Specific protein analyzer, and specific protein testing assembly and method

By independently setting up blood routine and specific protein detection components in a specific protein analyzer and using premixed pools and transfer units for sample processing, the problems of large blood volume, high cost and slow detection in the prior art are solved, and more flexible layout and more efficient detection are achieved.

WO2025050235A1PCT designated stage expired Publication Date: 2025-03-13ZYBIO INC
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Patent Information

Application Number
PCT/CN2023/116694
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-09-04
Publication Date
2025-03-13

AI Technical Summary

Technical Problem

The existing conventional blood tester for specific proteins and blood has problems such as large blood volume, high single test cost, slow detection speed and inflexible instrument layout.

Method used

A specific protein analyzer is designed to perform hemolytic reactions using a premixed cell unit through independent settings of blood routine detection components and specific protein detection components, and distribute the sample solution and the second reagent to the immune detection cell unit through the transfer unit for specific protein immune responses and detection.

Benefits of technology

A more flexible instrument layout is achieved, detection efficiency and speed is improved, blood volume and latex reagent are used, and the cost of a single test is reduced.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed in the present invention is a specific protein testing assembly, comprising: a premixing bath unit used for receiving a blood sample and then carrying out hemolytic reaction to obtain a sample solution; a reagent refrigeration compartment used for storing at least one second reagent required by a specific protein immune reaction; an immunodetection bath unit used for providing a place for specific protein immune response and detection; and a transfer unit used for distributing the sample solution in the premixing bath unit and the second reagent in the reagent refrigeration compartment to the immunodetection bath unit. The premixing bath unit comprises a premixing bath, a sample receiving position for receiving the blood sample, and a sample solution output position for outputting the sample solution. The premixing bath can move between the sample receiving position and the sample solution output position. The immunodetection bath unit receives the sample solution and the second reagent to complete specific protein immune response and detection. Also disclosed in the present invention are a specific protein analyzer and a specific protein testing method, which can effectively improve the test efficiency.
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Description

Specific protein analyzer, specific protein detection component and detection method Technical Field

[0001] The present invention belongs to the technical field of in vitro diagnosis, and specifically relates to a specific protein analyzer, a specific protein detection component and a detection method. Background Art

[0002] In hospital clinics, especially those for women and children, blood samples are routinely drawn from patients and examined. In analyzers that combine specific protein and routine blood tests, the sample for the specific protein immunoreaction is dispensed into the specific protein reaction pool assembly via the sampling needle of the routine blood test module. The latex reagent used for the immunoreaction is also drawn from a specific reagent station via the sampling needle of the routine blood test sampling and distribution module.

[0003] In existing analyzers, latex reagents are distributed using the sample needle of the routine blood sampling and distribution module. On the movement trajectory of the routine blood sampling and distribution module, multiple reaction pools required for routine blood testing, such as the HGB reaction pool, WNB reaction pool, RBC reaction pool, RET reaction pool, and DIFF reaction pool, are arranged. At the same time, the movement trajectory also includes the reagent port of the refrigeration component that stores latex reagents in the machine. If the analyzer contains at least two specific protein detection items, then more reaction pool components need to be arranged on the movement trajectory of the routine blood sampling and distribution module, which is not conducive to the layout of the instrument and makes the instrument longer in the depth direction. In addition, for specific protein detection, after the routine blood sampling and distribution module distributes the sample to the specific protein reaction pool, it needs to continue to complete the distribution of the latex reagent required for the specific protein immune reaction. In the entire detection process, the resources of the routine blood sampling and distribution module are occupied for a long time, which is not conducive to improving the speed of a single test.

[0004] Existing analyzers, when combined testing for specific proteins and routine blood tests, present challenges such as high blood volume and high per-test costs. Specifically, the combined testing of specific proteins with routine blood tests requires additional testing for specific proteins, resulting in high blood volume. Furthermore, when testing multiple protein items, multiple blood draws are required, further increasing blood volume. Furthermore, protein testing not only requires a high blood volume but also requires a high amount of latex reagent. Due to the high cost of latex reagents, the cost of a single test is high.

[0005] During the specific protein detection process, the amount or concentration of the second reagent (latex reagent) should match the whole blood sample volume. In a single test, the cost of latex reagent is relatively high, and reducing the consumption or concentration of latex reagent in a single test can effectively reduce the cost of a single test. However, since the reduction in the consumption or concentration of latex reagent in a single test requires a simultaneous reduction in the whole blood sample volume, this places higher demands on the minimum distribution accuracy of the routine blood sampling module, which is not conducive to reducing the instrument cost or the cost of a single test. In addition, in the existing scheme, when at least two specific protein items are included, the routine blood sampling module needs to distribute the sample to different specific protein reaction pools multiple times after absorbing the sample, which will also increase the consumption of whole blood samples.

[0006] During specific protein testing, the first reagent (including the hemolytic agent) and the second reagent (including the latex reagent) involved in the immune reaction are quantitatively matched to the blood sample. Furthermore, due to limitations in the detection system and reagent concentration, the linear range and low-value precision of specific protein testing are mutually constrained specifications, making it difficult to simultaneously meet the two performance indicators of a wider linear range and better low-value precision. Therefore, for extremely high-value samples, manual dilution by a certain multiple is usually required for testing, which is cumbersome.

[0007] Summary of the Invention

[0008] In view of this, the object of the present invention is to provide a specific protein analyzer and a specific protein detection component and detection method, which are not only convenient for layout but also can effectively improve detection efficiency.

[0009] In order to achieve the above object, the present invention provides the following technical solutions:

[0010] The present invention first proposes a specific protein detection component, comprising:

[0011] A premixing pool unit receives a blood sample and performs a hemolysis reaction to obtain a sample solution;

[0012] a reagent refrigeration chamber for storing at least one second reagent required for a specific protein immune reaction;

[0013] Immunoassay pool unit, used to provide a place for specific protein immune response and detection;

[0014] A transfer unit, configured to distribute the sample liquid in the premixing pool unit and the second reagent in the reagent refrigeration chamber to the immunoassay pool unit;

[0015] The premixing tank unit includes a premixing tank, a sample receiving position for receiving a blood sample, and a sample liquid output position for outputting a sample liquid. The premixing tank can be moved between the sample receiving position and the sample liquid output position.

[0016] The immunoassay pool unit receives the sample liquid and the second reagent to complete the specific protein immune reaction and detection.

[0017] Furthermore, the immunodetection pool unit includes at least one specific protein reaction pool.

[0018] Furthermore, the immune detection pool unit also includes a laser generating device and a signal detecting device for detecting the specific immune reaction results in the specific protein reaction pool.

[0019] Furthermore, the transfer unit includes a reagent needle and a motion mechanism for driving the reagent needle to move along a second path, the reagent needle is used to absorb the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool; the immunoassay pool unit and the reagent refrigeration chamber are both arranged along the second path, and the sample liquid output position is arranged on the second path.

[0020] Furthermore, the transfer unit includes a reagent needle, a motion mechanism for driving the reagent needle to move along the second path, and a reagent delivery tube arranged between the reagent refrigeration chamber and the specific protein reaction pool. The reagent needle is used to absorb the sample liquid and distribute the sample liquid to the specific protein reaction pool. The reagent delivery tube is used to distribute the second reagent in the reagent refrigeration chamber to the specific protein reaction pool. The immunoassay cell unit is arranged on the second path, and the sample liquid output position is set on the second path.

[0021] Furthermore, the second path is a straight path or a curved path.

[0022] Furthermore, the reagent refrigeration chamber includes a reagent bottle for containing a second reagent and a refrigeration unit for refrigerating the second reagent.

