Sample analysis apparatus and method of controlling the same

Abstract

The application is suitable for the field of medical instruments, and discloses a sample analysis device and a control method of the sample analysis device. The sample analysis device comprises a reagent container storage mechanism, a reconstitution solution dispensing mechanism, a standard sample dispensing mechanism, a sample dispensing mechanism, a reagent dispensing mechanism, a measuring mechanism and a control device. The reagent container storage mechanism is used for storing a reagent container loaded with a reagent and a standard sample container loaded with a freeze-dried standard sample. The reconstitution solution dispensing mechanism is used for performing a reconstitution solution dispensing action on the standard sample container loaded with the freeze-dried standard sample from the reagent container storage mechanism, so as to reconstitute the freeze-dried standard sample into a liquid standard sample by the reconstitution solution. The standard sample dispensing mechanism is used for dispensing the liquid standard sample from the standard sample container into a first reaction container for measurement. The application realizes the storage, automatic reconstitution and measurement of the freeze-dried standard sample in the sample analysis device.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a sample analysis device and a control method for the sample analysis device. Background Technology

[0002] In related technologies, in order to obtain a longer shelf life, standard samples such as quality control products and calibrators are generally produced and stored in lyophilized form (e.g., lyophilized powder form). Before being tested on the instrument, the operator manually reconstitutes the lyophilized standard sample into a liquid standard sample, and then manually places the reconstituted liquid standard sample into the sample analysis equipment for testing.

[0003] In the aforementioned related technologies, the lyophilized standard samples are manually reconstituted before being placed in the sample analysis equipment for determination. This approach has the following drawbacks in practical applications: 1) The reconstitution, dispensing, and transfer of lyophilized standard samples are complex, have a low degree of automation, and require a significant amount of work from operators, increasing their workload; 2) Manual reconstitution of lyophilized standard samples requires opening the standard sample container containing the lyophilized standard sample and adding the reconstitution solution. After reconstitution, the standard sample container containing the liquid standard sample is placed in the sample analysis equipment with the lid open. Long-term open storage of the standard sample container in the sample analysis equipment can easily lead to liquid buildup. 1) The problem of evaporation and failure of lyophilized standard samples may lead to loss of control over liquid standard sample testing items; 2) The reconstitution of lyophilized standard samples is done manually, and the operating parameters of the reconstitution process rely on the operator's experience, which can easily lead to human error in the reconstitution quality of lyophilized standard samples. That is, the reconstitution quality of manual reconstitution operation is random, which can easily affect the accuracy of liquid standard sample test results, and even lead to loss of control over liquid standard sample testing items; 3) The sample analysis equipment will only measure the sample to be tested after the standard sample has been measured, so the pre-test time of the standard sample will affect the clinical working time of the sample analysis equipment. Summary of the Invention

[0004] The first objective of this invention is to provide a sample analysis device that addresses the technical problem in related sample analysis devices where lyophilized standard samples are manually reconstituted into liquid standard samples before measurement, resulting in a heavy workload for operators and inaccurate measurement results due to human factors.

[0005] To achieve the above objectives, the present invention provides a sample analysis device, comprising:

[0006] A reagent container storage mechanism is used to store reagent containers containing reagents and standard sample containers containing lyophilized standard samples.

[0007] The reconstitution solution dispensing mechanism is used to perform a reconstitution solution dispensing action on the standard sample container that comes from the reagent container storage mechanism and contains the lyophilized standard sample, so as to reconstitute the lyophilized standard sample to form a liquid standard sample through the reconstitution solution;

[0008] A standard sample dispensing mechanism is used to draw at least a portion of the liquid standard sample contained in the standard sample container and dispense all or part of the drawn liquid standard sample into a first reaction container;

[0009] A sample dispensing mechanism for drawing at least a portion of a sample from a sample container and dispensing all or part of the drawn sample into a second reaction container;

[0010] A reagent dispensing mechanism, the reagent dispensing mechanism being configured to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and dispense all or part of the drawn reagent into the first reaction vessel, and to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and dispense all or part of the drawn reagent into the second reaction vessel;

[0011] The measuring apparatus is used to measure a first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data, and to measure a second reaction solution in the second reaction vessel, which is made of at least the sample and the reagent, to obtain sample test data;

[0012] A control device configured to: obtain the detection result of the liquid standard sample based on reference detection data obtained by the measuring mechanism from measuring the first reaction liquid;

[0013] The control device is further configured to: obtain the test result of the sample based on the sample test data obtained by the measuring mechanism measuring the second reaction solution;

[0014] Wherein, the standard sample dispensing mechanism is the same as at least one of the sample dispensing mechanism and the reagent dispensing mechanism, or the standard sample dispensing mechanism is set up independently of the sample dispensing mechanism and independently of the reagent dispensing mechanism;

[0015] The reconstitution dispensing mechanism is the same as at least one of the sample dispensing mechanism, the reagent dispensing mechanism, and the standard sample dispensing mechanism, or the reconstitution dispensing mechanism is set up independently of the sample dispensing mechanism, the reagent dispensing mechanism, and the standard sample dispensing mechanism.

[0016] In one embodiment, the sample analysis device has a first reconstituted solution dispensing position located outside the reagent container storage mechanism;

[0017] The sample analysis device further includes a first transfer mechanism, which is used to transfer the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism to the first reconstituted solution dispensing position.

[0018] The reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container from the reagent container storage mechanism, including: the reconstitution dispensing mechanism is used to perform the reconstitution dispensing action on the standard sample container located at the first reconstitution dispensing position;

[0019] Alternatively, a second reconstituted solution dispensing position may be formed within the reagent container storage mechanism;

[0020] The reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container from the reagent container storage mechanism, including: the reconstitution dispensing mechanism is used to perform the reconstitution dispensing action on the standard sample container located at the second reconstitution dispensing position.

[0021] In one embodiment, the sample analysis device further includes a mixing mechanism, which is used to perform a mixing action on the standard sample container after the reconstitution dispensing action is completed, so as to mix the liquid standard sample formed by the reconstitution of the lyophilized standard sample in the standard sample container.

[0022] In one embodiment, the mixing mechanism performs a mixing action on the standard sample container after the reconstituted solution dispensing action is completed by at least one of the following methods: driving the standard sample container to rotate and / or vibrate, performing suction and discharge actions on the liquid standard sample in the standard sample container, blowing air into the liquid standard sample in the standard sample container, performing a stirring action on the liquid standard sample in the standard sample container, and performing an ultrasonic mixing action on the liquid standard sample in the standard sample container.

[0023] In one embodiment, the sample analysis device further includes a first incubation mechanism, a first transfer mechanism, a second incubation mechanism, and a second transfer mechanism;

[0024] The first transfer mechanism is used to transfer the standard sample container after the reconstitution solution dispensing operation is completed to the first incubation mechanism for incubation treatment;

[0025] The second transfer mechanism is used to transfer the first reaction container, which is loaded with liquid standard sample after being dispensed by the standard sample dispensing mechanism, to the second incubation mechanism for incubation treatment, and to transfer the second reaction container, which is loaded with sample after being dispensed by the sample dispensing mechanism, to the second incubation mechanism for incubation treatment;

[0026] The first incubation institution and the second incubation institution are either two independently established institutions or the same institution.

[0027] As one implementation, when the sample analysis device has a first reconstituted solution dispensing position located outside the reagent container storage mechanism, the control device is further configured to:

[0028] When the first preset condition is met, the first transfer mechanism is controlled to transfer the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism to the first reconstitution solution dispensing position;

[0029] The reconstitution solution dispensing mechanism is controlled to perform a reconstitution solution dispensing action on the standard sample container located at the first reconstitution solution dispensing position;

[0030] The first transfer mechanism is controlled to transfer the standard sample container, after the reconstitution solution dispensing action has been completed, from the reconstitution solution dispensing position to the first incubation mechanism to perform the first incubation process;

[0031] The first transfer mechanism is controlled to transfer the standard sample container, after the first incubation treatment has been completed, from the first incubation mechanism to the mixing mechanism;

[0032] The mixing mechanism is controlled to perform a mixing action on the standard sample container after the first incubation treatment is completed;

[0033] The first transfer mechanism is controlled to transfer the standard sample container, after the mixing action is completed, from the mixing mechanism to the first incubation mechanism to perform the second incubation process;

[0034] The first transfer mechanism is controlled to transfer the standard sample container, after completing the second incubation treatment, from the first incubation mechanism to the liquid aspiration position;

[0035] The standard sample dispensing mechanism is controlled to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into the first reaction vessel;

[0036] The second transfer mechanism is controlled to transfer the first reaction vessel, after the liquid standard sample has been dispensed, to the second incubation mechanism to perform the third incubation process;

[0037] The reagent dispensing mechanism is controlled to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and to dispense all or part of the drawn reagent into the first reaction vessel after the third incubation treatment has been completed;

[0038] The measuring mechanism is controlled to measure the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data;

[0039] The liquid absorption position and the first reconstituted solution dispensing position are located at the same location or at two different locations.

[0040] In one implementation, after the control device draws at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispenses it into the first reaction vessel, the control device is further configured to:

[0041] The first transfer mechanism is controlled to transfer the standard sample container, after the liquid standard sample has been dispensed, from the liquid aspiration position to the reagent container storage mechanism for storage.

[0042] In one implementation, after controlling the first transfer mechanism to transfer the standard sample container after the liquid standard sample has been dispensed to the reagent container storage mechanism for storage, the control device is further configured to:

[0043] When the first preset condition is met again, it is determined whether the standard sample container that has been transferred from the aspiration position to the reagent container storage mechanism and contains the liquid standard sample meets the second preset condition.

[0044] If so, the reconstitution device is controlled to transfer the standard sample container that meets the second preset condition to the first incubation mechanism to perform the first incubation process;

[0045] The first transfer mechanism is controlled to transfer the standard sample container, after the first incubation treatment has been completed, from the first incubation mechanism to the mixing mechanism;

[0046] The mixing mechanism is controlled to perform a mixing action on the standard sample container after the first incubation treatment is completed;

[0047] The first transfer mechanism is controlled to transfer the standard sample container, after the mixing action is completed, from the mixing mechanism to the first incubation mechanism to perform the second incubation process;

[0048] The first transfer mechanism is controlled to transfer the standard sample container, after completing the second incubation treatment, from the first incubation mechanism to the liquid aspiration position;

[0049] The standard sample dispensing mechanism is controlled to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into another first reaction container;

[0050] The second transfer mechanism is controlled to transfer the first reaction vessel, after the liquid standard sample has been dispensed, to the second incubation mechanism to perform the third incubation process;

[0051] The reagent dispensing mechanism is controlled to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and to dispense all or part of the drawn reagent into the first reaction vessel after the third incubation treatment has been completed;

[0052] The measuring mechanism is controlled to measure the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data;

[0053] The second preset condition is that the volume of liquid standard sample loaded in the standard sample container is greater than or equal to the amount of liquid standard sample required for a standard sample testing item.

[0054] In one implementation, the lyophilized standard sample is a lyophilized quality control product, and the reference detection data is quality control data. The sample analysis device is pre-stored with at least one of the following first preset conditions: reaching a first preset time point of a first preset cycle; the cumulative running time of the sample analysis device since the last quality control item measurement reaches a first preset time; the number of times the sample analysis device continuously measures the sample to be tested reaches a first preset number; the cumulative number of times the sample analysis device cumulatively measures the sample to be tested since the last quality control item measurement reaches a second preset number; the reagent container is replaced to supply reagents; and information on the quality control item is obtained according to the instructions input by the operator through the human-computer interaction device.

[0055] In one embodiment, the reagent container storage mechanism is also used to store a reconstitution container containing the reconstitution solution, and the reconstitution solution dispensing mechanism performs a reconstitution solution dispensing operation on the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism, including: the reconstitution solution dispensing mechanism draws at least a portion of the reconstitution solution from the reconstitution container located in the reagent container storage mechanism, and dispenses all or part of the drawn reconstitution solution into the standard sample container containing the lyophilized standard sample;

[0056] Alternatively, the sample analysis device may have a reconstitution buffer space independent of the reagent container storage mechanism. The reconstitution buffer space is used to store a reconstitution container containing the reconstitution solution. The reconstitution dispensing mechanism performs a reconstitution dispensing action on the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism, including: the reconstitution dispensing mechanism draws at least a portion of the reconstitution solution from the reconstitution container located in the reconstitution buffer space, and dispenses all or part of the drawn reconstitution solution into the standard sample container containing the lyophilized standard sample.

