurement in sequence.

[0150] The sample analysis method in this embodiment is controlled and executed by the controller 60, and is described by taking one-step magnetic separation as an example.

[0151] Please refer to Figure 15 The sample analysis method of this embodiment includes the following steps:

[0152] S101: inject sample;

[0153] The first transfer mechanism 81 transfers the new holding cup 103 on the cup loading mechanism 71 to the sample injection site 101.

[0154] The sample dispensing mechanism 22 sucks sample S from the sample carrying mechanism 21 and injects the sucked sample S into the holding cup 103 on the sample injection site 101.

[0155] S102: inject reagent;

[0156] The first transfer mechanism 81 transfers the holding cup 103 containing sample S from the sample injection site 101 to the outer circle in the reaction mechanism 40; the reaction mechanism 40 transfers the holding cup 103 that needs to add magnetic bead reagent R to the reagent injection site.

[0157] The reagent dispensing mechanism 32 sucks reagent R from the reagent carrying mechanism 31 and injects the sucked magnetic bead reagent into the holding cup 103 at the sample reagent injection site in the reaction mechanism 40, so that the sample S and the magnetic bead reagent R in the holding cup 103 are mixed to form a reaction solution.

[0158] S103: vortex mixing;

[0159] The second transfer mechanism 82 transfers the holding cup 103 containing the reaction solution to the mixing site 102.

[0160] The vortex mixing device is used to perform vortex mixing operation on the reaction solution in the holding cup 103, so that the sample S and the magnetic bead reagent R are fully reacted.

[0161] In other embodiments, the ultrasonic device 10 can also be used to perform ultrasonic mixing operation on the reaction solution in the holding cup 103 on the mixing site 102.

[0162] S104: incubation;

[0163] The second transfer mechanism 82 transfers the holding cup 103 containing the vortex-mixed reaction solution from the mixing site 102 back to the inner circle of the reaction mechanism 40 for incubation for a preset time.

[0164] S105: magnetic separation;

[0165] The second transfer mechanism 82 transfers the holding cup 103 containing the incubated reaction solution from the reaction mechanism 40 to the magnetic separation mechanism 50;

[0166] Please refer to Figure 16 The magnetic separation mechanism 50 performs a magnetic separation operation on the incubated reaction solution, and the operation includes the following steps:

[0167] S1051: filling with cleaning solution;

[0168] The cleaning solution dispensing structure 51 sucks the cleaning solution from the cleaning solution carrying mechanism and fills the holding cup 103 containing the incubated reaction solution in the magnetic separation mechanism 50 with the cleaning solution, which is used to separate free substances in the incubated reaction solution.

[0169] S1052: ultrasonic mixing;

[0170] The ultrasonic device 10 emits ultrasonic waves into the reaction solution filled with the cleaning solution to perform an ultrasonic mixing operation on the reaction solution.

[0171] During the ultrasonic process, the controller 60 obtains the test item input or selected by the doctor, obtains the test item parameters from the test item, and matches the test item parameters to select one mixing mode from multiple mixing modes to perform a mixing operation on the reaction solution filled with the cleaning solution.

[0172] Different mixing modes have different mixing intensities or different mixing times, wherein the mixing intensity is controlled by the input power, and at least three ultrasonic mixing intensities including strong, medium and weak can be set, and at least two ultrasonic mixing times including 1s and 2s can be set.

[0173] The mixing mode at least includes the following:

[0174] The first mixing mode adopts the ultrasonic device 10 to perform an ultrasonic mixing operation, the ultrasonic mixing intensity is medium, and the ultrasonic mixing time is 1s;

[0175] The second mixing mode adopts the ultrasonic device 10 to perform an ultrasonic mixing operation, the ultrasonic mixing intensity is weak, and the ultrasonic mixing time is 2s.

