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WO2025050235A1 - Analyseur de protéine spécifique, et ensemble et procédé de test de protéine spécifique - Google Patents

Analyseur de protéine spécifique, et ensemble et procédé de test de protéine spécifique Download PDF

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Publication number
WO2025050235A1
WO2025050235A1 PCT/CN2023/116694 CN2023116694W WO2025050235A1 WO 2025050235 A1 WO2025050235 A1 WO 2025050235A1 CN 2023116694 W CN2023116694 W CN 2023116694W WO 2025050235 A1 WO2025050235 A1 WO 2025050235A1
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WIPO (PCT)
Prior art keywords
specific protein
reagent
pool
reaction
sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
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PCT/CN2023/116694
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English (en)
Chinese (zh)
Inventor
白新梅
黄青标
甘海
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Zybio Inc
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Zybio Inc
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Publication date
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Priority to PCT/CN2023/116694 priority Critical patent/WO2025050235A1/fr
Publication of WO2025050235A1 publication Critical patent/WO2025050235A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids

Definitions

  • the present invention belongs to the technical field of in vitro diagnosis, and specifically relates to a specific protein analyzer and a specific protein detection component and a detection method.
  • the sample used for the specific protein immune reaction is distributed to the specific protein reaction pool component through the sampling needle of the routine blood test module, and the latex reagent used for the immune reaction is also drawn from the specific reagent position through the sample needle of the routine blood test sampling and distribution module.
  • the sample needle of the routine blood sampling and distribution module is used to distribute latex reagents.
  • multiple reaction pools required for routine blood testing such as HGB reaction pool, WNB reaction pool, RBC reaction pool, RET reaction pool and DIFF reaction pool, are arranged.
  • 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 2 specific protein detection items, more reaction pool components need to be arranged on the trajectory of the movement of the routine blood sampling and distribution module, which is not conducive to the layout of the instrument and makes the depth direction of the instrument longer.
  • 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 response. 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 detection.
  • the amount or concentration of the second reagent should match the amount of whole blood sample.
  • 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.
  • the routine blood sampling module needs to distribute samples to different specific protein reaction pools multiple times after absorbing the sample, which will also increase the consumption of whole blood samples.
  • the ratio of the first reagent (including hemolytic agent) and the second reagent (including latex reagent) involved in the immune reaction to the blood sample is quantitatively designed. Due to the limitations of the detection system and reagent concentration, the linear range and the precision of the low value segment of specific protein detection are two mutually restrictive specifications. It is difficult to simultaneously meet the requirements of a larger linear range and better For extremely high-value samples, it is usually necessary to manually dilute them by a certain multiple for testing, which is cumbersome.
  • 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 the detection efficiency.
  • the present invention provides the following technical solutions:
  • the present invention first proposes a specific protein detection component, comprising:
  • 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.
  • the immunodetection cell unit includes at least one specific protein reaction cell.
  • 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.
  • 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
  • the sample liquid output position is arranged on the second path.
  • 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 warehouse 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 warehouse 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.
  • the second path is a straight path or a curved path.
  • the reagent refrigeration bin includes a reagent bottle for containing a second reagent and a refrigeration unit for refrigerating the second reagent.
  • the premixing tank unit also 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.
  • the premixing tank is connected to a first reagent supply device for distributing a first reagent required for a hemolysis reaction thereto.
  • 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.
  • first path and the second path are both straight paths, and the first path and the second path are parallel to each other.
  • 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.
  • routine blood test reaction pool is connected to a routine blood test reagent supply device for distributing reagents required for routine blood test thereto.
  • 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, wherein the sample needle is used to draw a blood sample and distribute the blood sample to the routine blood test reaction pool and the premixing pool located at the sample receiving position.
  • the routine blood test reaction pool unit includes a routine blood test reaction pool
  • 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 routine blood test reaction pool is connected to a routine blood test reagent supply device for distributing a reagent required for a routine blood 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.
  • the present invention also proposes a specific protein detection method using the specific protein detection component as described above, comprising the following steps:
  • Step 1 Distribute the blood sample and the first reagent into a premixing tank located at the 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 is completed After the reaction, the premixing pool is driven to move to the sample liquid output position;
  • 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.
