Sample analyzer

Abstract

The embodiment of the invention provides a sample analyzer, which comprises a sample supply device, a reagent supply device, a reaction device, a detection device and a controller, controlling the function module to perform a first detection operation and a second detection operation matched with the preset detection item on the sample to obtain first detection data corresponding to the first detection operation and second detection data corresponding to the second detection operation; outputting a detection result of the sample corresponding to the preset detection item according to the first detection data and the second detection data; wherein in the first detection operation, the sample supply device provides a first sample for the reaction device, in the second detection operation, the sample supply device provides a second sample for the reaction device, and the first sample and the second sample are samples of the same subject with different dilution multiples; and in the first detection operation and the second detection operation, reagents supplied to the reaction device by the reagent supply device correspond to the same reagent type.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a sample analyzer. Background Art

[0002] Chemiluminescent immunoassay is a non-radioactive immunoassay technology that has developed rapidly in recent years. Its principle is to use chemiluminescent substances to amplify signals and use their luminescence intensity to directly measure the immune binding process. Chemiluminescent immunoassay has become one of the important directions of immunological detection.

[0003] In chemiluminescent immunoassay, when the concentration of the sample to be tested reaches a certain level, the signal value will be low because the double antibody sandwich complex cannot be formed, which is called the hook effect. In other words, the hook effect refers to the phenomenon that in the double-site sandwich immunoassay, the linear trend of the high-dose section of the dose-response curve is not infinitely extended like a platform, but is bent downward like a hook, resulting in a false negative.

[0004] Due to the existence of the HOOK effect, the detected sample cannot be correctly distinguished as to whether its concentration exceeds the linear range of the instrument or the concentration of the detected sample itself is this value, resulting in experimental misdiagnosis, especially leading to an increase in the false negative rate. Summary of the invention

[0005] The main purpose of the embodiments of the present application is to provide a sample analyzer, which aims to reduce the probability of false negative test results due to the HOOK effect during the sample analysis process and improve the accuracy of the test results.

[0006] In a first aspect, an embodiment of the present application provides a sample analyzer, comprising:

[0007] A sample supply device, used for providing a sample;

[0008] A reagent supply device, used for providing a reagent to react with the sample;

[0009] The reaction device is provided with a reaction position for placing a reaction container, and the reaction container is used to receive the sample dispensed by the sample supply device and the reagent supplied by the reagent supply device, so that the sample and the reagent are mixed to form a reaction solution;

[0010] A detection device, used to detect the reaction liquid to obtain corresponding detection information;

[0011] A controller, used to control the functional modules of the sample analyzer to perform corresponding operations to realize the detection of the sample, wherein the functional modules at least include a sample supply device, a reagent supply device and a detection device;

[0012] The controller is also used to: after determining that the detection item of the sample is a preset detection item, control the functional module to perform a first detection operation and a second detection operation matching the preset detection item on the sample, and obtain first detection data corresponding to the first detection operation and second detection data corresponding to the second detection operation;

[0013] Outputting a test result of a sample corresponding to a preset test item according to the first test data and the second test data;

[0014] In which, in the first detection operation, the sample supply device provides a first sample to the reaction device, and in the second detection operation, the sample supply device provides a second sample to the reaction device, the first sample and the second sample are samples of the same subject with different dilution multiples, and the reagents provided by the reagent supply device to the reaction device in the first detection operation and the second detection operation correspond to the same reagent type.

[0015] In a second aspect, an embodiment of the present application further provides a sample analyzer, comprising:

[0016] A sample supply device, used for providing a sample to be tested;

[0017] A reagent supply device, used for providing a reagent to react with the sample;

[0018] The reaction device is provided with a reaction position for placing a reaction container, and the reaction container is used to receive the sample dispensed by the sample supply device and the reagent supplied by the reagent supply device, so that the sample and the reagent are mixed to form a reaction solution;

[0019] A detection device, used to detect the reaction liquid to obtain corresponding detection data;

[0020] A controller, used to control the functional modules of the sample analyzer to perform corresponding operations to realize the detection of the sample, wherein the functional modules at least include a sample supply device, a reagent supply device and a detection device;

[0021] The sample analyzer is provided with a first detection mode and a second detection mode, and the controller is used for:

[0022] When the sample analyzer is in the first detection mode, after the controller determines that the detection item of the sample is a preset detection item, the controller controls the function module to perform the first detection operation and the second detection operation matching the preset detection item on the sample, and obtains the first detection data corresponding to the first detection operation and the second detection data corresponding to the second detection operation; the detection result of the sample corresponding to the preset detection item is output according to the first detection data and the second detection data; wherein, in the first detection operation, the sample supply device provides the first sample to the reaction device, and in the second detection operation, the sample supply device provides the second sample to the reaction device, the first sample and the second sample are samples of the same subject with different dilution multiples, and in the first detection operation and the second detection operation, the reagent supply device provides the reagent to the reaction device with the same reagent type;

[0023] When the sample analyzer is in the second detection mode, the control function module performs a third detection operation on the sample that matches the preset detection item, and obtains third detection data corresponding to the third detection operation; when the third detection data does not meet the preset requirements, the control function module performs a fourth detection operation on the sample that matches the preset detection item, obtains fourth detection data corresponding to the fourth detection operation, and outputs the detection result of the sample corresponding to the preset detection item according to the fourth detection data; wherein, in the third detection operation, the sample supply device provides the reaction device with a third sample, and in the fourth detection operation, the sample supply device provides the reaction device with a fourth sample of the same subject as the third sample, the dilution multiple of the fourth sample is different from the dilution multiple of the third sample, and in the third detection operation and the fourth detection operation, the reagent supply device provides the reaction device with the same reagent type as the reagent provided by the reagent supply device.

[0024] High-concentration samples (sample concentration values ​​exceeding the preset value) are prone to HOOK effect during the detection process, which makes the test results of the samples to be tested present false negatives, resulting in low reliability of the test results. Therefore, the non-HOOK range is generally the detectable range of the instrument.

[0025] In the sample testing of traditional preset test items, if the sample analyzer causes a HOOK effect due to excessively high sample concentration when executing the preset test items on the sample, resulting in a false negative test result, the operator is required to dilute the sample to be tested to reduce the concentration value of the sample to be tested, and then use the sample analyzer to execute the preset test items again on the diluted sample to obtain a more accurate test result. This traditional detection mode is time-consuming and cannot efficiently obtain more accurate sample test results.

[0026] In the present application, during the sample detection process, two sample detection operations are performed, and the dilution multiples of the samples used in the two sample detection operations are different. In the case where the HOOK effect is prone to occur in samples with high concentration values, if the concentration of the initial sample is high, during the sample detection process, at least one group of detection operations will dilute the initial sample, or two groups of detection operations will dilute the initial sample by different multiples. In this way, after the high-concentration initial sample is diluted, the probability of the HOOK effect occurring in the diluted sample is lower. Therefore, by performing a comprehensive analysis of the first detection data and the second detection data, the detection result of the sample is finally obtained, which can effectively improve the accuracy of the detection result obtained by performing preset detection items on the sample.