[0176] The test item parameter includes a number, a letter or a combination of both, such as the test item parameter of the TNI (troponin) item is 2, and the test item parameter of the E2 (estradiol) item includes 0 and 1. The controller 60 pre-stores the item test parameters corresponding to different test items, and each item test parameter corresponds to a mixing mode. For example, the test item parameter 0 corresponds to the first mixing mode, when the controller 60 obtains the test item parameter 0, the ultrasonic device 10 is driven to perform ultrasonic mixing on the reaction solution with a strength of medium and a time of 1s; the test item parameter 1 corresponds to the second mixing mode, when the controller 60 obtains the test item parameter 1, the ultrasonic device 10 is driven to perform ultrasonic mixing on the reaction solution with a strength of weak and a time of 2s.

[0177] S1053: magnetic attraction;

[0178] The magnetic attraction structure 52 forms a magnetic field, the holding cup 103 is located in the magnetic field formed by the magnetic attraction structure 52, and the magnetic attraction structure 52 adsorbs the reaction complex combined with the magnetic beads in the reaction solution.

[0179] S1054: liquid discharge;

[0180] The liquid suction structure 53 is used to discharge other components in the reaction solution except the reaction complex combined with the magnetic beads from the holding cup 103, so that only the reaction complex combined with the magnetic beads is reserved in the reaction solution.

[0181] S106: substrate injection;

[0182] The substrate injection mechanism 54 injects the substrate A into the holding cup 103 after liquid suction, and the substrate A performs luminescent labeling on the reaction complex in the reaction solution.

[0183] S107: incubation;

[0184] The second transfer mechanism 82 transfers the holding cup 103 containing the reaction solution injected with the substrate A from the magnetic separation mechanism 50 back to the outer circle of the reaction mechanism 40 for incubation.

[0185] S108: light measurement;

[0186] The reaction mechanism 40 transfers the holding cup 103 containing the incubated reaction solution to the detection position;

[0187] The detection mechanism 90 detects the luminescent reaction complex in the holding cup 103;

[0188] After the light measurement is completed, the waste liquid suction mechanism sucks away the reaction solution from the holding cup 103;

[0189] The first transfer mechanism 81 transfers the holding cup 103 containing the discharged reaction solution from the reaction mechanism 40 to the cup throwing position 72.

[0190] The sample analysis method in the magnetic separation process, the reaction liquid is filled with cleaning liquid ultrasonic mixing operation, ultrasonic mixing operation can separate other substances from the reaction complex, and then improve the accuracy of the detection.

[0191] In order to verify the effectiveness of the sample analysis method for improving the accuracy of the detection, the following verification work is carried out:

[0192] Please refer to Figure 17 , the reaction liquid will form a group of interference after incubation, and the verification is used to study the influence of the interference on the final test value. For the same batch of model samples, clinical tests are carried out using ultrasonic mixing and without ultrasonic mixing respectively, the final test results are compared, and the standard test results of the centrifugal supernatant of the sample are compared. From the comparison of the test results, it can be seen that after ultrasonic mixing, the test of the model sample is no longer closer to the true value of the sample. That is, the ultrasonic mixing of the reaction liquid can improve the mixing effect and make the test value more accurate.

[0193] In one embodiment, a sample analysis method is provided, which is different from the sample analysis method in the above embodiment. The sample analysis method is a one-step multiple magnetic separation. The sample analysis method is illustrated by taking one-step four separation as an example. Multiple magnetic separation is also called multi-stage separation. Ultrasonic mixing operation needs to be performed on the reaction liquid filled with cleaning liquid in each stage of magnetic separation.

[0194] For multi-stage magnetic separation operation, the controller 60 has a mixing mode corresponding thereto preset therein. Taking four-stage magnetic separation operation as an example, the mixing mode at least includes the following:

[0195] The first mixing mode adopts ultrasonic device 10 to perform ultrasonic mixing operation during the first to fourth stage magnetic separation operation, the ultrasonic mixing strength is medium, and the ultrasonic mixing time is 1s.

