A test method and a sample analysis device based on chemiluminescence reaction

Abstract

A test method and a sample analysis device based on a chemiluminescence reaction, a first type of luminescence signal containing a lower layer of reaction liquid and a second type of luminescence signal containing an upper layer of reaction liquid are obtained, and whether the test is abnormal is judged according to the first type of luminescence signal and the second type of luminescence signal. The application provides a scheme for judging whether the test is abnormal.

Description

Technical Field

[0001] This invention relates to a testing method and sample analysis device based on chemiluminescence reaction. Background Technology

[0002] Sample analysis devices, such as immunoassay analyzers, are highly sensitive and specific analytical instruments commonly used in clinical laboratories to detect various analytical indicators in blood, urine, or other bodily fluids. Traditional immunoassay analyzers operate on various principles, such as chemiluminescence and electrochemiluminescence. For an example of a heterogeneous chemiluminescence immunoassay analyzer, please refer to [reference needed]. Figure 1 Its main working principle is as follows: When it is necessary to measure a certain component in a sample, the corresponding antibody / antigen can be coated on magnetic beads to form magnetic bead reagents, and a specific marker can be labeled on the antibody to form a labeled reagent (the reagent for measuring a certain analytical item generally has multiple components, such as the magnetic bead reagent component and the labeled reagent component here, etc. Different components of the same item can be packaged in different reagent containers or in different chambers of the same reagent container). The testing process first mixes the sample containing the analyte with the magnetic bead reagent, the labeled reagent and other reagents to form a sample reagent reaction solution (referred to as the reaction solution), and incubates the reaction under certain conditions to form a reaction complex; then, through the bound-free (B / F) washing separation technology, the unbound markers and other reagents and sample components in the reaction system are removed; then, a signal reagent is added to it, and the marker on the reaction complex reacts with the signal reagent (or catalyzes the signal reagent) to emit light, where the signal reagent can be one or more, such as luminescent substrate solution, pre-excitation solution and excitation solution and luminescence enhancement solution, etc. There are various specific methods for cleaning the coating. In addition to the magnetic bead cleaning method mentioned above, there are other methods such as coating the antibody on the reaction vessel wall or plastic beads.

[0003] The reliability of test results has always been a pursuit of technicians. Summary of the Invention

[0004] This invention provides a testing method and sample analysis device based on chemiluminescence reaction, which are described in detail below.

[0005] According to the first aspect, one embodiment provides a testing method based on a chemiluminescence reaction, comprising:

[0006] The sample to be tested and reagents are added to the reaction vessel in a controlled manner to prepare the reaction solution;

[0007] Control the incubation and magnetic separation cleaning of the reaction solution in the reaction vessel;

[0008] A signal reagent is added to the reaction solution in the reaction vessel after magnetic separation and cleaning to make the reaction solution glow;

[0009] Acquire the first type of luminescence signal that includes the luminescence signal of the lower reaction liquid;

[0010] Acquire a second type of luminescence signal that includes the luminescence signal of the upper reaction liquid, the second type of luminescence signal being different from the first type of luminescence signal;

[0011] Based on the first type of light emission signal and the second type of light emission signal, determine whether the test is abnormal.

[0012] In one embodiment, the testing method further acquires a third type of luminescence signal of the entire reaction liquid in the reaction vessel.

[0013] In one embodiment:

[0014] The luminescence signal of the lower layer of the reaction liquid in the reaction vessel is acquired and used as the first type of luminescence signal;

[0015] The luminescence signal of the upper layer of reaction liquid in the reaction vessel is acquired as the second type of luminescence signal.

[0016] In one embodiment:

[0017] After acquiring the third type of luminescent signal, the upper layer of reaction liquid in the reaction cup is drawn off and discharged into a new reaction cup;

[0018] The luminescence signal of the entire reaction liquid in the new reaction vessel is obtained as the second type of luminescence signal;

[0019] The luminescence signal of the remaining reaction liquid in the original reaction vessel is obtained and used as the first type of luminescence signal.

[0020] In one embodiment, when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the test result is calculated based on the third type of light emission signal.

[0021] In one embodiment, the luminescence signal of the entire reaction liquid in the reaction vessel is acquired as the second type of luminescence signal; the luminescence signal of the lower layer of reaction liquid in the reaction vessel is acquired as the first type of luminescence signal.

[0022] In one embodiment, after acquiring the second type of luminescent signal, the upper layer of reaction liquid in the reaction cup is controlled to be drawn in and removed.

[0023] The luminescence signal of the remaining reaction liquid in the original reaction vessel is obtained and used as the first type of luminescence signal.

[0024] In one embodiment, when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the test result is calculated based on the second type of light emission signal.

[0025] In one embodiment, the luminescence signal of the entire reaction liquid in the reaction vessel is acquired as the first type of luminescence signal; the luminescence signal of the upper layer of reaction liquid in the reaction vessel is acquired as the second type of luminescence signal.

[0026] In one embodiment:

[0027] After acquiring the first type of luminescent signal, the upper layer of reaction liquid in the reaction cup is drawn off and discharged into a new reaction cup;

[0028] The luminescence signal of the entire reaction liquid in the new reaction vessel is obtained as the second type of luminescence signal.

[0029] In one embodiment, when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the test result is calculated based on the first type of light emission signal.

[0030] In one embodiment, determining whether the test is abnormal based on the first type of light emission signal and the second type of light emission signal includes:

[0031] The test is judged to be abnormal based on the ratio of the first type of light emission signal to the second type of light emission signal;

[0032] If the ratio is greater than a threshold, the test is judged to be abnormal;

[0033] Conversely, the test is considered normal.

[0034] According to a second aspect, one embodiment provides a sample analysis apparatus, comprising:

[0035] A reaction cup loading mechanism for supplying and transporting empty reaction cups;

[0036] Sample injection unit, used to supply the sample to be tested;

[0037] The sample dispensing mechanism is used to draw and dispense samples into reaction cups;

[0038] Reagent component, used to hold reagents;

[0039] The reagent dispensing mechanism is used to draw and dispense reagents into the reaction vessel;

[0040] The reaction component includes multiple slots for placing reaction cups; the reaction component is used to incubate the reaction solution formed by the sample and reagents in the reaction cups;

[0041] The magnetic separation component is used for magnetic separation and cleaning of the reaction liquid in the reaction vessel;

[0042] The measuring component is used to measure the reaction solution to be tested;

[0043] A transfer mechanism is used to move the reaction cups;

[0044] The processor controls the sample dispensing mechanism and reagent dispensing mechanism to add the test sample and reagent to the reaction cup to prepare the reaction solution, controls the reaction component to incubate the reaction solution in the reaction cup, and controls the magnetic separation component to perform magnetic separation and cleaning of the reaction solution in the reaction cup. It then controls the sample dispensing mechanism to add a signal reagent to the reaction solution in the magnetically separated and cleaned reaction cup, causing the reaction solution to emit light. The processor acquires a first type of luminescence signal containing the luminescence signal of the lower reaction solution and a second type of luminescence signal containing the luminescence signal of the upper reaction solution, and determines whether the test is abnormal based on the first and second luminescence signals. The second type of luminescence signal is different from the first type of luminescence signal.

[0045] In one embodiment, the processor further controls the measuring component to acquire a third type of luminescence signal of the entire reaction liquid in the reaction cup; after acquiring the third type of luminescence signal, the processor controls the sample dispensing mechanism to draw up the upper layer of reaction liquid in the reaction cup and discharge it into a new reaction cup, and controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the new reaction cup as the second type of luminescence signal, and controls the measuring component to acquire the luminescence signal of the remaining reaction liquid in the original reaction cup as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the third type of luminescence signal; or,

[0046] The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup, as the second type of luminescence signal; after acquiring the second type of luminescence signal, the processor controls the sample dispensing mechanism to aspirate and remove the upper layer of reaction liquid in the reaction cup, and controls the measuring component to acquire the luminescence signal of the remaining reaction liquid in the original reaction cup, as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or,

[0047] The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; after acquiring the first type of luminescence signal, the processor controls the sample dispensing mechanism to draw up the upper layer of reaction liquid in the reaction cup and discharge it into a new reaction cup, and controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the new reaction cup as the second type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal.