[0027] It should be understood that the above general description and the following detailed description are merely exemplary and explanatory and cannot limit the disclosure of the embodiments of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0029] Figure 1 It is a test principle diagram of the sample analyzer for immunoassay;

[0030] Figure 2 is a block diagram of a sample analyzer in one embodiment;

[0031] Figure 3 is a schematic diagram of the structural layout of a sample analyzer in one embodiment;

[0032] Figure 4 is a schematic structural diagram of a sample dispensing mechanism of a sample analyzer in one embodiment;

[0033] Figure 5 It is a curve diagram showing the relationship between the signal value and sample concentration obtained during the HCG sample detection process;

[0034] Figure 6 This is a flow chart of an embodiment in which a sample analyzer performs two detection operations on the same sample, thereby outputting a detection result using data obtained from the two detection operations. DETAILED DESCRIPTION

[0035] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0036] In the description of this application, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0037] The flowcharts shown in the accompanying drawings are only examples and do not necessarily include all the contents and operations / steps, nor must they be executed in the order described. For example, some operations / steps may also be decomposed, combined or partially merged, so the actual execution order may change according to actual conditions.

[0038] Some implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the features in the following embodiments and implementation methods can be combined with each other.

[0039] See also Figure 1 and Figure 2 The present application provides a sample analyzer for analyzing a sample to be tested to obtain a corresponding analysis result.

[0040] In some embodiments, the sample analyzer includes, but is not limited to, at least one of the following: a biochemical analyzer, an immunoassay analyzer, a coagulation analyzer, and a urine analyzer.

[0041] Taking the sample analyzer as an immunoassay analyzer as an example, the immunoassay analyzer is a type of highly sensitive and specific analytical instrument, which is often used in clinical laboratories to detect various analytical indicators of blood, urine or other body fluids. Traditional immunoassay analyzers have a variety of implementation principles, such as chemiluminescence, electrochemiluminescence, etc.

[0042] like Figure 1As shown, taking the chemiluminescence immunoassay analyzer as an example, its main working principle is: when a certain component in the sample needs to be measured, the corresponding antibody / antigen can be coated on the magnetic beads to form a magnetic bead reagent, and a specific marker can be labeled on the antibody to form a labeled reagent (the reagents for measuring a certain analysis item generally have multiple components, such as the magnetic bead reagent component and the labeled reagent component here, and different components of the same item can be packaged in different reagent containers or in different cavities of the same reagent container). The test process firstly mixes the sample containing the analyte with the magnetic bead reagent, the labeling reagent and other reagents to form a sample reagent reaction solution (referred to as the reaction solution, also referred to as a mixture), and incubates under certain conditions to allow the sample and the reagent to fully react. At this time, the reaction solution includes the analyte and impurities. Usually, the analyte will be enriched on the surface of the magnetic particles of the added reagent (such as the surface of the magnetic beads), and then the impurities in the reaction solution (such as unbound labels and other reagents, samples) are removed by washing and separation (Bound-free, generally referred to as B / F) technology; then the signal reagent (also called substrate) is added thereto, and the label on the analyte reacts with the signal reagent (or catalyzes the signal reagent) to emit light, and the luminescence intensity of the analyte is detected, and the concentration of the analyte component in the sample can be calculated using the calibration curve. The signal reagent can be one or more, such as a luminescent substrate solution, a pre-excitation solution, an excitation solution, and a luminescence enhancement solution.

[0043] like Figure 2 As shown, the sample analyzer 100 includes a sample supply device 20, a reagent supply device 30, a reaction device 40, a detection device 60 and a controller 70. Among them, the sample supply device 20 is used to provide samples, and the reagent supply device 30 is used to provide reagents that react with samples. The reaction device 40 is provided with a reaction position for placing a reaction container, and the reaction container is used to receive the sample supplied by the sample supply device 20 and the reagent by the reagent supply device 30, so that the sample and the reagent are mixed to form a reaction liquid. Optionally, the reaction device 40 is also used to provide an incubation place for the reaction liquid in the reaction container to incubate the reaction liquid in the reaction container. It can be understood that the reaction container includes but is not limited to a reaction cup and a reaction tube.

[0044] The detection device 60 is used to detect the reaction liquid in the reaction container to obtain corresponding detection information. Optionally, the detection device 60 is used to measure the reaction liquid in the reaction cup or the reaction liquid incubated by the reaction device 40 to obtain the reaction data of the sample. For example, the detection device 60 detects the luminous intensity of the reaction liquid to obtain the corresponding detection information. Using the detection information and the preset calibration curve, the concentration of the analyte in the sample can be calculated. Optionally, the detection device 60 can also be an electrical detection device (such as an impedance measurement mechanism) or a detection device based on other principles (such as an imaging measurement mechanism).

[0045] See also Figure 2and Figure 3 In some embodiments, the sample supply device 20 includes a sample supply mechanism 21, a sample dispensing mechanism 22, and a sample dilution mechanism 23. The sample supply mechanism 21 is used to carry sample containers (such as sample tubes). Optionally, the sample supply mechanism 21 is also used to perform sample container scheduling. For example, the sample supply mechanism 21 is provided with a sample position for carrying sample tubes, and the sample tube placed in the sample position can be scheduled to the corresponding sample suction position.

[0046] Optionally, the sample supply mechanism 21 may include a sample delivery module (SDM) and a front track, the front track is used to implement the injection of sample tubes, the sample delivery module is used to implement the scheduling of sample tubes, and the sample tubes are used to carry samples.

[0047] Optionally, the sample supply mechanism 21 may also include a sample tray, wherein the sample tray includes a tray assembly and a drive assembly, the tray assembly is provided with a plurality of sample positions for placing sample tubes, and the sample tray is driven by the drive assembly to rotate its tray assembly, so that the sample liquid placed in the sample tube can be dispatched to a corresponding position, for example, the sample tube carrying the sample liquid can be dispatched to the position where the sample dispensing mechanism 22 absorbs the sample.

[0048] The sample dilution mechanism 23 is used to perform a sample dilution operation. For example, after the sample dispensing mechanism 22 discharges the sample to be diluted into the reaction container at the dilution position, the sample dilution mechanism 23 injects a diluent into the reaction container at the dilution position to dilute the sample in the reaction container at the dilution position. The dilution multiple of the sample can be controlled by adjusting the amount of the diluent injected into the reaction container by the sample dilution mechanism 20.

[0049] In some embodiments, the sample dispensing mechanism 22 is used to perform a sample dispensing operation. For example, the sample dispensing mechanism 22 draws the sample to be tested from the sample tube carried by the sample supply mechanism 21 and discharges the sample into one or more reaction containers to be loaded with the sample.

[0050] like Figure 4 As shown, the sample dispensing mechanism 22 includes a sample needle 221, a first driving component 222, and a first liquid transfer driving unit 223. The first driving component 222 is used to support the sample needle 221 and drive the sample needle 221 to move. For example, the sample needle 221 performs a two-dimensional or three-dimensional movement in space through the two-dimensional or three-dimensional first driving component 222, so that the sample needle 221 can move to the sample carried by the sample supply mechanism 21.

