Electrochemical immunodetection system

Abstract

The utility model relates to the field of medical instruments, in particular to an electrochemical immunodetection system. The utility model provides a test card and an electrochemical immunoassay analyzer. The electrode of the test card is inverted, the magnet assembly is arranged above the test card, and the blood cells can be far away from the electrode and the magnetic beads due to natural sedimentation in the incubation process by utilizing the density difference between the blood cells and the plasma, so that the plasma content around the electrode is increased, the blood cell content around the electrode is reduced, and the background current of detection is reduced; the detection sensitivity is improved. In addition, the magnet assembly is arranged in the instrument, so that the requirements of the test card on use and storage conditions are reduced, and the processing difficulty and the use cost of the test card are also reduced.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, and particularly relates to an electrochemical immunoassay system. Background Art

[0002] As an important part of biological fluids, whole blood carries rich information related to the state of physical health and plays a crucial role in health management and disease monitoring. Most patients with acute onset, severe symptoms and complex and diverse conditions often seek initial medical treatment in the emergency department, making the emergency department a department where acute and critical illnesses gather. Emergency laboratory tests are an important part of the auxiliary diagnosis of first aid medicine. The types of emergency laboratory test items, the accuracy and timeliness of test results can provide an important guarantee for the effective treatment of emergency patients within the golden time window. If whole blood can be directly tested immediately without additional centrifugation separation, the time from sample to result can be effectively shortened, which will greatly increase the possibility of patients obtaining immediate diagnosis and subsequent treatment during the golden treatment period.

[0003] Chinese Patent CN113406317A discloses a whole blood electrochemical blood gas detection device, which is an instrument for quantitatively measuring dissolved oxygen partial pressure (PO2), glucose, lactic acid, electrolytes, etc. in human whole blood samples to analyze and evaluate human blood components and respiratory conditions. This device cannot quantitatively detect immune markers such as cTNI and BNP for evaluating cardiac function and other indicators.

[0004] Chinese Patent CN110178032B discloses a whole blood electrochemical blood gas detection device. In addition to detecting conventional blood gas and electrolyte and other indicators, it also captures magnetic beads through minute magnets in the immunosensor set in the test card to achieve the enrichment of antibodies modified with signal molecules such as peroxidase (HRP), and detects the electrode electrical signal to detect cTNI, BNP and other indicators in whole blood.

[0005] However, in whole blood detection, a large number of blood cells will hinder the magnetic adsorption of magnetic beads near the magnet, which will lead to a decrease in the detection signal. More importantly, in the HRP-TMB system, since red blood cells in blood also contain peroxidase, when red blood cells adhere to the surface of magnetic beads or electrodes, if they are not cleaned thoroughly, the background signal will be increased due to blood contamination, resulting in a significant reduction in sensitivity in whole blood. At the same time, since the magnetic field generated by the minute magnet is greatly interfered by temperature and the internal magnetic field of the device, it has an adverse effect on the capture of magnetic beads and the enrichment effect of antibodies, which puts high requirements on the storage conditions and use conditions of the test card. In addition, the setting of minute magnets also increases the processing difficulty and cost of the test card. Summary of the Utility Model

[0006] In view of the above, the present utility model provides an electrochemical immunoassay system, which improves the magnet and electrode settings on the basis of the existing blood gas biochemical analysis device, avoids the interference of the external environment on the magnetic field of the magnet and the interference of other components of the sample to be tested on the magnetic beads, and solves the problem of insufficient sensitivity caused by high background signal and low detection signal in the existing technology during whole blood detection.

[0007] In order to achieve the above-mentioned utility model purpose, the present utility model provides the following technical solutions:

[0008] The present utility model provides an electrochemical immunoassay system, comprising a test card and an electrochemical immunoassay analyzer;

[0009] The test card and the electrochemical immunoassay analyzer are used in cooperation. The electrochemical immunoassay analyzer includes a housing, a signal acquisition component and a base component;

[0010] The housing includes an upper housing and a lower housing;

[0011] The base component is installed on the lower housing for placing the test card;

[0012] The signal acquisition component includes a driving member, a signal acquisition board and a magnet component;

[0013] The signal acquisition board is provided with probes;

[0014] The driving member is in transmission connection with the signal acquisition board and the magnet component. The driving member is configured to be able to drive the signal acquisition board and the magnet component to press down, so that the probes on the signal acquisition board are electrically connected to the sensor contacts on the test card, and the magnet component contacts the test card.

