Sample analysis method and sample analysis device

Abstract

The present invention provides a sample analysis device and method. After adding a magnetic bead reagent to a reaction vessel containing a sample, the reaction liquid in the reaction vessel is photographed to obtain an image. By determining whether the image shows any abnormalities, a decision is made as to whether to issue an alarm or continue the test. This can reduce clinical misdiagnosis and improve the accuracy and stability of test results.

Description

Technical Field

[0001] The present invention relates to the technical field of medical analysis, and in particular to a sample analysis method and a sample analysis device. Background Art

[0002] Sample analysis devices (such as immunoassay analyzers) are a type of highly sensitive and specific analytical instrument commonly used in clinical laboratories to detect various analytical indicators in blood, urine, or other body fluids. Traditional immunoassay analyzers have various implementation principles. Among them, heterogeneous chemiluminescence immunoassay analyzers, when measuring a component in a sample, can coat the corresponding antibody / antigen onto magnetic beads to form a magnetic bead reagent. The sample to be tested, the magnetic bead reagent, and other reagents are mixed together to form a sample-reagent reaction solution (referred to as the reaction solution). The reaction is then incubated under certain conditions to form a reaction complex. Unbound components in the reaction system are then removed through a Bound-free (generally referred to as B / F) washing and separation technique. A luminescent reagent (luminescent substrate solution or pre-excitation solution, excitation solution, and luminescence enhancement solution) is then added to the reaction solution, and the reaction solution is finally measured.

[0003] In the measurement of samples, people hope to obtain more stable test results and reduce clinical misjudgments caused by jump values ​​(non-reproducible false positives or initial false positives caused by samples and test conditions). This is also one of the problems that practitioners are currently working hard to solve. Summary of the Invention

[0004] According to the first aspect, an embodiment provides a sample analysis method, comprising the steps of:

[0005] aspirating the sample and adding the sample to the reaction vessel;

[0006] aspirating the magnetic bead reagent and adding the magnetic bead reagent into the reaction container containing the sample to obtain a reaction solution;

[0007] After adding the magnetic bead reagent into the reaction container, the reaction liquid in the reaction container is photographed to obtain an image, and it is determined whether the image is abnormal. If there is an abnormality, an alarm is issued or the subsequent test process is stopped.

[0008] According to the second aspect, an embodiment provides a sample analysis method, comprising the steps of:

[0009] aspirating the sample and adding the sample to the reaction vessel;

[0010] aspirating the magnetic bead reagent and adding the magnetic bead reagent into the reaction container containing the sample to obtain a reaction solution;

[0011] After adding the magnetic bead reagent into the reaction container, the optical information of the reaction liquid in the reaction container is collected to determine whether the optical information is abnormal. If there is an abnormality, an alarm is issued or the subsequent test process is stopped.

[0012] According to a third aspect, an embodiment provides a sample analysis device, comprising:

[0013] A sample adding mechanism, used for drawing the sample and adding the sample into the reaction container;

[0014] A magnetic bead reagent adding mechanism, used for sucking the magnetic bead reagent and adding the magnetic bead reagent into the reaction container with the sample added thereto to obtain a reaction solution;

[0015] A magnetic separation and cleaning mechanism, used for performing magnetic separation and cleaning on the reaction liquid in the reaction container;

[0016] A luminescent reagent adding mechanism, used for sucking the luminescent reagent and adding the luminescent reagent into the reaction container after magnetic separation and cleaning;

[0017] a measuring unit, used for measuring the reaction solution to which the luminescent reagent is added;

[0018] a photographing mechanism, configured to photograph the reaction solution in the reaction container to obtain an image after adding the magnetic bead reagent into the reaction container;

[0019] The processing unit is used to issue instructions and determine whether the image is abnormal. If there is any abnormality, an alarm is issued or the subsequent test process is stopped;

[0020] A control unit is used to control the operation and timing of at least the sample adding mechanism, magnetic bead reagent adding mechanism, magnetic separation and cleaning mechanism, luminescent reagent adding mechanism, measuring unit and shooting mechanism according to the instructions issued by the processing unit.

[0021] According to a fourth aspect, an embodiment provides a sample analysis device, comprising:

[0022] Memory, used to store programs;

[0023] The processor is configured to implement the sample analysis method by executing the program stored in the memory.