[0051] The first pipetting drive unit 223 is used to absorb the sample through the sample needle 221. For example, the sample to be tested is a blood sample to be tested. The sample needle 221 is driven by the first driving component 222 to move to the sample tube containing the blood sample carried on the sample supply mechanism 21, and absorbs the blood sample to be tested under the drive of the first pipetting drive unit 223, and transports the blood sample to be tested to a reaction container located in the reaction position of the reaction device 40, so that the blood sample to be tested absorbed by the sample dispensing mechanism 22 and the reagent provided by the reagent supply device 20 are mixed in the reaction container to prepare a reaction liquid.

[0052] like Figure 3 As shown, in some embodiments, the reagent supply device 30 includes a reagent carrying mechanism 31 for carrying reagents and a reagent dispensing mechanism 32 for performing reagent dispensing operations. In the process of preparing the reaction solution, the reagent dispensing mechanism 32 absorbs the corresponding reagent from the reagent carrying mechanism 31 and discharges the reagent into the corresponding reaction container in the reaction device 40, so that the reagent and the sample provided by the sample supply device are mixed to form a reaction solution. Among them, the reagent includes but is not limited to a coloring reagent, a diluent, a substrate solution, an enzyme-labeled reagent, etc.

[0053] In some embodiments, the reagent carrying mechanism 31 may be a reagent disk, which is a disc-shaped component having a plurality of positions for carrying reagent containers. The reagent carrying mechanism 31 can rotate and drive the reagent container it carries to rotate, and is used to rotate the reagent container to a specific position, such as a reagent aspiration position where the reagent is aspirated by the reagent dispensing mechanism 32. The number of the reagent carrying mechanisms 31 may be one or more.

[0054] In some embodiments, the reagent dispensing mechanism 32 may include a reagent needle, a second driving assembly, and a second liquid transfer drive unit. The reagent needle performs two-dimensional or three-dimensional movement in space through the two-dimensional or three-dimensional second driving assembly, so that the reagent needle can move and cooperate with the second liquid transfer drive unit to absorb the reagent carried by the reagent carrying mechanism 31, and move to the reaction container to be added with the reagent, and discharge the reagent into the reaction container.

[0055] In some embodiments, the second driving assembly and the first driving assembly 222 have the same structure, and / or the second pipetting driving unit and the first pipetting driving unit 223 have the same structure, which will not be described in detail herein.

[0056] In some embodiments, the reagent dispensing mechanism 32 does not add reagents by means of a reagent needle, but rather adds the reagents in the reagent tube to the reaction container through a dedicated pipeline. In this type of embodiment, there is only a sample needle 201, but no reagent needle.

[0057] It can be understood that, depending on the different body fluids to be tested and the different test items, there are different ways to add samples and reagents. For example, both samples and reagents can be added using the sample needle 221, or the sample is added using the sample needle 221 and the reagent is added using the reagent needle, or only the sample is added using the sample needle 221 and the reagent is added using other methods. That is, the sample dispensing mechanism 22 is used for both sample transfer and reagent transfer; or the sample dispensing mechanism 22 is used for sample transfer and the reagent dispensing mechanism 32 is used for reagent transfer; or the sample dispensing mechanism 22 is used for sample transfer and the reagent is connected to the reagent container carrying the reagent through a dedicated pipeline to add the reagent to the reaction container. Therefore, the sample needle 221 and / or the reagent needle are also called a pipetting needle, that is, the pipetting needle includes at least one of the sample needle 221 and the reagent needle.

[0058] In some embodiments, the reaction device 40 has a support portion 401, and the support portion 401 is provided with at least one reaction position, which is used to place a reaction container (e.g., a reaction cup 4011), and the reaction container is used to receive the sample supplied by the sample supply device 20 and the reagent supplied by the reagent supply device 30, and provide a reaction site for the sample and the reagent so that the sample and the reagent are mixed to form a reaction liquid. Optionally, the reaction device 40 is also used to incubate the reaction liquid in the reaction container so that the sample and the reagent are mixed more fully.

[0059] For example, the support portion 401 of the reaction device 40 may be a reaction disk, such as Figure 3 As shown, it is arranged in a disc-shaped component, having one or more reaction positions for placing reaction containers. The reaction disc can incubate the reaction liquid in the reaction container, and can rotate to drive the reaction container placed in the reaction position to rotate, thereby realizing the scheduling of the reaction containers in the reaction disc in the preset area.

[0060] It is understood that the reaction position for the reaction cup can be set not only on the reaction disk of the reaction device 40, but also independently from the reaction disk of the reaction device 40. The reaction position is set independently from the reaction disk means that the setting of the reaction position does not interfere with the rotation of the reaction disk itself.

[0061] In some embodiments, the sample analyzer 100 further includes a scheduling device, which is used to perform scheduling of a target object, wherein the target object includes but is not limited to a reaction container. For example, the scheduling device grabs the reaction container and drives the reaction container to move in a two-dimensional or three-dimensional space, thereby realizing the scheduling of the reaction container, or, after the reaction container is placed in a scheduling position set on the scheduling device, the scheduling device drives the reaction container placed in the scheduling position to move in a two-dimensional or three-dimensional space. That is, it can be understood that the scheduling device includes but is not limited to a gripper and a turntable.

[0062] For example, during the reaction liquid preparation process, the scheduling device schedules the reaction container to be loaded with the sample to the sample position in the sample analyzer, so that the sample dispensing mechanism 22 performs the sample filling operation on the reaction container placed at the sample position. After the sample filling operation is completed, the reaction container carrying the sample is scheduled to the reagent position, so that the reagent dispensing mechanism 32 performs the reagent filling operation on the reaction container placed at the reagent position, thereby allowing the sample and the reagent to mix in the reaction container to form a reaction liquid.

[0063] Alternatively, during the reaction liquid preparation process, the scheduling device schedules the reaction container to the reagent position so that the reagent dispensing mechanism 32 performs a reagent filling operation on the reaction container placed at the reagent position. After the reagent filling operation is completed, the reaction container carrying the reagent is scheduled to the sample position so that the sample dispensing mechanism 22 performs a sample filling operation on the reaction container placed at the sample position, thereby allowing the sample and the reagent to mix in the reaction container to form a reaction liquid.

[0064] In some embodiments, Figure 1 As shown, the sample analyzer 100 also includes a magnetic separation device 50, which is used to perform magnetic separation and cleaning (also called magnetic separation) on the reaction liquid in the reaction container, so as to extract the magnetic particles enriched with the analyte in the reaction liquid, and clean the impurities attached to the surface of the magnetic particles, thereby improving the purity of the analyte in the reaction liquid, and thus improving the accuracy of the sample detection results.

[0065] For example, after the sample and the reagent react to form a reaction solution, the reaction device 40 incubates the reaction solution in the reaction container. After the incubation is completed, the reaction container is dispatched to the magnetic separation position on the magnetic separation device to magnetically separate the reaction solution in the reaction container at the magnetic separation position. The reaction solution that has completed the magnetic separation and cleaning is dispatched to the reaction device 40 again for incubation, and then the detection device detects the incubated reaction solution to obtain corresponding detection information.