[0015] In some specific embodiments of the present utility model, the signal acquisition board of the above-mentioned electrochemical immunoassay system includes a signal board PCBA.

[0016] In some specific embodiments of the present utility model, the test card of the above-mentioned electrochemical immunoassay system includes a liquid package, an airbag, an electrode, an upper substrate, a glue sandwich layer, and a lower substrate;

[0017] The electrode includes the sensor contacts;

[0018] The glue sandwich layer is provided with a sample detection channel;

[0019] The electrode is located between the magnet component and the sample detection channel, and one side of the electrode is exposed in the sample detection channel.

[0020] In some specific embodiments of the present utility model, the electrode of the above-mentioned electrochemical immunoassay system is located between the magnet assembly and the magnetic beads in the sample detection channel.

[0021] In some specific embodiments of the present utility model, the upper substrate of the above-mentioned electrochemical immunoassay system is provided with a sample inlet, an air duct hole, an electrode hole, an airbag hole, a liquid package hole, and a seal that can connect the air duct and the liquid flow channel and is pasted with double-sided tape;

[0022] The adhesive layer is further provided with a waste liquid bin, an air duct hole, an airbag hole, a liquid package hole, and an incubation chamber;

[0023] The lower substrate is provided with an air duct, a liquid flow channel, an air hole, a waste liquid flow channel, and a spike;

[0024] The airbag, the air duct, the air duct hole, and the sample detection channel are sequentially connected;

[0025] The spike is provided in the liquid flow channel;

[0026] The spike can contact the airbag through the airbag hole;

[0027] The sample inlet, the incubation chamber, the liquid flow channel, and the sample detection channel are sequentially connected;

[0028] The sample detection channel, the waste liquid flow channel, the waste liquid bin, and the air hole are sequentially connected;

[0029] The electrode includes an insulating substrate, sensor contact points that penetrate through both sides and are used to connect the instrument, and an array of metal electrodes.

[0030] In some specific embodiments of the present utility model, the following are attached to the incubation chamber of the above-mentioned electrochemical immunoassay system:

[0031] (i), magnetic beads for immunoassay; and / or

[0032] (ii), microspheres for sedimenting cells;

[0033] The attachment includes attaching the magnetic beads to the incubation chamber by spraying.

[0034] In some specific embodiments of the present utility model, the magnetic beads of the above-mentioned electrochemical immunoassay system are labeled with a specific antigen or a specific antibody, and the specific antigen or specific antibody specifically binds to the target substance in the sample to be tested.

[0035] In some specific embodiments of the present utility model, the microspheres of the above-mentioned electrochemical immunoassay system are labeled with a specific antigen or a specific antibody, and the specific antigen or specific antibody specifically binds to the cells in the sample to be tested.

[0036] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the electrode is disposed within the electrode hole of the upper substrate, and the side of the electrode provided with the array of metal electrodes faces the laminated layer.

[0037] The material of the test card substrate includes one or more of aluminum alloy, PET, PC, glass, acrylic, and PDMS.

[0038] The processing method of the test card includes one or more of CNC machining, laser processing, injection molding, 3D printing, casting, die cutting, and soft etching.

[0039] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the electrode includes a working electrode.

[0040] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the electrode further includes a reference electrode.

[0041] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the electrode metal layer of the test card is attached to the insulating substrate by screen printing, electroplating, magnetron sputtering, or laser engraving.

[0042] The metal layer is made of a metal material, and the metal includes at least one of Cu, Ti, Ag, Pt, Pd, Gu, and Au.

[0043] The reference electrode is covered on the surface of the metal electrode by screen printing, electroplating, or dispensing.

[0044] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the magnet assembly includes a magnet mounting seat and a magnet.

[0045] The magnet mounting seat is fixedly connected to the signal acquisition board, and the magnet is connected to the magnet mounting seat.

[0046] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the magnet includes a magnetic metal or a magnetic field generating device.

[0047] The magnetic metal includes at least one of neodymium iron boron magnets, alnico magnets, or samarium cobalt magnets.

[0048] The magnetic field generating device includes an electromagnet.