[0024] According to a fifth aspect, an embodiment provides a computer-readable storage medium, comprising a program, wherein the program can be executed by a processor to implement the above-mentioned sample analysis method.

[0025] In the above embodiment, the reaction liquid is photographed after the reagent is added to obtain an image. By judging whether the image has any abnormalities, medical staff can be warned in advance or terminate the measurement before the measurement, thereby reducing the risk of clinical misjudgment and retesting caused by abnormalities in the reaction liquid, and further improving the stability and accuracy of the test results. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a structural block diagram of a sample analysis device according to an embodiment;

[0027] Figure 2 is a schematic structural diagram of a sample analysis device according to an embodiment;

[0028] Figure 3 is a flow chart of a sample analysis method according to an embodiment;

[0029] 10. Sample adding organization;

[0030] 11. Sample unit; 12. Sample collection device; 13. Sample needle cleaning unit; 14. Sample adding position;

[0031] 20. Magnetic bead reagent adding mechanism;

[0032] 21. Reagent unit; 22. Reagent collection device; 23. Reagent needle cleaning unit; 24. Reagent aspiration position;

[0033] 30. Reaction plate;

[0034] 31. Reagent adding position; 32. Measurement position;

[0035] 40. Magnetic separation and cleaning mechanism;

[0036] 41. Magnetic separation disc;

[0037] 50. Filming agency;

[0038] 51. Camera;

[0039] 60. Measurement unit;

[0040] 70. Mixing mechanism;

[0041] 71. Mixing position;

[0042] 80. Transferring agency;

[0043] 81. The first cup-grabbing hand; 82. The second cup-grabbing hand. DETAILED DESCRIPTION

[0044] The present invention will be further described in detail below by means of specific embodiments in conjunction with the accompanying drawings. Similar elements in different embodiments are numbered with associated similar elements. In the following embodiments, many detailed descriptions are provided to enable the present application to be better understood. However, those skilled in the art will readily appreciate that some of the features may be omitted in different circumstances, or may be replaced by other elements, materials, or methods. In some cases, some operations related to the present application are not shown or described in the specification. This is to avoid the core portion of the present application being overwhelmed by excessive descriptions, and for those skilled in the art, it is not necessary to describe these related operations in detail. They will fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0045] In addition, the features, operations, or characteristics described in the specification may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0046] The serial numbers assigned to components herein, such as "first," "second," etc., are used solely to distinguish the objects being described and do not convey any sequential or technical meaning. References to "connection" and "coupling" herein, unless otherwise specified, include both direct and indirect connections (couplings).

[0047] Currently, the magnetic bead particles in magnetic bead reagents are mostly 1-10 μm in size. The inventors have found that during the reaction process after adding magnetic beads to the reaction cup, due to the influence of multiple factors, the magnetic beads will agglomerate or aggregate, thereby forming particle agglomerates (substances formed by multiple magnetic beads aggregated together with a volume larger than that of a single magnetic bead). When the size of the particle agglomerates exceeds 20-50 μm, test abnormalities are often caused.

[0048] In this method, a photograph of the reaction solution is taken after adding the reagents and before the test. This allows identification of foreign matter in the reaction solution after the sample and reagents are mixed. In cases where foreign matter is present, users (e.g., medical staff) can receive early warning, reducing the risk of clinical misdiagnosis and retesting due to the presence of foreign matter, and further improving the stability of test results.

[0049] The reaction solution referred to in the present invention is a broad concept, and the liquid containing the sample and the magnetic bead reagent in the reaction container is called the reaction solution.

[0050] Please refer to Figure 1-2The present invention provides a sample analysis device, including a sample adding mechanism 10, a magnetic bead reagent adding mechanism 20, a reaction disk 30, a magnetic separation and cleaning mechanism 40, a luminescent reagent adding mechanism (not shown in the figure), a measuring unit 60, a shooting mechanism 50, a transfer mechanism 80, a control unit (not shown in the figure) and a processing unit (not shown in the figure).

[0051] The sample adding mechanism 10 is used to absorb the sample and add the sample into the reaction container. In this embodiment, the specific structure of the sample adding mechanism 10 is not limited. In some examples, the following can be used: Figure 2 The sample addition mechanism 10 shown includes a sample unit 11, a sample collection device 12, and a sample needle cleaning unit 13. The sample unit 11 is used to carry the sample. The sample unit 11 includes a sample delivery module, which includes a sample delivery module (SDM) and a front track (not shown).