[0048] In one embodiment, the sample analysis device further includes a receiver capable of acquiring optical signals;

[0049] The processor controls the receiver to identify and receive the luminescence signal of the lower layer of reaction liquid in the reaction vessel as the first type of luminescence signal, and to identify and receive the luminescence signal of the upper layer of reaction liquid in the reaction vessel as the second type of luminescence signal; the processor controls the measuring component to acquire the third type of luminescence signal of the entire reaction liquid in the reaction vessel; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the third type of luminescence signal; or,

[0050] The processor controls the receiver to identify and receive the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal; the processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the second type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or,

[0051] The processor controls the receiver to identify and receive the luminescence signal of the upper reaction liquid in the reaction cup as the second type of luminescence signal; the processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal.

[0052] In one embodiment:

[0053] The sample analysis device further includes a receiver capable of acquiring light signals, which is configured in the sample analysis device to specifically receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel; the processor controls the receiver to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel as the first type of light emission signal; the processor controls the measuring component to acquire the light emission signal from the entire reaction liquid in the reaction vessel as the second type of light emission signal; when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the second type of light emission signal; or,

[0054] The sample analysis device further includes a receiver capable of acquiring light signals, which is configured in the sample analysis device to receive the light emission signal of the upper layer of reaction liquid in the reaction cup; the processor controls the receiver to receive the light emission signal of the upper layer of reaction liquid in the reaction cup as the second type of light emission signal; the processor controls the measuring component to acquire the light emission signal of the entire reaction liquid in the reaction cup as the first type of light emission signal; when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the first type of light emission signal;

[0055] The sample analysis device further includes two receivers capable of receiving light signals. One receiver is configured to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel, and the other receiver is configured to receive the light emission signal from the upper layer of the reaction liquid in the reaction vessel. The processor controls the two receivers to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel as the first type of light emission signal, and to receive the light emission signal from the upper layer of the reaction vessel as the second type of light emission signal. The processor controls the measuring component to acquire the third type of light emission signal of the entire reaction liquid in the reaction vessel. When the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the third type of light emission signal.

[0056] In one embodiment, the reaction component includes a first aperture and / or a second aperture; the upper half of the first aperture is blocked so that only the light emission signal of the lower reaction liquid in the reaction cup placed therein is allowed to pass through the unblocked lower half of the first aperture; the lower half of the second aperture is blocked so that only the light emission signal of the upper reaction liquid in the reaction cup placed therein is allowed to pass through the unblocked upper half of the second aperture.

[0057] The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the second type of luminescence signal; the processor controls the transfer mechanism to move the reaction cup to the first position hole, and acquires the luminescence signal of the lower layer of reaction liquid in the reaction cup through the measuring component as the first type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or,

[0058] The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; the processor controls the transfer mechanism to move the reaction cup to the second position hole, and acquires the luminescence signal of the upper layer of reaction liquid in the reaction cup through the measuring component as the second type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal; or,

[0059] The processor controls the measuring component to acquire the third type of luminescence signal of the overall reaction liquid in the reaction cup; the processor controls the transfer mechanism to move the reaction cup to the first position hole, and acquires the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal through the measuring component; the processor controls the transfer mechanism to move the reaction cup to the second position hole, and acquires the luminescence signal of the upper layer of reaction liquid in the reaction cup as the second type of luminescence signal through the measuring component; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the third type of luminescence signal.

[0060] In one embodiment, the reaction component is arranged in a disc-shaped structure, and the reaction component is rotatable and drives the reaction cup placed in its aperture to rotate; the sample analysis device also includes a movable shielding window;

[0061] The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the second type of luminescence signal; the processor controls the shielding window to move to a predetermined position so that the measuring component can acquire the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or,

[0062] The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; the processor controls the shielding window to move to a predetermined position so that the measuring component can acquire the luminescence signal of the upper layer of reaction liquid in the reaction cup as the second type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal; or,

[0063] The processor controls the measuring component to acquire the third type of luminescence signal of the overall reaction liquid in the reaction cup; the processor controls the shielding window to move to different positions respectively, so as to acquire the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal and the luminescence signal of the upper layer of reaction liquid in the reaction cup as the second type of luminescence signal through the measuring component; when the test is judged to be normal according to the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result according to the third type of luminescence signal.

[0064] According to a third aspect, one embodiment provides a computer-readable storage medium including a program that can be executed by a processor to perform the methods as described in any of the embodiments herein.

[0065] Based on the chemiluminescence reaction-based test method, sample analysis device, and computer-readable storage medium of the above embodiments, a scheme for determining whether a test is abnormal is proposed. For example, a first type of luminescence signal containing the luminescence signal of the lower reaction liquid and a second type of luminescence signal containing the luminescence signal of the upper reaction liquid are obtained, and the test is determined to be abnormal based on the first type of luminescence signal and the second type of luminescence signal. Attached Figure Description

[0066] Figure 1 This is a schematic diagram illustrating the testing principle of an immunoassay analyzer according to one embodiment;

[0067] Figure 2 This is a data curve graph of an experiment in one embodiment;

[0068] Figure 3 This is a schematic diagram of the structure of a sample analysis device according to one embodiment;

[0069] Figure 4 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to one embodiment;

[0070] Figure 5 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to another embodiment;

[0071] Figure 6 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to another embodiment;

[0072] Figure 7 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to another embodiment;

[0073] Figure 8 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to another embodiment;

[0074] Figure 9 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to yet another embodiment;

[0075] Figure 10 This is a schematic diagram of an apparatus for acquiring different types of light emission signals according to yet another embodiment;

[0076] Figure 11 A flowchart illustrating a chemiluminescence-based testing method according to one embodiment;

[0077] Figure 12 A flowchart illustrating another embodiment of a chemiluminescence-based testing method;

[0078] Figure 13 A flowchart illustrating another embodiment of a chemiluminescence-based testing method;

[0079] Figure 14 A flowchart of a chemiluminescence reaction-based testing method according to one embodiment is provided;

[0080] Figure 15 A flowchart illustrating another embodiment of a chemiluminescence-based testing method;

[0081] Figure 16 A flowchart of a chemiluminescence reaction-based testing method according to yet another embodiment;

[0082] Figure 17 This is a flowchart of a chemiluminescence reaction-based testing method according to yet another embodiment. Detailed Implementation

[0083] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0084] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0085] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0086] The applicant's research found that during the aforementioned immunoassay tests, the introduction of heterogeneous substances such as precipitates from the sample or reagents can lead to the formation of magnetic bead-adhered fibrin and lipid particles and magnetic bead aggregates. These often encapsulate interfering substances that cause luminescence, resulting in abnormal luminescence values ​​in the luminescent substrate / excitation solution of each system, frequently leading to abnormal test results. If such false results are not identified, they can directly cause clinical laboratories to send incorrect clinical reports, resulting in medical accidents.

[0087] However, manufacturers are currently unaware of these issues, let alone having any measures or devices to identify abnormal test values ​​caused by particulate matter. From a clinical perspective, only highly experienced physicians are capable of interpreting test results based on a patient's specific clinical presentation. If they deem the test results inconsistent with the patient's clinical symptoms, these experienced physicians will retest the patient's sample.

[0088] This invention addresses this problem by proposing a testing method and sample analysis device based on chemiluminescence reaction to determine the reliability of the current test results and whether the current test results are abnormal due to the introduction of the aforementioned interfering substances, thus making the test results abnormal as well.

[0089] Specifically, based on the fact that particulate matter, after being added to the substrate and mixed, can settle to the bottom of the reaction vessel within a short time, such as 1 to 5 seconds, these settled particles continuously catalyze the luminescence of the surrounding substrate, thus causing the luminescence signal of the lower substrate to be higher than that of the upper substrate. For example Figure 2 The data from the inventor's experiments are shown in the left and right graphs. The solid line represents the luminescence signal value of the lower substrate, and the dashed line represents the luminescence signal value of the upper substrate. Specifically, the left graph shows the luminescence signal curve of the sample particles with strong jump values, where the luminescence signals of the upper and lower substrates differ significantly. The right graph shows the luminescence signal curve of the sample particles with weak jump values, or non-jump values, where the luminescence signals of the upper and lower substrates are relatively similar. Therefore, the applicant proposes that by analyzing and comparing the differences in luminescence values ​​between the upper and lower substrates, it is possible to predict jump values ​​and avoid false results that could lead to misjudgments in clinical testing.