[0049] In some specific embodiments of the present utility model, in the above-mentioned electrochemical immunoassay system, the area of the magnetic field generated by the magnet is 0.5 times, 1 time, 1.5 times, or 2 times the diameter of the metal electrode.

[0050] In some specific embodiments of the present utility model, the base assembly of the above-mentioned electrochemical immunoassay system includes an upper mounting seat and a lower mounting seat, and the upper mounting seat and the lower mounting seat are fixedly connected;

[0051] The lower part of the lower mounting seat is fixedly connected to the lower housing, and a groove for mounting the test card is provided on the upper part of the lower mounting seat;

[0052] The upper mounting seat is provided with through holes for the probes and the magnet assembly to pass through.

[0053] In some specific embodiments of the present utility model, the base assembly of the above-mentioned electrochemical immunoassay system is further provided with a test card feel component and a card insertion in-place judgment component.

[0054] In some specific embodiments of the present utility model, a pressing component is further provided on the upper mounting seat of the above-mentioned electrochemical immunoassay system;

[0055] The pressing component includes a motor and a pressing head;

[0056] The motor includes a liquid bag motor and an airbag motor, and the pressing head includes a liquid bag pressing head and an airbag pressing head.

[0057] In some specific embodiments of the present utility model, the above-mentioned electrochemical immunoassay system further includes a temperature control component;

[0058] The temperature control component includes a heat dissipation system and a test card heating device.

[0059] In some specific embodiments of the present utility model, the heat dissipation system of the above-mentioned electrochemical immunoassay system is installed in the housing, and the heat dissipation system includes a fan and a temperature sensor.

[0060] In some specific embodiments of the present utility model, the test card heating device of the above-mentioned electrochemical immunoassay system includes a rotating arm, a lifting plate, a spring, a heating sheet and a heating sheet mounting seat.

[0061] In some specific embodiments of the present utility model, a display touch screen is provided on the upper housing of the above-mentioned electrochemical immunoassay system, and a main control board is further provided on the lower housing.

[0062] The electrochemical immunoassay system of the present utility model has the following effects:

[0063] 1. By inverting the electrodes and arranging the magnet assembly above the test card, using the density difference between blood cells and plasma, during the incubation process, the blood cells will move away from the electrodes and magnetic beads due to natural sedimentation, thereby increasing the plasma content around the electrodes, reducing the blood cell content around the electrodes, reducing the background current of the detection, and improving the detection sensitivity;

[0064] 2. Setting the magnet assembly inside the instrument reduces the requirements for the usage and storage conditions of the test card, and also reduces the processing difficulty and usage cost of the test card. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art.

[0066] Figure 1 A perspective view of a half-section showing an embodiment of the present invention;

[0067] Figure 2 A perspective view of the housing showing an embodiment of the present invention;

[0068] Figure 3 A perspective view of the base assembly showing an embodiment of the present invention;

[0069] Figure 4 A sectional view of the base assembly showing an embodiment of the present invention;

[0070] Figure 5 A perspective view of the signal acquisition assembly showing an embodiment of the present invention;

[0071] Figure 6 A perspective view of the driving member showing an embodiment of the present invention;

[0072] Figure 7 A schematic diagram of the air flow direction showing an embodiment of the present invention;

[0073] Figure 8 A schematic diagram of the initial positions of the magnet assembly and the heating sheet showing an embodiment of the present invention;

[0074] Figure 9 A schematic diagram of the positions of the magnet assembly and the heating sheet in the working state showing an embodiment of the present invention;

[0075] Figure 10 A test card showing an embodiment of the present invention;

[0076] Figure 11 An exploded view of the test card showing an embodiment of the present invention;

[0077] Figure 12 The front and back structures of the electrode showing an embodiment of the present invention;

[0078] Figure 13 Showing Figure 12 A sectional view of the circled area.