[0052] The sample collection device 12 is used to aspirate the sample and discharge it into a reaction vessel located at the sample loading position 14. In one embodiment, the sample collection device 12 includes a single sample needle. In one embodiment, the entire process of sample collection and sample loading, or dispensing, is as follows: the sample needle moves to the sample aspiration position to aspirate the sample, then moves to a corresponding cleaning position to clean the outer wall, then moves to the sample loading position 14 to discharge the aspirated sample into a reaction vessel located within the reaction disk 30, and finally moves to a corresponding cleaning position to clean the inner and outer walls. For example, the sample collection device 12 can be cleaned at the sample needle cleaning unit 13.

[0053] The magnetic bead reagent adding mechanism 20 is used to absorb the magnetic bead reagent and add the magnetic bead reagent to the reaction container to which the sample is added, so as to obtain a reaction solution mixed with the magnetic bead reagent and the sample. Figure 2 The magnetic bead reagent adding mechanism 20 shown includes a reagent unit 21 , a reagent collecting device 22 and a reagent needle cleaning unit 23 .

[0054] The reagent unit 21 is used to hold magnetic bead reagents. In one embodiment, the reagent unit 21 is a disc-shaped structure with multiple positions for holding reagent containers. The reagent unit 21 can rotate and drive the reagent containers it holds to rotate, thereby rotating the reagent containers to the reagent aspiration position 24 for the reagent dispensing mechanism to aspirate the reagents. In one embodiment, the reagent unit 21 is a single unit that can be separately positioned outside the reaction disk 30.

[0055] The reagent collection device 22 is used to absorb the magnetic bead reagent and discharge it into the reaction container located at the reagent adding position 31. In one embodiment, the reagent collection device 22 includes a reagent needle, and the reagent needle is one. In one embodiment, the entire action process of the reagent collection device 22 to complete a reagent addition or dispensing is as follows: the reagent needle moves to the reagent absorption position 24 to absorb the magnetic bead reagent, then moves to the corresponding cleaning position to clean the outer wall, then moves to the reagent adding position 31 to discharge the absorbed magnetic bead reagent into the reaction container located at the reagent adding position 31, and finally moves to the corresponding cleaning position to clean the inner and outer walls. After completing one reagent absorption operation and before starting the next reagent absorption operation, the outer wall of the reagent needle must be cleaned, for example, by cleaning it at the reagent needle cleaning unit 23.

[0056] The reaction disk 30 is used to carry and arrange the reaction containers. In some embodiments, the reaction disk 30 is a disk-shaped structure with a plurality of placement positions for the reaction containers. The reaction disk 30 can rotate and drive the reaction containers in the placement positions to rotate. In some embodiments, the reagent addition position 31 is provided on the reaction disk 30, for example Figure 2 Reagent addition level 31 is displayed.

[0057] The magnetic separation and cleaning mechanism 40 is used to perform magnetic separation and cleaning on the reaction liquid in the reaction container. In this embodiment, the specific structure of the magnetic separation and cleaning mechanism 40 is not limited. In some embodiments, such as Figure 2 As shown, the magnetic separation cleaning mechanism 40 includes a magnetic separation disk 41 arranged in a disc-shaped structure, and the magnetic separation disk 41 includes a plurality of placement positions for placing the reaction vessel. The magnetic separation disk 41 can rotate and drive the reaction vessel in its placement position to rotate, and is used to schedule the reaction vessel to the injection position and the liquid absorption position in the magnetic separation disk 41 to complete the magnetic separation cleaning. The steps of magnetic separation cleaning can be as follows: injecting separation liquid into the reaction vessel, performing magnetic separation cleaning on the reaction liquid in the reaction vessel; then absorbing liquid from the reaction vessel to complete the magnetic separation cleaning, and finally waiting for the magnetic separation disk 41 to be dispatched.

[0058] The luminescent reagent addition mechanism is used to aspirate the luminescent reagent and add it to the reaction vessel after magnetic separation and cleaning. The luminescent reagent can be a luminescent substrate solution, a pre-excitation solution, an excitation solution, a luminescence enhancement solution, etc. The specific structure of the luminescent reagent addition mechanism is not limited in this embodiment. In some embodiments, the luminescent reagent addition mechanism includes a luminescent reagent injection needle for aspirating the luminescent reagent and injecting it into the reaction vessel after magnetic separation and cleaning.