  • 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.
  • the premixing tank is connected to a first reagent supply device for distributing a first reagent required for a hemolysis reaction thereto.
  • the first reagent supply device is used to distribute the first reagent to the premixing tank.
  • the immunoassay pool unit includes at least two specific protein reaction pools; in the 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 bin to the corresponding specific protein reaction pools.
  • step one after determining the number of specific protein detection items that need to be detected for 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 for 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 for the current blood sample.
  • step 2 comprises the following steps:
  • step 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;
  • step 24 the first reagent and/or diluent is added to the premixing pool to dilute the sample solution.
  • 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 warehouse to the corresponding specific protein reaction pools.
  • 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.
  • 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 bin are both arranged along the second path, and the sample liquid output position is located on the second path;
  • 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;
  • 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.
  • 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.
  • 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;
  • 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;
  • the sample liquid is sucked by a reagent needle and the sample liquid is distributed to the corresponding The specific protein reaction pool cleans the reagent needle after the sample liquid is distributed.
  • 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.
  • the sample solution is diluted.
  • step three during the process of 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.
  • the specific protein analyzer of the present invention is provided with a routine blood test component and a specific protein test component independently.
  • a blood sample is sucked by a routine blood sample sampling module and then moved along a first path to distribute the blood sample to a routine blood test reaction pool unit and a premixing pool located at a sample receiving position.
  • a routine blood test is completed.
  • a hemolysis reaction is performed to obtain a sample liquid.
  • the premixing pool is driven to move to a sample liquid output position, and then a transfer unit is used to distribute the sample liquid and a second reagent stored in a reagent refrigeration bin to an immunodetection pool unit to complete a specific protein immunoreaction and detection.
  • the specific protein analyzer has the following advantages:
  • the routine blood test component and the specific protein test component are independently arranged, that is, the immune detection pool unit does not need to be arranged on the moving path of the routine blood sampling module, and 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 arrangement 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;
  • 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;
  • the routine blood test component and the specific protein test component are independently set up.
  • 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.
  • 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, such as Therefore, when the sample solution in the premixing pool is distributed, during the period when the sample solution and the second reagent are subjected to specific protein immune reaction and detection in the immunodetection pool unit, the sample solution required for the next specific protein immune reaction can be prepared in the premixing pool, which can effectively improve the detection speed and efficiency compared with the method in the prior art in which the hemolysis reaction and the specific protein immune reaction are required to be carried out in sequence in the immunodetection pool unit;
  • the sample solution can be diluted in the premixing 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 routine blood sampling module.
  • the specific protein detection method of the present invention provides a premixing pool unit.
  • the blood sample and the first reagent are distributed to the premixing pool located at the sample receiving position for hemolysis reaction; during this process, the second reagent is distributed to the 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 the sample liquid output position is distributed to the corresponding specific protein reaction pool, so that in the specific protein reaction pool, the sample liquid and the second reagent are subjected to specific protein immunoreaction and detection; after the sample liquid is distributed, the premixing pool can be emptied and cleaned, and if there is an unfinished detection task, 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 this detection task can be carried out simultaneously; when the number of specific protein reaction pools is sufficient, when the specific protein immunoreaction and detection of this detection task have not
  • 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 premix 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 through the sample liquid.
  • 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 has a hook effect on the reaction curve of the high-value sample or exceeds the detection range, resulting in abnormal detection results; the present invention can automatically realize high-fold dilution of the high-value sample in the premixing pool unit, which can effectively improve the test accuracy of the high-value sample; 2 When a high-value sample is detected, there is no need to repeatedly draw the sample or reserve the sample in advance, and automatic high-fold dilution liquid detection can be achieved by a single draw, which has the advantages of simple operation, high blood sample utilization and low consumption.
  • FIG1 is a layout diagram of a specific protein analyzer embodiment 1 of the present invention.
  • FIG2 is a schematic diagram of a specific protein analyzer of this embodiment
  • FIG3 is a schematic diagram of the structure of a specific protein detection component
  • FIG4 is a schematic diagram of the structure when the second path is an arc curve path
  • FIG5 is a flow chart of Example 2 of a specific protein detection method of the present invention.