[0066] Optionally, the sample analyzer is also provided with a substrate adding component. After the magnetic separation is completed, the sample analyzer 100 adds the substrate to the reaction container after the magnetic separation and cleaning through the substrate adding component. If the substrate is added to the reaction container after the magnetic separation and cleaning, at this time, the reaction container is a mixture of the substrate and the analyte. Since the substrate does not change the properties of the analyte, but only increases the luminescence value of the analyte, the substrate and the analyte are still a reaction liquid containing the analyte after mixing. The detection device 60 detects the reaction liquid after the substrate is added, and through the calibration curve, the concentration of the component to be tested (the analyte) in the sample can be calculated.

[0067] The controller 70 is communicatively connected with the sample supply device 20, the reagent supply device 30, the reaction device 40, the magnetic separation device 50 and the detection device 60 to control at least one of the sample supply device 20, the reagent supply device 30, the reaction device 40, the magnetic separation device 50 and the detection device 60 to complete a preset operation, such as controlling the sample supply device 20 to provide a sample to the reaction container, controlling the reagent supply device to provide a reagent to the reaction container, or controlling the magnetic separation device 50 to complete magnetic separation and cleaning of the reaction liquid.

[0068] It is understandable that the controller 70 may be one or more and may be disposed in at least any one of the sample supply device 20, the reagent supply device 30, the reaction device 40, the magnetic separation device 50 and the detection device 60, or may be independently disposed, which is not limited here.

[0069] In some embodiments, the controller 70 includes at least a processor 701, a memory 702, a communication interface (not shown), and an I / O interface (not shown). The processor 701, the memory 702, the communication interface, and the I / O interface communicate via a bus. The processor 701 may be a central processing unit (CPU), and the processor may also be other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA), or other programmable logic devices, discrete gates or transistor logic devices, discrete hardware components, etc. Among them, the general-purpose processor may be a microprocessor or the processor may also be any conventional processor, etc.

[0070] The memory 702 is equipped with various computer programs such as operating systems and applications for the processor 701 to execute and the data required for executing the computer programs. During the analysis of the sample to be tested, if there is data that needs to be stored locally, it can be stored in the memory 702. The I / O interface includes but is not limited to serial interfaces such as USB, IEEE1394 or RS-232C, parallel interfaces such as SCSI, IDE or IEEE1284, and analog signal interfaces composed of D / A converters and converters. An input component is connected to the I / O interface, and the user can use the input component to directly input data to the controller 70. The input component includes but is not limited to a keyboard, a mouse, a touch screen or a control button. The display component can be connected to the controller 70 through the I / O interface to communicate with the controller 70 to provide relevant information prompts. The communication interface can be an interface of any communication protocol currently known, and the communication interface communicates with the outside world through a network. The controller 70 can transmit data between any components connected through the network with a preset communication protocol through the communication interface.

[0071] In some embodiments, the controller 70 is communicatively connected with the sample supply device 20, the reagent supply device 30, and the detection device 60, and is at least used to: control the functional modules of the sample analyzer 100 to perform corresponding operations to achieve detection of the sample, and the functional modules at least include the sample supply device 20, the reagent supply device 30, and the detection device 60;

[0072] The controller 70 is also used to: after determining that the detection item of the sample is a preset detection item, control the functional module to perform a first detection operation and a second detection operation matching the preset detection item on the sample, and obtain first detection data corresponding to the first detection operation and second detection data corresponding to the second detection operation;

[0073] Outputting a test result of a sample corresponding to a preset test item according to the first test data and the second test data;

[0074] In which, in the first detection operation, the sample supply device 20 provides a first sample to the reaction device 40, and in the second detection operation, the sample supply device 20 provides a second sample to the reaction device 40, the first sample and the second sample are samples of the same subject with different dilution multiples, and the reagents provided by the reagent supply device 30 to the reaction device 40 in the first detection operation and the second detection operation correspond to the same reagent type; and the first sample and the reagent are mixed to form a first reaction liquid, and the second sample and the reagent are mixed to form a second reaction liquid, and the detection device 60 detects the first reaction liquid during the first detection operation, and detects the second reaction liquid during the second detection operation.

[0075] It can be understood that the first reaction liquid and the second reaction liquid can be respectively carried in different reaction containers at different reaction positions of the reaction container 40, for example, the first reaction liquid is carried in a reaction container at a first reaction position of the reaction container 40, and the second reaction liquid is carried in a reaction container at a second reaction position of the reaction container 40. Alternatively, the reaction container has at least two independent reaction tanks, and the first reaction liquid and the second reaction liquid are respectively carried in different reaction tanks of the same reaction container.

[0076] In the present application, the first reaction liquid and the second reaction liquid are respectively carried in different reaction containers.

[0077] Optionally, the preset detection items include at least one of HCG detection items, hepatitis B surface antigen detection items and tumor marker detection items. Among them, the tumor marker detection items include but are not limited to CEA carcinoembryonic antigen detection, AFP alpha-fetoprotein detection, CA19-9 tumor marker detection, and CA15-3 tumor marker detection.

[0078] Optionally, the dilution factor of the second sample is greater than the dilution factor of the first sample. For example, the ratio of the dilution factor of the second sample to the dilution factor of the first sample is N, where N is greater than 1. It is understood that N can be set as needed, for example, N can be 50, 60, 70, 80, 85, 100, etc., which is not limited here. That is, the sample concentration of the first sample is greater than the sample concentration of the second sample.

[0079] For example, during the sample detection process, some detection items are prone to the HOOK effect, or the probability of the HOOK effect occurring is relatively high. Therefore, these detection items are set as preset detection items, and detection is performed through corresponding matching detection strategies to reduce the impact of the HOOK effect on the detection results and improve the reliability and accuracy of sample detection.

[0080] After determining that the detection item of the current sample is the preset detection item, the sample analyzer 100 performs a first detection operation and a second detection operation on the sample to be tested. In the first detection operation, the sample supply device 20 provides the first sample to the reaction device 40, and the reagent supply device provides the reagent that reacts with the first sample to the reaction device 40, so that the first sample and the reagent are mixed to form a first reaction liquid. The first reaction liquid is detected by the detection device 60 to obtain first detection information, and then the first detection data of the first sample is obtained using the first detection information and the calibration curve.

[0081] In the second detection operation, the sample supply device 20 provides the second sample to the reaction device 40, and the reagent supply device provides the reagent that reacts with the second sample to the reaction device 40, so that the second sample and the reagent are mixed to form a second reaction liquid, and the second reaction liquid is detected by the detection device 60 to obtain the second detection information, and then the second detection data of the second sample is obtained by using the second detection information and the calibration curve. Among them, the first sample and the second sample are samples of the same subject with different dilution multiples. For example, the first sample is undiluted sample A, and the second sample is sample A diluted N times. Alternatively, the first sample is sample A diluted x times, and the second sample is sample A diluted N*x times, and N and x are both greater than 1.

[0082] After obtaining the first detection data corresponding to the first sample and the second detection data corresponding to the second sample, the detection result of the sample is finally obtained by comprehensively analyzing the first detection data and the second detection data.

[0083] See also Figure 5 , based on the fact that high concentration samples (sample concentration values ​​exceed the preset value) are prone to HOOK effect during the detection process, this makes the test results of the samples to be tested present false negatives, resulting in low reliability of the test results. Therefore, the samples need to be diluted to avoid the HOOK effect in order to achieve accurate quantification. Figure 5 In the test, taking HCG detection as an example, the sandwich detection method of HCG+β is adopted, which is also called β-HCG (β human chorionic gonadotropin) sandwich detection method.