[0059] The measuring unit 60 is used to measure the reaction solution to which the luminescent reagent is added, for example Figure 2 In the embodiment, the reaction disk 30 has a measuring position 32 , and the measuring position 32 is used for the measuring unit 60 to measure the reaction container, that is, the measuring unit 60 measures the reaction container dispatched to the measuring position 32 .

[0060] The mixing mechanism 70 is used to mix the reaction solution in predetermined stages. In this embodiment, there are three predetermined stages, including a first stage after adding the magnetic bead reagent to the reaction vessel, a second stage after magnetic separation and cleaning of the reaction solution in the reaction vessel, and finally a third stage after adding the luminescent reagent to the reaction vessel. The specific structure of the mixing mechanism 70 is not limited in this embodiment. In some embodiments, in the first and third stages, the reaction vessel is dispatched to the mixing position 71 and mixed by the mixing mechanism 70. In the second stage, mixing can be achieved by repeatedly injecting and aspirating the separation liquid into the reaction vessel.

[0061] The transfer mechanism 80 is used to dispatch reaction containers at least between the sample loading position 14 , the reaction disk 30 and the magnetic separation and cleaning mechanism 40 .

[0062] The processing unit is used to issue instructions, and the control unit is used to control the operation and timing of at least the sample adding mechanism 10, the magnetic bead reagent adding mechanism 20, the magnetic separation and cleaning mechanism 40, the luminescent reagent adding mechanism, the mixing mechanism 70, the transfer mechanism 80 and the measuring unit 60 according to the instructions issued by the processing unit.

[0063] The following is an example of a brief test process of a sample to illustrate the coordination of the above-mentioned mechanisms and units. It should be noted that in this embodiment, not every step below is necessarily performed.

[0064] The processing unit sends instructions to the control unit. Under the control of the control unit, the sample collection device 12 absorbs the sample and discharges it into the reaction container located at the sample loading position 14. The transfer mechanism 80 dispatches the reaction container located at the sample loading position 14 and where the sample has been loaded to the reaction disk 30. The reaction container is injected with magnetic bead reagent by the reagent collection device 22 in the reaction disk 30. The reaction container is then dispatched from the reaction disk 30 to the mixing position 71 by the transfer mechanism 80 for mixing. The reaction container is then dispatched from the mixing position 71 back to the reaction disk 30 by the transfer mechanism 80 for incubation. After the incubation of the reaction container is completed, it is dispatched from the reaction disk 30 to the magnetic separation mechanism by the transfer mechanism 80 for magnetic separation and cleaning. During the magnetic separation and cleaning process, the reaction liquid in the reaction container will be mixed. After the magnetic separation and cleaning is completed, the luminescent reagent adding mechanism will add the luminescent reagent into the reaction container. Then the reaction container will be dispatched from the magnetic separation mechanism by the transfer mechanism 80 to the mixing position 71 to be mixed by the mixing mechanism 70, and finally returned to the reaction disk 30. After the reaction disk 30 rotates, the reaction container will be dispatched to the measurement position 32 for measurement by the measurement unit 60 to obtain the measurement result.

[0065] In order to coordinate with various scheduling-related positions on the reaction disk 30, in one embodiment, the transfer mechanism 80 may include a first cup grabbing hand 81 and a second cup grabbing hand 82. The motion trajectory of the first cup grabbing hand 81 passes through the sample loading position 14 and a placement position on the reaction disk 30. The second cup grabbing hand 82 is configured so that its motion trajectory passes through one or two placement positions on the reaction disk 30, as well as the mixing position 71 and the magnetic separation disk 41. In one embodiment, the first cup grabbing hand 81 is a three-dimensional movable structure or a rotating structure, and the second cup grabbing hand 82 is a three-dimensional movable structure or a rotating structure. The scheduling between the above positions can also be set on the motion trajectory of the corresponding cup grabbing hand according to actual conditions.

[0066] The photographing mechanism 50 includes at least a camera 51. Under the control of the control unit, the photographing mechanism 50 is configured to photograph the reaction solution in the reaction vessel after the magnetic bead reagent adding mechanism 20 has added the magnetic bead reagent to the reaction vessel. This image is then transmitted to the processing unit, which determines whether the image is abnormal. If so, an alarm is issued or subsequent testing procedures are halted. It will be readily understood that photographing the reaction solution occurs before the measuring unit 60 measures the reaction solution.