[0079] In the figure, 1 is an electrochemical immunoassay analyzer, 11 is a housing, 12 is a base assembly, 13 is a signal acquisition component, 14 is a heat dissipation system, 15 is a driving member, 16 is a main control board, 17 is a display touch screen, 111 is a decorative cover, 112 is an upper cover, 113 is a base, 114 is a C-shaped cover, 121 is a lower mounting seat, 122 is an upper mounting seat, 123 is a rotating arm, 124 is a lifting plate, 125 is a first spring, 126 is a heating sheet mounting seat, 127 is a heating sheet, 131 is a signal acquisition board, 132 is a probe, 133 is a mounting shell, 134 is a sealing plate, 135 is a rotating shaft, 136 is a left side plate, 137 is a right side plate, 138 is a probe support assembly, 141 is a lower rear cover, 151 is a mounting bracket, 152 is a coupling, 153 is a pinion shaft, 154 is a camshaft, 155 is a pinion, 156 is a large gear, 157 is a cam, 158 is a rotating stepper motor, 1111 is an air inlet, 1211 is a test card feel component, 1212 is a card insertion in-place judgment component, 1221 is a liquid packet motor, 1222 is a liquid packet press head, 1223 is an airbag motor, 1224 is an airbag press head, 1381 is a probe support, 1382 is a guide shaft, 1383 is a second spring, 1384 is a magnet mounting seat, 1385 is a magnet;

[0080] 2 is a test card, 21 is the main body part of the test card, 211 is an upper substrate, 2111 are air holes, 2112 are liquid packet holes, 2113 are airbag holes, 2114 are electrode holes, 2115 are air passage holes, 2116 is a sample injection port, 2117 is a seal, 212 is a sandwich layer, 2121 is a waste liquid chamber, 2122 are liquid packet holes, 2123 are air passage holes, 2124 is an incubation chamber, 2125 is a sample detection channel, 2126 are airbag holes, 213 is a lower substrate, 2131 are barbs, 2132 is an air passage, 2133 is a liquid flow channel, 2134 is a waste liquid flow channel, 22 is a liquid packet, 23 is an airbag, 24 is an electrode, 241 is an insulating substrate, 242 are metal contact points, 243 is an array of metal electrodes, 25 is a reference electrode. Detailed implementation manners

[0081] The present utility model discloses an electrochemical immunoassay detection system. Those skilled in the art can draw on the content herein and appropriately modify process parameters to achieve it. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art, and they are all regarded as included in the present utility model. The methods and applications of the present utility model have been described through preferred embodiments. Relevant personnel can obviously make changes or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit and scope of the present utility model to implement and apply the technology of the present utility model.

[0082] Unless otherwise specified, the raw materials, reagents, consumables and instruments involved in the present invention are all common commercial products and can be purchased from the market.

[0083] The utility model discloses an electrochemical immunoassay system, which comprises an electrochemical immunoassay analyzer 1 and a test card 2. The electrochemical immunoassay analyzer 1 and the test card 2 are used in combination.

[0084] In a first aspect, the electrochemical immunoassay system provided by the utility model comprises an electrochemical immunoassay analyzer 1;

[0085] The electrochemical immunoassay analyzer 1 comprises a housing 11, a base assembly 12, and a signal acquisition assembly 13;

[0086] The housing 11 includes an upper housing assembly and a lower housing.

[0087] In some specific embodiments, the upper shell of the electrochemical immunoassay system is provided with a display touch screen 17 , and the lower shell is also provided with a main control board 16 .

[0088] In some specific embodiments, the signal acquisition component 13 of the above-mentioned electrochemical immunoassay system includes a driving member 15, a signal acquisition board 131 and a magnet assembly. The driving member is transmission-connected to the signal acquisition board and the magnet assembly. The driving member is configured to drive the signal acquisition board and the magnet assembly downward so that the signal acquisition board is electrically connected to the sensor contacts on the test card 2, so that the magnet assembly contacts the test card 2.

[0089] Preferably, a signal acquisition board 131 is provided on the signal acquisition component, and a probe 132 is welded on the signal acquisition board 131 .

[0090] Preferably, the signal acquisition board 131 is a signal board PCBA.

[0091] In some specific embodiments, the magnet assembly includes a magnet mount and a magnet;

[0092] The magnet mounting seat includes a magnet mounting seat 1384;

[0093] The magnet includes and magnet 1385.

[0094] Preferably, the magnet mounting seat 1384 is fixedly connected to the signal acquisition board, and the magnet 1385 is connected to the magnet mounting seat 1384 .