[0090] The present invention will now be described.

[0091] Please refer to Figure 3 The sample analysis apparatus of some embodiments of the present invention includes a reaction cup loading mechanism 1, a sample injection component 33, a sample dispensing mechanism 3, a reagent component 5, a reagent dispensing mechanism 6, a reaction component 4, a measuring component 10, a magnetic separation component 91, a transfer mechanism, and a processor 99, which are described in detail below.

[0092] The reaction cup loading mechanism 1 is used to supply and transport empty reaction cups, for example, to supply and transport reaction cups to a dispensing position. In one embodiment, the dispensing position is used for a transfer mechanism to dispatch reaction cups to a sample dispensing position. In one embodiment, the reaction cup loading mechanism 1 includes a hopper 101, a pick-up mechanism 102, a reversing mechanism 103, and a transfer mechanism 104. The hopper 101 is used to store reaction cups. The pick-up mechanism 102 is used to pick up, transfer, and unload reaction cups. The reversing mechanism 103 is connected after the pick-up mechanism 102 and has a conveying groove that is obliquely downward from one side of the pick-up mechanism 102. The conveying groove has a size that allows the lower part of the reaction cup to extend into it, and the width of the conveying groove is smaller than the width of the suspension portion on the reaction cup. The conveying groove has a first groove bottom wall at least at one end near the pick-up mechanism 102, and the distance from the first groove bottom wall to the upper edge of the conveying groove is smaller than the distance from the bottom of the reaction cup to the suspension portion. The transfer mechanism 104 is connected to the reaction cup outlet of the aforementioned transfer tank. The transfer mechanism 104 has at least one reaction cup position for storing the reaction cup; the transfer mechanism 104 also has the aforementioned cup-separating position, for example, one of the reaction cup positions on the transfer mechanism 104 can be set as a cup-separating position. In one embodiment, the transfer mechanism 104 can be a disc-type structure.

[0093] The sample introduction component 33 is used to supply the sample to be tested. For example, the sample introduction component 33 can be implemented through a sample delivery module (SDM) and a front-end track.

[0094] The sample dispensing mechanism 3 is used to aspirate and dispense samples into reaction cups, for example, aspirating samples and dispensing them into reaction cups located at the sample dispensing position. In one embodiment, the sample dispensing mechanism 3 can be implemented using a sample needle, and the number of sample needles can be one. In one embodiment, the entire process of the sample dispensing mechanism 3 completing one sample dispensing or dispensing operation is as follows: moving to the aspiration position to aspirate the sample, then moving to the corresponding cleaning position to clean the outer wall, then moving to the sample dispensing position to dispense the aspirated sample into the reaction cup located at the sample dispensing position, and finally moving to the corresponding cleaning position to clean the inner and outer walls, for example, the cleaning of the sample dispensing mechanism 3 can be performed at the sample needle cleaning unit 32.

[0095] The reagent component 5 is used to hold the reagent. In one embodiment, the reagent component 5 is arranged in a disc-shaped structure and has multiple positions for holding the reagent container. The reagent component 5 is rotatable and drives the reagent container it holds to rotate, so as to rotate the reagent container to the reagent aspiration position for the reagent dispensing mechanism 6 to aspirate the reagent. In one embodiment, the reagent component 5 is a single unit, which can be separately disposed outside the reaction component 4.

[0096] The reagent dispensing mechanism 6 is used to aspirate and dispense reagents into reaction cups, for example, aspirating reagents and dispensing them into the reaction cup located at the reagent addition position. In one embodiment, the reagent dispensing mechanism 6 can be implemented using a reagent needle, and the number of reagent needles can be one. In one embodiment, the entire process of the reagent dispensing mechanism 6 completing one reagent addition or dispensing operation is as follows: moving to the reagent aspiration position to aspirate the reagent, then moving to the corresponding cleaning position for external wall cleaning, then moving to the reagent addition position to dispense the aspirated reagent into the reaction cup located at the reagent addition position, and finally moving to the corresponding cleaning position for cleaning the inner and outer walls. In one embodiment, when the reagent needle is set to continuously aspirate multiple reagents and then dispense them together, the reagent needle is controlled to continuously perform multiple reagent aspiration operations to aspirate the required multiple reagents; wherein, during the process of aspirating the required multiple reagents, after completing one reagent aspiration operation and before starting the next reagent aspiration operation, the outer wall of the reagent needle is cleaned, for example, at the reagent needle cleaning pool unit 61.

[0097] The reaction component 4 includes multiple holes or placement positions for placing reaction cups; the reaction component 4 is used to incubate the reaction solution formed by the sample and reagents in the reaction cups. In some embodiments, the reaction component 4 is arranged in a disk-shaped structure, having multiple holes or placement positions for placing reaction cups. The reaction component 4 is rotatable and drives the reaction cups in its placement positions to rotate, for managing the reaction cups and incubating the reaction solution in the reaction cups within the reaction component 4. In one embodiment, the reaction component 4 includes an inner ring portion and an outer ring portion that can rotate independently or together; the inner ring portion includes one or more rings of tracks, each ring of tracks having a plurality of placement positions for incubating the reaction cups and managing the reaction cups between the placement positions in the inner ring portion; the outer ring portion includes one or more rings of tracks, each ring of tracks having a plurality of placement positions for managing the reaction cups between the placement positions in the outer ring portion. Figure 3 The image shows an outer ring portion with one orbital 4a and an inner ring portion with three orbital 4b, 4c, and 4d. In one embodiment, the reaction component 4 is a single unit.

[0098] In one embodiment, the reaction component 4 has a measuring position and / or a waste liquid suction position; the measuring position is used for the measuring component 10 to measure the reaction cup, that is, the measuring component 10 measures the reaction cup that has been dispatched to the measuring position. In one embodiment, when the measuring component 10 is a photometric unit, the measuring position is a photometric position; after the measurement is completed, the waste liquid is suctioned from the reaction cup at the waste liquid suction position. In one embodiment, the measuring position and the waste liquid suction position are disposed on the outer ring of the reaction component 4. For example, the measuring position and the waste liquid suction position are both placement positions or holes on the outer ring of the reaction component 4. Figure 3The device includes a measurement position 414 and a waste liquid aspiration position 415. After the reaction cup has been measured, waste liquid is aspirated at the waste liquid aspiration position. In one embodiment, the sample analysis device further includes a waste liquid aspiration unit 11 for aspirating the reaction liquid from the completed reaction cup. The waste liquid aspiration unit 11 includes a waste liquid aspiration needle, the movement trajectory of which passes through the waste liquid aspiration position. In one embodiment, a reagent addition position is located within the reaction component 4, i.e., the reaction component 4 has a reagent addition position. In one embodiment, the reagent addition position is located on the outer ring of the reaction component 4, for example... Figure 3 The reagent addition site 412 is located in the reaction component 4; in one embodiment, the reagent addition site is disposed inside or outside the reaction component 4, for example... Figure 3 The image shows the sample application position 31, which is located outside the reaction component 4.

[0099] The measuring component 10 is used to measure the reaction solution to be tested. In one embodiment, the measuring component 10 is a photometric unit, for example, detecting the luminescence intensity of the reaction solution to be tested, and calculating the concentration of the analyte in the sample using, for example, a calibration curve. In one embodiment, the measuring component 10 is separately disposed outside the reaction component 4. In one embodiment, the measuring component 10 is separately disposed from the magnetic separation component 91. The measuring position can be disposed inside the reaction component 4 or outside the reaction component 4.

[0100] The magnetic separation component 91 is used to perform magnetic separation and cleaning of the reaction liquid in the reaction cup. In one embodiment, the magnetic separation component 91 includes a magnetic separation disk with a disc-shaped structure. The magnetic separation disk has one or more independently or simultaneously moving tracks, each track including multiple placement positions for placing the reaction cup. The magnetic separation disk can rotate and drive the reaction cups in its placement positions to rotate, thereby maneuvering the reaction cups within the magnetic separation disk to the liquid injection and liquid aspiration positions to complete the magnetic separation and cleaning. In one embodiment, the magnetic separation component 91 is separately disposed outside the reaction component 4.

[0101] The transfer mechanism is used to schedule the reaction cups, for example, to schedule the reaction cups at least between the reaction cup loading mechanism 1, the reaction component 4, and the magnetic separation component 91.