[0067] The above has fully described the various steps after adding the magnetic bead reagent to the reaction container. The shooting mechanism 50 can take pictures of the reaction liquid in the reaction container at any one or several steps after adding the magnetic bead reagent to the reaction container. In this embodiment, there is no restriction on the timing of taking pictures.

[0068] In some embodiments, the camera captures the reaction liquid in the reaction vessel within a predetermined time period after the predetermined stage of mixing the reaction liquid. In other words, the camera captures the reaction liquid within a predetermined time period after at least one of the first, second, and third stages. It will be appreciated that if the camera is scheduled to capture images in all three stages, but the image obtained in the first stage is determined to be abnormal, causing the test process to be terminated, the camera capture operations in the subsequent two stages will not be performed.

[0069] The characteristic of the above three stages is that they have just been mixed. At this time, the magnetic beads in the magnetic bead reagent will be suspended in the reaction solution and will settle to the bottom of the reaction vessel after a period of time. In view of this characteristic, in some embodiments, the above-mentioned preset time includes a first time period and a second time period. The time point at which the second time period starts is later than the time point at which the first time period starts. During the first time period, the particle agglomerates in the reaction solution have not settled to the bottom of the reaction vessel, and during the second time period, the particle agglomerates in the reactants have settled to the bottom of the reaction vessel. For example, the first time period is within 1 second after mixing, and the second time period is between 1 second and 5 seconds after mixing. During the first time period, the shooting mechanism 50 takes a picture of the reaction solution from the side of the reaction vessel. During the second time period, the shooting mechanism 50 takes a picture of the reaction solution from the bottom of the reaction vessel, thereby photographing the particle agglomerates that have settled to the bottom of the reaction vessel. Most of the magnetic bead reagents that have not formed particle agglomerates are still suspended in the reaction solution during the second time period.

[0070] By taking pictures during the preset time period after mixing, it is possible to better capture possible particle agglomerates by utilizing the position changes of the particle agglomerates after mixing.

[0071] In this embodiment, after obtaining the above-mentioned image, the processing unit performs recognition processing on the image to obtain at least one graphic in the image that is used to characterize the shape of the particle agglomerates in the reaction liquid. In this step, the processing unit uses existing image recognition software or algorithms to obtain graphics that may represent particle agglomerates. Then, the processing unit selects the graphic with the largest shape size among the at least one graphic and compares the shape size of the graphic with the preset shape size, wherein the shape size can be, for example, the diameter and / or area of ​​the graphic. If the shape size of the graphic is greater than the preset shape size, the image is determined to be abnormal. For example, the shape size is the diameter and area of ​​the graphic, the preset area is 0.02 square millimeters, and the preset diameter is 150 microns. If the diameter of the graphic with the largest shape size in the image is greater than 150 microns, or the area of ​​the image is greater than 0.02 square millimeters, the image is determined to be abnormal, and the processing unit issues an alarm instruction to alarm, or the processing unit issues an instruction so that the control unit no longer controls the subsequent measurement steps. In other embodiments, the shape size can also be other types of graphic features.

[0072] In some embodiments, the photographing mechanism 50 does not only take one image for analysis and judgment, but performs analysis and judgment based on multiple images. For example, in the above-mentioned first time period or second time period, the photographing mechanism 50 continuously photographs the reaction liquid in the reaction container at a rate of N frames / second to obtain N photos, where N is greater than or equal to 2 (for example, if N is 20, it is photographed at a rate of 20 frames per second). Similarly, the processing unit can select the graphic with the largest shape size in each image for comparison.

[0073] By taking multiple photos continuously, the error in the judgment result can be effectively reduced.

[0074] In addition to the shooting time, the present embodiment does not limit the number or position of the camera 51 in the shooting mechanism 50. According to the needs, the camera 51 can be one or more, for example, Figure 2 In the illustrated embodiment, there are two cameras 51. One camera 51 is positioned adjacent to the reaction disk 30 to photograph the reaction solution within the reaction vessel after the first and third mixing steps. The other camera 51 is positioned adjacent to the magnetic separation and cleaning mechanism 40 to photograph the reaction solution after the second mixing step. The camera 51 that photographs from the side of the reaction vessel can be positioned there, while the camera 51 that photographs from the bottom of the reaction vessel can be positioned at the bottom of the reaction vessel.