[0023] Furthermore, the premixing tank unit further includes a heating component, which is used to control the temperature in the premixing tank to provide a constant temperature incubation environment for the hemolysis reaction.

[0024] Furthermore, the premixing tank is connected to a first reagent supply device for distributing a first reagent required for a hemolysis reaction thereto.

[0025] The present invention also proposes a specific protein analyzer, comprising a routine blood test component and the specific protein test component as described above; the routine blood test component comprises a routine blood test sampling module moving along a first path and a routine blood test reaction pool unit arranged on the first path, and the sample receiving position is set on the first path; the routine blood test sampling module moves along the first path and is used to distribute the absorbed blood sample to the routine blood test reaction pool unit and the premixing pool located at the sample receiving position; the routine blood test reaction pool unit receives the blood sample to complete the routine blood test.

[0026] Furthermore, the first path and the second path are both straight paths, and the first path and the second path are parallel to each other.

[0027] Furthermore, the routine blood test reaction pool unit includes at least one routine blood test reaction pool arranged along the first path for completing routine blood test.

[0028] Furthermore, the routine blood test reaction pool is connected to a routine blood test reagent supply device for distributing reagents required for routine blood test thereto.

[0029] Furthermore, the routine blood test sampling module includes a sample needle and a linear motion mechanism for driving the sample needle to move along a first path. The sample needle is used to draw blood samples and distribute the blood samples to the routine blood test reaction pool and the premixing pool located at the sample receiving position.

[0030] Furthermore, it also includes a fluid circuit support device; the routine blood test reaction pool unit includes a routine blood test reaction pool, and the immunoassay pool unit includes a specific protein reaction pool; the premixing pool is connected to a first reagent supply device for distributing a first reagent required for a hemolysis reaction thereto; the routine blood test reaction pool is connected to a routine blood test reagent supply device for distributing reagents required for a routine blood test thereto;

[0031] The liquid circuit supporting device comprises:

[0032] a quantitative device, used for controlling the first reagent supply device to distribute the first reagent to the premixing tank and for controlling the routine blood test reagent supply device to distribute the routine blood test reagent to the routine blood test reaction tank;

[0033] A cleaning device, used for cleaning the routine blood test reaction pool, the specific protein reaction pool and the premixing pool;

[0034] The mixing device is used to perform mixing operations on the routine blood test reaction pool, the specific protein reaction pool and the premixing pool.

[0035] The present invention also provides a specific protein detection method using the specific protein detection component described above, comprising the following steps:

[0036] Step 1: Dispense the blood sample and the first reagent into a premixing tank located at a sample receiving position, mix the blood sample and the first reagent in the premixing tank, and perform a hemolysis reaction to obtain a sample solution; during or after the hemolysis reaction, drive the premixing tank to move to a sample solution output position;

[0037] During this process, the specific protein test item that needs to be tested for the blood sample is determined; the second reagent required for the specific protein test item in the reagent refrigeration chamber is distributed to the corresponding specific protein reaction pool using the transfer unit;

[0038] Step 2: Use the transfer unit to distribute the sample liquid to the corresponding specific protein reaction pool; after the sample liquid is distributed, empty the remaining sample liquid in the premixing pool and clean the premixing pool, and move the premixing pool to the sample receiving position;

[0039] Step 3: The sample solution and the second reagent are subjected to a specific protein immune reaction and detection in the specific protein reaction pool; after the specific protein immune reaction and detection are completed, the specific protein reaction pool is emptied and cleaned to restore the specific protein reaction pool in the detection state to an idle state;

[0040] Step 4: Obtain specific protein detection results.

[0041] Furthermore, the premixing pool unit includes a premixing pool and a heating component, and the heating component is used to control the temperature in the premixing pool to provide a constant temperature incubation environment for the hemolysis reaction; in the step one, the premixing pool is located at the sample receiving position, and the blood sample is distributed to the premixing pool using the routine blood sampling module.

[0042] Furthermore, the premixing tank is connected to a first reagent supply device for distributing a first reagent required for a hemolysis reaction thereto. In step 1, the first reagent supply device is used to distribute the first reagent to the premixing tank.

[0043] Furthermore, the immunoassay pool unit includes at least two specific protein reaction pools; in step one, before distributing the second reagent, the number of specific protein detection items that need to be detected in the blood sample is first determined; and the transfer unit is used to distribute the second reagents required for different specific protein detection items in the reagent refrigeration chamber to the corresponding specific protein reaction pools.

[0044] Furthermore, in step 1, after determining the number of specific protein detection items that need to be detected for the blood sample, it is determined whether the number of idle specific protein reaction pools is greater than or equal to the number of specific protein detection items that need to be detected for the current blood sample: if so, the second reagent is distributed; if not, wait for other specific protein reaction pools in the detection state to resume the idle state, and until the number of idle specific protein reaction pools is greater than or equal to the number of specific protein detection items that need to be detected for the current blood sample, the second reagent is distributed.

[0045] Furthermore, the step 2 includes the following steps:

[0046] 21) Using a transfer unit to distribute the sample solution to the corresponding specific protein reaction pool;

[0047] 22) mixing the sample solution with the second reagent in the specific protein reaction pool and performing specific protein immune reaction and detection;

[0048] 23) Determine whether the immune detection signal value exceeds the set threshold within the set time: if so, execute step 24); if not, execute step 3;

[0049] 24) diluting the remaining sample solution in the premix tank to obtain a diluted sample solution; simultaneously, draining and cleaning the specific protein reaction tank. After the specific protein reaction tank is cleaned, using the transfer unit to distribute the second reagent in the reagent refrigeration chamber to the specific protein reaction tank;

[0050] 25) Using a transfer unit, the sample liquid in the premixing pool is distributed to the specific protein reaction pool, so that the sample liquid is mixed with the second reagent in the specific protein reaction pool and a specific protein immunoreaction and detection is performed; after the sample liquid is distributed, the premixing pool is emptied and cleaned, and the premixing pool is moved to the sample receiving position; and step 4 is executed;

[0051] Furthermore, in step 24), the first reagent and / or diluent are added to the premixing pool to dilute the sample solution.

[0052] Furthermore, the immunoassay pool unit includes at least two specific protein reaction pools; in step 24), before distributing the second reagent, the number of specific protein detection items that need to be detected in the blood sample is first determined; then the transfer unit is used to distribute the second reagents required for different specific protein detection items in the reagent refrigeration chamber to the corresponding specific protein reaction pools.

[0053] Furthermore, in step 2 or step 25), the remaining sample liquid in the premixing tank is first drained at the sample liquid output position and the premixing tank is cleaned, and then the premixing tank is driven to move to the sample receiving position, or the premixing tank is first driven to move to the sample receiving position, and then the remaining sample liquid in the premixing tank is drained at the sample receiving position and the premixing tank is cleaned.

[0054] Furthermore, the transfer unit includes a reagent needle and a motion mechanism for driving the reagent needle to move along a second path, the reagent needle being used to aspirate the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool; the immunoassay cell unit and the reagent refrigeration chamber are both arranged along the second path, and the sample liquid output position is located on the second path;

[0055] In step 1 or step 1 and step 24), the second reagent is drawn up by a reagent needle and dispensed into the corresponding specific protein reaction pool; after the second reagent corresponding to each specific protein detection item is dispensed, the reagent needle is cleaned;

[0056] In the step 2 or step 21) and step 24), the sample liquid is sucked up by a reagent needle and the sample liquid is distributed to the corresponding specific protein reaction pool. After the sample liquid distribution is completed, the reagent needle is cleaned.