[0095] Preferably, the magnet includes one or more of an electromagnet, a neodymium iron boron magnet, an aluminum nickel cobalt magnet, and a samarium cobalt magnet, and the magnetic field area generated by the magnet is 0.5 to 2 times the diameter of the metal electrode.

[0096] In some specific embodiments, the base assembly 12 of the above-mentioned electrochemical immunoassay system is installed on the lower housing and is used to place the test card 2.

[0097] In some specific embodiments of the present utility model, the base assembly 12 of the above-mentioned electrochemical immunoassay system includes an upper mounting seat and a lower mounting seat, and the upper mounting seat and the lower mounting seat are fixedly connected.

[0098] Preferably, the lower part of the lower mounting seat is fixedly connected to the lower housing, and a groove for installing the test card 2 is provided on the upper part of the lower mounting seat.

[0099] Preferably, the upper mounting seat is provided with through holes for the probe 132 and the magnet assembly to pass through.

[0100] In some specific embodiments of the present utility model, a pressing assembly is further provided on the upper mounting seat of the above-mentioned electrochemical immunoassay system.

[0101] Preferably, the pressing assembly includes a motor and a pressing head.

[0102] Preferably, the motor includes a liquid bag motor 1221 and an air bag motor 1223, and the pressing head includes a liquid bag pressing head 1222 and an air bag pressing head 1224.

[0103] In some specific embodiments, the base assembly of the above-mentioned electrochemical immunoassay system is further provided with a test card feel component 1211 and a card insertion in-place judgment component 1212.

[0104] In some specific embodiments, in order to achieve precise control of the detection temperature and ensure the detection effect of the test card, the above-mentioned electrochemical immunoassay system further includes a temperature control component;

[0105] Preferably, the temperature control component includes a heat dissipation system and a test card heating device.

[0106] Preferably, the heat dissipation system is installed in the housing 11, and the heat dissipation system includes a fan and a temperature sensor.

[0107] Preferably, the test card heating device includes a rotating arm 123, a lifting plate 124, a first spring 125, a heating sheet 127 and a heating sheet mounting seat 126.

[0108] In some specific embodiments, the other parts of the above-mentioned electrochemical immunoassay system except the magnet assembly are the same as those of the blood gas biochemical analyzer in the patent with the application number 202110648575.4.

[0109] Second, the electrochemical immunoassay system provided by the present utility model includes a test card 2 used in cooperation with the electrochemical immunoassay analyzer of the first aspect;

[0110] The test card 2 includes a liquid packet 22, an airbag 23, an electrode 24, an upper substrate 211, a lamination layer 212, and a lower substrate 213;

[0111] The upper substrate is provided with a sample inlet 2116, an air passage hole 2115, an electrode hole 2114, an airbag hole 2113, a liquid packet hole 2112, and a seal 2117 that can connect the air passage and the liquid flow passage and is affixed with double-sided tape;

[0112] The lamination layer is provided with a waste liquid bin 2124, an air passage hole 2123, an airbag hole 2126, a liquid packet hole 2122, a sample detection channel 2125, and an incubation chamber 2124;

[0113] The lower substrate is provided with an air passage 2132, a liquid flow passage 2133, an air hole 2111, a waste liquid flow passage 2134, and a spike 2131;

[0114] Preferably, the lower substrate 213 is in contact with the groove of the lower mounting seat;

[0115] The airbag 23, the air passage 2131, the air passage hole 2123, the air passage hole 2115, and the sample detection channel 2125 are sequentially communicated;

[0116] The spike 2131 is provided in the liquid flow passage 2133;

[0117] The spike 2131 can contact the airbag 23 through the airbag hole 2113 and the airbag hole 2126;

[0118] The sample inlet 2116, the incubation chamber 2124, the liquid flow passage 2133, and the sample detection channel 2125 are sequentially communicated;

[0119] The sample detection channel 2125, the waste liquid flow passage 2134, the waste liquid bin 2121, and the air hole 2111 are sequentially communicated.

[0120] In some specific embodiments, in the above electrochemical immunoassay system, the electrode 24 includes an insulating substrate 241, a sensor contact that penetrates through both sides and is used to connect to an instrument, and an array of metal electrodes 243. The sensor contact includes a metal contact point 242;

[0121] The electrode is disposed in the electrode hole of the upper substrate, and the side of the electrode 24 provided with the array of metal electrodes 243 faces the lamination layer 212;

[0122] The material of the test card substrate includes one or more of aluminum alloy, PET, PC, glass, acrylic, and PDMS;

[0123] The processing methods of the test card include one or more of CNC machining, laser processing, injection molding, 3D printing, die casting, die cutting, and soft etching.