[0057] In one embodiment, the reagent container storage mechanism has a plurality of first receiving slots adapted to the reagent container, and the standard sample container is placed in the first receiving slot through an adapter adapted to the first receiving slot;

[0058] Alternatively, the reagent container storage mechanism may have a plurality of first receiving slots adapted to the reagent container and a plurality of second receiving slots adapted to the standard sample container, wherein the second receiving slots are different in shape and / or size from the first receiving slots.

[0059] In one embodiment, the reagent container storage mechanism is also used to place the reagent container containing the reagent to realize the loading of the reagent, and to place the standard sample container containing the lyophilized standard sample to realize the loading of the lyophilized standard sample.

[0060] In one embodiment, the reagent container storage mechanism is also used to place the standard sample container containing the liquid standard sample to realize the feeding of the liquid standard sample.

[0061] In one embodiment, the sample analysis device further includes a reagent loading mechanism and a third transfer mechanism. The reagent loading mechanism is used to place the reagent container containing the reagent to realize the loading of the reagent, and to place the standard sample container containing the lyophilized standard sample to realize the loading of the lyophilized standard sample.

[0062] The third transfer mechanism is used to transfer the reagent container containing the reagent from the reagent feeding mechanism to the reagent container storage mechanism, and to transfer the standard sample container containing the lyophilized standard sample from the reagent feeding mechanism to the reagent container storage mechanism.

[0063] In one embodiment, the sample analysis device has a first reconstitution dispensing position located outside the reagent container storage mechanism; the reagent container storage mechanism includes a reagent tray and a first driving mechanism, and the sample analysis device further includes a first transfer mechanism. The reagent tray is used to store the reagent container containing the reagent and the standard sample container containing the lyophilized standard sample. The first driving mechanism is used to drive the reagent tray to rotate so that the reagent container containing the reagent rotates to the reagent aspiration position and to drive the reagent tray to rotate so that the standard sample container containing the lyophilized standard sample rotates to the transfer position. The reagent dispensing mechanism is used to aspirate at least a portion of the reagent from the reagent container located at the reagent aspiration position and to dispense all or part of the aspirated reagent into the first reaction vessel. The first transfer mechanism is used to transfer the standard sample container located at the transfer position to the first reconstitution dispensing position. The reconstitution dispensing mechanism is used to perform a reconstitution dispensing operation on the standard sample container located at the first reconstitution dispensing position.

[0064] Alternatively, the sample analysis device may have a first reconstitution dispensing position located outside the reagent container storage mechanism; the reagent container storage mechanism includes a fixed storage component for storing the reagent container containing the reagent and the standard sample container for storing the lyophilized standard sample; the reagent dispensing mechanism is used to draw at least a portion of the reagent from the reagent containers located at different positions of the fixed storage component and dispense all or part of the drawn reagent into different first reaction containers; the first transfer mechanism is used to transfer the standard sample containers located at different positions of the fixed storage component to the first reconstitution dispensing position; and the reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container located at the first reconstitution dispensing position.

[0065] In one embodiment, the sample analysis device further includes a housing, in which the reagent container storage mechanism, the reconstitution solution dispensing mechanism, the standard sample dispensing mechanism, the sample dispensing mechanism, the reagent dispensing mechanism, the measuring mechanism, and the control device are all housed;

[0066] And / or, the sample analysis device further includes a refrigeration device for refrigerating the reagent container storage mechanism, so that the reagent container containing the reagent and the standard sample container containing the lyophilized standard sample are refrigerated in the reagent container storage mechanism.

[0067] In one implementation, the freeze-dried standard sample is a freeze-dried quality control sample, and the reference test data is quality control data;

[0068] Alternatively, the lyophilized standard sample may be a lyophilized calibrator, and the reference test data may be calibration data.

[0069] A second objective of this invention is to provide a control method for a sample analysis device, which includes the following testing procedure for standard samples:

[0070] The control reconstitution dispensing mechanism performs a reconstitution dispensing action on a standard sample container containing lyophilized standard samples from a reagent container storage mechanism, so as to reconstitute the lyophilized standard samples into liquid standard samples through the reconstitution solution;

[0071] The control standard sample dispensing mechanism draws at least a portion of the liquid standard sample contained in the standard sample container and dispenses all or part of the drawn liquid standard sample into the first reaction container;

[0072] The reagent dispensing mechanism draws at least a portion of the reagent from the reagent container of the reagent container storage mechanism and dispenses all or part of the drawn reagent into the first reaction vessel;

[0073] The control and measurement mechanism measures the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data;

[0074] The test results of the liquid standard sample are obtained based on the reference test data obtained by the testing institution from the test of the first reaction solution;

[0075] Wherein, the standard sample dispensing mechanism and the reagent dispensing mechanism are the same mechanism, or the standard sample dispensing mechanism is set up independently of the reagent dispensing mechanism;

[0076] The reconstitution dispensing mechanism is the same as at least one of the reagent dispensing mechanism and the standard sample dispensing mechanism, or the reconstitution dispensing mechanism is set up independently of the reagent dispensing mechanism and independently of the standard sample dispensing mechanism.

[0077] As one implementation, before the control reconstitution dispensing mechanism performs the reconstitution dispensing action on the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism, the control method further includes: when a first preset condition is met, controlling the first transfer mechanism to transfer the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism to a first reconstitution dispensing position located outside the reagent container storage mechanism;

[0078] The control mechanism for dispensing reconstituted solution performs a reconstituted solution dispensing action on a standard sample container containing lyophilized standard samples from a reagent container storage mechanism, including: controlling the reconstituted solution dispensing mechanism to perform a reconstituted solution dispensing action on the standard sample container located at the first reconstituted solution dispensing position;

[0079] After the controlled reconstitution dispensing mechanism performs a reconstitution dispensing action on a standard sample container from the reagent container storage mechanism and loaded with lyophilized standard samples, and before the controlled standard sample dispensing mechanism aspirates at least a portion of the liquid standard sample loaded in the standard sample container and dispenses all or part of the aspirated liquid standard sample into the first reaction vessel, the control method further includes: controlling the first transfer mechanism to transfer the standard sample container after the reconstitution dispensing action from the first reconstitution dispensing position to the first incubation mechanism to perform a first incubation treatment; controlling the first transfer mechanism to transfer the standard sample container after the first incubation treatment from the first incubation mechanism to a mixing mechanism; controlling the mixing mechanism to perform a mixing action on the standard sample container after the first incubation treatment; controlling the first transfer mechanism to transfer the standard sample container after the mixing action from the mixing mechanism to the first incubation mechanism to perform a second incubation treatment; and controlling the first transfer mechanism to transfer the standard sample container after the second incubation treatment from the first incubation mechanism to aspiration position.

[0080] The control of the standard sample dispensing mechanism to draw at least a portion of the liquid standard sample contained in the standard sample container and to dispense all or part of the drawn liquid standard sample into the first reaction container includes: controlling the standard sample dispensing mechanism to draw at least a portion of the liquid standard sample contained in the standard sample container located at the liquid aspiration position and to dispense it into the first reaction container.

[0081] As one implementation, after the standard sample dispensing mechanism draws at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispenses it into the first reaction vessel, the control method further includes:

[0082] The first transfer mechanism is controlled to transfer the standard sample container, after the liquid standard sample has been dispensed, from the liquid aspiration position to the reagent container storage mechanism for storage.

[0083] When the first preset condition is met again, it is determined whether the standard sample container that has been transferred from the aspiration position to the reagent container storage mechanism and contains the liquid standard sample meets the second preset condition.

[0084] If so, the reconstitution device is controlled to transfer the standard sample container that meets the second preset condition to the first incubation mechanism to perform the first incubation process;

[0085] The first transfer mechanism is controlled to transfer the standard sample container, after the first incubation treatment has been completed, from the first incubation mechanism to the mixing mechanism;

[0086] The mixing mechanism is controlled to perform a mixing action on the standard sample container after the first incubation treatment is completed;

[0087] The first transfer mechanism is controlled to transfer the standard sample container, after the mixing action is completed, from the mixing mechanism to the first incubation mechanism to perform the second incubation process;

[0088] The first transfer mechanism is controlled to transfer the standard sample container, after completing the second incubation treatment, from the first incubation mechanism to the liquid aspiration position;

[0089] The standard sample dispensing mechanism is controlled to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into another first reaction container;

[0090] The reagent dispensing mechanism is controlled to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and dispense all or part of the drawn reagent into the first reaction vessel;

[0091] The measuring mechanism is controlled to measure the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data.

[0092] The sample analysis device and its control method provided by this invention reuse a reagent container storage mechanism to store a standard sample container containing lyophilized standard samples. A reconstitution solution dispensing mechanism dispenses reconstitution solution into the standard sample container from the reagent container storage mechanism to reconstitute the lyophilized standard samples into liquid standard samples. A standard sample dispensing mechanism then distributes the liquid standard samples from the reconstituted lyophilized standard samples into a first reaction container for reaction and measurement. This achieves automatic reconstitution of lyophilized standard samples in the sample analysis device, as well as automatic dispensing and measurement of the reconstituted liquid standard samples. The process of reconstituted lyophilized standard samples into liquid standard samples and the subsequent measurement do not require manual intervention, thus improving the automation level of the sample analysis device. This reduces the workload and operational burden on operators during standard sample measurement, minimizes the impact of human factors on the measurement results, ensures the accuracy and validity of the measurement results, and reduces the pre-measurement time of standard samples on the clinical working time of the sample analysis device. Furthermore, storing the standard sample containers containing lyophilized standard samples in the reagent container storage mechanism eliminates the need for additional storage facilities for lyophilized standard samples. This facilitates the integration of sample analysis equipment, reduces its cost and footprint, and ultimately promotes its widespread adoption and application. Attached Figure Description

[0093] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0094] Figure 1 This is a schematic diagram of the sample analysis device provided in an embodiment of the present invention, which uses a method of loading reagents and lyophilized standard samples into a reagent container storage mechanism;

[0095] Figure 2 This is a schematic diagram of the sample analysis device provided in an embodiment of the present invention, which uses a reagent feeding mechanism to feed reagents and lyophilized standard samples.

[0096] Figure 3 This is a schematic diagram of the structure of the standard sample container provided in this embodiment of the invention, which is loaded onto the reagent container storage mechanism via an adapter;

[0097] Figure 4This is a schematic diagram of the structure of the standard sample container being directly mounted on the base of the reagent container storage mechanism according to an embodiment of the present invention;

[0098] Figure 5 This is a schematic diagram of the process for determination using lyophilized standard samples provided in an embodiment of the present invention;

[0099] Figure 6 This is a schematic diagram of the process for determination using liquid standard samples provided in an embodiment of the present invention.

[0100] Explanation of reference numerals: 10, Sample analysis equipment; 100, Reagent container storage mechanism; 110, Base; 200, Sample dispensing mechanism; 300, Reagent dispensing mechanism; 310, Mixed reagent dispensing mechanism; 320, Trigger reagent dispensing mechanism; 400, Measurement mechanism; 500, First transfer mechanism; 600, First incubation mechanism; 700, Second incubation mechanism; 800, Mixing mechanism; 900, Reaction vessel supply mechanism; 101, Second transfer mechanism; 102, Sample injection mechanism; 103, Housing; 104, Reagent loading mechanism; 105, Third transfer mechanism; 11, First reconstitution dispensing position; 20, Standard sample container; 30, Reagent container; 40, Adapter. Detailed Implementation

[0101] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0102] This invention is applicable to sample analysis equipment that uses lyophilized standard samples reconstituted into liquid standard samples as standard samples. These lyophilized standard samples include, but are not limited to, lyophilized quality control samples and lyophilized calibrators. Lyophilized quality control samples are used to reconstitute into liquid quality control samples for quality control determination, and lyophilized calibrators are used to reconstitute into liquid calibrators for calibration determination.

[0103] Reference Figure 1As shown, a first aspect of this invention provides a sample analysis device 10. The sample analysis device 10 includes a reagent container storage mechanism 100, a sample dispensing mechanism 200, a reagent dispensing mechanism 300, a measuring mechanism 400, and a control device. The reagent container storage mechanism 100 is used to store reagents; the sample dispensing mechanism 200 is used to dispense samples; the reagent dispensing mechanism 300 is used to dispense reagents; the measuring mechanism 400 is used to measure at least a reaction solution prepared from the sample and reagents; and the control device is used to obtain the sample detection result based on the sample detection data obtained from the measurement of the reaction solution by the measuring mechanism 400. The sample is a liquid sample collected from a human or animal. The sample analysis device 10 provided in this embodiment can realize automatic dispensing of samples and reagents, as well as automatic measurement and analysis of the reaction solution prepared from the sample and reagents.