[0102] Let's take a one-step test as an example to illustrate the coordination of the above-mentioned mechanisms, units, and components. Under the control of the processor 99, the transfer mechanism dispatches a reaction cup from the dispensing position of the reaction cup loading mechanism 1 to the sample dispensing position. The sample dispensing mechanism 3 draws the sample from the injection component 33 and dispenses it into the reaction cup located at the sample dispensing position. The sample dispensing position can be located inside the reaction component 4, that is, the sample dispensing position is a placement position in the reaction component 4, or it can be located outside the reaction component 4. When the sample dispensing position is outside the reaction component 4, the transfer mechanism dispatches the reaction cup located at the sample dispensing position and after sample dispensing to the reaction component 4. The reaction cup is then incubated by the reagent dispensing mechanism 6 inside the reaction component 4. After the incubation is completed, the reaction cup is dispatched from the reaction component 4 to the magnetic separation component 91 by the transfer mechanism for magnetic separation and cleaning. After the magnetic separation and cleaning is completed, the reaction cup is dispatched from the magnetic separation component 91 by the transfer mechanism for final measurement. In one embodiment, the reaction component 4 may have a measurement position. If the measurement component 10 is a photometry unit, then the reaction component 4 accordingly has a photometry position. In this case, after the reaction cup has completed magnetic separation and cleaning, it is transferred back to the reaction component 4 from the magnetic separation component 91 by the transfer mechanism. When the reaction component 4 moves the reaction cup 4 to its photometry position, the photometry unit performs photometry on the reaction cup.

[0103] To manage the reaction cups throughout the testing process, several scheduling-related positions can be set in the reaction component 4. These positions can be placement positions or apertures in the reaction component 4. In one embodiment, the reaction component 4 has a reagent addition position, a first pre-operation position, and a first post-operation position located in the outer ring, and a second post-operation position located in the inner ring, which will be described in detail below.

[0104] When the sample loading position is inside the reaction unit 4, the first front operation position is used to receive the reaction cup from the dispensing position into the reaction unit 4 by the transfer mechanism. When the sample loading position is outside the reaction unit 4, the first front operation position is used to receive the reaction cup dispatched from the sample loading position to the reaction unit 4 by the transfer mechanism. The first rear operation position is used to receive the reaction cup dispatched from the magnetic separation unit 91 to the reaction unit 4 by the transfer mechanism. The second rear operation position is used to allow the transfer mechanism to dispatch the reaction cup to the magnetic separation unit 91, or to receive the reaction cup dispatched from the mixing mechanism to the reaction unit 4 by the transfer mechanism. Of course, the functions of the above operation positions can also have other variations, and can be changed and set according to the actual situation in specific implementation.

[0105] To coordinate with the various scheduling-related positions within the reaction unit 4, in one embodiment, the transfer mechanism may include a first cup gripper 2 and a second cup gripper 7. In one embodiment, the first cup gripper 2 is configured to move through the dispensing position and the first pre-operation position; when the sample dispensing position is outside the reaction unit 4, the first cup gripper 2's movement trajectory also passes through the sample dispensing position. The second cup gripper 7 is configured to move through the first post-operation position, the second post-operation position, and the magnetic separation unit 91. In one embodiment, the first cup gripper 2 is a three-dimensional moving structure or a rotating structure, and the second cup gripper 7 is a three-dimensional moving structure or a rotating structure. The scheduling between the above positions can also be arranged on the movement trajectories of the corresponding cup grippers according to actual conditions.

[0106] When the sample addition position is located inside the reaction unit 4, the sample addition position can be the same position as the first pre-operation position or a different position; when the sample addition position is located outside the reaction unit 4, the reagent addition position can be the same position as the first pre-operation position or a different position.

[0107] Let's take the case where the sample addition position is located outside the reaction unit 4, and the reagent addition position and the first pre-operation position are not in the same location, for example... Figure 3 This section explains the scheduling and coordination between different positions from the perspective of a one-step test project's test process.

[0108] Under the control of processor 99, the first cup grabber 2 dispatches a reaction cup from the dispensing position of the reaction cup loading mechanism 1 to the sample dispensing position 31. After the sample dispensing mechanism 3 draws a sample from the injection component 33, it discharges the drawn sample into the reaction cup at the sample dispensing position 31. The first cup grabber 2 then dispatches the sample-dispensed reaction cup from the sample dispensing position 31 to the first pre-operation position 411 in the reaction component 4. The reaction component 4 then dispatches the reaction cup from the first pre-operation position 411 to the reagent dispensing position 412. The reagent dispensing mechanism draws reagent from the reagent aspiration position of the reagent unit 5 and discharges it into the reagent dispensing position 412. The reaction vessel is moved from the reaction vessel to the first post-operation position 413 by the reaction component 4, and then moved from the second post-operation position 42 by the second cup gripper 7 for incubation. After incubation, when the reaction vessel is not in the second post-operation position 42, the reaction component 4 will reposition the reaction vessel within the reaction component 4, first moving it to the second post-operation position 42, and then the second cup gripper 7 will move it from the second post-operation position 42 to the magnetic separation component 91 for magnetic separation and cleaning. After magnetic separation and cleaning, the second cup gripper 7 will move the reaction vessel from the magnetic separation component 91 to the magnetic separation component 91. Component 91 is dispatched to the first post-operation position 413 of the reaction component 4; then, within the predetermined substrate incubation time, the reaction component 4 can just dispatch the reaction cup to the measurement position 414 for measurement by the measurement component 10; then, the reaction component 4 dispatches the reaction cup from the measurement position 414 to the waste liquid suction position 415, the waste liquid suction unit 11 sucks up the waste liquid in the reaction cup at the waste liquid suction position 415, the reaction component 4 then dispatches the reaction cup from the waste liquid suction position 415 to the first pre-operation position 411, and the first cup gripper 2 then performs a cup-throwing operation on the reaction cup, for example, the first cup gripper 2 throws the reaction cup. The first pre-operation position 411 discards the reaction cups into one of the discarding holes 201 and 202. Discarding hole 201 is connected to a receiving device for waste cups, such as a waste bin, and discarding hole 202 is also connected to a receiving device for waste cups. The processor 99 can control the first cup gripper 2 to discard the reaction cups to be discarded from the first pre-operation position 411 into the discarding hole 201. When the receiving device for waste cups connected to the discarding hole 201 is full, the processor 99 notifies the user to replace the receiving device and controls the first cup gripper 2 to discard the reaction cups to be discarded from the first pre-operation position 411 into the discarding hole 202. The reaction cups that have undergone magnetic separation cleaning are then subjected to substrate addition for measurement. In one embodiment, substrate addition to the reaction cups can be performed in the magnetic separation component 91. In another embodiment, substrate addition to the reaction cups can also be performed on the reaction component 4, and correspondingly, a substrate addition position can be provided on the reaction component 4.

[0109] The above is a brief description of the sample analysis device.

[0110] In some embodiments of the present invention, two types of luminescence signals are acquired to determine whether the test is abnormal. For example, in some embodiments, the processor 99 controls the sample dispensing mechanism 3 and the reagent dispensing mechanism 6 to add the sample to be tested and the reagent to the reaction cup to prepare the reaction solution, controls the reaction component 4 to incubate the reaction solution in the reaction cup, and controls the magnetic separation component 91 to perform magnetic separation and cleaning of the reaction solution in the reaction cup. Then, the processor 99 controls the sample dispensing mechanism 6 to add a signal reagent to the reaction solution in the reaction cup after magnetic separation and cleaning, so that the reaction solution emits light. In some examples, the signal reagent can be a luminescent substrate liquid, a pre-excitation liquid, an excitation liquid, and a luminescence enhancement liquid, etc. The processor 99 acquires a first type of luminescence signal containing the luminescence signal of the lower reaction solution and a second type of luminescence signal containing the luminescence signal of the upper reaction solution. The second type of luminescence signal is different from the first type of luminescence signal. Based on the first type of luminescence signal and the second type of luminescence signal, the processor determines whether the test is abnormal.

