CN108333163B - Portable blood safety screening fluorescence immunoassay system - Google Patents

Portable blood safety screening fluorescence immunoassay system Download PDF

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Publication number
CN108333163B
CN108333163B CN201810304899.4A CN201810304899A CN108333163B CN 108333163 B CN108333163 B CN 108333163B CN 201810304899 A CN201810304899 A CN 201810304899A CN 108333163 B CN108333163 B CN 108333163B
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China
Prior art keywords
detection
card
blood
module
portable blood
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CN201810304899.4A
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CN108333163A (en
Inventor
栾建凤
丁万和
钟乾兴
唐雯
袁君
范许洲
王淑君
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Shengyi Suzhou Biotechnology Co ltd
Jinling Hospital
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Shengyi Suzhou Biotechnology Co ltd
Jinling Hospital
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Priority to CN201810304899.4A priority Critical patent/CN108333163B/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/6486Measuring fluorescence of biological material, e.g. DNA, RNA, cells

Abstract

The invention discloses a portable blood safety screening fluorescence immunoassay system, which comprises a portable blood fluorescence immunoassay instrument and a portable blood detection analysis card; the portable blood fluorescence immunoassay instrument comprises a detection mechanism, a main control board, a data storage module and a detection card tray for conveying the carrier table to the portable blood detection analysis card, wherein the detection mechanism comprises an alanine aminotransferase detection module, a four-item fluorescent infectious disease detection module, a blood group detection module and a hemoglobin detection module. The invention aims at the multiple items of detection needed in the blood screening combined detection process, and can rapidly and accurately control the detection reaction conditions and automatically complete the interpretation and output of multiple items of detection results by matching with the blood screening combined detection card.