[0104] In one implementation, the sample analysis device 10 further includes a reconstitution solution dispensing mechanism and a standard sample dispensing mechanism. The reagent container storage mechanism 100 is also used to store lyophilized standard samples; the reconstitution solution dispensing mechanism is used to perform a reconstitution solution dispensing operation on the lyophilized standard samples from the reagent container storage mechanism 100, so as to reconstitute the lyophilized standard samples into liquid standard samples using the reconstitution solution; the standard sample dispensing mechanism is used to dispense the liquid standard samples; the measuring mechanism 400 is also used to measure the reaction solution prepared from at least the liquid standard samples and reagents; the control device is also used to obtain the detection result of the liquid standard samples based on the reference detection data obtained by the measuring mechanism 400 from the measurement of the reaction solution prepared from at least the liquid standard samples and reagents. The standard sample dispensing mechanism is the same as at least one of the sample dispensing mechanism 200 and the reagent dispensing mechanism 300, or the standard sample dispensing mechanism is set up independently of both the sample dispensing mechanism 200 and the reagent dispensing mechanism 300; that is, the standard samples can be dispensed using either the sample dispensing mechanism 200 or the reagent dispensing mechanism 300, or a separate additional dispensing mechanism can be set up for dispensing. The reconstitution solution dispensing mechanism is the same as at least one of the sample dispensing mechanism 200, reagent dispensing mechanism 300, and standard sample dispensing mechanism; alternatively, the reconstitution solution dispensing mechanism is set up independently of the sample dispensing mechanism 200, reagent dispensing mechanism 300, and standard sample dispensing mechanism. That is, the reconstitution solution can be dispensed using one of the sample dispensing mechanism 200, reagent dispensing mechanism 300, and standard sample dispensing mechanism, or a separate additional dispensing mechanism can be set up for dispensing the reconstitution solution. The lyophilized standard sample is prepared from a liquid standard sample of known concentration (i.e., a liquid standard sample with a known concentration of the target analyte, the same as the target analyte to be detected in the sample) through a lyophilization process. This implementation scheme reuses the reagent container storage mechanism 100 to store lyophilized standard samples, and dispenses reconstitution solution into the lyophilized standard samples from the reagent container storage mechanism 100 to reconstitute the lyophilized standard samples into liquid standard samples. The liquid standard samples formed by the reconstitution of the lyophilized standard samples are then distributed to the reaction container for reaction and measurement via the standard sample distribution mechanism. This achieves automatic reconstitution of lyophilized standard samples in the sample analysis device 10, as well as automatic distribution and measurement of the reconstituted liquid standard samples. The process of reconstitution of lyophilized standard samples into liquid standard samples and the subsequent measurement do not require manual intervention, thus improving the automation level of the sample analysis device 10. This reduces the workload and operational burden of operators during standard sample measurement, minimizes the impact of human factors on the standard sample measurement results, ensures the accuracy and validity of the standard sample measurement results, and reduces the impact of the pre-measurement time of standard samples on the clinical working time of the sample analysis device 10.Furthermore, storing lyophilized standard samples in the reagent container storage mechanism 100 eliminates the need for additional storage facilities, thereby improving the integration level of the sample analysis equipment 10, reducing its cost and footprint, and ultimately facilitating its widespread adoption and application. Reconstitution of the lyophilized standard samples via dispensing of reconstitution solutions is a simple and easy-to-implement method.

[0105] Prior to this application, the reconstitution solution was dispensed manually, and the dispensing volume relied on the operator's experience, which could lead to human error in the reconstitution quality of the lyophilized standard sample. In this embodiment, the reconstitution solution is dispensed automatically by the reconstitution solution dispensing mechanism, which effectively improves the consistency of the dispensing volume and the dispensing accuracy, and helps to reduce the impact of the dispensing volume of the reconstitution solution on the measurement results of the liquid standard sample.

[0106] In one embodiment, the reagent container storage mechanism 100 is used to store reagents and to store lyophilized standard samples, including: the reagent container storage mechanism 100 is used to store a reagent container 30 containing reagents, and a standard sample container 20 containing lyophilized standard samples. The reconstitution dispensing mechanism is used to perform a reconstitution dispensing operation on the lyophilized standard samples from the reagent container storage mechanism 100, including: the reconstitution dispensing mechanism is used to perform a reconstitution dispensing operation on the standard sample container 20 containing the lyophilized standard samples from the reagent container storage mechanism 100, so as to reconstitute the lyophilized standard samples to form liquid standard samples using a reconstitution solution. The standard sample dispensing mechanism is used to dispense liquid standard samples, including: the standard sample dispensing mechanism is used to aspirate at least a portion of the liquid standard sample contained in the standard sample container 20 and dispense all or part of the aspirated liquid standard sample into a first reaction container. The sample dispensing mechanism 200 is used to dispense samples, including: the sample dispensing mechanism 200 is used to aspirate at least a portion of the sample from the sample container and dispense all or part of the aspirated sample into a second reaction container. The reagent dispensing mechanism 300 is used to dispense reagents, including: drawing at least a portion of the reagent from the reagent container 30 of the reagent container storage mechanism 100 and dispensing all or part of the drawn reagent into a first reaction container; and drawing at least a portion of the reagent from the reagent container 30 of the reagent container storage mechanism 100 and dispensing all or part of the drawn reagent into a second reaction container. The measuring mechanism 400 is used to measure a reaction solution prepared at least from a sample and a reagent, and to measure a reaction solution prepared at least from a liquid standard sample and a reagent, including: measuring a first reaction solution prepared at least from a liquid standard sample and a reagent in the first reaction container to obtain reference test data; and measuring a second reaction solution prepared at least from a sample and a reagent in the second reaction container to obtain sample test data. The aforementioned control device is used to obtain a sample detection result based on sample detection data obtained by measuring the reaction solution by the measuring mechanism 400, and to obtain a liquid standard sample detection result based on reference detection data obtained by measuring the reaction solution made of at least a liquid standard sample and a reagent by the measuring mechanism 400. The control device is configured to: obtain a liquid standard sample detection result based on reference detection data obtained by measuring the first reaction solution by the measuring mechanism 400; and the control device is further configured to: obtain a sample detection result based on sample detection data obtained by measuring the second reaction solution by the measuring mechanism 400.In this embodiment, the storage of lyophilized standard samples, the reconstitution of lyophilized standard samples, the storage of liquid standard samples formed by the reconstitution of lyophilized standard samples, and the aspiration of liquid standard samples are all performed within the same standard sample container 20. That is, after the lyophilized standard samples are reconstituted, there is no need for aliquoting; the original standard sample container 20 used for storing lyophilized standard samples is directly used as the container for storing liquid standard samples and for the standard sample dispensing mechanism to aspirate liquid standard samples. This saves time and consumable materials for aliquoting liquid standard samples, thereby reducing the time required for standard sample items and lowering the operating cost of the sample analysis equipment 10. Of course, in an alternative embodiment, the lyophilized standard samples can also be aliquoted into other containers after reconstitution.

[0107] As one implementation method, the freeze-dried standard sample is a solid standard sample prepared by a vacuum freeze-drying process. Vacuum freeze-drying is a freeze-drying technology that utilizes the principle of sublimation to dehydrate materials. Specifically, vacuum freeze-drying technology freezes water-containing materials into a solid state, and utilizes the sublimation properties of water under low temperature and low pressure conditions to dehydrate the materials at low temperature, thus achieving freeze-drying. Because vacuum freeze-drying technology is carried out in a low-temperature, low-oxygen environment, most biological reactions are halted, and no liquid water is present during the process. Water sublimates directly in a solid state, maximizing the preservation of the original structure and shape of the material, ultimately yielding high-quality freeze-dried products with both excellent appearance and internal quality.

[0108] In one implementation, the lyophilized standard sample is a lyophilized quality control sample, the liquid standard sample is a liquid quality control sample, and the reference detection data is the quality control data. Specifically, the lyophilized quality control sample is prepared from a liquid quality control sample of known concentration through a lyophilization process. The liquid quality control sample is used to perform the determination of the quality control items of the sample analysis device 10. By comparing the actual measurement results of the liquid quality control sample in the sample analysis device 10 with the preset known results (i.e., target values) in the sample analysis device 10, it can be confirmed whether the sample analysis device 10 is in normal working order. Of course, in specific applications, the lyophilized standard sample is not limited to the lyophilized quality control sample. For example, as an alternative implementation, the lyophilized standard sample is a lyophilized calibrator, the liquid standard sample is a liquid calibrator, and the reference detection data is the calibration data. The lyophilized calibrator is prepared from a liquid calibrator of known concentration through a lyophilization process. The liquid calibrator is used to calibrate the various sample determination items of the sample analysis device 10.

[0109] As one implementation method, the reconstitution solution is one of pure water, deionized water, or distilled water, which is low in cost and does not cause a chemical reaction with the standard sample. Of course, in specific applications, the method of setting up the reconstitution solution is not limited to these.

[0110] In one implementation, the standard sample dispensing mechanism, sample dispensing mechanism 200, and reconstitution solution dispensing mechanism are the same mechanism; that is, sample dispensing mechanism 200 is time-multiplexed to perform sample dispensing, standard sample dispensing, and reconstitution solution dispensing actions. Reagent dispensing mechanism 300 is set independently of sample dispensing mechanism 200; that is, reagent dispensing mechanism 300 and sample dispensing mechanism 200 are not the same dispensing mechanism, and sample dispensing and reagent dispensing actions are performed by different dispensing mechanisms. This configuration improves the integration of the sample analysis device 10, thereby reducing the cost and size of the sample analysis device 10. Of course, in specific applications, the arrangement of the standard sample dispensing mechanism and the reconstitution solution dispensing mechanism is not limited to this. For example, as an alternative implementation, the standard sample dispensing mechanism and the sample dispensing mechanism 200 are the same mechanism, the reconstitution solution dispensing mechanism and the reagent dispensing mechanism 300 are the same mechanism, and the reagent dispensing mechanism 300 is set independently of the sample dispensing mechanism 200; or, as another alternative implementation, the standard sample dispensing mechanism, the reconstitution solution dispensing mechanism and the reagent dispensing mechanism 300 are the same mechanism, and the reagent dispensing mechanism 300 is set independently of the sample dispensing mechanism 200; or, as yet another alternative implementation, at least one of the standard sample dispensing mechanism and the reconstitution solution dispensing mechanism is set independently of both the reagent dispensing mechanism 300 and the sample dispensing mechanism 200.

[0111] In one implementation, the sample dispensing mechanism 200 includes a sample needle, a first suction / dispensing driving component, and a first motion driving component. The sample needle is used for at least aspirating and dispensing liquid standard samples, and for aspirating and dispensing samples. The first suction / dispensing driving component provides driving force for the sample needle to perform suction and dispensing actions. The first motion driving component drives the sample needle to move in two-dimensional or three-dimensional space, so that the sample needle moves to different positions, such as a standby position, a sample aspiration position, a liquid standard sample aspiration position, a sample dispensing position, a cleaning position, etc.

[0112] In one implementation, the first suction / discharge driving component includes a syringe or a plunger pump. Of course, in specific applications, the arrangement of the first suction / discharge driving component is not limited to this; for example, it can also be a positive or negative pressure driving structure.

[0113] In one embodiment, the standard sample container 20 includes a glass bottle body and a sealing member. The glass bottle body has an inner cavity and a bottle mouth. The inner cavity is used to contain lyophilized standard samples and liquid standard samples formed by reconstitution of the lyophilized standard samples. The bottle mouth communicates with the inner cavity to allow at least a portion of the liquid standard sample to be drawn out of the inner cavity. The sealing member is used to seal the bottle mouth and includes a stopper at least partially inserted into the bottle mouth and / or a cap at least partially fitted outside the bottle mouth. In specific applications, the bottle mouth is used to allow at least a portion of the liquid standard sample to be drawn out of the inner cavity. The sealing member is used to seal the bottle mouth. The glass bottle body can block moisture and oxygen, thereby extending the shelf life of the lyophilized standard samples. Furthermore, the size of the glass bottle body is ideal for high-density lyophilized standard samples, making it a cost-effective packaging form for lyophilized standard samples.