[0057] Furthermore, the amount of sample liquid drawn by the reagent needle is greater than or equal to the amount of sample liquid required for all specific protein detection items that need to be detected in the corresponding blood sample.

[0058] Furthermore, the transfer unit includes a reagent needle, a motion mechanism for driving the reagent needle to move along the second path, and a reagent delivery tube disposed between the reagent refrigeration chamber and the specific protein reaction pool. The reagent needle is used to draw a sample liquid and distribute the sample liquid to the specific protein reaction pool. The reagent delivery tube is used to distribute the second reagent in the reagent refrigeration chamber to the specific protein reaction pool. The immunoassay cell unit is arranged on the second path, and the sample liquid output position is located on the second path.

[0059] In step 1 or step 1 and step 24), the second reagent is distributed to the corresponding specific protein reaction pool using a reagent delivery tube; after the second reagent corresponding to each specific protein detection item is distributed, the reagent delivery tube is cleaned;

[0060] In the step 2 or step 21) and step 24), the sample liquid is sucked up by a reagent needle and the sample liquid is distributed to the corresponding specific protein reaction pool. After the sample liquid distribution is completed, the reagent needle is cleaned.

[0061] Furthermore, the amount of sample liquid drawn by the reagent needle is greater than or equal to the amount of sample liquid required for all specific protein detection items that need to be detected in the corresponding blood sample.

[0062] Furthermore, in the step 1, the sample solution is diluted.

[0063] Furthermore, in step three, during the process of performing the specific protein immune response and detection, it is determined whether all detection tasks are completed: if so, step four is executed; if not, step one is executed.

[0064] The beneficial effects of the present invention are:

[0065] The specific protein analyzer of the present invention is provided with a routine blood test component and a specific protein test component independently. During operation, a blood sample is drawn by a routine blood sample sampling module and then moved along a first path to be distributed to a routine blood test reaction pool unit and a premixing pool located at a sample receiving position. After receiving the blood sample, the routine blood test is completed in the routine blood test reaction pool unit. After receiving the blood sample, the premixing pool performs a hemolysis reaction to obtain a sample liquid. During or after the hemolysis reaction, the premixing pool is driven to move to a sample liquid output position. Then, a transfer unit is used to distribute the sample liquid and a second reagent stored in a reagent refrigeration chamber to an immunoassay pool unit to complete a specific protein immunoreaction and detection. Compared with existing specific protein analyzers, the present invention has the following advantages:

[0066] (1) The layout is more flexible: the routine blood test component and the specific protein test component are arranged independently of each other, that is, the immune detection pool unit does not need to be arranged on the moving path of the routine blood sampling module. It only needs to drive the premixing pool to move between the sample receiving position and the sample liquid output position, so that the sample receiving position is arranged on the moving path (first path) of the routine blood sampling module, and the sample liquid receiving position is arranged on the moving path (second path) of the transfer unit; the layout of the routine blood test component and the specific protein test component is more flexible and changeable, which is conducive to reducing the overall size of the whole machine and facilitating the miniaturization of the instrument;

[0067] In particular, the first path and the second path may be parallel to each other, so that not only the length in the depth direction can be reduced, but also the size in the width direction can be controlled to reduce the occupied space;

[0068] (2) Reducing the occupancy time of the routine blood sampling module: During operation, even if at least two specific protein detection items are required, the number of times the routine blood reaction pool unit allocates blood samples to the premixing pool is related to the type of hemolytic agent required for different specific protein detection items. If the hemolytic agent required for all specific protein detection items is the same, the routine blood reaction pool unit only needs to allocate blood samples to the premixing pool once, which can effectively reduce the occupancy time of the routine blood sampling module;

[0069] (3) Improve detection speed and efficiency: The routine blood test component and the specific protein detection component are set independently of each other. The routine blood sampling module only performs the absorption and distribution of blood samples, and does not need to perform the absorption and distribution of the second reagent. After performing the absorption and distribution of the blood sample, the routine blood sampling module can start the blood sample absorption action for the next test item, which can effectively shorten the time required for a single test and improve the detection speed and efficiency.

[0070] (4) The premixing pool receives the blood sample and performs a hemolysis reaction, that is, the hemolysis reaction is not performed in the immunoassay pool unit. In this way, after the sample liquid in the premixing pool is distributed, during the period when the sample liquid and the second reagent perform a specific protein immunoassay reaction and detection in the immunoassay pool unit, the sample liquid required for the next specific protein immunoassay can be prepared in the premixing pool. Compared with the prior art method in which the hemolysis reaction and the specific protein immunoassay need to be performed in sequence in the immunoassay pool unit, the detection speed and efficiency can be effectively improved;

[0071] (5) The sample liquid can be diluted in the premixed pool, thereby reducing the specific protein immune response and the amount of blood sample during detection, thereby reducing the amount of the second reagent used and reducing the detection cost without increasing the requirements for the minimum distribution accuracy of the blood routine sampling module.

[0072] The specific protein detection method of the present invention provides a premixing pool unit. During the specific protein detection process, a blood sample and a first reagent are distributed to a premixing pool located at a sample receiving position for a hemolysis reaction. During this process, a second reagent is distributed to a corresponding specific protein reaction pool. After the hemolysis reaction is completed, a sample liquid is obtained, and the sample liquid in the premixing pool located at a sample liquid output position is distributed to a corresponding specific protein reaction pool. In this way, the sample liquid and the second reagent undergo a specific protein immunoreaction and detection in the specific protein reaction pool. After the sample liquid is distributed, the premixing pool can be emptied and cleaned. If there are unfinished detection tasks, the sample liquid required for the next detection task can be prepared in the premixing pool. That is, the sample liquid required for the next detection task and the specific protein immunoreaction and detection of the current detection task can be carried out simultaneously. If the number of specific protein reaction pools is sufficient, if the specific protein immunoreaction and detection of the current detection task has not yet been completed, the specific protein immunoreaction and detection of the next detection task can also be carried out in an idle specific protein reaction pool. In this way, compared with the existing technology, the specific protein detection method of the present invention can effectively improve detection efficiency.

[0073] In addition, during the specific protein detection process, the sample liquid is distributed into the specific protein reaction pool and mixed with the second reagent for specific protein immune reaction and detection. If the immune detection signal value exceeds the set threshold, it indicates that the sample liquid is a high-value sample. In this way, the sample liquid can be directly diluted in the premixed pool, and the diluted sample liquid is mixed with the second reagent in the specific protein reaction pool for specific protein immune reaction and detection. If the immune detection signal value does not exceed the set threshold, it indicates that the sample liquid is not a high-value sample. In this way, the specific protein immune reaction and detection can be directly performed on the sample liquid. In this way, The specific protein detection and analysis method of the present invention has the following advantages: ① Due to the limitations of the linearity of the detection parameters and the low-value precision, the fixed ratio may cause a hook effect or exceed the detection range in the reaction curve of high-value samples, resulting in abnormal detection results; the present invention can automatically achieve high-fold dilution of high-value samples in the premixing pool unit, which can effectively improve the test accuracy of high-value samples; ② When a high-value sample is detected, there is no need to repeatedly draw the sample or reserve the sample in advance. Automatic high-fold dilution liquid detection can be achieved with a single draw, which has the advantages of simple operation, high blood sample utilization and low consumption. BRIEF DESCRIPTION OF THE DRAWINGS

[0074] In order to make the purpose, technical solutions and beneficial effects of the present invention more clear, the present invention provides the following drawings for illustration:

[0075] FIG1 is a layout diagram of a specific protein analyzer embodiment 1 of the present invention;

[0076] FIG2 is a schematic diagram of a specific protein analyzer according to this embodiment;

[0077] FIG3 is a schematic diagram of the structure of a specific protein detection component;

[0078] FIG4 is a schematic structural diagram when the second path is an arc curve path;

[0079] FIG5 is a flow chart of Example 2 of the specific protein detection method of the present invention;

[0080] FIG6 is a timing diagram showing a case where there are two specific protein reaction pools and the two specific protein reaction pools respectively perform specific protein immune reaction and detection on different blood samples;

[0081] FIG7 is a flow chart of Example 3 of the specific protein detection method of the present invention;

[0082] FIG8 is a timing diagram of a specific protein reaction pool performing specific protein immune reaction and detection.