[0196] The second mixing mode adopts ultrasonic device 10 to perform ultrasonic mixing operation during the first stage magnetic separation operation, the ultrasonic mixing strength is medium, and the ultrasonic mixing time is 1s; vortex mixing device 200 is adopted to perform vortex mixing operation during the second, third and fourth stage magnetic separation operation, the vortex mixing strength is strong, and the vortex mixing time is 2s.

[0197] The third mixing mode adopts ultrasonic device 10 to perform ultrasonic mixing operation during the first and second stage magnetic separation operation, the ultrasonic mixing strength is medium, and the ultrasonic mixing time is 1s; vortex mixing device 200 is adopted to perform vortex mixing operation during the third and fourth stage magnetic separation operation, the vortex mixing strength is strong, and the vortex mixing time is 2s.

[0198] The fourth mixing mode is that the ultrasonic device 10 is used to perform ultrasonic mixing operation in the first, second and third magnetic separation operations, the ultrasonic mixing strength is medium, and the ultrasonic mixing time is 1s; the vortex mixing device 200 is used to perform vortex mixing operation in the fourth magnetic separation operation, the vortex mixing strength is strong, and the vortex mixing time is 2s.

[0199] The test item parameters include numbers, letters or a combination of both, such as A, B, C, D. The controller 60 pre-stores test item parameters corresponding to different test items, and each test item parameter corresponds to a mixing mode. For example, the test item parameters A, B, C and D are sequentially and one-to-one corresponding to the four mixing modes described above.

[0200] Please refer to Figure 18 The sample analysis method of the embodiment includes the following steps for four-stage magnetic separation operation:

[0201] S201: Add sample;

[0202] The first transfer mechanism 81 transfers the new holding cup 103 on the cup adding mechanism 71 to the sample adding position 101;

[0203] The sample dispensing mechanism 22 sucks the sample S from the sample carrying mechanism 21 and adds the sucked sample S to the holding cup 103 on the sample adding position 101.

[0204] S202: Add reagent;

[0205] The first transfer mechanism 81 transfers the holding cup 103 containing the sample S from the sample adding position 101 to the outer circle in the reaction mechanism 40; the reaction mechanism 40 transfers the holding cup 103 that needs to add magnetic bead reagent to the reagent adding position;

[0206] The reagent dispensing mechanism 32 sucks the reagent R from the reagent carrying mechanism 31 and adds the sucked reagent to the holding cup 103 at the sample reagent adding position in the reaction mechanism 40, and the sample S and the reagent R in the holding cup 103 are mixed to form a reaction solution.

[0207] S203: Vortex mixing;

[0208] The second transfer mechanism 82 transfers the holding cup 103 containing the reaction solution to the mixing position 102;

[0209] The vortex mixing device is used to perform vortex mixing operation on the reaction solution in the holding cup 103, so that the sample S and the reagent R are fully reacted.

[0210] In other embodiments, the ultrasonic device 10 can also be used to perform ultrasonic mixing on the reaction solution in the holding cup 103 in the mixing position 102.

[0211] S204: Incubation;

[0212] The second transfer mechanism 82 transfers the holding cup 103 containing the vortex-mixed reaction solution from the mixing position 102 to the inner circle of the reaction mechanism 40 for incubation for a preset time.

[0213] S205: First-stage magnetic separation;

[0214] The second transfer mechanism 82 transfers the holding cup 103 containing the incubated reaction solution from the reaction mechanism 40 to the magnetic separation mechanism 50;

[0215] Please refer to Figure 19 The magnetic separation mechanism 50 performs magnetic separation on the incubated reaction solution, which includes the following steps:

[0216] S2051: Filling with washing solution;

[0217] The washing solution dispensing structure 51 sucks the washing solution from the washing solution carrying mechanism and fills the holding cup 103 containing the incubated reaction solution in the magnetic separation mechanism 50 with the washing solution, which is used to separate free substances from the incubated reaction solution.

