Liquid path system for chemiluminescence immunity analyzer and pressure monitoring method

By designing a liquid system for chemiluminescence immunoassays, including a magnetic bead cleaning unit, a substrate filling unit, a sample filling and cleaning unit and a gas-liquid separator, the pressure detection module and controller are used to amplify and monitor pressure signals, the problems of poor quantitative accuracy, low reliability and poor repeatability in the existing liquid system are solved, high-precision judgment and stability are achieved, and the reliability and accuracy of the detection results are improved.

CN119555928APending Publication Date: 2025-03-04AUTOBIO LABTEC INSTR CO LTD
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Patent Information

Application Number
CN202411779122.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-05
Publication Date
2025-03-04

AI Technical Summary

Technical Problem

The liquid system of the existing chemiluminescence measuring instrument has poor quantitative accuracy of the liquid module, low reliability of each module in the system, and poor repeatability of each module in the test process, resulting in failure of detection.

Method used

A liquid system for chemiluminescence immunoassays is designed, including a magnetic bead cleaning unit, a substrate sampling unit, a sampling and cleaning unit and a gas-liquid separator. The pressure detection module and a controller are used to amplify and monitor the pressure signal to achieve high-precision real-time monitoring of sample filling and internal cleaning.

Benefits of technology

Through high-precision pressure monitoring and gas-liquid separation device, high-precision judgment and stability of the liquid system are achieved, the samples are vaccinated and needle blocked are solved, and the reliability and accuracy of the detection results are improved.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a liquid path system for a chemiluminescence immunoassay analyzer and a pressure monitoring method.The liquid path system comprises a magnetic bead cleaning unit, a substrate sample adding unit, a sample adding and cleaning unit and a first container, the sample adding and cleaning unit comprises a first pump, a gas-liquid separator and a pressure detection module, an outlet of the first pump is connected with the gas-liquid separator, and an outlet of the first pump is connected with the pressure detection module; a water outlet of the gas-liquid separator is connected with the sample adding pump, and the pressure detection module transmits a detected sample taking and adding pressure signal and an inner cleaning pressure signal to the controller. The pressure module can detect a sample taking and adding pressure signal and an internal cleaning pressure signal, high-precision real-time monitoring of pressure values in two modes of sample adding and internal cleaning can be realized by amplifying the signals by different multiples, full-range covering early warning and warning of pressure in different states can be realized, empty suction and needle blockage of a sample can be accurately judged, and the detection accuracy is improved. And air suction and alarm needle blockage are realized.
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Description

Technical Field

[0001] The present invention relates to the technical field of liquid circuits of in vitro diagnostic equipment, and in particular to a liquid circuit system and a pressure monitoring method for a chemiluminescent immunoassay analyzer. Background Art

[0002] The liquid circuit module is the core execution module for in vitro diagnostic equipment to achieve fully automated testing. The liquid circuit system of the existing chemiluminescence analyzer mainly includes the sample needle / reagent needle module, substrate module, magnetic bead cleaning module, sample needle and reagent needle cleaning module, and waste liquid treatment module. These modules are used to achieve sample sampling / filling, reagent sampling / filling, substrate sampling / filling, magnetic bead cleaning liquid filling / discharging, sample needle and reagent needle cleaning, waste liquid treatment of the cleaning mechanism, overall liquid circuit system, pipeline maintenance and treatment, etc.

[0003] According to statistics, the vast majority of dark sample detection failures during the operation of chemiluminescence measurement instruments are attributed to failures in the liquid circuit system. The main causes of failure include poor quantitative accuracy of the liquid circuit module, low reliability of each module in the system, and poor repeatability of each module in the test process. It can be seen that the stability, consistency, and accuracy of the liquid circuit system directly affect the core of clinical test results. Therefore, reliability design of the liquid circuit system of the chemiluminescence measurement instrument is crucial for chemiluminescence measurement instruments. Summary of the invention

[0004] In view of this, the present invention proposes a liquid circuit system for a chemiluminescent immunoassay analyzer. The present invention also proposes a pressure monitoring method, which adopts the liquid circuit system of the present invention.