[0114] In one implementation, the sample needle has a puncture function, i.e., the sample needle is a puncture needle. The sample needle is used to puncture the stopper and / or cap of the standard sample container 20 to at least partially penetrate into the standard sample container 20 and aspirate the liquid standard sample. The sample needle can directly puncture the sealing member (stopper and / or cap) of the standard sample container 20 for sample aspiration or dispensing of reconstituted solution, eliminating the need for a stopper removal mechanism and a cap removal mechanism. This simplifies the structure of the sample analysis device 10, and because it saves time on stopper removal and / or cap removal, it improves the measurement efficiency. In this implementation, the reconstituted liquid standard sample can be directly aspirated for measurement without secondary dispensing to other containers, and without removing the stopper and / or cap of the standard sample container 20 containing the liquid standard sample. This makes the measurement of liquid standard samples more convenient and helps reduce the contact between liquid standard samples and air, resulting in more stable performance of the liquid standard samples. Of course, in specific applications, the sample needle can also be set as a non-puncture needle. By setting a stopper removal mechanism and / or a cap removal mechanism, the stopper and / or cap of the standard sample container 20 can be removed before the sample needle is inserted into the standard sample container 20 to aspirate or dispense the reconstituted solution.

[0115] In one implementation, the sample analysis device 10 further includes a refrigeration device for cooling the reagent container storage mechanism 100, thereby refrigerating the reagent container 30 containing reagents and the standard sample container 20 containing lyophilized standard samples within the reagent container storage mechanism 100. The reagent container storage mechanism 100 and the refrigeration device together form a refrigeration mechanism that can be used to refrigerate the reagent container 30 containing reagents and the standard sample container 20 containing lyophilized standard samples, thereby helping to prevent the reagents and lyophilized standard samples from deteriorating.

[0116] In one implementation, the cooling device includes a semiconductor cooling chip, which features high cooling efficiency, small size, and energy saving and environmental friendliness. This embodiment uses a semiconductor cooling chip for cooling the reagent container storage mechanism 100, which helps reduce the size of the sample analysis device 10 and improves its energy saving and environmental protection performance.

[0117] Reference Figure 1 As shown, in one embodiment, the sample analysis device 10 also includes a housing 103, and a reagent container storage mechanism 100, a reconstitution solution dispensing mechanism, a standard sample dispensing mechanism, a sample dispensing mechanism 200, a reagent dispensing mechanism 300, a measuring mechanism 400, and a control device are all housed within the housing 103. The housing 103 serves as the outer shell of the sample analysis device 10. In this embodiment, the reagent container storage mechanism 100 for storing lyophilized standard samples and the reconstitution solution dispensing mechanism are both located within the housing 103, which helps to improve the compactness of the sample analysis device 10's structure.

[0118] Reference Figure 1 As shown, in one embodiment, the sample analysis device 10 has a first reconstitution dispensing position 11 located outside the reagent container storage mechanism 100. The sample analysis device 10 also includes a first transfer mechanism 500, which is used to transfer a standard sample container 20 containing a lyophilized standard sample from the reagent container storage mechanism 100 to the first reconstitution dispensing position 11. The reconstitution dispensing mechanism is used to perform a reconstitution dispensing operation on the standard sample container 20 from the reagent container storage mechanism 100, including: the reconstitution dispensing mechanism performs a reconstitution dispensing operation on the standard sample container 20 located at the first reconstitution dispensing position 11. The first reconstitution dispensing position 11 is the reconstitution working position for the lyophilized standard sample. In this implementation scheme, the reconstitution station for lyophilized standard samples is located outside the reagent container storage mechanism 100. The reconstitution solution dispensing mechanism is used to dispense reconstitution solution to the lyophilized standard samples located outside the reagent container storage mechanism 100. The reconstitution of lyophilized standard samples is performed outside the reagent container storage mechanism 100. In this way, on the one hand, the low temperature environment inside the reagent container storage mechanism 100 can be avoided from affecting the reconstitution efficiency of lyophilized standard samples, and on the other hand, the impact of the reconstitution of lyophilized standard samples on the reagent dispensing efficiency can be reduced.

[0119] Of course, in specific applications, as an alternative implementation, the reconstitution station for lyophilized standard samples can also be located within the reagent container storage mechanism 100, i.e., a second reconstitution dispensing station is formed within the reagent container storage mechanism 100; the aforementioned reconstitution dispensing mechanism is used to perform reconstitution dispensing operations on the standard sample container 20 from the reagent container storage mechanism 100, including: the reconstitution dispensing mechanism is used to perform reconstitution dispensing operations on the standard sample container 20 located at the second reconstitution dispensing station. To reduce the impact of the low-temperature environment inside the reagent container storage mechanism 100 on the reconstitution efficiency of lyophilized standard samples, in the improved scheme, the interior of the reagent container storage mechanism 100 can be divided into different temperature zones, such as a refrigeration zone and a reconstitution zone, with the temperature of the reconstitution zone being higher than that of the refrigeration zone, and the second reconstitution dispensing station located in the reconstitution zone.

[0120] Reference Figure 1 As shown, in one embodiment, the sample analysis device 10 further includes a first incubation mechanism 600 and a first transfer mechanism 500. The first transfer mechanism 500 is used to transfer the standard sample container 20 after the reconstitution solution dispensing operation to the first incubation mechanism 600 for incubation processing. The first incubation mechanism 600 is mainly used to hold the standard sample container 20 after the reconstitution solution dispensing operation for reconstitution. In this embodiment, transferring the standard sample container 20 after the reconstitution solution dispensing operation to the first incubation mechanism 600 for incubation processing can help avoid the standard sample container 20 occupying the first reconstitution solution dispensing position 11.

[0121] In one implementation, the first incubation mechanism 600 is equipped with a heating element, which can heat and control the temperature of the standard sample container 20 in the first incubation mechanism 600, thereby improving the reconstitution efficiency of the lyophilized standard sample. Of course, in specific applications, as an alternative implementation, the first incubation mechanism 600 may not be equipped with a heating element, and the lyophilized standard sample in the standard sample container 20 may be naturally rewarmed and reconstituted in the first incubation mechanism 600 under natural temperature conditions.

[0122] In one implementation, the first incubation mechanism 600 is provided with a plurality of first receiving holes, each first receiving hole being used to receive a standard sample container 20 for incubation. The plurality of first receiving holes specifically refers to at least two first receiving holes. In this embodiment, providing a plurality of first receiving holes in the first incubation mechanism 600 facilitates the parallel incubation of multiple standard sample containers 20 after reconstitution dispensing, thereby improving the reconstitution efficiency of batch lyophilized standard samples. Of course, in specific applications, as an alternative implementation, the number of first receiving holes can also be one.

[0123] In the above scheme, the transfer of the standard sample container 20 between the reagent container storage mechanism 100 and the first reconstitution solution dispensing position 11, and the transfer of the standard sample container 20 between the first reconstitution solution dispensing position 11 and the first incubation mechanism 600, are performed by the same transfer mechanism, which can help reduce the cost and volume of the sample analysis device 10. Of course, in specific applications, as an alternative implementation scheme, the transfer of the standard sample container 20 between the reagent container storage mechanism 100 and the first reconstitution solution dispensing position 11, and the transfer of the standard sample container 20 between the first reconstitution solution dispensing position 11 and the first incubation mechanism 600, can also be performed by two different transfer mechanisms.

[0124] Reference Figure 1 As shown, in one embodiment, the sample analysis device 10 further includes a second incubation mechanism 700 and a second transfer mechanism 101. The second transfer mechanism 101 is used to transfer a first reaction container containing liquid standard samples dispensed by the standard sample dispensing mechanism to the second incubation mechanism 700 for incubation processing, and to transfer a second reaction container containing samples dispensed by the sample dispensing mechanism 200 to the second incubation mechanism 700 for incubation processing. The second incubation mechanism 700 is mainly used to hold the reaction container for incubating liquids containing at least the sample or liquid standard sample, thereby improving the detection efficiency of the sample and liquid standard sample.

[0125] In one embodiment, the second incubation mechanism 700 is provided with a plurality of second receiving holes, each second receiving hole being used to accommodate a reaction vessel for incubation. In this embodiment, providing a plurality of second receiving holes in the second incubation mechanism 700 facilitates the placement of multiple reaction vessels in the second incubation mechanism 700 for parallel incubation, thereby improving the determination efficiency of batch samples and liquid standard samples.

[0126] In one implementation, the first incubation mechanism 600 and the second incubation mechanism 700 are two independently configured mechanisms, meaning they are two different incubation mechanisms. The first incubation mechanism 600 is mainly used to carry the standard sample container 20 after the reconstitution dispensing operation for reconstitution, while the second incubation mechanism 700 is mainly used to carry the reaction container after sample dispensing or liquid standard sample dispensing for incubation. Therefore, the incubation objects are different, and the temperature control conditions will also differ. Separating the first incubation mechanism 600 and the second incubation mechanism 700 independently reduces the manufacturing and control difficulty of the incubation mechanisms. Furthermore, it ensures that the transport of the standard sample container 20 and the transport of the reaction container do not interfere with each other, thus guaranteeing the continuous and stable operation of the sample analysis equipment 10. Of course, in specific applications, as an alternative implementation, the first incubation mechanism 600 and the second incubation mechanism 700 can be set as the same incubation mechanism. To meet the assembly requirements of the reaction vessel and the standard sample container 20, a first receiving hole and a second receiving hole can be set on the same incubation mechanism, or only one receiving hole can be set, and at least one of the reaction vessel and the standard sample container 20 can be accommodated in the receiving hole through the adapter 40. In order to meet the temperature control requirements of incubation during the reconstitution of lyophilized standard samples and the temperature control requirements of incubation during sample determination, different temperature control conditions or different temperature control zones can be set on the same incubation mechanism.

[0127] Reference Figure 1 As shown, in one embodiment, the sample analysis device 10 further includes a mixing mechanism 800. The mixing mechanism 800 is used to perform a mixing action on the standard sample container 20 after the reconstitution solution dispensing operation, so as to mix the liquid standard sample formed by the reconstitution of the lyophilized standard sample in the standard sample container 20. In this embodiment, by using the mixing mechanism 800 to perform a mixing action on the standard sample container 20 after the reconstitution solution dispensing operation, the dissolution of the lyophilized standard sample can be accelerated and its concentration distribution can be made uniform, thereby facilitating the speed of reconstitution of the lyophilized standard sample and ensuring the sufficiency and efficiency of reconstitution.

[0128] In one implementation, the mixing mechanism 800 performs a mixing action on the standard sample container 20 after the reconstituted solution dispensing operation by at least one of the following methods: driving the standard sample container 20 to rotate and / or vibrate, performing suction and discharge actions on the liquid standard sample in the standard sample container 20, blowing air into the liquid standard sample in the standard sample container 20, performing a stirring action on the liquid standard sample in the standard sample container 20, and performing an ultrasonic mixing action on the liquid standard sample in the standard sample container 20. Specifically, the mixing mechanism 800 performs a mixing operation on the liquid in the standard sample container 20 by at least one of the following methods: shaking mixing, inverting mixing, vibration mixing, suction and discharge mixing, blowing air bubble mixing, stirring mixing, and ultrasonic mixing.