[0111] The first and second types of luminescent signals can take many forms. For example, in one case, the first type of luminescent signal is the luminescent signal of the lower layer of the reaction liquid in the reaction vessel, and the second type of luminescent signal is the luminescent signal of the upper layer of the reaction liquid in the reaction vessel. In another case, the first type of luminescent signal is the luminescent signal of the lower layer of the reaction vessel, and the second type of luminescent signal is the luminescent signal of the entire reaction liquid in the reaction vessel. In yet another case, the first type of luminescent signal is the luminescent signal of the entire reaction liquid in the reaction vessel, and the second type of luminescent signal is the luminescent signal of the upper layer of the reaction vessel. The following details how to obtain these two types of luminescent signals.

[0112] In some cases, the two types of signals mentioned above can be obtained by dividing the cup.

[0113] In some embodiments, the processor 99 further controls the measuring component 10 to acquire a third type of luminescence signal of the entire reaction liquid in the reaction cup; the third type of luminescence signal can be used to calculate the test result, and the third type of luminescence signal can be a luminescence signal at a specific moment or a luminescence signal at multiple specific moments. After acquiring the third type of luminescence signal, the processor 99 controls the sample dispensing mechanism 3 to draw the upper layer of reaction liquid in the reaction cup and discharge it into a new reaction cup, and controls the measuring component 10 to acquire the luminescence signal of the entire reaction liquid in the new reaction cup as a second type of luminescence signal, and controls the measuring component 10 to acquire the luminescence signal of the remaining reaction liquid in the original reaction cup as a first type of luminescence signal. When the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor 99 calculates the test result based on the third type of luminescence signal.

[0114] In some embodiments, the processor 99 controls the measuring component 10 to acquire the luminescence signal of the entire reaction liquid in the reaction cup as a second type of luminescence signal; after acquiring the second type of luminescence signal, the processor 99 controls the sample dispensing mechanism 3 to absorb and remove the upper layer of reaction liquid in the reaction cup, and controls the measuring component 10 to acquire the luminescence signal of the remaining reaction liquid in the original reaction cup as a first type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor 99 calculates the test result based on the second type of luminescence signal. It can be understood that since the second type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction cup, in addition to being used as the luminescence signal for judging the test to be normal in this embodiment, it can also be reused as the luminescence signal for calculating the test result.

[0115] In some embodiments, the processor 99 controls the measuring component 10 to acquire the luminescence signal of the entire reaction liquid in the reaction cup as a first type of luminescence signal; after acquiring the first type of luminescence signal, the processor 99 controls the sample dispensing mechanism 3 to draw up the upper layer of reaction liquid in the reaction cup and discharge it into a new reaction cup, and controls the measuring component 10 to acquire the luminescence signal of the entire reaction liquid in the new reaction cup as a second type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor 99 calculates the test result based on the first type of luminescence signal. It can be understood that since the first type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction cup, in addition to being used as the luminescence signal for judging the test to be normal in this embodiment, it can also be reused as the luminescence signal for calculating the test result.

[0116] In some cases, the two types of signals mentioned above can also be obtained by not separating the cups.

[0117] In some schemes, a receiver 12 capable of acquiring light signals—such as a photomultiplier tube PMT—can be introduced to identify the light emission signals of the upper and lower substrates. Figure 4 This is one example.

[0118] In some embodiments, the processor 99 controls the receiver 12 to identify and receive the light emission signal of the lower layer of reaction liquid in the reaction cup as a first type of light emission signal, and to identify and receive the light emission signal of the upper layer of reaction liquid in the reaction cup as a second type of light emission signal; the processor 99 controls the measuring component 10 to acquire the third type of light emission signal of the entire reaction liquid in the reaction cup; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the third type of light emission signal.

[0119] In some embodiments, the processor 99 controls the receiver 12 to identify and receive the light emission signal of the lower layer of the reaction liquid in the reaction cup as a first type of light emission signal; the processor 99 controls the measuring component 10 to acquire the light emission signal of the entire reaction liquid in the reaction cup as a second type of light emission signal; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the second type of light emission signal. It can be understood that since the second type of light emission signal is the light emission signal of the entire reaction liquid in the reaction cup, in addition to being used as the light emission signal for judging the test to be normal in this embodiment, it can also be reused as the light emission signal for calculating the test result.

[0120] In some embodiments, the processor 99 controls the receiver 12 to identify and receive the light emission signal of the upper reaction liquid in the reaction cup as a second type of light emission signal; the processor 99 controls the measuring component 10 to acquire the light emission signal of the entire reaction liquid in the reaction cup as a first type of light emission signal; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the first type of light emission signal. It can be understood that since the first type of light emission signal is the light emission signal of the entire reaction liquid in the reaction cup, in addition to being used as the light emission signal for judging the test to be normal in this embodiment, it can also be reused as the light emission signal for calculating the test result.

[0121] Some embodiments, for example Figure 5 A receiver 13 capable of acquiring light signals can be introduced into the sample analysis device. This receiver 13 is configured to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel. The processor 99 controls the receiver 13 to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel as a first type of light emission signal; the processor 99 controls the measuring component 10 to acquire the light emission signal from the entire reaction liquid in the reaction vessel as a second type of light emission signal; when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the second type of light emission signal. It can be understood that since the second type of light emission signal is the light emission signal from the entire reaction liquid in the reaction vessel, it can be reused not only as the light emission signal for determining that the test is normal in this embodiment, but also as the light emission signal for calculating the test result.

[0122] Some embodiments, for example Figure 6A receiver 14 capable of acquiring light signals can be introduced into the sample analysis device. This receiver is configured to receive the light emission signal from the upper layer of the reaction liquid in the reaction vessel. The processor 99 controls the receiver 14 to receive the light emission signal from the upper layer of the reaction liquid in the reaction vessel as a second type of light emission signal; the processor 99 controls the measuring component 10 to acquire the light emission signal from the entire reaction liquid in the reaction vessel as a first type of light emission signal; when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the first type of light emission signal. It can be understood that since the first type of light emission signal is the light emission signal from the entire reaction liquid in the reaction vessel, it can be reused not only as the light emission signal for determining that the test is normal in this embodiment, but also as the light emission signal for calculating the test result.

[0123] Some embodiments, for example Figure 7 Two receivers 13 and 14 capable of transmitting light signals can be introduced into the sample analysis device. One receiver 13 is configured to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel, and the other receiver 14 is configured to receive the light emission signal from the upper layer of the reaction liquid in the reaction vessel. The processor controls the two receivers 13 and 14 to receive the light emission signal from the lower layer of the reaction vessel as a first type of light emission signal and to receive the light emission signal from the upper layer of the reaction vessel as a second type of light emission signal, respectively. In some examples, the two receivers 13 and 14 can perform synchronous photometry. The processor 99 controls the measuring component 10 to acquire the third type of light emission signal of the entire reaction liquid in the reaction vessel. When the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the third type of light emission signal.

[0124] In some solutions, different types of light emission signals can be obtained by blocking the upper or lower half of the aperture.

[0125] In some embodiments, the reaction component 4 includes a first aperture and / or a second aperture; the upper half of the first aperture is blocked so that only the light emission signal of the lower reaction liquid in the reaction cup placed therein is allowed to pass through the unblocked lower half of the first aperture; the lower half of the second aperture is blocked so that only the light emission signal of the upper reaction liquid in the reaction cup placed therein is allowed to pass through the unblocked upper half of the second aperture. For example Figure 8 This is an example of the first hole position, the second hole position, and the normal hole position.

[0126] In some embodiments, the processor 99 controls the measuring component 10 to acquire the light emission signal of the entire reaction liquid in the reaction cup as a second type of light emission signal; the processor 99 controls the transfer mechanism to move the reaction cup to the first orifice, and acquires the light emission signal of the lower layer of reaction liquid in the reaction cup through the measuring component 10 as a first type of light emission signal; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the second type of light emission signal. It can be understood that since the second type of light emission signal is the light emission signal of the entire reaction liquid in the reaction cup, in addition to being used as the light emission signal for judging the test to be normal in this embodiment, it can also be reused as the light emission signal for calculating the test result.

[0127] In some embodiments, the processor 99 controls the measuring component 10 to acquire the light emission signal of the entire reaction liquid in the reaction cup as a first type of light emission signal; the processor 99 controls the transfer mechanism to move the reaction cup to the second position hole, and acquires the light emission signal of the upper layer of reaction liquid in the reaction cup through the measuring component 10 as a second type of light emission signal; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the first type of light emission signal. It can be understood that since the first type of light emission signal is the light emission signal of the entire reaction liquid in the reaction cup, in addition to being used as the light emission signal for judging the test to be normal in this embodiment, it can also be reused as the light emission signal for calculating the test result.