Description

Portable blood safety screening fluorescence immunoassay system
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a portable blood safety screening fluorescence immunoassay system which is used for emergency pre-transfusion blood safety screening in field operations, pre-operation blood screening and preliminary pre-street blood safety screening.
Background
The existing blood safety screening methods mainly comprise a fluorescence immunoassay method, a solid-phase percolation method, a dry chemical velocity method, a dry chemical spot method and the like, but most blood screening detection products on the market are single-item detection, detection reagents are judged by naked eyes, and products judged by using instruments have the defects of more or less complicated operation, heavy instruments, long detection time and incapability of being carried about. Few combined detection products have few detection coverage projects, cannot meet the requirements of one card for multiple blood screening, and have the condition that the detection accuracy is lower than that of single detection. The main blood screening detection products such as gold-labeled reader and dry chemical analyzer on the market at present are separated and independent, and mostly single-channel detection is carried out for a single detection item, when multiple items are needed to be detected, the detection can only be carried out through different detection instruments, and serious efficiency problems exist when multiple persons are detected. It is therefore desirable to provide a portable blood test analysis card, portable blood fluoroimmunoassay meter and portable blood safety screening fluoroimmunoassay system suitable for multi-item testing.
Disclosure of Invention
Most of blood screening detection products on the market at present are single-item detection, few combined detection products have incomplete detection coverage items, the operation is complex, the requirements of one card for multiple blood screening cannot be met, the possibility of errors is high when manual interpretation is adopted, and the detection precision of multiple combined detection is lower than that of single-item detection. The invention aims to provide a portable blood safety screening fluorescence immunoassay system aiming at the technical problems.
The aim of the invention can be achieved by the following technical scheme:
A portable blood safety screening fluorescence immunoassay system comprises a portable blood fluorescence immunoassay instrument and a portable blood detection analysis card;
The portable blood fluorescence immunoassay analyzer comprises a detection mechanism, a main control board, a data storage module and a detection card tray for conveying the portable blood detection analysis card of the carrier, wherein the detection mechanism comprises an alanine aminotransferase detection module, four detection modules for fluorescent infectious diseases, a blood group detection module and a hemoglobin detection module;
the portable blood detection analysis card is any one of the following (I) to (II):
The detection and analysis card is any one of a blood group detection reagent card, an infectious disease four detection reagent card, an ALT detection reagent card and a hemoglobin detection reagent card;
And (II) the detection and analysis card comprises at least two of a blood type detection reagent card, an infectious disease four detection reagent card, an ALT detection reagent card and a hemoglobin detection reagent card, and the two adjacent detection reagent cards are combined and spliced together through a connecting piece.
As a preferable technical scheme of the portable blood fluorescence immunoassay analyzer, the hemoglobin detection module is fixed at the bottom of the detection card tray, a warm bath module is also arranged below the detection card tray, and the detection card tray is erected on a bottom plate and is driven to move in and out by a driving device I;
The bottom plate is vertically and fixedly provided with a guide rail, the alanine aminotransferase detection module is assembled on a sliding block of the guide rail through a structural bracket, and the alanine aminotransferase detection module is driven to move up and down above the detection card tray through a driving device II;
The blood type detection module is arranged on a module installation area of the structural member support, a backlight plate for fluorescence excitation irradiation for detecting four infectious diseases is also arranged on the backlight plate installation area of the structural member support, the structural member support is fixedly arranged below the fixing plate, the four fluorescent infectious disease detection modules are fixedly arranged above the fixing plate, and the main control plate layer is fixedly arranged above the four fluorescent infectious disease detection modules; the fixing plate is fixed on the bottom plate through a stud;
The data storage module, the warm bath module and each module of the detection mechanism are all connected with the main control board through FPC wires.
Further preferably, the portable blood fluorescence immunoassay analyzer is externally provided with a shell, and the shell is divided into an upper shell and a lower shell; the bottom plate is fixedly arranged on the lower shell, and the data storage module is fixed at the panel assembly part of the upper shell.
Still further preferably, the portable blood fluorescence immunoassay analyzer further comprises at least one component selected from the group consisting of a printer, a display screen, a key panel, a power interface, a PS2 scanner interface, and a USB interface. The printer is arranged at the printer assembling part of the upper shell and is connected to the interface board through an FPC wire, and the interface board is arranged on the lower shell; the display screen is arranged in a display window at the middle position of the upper shell and is connected to the main control board through an FPC wire; the key panel is arranged at the key installation part of the upper shell and is connected to the main control board through an FPC wire; the power interface is used for inputting a working power supply and charging a standby battery, and the standby battery is assembled in a battery mounting groove of the lower shell.
The driving device I comprises a direct current motor and a screw rod, wherein the direct current motor is connected with the detection card tray through the screw rod, and the direct current motor drives the detection card tray to move in and out; the detection card tray is erected on the bottom plate through two support shafts which are arranged in parallel, and two ends of each support shaft are respectively fixed on the bottom plate;
the driving device II is a stepping motor which is fixedly arranged on the vertical connecting plate of the fixing plate.
The preferable technical scheme of the portable blood detection analysis card is as follows: the kit comprises a blood type detection reagent card, four detection reagent cards for infectious diseases, an ALT detection reagent card and a hemoglobin detection reagent card, wherein two adjacent detection reagent cards are combined and spliced together through a connecting piece; further preferably, the blood type detection reagent card, the four detection reagent cards for infectious diseases, the ALT detection reagent card and the hemoglobin detection reagent card are sequentially spliced and combined.