[0129] Reference Figure 1 , Figure 3 and Figure 5As shown, in one embodiment, when the sample analysis device 10 has a first reconstitution solution dispensing position 11 located outside the reagent container storage mechanism 100, the control device is further configured to: when a first preset condition is met, control the first transfer mechanism 500 to transfer the standard sample container 20 containing the lyophilized standard sample from the reagent container storage mechanism 100 to the first reconstitution solution dispensing position 11; control the reconstitution solution dispensing mechanism to perform a reconstitution solution dispensing action on the standard sample container 20 located at the first reconstitution solution dispensing position 11; control the first transfer mechanism 500 to transfer the standard sample container 20 after the reconstitution solution dispensing action from the reconstitution solution dispensing position to the first incubation mechanism 600 to perform a first incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20 after the first incubation treatment from the first incubation mechanism 600 to the mixing mechanism 800; control the mixing mechanism 800 to perform a mixing action on the standard sample container 20 after the first incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20 after the mixing action from the first incubation mechanism 600 to the first incubation mechanism 600. The mixing mechanism 800 transfers the sample to the first incubation mechanism 600 to perform a second incubation treatment; the first transfer mechanism 500 is controlled to transfer the standard sample container 20, after the second incubation treatment, from the first incubation mechanism 600 to the aspiration position; the standard sample dispensing mechanism is controlled to aspirate at least a portion of the liquid standard sample contained in the standard sample container 20 located at the aspiration position and dispense it into the first reaction container; the second transfer mechanism 101 is controlled to transfer the first reaction container, after the liquid standard sample dispensing is completed, to the second incubation mechanism 700 to perform a third incubation treatment; the reagent dispensing mechanism 300 is controlled to aspirate at least a portion of the reagent from the reagent container storage mechanism 100 and dispense all or part of the aspirated reagent into the first reaction container, after the third incubation treatment is completed; the measuring mechanism 400 is controlled to measure the first reaction solution in the first reaction container, which is made of at least the liquid standard sample and the reagent, to obtain reference detection data; wherein, the aspiration position and the first reconstituted solution dispensing position 11 are located at the same position or at two different positions. The first incubation treatment involves placing the standard sample container 20 in the first incubation mechanism 600 and allowing it to stand for a period of time. The first preset condition is the condition for performing the standard sample detection. In this embodiment, when it is necessary to determine the standard sample, the lyophilized standard sample is first transferred to the first reconstitution solution dispensing position 11 located outside the reagent container storage mechanism 100. Then, the reconstitution solution is dispensed into the lyophilized standard sample, and the mixture of the lyophilized standard sample and the reconstitution solution is subjected to the first incubation treatment. Then, the liquid after the first incubation treatment is mixed, and then the mixed liquid is subjected to the second incubation treatment. In this way, the automatic reconstitution of the lyophilized standard sample is completed. The reconstituted liquid standard sample is transferred to the liquid absorption position, and subsequent liquid standard sample dispensing, reaction, and determination can continue. The first incubation treatment is mainly used to dissolve the lyophilized standard sample in the standard sample container 20 under the action of the reconstitution solution.The second incubation process is mainly used to dissolve air bubbles in the liquid standard sample. The first receiving hole used for the second incubation process in the same standard sample container 20 can be the same as the first receiving hole used for the first incubation process, or they can be two different first receiving holes. In this embodiment, reusing the first incubation mechanism 600 to perform both the first and second incubation processes helps reduce the number of incubation mechanisms and improves the structural compactness of the sample analysis device 10. Of course, in specific applications, as an alternative implementation, the first and second incubation processes can also be performed in different incubation mechanisms.

[0130] In one implementation, the first preset condition is a condition pre-stored in the sample analysis device 10 for triggering the control device to automatically control the execution of standard sample testing items. In this implementation, the control device automatically triggers the execution of standard sample testing items according to the pre-stored first preset condition, without the need for manual intervention, thus reducing the workload of operators. Of course, in specific applications, as an alternative implementation, the standard sample testing items can also be set to be manually triggerable.

[0131] In one implementation, when the lyophilized standard sample is a lyophilized quality control product and the reference test data is quality control data, the sample analysis device 10 pre-stores at least one of the following first preset conditions: reaching a first preset time point of a first preset cycle; the cumulative running time of the sample analysis device 10 since the last quality control item measurement reaching a first preset time; the number of consecutive sample measurements by the sample analysis device 10 reaching a first preset number; the cumulative number of sample measurements by the sample analysis device 10 since the last quality control item measurement reaching a second preset number; replacing the reagent container 30 to supply reagents; and obtaining information on the execution of the quality control item according to the instructions input by the operator through the human-machine interface device. The control device is configured to control the execution of the quality control item when any one or more of the first preset conditions are met. The first preset conditions pre-stored in the sample analysis device 10 can be one or more; when the sample analysis device 10 pre-stores two or more first preset conditions, the control device controls the execution of the quality control item when any one of the first preset conditions is met. In this implementation plan, the execution of quality control items will not take up the time of the sample measurement cycle, and will be automatically executed according to the set program when the first preset condition is met. This makes it easy for operators to be unaware of the execution process of quality control items, and greatly reduces the interference of the quality control measurement process on operators.

[0132] In one implementation, the first preset period is daily. The first preset time point of the first preset period is 7:00 AM, 7:30 AM, 8:00 AM, 8:30 AM, 9:00 AM, or 9:30 AM daily. Of course, in specific applications, the setting of the first preset time point of the first preset period is not limited to this. It can be flexibly set according to the usage of the sample analysis equipment 10 in the specific application scenario. For example, it can also be two days, three days, four days, five days, six days, or one week.

[0133] In one implementation, the duration of the first incubation treatment is different from the duration of the second incubation treatment.

[0134] Reference Figure 1 , Figure 3 and Figure 5 As shown, in one embodiment, after the control standard sample dispensing mechanism draws at least a portion of the liquid standard sample contained in the standard sample container 20 located at the aspiration position and dispenses it into the first reaction vessel, the control device is further configured to: control the first transfer mechanism 500 to transfer the standard sample container 20, after the liquid standard sample dispensing is completed, from the aspiration position to the reagent container storage mechanism 100 for storage. In this embodiment, after the liquid standard sample formed by reconstitution of lyophilized standard sample has completed the liquid standard sample dispensing task for the current standard sample detection project, if there is no standard sample detection project that requires the use of this liquid standard sample, the liquid standard sample is first transferred to the reagent container storage mechanism 100 for storage. That is, the reagent container storage mechanism 100 is reused to store the liquid standard sample formed by reconstitution of lyophilized standard sample, thereby helping to prevent the liquid standard sample from deteriorating.

[0135] Reference Figure 1 , Figure 3 and Figure 6As shown, in one embodiment, after the first transfer mechanism 500 transfers the standard sample container 20 containing the liquid standard sample to the reagent container storage mechanism 100 for storage, the control device is further configured to: when the first preset condition is met again, determine whether the standard sample container 20 containing the liquid standard sample, which has been transferred from the aspiration position to the reagent container storage mechanism 100, meets the second preset condition; if so, control the reconstitution device to transfer the standard sample container 20 that meets the second preset condition to the first incubation mechanism 600 to perform the first incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20, which has completed the first incubation treatment, from the first incubation mechanism 600 to the mixing mechanism 800; control the mixing mechanism 800 to perform a mixing action on the standard sample container 20, which has completed the first incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20, which has completed the mixing action, from the mixer... The first incubation unit 800 is transferred to the first incubation unit 600 to perform a second incubation treatment; the first transfer unit 500 is controlled to transfer the standard sample container 20 after the second incubation treatment from the first incubation unit 600 to the liquid aspiration position; the standard sample dispensing unit is controlled to aspirate at least a portion of the liquid standard sample contained in the standard sample container 20 located at the liquid aspiration position and dispense it to another first reaction container; the second transfer unit 101 is controlled to transfer the first reaction container after the liquid standard sample dispensing is completed to the second incubation unit 700 to perform a third incubation treatment; the reagent dispensing unit 300 is controlled to aspirate at least a portion of the reagent from the reagent container 30 from the reagent container storage unit 100 and dispense all or part of the aspirated reagent to the first reaction container after the third incubation treatment is completed; the measuring unit 400 is controlled to measure the first reaction solution in the first reaction container, which is at least made of liquid standard sample and reagent, to obtain reference detection data. In this implementation plan, when the first preset condition is met and a standard sample testing item needs to be performed, the liquid standard sample in the reagent container storage mechanism 100 is first checked to see if the second preset condition is met. If the second preset condition is met, the liquid standard sample is preferentially retrieved for testing to avoid wasting the liquid standard sample. If the second preset condition is not met, the lyophilized standard sample needs to be reconstituted.

[0136] As one implementation method, the second preset condition is that the volume of liquid standard sample loaded in the standard sample container 20 is greater than or equal to the required amount of liquid standard sample for one standard sample testing item (one quality control item or one calibration item). In this implementation method, when the first preset condition is met and a standard sample testing item needs to be performed, the remaining amount of liquid standard sample stored in the reagent container storage mechanism 100 is first checked. If the remaining amount is sufficient, the liquid standard sample is preferentially transferred out for testing to avoid waste of liquid standard sample; if the remaining amount is insufficient, the lyophilized standard sample needs to be reconstituted.

[0137] As an alternative implementation to the aforementioned second preset condition, the second preset condition is: the volume of liquid standard sample loaded in the standard sample container 20 is greater than or equal to the required amount of liquid standard sample for one standard sample testing item (one quality control item or one calibration item), and the liquid standard sample in the standard sample container 20 is within its expiration date. In this implementation, in addition to sufficient remaining quantity, the second preset condition also requires that the sample be within its expiration date. Thus, in specific applications, when the first preset condition is met and a standard sample testing item needs to be performed, it is first checked whether the liquid standard sample in the standard sample container 20 stored in the reagent container storage mechanism 100 is within its expiration date and whether the remaining quantity is sufficient. If it is within its expiration date and the remaining quantity is sufficient, the liquid standard sample in the standard sample container 20 is preferentially retrieved for testing; if it is past its expiration date or the remaining quantity is insufficient, the lyophilized standard sample needs to be reconstituted.

[0138] In one embodiment, the reagent container storage mechanism 100 is also used to store a reconstitution solution container containing the reconstitution solution. The aforementioned reconstitution solution dispensing mechanism performs a reconstitution solution dispensing operation on a standard sample container 20 containing lyophilized standard samples from the reagent container storage mechanism 100. This includes: the reconstitution solution dispensing mechanism drawing at least a portion of the reconstitution solution from the reconstitution solution container located within the reagent container storage mechanism 100, and dispensing all or part of the drawn reconstitution solution into the standard sample container 20 containing the lyophilized standard samples. In this embodiment, the reagent container storage mechanism 100 is also reused to store a reconstitution solution container containing the reconstitution solution. This eliminates the need for an additional storage mechanism within the sample analysis device 10 to store the reconstitution solution container, thereby improving the structural compactness of the sample analysis device 10.

[0139] Of course, in specific applications, the reconstitution solution is not limited to being stored within the reagent container storage mechanism 100. For example, as an alternative implementation, the sample analysis device 10 has a reconstitution solution buffer space independent of the reagent container storage mechanism 100. This buffer space is used to store reconstitution solution containers containing the reconstitution solution. The aforementioned reconstitution solution dispensing mechanism performs a reconstitution solution dispensing action on the standard sample container 20 containing lyophilized standard samples from the reagent container storage mechanism 100. This includes: the reconstitution solution dispensing mechanism drawing at least a portion of the reconstitution solution from the reconstitution solution container located in the reconstitution solution buffer space and dispensing all or part of the drawn reconstitution solution into the standard sample container 20 containing the lyophilized standard samples. The reconstitution solution buffer space is independent of the reagent container storage mechanism 100, that is, it is located outside the reagent container storage mechanism 100. In this alternative implementation, the sample analysis device 10 has a separate reconstitution solution buffer space for storing reconstitution solution containers containing the reconstitution solution. The reconstitution solution containers containing the reconstitution solution can be manually placed in the reconstitution solution buffer space by an operator; or they can be scheduled and placed in the reconstitution solution buffer space by a scheduling mechanism.

[0140] Reference Figure 3 As shown, in one embodiment, the reagent container storage mechanism 100 has a plurality of first receiving slots adapted to the reagent container 30, and the standard sample container 20 is placed in the first receiving slot via an adapter 40 adapted to the first receiving slot. Since the standard sample container 20 and the reagent container 30 differ in shape, this embodiment allows the standard sample container 20 to be loaded into the first receiving slot of the reagent container storage mechanism 100 via the adapter 40 without modifying the reagent container storage mechanism 100.

[0141] Of course, in specific applications, the loading method of the standard sample container 20 in the reagent container storage mechanism 100 is not limited to the above scheme. For example, refer to Figure 4 As shown, as an alternative implementation, the reagent container storage mechanism 100 has multiple first receiving slots adapted to reagent containers 30 and multiple second receiving slots adapted to standard sample containers 20, the second receiving slots having a different shape and / or size than the first receiving slots. Specifically, the reagent container storage mechanism 100 has at least one base 110, and each base 110 has at least one second receiving slot. That is, the base 110 on the reagent container storage mechanism 100 is specifically designed for the standard sample containers 20, and the standard sample containers 20 can be directly loaded into the second receiving slots of the base 110 without the use of the adapter 40. In this alternative implementation, the reagent container storage mechanism 100 is provided with at least two types of receiving slots, one of which is used to directly load reagent containers 30, and the other is used to directly load standard sample containers 20, without the need for the adapter 40. As a further implementation, the first receiving slots and the second receiving slots can be separated to facilitate the management of reagent containers 30 and standard sample containers 20.