[0124] In some specific embodiments, the electrode 24 of the above-mentioned electrochemical immunoassay system includes a working electrode.

[0125] In some specific embodiments, the electrode 24 of the above-mentioned electrochemical immunoassay system further includes a reference electrode 25;

[0126] In some specific embodiments, the electrode metal layer of the test card of the above-mentioned electrochemical immunoassay system is attached to the insulating substrate 241 by screen printing, electroplating, magnetron sputtering, or laser engraving;

[0127] The metal layer is made of a metal material, and the metal includes at least one of Cu, Ti, Ag, Pt, Pd, Gu, and Au;

[0128] The reference electrode 25 is covered on the surface of the metal electrode by screen printing, electroplating, or dispensing.

[0129] In some specific embodiments, the liquid packet 22 of the above-mentioned electrochemical immunoassay system includes a substrate;

[0130] Preferably, the substrate includes TMB.

[0131] In some specific embodiments, the working process of the above-mentioned electrochemical immunoassay system includes:

[0132] 1. After the blood sample to be tested is mixed with the detection reagent containing the enzyme-labeled substance, it is injected into the test card 2 through the sampling port 2116, flows through the incubation chamber 2124, and washes down the magnetic beads attached to the incubation chamber 2124;

[0133] The enzyme-labeled substance includes an enzyme-labeled antibody or an enzyme-labeled antigen that can specifically bind to the target substance;

[0134] 2. The blood sample mixed with the magnetic beads enters the reaction zone inside the electrode (i.e., the sample detection channel 2125) through the flow channel, and the magnetic beads are enriched near the working electrode (i.e., the sample detection channel side of the array metal electrode 243 in the electrode 24) under the action of the magnetic field of the magnet 1385;

[0135] 3. After capture by the sandwich method, the reaction solution is discharged using the airbag 23;

[0136] At this time, if the target substance exists in the blood sample to be tested, it will bind to the enzyme-labeled substance and the magnetic beads, and the three are connected, indirectly retaining the enzyme-labeled substance with the magnetic beads in the sample detection channel 2125;

[0137] 4. The liquid packet motor 1221 drives the liquid packet press head 1222 to press the liquid packet for the first time, so that the reagent containing the substrate is fully rinsed and discharged in the electrode reaction area;

[0138] 5. The liquid packet motor 1221 drives the liquid packet press head 1222 to press the liquid packet again, so that the reagent containing the substrate fills the electrode reaction area. At this time, if there is a target in the blood sample to be tested, it means that the enzyme-labeled substance is retained, then the enzyme on the enzyme-labeled substance reacts with the substrate to generate an electrochemical signal; otherwise, the enzyme-labeled substance is not retained, the substrate does not undergo the expected reaction, and no expected electrochemical signal is generated;

[0139] 6. After incubating for a certain period of time, signals are acquired through the probe 132 on the signal acquisition component 13, and the detection results are obtained through analysis.

[0140] In some specific embodiments, during the working process of the above-mentioned electrochemical immunoassay system, the magnetic beads do not adhere to the test card 2, but are mixed with the blood sample to be tested and the detection reagent containing the enzyme-labeled substance, and then injected into the test card 2 through the sample inlet 2116.

[0141] In some specific embodiments, the working process of the above-mentioned electrochemical immunoassay system includes:

[0142] 1. The blood sample to be tested is mixed with the detection reagent containing the enzyme-labeled substance and the microspheres capable of aggregating cells, and then injected into the test card 2 through the sample inlet 2116, flowing through the incubation chamber 2124, and flushing the magnetic beads attached to the incubation chamber 2124;

[0143] The enzyme-labeled substance includes an enzyme-labeled antibody or an enzyme-labeled antigen capable of specifically binding to the target;