[0083] Explanation of the accompanying drawings: 10-routine blood test component; 11-first path; 12-routine blood test sampling module; 13-routine blood test reaction pool unit; 14-routine blood test reaction pool; 20-specific protein detection component; 21-immunoassay pool unit; 22-reagent refrigeration bin; 23-transfer unit; 24-specific protein reaction pool; 25-second path; 26-reagent bottle; 27-refrigeration unit; 28-reagent needle; 29-movement mechanism; 30-premixing pool unit; 31-premixing pool; 32-first reagent supply device; 33-sample receiving position; 34-sample liquid output position; 35-third path; 40-liquid path support device; 41-quantification device; 42-cleaning device; 43-mixing device. DETAILED DESCRIPTION

[0084] The present invention will be further described below with reference to the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and implement it. However, the embodiments are not intended to limit the present invention.

[0085] Example 1

[0086] As shown in FIG. 1-2 , the specific protein analyzer of this embodiment includes a routine blood test component 10 and a specific protein test component 20 .

[0087] The routine blood test component 10 of this embodiment includes a routine blood test sampling module 12 that moves along a first path 11 and a routine blood test reaction pool unit 13 arranged on the first path 11. The sample receiving position 33 of the premixing pool unit 30 is set on the first path 11. The routine blood test sampling module 12 moves along the first path and is used to distribute the absorbed blood sample to the routine blood test reaction pool unit 13 and the premixing pool 31. The routine blood test reaction pool unit 13 receives the blood sample to complete the routine blood test, and the premixing pool 31 performs a hemolysis reaction after receiving the blood sample to obtain the sample liquid. Specifically, the routine blood test reaction pool unit 13 includes at least one routine blood test reaction pool 14 arranged along the first path 11 for completing the routine blood test. The number of routine blood test reaction pools 14 is set according to actual needs, but all routine blood test reaction pools 14 are arranged on the first path 11. The routine blood test reaction pool 14 is connected to a routine blood test reagent supply device (not shown in the figure) for distributing the reagents required for the routine blood test thereto. The routine blood sampling module 13 includes a sample needle (not shown in the figure) and a linear motion mechanism (not shown in the figure) for driving the sample needle to move along the first path 11. The sample needle is used to draw blood samples and distribute the blood samples to the routine blood reaction pool 14 and the premixing pool 31.

[0088] As shown in FIG3 , the specific protein detection component 20 of this embodiment includes:

[0089] The premixing cell unit 30 receives the blood sample and performs hemolysis reaction to obtain a sample solution;

[0090] A reagent refrigeration chamber 22 is used to store at least one second reagent required for a specific protein immune reaction;

[0091] The immunoassay cell unit 21 is used to provide a place for specific protein immune reaction and detection;

[0092] The transfer unit 23 is used to distribute the sample liquid in the premixing pool unit 30 and the second reagent in the reagent cooling chamber 22 to the immunoassay pool unit 21 .

[0093] The premixing cell unit 30 of this embodiment includes a premixing cell 31, a sample receiving position 33 for receiving a blood sample, and a sample liquid output position 34 for outputting a sample liquid. The premixing cell 31 is movable between the sample receiving position 33 and the sample liquid output position 34. The immunodetection cell unit 21 receives the sample liquid and a second reagent to perform a specific protein immune reaction and detection.

[0094] Specifically, the immunoassay cell unit 21 includes at least one specific protein reaction cell 24. The number of specific protein reaction cells 24 is set according to actual needs. In this embodiment, two specific protein reaction cells 24 are provided. The immunoassay cell unit 21 of this embodiment also includes a laser generator and a signal detection device for detecting the specific immune reaction results within the specific protein reaction cell 24. Specifically, different specific protein detection projects require the use of different second reagents. Therefore, it is necessary to store the second reagents required for various specific protein detection projects in the reagent refrigeration chamber 22, such as the SRE latex reagent for detecting SAA and the CRE latex reagent for detecting CRP.

[0095] The transfer unit 23 of this embodiment includes a reagent needle 28 and a motion mechanism 29 for driving the reagent needle 28 along the second path 25. The reagent needle 28 is used to aspirate the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool 24. In this embodiment, the immunoassay cell unit 21 and the reagent refrigeration chamber 22 are both arranged along the second path 25, and the sample liquid output position 34 is arranged on the second path 25. In this way, the transfer unit 23 can be used to distribute the sample liquid obtained through the hemolysis reaction in the premixing pool 31 to the specific protein reaction pool 24, and the second reagent stored in the reagent refrigeration chamber 22 can also be distributed to the specific protein reaction pool 24.

[0096] Of course, the transfer unit can also be implemented in many other ways. For example, the transfer unit 23 includes a reagent needle 28, a motion mechanism 29 for driving the reagent needle 28 to move along the second path 25, and a reagent delivery tube arranged between the reagent refrigeration chamber 22 and the specific protein reaction pool 24. The reagent needle 28 is used to draw the sample liquid and distribute the sample liquid to the specific protein reaction pool 24. The reagent delivery tube is used to distribute the second reagent in the reagent refrigeration chamber 22 to the specific protein reaction pool 24. The immunoassay cell unit 21 is arranged on the second path 25, and the sample liquid output position 34 is arranged on the second path 25. In this case, the reagent needle 28 is only used to draw and distribute the sample liquid, and the second reagent is transported and distributed using the reagent delivery tube, which can reduce the resource occupation time of the reagent needle 28.

[0097] In this embodiment, the first path 11 is a straight path, and the second path 25 is also a straight path. In this embodiment, the first path 11 and the second path 25 are parallel to each other, and the premixing tank 31 moves along the third path 35 between the sample receiving position 33 and the sample liquid output position 34. In this embodiment, the third path 35 is perpendicular to the first path 11 and the second path 25. Of course, in other embodiments, the first path 11 and the second path 25 can also have a certain angle between them, and the third path 35 can also not be perpendicular to the first path 11 and the second path 25, which will not be described in detail. In other embodiments, the second path 25 can also be a curved path, such as a circular arc path, as shown in Figure 4, which will not be described in detail.

[0098] In this embodiment, the reagent refrigeration chamber 22 includes a reagent bottle 26 for holding the second reagent and a refrigeration unit 27 for refrigerating the second reagent. In this embodiment, the second reagent is a latex reagent, and the refrigeration unit 27 provides a refrigerated environment of 2-8°C for the latex reagent.

[0099] In this embodiment, the premixing tank unit 30 further includes a heating assembly (not shown) for controlling the temperature within the premixing tank 31 to provide a constant incubation temperature environment for the hemolysis reaction. A first reagent supply device 32 is connected to the premixing tank 30 for dispensing the first reagent required for the hemolysis reaction therein.

[0100] The specific protein analyzer of this embodiment further includes a fluid path support device 40. The fluid path support device of this embodiment includes:

[0101] The quantitative device 41 is used to control the first reagent supply device 32 to distribute the first reagent to the premixing tank 31 and to control the blood routine test reagent supply device to distribute the blood routine test reagent to the blood routine reaction tank 14;

[0102] A cleaning device 42 is used to clean the blood routine reaction pool 14, the specific protein reaction pool 24 and the premixing pool 31;

[0103] The mixing device 43 is used to perform a mixing operation on the routine blood test reaction pool 14 , the specific protein reaction pool 24 and the premixing pool 31 .