[0075] Please refer to Figure 3 , the present invention also provides a sample analysis method, comprising the following steps;

[0076] Step 100: aspirate the sample and add the sample into the reaction container.

[0077] Step 200: aspirate the magnetic bead reagent and add the magnetic bead reagent to the reaction container containing the sample to obtain a reaction solution.

[0078] Step 300: Take a picture of the reaction solution in the reaction container to obtain an image.

[0079] In some embodiments, step 200 further includes:

[0080] Step 201: Mix the reaction solution for the first time.

[0081] In some embodiments, step 201 further includes:

[0082] Step 210: Perform magnetic separation and cleaning on the reaction liquid in the reaction container.

[0083] Step 211 , mixing the reaction solution for the second time during the magnetic separation and cleaning process.

[0084] In some embodiments, step 211 further includes:

[0085] Step 220: aspirate the luminescent reagent and add the luminescent reagent into the reaction container after magnetic separation and cleaning.

[0086] Step 221, mixing the reaction solution for the third time.

[0087] In this embodiment, the reaction liquid can be photographed after obtaining it and before measuring it. That is, this embodiment does not restrict the timing of taking the photograph. In some embodiments, the timing of taking the photograph can be set within a preset time period after at least one of step 201, step 211, and step 221. In other words, the photograph can be taken within a preset time period after at least one of the first, second, and third mixing. It is easy to understand that if the image obtained after the first mixing is abnormal, causing the measurement to be terminated, the second or third mixing will not be performed.

[0088] The characteristic of the above-mentioned preset time period is that they have just been mixed. At this time, the magnetic beads in the magnetic bead reagent will be suspended in the reaction solution and will settle to the bottom of the reaction vessel after a period of time. In view of this feature, in some embodiments, the above-mentioned preset time includes a first time period and a second time period. The time point at which the second time period starts is later than the time point at which the first time period starts. During the first time period, the particle agglomerates in the reaction solution have not settled to the bottom of the reaction vessel, and during the second time period, the particle agglomerates in the reactants have settled to the bottom of the reaction vessel. For example, within 1s after mixing is the first time period, and between 1s and 5s after uniform mixing is the second time period. During the first time period, the reaction solution is photographed from the side of the reaction vessel, and during the second time period, the reaction solution is photographed from the bottom of the reaction vessel, thereby photographing the particle agglomerates that have settled to the bottom of the reaction vessel. Most of the magnetic bead reagents that have not formed particle agglomerates are still suspended in the reaction solution during the second time period.

[0089] By taking pictures during the preset time period after mixing, it is possible to better capture possible particle agglomerates by utilizing the position changes of the particle agglomerates after mixing.

[0090] Step 400 , determining whether the image has any abnormality. If the image has any abnormality, executing step 500 ; if the image has no abnormality, executing step 600 .

[0091] After obtaining the image, the image can be identified and processed to obtain at least one graphic in the image that is used to characterize the shape of the particle agglomerates in the reaction liquid. In this step, existing image recognition software or algorithms can be used to obtain graphics that may represent particle agglomerates, and then the graphic with the largest shape size in at least one graphic is selected, and the shape size of the graphic is compared with the preset shape size, wherein the shape size can be, for example, the diameter and / or area of ​​the graphic. If the shape size of the graphic is larger than the preset shape size, the image is determined to be abnormal. For example, the shape size is the diameter and area of ​​the graphic, the preset area is 0.02 square millimeters, and the preset diameter is 150 microns. If the diameter of the graphic with the largest shape size in the image is greater than 150 microns, or the area of ​​the image is greater than 0.02 square millimeters, the image is determined to be abnormal, an alarm is issued, or the subsequent measurement steps are terminated. In other embodiments, the shape size can also be other types of graphic features.

[0092] In some embodiments, not only one image is taken for analysis and judgment, but analysis and judgment are performed based on multiple images. For example, in the above-mentioned first time period or second time period, the reaction liquid in the reaction container is continuously photographed at a rate of N frames / second to obtain N photos, where N is greater than or equal to 2 (for example, if N is 20, it is photographed at a rate of 20 frames per second). Similarly, the shape with the largest size in each image can be selected for comparison.

[0093] By taking multiple photos continuously, the error in the judgment result can be effectively reduced.

[0094] Step 500: Alarm or terminate the subsequent test process.

[0095] Step 600, continue testing.