[0005] To achieve the above object, the present invention adopts the following technical solutions: The liquid circuit system for a chemiluminescent immunoassay analyzer of the present invention comprises a magnetic bead cleaning unit, a substrate loading unit, a loading and cleaning unit and a first container for containing purified water, the loading and cleaning unit comprises a loading pump and a loading needle connected in sequence, the loading and cleaning unit further comprises a first pump connected to the first container, a gas-liquid separator and an overflow valve, the outlet of the first pump is connected to the gas-liquid separator, a water outlet of the gas-liquid separator is connected to the loading pump, the other outlet thereof is connected to the inlet of the overflow valve, and the outlet of the overflow valve is connected to the first container; the loading and cleaning unit further comprises a pressure detection module arranged between the loading pump and the loading needle, the signal output end of the pressure detection module is connected to the signal input end of the controller, the pressure detection module transmits the detected loading pressure signal and the internal cleaning pressure signal to the controller, the controller amplifies the internal cleaning pressure signal by ≥32 times and converts it into a pressure value P1, and the controller amplifies the loading pressure signal by <32 times and converts it into a pressure value P4.

[0006] The beneficial effect is that the pressure module of the present invention can detect the sampling pressure signal and the internal cleaning pressure signal, and can realize high-precision real-time monitoring of the pressure values ​​in the sampling and internal cleaning modes by amplifying the signals by different multiples, thereby realizing high-precision judgment of the internal cleaning and sampling operations. Through practice, the present invention has achieved full-range coverage of early warning and alarm under different pressure states, with an early warning success rate of 100%; it can also accurately judge the empty suction and needle blockage of the sample, with an empty suction and alarm needle blockage success rate of 100%.

[0007] The present invention adds a gas-liquid separation device to the sample addition and cleaning unit, which can achieve efficient separation of gas and liquid, thereby ensuring that the entire unit is always filled with the first washing liquid, thereby ensuring the sample addition stability and consistency of the system and the accuracy and reliability of clinical test results. In practice, when 20-1000 μL of bubbles are introduced, these bubbles can be smoothly discharged from the gas-liquid separation device, and the bubble discharge time can be controlled within 1 second.

[0008] Preferably, the substrate unit includes a first buffer tank and a substrate loading unit with the same number of substrate types, the substrate loading unit includes a substrate container, a substrate pump and a substrate needle, and the first buffer tank is connected to the first container through the loading and cleaning unit. The beneficial effect is that the present invention can flush the first washing liquid into the first buffer tank with the help of the loading and cleaning unit, and the substrate needle can be immersed in the first washing liquid, thereby solving the problem of crystallization of the outer wall of the needle caused by the volatilization of the substrate when the substrate needle is used for a long time or not used for a long time, ensuring the quantitative accuracy and stability of the substrate unit, and its injection volume accuracy and CV can be controlled within 1%.

[0009] Preferably, the sample loading and cleaning unit also includes a washing station, which has a main cleaning chamber and an overflow chamber connected to the main cleaning chamber, the sewage outlet of the overflow chamber is connected to the waste liquid container through a first sewage outlet pipeline, and the sewage outlet of the main cleaning chamber is connected to the waste liquid container through a second sewage outlet pipeline; the upper part of the washing station has two inlets, and the two inlets are connected to the first container through a cleaning pipeline.

[0010] The beneficial effect is that the outer wall of the sample adding needle of the present invention is coated with a hydrophobic coating (such as a Teflon coating or a nano hydrophobic coating, etc.), and the sample adding needle cooperates with the sample adding and cleaning unit to solve the error caused by the hanging liquid on the outer surface of the existing sample adding needle, and the carryover pollution caused by unclean cleaning. In practice, by adopting the scheme of the present invention, the carryover pollution rate of the sample adding needle can be controlled within 1ppm, and the hanging liquid amount on the outer wall of the sample adding needle after cleaning is controlled within 1.83μL, and the hanging liquid amount on the needle tip is within 0.29μL, the cleaning effect is good, and the accuracy of the sample adding is guaranteed.

[0011] Preferably, the first sewage discharge pipeline is provided with a first sewage discharge pump, the second sewage discharge pipeline is provided with a second sewage discharge pump, the cleaning pipeline is provided with a second pump, and a one-way valve is provided at the inlet end of the second pump.

[0012] Preferably, the magnetic bead cleaning unit includes a second magnetic bead pump, multiple injection needles and multiple withdrawal needles, the first port of the second magnetic bead pump has multiple injection branches, each injection branch is provided with a first solenoid valve and is connected to one of the injection needles, the second port of the second magnetic bead pump is divided into two paths, one is connected to the second container containing the magnetic bead cleaning liquid, and the other is connected to the first container; each of the withdrawal needles is connected to the waste liquid container through a withdrawal pipeline, and a withdrawal pump is provided on the withdrawal pipeline.