[0218] S2052: Ultrasonic mixing;

[0219] The ultrasonic device 10 emits ultrasonic waves into the reaction solution filled with the washing solution to perform ultrasonic mixing on the reaction solution.

[0220] During the ultrasonic process: the controller 60 obtains the test item input or selected by the doctor and obtains the test item parameter A from the test item. The controller 60 controls the ultrasonic device 10 to perform ultrasonic mixing on the reaction solution filled with the washing solution in each stage of magnetic separation.

[0221] S2053: Magnetic attraction;

[0222] The magnetic attraction structure 52 forms a magnetic field, and the holding cup 103 is located in the magnetic field formed by the magnetic attraction structure 52, and the magnetic attraction structure 52 adsorbs the reaction complex combined with the magnetic beads in the reaction solution.

[0223] S2054: Liquid discharge;

[0224] The liquid suction structure 53 is used to discharge other components in the holding cup 103 except the reaction complex combined with the magnetic beads, so that only the reaction complex combined with the magnetic beads remains in the reaction solution.

[0225] S206: Second-stage magnetic separation;

[0226] The second-stage magnetic separation continues the same magnetic separation operation as the sub-steps of the first-stage magnetic separation on the reaction solution after the first-stage magnetic separation is completed. During the second-stage magnetic separation, the ultrasonic device 10 is also used to perform the ultrasonic mixing operation on the reaction solution filled with the cleaning solution.

[0227] S207: third-stage magnetic separation;

[0228] The third-stage magnetic separation continues the same magnetic separation operation as the sub-steps of the first-stage magnetic separation on the reaction solution after the second-stage magnetic separation is completed. During the third-stage magnetic separation, the ultrasonic device 10 is also used to perform the ultrasonic mixing operation on the reaction solution filled with the cleaning solution.

[0229] S208: fourth-stage magnetic separation;

[0230] The fourth-stage magnetic separation continues the same magnetic separation operation as the sub-steps of the first-stage magnetic separation on the reaction solution after the third-stage magnetic separation is completed. During the fourth-stage magnetic separation, the ultrasonic device 10 is also used to perform the ultrasonic mixing operation on the reaction solution filled with the cleaning solution.

[0231] S209: filling of substrate;

[0232] After the fourth magnetic separation operation is completed, the substrate filling mechanism 54 fills the substrate A into the holding cup 103, and the substrate A performs luminescent labeling on the reaction complex in the reaction solution.

[0233] S210: incubation;

[0234] The second transfer mechanism 82 transfers the holding cup 103 filled with the reaction solution and the substrate A from the magnetic separation mechanism 50 back to the outer circle of the reaction mechanism 40 for incubation.

[0235] S211: light measurement;

[0236] The reaction mechanism 40 transfers the holding cup 103 of the incubated reaction solution to the detection position;

[0237] The measuring mechanism 90 detects the luminescent reaction complex in the holding cup 103;

[0238] After the light measurement is completed, the waste liquid suction mechanism sucks away the reaction solution from the holding cup 103;

[0239] The first transfer mechanism 81 transfers the holding cup 103 of the reaction solution from the reaction mechanism 40 to the cup throwing position 72.

[0240] Please refer to Figure 20 The mixing method of the four-stage magnetic separation operation in the embodiment has the following embodiment scheme:

[0241] Embodiment one: as in the above embodiments, the ultrasonic mixing operation is performed in each of the four stages of magnetic separation operation.

[0242] Embodiment two: in the first stage of the four stages of magnetic separation operation, the ultrasonic device 10 is used to perform the ultrasonic mixing operation on the reaction solution to which the cleaning liquid is added; in the remaining stages of magnetic separation operation, the vortex mixing device 200 is used to perform the vortex mixing operation on the reaction solution to which the cleaning liquid is added. For example, in the first stage of magnetic separation operation, the ultrasonic device 10 performs the ultrasonic mixing operation on the reaction solution to which the cleaning liquid is added; in the second, third and fourth stages of magnetic separation operation, the vortex mixing device 200 performs the vortex mixing operation on the reaction solution to which the cleaning liquid is added.