[0144] 2. The blood sample mixed with the magnetic beads enters the reaction area inside the electrode (i.e., the sample detection channel 2125) through the flow channel. Under the action of the magnetic field of the magnet 1385, the magnetic beads are enriched near the working electrode (i.e., the sample detection channel side of the array of metal electrodes 243 in the electrode 24), while the microspheres bind to one or more, one or more types of cells (such as red blood cells, white blood cells) in the blood, aggregate, and accelerate the sedimentation of the cells, away from the electrode at the top;

[0145] 3. After capture by the sandwich method, the reaction solution is discharged using the airbag 23;

[0146] 4. The liquid packet motor 1221 drives the liquid packet press head 1222 to press the liquid packet for the first time, so that the reagent containing the substrate is fully rinsed and discharged in the electrode reaction area;

[0147] 5. The liquid bag motor 1221 drives the liquid bag press head 1222 to press the liquid bag again, so that the reagent containing the substrate fills the electrode reaction area. After incubating for a certain period of time, signals are obtained through the probe 132 on the signal acquisition component 13, and the detection results are analyzed and obtained.

[0148] In some specific embodiments, during the working process of the above-mentioned electrochemical immunoassay system, the magnetic beads do not adhere to the test card 2, but are mixed with the blood sample to be tested and the detection reagent containing the enzyme-labeled substance and the microspheres capable of aggregating cells, and then are injected into the test card 2 through the sample inlet 2116.

[0149] In some specific embodiments, during the working process of the above-mentioned electrochemical immunoassay system, the microspheres capable of aggregating cells adhere to the incubation chamber 2124 on the test card 2, while the magnetic beads do not adhere to the test card 2.

[0150] In some specific embodiments, during the working process of the above-mentioned electrochemical immunoassay system, both the microspheres capable of aggregating cells and the magnetic beads adhere to the incubation chamber 2124 on the test card 2.

[0151] In some specific embodiments, the concentration of the reagent during the working process of the above-mentioned electrochemical immunoassay system is a concentration that can cause cells (such as red blood cells) to shrink.

[0152] In this embodiment:

[0153] 1) Mix 50 µL of blood sample containing the antigen (Huading recombinant human cardiac troponin complex, product number 60005, content 0 ng / mL, 0.1 ng / mL, 1 ng / mL or 10 ng / mL) with 2.5 µL of the detection reagent, and then inject it into the incubation chamber from the sample inlet through a syringe or pipette. Fold and seal it, and bond it to the upper substrate of the test card through the adhesive layer to form a passage between the air duct and the liquid flow channel.

[0154] 2) Press the airbag to drive the blood sample, push the blood sample from the incubation chamber into the sample detection flow channel, and stop the sample in the sample detection area through the in-place electrode, and let it stand and incubate for 3 - 5 minutes.

[0155] 3) After incubation is completed, the magnet approaches the working electrode and stops when it is 0 - 2 mm away from the working electrode. Through magnetic attraction, the magnetic beads gradually detach from the blood and adsorb on the electrode surface. This step takes 1 - 3 minutes.

[0156] 4) By alternately pressing down the liquid bag and the airbag, continuously inject TMB solution and air into the sample detection flow channel. After circulating 2 - 4 times, the sample detection flow channel is filled with TMB solution. After incubating the TMB solution for 1 minute, connect the electrode to the electrochemical workstation, apply a voltage of -0.2 V to the electrode for 60 seconds, and read the current signal at 60 seconds.

[0157] The above detection reagents include Detection Reagent 1, Detection Reagent 2, Detection Reagent 3 or Detection Reagent 4, and the components and ratios are shown in Table 1 as follows:

[0158] Table 1

[0159]

[0160] Four different treatment methods are set up, which are respectively:

[0161] (1): Control: 50 μL of blood sample (plasma) is mixed with Detection Reagent 1, and the electrode of the test card is placed upright;

[0162] (2): Upright: 50 μL of blood sample (whole blood) is mixed with Detection Reagent 1, and the electrode of the test card is placed upright;

[0163] (3): Upright + salt: 50 μL of blood sample (whole blood) is mixed with Detection Reagent 2, and the electrode of the test card is placed upright;

[0164] (4) Upright + salt + microspheres: 50 μL of blood sample (whole blood) is mixed with Detection Reagent 3, and the electrode of the test card is placed upright.

[0165] (5): Inverted + salt + microspheres: 50 μL of blood sample (whole blood) is mixed with Detection Reagent 3, and the electrode of the test card is placed inverted.