[0013] The present invention also provides a pressure monitoring method for the liquid circuit system based on the present invention, the method includes internal cleaning pressure monitoring, the internal cleaning pressure monitoring includes the following contents: real-time acquisition of internal cleaning pressure signal, amplification of the pressure signal by at least 32 times to obtain pressure P n , generate an internal cleaning pressure data curve, calculate and determine the maximum pressure value in the internal cleaning process according to the internal cleaning pressure curve and define it as P1. If P1 is within the range of the first threshold value P2 and the second threshold value P3, the internal cleaning pressure is normal and no alarm is given; if P1<P2, the reported internal cleaning pressure is too small, the opening of the overflow valve is reduced, and the internal cleaning pressure is adjusted until P2≤P1≤P3; if P1>P3, the reported internal cleaning pressure is too large, the opening of the overflow valve is increased, and the internal cleaning pressure is adjusted until P2≤P1≤P3.

[0014] The pressure monitoring method of the present invention also includes pumping and injection pressure monitoring, which includes the following contents: real-time acquisition of pressure signals during pumping or injection, amplification of the pressure signals by less than 32 times to obtain pressure P x , generate a pumping or injection pressure data curve, determine the maximum pressure value in the pumping or injection process according to the pumping or injection pressure data curve and define it as P4; if P4 is within the range of the third threshold value P5 and the fourth threshold value P6, the pumping or injection pressure is normal and no alarm is given; if P4<P5, report empty suction, abandon the test, and continue with subsequent sampling; if P4>P6, report needle blockage, start the first pump, perform internal cleaning of the sampling pump and the sampling needle, and perform internal cleaning pressure monitoring during the internal cleaning process.

[0015] Compared with the prior art, the pressure module of the present invention can detect the sampling pressure signal and the internal cleaning pressure signal, and can realize high-precision real-time monitoring of the pressure values ​​in the sampling and internal cleaning modes by amplifying the signals by different multiples, thereby realizing high-precision judgment of the internal cleaning and sampling operations. Through practice, the present invention has achieved full-range coverage of early warning and alarm under different pressure states, with an early warning success rate of 100%; it can also accurately judge the empty suction and needle blockage of the sample, with an empty suction and alarm needle blockage success rate of 100%.

[0016] The present invention adds a gas-liquid separation device to the sample addition and cleaning unit, which can achieve efficient separation of gas and liquid, thereby ensuring that the entire unit is always filled with the first washing liquid, thereby ensuring the sample addition stability and consistency of the system and the accuracy and reliability of clinical test results. In practice, when 20-1000 μL of bubbles are introduced, these bubbles are smoothly discharged from the gas-liquid separation device, and the bubble discharge time can be controlled within 1 second. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the present invention.

[0018] Figure 2 It is a flow chart of the internal cleaning pressure monitoring of the present invention.

[0019] Figure 3 It is a flow chart of the pumping pressure monitoring of the present invention. DETAILED DESCRIPTION

[0020] The following is a detailed description of an embodiment of the present invention in conjunction with the accompanying drawings. This embodiment is implemented on the premise of the technical solution of the present invention, and a detailed implementation method and a specific operation process are given, but the protection scope of the present invention is not limited to the following embodiment.

[0021] It should be noted that, in the description of the present invention, relational terms such as “first” and “second” are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations.