[0142] In one implementation, the reagent container storage mechanism 100 is also used to place reagent containers 30 containing reagents for reagent loading, and to place standard sample containers 20 containing lyophilized standard samples for lyophilized standard sample loading. In this embodiment, the standard sample containers 20 containing lyophilized standard samples and the reagent containers 30 containing reagents are directly loaded and stored in the reagent container storage mechanism 100. In specific applications, the standard sample containers 20 containing lyophilized standard samples and the reagent containers 30 containing reagents can be placed in the reagent container storage mechanism 100 by an operator or by an automated operating device such as a robotic arm to load the lyophilized standard samples and reagents.

[0143] In one implementation, the reagent container storage mechanism 100 is also used to place the standard sample container 20 containing the liquid standard sample for loading the liquid standard sample. In this embodiment, the reagent container storage mechanism 100 can be used for loading both lyophilized standard samples and liquid standard samples. Of course, in specific applications, as an alternative implementation, the liquid standard sample can also be loaded at other locations and then transferred to the reagent container storage mechanism 100 by other transfer mechanisms; or, as another alternative implementation, the sample analysis device 10 can also be configured to only load lyophilized standard samples and not liquid standard samples.

[0144] In the above scheme, the standard sample container 20 containing the lyophilized standard sample and the reagent container 30 containing the reagent are directly loaded into the reagent container storage mechanism 100. Of course, in specific applications, the loading method for reagents and lyophilized standard samples is not limited to this. For example, refer to... Figure 2 As shown, as an alternative implementation, the sample analysis device 10 further includes a reagent loading mechanism 104 and a third transfer mechanism 105. The reagent loading mechanism 104 is used to place a reagent container 30 containing reagents for reagent loading, and to place a standard sample container 20 containing lyophilized standard samples for lyophilized standard sample loading. The third transfer mechanism 105 is used to transfer the reagent container 30 containing reagents from the reagent loading mechanism 104 to the reagent container storage mechanism 100, and to transfer the standard sample container 20 containing lyophilized standard samples from the reagent loading mechanism 104 to the reagent container storage mechanism 100. The reagent loading mechanism 104 is set independently of the reagent container storage mechanism 100, that is, the reagent loading mechanism 104 and the reagent container storage mechanism 100 are two different mechanisms. The reagent loading mechanism 104 can be disc-shaped or other shapes. The standard sample container 20 containing lyophilized standard samples and the reagent container 30 containing reagents can be placed in the reagent loading mechanism 104 by an operator or an automated device such as a robotic arm to load the lyophilized standard samples and reagents. A third transfer mechanism 105 is used to transfer the reagent container 30 and the standard sample container 20 between the reagent container storage mechanism 100 and the reagent loading mechanism 104. In this embodiment, a separate reagent loading mechanism 104 is provided for loading reagents and lyophilized standard samples, which helps to reduce the impact of reagent and lyophilized standard sample loading on reagent dispensing, reagent refrigeration, and lyophilized standard sample refrigeration.

[0145] In one embodiment, the sample analysis device 10 has a first reconstituted solution dispensing position 11 located outside the reagent container storage mechanism 100. The reagent container storage mechanism 100 includes a reagent tray and a first driving mechanism. The sample analysis device 10 also includes a first transfer mechanism 500. The reagent tray is used to store a reagent container 30 containing reagents and a standard sample container 20 containing lyophilized standard samples. The first driving mechanism is used to drive the reagent tray to rotate so that the reagent container 30 containing reagents rotates to the reagent aspiration position and to drive the reagent tray to rotate so that the standard sample container 20 containing lyophilized standard samples rotates to the transfer position. The reagent dispensing mechanism 300 is used to aspirate at least a portion of the reagent from the reagent container 30 located at the reagent aspiration position and to dispense all or part of the aspirated reagent into the first reaction container. The first transfer mechanism 500 is used to transfer the standard sample container 20 located at the transfer position to the first reconstituted solution dispensing position 11. The reconstituted solution dispensing mechanism is used to perform a reconstituted solution dispensing operation on the standard sample container 20 located at the first reconstituted solution dispensing position 11. In this embodiment, the reagent tray is a rotatable structure. Driven by the first driving mechanism, the reagent container 30 and the standard sample container 20 on the tray can rotate to different positions, such as the reagent aspiration position and the transfer position. The reagent dispensing device is used to aspirate at least a portion of the reagent from the reagent container 30 located at the reagent aspiration position and to dispense all or part of the aspirated reagent into the reaction vessel. In this embodiment, the first transfer mechanism 500 aspirates the reagent at a fixed position and picks up and places the standard sample container 20 onto the reagent tray at a fixed position, thereby simplifying the movement trajectory and stroke of the first transfer mechanism 500.

[0146] In one embodiment, the reagent tray is disc-shaped. The reagent tray has at least one ring of receiving grooves along its circumference, which may include multiple first receiving grooves or multiple first receiving grooves and multiple second receiving grooves. The first receiving grooves are adapted to the reagent container 30, and the second receiving grooves are adapted to the standard sample container 20. Of course, in specific applications, the reagent container 30 can also be of other shapes.

[0147] In one implementation, the reagent tray can rotate the reagent container 30 and the standard sample container 20 on it, so that each container, reagent container 30, and standard sample container 20 rotates to a different position, such as a reagent aspiration position, a reagent container 30 loading position, and a standard sample container 20 loading position. The reagent dispensing device is used to aspirate at least a portion of the reagent from the reagent container 30 located at the reagent aspiration position and dispense all or part of the aspirated reagent into the reaction vessel. Of course, in specific applications, as an alternative implementation, the reagent tray can also be configured as a fixed, non-rotating system.

[0148] In the above scheme, the reagent container storage mechanism 100 can drive the reagent container 30 and the standard sample container 20 thereon to rotate. Of course, in specific applications, the arrangement of the reagent container storage mechanism 100 is not limited to this. For example, as an alternative implementation scheme, the reagent container storage mechanism 100 includes a fixed storage component for storing the reagent container 30 containing reagents and the standard sample container 20 containing lyophilized standard samples. The reagent dispensing mechanism 300 is used to draw at least a portion of the reagents from the reagent containers 30 located at different positions of the fixed storage component and dispense all or part of the drawn reagents into different first reaction containers. The first transfer mechanism 500 is used to transfer the standard sample containers 20 located at different positions of the fixed storage component to the first reconstitution dispensing position 11 located outside the reagent container storage mechanism 100. The reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample containers 20 located at the first reconstitution dispensing position 11. In this alternative embodiment, the sample analysis device 10 also has a first reconstitution dispensing position 11 located outside the reagent container storage mechanism 100; the difference is that the reagent container storage mechanism 100 is a fixed structure, which cannot drive the reagent container 30 and standard sample container 20 on it to rotate. Through the movement of the reagent dispensing mechanism 300, the reagent dispensing mechanism 300 can draw reagents from different reagent containers 30; through the movement of the first transfer mechanism 500, the first transfer mechanism 500 can transfer different standard sample containers 20 out of the reagent container storage mechanism 100 for reconstitution and determination.

[0149] In one implementation, the first reaction vessel and the second reaction vessel are two reaction vessels of the same shape and size. That is, the first reaction vessel and the second reaction vessel are two reaction vessels of the same specifications. Of course, in specific applications, the first reaction vessel and the second reaction vessel can also be two reaction vessels of different shapes and / or sizes.

[0150] Reference Figure 1 and Figure 3As shown, in one embodiment, the sample analysis device 10 further includes a reaction vessel supply mechanism 900, which has one container output channel for outputting a first reaction vessel and a second reaction vessel. A standard sample dispensing mechanism is used to aspirate at least a portion of the liquid standard sample contained in a standard sample container 20 and dispense it into the first reaction vessel output from the container output channel; a sample dispensing mechanism 200 is used to aspirate at least a portion of the test sample contained in a sample container and dispense it into the second reaction vessel output from the container output channel. In this embodiment, the standard sample determination and the test sample determination share the same reaction vessel supply mechanism 900 to supply the reaction vessel, which simplifies the structure of the sample analysis device 10. Of course, in specific applications, the standard sample determination and the test sample determination use different reaction vessel supply mechanisms 900 to supply the reaction vessels. For example, as an alternative embodiment, the sample analysis device 10 includes two reaction vessel supply mechanisms 900, one for outputting the first reaction vessel and the other for outputting the second reaction vessel.

[0151] In one implementation, the reaction vessel is a disposable container, meaning that after carrying the sample and completing the corresponding measurement, the reaction vessel is discarded and recycled without needing to be cleaned and reused within the sample analysis device 10, thus simplifying the structure and operating procedures of the sample analysis device 10. Of course, in specific applications, the reaction vessel can also be cleaned and recycled.

[0152] In one implementation, the second transfer mechanism 101 is used to transfer reaction containers, for example, between a sample loading position, an incubation position, a trigger reagent loading position, a detection position, and a recovery position. The second transfer mechanism 101 may include multiple robotic arms.

[0153] Reference Figure 1 As shown, in one embodiment, the sample analysis device 10 also includes a sample introduction mechanism 102. The sample introduction mechanism 102 includes a loading area, an unloading area, and a suction channel. The loading area is used to place sample containers containing samples to load the samples, and the unloading area is used to store sample containers after the analysis is completed, awaiting retrieval. The suction channel is used to sequentially transport sample containers from the loading area to the suction position and the unloading area. The sample dispensing mechanism 200 is used to aspirate samples from the sample containers located at the suction position.

[0154] In one implementation, the sample is a blood sample. Sample testing data includes coagulation test data. The sample analysis device 10 is a coagulation analysis device used to determine coagulation-related parameters of the sample. The sample analysis device 10 employs at least one method selected from coagulation, immunoturbidimetry, and chromogenic substrate methods to determine coagulation test items in a reaction solution prepared from at least the sample and reagents. The main procedure for the coagulation test includes: adding the sample and reagents (potentially one or more reagents) to a reaction container, mixing and incubating the mixture to prepare a second reaction solution, then illuminating the second reaction container containing the second reaction solution with light emitted from an illumination component, which is received by a light receiving component (e.g., a detector PD), and analyzing the received optical signal (e.g., light intensity) to complete the analysis of the second reaction solution. Of course, in specific applications, the sample analysis device 10 is not limited to a coagulation analysis device; for example, it can also be a biochemical analysis device, an immunoassay device, or a blood cell analysis device.

[0155] Reference Figure 1 and Figure 3 As shown, in one embodiment, the reagent dispensing mechanism 300 includes a mixing reagent dispensing mechanism 310 and a triggering reagent dispensing mechanism 320. The mixing reagent dispensing mechanism 310 is used to draw mixed reagents from the mixing reagent container 30 and dispense them into the reaction vessel, and the triggering reagent dispensing mechanism 320 is used to draw triggering reagents from the triggering reagent container 30 and dispense them into the reaction vessel. The mixing reagent dispensing mechanism 310 and the triggering reagent dispensing mechanism 320 are arranged independently of each other and can operate in parallel, so that the mixing reagent dispensing operation of one reaction vessel can be performed simultaneously with the triggering reagent dispensing operation of another reaction vessel. Of course, in specific applications, as an alternative embodiment, the mixing reagent dispensing operation and the triggering reagent dispensing operation can also be performed by the same reagent dispensing mechanism.

[0156] In one embodiment, the mixing reagent dispensing mechanism 310 includes a mixing reagent needle, a second suction / dispensing driving component for driving the mixing reagent needle to aspirate and dispense the mixed reagent, and a second motion driving component for driving the mixing reagent needle to perform spatial movement. The triggering reagent dispensing mechanism 320 includes a triggering reagent needle, a third suction / dispensing driving component for driving the triggering reagent needle to aspirate and dispense the triggering reagent, and a third motion driving component for driving the triggering reagent needle to perform spatial movement.

[0157] In one implementation, each coagulation test includes at least a sample addition period, an incubation period, a trigger reagent period, and a measurement period, performed sequentially. During the sample addition period, the control device controls the sample addition operation. During the incubation period, the control device controls the incubation operation. During the trigger reagent period, the control device controls the addition of the trigger reagent. During the measurement period, the control device controls the measurement operation.

[0158] In one implementation, each coagulation test includes a cup-discarding period after the measurement period. That is, each coagulation test includes a sample addition period, an incubation period, a trigger reagent period, a measurement period, and a cup-discarding period, performed sequentially. During the cup-discarding period, the control device controls the discarding of the reaction vessel after the measurement is completed.