[0243] Embodiment three: in the first and second stages of the four stages of magnetic separation operation, the ultrasonic device 10 is used to perform the ultrasonic mixing operation on the reaction solution to which the cleaning liquid is added; in the remaining two stages of magnetic separation operation, the vortex mixing device 200 is used to perform the vortex mixing operation on the reaction solution to which the cleaning liquid is added. For example, in the first and second stages of magnetic separation operation, the ultrasonic device 10 performs the ultrasonic mixing operation on the reaction solution to which the cleaning liquid is added; in the third and fourth stages of magnetic separation operation, the vortex mixing device 200 performs the vortex mixing operation on the reaction solution to which the cleaning liquid is added.

[0244] Embodiment four: in the first, second and third stages of the four stages of magnetic separation operation, the ultrasonic device 10 is used to perform the ultrasonic mixing operation on the reaction solution to which the cleaning liquid is added; in the remaining stage of magnetic separation operation, the vortex mixing device 200 is used to perform the vortex mixing operation on the reaction solution to which the cleaning liquid is added. For example, in the first, second and third stages of magnetic separation operation, the ultrasonic device 10 performs the ultrasonic mixing operation on the reaction solution to which the cleaning liquid is added; in the fourth stage of magnetic separation operation, the vortex mixing device 200 performs the vortex mixing operation on the reaction solution to which the cleaning liquid is added.

[0245] In the above embodiments two to four, the vortex mixing device 200 is used to replace the ultrasonic device 10 to perform the vortex mixing operation on the reaction solution to which the cleaning liquid is added in some stages of magnetic separation operation. In the multiple stages of magnetic separation operation, the mixing of the ultrasonic device 10 and the vortex mixing device 200 can meet the mixing requirements of different test items, so that different test items can perform effective mixing on the reaction solution to which the cleaning liquid is added in the magnetic separation operation, thereby improving the accuracy of detection.

[0246] The above application of specific examples is used to illustrate the present application, which is only used to help understand the present application and does not limit the present application. For those skilled in the art to which the present application belongs, according to the idea of the present application, several simple deductions, deformations or substitutions can be made.

Claims

1. A sample analyzer characterized by, The application relates to a magnetic separation device for a sample, comprising: a sample carrying mechanism for carrying a sample; a reagent carrying mechanism for carrying a reagent; a sample dispensing mechanism for sucking the sample from the sample carrying mechanism and discharging the sample into a containing cup; a reagent dispensing mechanism for sucking the reagent from the reagent carrying mechanism and discharging the reagent into the containing cup; a reaction mechanism for providing an incubation place for a reaction solution in the containing cup, the reaction solution being formed by mixing the sample and the reagent; a magnetic separation mechanism comprising a washing liquid dispensing structure, a magnetic attraction structure and a liquid sucking structure, the washing liquid dispensing structure being used for injecting washing liquid into the containing cup, the magnetic attraction structure being used for performing a magnetic attraction operation on the reaction solution, and the liquid sucking structure being used for performing a liquid sucking operation; a second transfer mechanism for transferring the containing cup containing the incubated reaction solution from the reaction mechanism into the magnetic separation mechanism; a measuring mechanism for measuring the reaction solution; an ultrasonic device for generating ultrasonic vibration to form ultrasonic waves; and a controller connected with the ultrasonic device, the magnetic separation mechanism and the second transfer mechanism, the controller being used for controlling the second transfer mechanism to transfer the containing cup containing the incubated reaction solution from the reaction mechanism into the magnetic separation mechanism, the controller being used for controlling the washing liquid dispensing structure to inject washing liquid into the containing cup, and the controller being used for controlling the ultrasonic device to emit ultrasonic waves into the reaction solution containing the washing liquid to disperse the agglomerated substances in the reaction solution. The magnetic separation mechanism is used for performing a multi-stage magnetic separation operation on the reaction solution, and during each stage of the magnetic separation operation, the controller is used for controlling the ultrasonic device to perform an ultrasonic mixing operation on the reaction solution containing the washing liquid.