[0022] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected" and "connection" that may appear should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0023] like Figure 1As shown, the liquid path system for a chemiluminescent immunoassay analyzer of the present invention comprises a magnetic bead cleaning unit 300, a substrate unit 200, a sample loading and cleaning unit 100 and a first container 400 containing purified water, wherein the sample loading and cleaning unit 100 comprises a sample loading pump 103 and a sample loading needle 101 connected in sequence, and a fifth solenoid valve 104 is arranged at the inlet of the sample loading pump; the sample loading and cleaning unit 100 further comprises a first pump 106 connected to the first container 400, a gas-liquid separator 105 and an overflow valve 107, wherein the outlet of the first pump 106 is connected to the gas-liquid separator 105, a water outlet of the gas-liquid separator 105 is connected to the sample loading pump 103, and the other outlet thereof is connected to the inlet of the overflow valve 107, and the outlet of the overflow valve 107 is connected to the first container 400. The present invention adds a gas-liquid separator to achieve efficient separation of gas and liquid, thereby ensuring that the sample addition and cleaning unit 100 is always filled with the first washing liquid during the cleaning process, thereby ensuring the sample addition stability, consistency and accuracy and reliability of the clinical test results of the system. According to practice, when 20-1000 μL of bubbles are introduced, these bubbles are discharged through the gas-liquid separator, and the bubble discharge time can be controlled within 1s; the sample addition and cleaning unit 100 also includes a pressure detection module 102 (a pressure sensor is selected) arranged between the sample addition pump 103 and the sample addition needle 101, and the signal output end of the pressure detection module 102 is connected to the signal input end of the controller. The pressure detection module 102 transmits the detected sample addition pressure signal and the internal cleaning pressure signal to the controller, and the controller amplifies the internal cleaning pressure signal by 32 times or more and converts it into a pressure value P1, and the preset pressure range of the internal cleaning is P2-P3; the controller amplifies the sample addition pressure signal by 32 times or less (excluding 32 times) and converts it into a pressure value P4, and the preset pressure range of the sample addition is P5-P6.

[0024] The sample addition and cleaning unit 100 of the present invention has two working states, namely, extraction and internal cleaning. During the extraction and internal cleaning process, a pressure detection module 102 is used to realize high-precision real-time monitoring of the pressure in the two states, realize 100% early warning of conditions such as empty suction and blockage, and also realize early warning of the full range of pressure under different states. In the present invention, the controller is equipped with an alarm module (a sound alarm or a combination of a sound alarm and an indicator light can be used), and the overflow valve can be a manual valve or an electric control valve. When the overflow valve is an electric control valve, its control input end is connected to the control output end of the controller. When the pressure value P1 is not within the range of P2 to P3, the alarm module gives an alarm prompt, and the operator can manually adjust the opening of the overflow valve, or use the controller to automatically adjust the opening of the overflow valve until the pressure value P1 is within the preset pressure range (i.e., P2 to P3).

[0025] Combination Figure 1It can be seen that the sample loading and cleaning unit 100 also includes a washing station 108, which has a main cleaning chamber and an overflow chamber connected to the main cleaning chamber, the sewage outlet of the overflow chamber is connected to the waste liquid container 500 through a first sewage outlet pipeline, and the sewage outlet of the main cleaning chamber is connected to the waste liquid container 500 through a second sewage outlet pipeline; the upper part of the washing station 108 has two inlets, and the two inlets are connected to the first container 400 through a cleaning pipeline 3.5. The first sewage outlet pipeline is provided with a first sewage pump 109, the second sewage outlet pipeline is provided with a second sewage pump 110, the cleaning pipeline 3.5 is provided with a second pump 111, and the inlet end of the second pump 111 is provided with a one-way valve 3.6. During external cleaning, the second pump 111 pumps the first washing liquid into the main cleaning chamber to rinse the outer wall of the sampling needle 101, and the waste liquid is discharged into the waste liquid container 500 through the first sewage pipe. The first washing liquid in the main cleaning chamber can overflow into the overflow chamber and be discharged into the waste liquid container 500 through the second sewage pipe. Even if the first sewage pipe fails, the waste liquid can be discharged in time.

[0026] In actual processing, the outer wall of the sample needle 101 is coated with a Teflon coating (of course, a super-hydrophobic nano coating or other hydrophobic coating can also be used in actual processing) to increase the hydrophobicity of the outer wall of the sample needle. The coated sample needle and the washing station 108 cooperate to fundamentally solve the problems of inaccurate quantification caused by hanging liquid on the outer surface of the sample needle 101, the phenomenon of diluting the sample due to hanging liquid on the needle wall, and the high carryover contamination rate caused by incomplete cleaning of the needle surface. The sample needle can also be cleaned in the shortest possible time with a lower first washing liquid. According to practice, the carryover contamination rate of the sample needle 101 is ≤1ppm; after cleaning, the hanging liquid volume on the outer wall of the sample needle 101 is controlled at 1.83μL, and the hanging liquid volume on the needle tip is within 0.29μL, and the cleaning effect is good.