[0104] The specific implementation of the specific protein detection method of the present invention is described below in conjunction with the above-mentioned specific protein analyzer.

[0105] Example 2

[0106] As shown in FIG5 , the specific protein detection method of this embodiment includes the following steps.

[0107] Step 1: The blood sample and the first reagent are distributed to the premixing pool 31 located at the sample receiving position 33, so that the blood sample and the first reagent are mixed in the premixing pool 31 and undergo hemolysis reaction to obtain a sample liquid. During the hemolysis reaction or after the hemolysis reaction is completed, the premixing pool 31 is driven to move to the sample liquid output position 34. In this embodiment, the sample receiving position 33 of the premixing pool unit 30 is located on the first path 11, so that the blood sample can be directly distributed to the premixing pool 31 using the routine blood sampling module 12. The first reagent is distributed to the premixing pool 31 through the first reagent supply device 32. In some embodiments, the sample liquid can also be diluted to reduce the specific protein immune reaction and the amount of the second reagent used in the detection process, and to save detection costs. Specifically, the sample liquid can be diluted by adding the first reagent and / or diluent to the premixing pool 31.

[0108] During this process, the specific protein detection item to be detected for the blood sample is determined; and the second reagent required for the specific protein detection item in the reagent refrigeration chamber 22 is distributed to the corresponding specific protein reaction pool 24 by the transfer unit.

[0109] Specifically, when the immunoassay pool unit 21 includes at least two specific protein reaction pools 24, it is possible to simultaneously perform different specific protein detection items on the same blood sample. When it is necessary to perform at least two specific protein detection items on the same blood sample, before allocating the second reagent, the number of specific protein detection items that the blood sample needs to be detected is first determined; the transfer unit 23 is used to allocate the second reagents required for different specific protein detection items in the reagent refrigeration bin 22 to the corresponding specific protein reaction pools 24. In this embodiment, after determining the number of specific protein detection items that the blood sample needs to be detected, it is determined whether the number of specific protein reaction pools 24 in the idle state is greater than or equal to the number of specific protein detection items that the current blood sample needs to be detected: if so, the second reagent is allocated; if not, wait for the other specific protein reaction pools 24 in the detection state to resume the idle state until the number of specific protein reaction pools 24 in the idle state is greater than or equal to the number of specific protein detection items that the current blood sample needs to be detected, and then the second reagent is allocated.

[0110] Step 2: Use the transfer unit 23 to distribute the sample liquid to the corresponding specific protein reaction pool 24. After the sample liquid is distributed, the remaining sample liquid in the premixing pool 31 is drained and cleaned, and the premixing pool 31 is moved to the sample receiving position 33. Specifically, the remaining sample liquid in the premixing pool 31 can be drained and cleaned at the sample liquid output position 34 before the premixing pool 31 is moved to the sample receiving position 33. Alternatively, the premixing pool 31 can be moved to the sample receiving position 33 first, and then the remaining sample liquid in the premixing pool 31 is drained and cleaned at the sample receiving position 33.

[0111] Step 3: The sample solution and the second reagent undergo a specific protein immunoreaction and detection within the specific protein reaction pool. After the specific protein immunoreaction and detection are complete, the specific protein reaction pool 24 is drained and cleaned, returning the specific protein reaction pool in the detection state to an idle state. When the immunodetection pool unit 21 includes at least two specific protein reaction pools 24, during the specific protein immunoreaction and detection process, a determination is made as to whether all detection tasks are complete. If so, step 4 is executed; if not, step 1 is executed. In other words, if there are idle specific protein reaction pools 24 and a detection task is not completed, the next detection task can be started while the specific protein immunoreaction and detection of the previous detection task is in progress.

[0112] Step 4: Obtain specific protein detection results.

[0113] In this embodiment, the transfer unit 23 includes a reagent needle 28 and a motion mechanism 29 for driving the reagent needle 28 along the second path 25. The reagent needle 28 is used to aspirate sample liquid or a second reagent and distribute it to the specific protein reaction well 24. In this embodiment, the immunoassay cell unit 21 and the reagent refrigeration chamber 22 are both located along the second path 25, and the sample liquid output port 34 of the premixing cell unit 30 is located on the second path 25. Thus, the transfer unit 23 can be used to distribute the sample liquid obtained through the hemolysis reaction in the premixing cell 31 to the specific protein reaction well 24, and can also distribute the second reagent stored in the reagent refrigeration chamber 22 to the specific protein reaction well 24. Thus, in step one, the reagent needle 28 is used to aspirate the second reagent and distribute it to the corresponding specific protein reaction well 24. After the second reagent corresponding to each specific protein test item is distributed, the reagent needle 28 is cleaned. In step two, the reagent needle 28 is used to aspirate the sample liquid and distribute it to the corresponding specific protein reaction well 24. After the sample liquid is distributed, the reagent needle 28 is cleaned. In a preferred implementation of this embodiment, the amount of sample liquid drawn by the reagent needle 28 is greater than or equal to the amount of sample liquid required for all specific protein detection items that need to be detected in the corresponding blood sample. In this way, the reagent needle 28 only needs to draw a sufficient amount of sample liquid once, and there is no need to draw the sample liquid multiple times, which can effectively improve efficiency.

[0114] Of course, the transfer unit can also be implemented in a variety of other ways, as follows: the transfer unit 23 includes a reagent needle 28, a motion mechanism 29 for driving the reagent needle 28 to move along the second path 25, and a reagent delivery tube arranged between the reagent refrigeration chamber 22 and the specific protein reaction pool 24. The reagent needle 28 is used to draw the sample liquid and distribute the sample liquid to the specific protein reaction pool 24. The reagent delivery tube is used to distribute the second reagent in the reagent refrigeration chamber 22 to the specific protein reaction pool 24. The immunoassay cell unit 21 is arranged on the second path 25, and the sample liquid output position 34 of the premixed cell unit 30 is arranged on the second path 25. At this time, the reagent needle 28 is only used to draw and distribute the sample liquid, and the second reagent is transported and distributed using the reagent delivery tube, which can reduce the resource occupancy time of the reagent needle 28. In this way, in step one, the second reagent is distributed to the corresponding specific protein reaction pool 24 using the reagent delivery tube; after the second reagent corresponding to each specific protein detection item is distributed, the reagent delivery tube is cleaned. In step 2, the sample liquid is drawn by the reagent needle 28 and dispensed into the corresponding specific protein reaction reservoir 24. After the sample liquid is dispensed, the reagent needle 28 is cleaned. In a preferred embodiment of this embodiment, the amount of sample liquid drawn by the reagent needle 28 is greater than or equal to the amount of sample liquid required for all specific protein tests to be performed on the corresponding blood sample. In this way, the reagent needle 28 only needs to draw a sufficient amount of sample liquid once, eliminating the need for multiple draws, which can effectively improve efficiency.

[0115] As shown in Figure 6, there are two specific protein reaction pools and the two specific protein reaction pools perform specific protein immune reactions and detection on different blood samples respectively. As shown in Figure 5:

[0116] (1) The end time T1 of the transfer unit 23 dispensing the second reagent into the corresponding specific protein reaction pool 24 is any time before the start time T2 of dispensing the sample solution into the specific protein reaction pool 24, that is, (T2-T1)≥0;

[0117] (2) The start time T4 of emptying and cleaning the premixing pool begins at any time T3 after the reagent needle 28 aspirates the sample liquid out of the premixing pool unit 30, that is, (T4-T3)≥0;

[0118] (3) The common resource of the two specific protein reaction pools 24 is the transfer unit 23, so the interval time △T between the two specific protein reaction pools 24 and the transfer unit 23 is ≥ 50ms, and the emptying and cleaning end time T5 of the premixing pool 31 of the previous detection task can be before the hemolysis reaction process of the premixing pool 31 of the next detection task.