  • FIG6 is a timing diagram when 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;
  • FIG7 is a flow chart of Example 3 of the specific protein detection method of the present invention.
  • FIG8 is a timing diagram of a specific protein reaction pool performing specific protein immune reaction and detection.
  • 10-blood routine test component 11-first path; 12-blood routine sampling module; 13-blood routine reaction pool unit; 14-blood routine 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 tank unit; 31-premixing tank; 32-first reagent supply device; 33-sample receiving position; 34-sample liquid output position; 35-Third Path; 40-Liquid circuit support device; 41-Quantitative device; 42-Cleaning device; 43-Mixing device.
  • the specific protein analyzer of this embodiment includes a routine blood test component 10 and a specific protein test component 20 .
  • 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 that is arranged on the first path 11.
  • the sample receiving position 33 of the premixing pool unit 30 is arranged 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 a sample liquid.
  • the routine blood test reaction pool unit 13 includes at least one routine blood test reaction pool 14 that is arranged along the first path 11 and is used to complete the routine blood test.
  • routine blood test reaction pools 14 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.
  • a routine blood test reagent supply device (not shown in the figure) for distributing reagents required for routine blood test to the routine blood test reaction pool 14 is connected.
  • the routine blood test sampling module 13 includes a sample The sample needle (not shown) and a linear motion mechanism (not shown) 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 .
  • the specific protein detection component 20 of this embodiment includes:
  • the premixing pool unit 30 receives the blood sample and performs hemolysis reaction to obtain a sample solution
  • a reagent refrigeration chamber 22 used to store at least one second reagent required for a specific protein immune reaction
  • the immunodetection pool unit 21 is used to provide a place for specific protein immune reaction and detection
  • the transfer unit 23 is used to distribute the sample liquid in the premixing pool unit 30 and the second reagent in the reagent refrigeration chamber 22 to the immunoassay pool unit 21 .
  • the premixing pool unit 30 of this embodiment includes a premixing pool 31, a sample receiving position 33 for receiving a blood sample, and a sample liquid output position 34 for outputting a sample liquid, and the premixing pool 31 can be moved between the sample receiving position 33 and the sample liquid output position 34.
  • the immunodetection pool unit 21 receives the sample liquid and the second reagent to complete the specific protein immune reaction and detection.
  • the immunodetection pool unit 21 includes at least one specific protein reaction pool 24.
  • the number of specific protein reaction pools 24 is set according to actual needs.
  • the specific protein reaction pools 24 are set to two.
  • the immunodetection pool unit 21 of this embodiment also includes a laser generator and a signal detection device for detecting the specific immune response results in the specific protein reaction pool 24.
  • 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 warehouse 22, such as SRE latex reagents for detecting SAA projects and CRE latex reagents for detecting CRP projects.
  • the transfer unit 23 of this embodiment 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 absorb the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool 24.
  • the immunoassay pool unit 21 and the reagent refrigeration bin 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 by hemolysis reaction in the premix pool 31 to the specific protein reaction pool 24, and the second reagent stored in the reagent refrigeration bin 22 can also be distributed to the specific protein reaction pool 24.
  • the transfer unit can also be implemented in other ways, such as 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 bin 22 and the specific protein reaction pool 24, the reagent needle 28 is used to absorb 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 bin 22 to the specific protein reaction pool 24, the immunodetection cell unit 21 is arranged on the second path 25, and the sample liquid output position 34 is arranged on the second path 25.
  • the reagent needle 28 is only used to absorb 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.
  • the first path 11 is a straight path
  • the second path 25 is also a straight path.
  • 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, and in this embodiment, the third path 35 is perpendicular to the first path 11 and the second path 25.
  • the first path 11 and the second path 25 can also have a certain angle, and the third path 35 and the first path 11 and the second path 25 may not be perpendicular to each other, which will not be repeated.
  • the second path 25 can also be set as a curved path, such as a circular arc path, as shown in Figure 4, which will not be repeated.
  • the reagent refrigeration bin 22 includes a reagent bottle 26 for containing the second reagent and a refrigeration unit 27 for refrigerating the second reagent.
  • the second reagent is a latex reagent
  • the refrigeration unit 27 provides a refrigerated environment of 2-8°C for the latex reagent.