[0027] Combination Figure 1 It can be seen that the substrate unit 200 includes a first buffer tank 204 (the sewage outlet of the first buffer tank 204 is connected to the waste liquid container through a sewage pipeline, which is not shown in the figure) and a substrate sample adding unit (two in the present invention) that is the same as the number of substrate types. The substrate sample adding unit includes a substrate container, a substrate pump 202 (using a plunger pump) and a substrate needle 201. The substrate needle 201 and the substrate container are connected to the substrate pump 202 through a second solenoid valve 203 (a two-position three-way solenoid valve). The substrate pump 202 can be used to To realize the extraction and injection of substrate, the first buffer pool 204 is connected to the first container 400 through the sample addition and cleaning unit 100, and purified water can be injected into the first buffer pool 204 by using the sample addition and cleaning unit 100. After the injection, the substrate needle 201 can be immersed in the purified water, thereby solving the problem of crystallization of the outer wall of the needle caused by volatilization of the substrate when the substrate needle 201 is used for a long time or has not been used for a long time, ensuring the quantitative accuracy and stability of the substrate module, and the accuracy of the injection amount and CV can be controlled within 1%.

[0028] Combination Figure 1 It can be seen that the magnetic bead cleaning unit 300 includes a magnetic bead cleaning pump 304 (preferably a plunger pump), a plurality of injection needles 301 and a plurality of extraction needles 302. The first port of the magnetic bead cleaning pump 304 has a plurality of injection branches, each of which is provided with a first solenoid valve 303 and connected to an injection needle 301. The second port of the magnetic bead cleaning pump 304 is divided into two paths, one of which is connected to the second container 600 containing the magnetic bead cleaning solution, and the other is connected to the first container 400. The first container 400 and the second container 600 are connected through a third solenoid valve. The magnetic bead cleaning unit 300 is connected to the waste liquid container 500 through a third drainage pipeline, and a third drainage pump 308 is provided on the third drainage pipeline, and the waste liquid can be pumped into the waste liquid container 500 by the third drainage pump 308; The magnetic bead cleaning unit 300 of the present invention has a maintenance working condition and a pumping working condition. In the maintenance working condition, the magnetic bead cleaning pump 304 is in a state of being connected to the first container 400. The magnetic bead cleaning pump 304 is used to inject the first washing liquid (preferably purified water) into the second buffer tank 309, and the injection needle 301 and the withdrawal needle 302 can be immersed in the purified water. In this process, the immersion liquid can be pumped into the waste liquid container 500 by the withdrawal pump 307, and then the purified water is injected into the second buffer tank 309 for secondary immersion. This is repeated many times to achieve the maintenance and flushing of the magnetic bead cleaning unit 300, thereby avoiding the crystallization of the magnetic bead cleaning liquid in the pipeline, and also avoiding the failure of the injection system caused by bubbles precipitated or abnormally introduced in the pipeline; Under the pumping condition, the magnetic bead cleaning pump 304 is switched to a state connected to the second container 600, the fourth solenoid valve 306 is opened, and the magnetic bead cleaning pump 304 pumps liquid at full stroke. After the pumping is completed, the fourth solenoid valve 306 is closed, and the magnetic bead cleaning liquid is dispensed into the second buffer tank 309 by the magnetic bead cleaning pump 304, and discharged into the waste liquid container 500 by the third sewage pump 308, thereby achieving pre-rinsing of all dispensing branches to prevent cross contamination; after pre-rinsing, repeat the above operation, inject magnetic bead cleaning liquid into the reaction cup at the same time, and after cleaning, use the liquid extraction needle 302 and the liquid extraction pump 307 to extract the cleaning liquid in the reaction cup to achieve cleaning of the magnetic beads in the reaction cup.

[0029] In the present invention, since the pipeline flow resistance of each injection branch is different, and the diameter of the first injection needle 301 and the remaining injection needles 301 are different, the pressure decay of each injection branch is different. In order to ensure that the injection amount in each reaction cup is consistent, the present invention adopts the following calculation method: The flow rate at the outlet of each injection needle 301 QThe required volume of wash solution for each cuvette V Satisfies formula (1): V = Q *t( t is the injection time), V are known parameters, Q It can be obtained through routine experiments; The flow rate Q at the outlet of each injection needle 301 satisfies formula (2): ; In the above formula, μ is the flow coefficient, d is the pipe cross-sectional area of ​​the injection branch, l is the length of the pipe of the injection branch, Pc is the outlet pressure of the magnetic bead washing pump 304; P is the pressure at the outlet of the injection needle 301; In actual calculation, the injection time can be determined according to formula (1), and the length of the branch pipe can be determined according to the injection time and formula (2). By reasonably designing the length of the branch pipe and the injection time, the consistency and stability of multiple injections of each branch and the simultaneous injection of multiple branches can be ensured.