[0096] In some cases, in addition to capturing images and determining whether they are abnormal, optical information from the reaction solution can be obtained after adding a magnetic bead reagent to the reaction vessel. This optical information can be used to determine whether it is abnormal, triggering an alarm or terminating the test. For example, a laser can be irradiated onto the reaction solution and the amount of laser light reflected or transmitted can be measured to determine whether particle agglomerates are present.

[0097] The sample analysis method of the above embodiment enables medical staff to receive early warning or terminate the measurement before the measurement, thereby reducing the risk of clinical misjudgment and retesting caused by abnormalities in the reaction solution, and further improving the stability and accuracy of the test results.

[0098] The above examples are used to illustrate the present invention, which are only used to help understand the present invention and are not intended to limit the present invention. Those skilled in the art can make several simple deductions, modifications or substitutions based on the concept of the present invention.

Claims

1. A sample analysis method comprising the steps of: aspirating the sample and adding the sample to the reaction vessel; aspirating the magnetic bead reagent and adding the magnetic bead reagent into the reaction container containing the sample to obtain a reaction solution; It is characterized by: After adding the magnetic bead reagent into the reaction container, within a preset time period, the reaction liquid in the reaction container is photographed to obtain an image, and whether the image is abnormal is determined. If abnormal, an alarm is issued or the subsequent test process is stopped; The preset time period includes a first time period and a second time period, the start time of the second time period is later than the start time of the first time period, the particle agglomerates in the reaction liquid have not settled to the bottom of the reaction container during the first time period, and the particle agglomerates in the reaction liquid have settled to the bottom of the reaction container during the second time period; the particle agglomerates are substances formed by multiple magnetic beads aggregated together, the volume of which exceeds that of a single magnetic bead; and photographing the reaction liquid in the reaction container to obtain an image within the preset time period includes: During the first time period, photographing the reaction liquid from the side of the reaction container to obtain an image; During the second time period, the reaction liquid is photographed from the bottom of the reaction container to obtain an image.

2. The sample analysis method according to claim 1, wherein: Determining whether the image is abnormal includes: performing recognition processing on the image to obtain at least one graphic in the image for characterizing the shape of particle agglomerates in the reaction solution; A graphic with the largest shape size among the at least one graphic is selected, the shape size of the graphic is compared with a preset shape size, and whether the image has an abnormality is determined based on the comparison result.

3. The method according to claim 2, wherein Determining whether the image is abnormal based on the comparison result includes: If the shape and size of the graphic are larger than the preset shape and size, the image is abnormal.

4. The method according to claim 2, wherein The shape dimensions include diameter and / or area.

5. The method according to claim 2, wherein The images include: N photos obtained by continuously photographing the reaction liquid in the reaction container at a rate of N frames / second, wherein N is greater than or equal to 2.

6. The method according to claim 1, wherein The step of photographing the reaction liquid in the reaction container within a preset time period to obtain an image comprises: Mixing the reaction solution for the first time; Within a preset time period after the first mixing, the reaction liquid in the reaction container is photographed to obtain an image.

7. The method according to claim 1, wherein The step of photographing the reaction liquid in the reaction container within a preset time period to obtain an image comprises: Mixing the reaction solution for the first time; performing magnetic separation and cleaning on the reaction liquid in the reaction container, and mixing the reaction liquid for a second time during the magnetic separation and cleaning process; Within a preset time period after the second mixing, the reaction liquid in the reaction container is photographed to obtain an image.

8. The method according to claim 1, wherein The step of photographing the reaction liquid in the reaction container within a preset time period to obtain an image comprises: Mixing the reaction solution for the first time; performing magnetic separation and cleaning on the reaction liquid in the reaction container, and mixing the reaction liquid for a second time during the magnetic separation and cleaning process; After aspirating the luminescent reagent and adding the luminescent reagent to the reaction container after magnetic separation and cleaning, the reaction solution is mixed for the third time; Within a preset time period after the third mixing, the reaction liquid in the reaction container is photographed to obtain an image.