[0159] In one implementation, the coagulation tests that the sample analysis device 10 can perform include, but are not limited to: prothrombin (PT), activated partial thromboplastin (APTT), fibrinogen (FIB), thrombin (TT), and antithrombin III (ATIII). Among these, the activated partial thromboplastin (APTT) test is a multi-reagent assay, requiring the addition of mixed reagents during incubation to prepare the reaction solution.

[0160] In one implementation, the sample analysis device 10 is a standalone sample analyzer. Alternatively, the sample analysis device 10 may also be a sample analysis pipeline or a sample cascade system.

[0161] The sample analysis device 10 provided in the first aspect of the present invention not only realizes the automated reconstitution and determination of freeze-dried standard samples, but also has the advantages of high integration, low cost and low space occupation, which is conducive to the promotion and application of the sample analysis device 10 in laboratories, medical institutions and other occasions.

[0162] A second aspect of this invention provides a control method for a sample analysis device 10, comprising the following standard sample testing process: controlling a reconstitution dispensing mechanism to perform a reconstitution dispensing action on a standard sample container 20 containing lyophilized standard samples from a reagent container storage mechanism 100, so as to reconstitute the lyophilized standard samples into liquid standard samples using a reconstitution solution; controlling a standard sample dispensing mechanism to draw at least a portion of the liquid standard samples contained in the standard sample container 20 and dispensing all or part of the drawn liquid standard samples into a first reaction container; controlling a reagent dispensing mechanism 300 to draw at least a portion of the reagents from a reagent container 30 from the reagent container storage mechanism 100 and dispensing all or part of the drawn reagents into a first reaction container. All or part of the solution is distributed into the first reaction vessel; the control and measurement mechanism 400 measures the first reaction solution in the first reaction vessel, which is made of at least a liquid standard sample and a reagent, to obtain reference detection data; based on the reference detection data obtained by the measurement mechanism 400 on the first reaction solution, the detection result of the liquid standard sample is obtained; wherein, the standard sample distribution mechanism and the reagent distribution mechanism 300 are the same mechanism, or the standard sample distribution mechanism is set independently of the reagent distribution mechanism 300; the reconstitution solution dispensing mechanism is the same mechanism as at least one of the reagent distribution mechanism 300 and the standard sample distribution mechanism, or the reconstitution solution dispensing mechanism is set independently of the reagent distribution mechanism 300 and independently of the standard sample distribution mechanism.

[0163] As one implementation, before the control reconstitution dispensing mechanism performs the reconstitution dispensing action on the standard sample container 20 containing the lyophilized standard sample from the reagent container storage mechanism 100, the control method further includes: when a first preset condition is met, controlling the first transfer mechanism 500 to transfer the standard sample container 20 containing the lyophilized standard sample from the reagent container storage mechanism 100 to the first reconstitution dispensing position 11 located outside the reagent container storage mechanism 100.

[0164] As one implementation, the above-mentioned control reconstitution dispensing mechanism performs a reconstitution dispensing operation on a standard sample container 20 containing lyophilized standard samples from a reagent container storage mechanism 100, including: controlling the reconstitution dispensing mechanism to perform a reconstitution dispensing operation on the standard sample container 20 located at the first reconstitution dispensing position 11.

[0165] As one implementation, after the control reconstitution dispensing mechanism performs a reconstitution dispensing operation on the standard sample container 20 containing lyophilized standard samples from the reagent container storage mechanism 100, and before the control standard sample dispensing mechanism aspirates at least a portion of the liquid standard samples contained in the standard sample container 20 and dispenses all or part of the aspirated liquid standard samples into the first reaction container, the control method further includes: controlling the first transfer mechanism 500 to transfer the standard sample container 20, after the reconstitution dispensing operation has been completed, from the first reconstitution dispensing position 11 to the first incubation mechanism 600, to perform... First incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20 after the first incubation treatment from the first incubation mechanism 600 to the mixing mechanism 800; control the mixing mechanism 800 to perform a mixing action on the standard sample container 20 after the first incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20 after the mixing action from the mixing mechanism 800 to the first incubation mechanism 600 to perform the second incubation treatment; control the first transfer mechanism 500 to transfer the standard sample container 20 after the second incubation treatment from the first incubation mechanism 600 to the liquid aspiration position.

[0166] In one embodiment, the above-mentioned control standard sample dispensing mechanism draws at least a portion of the liquid standard sample contained in the standard sample container 20 and dispenses all or part of the drawn liquid standard sample into the first reaction container, including: controlling the standard sample dispensing mechanism to draw at least a portion of the liquid standard sample contained in the standard sample container 20 located at the liquid aspiration position and dispense it into the first reaction container.

[0167] In one embodiment, after the standard sample dispensing mechanism draws at least a portion of the liquid standard sample contained in the standard sample container 20 located at the aspiration position and dispenses it into the first reaction vessel, the control method further includes: controlling the first transfer mechanism 500 to transfer the standard sample container 20, after the liquid standard sample dispensing is completed, from the aspiration position to the reagent container storage mechanism 100 for storage; when the first preset condition is met again, determining whether the standard sample container 20, which has been transferred from the aspiration position to the reagent container storage mechanism 100 and contains the liquid standard sample, meets the second preset condition; if so, controlling the reconstitution device to transfer the standard sample container 20 that meets the second preset condition to the first incubation mechanism 600 to perform the first incubation treatment; controlling the first transfer mechanism 500 to transfer the standard sample container 20, after the first incubation treatment is completed, from the first incubation mechanism 600 to the mixing mechanism 800; controlling the mixing mechanism 800 to... After the first incubation treatment, the standard sample container 20 is mixed. The first transfer mechanism 500 is controlled to transfer the standard sample container 20, after the mixing treatment, from the mixing mechanism 800 to the first incubation mechanism 600 to perform the second incubation treatment. The first transfer mechanism 500 is controlled to transfer the standard sample container 20, after the second incubation treatment, from the first incubation mechanism 600 to the liquid aspiration position. The standard sample dispensing mechanism is controlled to aspirate at least a portion of the liquid standard sample contained in the standard sample container 20 located at the liquid aspiration position and dispense it into another first reaction container. The reagent dispensing mechanism 300 is controlled to aspirate at least a portion of the reagent from the reagent container storage mechanism 100 and dispense all or part of the aspirated reagent into the first reaction container. The measuring mechanism 400 is controlled to measure the first reaction solution in the first reaction container, which is made of at least the liquid standard sample and the reagent, to obtain reference detection data.

[0168] Apart from the above, other parts and principles of the control method of the sample analysis device 10 provided in the second aspect of the present invention can be referred to the control method and principle of the control device in the sample analysis device 10 provided in the first aspect, and will not be described in detail here.

[0169] A third aspect of this invention provides a computer-readable storage medium storing a computer program. When the computer program is executed by a processor (e.g., the controller described above), it causes the processor to implement the steps of the control method for the sample analysis device 10 described above. The computer-readable storage medium may be an internal storage unit of the sample analysis device 10, such as a hard disk or memory of the sample analysis device 10; or it may be an external storage device of the sample analysis device 10, such as a pluggable hard disk, smart media card (SMC), secure digital (SD) card, flash card, etc., provided on the sample analysis device 10.

[0170] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. A sample analysis device, characterized in that: include: A reagent container storage mechanism is used to store reagent containers containing reagents and standard sample containers containing lyophilized standard samples. The reconstitution solution dispensing mechanism is used to perform a reconstitution solution dispensing action on the standard sample container that comes from the reagent container storage mechanism and contains the lyophilized standard sample, so as to reconstitute the lyophilized standard sample to form a liquid standard sample through the reconstitution solution; A standard sample dispensing mechanism is used to draw at least a portion of the liquid standard sample contained in the standard sample container and dispense all or part of the drawn liquid standard sample into a first reaction container; A sample dispensing mechanism for drawing at least a portion of a sample from a sample container and dispensing all or part of the drawn sample into a second reaction container; A reagent dispensing mechanism, the reagent dispensing mechanism being configured to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and dispense all or part of the drawn reagent into the first reaction vessel, and to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and dispense all or part of the drawn reagent into the second reaction vessel; The measuring apparatus is used to measure a first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data, and to measure a second reaction solution in the second reaction vessel, which is made of at least the sample and the reagent, to obtain sample test data; A control device configured to: obtain the detection result of the liquid standard sample based on reference detection data obtained by the measuring mechanism from measuring the first reaction liquid; The control device is further configured to: obtain the test result of the sample based on the sample test data obtained by the measuring mechanism measuring the second reaction solution; Wherein, the standard sample dispensing mechanism is the same as at least one of the sample dispensing mechanism and the reagent dispensing mechanism, or the standard sample dispensing mechanism is set up independently of the sample dispensing mechanism and independently of the reagent dispensing mechanism; The reconstitution dispensing mechanism is the same as at least one of the sample dispensing mechanism, the reagent dispensing mechanism, and the standard sample dispensing mechanism, or the reconstitution dispensing mechanism is set up independently of the sample dispensing mechanism, the reagent dispensing mechanism, and the standard sample dispensing mechanism.

2. The sample analysis device as described in claim 1, characterized in that: The sample analysis device has a first reconstituted solution dispensing position located outside the reagent container storage mechanism; The sample analysis device further includes a first transfer mechanism, which is used to transfer the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism to the first reconstituted solution dispensing position. The reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container from the reagent container storage mechanism, including: the reconstitution dispensing mechanism is used to perform the reconstitution dispensing action on the standard sample container located at the first reconstitution dispensing position; Alternatively, a second reconstituted solution dispensing position may be formed within the reagent container storage mechanism; The reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container from the reagent container storage mechanism, including: the reconstitution dispensing mechanism is used to perform the reconstitution dispensing action on the standard sample container located at the second reconstitution dispensing position.

3. The sample analysis device as described in claim 2, characterized in that: The sample analysis device further includes a mixing mechanism, which is used to perform a mixing action on the standard sample container after the reconstitution dispensing action is completed, so as to mix the liquid standard sample formed by the reconstitution of the lyophilized standard sample in the standard sample container.

4. The sample analysis device as described in claim 3, characterized in that: The mixing mechanism performs a mixing action on the standard sample container after the reconstituted solution dispensing action is completed by at least one of the following methods: driving the standard sample container to rotate and / or vibrate, performing suction and discharge actions on the liquid standard sample in the standard sample container, blowing air into the liquid standard sample in the standard sample container, performing stirring actions on the liquid standard sample in the standard sample container, and performing ultrasonic mixing actions on the liquid standard sample in the standard sample container.

5. The sample analysis device as described in claim 3, characterized in that: The sample analysis equipment further includes a first incubation mechanism, a first transfer mechanism, a second incubation mechanism, and a second transfer mechanism; The first transfer mechanism is used to transfer the standard sample container after the reconstitution solution dispensing operation is completed to the first incubation mechanism for incubation treatment; The second transfer mechanism is used to transfer the first reaction container, which is loaded with liquid standard sample after being dispensed by the standard sample dispensing mechanism, to the second incubation mechanism for incubation treatment, and to transfer the second reaction container, which is loaded with sample after being dispensed by the sample dispensing mechanism, to the second incubation mechanism for incubation treatment; The first incubation institution and the second incubation institution are either two independently established institutions or the same institution.

6. The sample analysis device as described in claim 5, characterized in that: When the sample analysis device forms a first reconstituted solution dispensing position located outside the reagent container storage mechanism, the control device is further configured to: When the first preset condition is met, the first transfer mechanism is controlled to transfer the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism to the first reconstitution solution dispensing position; The reconstitution solution dispensing mechanism is controlled to perform a reconstitution solution dispensing action on the standard sample container located at the first reconstitution solution dispensing position; The first transfer mechanism is controlled to transfer the standard sample container, after the reconstitution solution dispensing action has been completed, from the reconstitution solution dispensing position to the first incubation mechanism to perform the first incubation process; The first transfer mechanism is controlled to transfer the standard sample container, after the first incubation treatment has been completed, from the first incubation mechanism to the mixing mechanism; The mixing mechanism is controlled to perform a mixing action on the standard sample container after the first incubation treatment is completed; The first transfer mechanism is controlled to transfer the standard sample container, after the mixing action is completed, from the mixing mechanism to the first incubation mechanism to perform the second incubation process; The first transfer mechanism is controlled to transfer the standard sample container, after completing the second incubation treatment, from the first incubation mechanism to the liquid aspiration position; The standard sample dispensing mechanism is controlled to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into the first reaction vessel; The second transfer mechanism is controlled to transfer the first reaction vessel, after the liquid standard sample has been dispensed, to the second incubation mechanism to perform the third incubation process; The reagent dispensing mechanism is controlled to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and to dispense all or part of the drawn reagent into the first reaction vessel after the third incubation treatment has been completed; The measuring mechanism is controlled to measure the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data; The liquid absorption position and the first reconstituted solution dispensing position are located at the same location or at two different locations.