2. The sample analyzer of claim 1, wherein, The application further comprises a vortex mixing device, which is used for performing a vortex mixing operation on the reaction solution containing the washing liquid.

3. The sample analyzer of claim 1, wherein, The magnetic separation mechanism is used for performing a multi-stage magnetic separation operation on the reaction solution, wherein during a first stage of the magnetic separation operation, the controller controls the ultrasonic device to perform an ultrasonic mixing operation on the reaction solution containing the washing liquid; and during the remaining stages of the magnetic separation operation, the controller controls one or both of the ultrasonic device and the vortex mixing device to perform a mixing operation on the reaction solution containing the washing liquid. During the remaining stages of the magnetic separation operation, the controller controls one or both of the ultrasonic device and the vortex mixing device to perform a mixing operation on the reaction solution containing the washing liquid according to different test items.

4. The sample analyzer of claim 3, wherein, When the controller controls the ultrasonic device to perform an ultrasonic mixing operation on the reaction solution containing the washing liquid, the controller is used for acquiring test item parameters, and according to the test item parameters, one ultrasonic mode is matched from a plurality of preset ultrasonic modes to perform an ultrasonic mixing operation on the reaction solution containing the washing liquid.

5. The sample analyzer of claim 1, wherein, The plurality of ultrasonic modes respectively have different ultrasonic intensities and / or ultrasonic action times.

6. The sample analyzer of claim 5, wherein, ​ 7. The sample analyzer of claim 1, wherein, The ultrasonic device comprises an ultrasonic transducer, a transmission member and a moving device, the ultrasonic transducer is used to form ultrasonic vibration, the transmission member has a first end and a second end, the first end of the transmission member is connected with the ultrasonic transducer, and the outer diameter of the second end of the transmission member is smaller than the inner diameter of the containing cup; the moving device is connected with the ultrasonic transducer, and the moving device is used to drive the ultrasonic transducer and the transmission member to move relative to the containing cup, and the second end of the transmission member can be inserted into the reaction solution in the containing cup to transmit the ultrasonic vibration generated by the ultrasonic transducer to the reaction solution in the containing cup.

8. The sample analyzer of claim 1, wherein, The ultrasonic device is installed in the magnetic separation mechanism, and the ultrasonic device comprises an ultrasonic transducer and a transmission member, the ultrasonic transducer is used to form ultrasonic vibration, the transmission member has a first end and a second end, and the first end of the transmission member is connected with the ultrasonic transducer; the second end of the transmission member is used to abut against the outer wall of the containing cup in the magnetic separation mechanism, and the part of the outer wall of the containing cup in contact with the transmission member is the part surrounding the reaction solution, so as to transmit the ultrasonic vibration generated by the ultrasonic transducer to the reaction solution in the containing cup.

9. The sample analyzer of claim 7 or 8, wherein, The transmission member is of a solid structure, and the outer diameter of the transmission member gradually decreases or decreases in steps from the first end to the second end.

10. The sample analyzer of claim 1, wherein, The ultrasonic device is also used to perform ultrasonic mixing operation on at least one of the sample, the reagent, the reaction solution to be incubated, the reaction solution after incubation.

11. A method of sample analysis, characterized by The method comprises the following steps: The second transfer mechanism transfers the containing cup containing the reaction solution after incubation from the reaction mechanism to the magnetic separation mechanism; The magnetic separation mechanism performs magnetic separation operation on the reaction solution after incubation; The measuring mechanism performs light measurement on the reaction solution; The magnetic separation mechanism performs magnetic separation operation on the reaction solution after incubation, and specifically comprises the following steps: The washing liquid injection structure injects washing liquid into the containing cup; The ultrasonic device emits ultrasonic waves to the reaction solution added with the washing liquid to disperse the agglomerated substances in the reaction solution; The magnetic attraction structure performs magnetic attraction operation on the reaction solution added with the washing liquid through the ultrasonic device; The liquid suction structure sucks the liquid after the magnetic attraction.