[0084] In the sample testing of traditional preset test items, if the sample analyzer causes a HOOK effect due to excessively high sample concentration when executing the preset test items on the sample, resulting in a false negative test result, the operator is required to dilute the sample to be tested to reduce the concentration value of the sample to be tested, and then use the sample analyzer to execute the preset test items again on the diluted sample to obtain a more accurate test result. This traditional detection mode is time-consuming and cannot efficiently obtain more accurate sample test results.

[0085] In the present application, during the sample detection process, two sample detection operations are performed, and the dilution multiples of the samples used in the two sample detection operations are different. In the case where the high-concentration sample is prone to the HOOK effect, if the concentration of the initial sample is high, during the sample detection process, at least one group of detection operations will dilute the initial sample, or two groups of detection operations will dilute the initial sample by different multiples. In this way, after the high-concentration initial sample is diluted, the probability of the HOOK effect occurring in the diluted sample is low. Therefore, by performing a comprehensive analysis of the first detection data and the second detection data, the detection result of the sample is finally obtained, which can effectively improve the accuracy of the detection result obtained by the preset detection item of the sample. At the same time, there is no need to perform a second detection on the sample again when the detection data obtained by performing a detection operation on the sample is invalid, which can effectively save the sample detection time.

[0086] In some embodiments, the detection device 60 detects the first reaction liquid by controlling the reaction device 40 to incubate the first reaction liquid in the reaction container, and after the incubation of the first reaction liquid is completed, controlling the magnetic separation device 80 to perform magnetic separation on the first reaction liquid, and then controlling the detection device 60 to detect the first reaction liquid that has undergone magnetic separation to obtain first detection information, and using the first detection information and the calibration curve to obtain first detection data of the first sample.

[0087] Optionally, before the detection device 60 detects the first reaction liquid that has completed magnetic separation, the controller 60 is also used to control the scheduling device to schedule the first reaction liquid after magnetic separation to the reaction device 40 for incubation, and schedule the first reaction liquid that has completed incubation to the detection device 60 for detection, to obtain first detection information, and to obtain first detection data of the first sample using the first detection information and the calibration curve.

[0088] The detection device 60 detects the second reaction liquid by dispatching the reaction container carrying the second reaction liquid to the incubation position of the reaction device 40, and controlling the reaction device 40 to incubate the second reaction liquid. After the incubation of the second reaction liquid is completed, the magnetic separation device 80 is controlled to perform magnetic separation on the second reaction liquid, and then the detection device 60 detects the second reaction liquid that has completed the magnetic separation to obtain second detection information, and uses the second detection information and the calibration curve to obtain second detection data of the second sample.

[0089] Optionally, before the detection device 60 detects the second reaction liquid that has completed magnetic separation, the controller 60 is also used to control the scheduling device to schedule the second reaction liquid after magnetic separation to the reaction device 40 for incubation, and schedule the second reaction liquid that has completed incubation to the detection device 60 for detection, to obtain second detection information, and to obtain second detection data of the second sample using the second detection information and the calibration curve.

[0090] In some embodiments, the controller 70 performs the following steps during the process of controlling the functional module to perform the first detection operation and the second detection operation on the sample that match the preset detection items:

[0091] Control the sample supply device 20 to dispatch the sample container containing the sample to the sample suction position, and suck the sample volume corresponding to the sample required for at least two detection operations from the sample container located at the sample suction position;

[0092] Controlling the sample supply device 20 to perform a sample dilution operation on at least part of the sample, and respectively supplying a first sample and a second sample of the same subject with different dilution multiples to the reaction device 40, and controlling the reagent supply device 30 to supply reagents to the reaction device 40, so that the first sample and the reagent are prepared in the reaction device 40 to form a first reaction liquid, and the second sample and the reagent are prepared in the reaction device 40 to form a second reaction liquid;

[0093] The control detection device 60 detects the first reaction liquid and the second reaction liquid respectively to obtain first detection data corresponding to the first reaction liquid and second detection data corresponding to the second reaction liquid.

[0094] Exemplarily, the supply device 20 supplies the first sample and the second sample with different dilution times to the reaction device 40 in the following manner:

[0095] The sample supply mechanism 21 of the sample supply device 20 is controlled to dispatch the sample container containing the sample to the sample suction position, and the sample dispensing mechanism 22 of the sample supply device 20 is controlled to suck at least two sample volumes corresponding to the samples required for the detection operations from the sample container at the sample suction position.

[0096] After the sample aspiration operation is completed, the sample dispensing mechanism 22 is controlled to dispense part of the sample into the reaction device 40, and the undiluted sample can be used as the first sample, and the sample dispensing mechanism 22 dispenses part of the sample into the reaction container located at the dilution position, and controls the sample dilution mechanism 23 to inject a diluent into the reaction container located at the dilution position to dilute the sample in the reaction container to obtain a second sample, and then controls the sample dispensing mechanism 22 to absorb the second sample from the dilution position, and dispenses the second sample into the reaction device 40. In this way, the sample supply device 20 supplies the first sample and the second sample with different dilution multiples to the reaction device 40, so that the first sample and the reagent are prepared in the reaction device 40 to form a first reaction liquid, and the second sample and the reagent are prepared in the reaction device 40 to form a second reaction liquid.

[0097] Alternatively, after the sample aspirating operation is completed, the sample dispensing mechanism 22 is controlled to dispense the sample into the reaction container at the first dilution position and the reaction container at the second dilution position, and the sample dilution mechanism 23 is controlled to inject different amounts of diluent into the reaction container at the first dilution position and the reaction container at the second dilution position, so as to dilute the samples in the two reaction containers into the first sample and the second sample with different dilution times, and then the sample dispensing mechanism 22 is controlled to correspondingly absorb the first sample from the first dilution position and dispense the first sample into the reaction device 40, and to correspondingly absorb the second sample from the second dilution position and dispense the second sample into the reaction device 40. In this way, the sample supply device 20 supplies the first sample and the second sample with different dilution times to the reaction device 40, so that the first sample and the reagent are prepared in the reaction device 40 to form a first reaction liquid, and the second sample and the reagent are prepared in the reaction device 40 to form a second reaction liquid.

[0098] Based on the fact that the samples required for at least two detection operations are aspirated through one sampling operation, the time consumption of sampling can be effectively reduced compared with asynchronously performing two sampling operations, thereby achieving sample detection efficiently compared with asynchronously performing two sampling operations.

[0099] It is understandable that the reagent supply device 30 supplies reagents to the reaction device 40 before the sample supply device 20 supplies the corresponding first sample and second sample to the reaction device 40, or after the sample supply device 20 supplies the corresponding first sample and second sample to the reaction device 40, which is not limited here.

[0100] It can also be understood that the dilution position can be set in the reaction device 40, or can be set independently of the reaction device 40, which is not limited here.