[0030] Through practice, under laboratory test environment conditions, the residual amount of waste liquid in the reaction container can be less than 7 μL; the contamination rate of the magnetic bead cleaning system can be ≤1ppm; the accuracy of the injection volume and CV can be ≤1%.

[0031] During actual installation, the magnetic bead cleaning pump 304, the sample addition pump 103 and the substrate pump 202 can be plunger pumps, and of course reciprocating pumps, injection pumps, etc. can also be used; the first sewage pump 109, the second sewage pump 110, the third sewage pump 308, the liquid pump 307, the second pump 111 and the first pump 106 can be diaphragm pumps, gear pumps or peristaltic pumps, etc. The control input end of each pump of the present invention is connected to the control output end of the controller, and the control input ends of the first solenoid valve 303, the second solenoid valve 203, the third solenoid valve 305, and the fourth solenoid valve 306 are connected to the control output end of the controller, thereby realizing automatic control.

[0032] Combination Figure 2-3 It can be seen that the present invention proposes a pressure monitoring method for a sample needle, which adopts the sample needle and cleaning unit of the present invention, including internal cleaning pressure monitoring and injection pressure monitoring. In actual operation, the sample needle needs to be internally cleaned after each injection action. The internal cleaning pressure monitoring includes the following: using the pressure monitoring module 102 to continuously collect the internal cleaning pressure signal (i.e., the pressure signal between the sample needle and the sample pump) in real time, amplifying the collected pressure signal by ≥32 times to obtain the pressure P n, and generate an internal cleaning pressure data curve, calculate and determine the maximum pressure value in the internal cleaning process according to the internal cleaning pressure curve and define it as P1, compare the pressure value P1 with the first threshold value P2 and the second threshold value P3, specifically: if P2≤P1≤P3, the internal cleaning pressure is normal and no alarm is given; if P1<P2, report that the internal cleaning pressure is too low, manually or automatically adjust the overflow valve 107 to reduce its opening to reduce diversion, until P2≤P1≤P3; if P1>P3, report that the internal cleaning pressure is too high, manually or automatically adjust the overflow valve 107 to increase its opening to increase diversion, until P2≤P1≤P3; The pressure monitoring of extraction and injection includes the following: using the pressure monitoring module 102 to collect the pressure signal during extraction or injection in real time (the collection location is the pipeline between the sampling needle and the sampling pump), amplifying the pressure signal by less than 32 times to obtain the pressure P x (Processed by the controller), generate a liquid extraction or injection pressure data curve, determine the maximum pressure value in the liquid extraction or injection process according to the liquid extraction or injection pressure data curve and define it as P4, and compare P4 with the third threshold value P5 and the fourth threshold value P6. Among them, if P5≤P4≤P6, the liquid extraction or injection pressure is normal and no alarm is given; if P4<P5, report that the liquid extraction is empty, abandon the test, and continue with the subsequent sample addition; If P4>P6, needle blockage is reported, the first pump 106 is started, and the sample pump 103 and the sample needle 101 are internally cleaned. The above-mentioned internal cleaning pressure monitoring is performed during the internal cleaning process.

[0033] Through practice, the present invention can not only achieve early warning and alarm covering the entire range of pressures under different states, with an early warning success rate of 100%; by designing appropriate empty suction and needle blockage pressure alarm values ​​through simulated samples of different concentrations, the empty suction and needle blockage alarm success rate of samples can be achieved with 100% under laboratory test environment conditions.