[0119] In this embodiment, the first reagent includes a hemolytic agent, and the second reagent includes a latex reagent.

[0120] Example 3

[0121] As shown in FIG7 , the specific protein detection method of this embodiment includes the following steps.

[0122] Step 1: The blood sample and the first reagent are distributed to the premixing pool 31 located at the sample receiving position 33, so that the blood sample and the first reagent are mixed in the premixing pool 31 and undergo hemolysis reaction to obtain a sample liquid. During the hemolysis reaction or after the hemolysis reaction is completed, the premixing pool 31 is driven to move to the sample liquid output position 34. In this embodiment, the sample receiving position 33 of the premixing pool unit 30 is located on the first path 11, so that the blood sample can be directly distributed to the premixing pool 31 using the routine blood sampling module 12. The first reagent is distributed to the premixing pool 31 through the first reagent supply device 32. In some embodiments, the sample liquid can also be diluted to reduce the specific protein immune reaction and the amount of the second reagent used in the detection process, and to save detection costs. Specifically, the sample liquid can be diluted by adding the first reagent and / or diluent to the premixing pool 31.

[0123] During this process, the specific protein detection item to be detected for the blood sample is determined; and the second reagent required for the specific protein detection item in the reagent refrigeration chamber 22 is distributed to the corresponding specific protein reaction pool 24 by the transfer unit.

[0124] Specifically, when the immunoassay pool unit 21 includes at least two specific protein reaction pools 24, it is possible to simultaneously perform different specific protein detection items on the same blood sample. When it is necessary to perform at least two specific protein detection items on the same blood sample, before allocating the second reagent, the number of specific protein detection items that the blood sample needs to be detected is first determined; the transfer unit 23 is used to allocate the second reagents required for different specific protein detection items in the reagent refrigeration bin 22 to the corresponding specific protein reaction pools 24. In this embodiment, after determining the number of specific protein detection items that the blood sample needs to be detected, it is determined whether the number of specific protein reaction pools 24 in the idle state is greater than or equal to the number of specific protein detection items that the current blood sample needs to be detected: if so, the second reagent is allocated; if not, wait for the other specific protein reaction pools 24 in the detection state to resume the idle state until the number of specific protein reaction pools 24 in the idle state is greater than or equal to the number of specific protein detection items that the current blood sample needs to be detected, and then the second reagent is allocated.

[0125] Step 2: Use the transfer unit 23 to distribute the sample liquid to the corresponding specific protein reaction pool 24. After the sample liquid is distributed, the remaining sample liquid in the premixing pool 31 is emptied and the premixing pool 31 is cleaned, and the premixing pool 31 is moved to the sample receiving position 33. Specifically, in this embodiment, step 2 includes the following steps.

[0126] 21) Use the transfer unit 23 to distribute the sample solution to the corresponding specific protein reaction pool 24.

[0127] 22) The sample liquid is mixed with the second reagent in the specific protein reaction pool 24 to perform specific protein immune reaction and detection.

[0128] 23) Determine whether the immune detection signal value exceeds the set threshold within the set time: if so, execute step 24); if not, execute step 3.

[0129] 24) dilutes the remaining sample solution in the premixing tank 31 to obtain a diluted sample solution; simultaneously, the specific protein reaction tank 24 is drained and cleaned. After the specific protein reaction tank 24 is cleaned, the second reagent in the reagent cooling chamber 22 is distributed to the specific protein reaction tank using the transfer unit 23. In this embodiment, the first reagent and / or diluent are added to the premixing tank 31 to dilute the sample solution.

[0130] Similarly, when the immunoassay pool unit 21 includes at least two specific protein reaction pools 24, it is possible to simultaneously perform different specific protein tests on the same blood sample. When at least two specific protein tests are required on the same blood sample, the number of specific protein tests required is determined before distributing the second reagent. The transfer unit 23 then distributes the second reagents required for the different specific protein tests within the reagent refrigeration chamber 22 to the corresponding specific protein reaction pools 24.

[0131] 25) Use the transfer unit to distribute the sample liquid in the premixing tank 31 to the specific protein reaction tank, so that the sample liquid is mixed with the second reagent in the specific protein reaction tank and a specific protein immunoreaction and detection is performed; after the sample liquid is distributed, the premixing tank 31 is emptied and cleaned, and the premixing tank 31 is moved to the sample receiving position; and step 4 is executed.

[0132] Specifically, the remaining sample liquid in the premixing tank 31 can be drained at the sample liquid output position 34 and the premixing tank 31 can be cleaned, and then the premixing tank 31 can be driven to move to the sample receiving position 33; or the premixing tank 31 can be driven to move to the sample receiving position 33, and then the remaining sample liquid in the premixing tank 31 can be drained at the sample receiving position 33 and the premixing tank 31 can be cleaned.

[0133] Step 3: The sample solution and the second reagent undergo a specific protein immunoreaction and detection within the specific protein reaction pool. After the specific protein immunoreaction and detection are complete, the specific protein reaction pool 24 is drained and cleaned, returning the specific protein reaction pool in the detection state to an idle state. When the immunodetection pool unit 21 includes at least two specific protein reaction pools 24, during the specific protein immunoreaction and detection process, a determination is made as to whether all detection tasks are complete. If so, step 4 is executed; if not, step 1 is executed. In other words, if there are idle specific protein reaction pools 24 and a detection task is not completed, the next detection task can be started while the specific protein immunoreaction and detection of the previous detection task is in progress.

[0134] Step 4: Obtain specific protein detection results.

[0135] In this embodiment, the transfer unit 23 includes a reagent needle 28 and a motion mechanism 29 for driving the reagent needle 28 to move along the second path 25. The reagent needle 28 is used to aspirate the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool 24. In this embodiment, the immunoassay cell unit 21 and the reagent refrigeration chamber 22 are both arranged along the second path 25, and the sample liquid output position 34 of the premixing cell unit 30 is arranged on the second path 25. In this way, the transfer unit 23 can be used to distribute the sample liquid obtained by the hemolysis reaction in the premixing cell 31 into the specific protein reaction pool 24, and the second reagent stored in the reagent refrigeration chamber 22 can also be distributed into the specific protein reaction pool 24. In this way, in steps 1 and 24, the reagent needle 28 is used to aspirate the second reagent and distribute the second reagent to the corresponding specific protein reaction pool 24; after the second reagent corresponding to each specific protein detection item is distributed, the reagent needle 28 is cleaned. In steps 21) and 24), the sample liquid is drawn by a reagent needle 28 and dispensed into the corresponding specific protein reaction reservoir 24. After the sample liquid is dispensed, the reagent needle 28 is cleaned. In a preferred embodiment of this embodiment, the amount of sample liquid drawn by the reagent needle 28 is greater than or equal to the amount of sample liquid required for all specific protein tests to be performed on the corresponding blood sample. In this manner, the reagent needle 28 only needs to draw a sufficient amount of sample liquid in a single pass, eliminating the need for multiple draws, which effectively improves efficiency.