[0101] See also Figure 6 In some embodiments, the dilution multiple of the second sample is greater than the dilution multiple of the first sample. When the controller 70 outputs the test result of the sample corresponding to the preset test item according to the first test data and the second test data, the controller 70 executes:

[0102] Determine whether the second detection data is greater than a first threshold, wherein the first threshold is set according to an upper detection limit value corresponding to the preset detection item during the execution of the preset detection item by the sample analyzer;

[0103] When the second detection data is greater than the first threshold, outputting the detection result of the sample corresponding to the preset detection item according to the second detection data;

[0104] When the second detection data is less than or equal to the first threshold, the difference between the first detection data and the second detection data is obtained, and the detection result of the sample corresponding to the preset detection item is output according to the difference, the first detection data and the second detection data.

[0105] Exemplarily, the preset detection item is the HCG detection item, and the dilution multiple of the second sample is greater than the dilution multiple of the first sample. For example, the first sample is an undiluted sample, and the second sample is a sample diluted N times.

[0106] At the same time, based on the fact that the sample analyzer has a certain detection range for the preset detection items, taking the HCG detection item as an example, the concentration range of the sample that can be detected by the sample analyzer usually has a certain concentration range. For example, the concentration detection range of the sample analyzer for the HCG detection item is between 0.5 and 5000mIU / mL.

[0107] After the sample is diluted N times, the sample detection range that can be detected by the sample analyzer is also magnified N times, that is, the sample detection range is between N*0.5 and N*5000mIU / mL. For example, when N is 80, the upper limit of the concentration detection range is 80*5000mIU / mL, that is, the upper limit of the concentration detection range is 400000mIU / mL.

[0108] Based on the fact that the sample concentration of the first sample is greater than the sample concentration of the second sample, during the detection process, the probability of the HOOK effect occurring in the first sample is greater than that of the second sample. Therefore, it is possible to determine whether the second detection data corresponding to the second sample meets the requirements for output as the detection result. If the second detection data meets the requirements for output as the detection result, the second detection data is output as the detection result of the current sample.

[0109] like Figure 6 As shown, the detection device 60 detects the luminescence intensity of the reaction liquid prepared by the sample to be tested, and obtains corresponding detection information (such as the luminescence intensity value). The concentration of the sample to be tested can be calculated using the detection information and a preset calibration curve, wherein the calibration curve is a relative relationship curve between the luminescence intensity value and the sample concentration.

[0110] That is, after performing luminescence detection on the first reaction liquid prepared by the first sample, the first detection information of the first sample (such as a first luminescence intensity value) is obtained, and the sample detection concentration C1 of the first sample is calculated using the first detection information and a preset calibration curve. Since the first sample has not been diluted, the sample detection concentration C1 of the first sample can be used as the first detection data corresponding to the first sample.

[0111] After performing luminescence detection on the second reaction liquid prepared by the second sample, second detection information of the second sample (such as a second luminescence intensity value) is obtained, and the controller 70 uses the second detection information and a preset calibration curve to calculate the sample detection concentration C of the second sample. Based on the fact that the second sample is a sample that has been diluted N times, the second detection data C2 corresponding to the second sample satisfies, C2=C*N.

[0112] Therefore, after obtaining the first test data (C1) of the first sample and the second test data (C2) of the second sample, first determine whether C2 is greater than the first threshold value. The first threshold value is set according to the upper limit value of the detection of the HCG detection item by the sample analyzer during the execution of the HCG detection item by the sample analyzer, such as the first threshold value being the upper limit value of the detection of the HCG detection item. When C2 is greater than the first threshold value, the test result of the HCG detection item corresponding to the sample to be tested is output according to C2, indicating that the second test data can be output as the test result. Then, the test result corresponding to the HCG detection item of the sample to be tested is output according to the second test data.

[0113] When C2 is less than or equal to the first threshold, indicating that the second test data cannot be directly output as the test result, the difference between C1 and C2 is obtained, and the test result of the HCG test item corresponding to the sample is output according to the difference, C1 and C2.

[0114] like Figure 6 As shown, optionally, in the process of outputting the detection result of the sample corresponding to the preset detection item according to the second detection data, the controller 70 executes:

[0115] Determine whether the second detection data is greater than a second threshold, and the second threshold is greater than the first threshold;

[0116] When the second detection data is less than or equal to the second threshold, outputting the second detection data as a detection result of the preset detection item;

[0117] When the second detection data is greater than the second threshold, a first prompt message is outputted to indicate that the sample concentration exceeds the upper detection limit of the device.

[0118] Exemplarily, based on the fact that the second sample is N times diluted compared to the first sample, when C2 is greater than the first threshold, it is necessary to determine whether C2 is greater than a second threshold, and the second threshold is greater than the first threshold. Optionally, the second threshold is N times the first threshold.

[0119] When C2 is less than or equal to the second threshold, it indicates that no HOOK reaction occurs in the second sample during the HCG detection project, and the second detection data obtained by the detection is relatively reliable and can be output as the detection result. Therefore, the obtained second detection data C2 is output as the detection result.

[0120] When C2 is greater than the second threshold, it indicates that the sample concentration of the second sample exceeds the detection upper limit of the sample analyzer, and the first prompt information indicating that the sample concentration exceeds the detection upper limit of the device is output.

[0121] like Figure 6 As shown, optionally, in the process of outputting the detection result of the sample corresponding to the preset detection item according to the difference, the first detection data and the second detection data, the controller 70 executes:

[0122] Determine whether the difference is greater than a third threshold;

[0123] When the difference is less than or equal to the third threshold, determining whether the first detection data is greater than the first threshold, and the first threshold is greater than the third threshold;

[0124] When the first detection data is greater than the first threshold, the second detection data is output as the detection result of the preset detection item;

[0125] When the first detection data is less than or equal to the first threshold, the first detection data is output as a detection result of the preset detection item.

[0126] Optionally, the controller 70 is further configured to: output an alarm message when the difference is greater than a third threshold.

[0127] For example, it is possible to determine whether the HOOK effect occurs during the sample detection process according to a difference △ between a first sample concentration C1 corresponding to the first sample and a second sample concentration C2 corresponding to the second sample.

[0128] When the difference △ is greater than the third threshold, it indicates that a HOOK effect occurs during the sample detection process, or an abnormality occurs in the sample analyzer, and an alarm message is output, wherein the alarm message includes at least one of a hook alarm message and a system abnormality message, and the third threshold is less than the first threshold.

[0129] When the difference △ is less than or equal to the third threshold value, it indicates that no HOOK effect occurs during the sample detection process, and then one detection data is selected from the first sample concentration C1 and the second sample concentration C2 as the detection result to be output, that is, when the first sample concentration C1 is greater than the first threshold value, the second sample concentration C2 is output as the detection result of the HCG detection item; when the first sample concentration C1 is less than or equal to the first threshold value, the first sample concentration C1 is output as the detection result of the HCG detection item.

[0130] In some embodiments, when the controller 70 outputs the detection result of the sample corresponding to the preset detection item according to the first detection data and the second detection data, the controller 70 executes:

[0131] Determining whether a HOOK effect occurs in the first detection operation and the second detection operation according to the first detection data and the second detection data;

[0132] When it is determined that a HOOK effect occurs in the first detection operation and the second detection operation, an alarm message is output, and the alarm message includes at least one of a hook alarm message and a system abnormality message.

[0133] Optionally, the controller 70 performs, in the process of determining whether the HOOK effect occurs in the first detection operation and the second detection operation according to the first detection data and the second detection data:

[0134] Whether a HOOK effect occurs in the first detection operation and the second detection operation is determined according to a difference between the first detection data and the second detection data.