[0166] The results are shown in Table 2 and Table 3. All these treatments improve the analytical performance and reduce the probability of false positives and false negatives.

[0167] Table 2

[0168]

[0169] Table 3

[0170]

[0171] The above are only the preferred embodiments of the present utility model. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present utility model, several improvements and modifications can still be made, and these improvements and modifications should also be regarded as the protection scope of the present utility model.

Claims

1. An electrochemical immunoassay system, comprising a test card and an electrochemical immunoassay analyzer; The test card is used in conjunction with the electrochemical immunoassay analyzer, which includes a housing, a signal acquisition component, and a base component; The housing comprises an upper housing and a lower housing; The base assembly is mounted on the lower housing and is used to place the test card; It is characterized in that The signal acquisition assembly includes a driving member, a signal acquisition board and a magnet assembly; The signal acquisition board is provided with a probe; The driving member is in transmission connection with the signal acquisition board and the magnet assembly, and the driving member is configured to be able to drive the signal acquisition board and the magnet assembly to be pressed down, so that the probe on the signal acquisition board is electrically connected to the sensor contact on the test card, and the magnet assembly is in contact with the test card.

2. The electrochemical immunoassay system according to claim 1, wherein The test card comprises a liquid bag, an air bag, an electrode, an upper substrate, an interlayer, and a lower substrate; The electrode includes the sensor contact; The interlayer is provided with a sample detection channel; The electrode is located between the magnet assembly and the sample detection channel.

3. The electrochemical immunoassay system according to claim 2, characterized in that, The upper substrate is provided with a sample inlet, an airway hole, an electrode hole, an airbag hole, a liquid bag hole, and a seal that can connect the airway and the liquid flow channel and is affixed with double-sided tape; The interlayer is also provided with a waste liquid bin, an airway hole, an air bag hole, a liquid bag hole, and an incubation bin; The lower substrate is provided with air channels, liquid flow channels, air holes, waste liquid flow channels, and thorns; The airbag, the airway, the airway hole, and the sample detection channel are connected in sequence; The thorn is provided in the liquid flow channel; The spur may contact the airbag through the airbag hole; The sample inlet, the incubation chamber, the liquid flow channel, and the sample detection channel are connected in sequence; The sample detection channel, the waste liquid flow channel, the waste liquid tank, and the air hole are connected in sequence; The electrode comprises an insulating substrate, sensor contact points penetrating through two sides and used for connecting to an instrument, and an array metal electrode.

4. The electrochemical immunoassay system according to claim 3, wherein The incubation chamber is attached with: (i) Magnetic beads for immunoassay; and / or (ii) Microspheres used to settle cells.

5. The electrochemical immunoassay system according to claim 1, characterized in that, The magnet assembly comprises a magnet mounting seat and a magnet; The magnet mounting seat is fixedly connected to the signal acquisition board, and the magnet is connected to the magnet mounting seat.

6. The electrochemical immunoassay system according to claim 1, wherein The base assembly comprises an upper mounting seat and a lower mounting seat, wherein the upper mounting seat and the lower mounting seat are fixedly connected; The lower portion of the lower mounting seat is fixedly connected to the lower shell, and the upper portion of the lower mounting seat is provided with a groove for mounting the test card; The upper mounting seat is provided with a through hole for the probe and the magnet assembly to pass through.

7. The electrochemical immunoassay system according to claim 6, wherein The upper mounting seat is also provided with a pressing assembly; The pressing assembly includes a motor and a pressing head; The motor includes a liquid-encapsulated motor and an airbag motor, and the pressure head includes a liquid-encapsulated pressure head and an airbag pressure head.

8. The electrochemical immunoassay system according to claim 1, wherein The electrochemical immunoassay analyzer also includes a temperature control component; The temperature control assembly includes a heat dissipation system and a test card heating device.

9. The electrochemical immunoassay system according to claim 8, wherein The heat dissipation system is installed in the housing, and the heat dissipation system includes a fan and a temperature sensor; The test card heating device comprises a rotating arm, a lifting plate, a spring, a heating plate and a heating plate mounting seat.

10. The electrochemical immunoassay system according to claim 1, characterized in that The upper shell is provided with a display touch screen, and the lower shell is also provided with a main control board.

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