[0128] The processor 99 controls the measuring component 10 to acquire the third type of luminescence signal of the overall reaction liquid in the reaction cup; the processor 99 controls the transfer mechanism to move the reaction cup to the first orifice, and acquires the luminescence signal of the lower layer of reaction liquid in the reaction cup through the measuring component 10 as the first type of luminescence signal; the processor 99 controls the transfer mechanism to move the reaction cup to the second orifice, and acquires the luminescence signal of the upper layer of reaction liquid in the reaction cup through the measuring component 10 as the second type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor 99 calculates the test result based on the third type of luminescence signal.

[0129] In some solutions, a movable obstruction window can be used to acquire different types of signals. For example... Figure 9 As an example, the shielding windows include a normal, intact window—the luminescence signal of the entire reaction liquid in the reaction vessel can be transmitted through the normal, intact window; an upper window—the luminescence signal of the upper layer of reaction liquid in the reaction vessel can be transmitted through the upper window; and a lower window—the luminescence signal of the lower layer of reaction liquid in the reaction vessel can be transmitted through the lower window. Figure 9 The shielding window can be rotated and moved in the manner indicated by the arrows in the diagram, so that the window between the receiver or measuring component 10 and the reaction cup is a normal, complete window, an upper window, or a lower window, thereby allowing the receiver or measuring component 10 to receive different light emission signals. Figure 10 In another example, the blocking window includes a half-window. By moving the blocking window up and down, when this half-window faces the upper layer of the reaction liquid in the reaction cup, the light emission signal of the upper layer of the reaction liquid in the reaction cup can be transmitted through the half-window, while the light emission signal of the lower layer of the reaction liquid in the reaction cup is blocked; when this half-window faces the lower layer of the reaction liquid in the reaction cup, the light emission signal of the lower layer of the reaction liquid in the reaction cup can be transmitted through the half-window, while the light emission signal of the upper layer of the reaction liquid in the reaction cup is blocked; in some examples, when the blocking window is moved upward, the blocking window can completely not block the reaction cup, and in this case, the light emission signal of the entire reaction liquid in the reaction cup can be obtained by, for example, the measuring component 10.

[0130] In some embodiments, the processor 99 controls the measuring component 10 to acquire the light emission signal of the entire reaction liquid in the reaction cup as a second type of light emission signal; the processor 99 controls the shielding window to move to a predetermined position so as to acquire, for example, the light emission signal of the lower layer of reaction liquid in the reaction cup as a first type of light emission signal through the measuring component 10; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result based on the second type of light emission signal. It can be understood that since the second type of light emission signal is the light emission signal of the entire reaction liquid in the reaction cup, in addition to being used as the light emission signal for judging the test to be normal in this embodiment, it can also be reused as the light emission signal for calculating the test result.

[0131] In some embodiments, the processor 99 controls the measuring component 10 to acquire the light emission signal of the entire reaction liquid in the reaction cup as a first type of light emission signal; the processor 99 controls the shielding window to move to a predetermined position to acquire, for example, the light emission signal of the upper layer of reaction liquid in the reaction cup as a second type of light emission signal through the measuring component 10; when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, the processor 99 calculates the test result using the first type of light emission signal. It can be understood that since the first type of light emission signal is the light emission signal of the entire reaction liquid in the reaction cup, in addition to being used as the light emission signal for judging the test to be normal in this embodiment, it can also be reused as the light emission signal for calculating the test result.

[0132] In some embodiments, the processor 99 controls the measuring component 10 to acquire a third type of luminescence signal of the overall reaction liquid in the reaction cup; the processor 99 controls the shielding window to move to different positions respectively, so as to acquire, for example, the luminescence signal of the lower layer of reaction liquid in the reaction cup as a first type of luminescence signal, and the luminescence signal of the upper layer of reaction liquid in the reaction cup as a second type of luminescence signal through the measuring component 10; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor 99 calculates the test result based on the third type of luminescence signal.

[0133] In some of the above embodiments, the processor 99 can determine whether the test is normal based on the first type of light emission signal and the second type of light emission signal as follows: The test is judged to be normal based on the ratio of the first type of light emission signal and the second type of light emission signal; when the ratio is greater than a threshold, the test is judged to be abnormal. This threshold can be a fixed value or a range. For example, when the first type of light emission signal is the light emission signal of the lower layer of reaction liquid and the second type of light emission signal is the light emission signal of the upper layer of reaction liquid, the threshold range can be 1.05 to 1.2.

[0134] The above describes the sample analysis apparatus of some embodiments of the present invention. Some embodiments of the present invention also disclose a test method based on chemiluminescence reaction, which will be described in detail below.

[0135] Please refer to Figure 11 Some embodiments of the chemiluminescence-based testing method include the following steps:

[0136] Step 1000: Control the addition of the sample to be tested and reagents to the reaction vessel to prepare the reaction solution.

[0137] Step 1100: Control the incubation and magnetic separation cleaning of the reaction solution in the reaction vessel.

[0138] Step 1200: Control the addition of a signal reagent to the reaction solution in the reaction vessel after magnetic separation and cleaning, so that the reaction solution emits light. In some examples, the signal reagent may be a luminescent substrate solution, a pre-excitation solution and an excitation solution, as well as a luminescence enhancement solution, etc.

[0139] Step 2100: Obtain the first type of luminescence signal containing the luminescence signal of the lower reaction liquid;

[0140] Step 2200: Obtain a second type of luminescence signal containing the luminescence signal of the upper reaction liquid. The second type of luminescence signal is different from the first type of luminescence signal.

[0141] Step 2300: Determine whether the test is abnormal based on the first type of light emission signal and the second type of light emission signal.

[0142] In some embodiments, step 2300 can determine whether the test is normal based on the first type of luminescence signal and the second type of luminescence signal: the ratio of the first type of luminescence signal to the second type of luminescence signal is used to determine whether the test is normal; when the ratio is greater than a threshold, the test is considered abnormal. This threshold can be a fixed value or a range. For example, when the first type of luminescence signal is the luminescence signal of the lower layer of the reaction liquid and the second type of luminescence signal is the luminescence signal of the upper layer of the reaction liquid, the threshold range can be 1.05 to 1.2.

[0143] The first and second types of luminescent signals can take many forms. For example, in one case, the first type of luminescent signal is the luminescent signal of the lower layer of the reaction liquid in the reaction vessel, and the second type of luminescent signal is the luminescent signal of the upper layer of the reaction liquid in the reaction vessel. In another case, the first type of luminescent signal is the luminescent signal of the lower layer of the reaction vessel, and the second type of luminescent signal is the luminescent signal of the entire reaction liquid in the reaction vessel. In yet another case, the first type of luminescent signal is the luminescent signal of the entire reaction liquid in the reaction vessel, and the second type of luminescent signal is the luminescent signal of the upper layer of the reaction vessel. The following details how to obtain these two types of luminescent signals.

[0144] The following section will first describe the scheme in which the first type of luminescent signal is the luminescent signal of the lower layer of the reaction liquid in the reaction vessel, and the second type of luminescent signal is the luminescent signal of the upper layer of the reaction vessel.

[0145] Please refer to Figure 12 Some embodiments of the chemiluminescence reaction-based testing method further include step 2000, acquiring a third type of luminescence signal of the entire reaction liquid in the reaction vessel. The third type of luminescence signal can be used to calculate the test result; it can be a luminescence signal at a specific moment or at multiple specific moments. A first type of luminescence signal and a second type of luminescence signal can be acquired in the same reaction vessel. For example, in step 2100, the luminescence signal of the lower layer of the reaction liquid in the reaction vessel can be acquired as the first type of luminescence signal; in step 2200, the luminescence signal of the upper layer of the reaction liquid in the reaction vessel can be acquired as the second type of luminescence signal. In some embodiments, when step 2300 determines that the test is normal based on the first and second type of luminescence signals, step 2400 calculates the test result based on the third type of luminescence signal.