9. A sample analysis method comprising the steps of: aspirating the sample and adding the sample to the reaction vessel; aspirating the magnetic bead reagent and adding the magnetic bead reagent into the reaction container containing the sample to obtain a reaction solution; It is characterized by: After adding the magnetic bead reagent into the reaction container, the optical information of the reaction liquid in the reaction container is collected within a preset time period to determine whether the optical information is abnormal. If there is an abnormality, an alarm is issued or the subsequent test process is stopped; The preset time period includes a first time period and a second time period, the start time of the second time period is later than the start time of the first time period, the particle agglomerates in the reaction liquid have not settled to the bottom of the reaction container during the first time period, and the particle agglomerates in the reaction liquid have settled to the bottom of the reaction container during the second time period; the particle agglomerates are substances formed by multiple magnetic beads aggregated together, the volume of which exceeds that of a single magnetic bead; and collecting optical information of the reaction liquid in the reaction container during the preset time period includes: During the first time period, collecting optical information of the reaction liquid in the reaction container from the side of the reaction container; During the second time period, optical information of the reaction liquid in the reaction container is collected from the bottom of the reaction container.

10. A sample analysis device comprising: A sample adding mechanism, used for drawing the sample and adding the sample into the reaction container; A magnetic bead reagent adding mechanism, used for sucking the magnetic bead reagent and adding the magnetic bead reagent into the reaction container with the sample added thereto to obtain a reaction solution; A magnetic separation and cleaning mechanism, used for performing magnetic separation and cleaning on the reaction liquid in the reaction container; A luminescent reagent adding mechanism, used for sucking the luminescent reagent and adding the luminescent reagent into the reaction container after magnetic separation and cleaning; a measuring unit, used for measuring the reaction solution to which the luminescent reagent is added; It is characterized in that it also includes: A photographing mechanism, configured to photograph the reaction liquid in the reaction container to obtain an image within a preset time period after adding a magnetic bead reagent to the reaction container; wherein the preset time period includes a first time period and a second time period, the second time period starts later than the first time period, particle agglomerates in the reaction liquid have not settled to the bottom of the reaction container during the first time period, and particle agglomerates in the reaction liquid have settled to the bottom of the reaction container during the second time period; the particle agglomerates are substances formed by a plurality of magnetic beads aggregated together, the volume of which exceeds that of a single magnetic bead; photographing the reaction liquid in the reaction container to obtain an image within the preset time period, comprising: During the first time period, photographing the reaction liquid from the side of the reaction container to obtain an image; During the second time period, photographing the reaction liquid from the bottom of the reaction container to obtain an image; The processing unit is used to issue instructions and determine whether the image is abnormal. If there is any abnormality, an alarm is issued or the subsequent test process is stopped; A control unit is used to control the operation and timing of at least the sample adding mechanism, magnetic bead reagent adding mechanism, magnetic separation and cleaning mechanism, luminescent reagent adding mechanism, measuring unit and shooting mechanism according to the instructions issued by the processing unit.

11. The device according to claim 10, wherein The processing unit determines whether the image is abnormal, including: The processing unit performs recognition processing on the image to obtain at least one graphic in the image for representing the shape of the particle agglomerates in the reaction liquid; The processing unit selects a graphic with the largest shape size among the at least one graphic, compares the shape size of the graphic with a preset shape size, and determines whether the image has an abnormality based on the comparison result.

12. The device according to claim 11, wherein Determining whether the image is abnormal based on the comparison result includes: If the shape and size of the graphic are larger than the preset shape and size, the image is abnormal.

13. The device according to claim 11, wherein The shape dimensions include diameter and / or area.

14. The device according to claim 11, wherein The images include: N photos obtained by continuously photographing the reaction liquid in the reaction container at a rate of N frames / second, wherein N is greater than or equal to 2.

15. The device according to claim 10, wherein Also includes: A mixing mechanism, configured to mix the reaction solution at a preset stage under the control of the control unit; The preset stage includes: The first stage after adding the magnetic bead reagent into the reaction container; and A second stage of magnetic separation and cleaning of the reaction liquid in the reaction container; and The third stage after adding the luminescent reagent into the reaction container; The step of photographing the reaction liquid in the reaction container within a preset time period to obtain an image comprises: In at least one of the first stage, the second stage and the third stage, the mixing mechanism mixes the reaction liquid, and the photographing mechanism photographs the reaction liquid in the reaction container within a preset time period after the mixing to obtain an image.

16. A sample analysis device, characterized in that: include: Memory, used to store programs; A processor, configured to implement the method according to any one of claims 1 to 9 by executing the program stored in the memory.

17. A computer-readable storage medium, characterized in that The method comprises a program which can be executed by a processor to implement the method according to any one of claims 1 to 9.

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