[0034] Finally, it should be emphasized that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions recorded in the aforementioned embodiments without creative work, or replace some of the technical features therein with equivalents. Therefore, any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A liquid circuit system for a chemiluminescent immunoassay analyzer, the liquid circuit system comprising a magnetic bead cleaning unit, a substrate unit, a sample loading and cleaning unit and a first container for containing purified water, the sample loading and cleaning unit comprising a sample loading pump and a sample loading needle connected in sequence, characterized in that: The sampling and cleaning unit also includes a first pump, a gas-liquid separator and an overflow valve connected to the first container, the outlet of the first pump is connected to the gas-liquid separator, a water outlet of the gas-liquid separator is connected to the sampling pump, and the other outlet is connected to the inlet of the overflow valve, and the outlet of the overflow valve is connected to the first container; the sampling and cleaning unit also includes a pressure detection module arranged between the sampling pump and the sampling needle, the signal output end of the pressure detection module is connected to the signal input end of the controller, the pressure detection module transmits the detected sampling pressure signal and internal cleaning pressure signal to the controller, the controller amplifies the internal cleaning pressure signal by ≥32 times and converts it into a pressure value P1, and the controller amplifies the sampling pressure signal by <32 times and converts it into a pressure value P4.

2. The liquid path system for a chemiluminescent immunoassay analyzer according to claim 1, characterized in that: The substrate unit comprises a first buffer pool and substrate loading units of the same number as the substrate types, the substrate loading unit comprises a substrate container, a substrate pump and a substrate needle, and the first buffer pool is connected to the first container through the loading and cleaning unit.

3. The liquid path system for a chemiluminescent immunoassay analyzer according to claim 1, characterized in that: The sample loading and cleaning unit also includes a washing station, which has a main cleaning chamber and an overflow chamber connected to the main cleaning chamber, the sewage outlet of the overflow chamber is connected to the waste liquid container through a first sewage outlet pipeline, and the sewage outlet of the main cleaning chamber is connected to the waste liquid container through a second sewage outlet pipeline; the upper part of the washing station is provided with two inlets, and the two inlets are connected to the first container through a cleaning pipeline.

4. The liquid path system for a chemiluminescent immunoassay analyzer according to claim 3, characterized in that: The first sewage pipeline is provided with a first sewage pump, the second sewage pipeline is provided with a second sewage pump, the cleaning pipeline is provided with a second pump, and a one-way valve is arranged at the inlet end of the second pump.

5. The liquid path system for a chemiluminescent immunoassay analyzer according to claim 3, characterized in that: The magnetic bead cleaning unit includes a second magnetic bead pump, multiple injection needles and multiple withdrawal needles. The first port of the second magnetic bead pump has multiple injection branches, each of which is provided with a first solenoid valve and connected to an injection needle. The second port of the second magnetic bead pump is divided into two paths, one is connected to the second container containing magnetic bead cleaning liquid, and the other is connected to the first container; each of the withdrawal needles is connected to the waste liquid container through a withdrawal pipeline, and a withdrawal pump is provided on the withdrawal pipeline.

6. A pressure monitoring method, characterized in that: The liquid path system for a chemiluminescent immunoassay analyzer according to any one of claims 1 to 5 is used, comprising an internal cleaning pressure monitor, wherein the internal cleaning pressure monitor It includes the following: real-time collection of internal cleaning pressure signals, amplification of the pressure signals by at least 32 times to calculate the pressure P n , and generate an internal cleaning pressure data curve. The maximum pressure value in the internal cleaning process is calculated and defined as P1 according to the internal cleaning pressure curve. If P1 is within the range of the first threshold value P2 and the second threshold value P3, the internal cleaning pressure is normal and no alarm is given; if P1<P2, the reported internal cleaning pressure is too small, the opening of the overflow valve is reduced, and the internal cleaning pressure is adjusted until P2≤P1≤P3; if P1>P3, the reported internal cleaning pressure is too large, the opening of the overflow valve is increased, and the internal cleaning pressure is adjusted until P2≤P1≤P3.

7. The pressure monitoring method according to claim 1, characterized in that: It also includes pumping and injection pressure monitoring, which includes the following: real-time acquisition of pressure signals during pumping or injection, amplification of the pressure signals by less than 32 times, and calculation of the pressure P x , and generate a pumping or injection pressure data curve; determine the maximum pressure value in the pumping or injection process according to the pumping or injection pressure data curve and define it as P4; if P4 is within the range of the third threshold value P5 and the fourth threshold value P6, the pumping or injection pressure is normal and no alarm is given; if P4<P5, report that the pumping is empty, abandon the test, and continue with subsequent sample addition; if P4>P6, report that the needle is blocked, start the first pump, perform internal cleaning of the sample pump and the sample addition needle, and perform internal cleaning pressure monitoring during the internal cleaning process.