[0146] Alternatively, a cup-splitting method can be used to obtain different types of luminous signals. For example, please refer to... Figure 13 After acquiring the third type of luminescence signal in step 2000, in step 2010, the upper layer of reaction liquid in the reaction cup is drawn and discharged into a new reaction cup; in step 2200, the luminescence signal of the entire reaction liquid in the new reaction cup is acquired as the second type of luminescence signal; in step 2100, the luminescence signal of the remaining reaction liquid in the original reaction cup is acquired as the first type of luminescence signal. In some embodiments, when step 2300 determines that the test is normal based on the first and second type of luminescence signals, step 2400 calculates the test result based on the third type of luminescence signal.

[0147] The following section will further explain the scheme in which the first type of luminescent signal is the luminescent signal of the lower layer of the reaction liquid in the reaction vessel, and the second type of luminescent signal is the luminescent signal of the entire reaction liquid in the reaction vessel.

[0148] Please refer to Figure 14 In some embodiments, step 2100 may involve acquiring the luminescence signal of the lower layer of the reaction liquid in the reaction vessel as a first type of luminescence signal; step 2200 may involve acquiring the luminescence signal of the entire reaction liquid in the reaction vessel as a second type of luminescence signal. In some embodiments, when step 2300 determines that the test is normal based on the first type of luminescence signal and the second type of luminescence signal, step 2400 calculates the test result based on the second type of luminescence signal. Since the second type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction vessel, in addition to being used as the luminescence signal for determining that the test is normal in this embodiment, it can also be reused as the luminescence signal for calculating the test result.

[0149] Please refer to Figure 15 In some embodiments, step 2200 may involve acquiring the luminescence signal of the entire reaction liquid in the reaction vessel as a second type of luminescence signal; after acquiring the second type of luminescence signal in step 2200, step 2020 controls the aspiration and removal of the upper layer of reaction liquid in the reaction vessel; step 2100 may involve acquiring the luminescence signal of the remaining reaction liquid in the original reaction vessel as a first type of luminescence signal. In some embodiments, when step 2300 determines that the test is normal based on the first type of luminescence signal and the second type of luminescence signal, step 2400 calculates the test result based on the second type of luminescence signal. Since the second type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction vessel, in addition to being used as the luminescence signal for determining that the test is normal in this embodiment, it can also be reused as the luminescence signal for calculating the test result.

[0150] The following section will further explain the scheme in which the first type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction vessel, and the second type of luminescence signal is the luminescence signal of the upper layer of reaction liquid in the reaction vessel.

[0151] Please refer to Figure 16 In some embodiments, step 2100 may involve acquiring the luminescence signal of the entire reaction liquid in the reaction vessel as a first type of luminescence signal; step 2200 may involve acquiring the luminescence signal of the upper layer of reaction liquid in the reaction vessel as a second type of luminescence signal. In some embodiments, when step 2300 determines that the test is normal based on the first type of luminescence signal and the second type of luminescence signal, step 2400 calculates the test result based on the first type of luminescence signal. Since the first type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction vessel, in addition to being used as the luminescence signal for determining that the test is normal in this embodiment, it can also be reused as the luminescence signal for calculating the test result.

[0152] Please refer to Figure 17In some embodiments, step 2100 may involve acquiring the luminescence signal of the entire reaction liquid in the reaction vessel as a first type of luminescence signal; after acquiring the first type of luminescence signal in step 2100, step 2030 controls the aspiration of the upper layer of reaction liquid in the reaction vessel and discharges it into a new reaction vessel; step 2200 may involve acquiring the luminescence signal of the entire reaction liquid in the new reaction vessel as a second type of luminescence signal. In some embodiments, when step 2300 determines that the test is normal based on the first type of luminescence signal and the second type of luminescence signal, step 2400 calculates the test result based on the first type of luminescence signal. Since the first type of luminescence signal is the luminescence signal of the entire reaction liquid in the reaction vessel, in addition to being used as the luminescence signal for determining that the test is normal in this embodiment, it can also be reused as the luminescence signal for calculating the test result.

[0153] This is a description of the chemiluminescence reaction-based testing method of the present invention.

[0154] Some embodiments of the present invention can predict in advance abnormal luminescence of the reaction liquid caused by the introduction of interfering substances, thus avoiding the sending of erroneous clinical reports. This is a scheme for identifying abnormal luminescence values ​​caused by heterogeneous substances, and can provide early warning of jump values.

[0155] This document describes various exemplary embodiments with reference to them. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope of this document. For example, various operational steps and components for performing operational steps can be implemented in different ways depending on the specific application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps can be deleted, modified, or combined with other steps).

[0156] In the above embodiments, implementation can be achieved, in whole or in part, by software, hardware, firmware, or any combination thereof. Furthermore, as those skilled in the art will understand, the principles herein can be reflected in a computer program product on a computer-readable storage medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions can be loaded onto a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to form a machine, such that instructions executing on the computer or other programmable data processing apparatus can generate means for implementing a specified function. These computer program instructions can also be stored in a computer-readable storage medium that can instruct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium can form an article of manufacture including means for implementing the specified function. The computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to perform a series of operational steps on the computer or other programmable apparatus to produce a computer-implemented process, such that instructions executing on the computer or other programmable apparatus can provide steps for implementing the specified function.

[0157] While the principles herein have been illustrated in various embodiments, numerous modifications to the structures, arrangements, proportions, elements, materials, and components, particularly suited to specific environments and operational requirements, may be used without departing from the principles and scope of this disclosure. These modifications and other alterations or alterations will be included within the scope of this document.

[0158] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, article, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.

[0159] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined only by the claims.

Claims

1. A testing method based on chemiluminescence reaction, characterized in that, include: The sample to be tested and reagents are added to the reaction vessel in a controlled manner to prepare the reaction solution; Control the incubation and magnetic separation cleaning of the reaction solution in the reaction vessel; A signal reagent is added to the reaction solution in the reaction vessel after magnetic separation and cleaning to make the reaction solution glow; Acquire the first type of luminescence signal that includes the luminescence signal of the lower reaction liquid; Acquire a second type of luminescence signal that includes the luminescence signal of the upper reaction liquid, the second type of luminescence signal being different from the first type of luminescence signal; Based on the first type of luminescence signal and the second type of luminescence signal, it is determined whether the test is abnormal; wherein, the first type of luminescence signal and the second type of luminescence signal characterize the luminescence intensity of the reaction solution.

2. The test method as described in claim 1, characterized in that: It also acquires the third type of luminescence signal of the entire reaction liquid in the reaction vessel.

3. The test method as described in claim 2, characterized in that: The luminescence signal of the lower layer of reaction liquid in the reaction vessel is acquired and used as the first type of luminescence signal; The luminescence signal of the upper reaction liquid in the reaction vessel is acquired as the second type of luminescence signal.

4. The test method as described in claim 2, characterized in that: After acquiring the third type of luminescent signal, the upper layer of reaction liquid in the reaction cup is drawn off and discharged into a new reaction cup; The luminescence signal of the entire reaction liquid in the new reaction vessel is obtained as the second type of luminescence signal; The luminescence signal of the remaining reaction liquid in the original reaction vessel is obtained and used as the first type of luminescence signal.

5. The test method as described in any one of claims 2 to 4, characterized in that, If the test is deemed normal based on the first type of light emission signal and the second type of light emission signal, then the test result is calculated based on the third type of light emission signal.

6. The test method as described in claim 1, characterized in that, The luminescence signal of the entire reaction liquid in the reaction vessel is acquired as the second type of luminescence signal; the luminescence signal of the lower layer of reaction liquid in the reaction vessel is acquired as the first type of luminescence signal.

7. The test method as described in claim 6, characterized in that: After acquiring the second type of luminescent signal, the upper layer of reaction liquid in the reaction cup is drawn up and removed. The luminescence signal of the remaining reaction liquid in the original reaction vessel is obtained and used as the first type of luminescence signal.

8. The test method as described in claim 6 or 7, characterized in that, When the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the test result is calculated based on the second type of light emission signal.

9. The test method as described in claim 1, characterized in that, The luminescence signal of the entire reaction liquid in the reaction vessel is acquired as the first type of luminescence signal; the luminescence signal of the upper layer of reaction liquid in the reaction vessel is acquired as the second type of luminescence signal.

10. The test method as described in claim 9, characterized in that: After acquiring the first type of luminescent signal, the upper layer of reaction liquid in the reaction cup is drawn off and discharged into a new reaction cup; The luminescence signal of the entire reaction liquid in the new reaction vessel is obtained as the second type of luminescence signal.