  • the premixing tank unit 30 further includes a heating assembly (not shown in the figure), which is used to control the temperature in the premixing tank 31 to provide a constant temperature incubation environment for the hemolysis reaction.
  • the premixing tank 30 is connected to a first reagent supply device 32 for dispensing the first reagent required for the hemolysis reaction thereto.
  • the specific protein analyzer of this embodiment further includes a fluid path support device 40.
  • the fluid path support device of this embodiment includes:
  • 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 reagent supply device to distribute the blood routine test reagent to the blood routine reaction tank 14;
  • a cleaning device 42 used for cleaning the blood routine reaction pool 14, the specific protein reaction pool 24 and the premixing pool 31;
  • 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 .
  • the specific protein detection method of this embodiment includes the following steps.
  • Step 1 distribute the blood sample and the first reagent 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 a hemolysis reaction is performed to obtain a sample liquid.
  • the premixing pool 31 is driven to move to the sample liquid output position 34.
  • 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.
  • the sample liquid can also be diluted to reduce the amount of the second reagent used in the specific protein immune reaction and the detection process, and save the detection cost.
  • the sample liquid can be diluted by adding the first reagent and/or diluent to the premixing pool 31.
  • the specific protein detection item to be detected in the blood sample is determined; and the second reagent required for the specific protein detection item in the reagent refrigeration bin 22 is distributed to the corresponding specific protein reaction pool 24 by using the transfer unit.
  • the immune detection pool unit 21 includes at least two specific protein reaction pools 24, it is possible to simultaneously detect different specific protein detection items for the same blood sample.
  • the number of specific protein detection items that need to be detected for the blood sample is first determined; the second reagents required for different specific protein detection items in the reagent refrigeration bin 22 are respectively allocated to the corresponding specific protein reaction pools 24 using the transfer unit 23.
  • the second reagent is allocated; if not, wait for 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 need to be detected for the current blood sample, and then the second reagent is allocated.
  • 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, so that the premixing pool 31 is moved to the sample receiving position 33.
  • the remaining sample liquid in the premixing pool 31 can be emptied and the premixing pool 31 can be cleaned at the sample liquid output position 34, and then the premixing pool 31 can be driven to move to the sample receiving position 33; or the premixing pool 31 can be driven to move to the sample receiving position 33, and then the remaining sample liquid in the premixing pool 31 can be emptied and the premixing pool 31 can be cleaned at the sample receiving position 33.
  • Step 3 The sample liquid 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 24 is emptied and cleaned to restore the specific protein reaction pool in the detection state to an idle state.
  • the immune detection pool unit 21 includes at least two specific protein reaction pools 24, during the process of performing the specific protein immune reaction and detection, it is determined whether all detection tasks are completed: if so, step 4 is executed; if not, step 1 is executed. That is, under the condition that there is an idle specific protein reaction pool 24 and the detection task is not completed, the next detection task can be started during the process of performing the specific protein immune reaction and detection of the previous detection task.
  • Step 4 Get specific protein detection results.
  • 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 bin 22 and the specific protein reaction pool 24, the reagent needle 28 is used to absorb 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 bin 22 to the specific protein reaction pool 24, the immunoassay pool unit 21 is arranged on the second path 25, and the sample liquid output position 34 of the premix pool unit 30 is arranged on the second path 25.
  • the reagent needle 28 is only used to absorb and distribute the sample liquid, and the second reagent is transported and distributed by the reagent delivery tube, which can reduce the resource occupation time of the reagent needle 28.
  • the second reagent is distributed to the corresponding specific protein reaction pool 24 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.
  • the sample liquid is sucked by the reagent needle 28 and distributed to the corresponding specific protein reaction pool 24. After the sample liquid is distributed, the reagent needle 28 is cleaned.
  • the amount of sample liquid sucked 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 suck a sufficient amount of sample liquid once, and does not need to suck the sample liquid multiple times, which can effectively improve efficiency.
  • FIG6 it is a timing diagram when 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.
  • FIG5 it is a timing diagram when 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.
  • 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;
  • the common resource of the two specific protein reaction pools 24 is the transfer unit 23, so the interval time ⁇ T ⁇ 50ms between the two specific protein reaction pools 24 alternatingly using the transfer unit 23, 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.