[0135] Optionally, the controller 70 may determine whether the sample has a HOOK effect in the first detection operation and the second detection operation according to the first detection data and the second detection data, or may also:

[0136] Since the sample concentration of the first sample is greater than the sample concentration of the second sample, when the second sample has the HOOK effect, the first sample also has the HOOK effect.

[0137] The controller 70 may determine whether the sample has a HOOK effect in the first detection operation and the second detection operation according to the first detection data and the second detection data, or may also:

[0138] A reaction curve is generated according to the detection data. The reaction curve may be one or more of a reaction rate curve in which the reaction rate changes with time or a reaction acceleration curve in which the reaction acceleration changes with time.

[0139] In some embodiments, before the control function module performs the first detection operation and the second detection operation on the sample that match the preset detection items, the controller 70 is further configured to:

[0140] Controlling the sample analyzer to detect at least two groups of calibration samples to obtain corresponding at least two calibration information;

[0141] The reaction curve of the preset detection item is calibrated according to at least two calibration information to obtain a calibration reaction curve, wherein the first detection data and the second detection data are obtained using the calibration reaction curve.

[0142] Exemplarily, before performing the test, the sample analyzer detects at least two groups of calibration samples of known concentrations to obtain corresponding at least two groups of calibration information, that is, the sample analyzer 100 controls the sample supply device 20 to supply at least two groups of calibration samples of known concentrations to the reaction device 40, and controls the reagent supply device to supply corresponding reagents to the reaction device 40, so that at least two groups of calibration samples of known concentrations react with the reagents to form at least two groups of calibration reaction liquids respectively, and the detection device 60 detects the at least two groups of calibration reaction liquids to obtain at least two groups of calibration information, and then uses the calibration information to calibrate the preset reaction curve to obtain the calibration reaction curve, and uses the calibration reaction curve as the calibration curve. During the sample detection process, the sample concentration corresponding to the sample to be tested is calculated using the calibration curve and the detection information obtained by the detection device 60; preferably, in one embodiment, before performing the test, the sample analyzer detects at least three groups of calibration samples of known concentrations to obtain corresponding at least three groups of calibration information.

[0143] For example, the first detection data is first detection information obtained after the detection device detects the first sample, and the first detection data is calculated using the first detection information and the calibration reaction curve.

[0144] Similarly, the second detection data is second detection information obtained after the detection device detects the second sample, and the second detection data is calculated using the second detection information and the calibration reaction curve.

[0145] In some embodiments, in order to enable the sample analyzer to meet the needs of users, the sample analyzer is provided with two different detection modes, namely, a first detection mode and a second detection mode, wherein when the sample analyzer 100 is in the first detection mode, after determining that the detection item of the sample is a preset detection item, the controller 70 controls the functional module to perform a first detection operation and a second detection operation matching the preset detection item on the sample, and obtains first detection data corresponding to the first detection operation and second detection data corresponding to the second detection operation; and outputs the detection result of the sample corresponding to the preset detection item according to the first detection data and the second detection data; wherein in the first detection operation, the sample supply device 20 provides a first sample to the reaction device 40, and in the second detection operation, the sample supply device 20 provides a second sample to the reaction device 40, the first sample and the second sample are samples of the same subject with different dilution multiples, and in the first detection operation and the second detection operation, the reagent supply device 30 provides the reagent to the reaction device 40 The reagent type corresponding to the reagent is the same;

[0146] When the sample analyzer 100 is in the second detection mode, the control function module performs a third detection operation on the sample that matches the preset detection item, and obtains third detection data corresponding to the third detection operation; when the third detection data does not meet the preset requirements, the control function module performs a fourth detection operation on the sample that matches the preset detection item, obtains fourth detection data corresponding to the fourth detection operation, and outputs the detection result of the sample corresponding to the preset detection item according to the fourth detection data; wherein, in the third detection operation, the sample supply device 20 provides the reaction device 40 with a third sample, and in the fourth detection operation, the sample supply device 20 provides the reaction device 40 with a fourth sample of the same subject as the third sample, the dilution multiple of the fourth sample is different from the dilution multiple of the third sample, and in the third detection operation and the fourth detection operation, the reagent supply device 30 provides the reaction device 40 with the same reagent type as the reagent provided by the reaction device 40.

[0147] Optionally, a method of judging whether the third detection data meets the preset requirement may be:

[0148] It is determined whether the third detection data exceeds the detection upper limit of the sample analyzer. When the third detection data exceeds the detection upper limit of the sample analyzer, a fourth detection operation is performed.

[0149] Exemplarily, when the third detection data exceeds the detection upper limit of the sample analyzer, it indicates that the current sample concentration is too high and the sample detection operation needs to be performed again.

[0150] Optionally, a method for determining whether the third detection data meets the preset requirement may also be:

[0151] It is determined whether the third detection data exceeds a preset concentration value. When the third detection data exceeds the preset concentration value, a fourth detection operation is performed. The preset concentration value is less than the detection upper limit of the sample analyzer.

[0152] Exemplarily, the preset concentration value is the threshold value of high-concentration samples. The sample concentration is within the detection range of the sample analyzer. When the obtained detection data exceeds the preset concentration value, it indicates that the current sample concentration is too high and the sample detection operation needs to be re-executed.

[0153] Optionally, a method of judging whether the third detection data meets the preset requirement may be:

[0154] It is determined whether the third detection data exceeds the dilutable concentration lower limit. When the third detection data exceeds the dilutable concentration lower limit, a fourth detection operation is performed, and the dilutable concentration lower limit is less than the detection upper limit of the sample analyzer.

[0155] Exemplarily, the lower limit of the dilutable concentration is within the detection range of the sample analyzer. When the third detection data exceeds the lower limit of the dilutable concentration, it indicates that an abnormality may occur in the sample analyzer during the sample detection process, and the sample needs to be re-detected to further determine whether the detection result is accurate.

[0156] Optionally, the dilution factor of the fourth sample is greater than the dilution factor of the third sample.

[0157] It should be noted that those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working process of the above-described liquid aspiration control method can refer to the corresponding working process of the aforementioned sample analyzer and will not be repeated here.

[0158] It should be understood that the terms used in this application specification are only for the purpose of describing specific embodiments and are not intended to limit the application. As used in this application specification and the appended claims, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are intended to include plural forms.

[0159] It should also be understood that the term "and / or" used in the specification of this application and the appended claims refers to any combination of one or more of the associated listed items and all possible combinations, including these combinations. It should be noted that, in this article, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or system including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or system. In the absence of further restrictions, an element defined by the sentence "including a..." does not exclude the presence of other identical elements in the process, method, article or system including the element.