[0136] Of course, the transfer unit can also be implemented in a variety of other ways, as follows: the transfer unit 23 includes a reagent needle 28, a motion mechanism 29 for driving the reagent needle 28 to move along the second path 25, and a reagent delivery tube arranged between the reagent refrigeration chamber 22 and the specific protein reaction pool 24. The reagent needle 28 is used to draw the sample liquid and distribute the sample liquid to the specific protein reaction pool 24. The reagent delivery tube is used to distribute the second reagent in the reagent refrigeration chamber 22 to the specific protein reaction pool 24. The immunoassay cell unit 21 is arranged on the second path 25, and the sample liquid output position 34 of the premixed cell unit 30 is arranged on the second path 25. At this time, the reagent needle 28 is only used to draw and distribute the sample liquid, and the second reagent is transported and distributed using the reagent delivery tube, which can reduce the resource occupancy time of the reagent needle 28. In this way, in step 1 and step 24), the second reagent is distributed to the corresponding specific protein reaction pool 24 using the reagent delivery tube; after the second reagent corresponding to each specific protein detection item is distributed, the reagent delivery tube is cleaned. In steps 21) and 24), the sample liquid is drawn by a reagent needle 28 and dispensed into the corresponding specific protein reaction reservoir 24. After the sample liquid is dispensed, the reagent needle 28 is cleaned. In a preferred embodiment of this embodiment, the amount of sample liquid drawn by the reagent needle 28 is greater than or equal to the amount of sample liquid required for all specific protein tests to be performed on the corresponding blood sample. In this manner, the reagent needle 28 only needs to draw a sufficient amount of sample liquid in a single pass, eliminating the need for multiple draws, which effectively improves efficiency.

[0137] As shown in FIG8 , it is a timing diagram of executing step 2 and step 3 of the specific protein detection method of this embodiment. As can be seen from FIG8 :

[0138] (1) The start time of the specific protein immune reaction and detection between the sample solution and the second reagent is recorded as T21, and the time of detecting the immune detection signal value is recorded as T22, and the following conditions are satisfied: (T22-T21) ≥ 1 second. The immune detection signal value is collected at time T22, and the immune detection signal value at this time is determined and compared with a preset threshold value;

[0139] (2) If the immunoassay signal value collected at time T22 is higher than the preset threshold, the specific protein reaction pool 24 is drained and cleaned, and the sample liquid is diluted in the premixing pool 31 to prepare a diluted sample liquid. The cleaning operation of the specific protein reaction pool 24 is completed within the time period T22 to T24. After the diluted sample liquid is prepared and transferred at time T25, the premixing pool 31 is drained and cleaned, and the start time of draining and cleaning the premixing pool 31 is T26 ≥ T25;

[0140] (3) If the immune detection signal value collected at time T22 is less than the preset threshold, the specific protein immune reaction and detection in the specific protein reaction pool 24 continue until the end; during the process of continuing the specific protein immune reaction and detection, the premixing pool 31 is emptied and cleaned, and the starting time for emptying and cleaning the premixing pool 31 is T23 ≥ T22.

[0141] In this embodiment, the first reagent includes a hemolytic agent, and the second reagent includes a latex reagent.

[0142] The above embodiments are merely preferred embodiments for the purpose of fully illustrating the present invention, and the scope of protection of the present invention is not limited thereto. Equivalent substitutions or modifications made by those skilled in the art based on the present invention are within the scope of protection of the present invention. The scope of protection of the present invention shall be subject to the claims.

Claims

1. A specific protein detection component, characterized in that: include: A premixing pool unit receives a blood sample and performs a hemolysis reaction to obtain a sample solution; A reagent refrigeration chamber for storing at least one second reagent required for a specific protein immune response; An immunoassay pool unit is used to provide a place for specific protein immune response and detection; A transfer unit, used for distributing the sample liquid in the premixing pool unit and the second reagent in the reagent refrigeration bin to the immunoassay pool unit; The premixing tank unit comprises a premixing tank, a sample receiving position for receiving a blood sample, and a sample liquid output position for outputting a sample liquid, and the premixing tank can be moved between the sample receiving position and the sample liquid output position; The immunoassay pool unit receives the sample fluid and the second reagent to complete specific protein immune reaction and detection.

2. The specific protein detection component according to claim 1, characterized in that: The immunodetection cell unit comprises at least one specific protein reaction cell.

3. The specific protein detection component according to claim 2, characterized in that: The immune detection pool unit also includes a laser generating device and a signal detecting device for detecting the specific immune reaction results in the specific protein reaction pool.

4. The specific protein detection component according to claim 2, characterized in that: The transfer unit includes a reagent needle and a motion mechanism for driving the reagent needle to move along a second path, the reagent needle is used to absorb sample liquid or a second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool; the immunoassay pool unit and the reagent refrigeration chamber are both arranged along the second path, and the sample liquid output position is arranged on the second path.

5. The specific protein detection assembly according to claim 2, characterized in that: The transfer unit includes a reagent needle, a motion mechanism for driving the reagent needle to move along the second path, and a reagent delivery tube arranged between the reagent refrigeration bin and the specific protein reaction pool. The reagent needle is used to absorb the sample liquid and distribute the sample liquid to the specific protein reaction pool. The reagent delivery tube is used to distribute the second reagent in the reagent refrigeration bin to the specific protein reaction pool. The immunodetection cell unit is arranged on the second path, and the sample liquid output position is set on the second path.

6. The specific protein detection assembly according to claim 4 or 5, characterized in that: The second path is a straight path or a curved path.

7. The specific protein detection assembly according to claim 1, characterized in that: The reagent refrigeration bin comprises a reagent bottle for containing a second reagent and a refrigeration unit for refrigerating the second reagent.

8. The specific protein detection assembly according to claim 1, characterized in that: The premixing tank unit further comprises a heating component, and the heating component is used to control the temperature in the premixing tank to provide a constant temperature incubation environment for the hemolysis reaction.

9. The specific protein detection component according to claim 1, characterized in that: The premixing tank is connected to a first reagent supply device for distributing a first reagent required for a hemolytic reaction thereto.

10. A specific protein analyzer, characterized in that: It comprises a routine blood test component and a specific protein test component as described in any one of claims 1 to 9; the routine blood test component comprises a routine blood sample module moving along a first path and a routine blood reaction pool unit arranged on the first path, and the sample receiving position is set on the first path; the routine blood sample module moves along the first path and is used to distribute the absorbed blood sample to the routine blood reaction pool unit and the premixing pool located at the sample receiving position; the routine blood reaction pool unit receives the blood sample to complete the routine blood test.

11. The specific protein analyzer according to claim 10, characterized in that: The first path and the second path are both straight paths, and the first path and the second path are parallel to each other.

12. The specific protein analyzer according to claim 10, characterized in that: The routine blood test reaction pool unit includes at least one routine blood test reaction pool arranged along the first path for completing the routine blood test.

13. The specific protein analyzer according to claim 12, characterized in that: The routine blood test reaction pool is connected to a routine blood test reagent supply device for distributing reagents required for routine blood test thereto.

14. The specific protein analyzer according to claim 12, characterized in that: The routine blood sampling module includes a sample needle and a linear motion mechanism for driving the sample needle to move along a first path. The sample needle is used to draw a blood sample and distribute the blood sample to the routine blood reaction pool and the premixing pool located at the sample receiving position.

15. The specific protein analyzer according to claim 10, characterized in that: It also includes a liquid circuit support device; the routine blood test reaction pool unit includes a routine blood test reaction pool, and the immune detection pool unit includes a specific protein reaction pool; the premixing pool is connected to a first reagent supply device for distributing a first reagent required for a hemolytic reaction thereto; The blood routine test reaction pool is connected to a blood routine test reagent supply device for distributing reagents required for blood routine test thereto; The liquid circuit supporting device comprises: A quantitative device, used for controlling the first reagent supply device to distribute the first reagent to the premixing pool and for controlling the blood routine reagent supply device to distribute the blood routine test reagent to the blood routine reaction pool; A cleaning device, used for cleaning the routine blood test reaction pool, the specific protein reaction pool and the premixing pool; The mixing device is used to perform mixing operations on the routine blood test reaction pool, the specific protein reaction pool and the premixing pool.