  • the first reagent includes a hemolytic agent
  • the second reagent includes a latex reagent
  • the specific protein detection method of this embodiment includes the following steps.
  • Step 1 Distribute the blood sample and the first reagent to the premixing tank 31 located at the sample receiving position 33, mix the blood sample and the first reagent in the premixing tank 31 and perform a hemolysis reaction to obtain a sample solution.
  • the premixing tank 31 is driven to move to the sample liquid output position 34.
  • the sample receiving position 33 of the premixing tank unit 30 is located on the first path 11, so that the blood sample can be directly distributed to the premixing tank 31 using the blood routine sampling module 12.
  • the first reagent is distributed to the premixing tank 31 through the first reagent supply device 32.
  • the sample liquid can also be diluted to reduce the specific protein immune response and the amount of the second reagent used in the detection process, and save detection costs.
  • the sample liquid can be diluted by adding the first reagent and/or diluent to the premixing tank 31.
  • the specific protein detection item to be detected in the blood sample is determined; and the second reagent required for the specific protein detection item in the reagent refrigeration bin 22 is distributed to the corresponding specific protein reaction pool 24 by using the transfer unit.
  • the immune detection pool unit 21 includes at least two specific protein reaction pools 24, it is possible to simultaneously detect different specific protein detection items for the same blood sample.
  • the number of specific protein detection items that need to be detected for the blood sample is first determined; the second reagents required for different specific protein detection items in the reagent refrigeration bin 22 are respectively allocated to the corresponding specific protein reaction pools 24 using the transfer unit 23.
  • the second reagent is allocated; if not, wait for 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 need to be detected for the current blood sample, and then the second reagent is allocated.
  • 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, empty the remaining sample liquid in the premixing pool 31 and clean the premixing pool 31, so that the premixing pool 31 is moved to the sample receiving position 33.
  • step 2 includes the following steps.
  • the premixing tank 31 dilutes the remaining sample liquid in the premixing tank 31 to obtain the diluted sample liquid; at the same time, the specific protein reaction tank 24 is emptied and cleaned. After the specific protein reaction tank 24 is cleaned, the second reagent in the reagent refrigeration bin 22 is distributed to the specific protein reaction tank by the transfer unit 23. In this embodiment, the first reagent and/or the diluent are added to the premixing tank 31 to dilute the sample liquid.
  • step 25 Use the transfer unit to distribute the sample liquid in the premixing pool 31 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 31 is emptied and cleaned, and the premixing pool 31 is moved to the sample receiving position; execute step 4.
  • the remaining sample liquid in the premixing tank 31 can be emptied 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 emptied at the sample receiving position 33 and the premixing tank 31 can be cleaned.
  • Step 3 The sample liquid 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 24 is emptied and cleaned to restore the specific protein reaction pool in the detection state to an idle state.
  • the immune detection pool unit 21 includes at least two specific protein reaction pools 24, during the process of performing the specific protein immune reaction and detection, it is determined whether all detection tasks are completed: if so, step 4 is executed; if not, step 1 is executed. That is, under the condition that there is an idle specific protein reaction pool 24 and the detection task is not completed, the next detection task can be started during the process of performing the specific protein immune reaction and detection of the previous detection task.
  • Step 4 Get specific protein detection results.
  • 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 absorb the sample liquid or the second reagent and distribute the sample liquid or the second reagent to the specific protein reaction pool 24.
  • the immunoassay pool unit 21 and the reagent refrigeration bin 22 are both arranged along the second path 25, and the sample liquid output position 34 of the premixing pool 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 hemolysis reaction in the premixing pool 31 to the specific protein reaction pool 24, and the second reagent stored in the reagent refrigeration bin 22 can also be distributed to the specific protein reaction pool 24.
  • the reagent needle 28 is used to absorb 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.
  • the sample liquid is sucked by the reagent needle 28 and distributed to the corresponding specific protein reaction pool 24. After the sample liquid is distributed, the reagent needle 28 is cleaned.
  • the amount of sample liquid sucked 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 suck a sufficient amount of sample liquid once, and does not need to suck the sample liquid multiple times, which can effectively improve efficiency.