7. The sample analysis device as described in claim 6, characterized in that: After the control device draws at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispenses it into the first reaction vessel, the control device is further configured to: The first transfer mechanism is controlled to transfer the standard sample container, after the liquid standard sample has been dispensed, from the liquid aspiration position to the reagent container storage mechanism for storage.

8. The sample analysis device as described in claim 7, characterized in that: After the first transfer mechanism transfers the standard sample container, after the liquid standard sample has been dispensed, to the reagent container storage mechanism for storage, the control device is further configured to: When the first preset condition is met again, it is determined whether the standard sample container that has been transferred from the aspiration position to the reagent container storage mechanism and contains the liquid standard sample meets the second preset condition. If so, the reconstitution device is controlled to transfer the standard sample container that meets the second preset condition to the first incubation mechanism to perform the first incubation process; The first transfer mechanism is controlled to transfer the standard sample container, after the first incubation treatment has been completed, from the first incubation mechanism to the mixing mechanism; The mixing mechanism is controlled to perform a mixing action on the standard sample container after the first incubation treatment is completed; The first transfer mechanism is controlled to transfer the standard sample container, after the mixing action is completed, from the mixing mechanism to the first incubation mechanism to perform the second incubation process; The first transfer mechanism is controlled to transfer the standard sample container, after completing the second incubation treatment, from the first incubation mechanism to the liquid aspiration position; The standard sample dispensing mechanism is controlled to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into another first reaction container; The second transfer mechanism is controlled to transfer the first reaction vessel, after the liquid standard sample has been dispensed, to the second incubation mechanism to perform the third incubation process; The reagent dispensing mechanism is controlled to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and to dispense all or part of the drawn reagent into the first reaction vessel after the third incubation treatment has been completed; The measuring mechanism is controlled to measure the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data; The second preset condition is that the volume of liquid standard sample loaded in the standard sample container is greater than or equal to the amount of liquid standard sample required for a standard sample testing item.

9. The sample analysis device according to any one of claims 6 to 8, characterized in that: The lyophilized standard sample is a lyophilized quality control product, and the reference test data is quality control data. The sample analysis device is pre-stored with at least one of the following first preset conditions: reaching a first preset time point of a first preset cycle; the cumulative running time of the sample analysis device since the last quality control item measurement has reached a first preset time; the number of times the sample analysis device continuously measures the sample to be tested has reached a first preset number; the cumulative number of times the sample analysis device cumulatively measures the sample to be tested since the last quality control item measurement has reached a second preset number; the reagent container is replaced to supply reagents; and the information on the quality control item is obtained according to the instructions input by the operator through the human-computer interaction device.

10. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The reagent container storage mechanism is also used to store a reconstituted solution container containing the reconstituted solution. The reconstituted solution dispensing mechanism performs a reconstituted solution dispensing action on the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism, including: the reconstituted solution dispensing mechanism draws at least a portion of the reconstituted solution from the reconstituted solution container located in the reagent container storage mechanism, and dispenses all or part of the drawn reconstituted solution into the standard sample container containing the lyophilized standard sample; Alternatively, the sample analysis device may have a reconstitution buffer space independent of the reagent container storage mechanism. The reconstitution buffer space is used to store a reconstitution container containing the reconstitution solution. The reconstitution dispensing mechanism performs a reconstitution dispensing action on the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism, including: the reconstitution dispensing mechanism draws at least a portion of the reconstitution solution from the reconstitution container located in the reconstitution buffer space, and dispenses all or part of the drawn reconstitution solution into the standard sample container containing the lyophilized standard sample.

11. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The reagent container storage mechanism has a plurality of first receiving slots adapted to the reagent container, and the standard sample container is placed in the first receiving slot through an adapter adapted to the first receiving slot; Alternatively, the reagent container storage mechanism may have a plurality of first receiving slots adapted to the reagent container and a plurality of second receiving slots adapted to the standard sample container, wherein the second receiving slots are different in shape and / or size from the first receiving slots.

12. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The reagent container storage mechanism is also used to place the reagent container containing the reagent to realize the loading of the reagent, and to place the standard sample container containing the lyophilized standard sample to realize the loading of the lyophilized standard sample.

13. The sample analysis device as described in claim 12, characterized in that: The reagent container storage mechanism is also used to place the standard sample container containing the liquid standard sample to realize the feeding of the liquid standard sample.

14. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The sample analysis device further includes a reagent loading mechanism and a third transfer mechanism. The reagent loading mechanism is used to place the reagent container containing the reagent to realize the loading of the reagent, and to place the standard sample container containing the lyophilized standard sample to realize the loading of the lyophilized standard sample. The third transfer mechanism is used to transfer the reagent container containing the reagent from the reagent feeding mechanism to the reagent container storage mechanism, and to transfer the standard sample container containing the lyophilized standard sample from the reagent feeding mechanism to the reagent container storage mechanism.

15. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The sample analysis device has a first reconstitution dispensing position located outside the reagent container storage mechanism; the reagent container storage mechanism includes a reagent tray and a first driving mechanism, and the sample analysis device further includes a first transfer mechanism. The reagent tray is used to store the reagent container containing the reagent and the standard sample container containing the lyophilized standard sample. The first driving mechanism is used to drive the reagent tray to rotate so that the reagent container containing the reagent rotates to the reagent aspiration position and to drive the reagent tray to rotate so that the standard sample container containing the lyophilized standard sample rotates to the transfer position. The reagent dispensing mechanism is used to aspirate at least a portion of the reagent from the reagent container located at the reagent aspiration position and to dispense all or part of the aspirated reagent into the first reaction container. The first transfer mechanism is used to transfer the standard sample container located at the transfer position to the first reconstitution dispensing position. The reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container located at the first reconstitution dispensing position. Alternatively, the sample analysis device may have a first reconstitution dispensing position located outside the reagent container storage mechanism; the reagent container storage mechanism includes a fixed storage component for storing the reagent container containing the reagent and the standard sample container for storing the lyophilized standard sample; the reagent dispensing mechanism is used to draw at least a portion of the reagent from the reagent containers located at different positions of the fixed storage component and dispense all or part of the drawn reagent into different first reaction containers; the first transfer mechanism is used to transfer the standard sample containers located at different positions of the fixed storage component to the first reconstitution dispensing position; and the reconstitution dispensing mechanism is used to perform a reconstitution dispensing action on the standard sample container located at the first reconstitution dispensing position.

16. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The sample analysis device also includes a housing, and the reagent container storage mechanism, the reconstituted solution dispensing mechanism, the standard sample dispensing mechanism, the sample dispensing mechanism, the reagent dispensing mechanism, the measuring mechanism, and the control device are all housed within the housing; And / or, the sample analysis device further includes a refrigeration device for refrigerating the reagent container storage mechanism, so that the reagent container containing the reagent and the standard sample container containing the lyophilized standard sample are refrigerated in the reagent container storage mechanism.

17. The sample analysis apparatus according to any one of claims 1 to 8, characterized in that: The freeze-dried standard sample is a freeze-dried quality control sample, and the reference test data is quality control data. Alternatively, the lyophilized standard sample may be a lyophilized calibrator, and the reference test data may be calibration data.

18. A control method for a sample analysis device, characterized in that: The testing procedure includes the following standard samples: The control reconstitution dispensing mechanism performs a reconstitution dispensing action on a standard sample container containing lyophilized standard samples from a reagent container storage mechanism, so as to reconstitute the lyophilized standard samples into liquid standard samples through the reconstitution solution; The control standard sample dispensing mechanism draws at least a portion of the liquid standard sample contained in the standard sample container and dispenses all or part of the drawn liquid standard sample into the first reaction container; The reagent dispensing mechanism draws at least a portion of the reagent from the reagent container of the reagent container storage mechanism and dispenses all or part of the drawn reagent into the first reaction vessel; The control and measurement mechanism measures the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data; The test results of the liquid standard sample are obtained based on the reference test data obtained by the testing institution from the test of the first reaction solution; Wherein, the standard sample dispensing mechanism and the reagent dispensing mechanism are the same mechanism, or the standard sample dispensing mechanism is set up independently of the reagent dispensing mechanism; The reconstitution dispensing mechanism is the same as at least one of the reagent dispensing mechanism and the standard sample dispensing mechanism, or the reconstitution dispensing mechanism is set up independently of the reagent dispensing mechanism and independently of the standard sample dispensing mechanism.

19. The control method for the sample analysis device as described in claim 18, characterized in that: Before the control reconstitution dispensing mechanism performs the reconstitution dispensing action on the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism, the control method further includes: when a first preset condition is met, controlling the first transfer mechanism to transfer the standard sample container containing the lyophilized standard sample from the reagent container storage mechanism to a first reconstitution dispensing position located outside the reagent container storage mechanism; The control mechanism for dispensing reconstituted solution performs a reconstituted solution dispensing action on a standard sample container containing lyophilized standard samples from a reagent container storage mechanism, including: controlling the reconstituted solution dispensing mechanism to perform a reconstituted solution dispensing action on the standard sample container located at the first reconstituted solution dispensing position; After the controlled reconstitution dispensing mechanism performs a reconstitution dispensing action on a standard sample container from the reagent container storage mechanism and loaded with lyophilized standard samples, and before the controlled standard sample dispensing mechanism aspirates at least a portion of the liquid standard sample loaded in the standard sample container and dispenses all or part of the aspirated liquid standard sample into the first reaction vessel, the control method further includes: controlling the first transfer mechanism to transfer the standard sample container after the reconstitution dispensing action from the first reconstitution dispensing position to the first incubation mechanism to perform a first incubation treatment; controlling the first transfer mechanism to transfer the standard sample container after the first incubation treatment from the first incubation mechanism to a mixing mechanism; controlling the mixing mechanism to perform a mixing action on the standard sample container after the first incubation treatment; controlling the first transfer mechanism to transfer the standard sample container after the mixing action from the mixing mechanism to the first incubation mechanism to perform a second incubation treatment; and controlling the first transfer mechanism to transfer the standard sample container after the second incubation treatment from the first incubation mechanism to aspiration position. The control of the standard sample dispensing mechanism to draw at least a portion of the liquid standard sample contained in the standard sample container and to dispense all or part of the drawn liquid standard sample into the first reaction container includes: controlling the standard sample dispensing mechanism to draw at least a portion of the liquid standard sample contained in the standard sample container located at the liquid aspiration position and to dispense it into the first reaction container.

20. The control method for the sample analysis device as described in claim 19, characterized in that: After the control method controls the standard sample dispensing mechanism to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into the first reaction vessel, the control method further includes: The first transfer mechanism is controlled to transfer the standard sample container, after the liquid standard sample has been dispensed, from the liquid aspiration position to the reagent container storage mechanism for storage. When the first preset condition is met again, it is determined whether the standard sample container that has been transferred from the aspiration position to the reagent container storage mechanism and contains the liquid standard sample meets the second preset condition. If so, the reconstitution device is controlled to transfer the standard sample container that meets the second preset condition to the first incubation mechanism to perform the first incubation process; The first transfer mechanism is controlled to transfer the standard sample container, after the first incubation treatment has been completed, from the first incubation mechanism to the mixing mechanism; The mixing mechanism is controlled to perform a mixing action on the standard sample container after the first incubation treatment is completed; The first transfer mechanism is controlled to transfer the standard sample container, after the mixing action is completed, from the mixing mechanism to the first incubation mechanism to perform the second incubation process; The first transfer mechanism is controlled to transfer the standard sample container, after completing the second incubation treatment, from the first incubation mechanism to the liquid aspiration position; The standard sample dispensing mechanism is controlled to draw at least a portion of the liquid standard sample contained in the standard sample container located at the aspiration position and dispense it into another first reaction container; The reagent dispensing mechanism is controlled to draw at least a portion of the reagent from the reagent container from the reagent container storage mechanism and dispense all or part of the drawn reagent into the first reaction vessel; The measuring mechanism is controlled to measure the first reaction solution in the first reaction vessel, which is made of at least the liquid standard sample and the reagent, to obtain reference test data.

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