12. The sample analysis method of claim 11, wherein, The magnetic separation mechanism performs multi-stage magnetic separation operation on the reaction solution after incubation, and in each stage of the magnetic separation operation, the ultrasonic device performs ultrasonic mixing operation on the reaction solution added with the washing liquid.

13. The sample analysis method of claim 11, wherein, The magnetic separation mechanism performs multi-stage magnetic separation operation on the reaction solution, wherein in the first stage of the magnetic separation operation, the ultrasonic device performs ultrasonic mixing operation on the reaction solution added with the washing liquid; and in the remaining stages of the magnetic separation operation, one or both of the ultrasonic device and the vortex mixing device are selected to perform mixing operation on the reaction solution added with the washing liquid.

14. The sample analysis method as described in claim 11, characterized in that, The ultrasonic mixing operation of the ultrasonic device is controlled through the following steps: According to the test item, the corresponding test item parameter is obtained; According to the test item parameter, one of the plurality of ultrasonic modes is matched from the plurality of preset ultrasonic modes to perform ultrasonic mixing operation on the reaction solution.

15. The method of claim 14, wherein the sample analysis method is selected from the group consisting of immunoassay, nucleic acid amplification, and mass spectrometry. 15 The plurality of ultrasonic modes have different ultrasonic intensities and / or ultrasonic action times.

16. The sample analysis method as described in claim 11, characterized in that, Before the magnetic separation mechanism performs the magnetic separation operation on the incubated reaction liquid, the method further comprises the following steps: The sample dispensing mechanism and the reagent dispensing mechanism respectively inject the sample and the reagent into the holding cup to form the reaction liquid; The reaction liquid is incubated in the reaction mechanism.

17. A method of sample analysis, characterized by, The method comprises the following steps: The magnetic separation mechanism performs multi-stage magnetic separation operation on the incubated reaction liquid; The measurement mechanism performs light measurement on the reaction liquid; The magnetic separation mechanism performs multi-stage magnetic separation operation on the incubated reaction liquid, specifically comprising the following steps: The cleaning liquid dispensing structure injects the cleaning liquid into the reaction liquid in the holding cup; One or both of the ultrasonic device and the vortex mixing device perform mixing operation on the reaction liquid with the injected cleaning liquid; The magnetic attraction structure performs magnetic attraction operation on the ultrasonic reaction liquid; The liquid suction structure sucks the liquid after the magnetic attraction operation; During the first-stage magnetic separation operation, the ultrasonic device performs ultrasonic mixing operation on the reaction liquid with the injected cleaning liquid to disperse the agglomerated material in the reaction liquid; during the remaining-stage magnetic separation operation, one or both of the ultrasonic device and the vortex mixing device perform mixing operation on the reaction liquid with the injected cleaning liquid according to different test items.

18. The sample analysis method of claim 17, wherein, The method further comprises the following steps: According to the test item, a corresponding test item parameter is obtained; According to the test item parameter, a mixing mode is matched from a plurality of preset mixing modes; According to the matched mixing mode, the corresponding ultrasonic device and / or vortex mixing device perform mixing operation on the reaction liquid with the injected cleaning liquid.

19. The sample analysis method of claim 17, wherein, Before the magnetic separation mechanism performs the multi-stage magnetic separation operation on the incubated reaction liquid, the method further comprises the following steps: The sample dispensing mechanism and the reagent dispensing mechanism respectively inject the sample and the reagent into the holding cup to form the reaction liquid; The reaction liquid is incubated in the reaction mechanism.

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