16. A method for detecting a specific protein using the specific protein detection assembly according to any one of claims 1 to 9, characterized in that: The steps include: Step 1: Distribute the blood sample and the first reagent into a premixing tank located at a sample receiving position, mix the blood sample and the first reagent in the premixing tank and perform a hemolysis reaction to obtain a sample solution; during the hemolysis reaction or after the hemolysis reaction is completed, drive the premixing tank to move to a sample solution output position; In this process, the specific protein detection item to be detected for the blood sample is determined; the second reagent required for the specific protein detection item in the reagent refrigeration bin is distributed to the corresponding specific protein reaction pool by using the transfer unit; Step 2: Use the transfer unit to distribute the sample liquid to the corresponding specific protein reaction pool; after the sample liquid is distributed, empty the remaining sample liquid in the premixing pool and clean the premixing pool, so that the premixing pool is moved to the sample receiving position; Step 3: the sample solution and the second reagent are subjected to specific protein immune reaction and detection in the specific protein reaction pool; after the specific protein immune reaction and detection are completed, the specific protein reaction pool is emptied and cleaned to restore the specific protein reaction pool in the detection state to an idle state; Step 4: Get specific protein detection results.

17. The method for detecting a specific protein according to claim 16, characterized in that: The premixing pool unit includes a premixing pool and a heating component, wherein the heating component is used to control the temperature in the premixing pool to provide a constant temperature incubation environment for the hemolysis reaction; in the step one, the premixing pool is located at the sample receiving position, and the blood sample is distributed to the premixing pool using the routine blood sampling module.

18. The method for detecting a specific protein according to claim 17, characterized in that: The premixing tank is connected to a first reagent supply device for distributing a first reagent required for a hemolysis reaction thereto. In the step 1, the first reagent supply device is used to distribute the first reagent to the premixing tank.

19. The method for detecting a specific protein according to claim 16, characterized in that: The immunoassay pool unit includes at least two specific protein reaction pools; in the step 1, before distributing the second reagent, the number of specific protein detection items that need to be detected in the blood sample is first determined; and the second reagents required for different specific protein detection items in the reagent refrigeration bin are respectively distributed to the corresponding specific protein reaction pools using the transfer unit.

20. The method for detecting a specific protein according to claim 19, characterized in that: In the step 1, after determining the number of specific protein detection items that need to be detected in the blood sample, determine whether the number of specific protein reaction pools in an idle state is greater than or equal to the number of specific protein detection items that need to be detected in the current blood sample: if so, perform the second reagent allocation; if not, wait for other specific protein reaction pools in the detection state to resume the idle state, and perform the second reagent allocation until the number of specific protein reaction pools in an idle state is greater than or equal to the number of specific protein detection items that need to be detected in the current blood sample.

21. The method for detecting a specific protein according to claim 16, characterized in that: The step 2 comprises the following steps: 21) using a transfer unit to distribute the sample solution to a corresponding specific protein reaction pool; 22) mixing the sample solution with the second reagent in the specific protein reaction pool and performing specific protein immune reaction and detection; 23) Determine whether the immune detection signal value exceeds the set threshold within the set time: if so, execute step 24); if not, execute step 3; 24) diluting the remaining sample solution in the premix pool to obtain a diluted sample solution; at the same time, emptying and cleaning the specific protein reaction pool. After the specific protein reaction pool is cleaned, the transfer unit is used to distribute the second reagent in the reagent refrigeration bin to the specific protein reaction pool. Fixed protein reaction pool; 25) using a transfer unit to distribute the sample liquid in the premixing pool to the specific protein reaction pool, so that the sample liquid is mixed with the second reagent in the specific protein reaction pool and a specific protein immune reaction and detection are performed; after the sample liquid is distributed, the premixing pool is emptied and cleaned, and the premixing pool is moved to the sample receiving position; and step 4 is executed; 22. The specific protein detection method according to claim 21, characterized in that: In the step 24), the first reagent and / or diluent is added to the premixing pool to dilute the sample solution.

23. The specific protein detection method according to claim 21, characterized in that: The immunoassay pool unit includes at least two specific protein reaction pools; in the step 24), before distributing the second reagent, the number of specific protein detection items that need to be detected in the blood sample is first determined; and then the transfer unit is used to distribute the second reagents required for different specific protein detection items in the reagent refrigeration bin to the corresponding specific protein reaction pools.

24. The method for detecting a specific protein according to claim 21, characterized in that: In the step 2 or step 25), the remaining sample liquid in the premixing tank is first emptied at the sample liquid output position and the premixing tank is cleaned, and then the premixing tank is driven to move to the sample receiving position, or the premixing tank is first driven to move to the sample receiving position, and then the remaining sample liquid in the premixing tank is emptied at the sample receiving position and the premixing tank is cleaned.

25. The method for detecting a specific protein according to claim 21, characterized in that: The transfer unit includes a reagent needle and a motion mechanism for driving the reagent needle to move along the second path, the reagent needle is used to absorb the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool; the immunoassay pool unit and the reagent refrigeration chamber are both arranged along the second path, and the sample liquid output position is located on the second path; In the step 1 or the step 1 and the step 24), the second reagent is sucked by the reagent needle and the second reagent is distributed to the corresponding specific protein reaction pool; after the second reagent corresponding to each specific protein detection item is distributed, the reagent needle is cleaned; In the step 2 or step 21) and step 24), the sample liquid is sucked by a reagent needle and distributed to the corresponding specific protein reaction pool. After the sample liquid is distributed, the reagent needle is cleaned.

26. The method for detecting a specific protein according to claim 25, characterized in that: The amount of sample liquid drawn by the reagent needle is greater than or equal to the amount of sample liquid required for all specific protein detection items that need to be detected in the corresponding blood sample.

27. The method for detecting a specific protein according to claim 21, characterized in that: The transfer unit includes a reagent needle, a motion mechanism for driving the reagent needle to move along the second path, and a reagent delivery tube arranged between the reagent refrigeration bin and the specific protein reaction pool, the reagent needle is used to absorb the sample liquid and distribute the sample liquid to the specific protein reaction pool, the reagent delivery tube is used to distribute the second reagent in the reagent refrigeration bin to the specific protein reaction pool, the immunodetection cell unit is arranged on the second path, and the sample liquid output position is located on the second path; In the step 1 or the step 1 and the step 24), the second reagent is distributed to the corresponding specific protein reaction pool by using the reagent delivery tube; after the second reagent corresponding to each specific protein detection item is distributed, the reagent delivery tube is cleaned; In the step 2 or step 21) and step 24), the sample liquid is sucked by a reagent needle and distributed to the corresponding specific protein reaction pool. After the sample liquid is distributed, the reagent needle is cleaned.

28. The method for detecting a specific protein according to claim 27, characterized in that: The amount of sample liquid drawn by the reagent needle is greater than or equal to the amount of sample liquid required for all specific protein detection items that need to be detected in the corresponding blood sample.

29. The method for detecting a specific protein according to claim 21, characterized in that: In the step 1, the sample solution is diluted.

30. The method for detecting a specific protein according to claim 21, characterized in that: In step three, during the process of specific protein immune response and detection, determine whether all detection tasks are completed: if so, execute step four; if not, execute step one.

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