[0160] The serial numbers of the embodiments of the present application are for description only and do not represent the advantages and disadvantages of the embodiments. The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed in the present application, and these modifications or replacements should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. A sample analyzer, It is characterized in that include: A sample supply device, used for providing a sample; a reagent supply device, for providing a reagent for reacting with the sample; A reaction device, provided with a reaction position for placing a reaction container, wherein the reaction container is used to receive the sample dispensed by the sample supply device and the reagent supplied by the reagent supply device, so that the sample and the reagent are mixed to form a reaction solution; A detection device, used to detect the reaction liquid to obtain corresponding detection information; A controller, used to control the functional modules of the sample analyzer to perform corresponding operations to realize the detection of the sample, wherein the functional modules at least include the sample supply device, the reagent supply device and the detection device; The controller is further used to: after determining that the detection item of the sample is a preset detection item, control the functional module to perform a first detection operation and a second detection operation matching the preset detection item on the sample, and obtain first detection data corresponding to the first detection operation and second detection data corresponding to the second detection operation; Outputting a test result of the sample corresponding to the preset test item according to the first test data and the second test data; In which, in the first detection operation, the sample supply device provides a first sample to the reaction device, and in the second detection operation, the sample supply device provides a second sample to the reaction device, the first sample and the second sample are samples of the same subject with different dilution multiples, and the reagents provided by the reagent supply device to the reaction device in the first detection operation and the second detection operation correspond to the same reagent type.

2. The sample analyzer according to claim 1, It is characterized in that In the process of outputting the detection result of the sample corresponding to the preset detection item according to the first detection data and the second detection data, the controller executes: Determine whether the second detection data is greater than a first threshold; When the second detection data is greater than the first threshold, outputting the detection result of the sample corresponding to the preset detection item according to the second detection data; When the second detection data is less than or equal to the first threshold, a difference between the first detection data and the second detection data is obtained, and a detection result of the sample corresponding to the preset detection item is output according to the difference, the first detection data and the second detection data.

3. The sample analyzer according to claim 2, It is characterized in that In the process of outputting the detection result of the sample corresponding to the preset detection item according to the second detection data, the controller executes: Determine whether the second detection data is greater than a second threshold, and the second threshold is greater than the first threshold; When the second detection data is less than or equal to the second threshold, outputting the second detection data as the detection result of the preset detection item; When the second detection data is greater than the second threshold, first prompt information is outputted to indicate that the sample concentration exceeds the upper detection limit of the device.

4. The sample analyzer according to claim 2, It is characterized in that The controller performs, in the process of outputting the detection result of the sample corresponding to the preset detection item according to the difference, the first detection data and the second detection data, Determining whether the difference is greater than a third threshold; When the difference is less than or equal to a third threshold, determining whether the first detection data is greater than the first threshold, and the first threshold is greater than the third threshold; When the first detection data is greater than the first threshold, outputting the second detection data as the detection result of the preset detection item; When the first detection data is less than or equal to the first threshold, the first detection data is output as a detection result of the preset detection item.

5. The sample analyzer according to claim 4, It is characterized in that The controller is also used for: When the difference is greater than the third threshold, an alarm message is output.

6. The sample analyzer according to any one of claims 1 to 5, It is characterized in that The dilution factor of the second sample is greater than the dilution factor of the first sample.

7. The sample analyzer according to claim 1, It is characterized in that In the process of outputting the detection result of the sample corresponding to the preset detection item according to the first detection data and the second detection data, the controller executes: Determining whether a HOOK effect occurs in the first detection operation and the second detection operation according to the first detection data and the second detection data; When it is determined that a HOOK effect occurs in the first detection operation and the second detection operation, an alarm message is output.

8. The sample analyzer according to claim 7, It is characterized in that The controller is also used for: Whether a HOOK effect occurs in the first detection operation and the second detection operation is determined according to a difference between the first detection data and the second detection data.

9. The sample analyzer according to claim 1, It is characterized in that The preset detection items include at least one of an HCG (human chorionic gonadotropin) detection item, a hepatitis B surface antigen detection item and a tumor marker detection item.

10. The sample analyzer according to claim 1, It is characterized in that Before controlling the functional module to perform the first detection operation and the second detection operation on the sample that match the preset detection item, the controller is further used to: Controlling the sample analyzer to detect at least two groups of calibration samples to obtain corresponding at least two calibration information; The reaction curve of the preset detection item is calibrated according to at least two of the calibration information to obtain a calibration reaction curve, wherein the first detection data and the second detection data are obtained using the calibration reaction curve.

11. The sample analyzer according to any one of claims 1 to 10, It is characterized in that The controller, in the process of controlling the functional module to perform a first detection operation and a second detection operation on the sample that match the preset detection item, executes: Controlling the sample supply device to dispatch the sample container containing the sample to the sample aspirating position, and aspirating the sample volume corresponding to the sample required for at least two detection operations from the sample container located at the sample aspirating position; Controlling the sample supply device to perform a sample dilution operation on at least part of the samples, and respectively supplying a first sample and a second sample of the same subject with different dilution multiples to the reaction device, and controlling the reagent supply device to supply the reagent to the reaction device, so that the first sample and the reagent are prepared in the reaction device to form a first reaction liquid, and the second sample and the reagent are prepared in the reaction device to form a second reaction liquid; The detection device is controlled to detect the first reaction liquid and the second reaction liquid respectively to obtain the first detection data corresponding to the first reaction liquid and the second detection data corresponding to the second reaction liquid.

12. A sample analyzer, It is characterized in that include: A sample supply device, used for providing a sample to be tested; a reagent supply device, for providing a reagent for reacting with the sample; A reaction device, provided with a reaction position for placing a reaction container, wherein the reaction container is used to receive the sample dispensed by the sample supply device and the reagent supplied by the reagent supply device, so that the sample and the reagent are mixed to form a reaction solution; A detection device, used to detect the reaction liquid to obtain corresponding detection data; A controller, used to control the functional modules of the sample analyzer to perform corresponding operations to realize the detection of the sample, wherein the functional modules at least include the sample supply device, the reagent supply device and the detection device; The sample analyzer is provided with a first detection mode and a second detection mode, and the controller is used for: When the sample analyzer is in the first detection mode, the controller controls the functional module to perform a first detection operation and a second detection operation matching the preset detection item on the sample after determining that the detection item of the sample is a preset detection item, and obtains first detection data corresponding to the first detection operation and second detection data corresponding to the second detection operation; Outputting the test result of the sample corresponding to the preset test item according to the first test data and the second test data; wherein, in the first test operation, the sample supply device provides the first sample to the reaction device, and in the second test operation, the sample supply device provides the second sample to the reaction device, the first sample and the second sample are samples of the same subject with different dilution multiples, and in the first test operation and the second test operation, the reagents provided by the reagent supply device to the reaction device correspond to the same reagent type; When the sample analyzer is in the second detection mode, the functional module is controlled to perform a third detection operation on the sample that matches the preset detection item, and obtain third detection data corresponding to the third detection operation; when the third detection data does not meet the preset requirements, the functional module is controlled to perform a fourth detection operation on the sample that matches the preset detection item, and obtain fourth detection data corresponding to the fourth detection operation, and output the detection result of the sample corresponding to the preset detection item according to the fourth detection data; wherein, in the third detection operation, the sample supply device provides the reaction device with a third sample, and in the fourth detection operation, the sample supply device provides the reaction device with a fourth sample of the same subject as the third sample, the dilution multiple of the fourth sample is different from the dilution multiple of the third sample, and in the third detection operation and the fourth detection operation, the reagent supply device provides the reaction device with the same reagent type as the reagent provided by the reagent supply device.

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