  • 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 motion mechanism 29 disposed between the reagent refrigeration chamber 22 and the specific protein
  • the reagent delivery tube between the reaction pools 24, the reagent needle 28 is used to absorb 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 warehouse 22 to the specific protein reaction pool 24, the immunodetection pool unit 21 is arranged on the second path 25, and the sample liquid output position 34 of the premixed pool unit 30 is set on the second path 25.
  • the reagent needle 28 is only used to absorb 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.
  • the second reagent is distributed to the corresponding specific protein reaction pool 24 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.
  • the sample liquid is absorbed by the reagent needle 28 and the sample liquid is distributed to the corresponding specific protein reaction pool 24, and after the sample liquid is distributed, the reagent needle 28 is cleaned.
  • the amount of sample liquid absorbed 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 absorb a sufficient amount of sample liquid at one time, and there is no need to absorb the sample liquid multiple times, which can effectively improve efficiency.
  • FIG8 it is a timing diagram for executing step 2 and step 3 of the specific protein detection method of this embodiment. As can be seen from FIG8 :
  • T21 The starting 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;
  • the specific protein reaction pool 24 is emptied and cleaned, and the sample solution is diluted in the premixing pool 31 to prepare a diluted sample solution.
  • the cleaning operation of the specific protein reaction pool 24 is completed in the time period from T22 to T24. After the diluted sample solution is prepared and transferred at time T25, the premixing pool 31 is emptied and cleaned, and the start time of emptying and cleaning the premixing pool 31 is T26 ⁇ T25;
  • 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.
  • the first reagent includes a hemolytic agent
  • the second reagent includes a latex reagent

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Abstract

La présente invention concerne un ensemble de test de protéine spécifique, comprenant : une unité de bain de prémélange utilisée pour recevoir un échantillon sanguin, puis effectuer une réaction hémolytique afin d'obtenir une solution d'échantillon ; un compartiment réfrigéré de réactif utilisé pour stocker au moins un second réactif requis par une réaction immunitaire de protéine spécifique ; une unité de bain d'immunodétection utilisée pour fournir un emplacement pour la réponse immunitaire et la détection de la protéine spécifique ; et une unité de transfert utilisée pour distribuer la solution d'échantillon dans l'unité de bain de prémélange et le second réactif dans le compartiment réfrigéré de réactif à l'unité de bain d'immunodétection. L'unité de bain de prémélange comprend un bain de prémélange, une position de réception d'échantillon pour recevoir l'échantillon sanguin, et une position de sortie de solution d'échantillon pour délivrer en sortie la solution d'échantillon. Le bain de prémélange peut se déplacer entre la position de réception d'échantillon et la position de sortie de solution d'échantillon. L'unité de bain d'immunodétection reçoit la solution d'échantillon et le second réactif pour achever la réponse immunitaire et la détection de la protéine spécifique. La présente invention divulgue également un analyseur et un procédé de test de protéine spécifique, qui permettent d'améliorer l'efficacité de test.
PCT/CN2023/116694 2023-09-04 2023-09-04 Analyseur de protéine spécifique, et ensemble et procédé de test de protéine spécifique Pending WO2025050235A1 (fr)

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CN115524495A (zh) * 2021-06-25 2022-12-27 深圳迈瑞生物医疗电子股份有限公司 一种样本分析装置和方法
CN115684601A (zh) * 2021-07-30 2023-02-03 深圳迈瑞生物医疗电子股份有限公司 样本分析方法及样本分析仪
CN115932301A (zh) * 2023-01-03 2023-04-07 中元汇吉生物技术股份有限公司 样本检测方法和样本分析仪

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101147071A (zh) * 2005-04-01 2008-03-19 株式会社三菱化学药得论 生物样品的复合自动分析装置、自动分析方法以及反应杯
CN113176417A (zh) * 2014-07-01 2021-07-27 深圳迈瑞生物医疗电子股份有限公司 一种检测血液样本中血常规参数和c反应蛋白参数的方法
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CN115684601A (zh) * 2021-07-30 2023-02-03 深圳迈瑞生物医疗电子股份有限公司 样本分析方法及样本分析仪
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