11. The test method as described in claim 9 or 10, characterized in that, When the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the test result is calculated based on the first type of light emission signal.

12. The test method as described in claim 1, characterized in that, The step of determining whether the test is abnormal based on the first type of light emission signal and the second type of light emission signal includes: The test is judged to be abnormal based on the ratio of the first type of light emission signal to the second type of light emission signal; If the ratio is greater than a threshold, the test is judged to be abnormal; Conversely, if the result is negative, the test is considered normal.

13. A sample analysis device, characterized in that, include: A reaction cup loading mechanism for supplying and transporting empty reaction cups; Sample injection unit, used to supply the sample to be tested; The sample dispensing mechanism is used to draw and dispense samples into reaction cups; Reagent component, used to hold reagents; The reagent dispensing mechanism is used to draw and dispense reagents into the reaction vessel; The reaction component includes multiple slots for placing reaction cups; the reaction component is used to incubate the reaction solution formed by the sample and reagents in the reaction cups; The magnetic separation component is used for magnetic separation and cleaning of the reaction liquid in the reaction vessel; The measuring component is used to measure the reaction solution to be tested; A transfer mechanism is used to move the reaction cups; The processor controls the sample dispensing mechanism and reagent dispensing mechanism to add the sample and reagent to the reaction vessel to prepare the reaction solution, controls the reaction component to incubate the reaction solution in the reaction vessel, controls the magnetic separation component to perform magnetic separation and cleaning of the reaction solution in the reaction vessel, and then controls the sample dispensing mechanism to add a signal reagent to the reaction solution in the magnetically separated and cleaned reaction vessel to make the reaction solution emit light; the processor acquires a first type of light emission signal containing the light emission signal of the lower reaction solution and a second type of light emission signal containing the light emission signal of the upper reaction solution, and determines whether the test is abnormal based on the first type of light emission signal and the second type of light emission signal; The second type of luminescent signal is different from the first type of luminescent signal; wherein the first type of luminescent signal and the second type of luminescent signal characterize the luminescence intensity of the reaction solution.

14. The sample analysis apparatus as described in claim 13, characterized in that: The processor further controls the measuring component to acquire a third type of luminescence signal from the entire reaction liquid in the reaction cup; after acquiring the third type of luminescence signal, the processor controls the sample dispensing mechanism to draw up the upper layer of reaction liquid from the reaction cup and discharge it into a new reaction cup, and controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the new reaction cup as the second type of luminescence signal, and controls the measuring component to acquire the luminescence signal of the remaining reaction liquid in the original reaction cup as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the third type of luminescence signal; or, The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup, as the second type of luminescence signal; after acquiring the second type of luminescence signal, the processor controls the sample dispensing mechanism to aspirate and remove the upper layer of reaction liquid in the reaction cup, and controls the measuring component to acquire the luminescence signal of the remaining reaction liquid in the original reaction cup, as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or, The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; after acquiring the first type of luminescence signal, the processor controls the sample dispensing mechanism to draw up the upper layer of reaction liquid in the reaction cup and discharge it into a new reaction cup, and controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the new reaction cup as the second type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal.

15. The sample analysis apparatus as described in claim 13, characterized in that, It also includes a receiver capable of acquiring light signals; The processor controls the receiver to identify and receive the light emission signal of the lower layer of reaction liquid in the reaction cup as the first type of light emission signal, and to identify and receive the light emission signal of the upper layer of reaction liquid in the reaction cup as the second type of light emission signal; The processor controls the measuring component to acquire a third type of luminescence signal from the entire reaction liquid in the reaction vessel; when the test is determined to be normal based on the first and second type of luminescence signals, the processor calculates the test result based on the third type of luminescence signal; or, The processor controls the receiver to identify and receive the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal; the processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the second type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or, The processor controls the receiver to identify and receive the luminescence signal of the upper reaction liquid in the reaction cup as the second type of luminescence signal; the processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal.

16. The sample analysis apparatus as described in claim 13, characterized in that: The sample analysis device further includes a receiver capable of acquiring light signals, which is configured in the sample analysis device to specifically receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel; the processor controls the receiver to receive the light emission signal from the lower layer of the reaction liquid in the reaction vessel as the first type of light emission signal; the processor controls the measuring component to acquire the light emission signal from the entire reaction liquid in the reaction vessel as the second type of light emission signal; when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the second type of light emission signal; or, The sample analysis device further includes a receiver capable of acquiring light signals, which is configured in the sample analysis device to receive the light emission signal of the upper layer of reaction liquid in the reaction cup; the processor controls the receiver to receive the light emission signal of the upper layer of reaction liquid in the reaction cup as the second type of light emission signal; the processor controls the measuring component to acquire the light emission signal of the entire reaction liquid in the reaction cup as the first type of light emission signal; when the test is determined to be normal based on the first type of light emission signal and the second type of light emission signal, the processor calculates the test result based on the first type of light emission signal; The sample analysis device also includes two receivers capable of acquiring light signals. One receiver is configured in the sample analysis device in a manner that limits its use to receiving the light emission signal of the lower layer of reaction liquid in the reaction cup, and the other receiver is configured in the sample analysis device in a manner that limits its use to receiving the light emission signal of the upper layer of reaction liquid in the reaction cup. The processor controls the two receivers to receive the light emission signal of the lower layer of the reaction liquid in the reaction cup as the first type of light emission signal, and to receive the light emission signal of the upper layer of the reaction liquid in the reaction cup as the second type of light emission signal; The processor controls the measuring component to acquire the third type of luminescence signal of the entire reaction liquid in the reaction cup; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the third type of luminescence signal.

17. The sample analysis apparatus as described in claim 13, characterized in that, The reaction component includes a first aperture and / or a second aperture; the upper half of the first aperture is blocked so that only the light emission signal of the lower reaction liquid in the reaction cup placed therein is allowed to pass through the unblocked lower half of the first aperture; the lower half of the second aperture is blocked so that only the light emission signal of the upper reaction liquid in the reaction cup placed therein is allowed to pass through the unblocked upper half of the second aperture. The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the second type of luminescence signal; the processor controls the transfer mechanism to move the reaction cup to the first orifice, and acquires the luminescence signal of the lower layer of reaction liquid in the reaction cup through the measuring component as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or, The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; the processor controls the transfer mechanism to move the reaction cup to the second orifice, and acquires the luminescence signal of the upper layer of reaction liquid in the reaction cup through the measuring component as the second type of luminescence signal; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal; or, The processor controls the measuring component to acquire the third type of luminescence signal of the overall reaction liquid in the reaction cup; the processor controls the transfer mechanism to move the reaction cup to the first orifice, and acquires the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal through the measuring component; the processor controls the transfer mechanism to move the reaction cup to the second orifice, and acquires the luminescence signal of the upper layer of reaction liquid in the reaction cup as the second type of luminescence signal through the measuring component; when the test is judged to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the third type of luminescence signal.

18. The sample analysis apparatus as described in claim 13, characterized in that, The reaction component is arranged in a disc-shaped structure, and the reaction component can rotate to drive the reaction cup placed in its aperture to rotate; the sample analysis device also includes a movable shielding window; The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the second type of luminescence signal; the processor controls the shielding window to move to a predetermined position so that the measuring component can acquire the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the second type of luminescence signal; or, The processor controls the measuring component to acquire the luminescence signal of the entire reaction liquid in the reaction cup as the first type of luminescence signal; the processor controls the shielding window to move to a predetermined position so that the measuring component can acquire the luminescence signal of the upper layer of reaction liquid in the reaction cup as the second type of luminescence signal; when the test is determined to be normal based on the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result based on the first type of luminescence signal; or, The processor controls the measuring component to acquire the third type of luminescence signal of the overall reaction liquid in the reaction cup; the processor controls the shielding window to move to different positions respectively, so as to acquire the luminescence signal of the lower layer of reaction liquid in the reaction cup as the first type of luminescence signal and the luminescence signal of the upper layer of reaction liquid in the reaction cup as the second type of luminescence signal through the measuring component; when the test is judged to be normal according to the first type of luminescence signal and the second type of luminescence signal, the processor calculates the test result according to the third type of luminescence signal.

19. A computer-readable storage medium, characterized in that, Includes a program that can be executed by a processor to implement the method as described in any one of claims 1 to 12.

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