The blood type detection reagent card comprises an upper cover, a base and a blood type detection test strip, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the blood type detection test strip is arranged in a clamping groove of the base, a positioning hole and a blood type sample adding hole are formed in the upper cover, and the blood type sample adding hole corresponds to a blood type sample adding area of the blood type detection test strip; the back of the base is provided with positioning plate ribs;
The four detection reagent cards for infectious diseases comprise an upper cover, a base and four detection test strips for infectious diseases, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the four detection test strips for infectious diseases are respectively arranged in a clamping groove of the base, an observation window, a label window, a sample loading hole and a chromatography auxiliary liquid loading hole are formed in the upper cover, the observation window corresponds to NC films on the four detection test strips for infectious diseases, the sample loading hole and the chromatography auxiliary liquid loading hole correspond to a loading area and a chromatography auxiliary liquid loading area on the four detection test strips for infectious diseases respectively, and a positioning plate rib is arranged on the back surface of the base;
The ALT detection reagent card comprises an upper cover, a base and an ALT detection test strip, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the ALT detection test strip is arranged in a clamping groove of the base, and an ALT detection window, an ALT sample adding hole and a positioning hole are formed in the upper cover; the back of the base is provided with a heating hole and a positioning plate rib respectively;
The hemoglobin detection reagent card comprises an upper cover, a base and a Hb detection test strip, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the Hb detection test strip is arranged in a clamping groove of the base, a hemoglobin sample adding hole is formed in the upper cover, and a hemoglobin light hole and a positioning plate rib are respectively formed in the back of the base.
The connecting piece comprises a male movable buckle and a female movable buckle, and two adjacent single detection reagent cards are spliced by the combination of the male movable buckle and the female movable buckle.
The blood type test strip is sequentially provided with a substrate, absorbent paper III, absorbent paper II, absorbent paper I, a buffer pad and an antibody pad from bottom to top, wherein the overlapped part of the antibody pad and the buffer pad forms a blood type sample adding area;
The four detection test strips for infectious diseases are sequentially provided with a glass fiber pad, an antibody pad, an NC film and a substrate from top to bottom, one end of the glass fiber pad is partially overlapped with one end of the antibody pad, the other end of the antibody pad is partially overlapped with one end of the NC film, and the other end of the NC film is partially covered with water absorbing paper; the sample adding area is positioned at the part above the glass fiber pad and close to the antibody pad, and the chromatographic auxiliary liquid sample adding area is positioned at the position 3-5 mm below the sample adding area.
In the portable blood fluorescence immunoassay analyzer, the printer is preferably a thermal printer as a data printing output device. The display screen is used as information display and indication equipment. The key panel is used as man-machine interaction equipment for function setting or selection. The PS2 scanner interface serves as a barcode scanner input device. The USB interface is used as USB master-slave connection equipment, and can realize the functions of data storage and data transmission. The power interface is used for power supply working power supply input and standby battery charging. The data storage module is preferably an RFID module and is used for detecting the input of information such as card batches, parameters and the like and storing the detected data after the detection. The guide rail is used for guiding the upward and downward movement of the alanine aminotransferase detection module. The stepping motor is used for driving the alanine aminotransferase detection module to move up and down. The main control board is used for comprehensively controlling and coordinating the normal operation of all electric components in the instrument.
This patent contains portable blood fluorescence immunoassay appearance and portable blood detection analysis card, detects the application to blood safety screening especially: compared with other detection reagent products, the portable blood detection analysis card covers the national requirement of blood safety screening multiple item detection, can comprehensively carry out multiple item detection, can carry out single item detection according to the needs respectively, has small sample size, has the common size of a credit card, and is convenient to carry; compared with other detection instruments, the portable blood fluorescence immunoassay instrument adopts a semi-automatic detection mode, has small volume, light weight, convenient carrying and strong shock resistance, can rapidly and accurately control the detection reaction temperature and time, automatically analyzes and interprets the detection result, and completes the output of the detection result within ten minutes.
Key term interpretation:
a) Portable: the portable anti-seismic door is mainly characterized by being portable, light and strong in anti-seismic property, and is suitable for field conditions.
B) Blood safety screening: the blood safety screening mentioned in the patent is comprehensive multi-item screening, and generally comprises blood group ABO and blood group RhD typing detection, alanine aminotransferase detection, hemoglobin detection and infectious disease four-item (hepatitis B surface antibody, AIDS, syphilis and hepatitis C) detection according to national regulations; preoperative blood screening.
C) Fluorescent immunization: the method of fluorescence immune labeling and antigen-antibody immune cross-linking is applied in the patent.
D) Analysis system: the portable blood fluorescence immunoassay system comprises a portable blood fluorescence immunoassay instrument and a portable blood detection analysis card, and is called a portable blood safety screening fluorescence immunoassay system.
The invention has the beneficial effects that:
The portable blood safety screening fluorescence immunoassay system can complete a plurality of tests: the blood screening multi-project detection is completed on a portable blood detection analysis card by adopting a trace whole blood specimen, the detection result is accurately interpreted by using a portable blood fluorescence immunoassay analyzer, and the detection data is output after being arranged and analyzed in the analyzer, so that a detector obtains an intuitive detection interpretation result. The portable blood detection analysis card and the portable blood fluorescence immunoassay analyzer are convenient to carry, can detect at any time, are suitable for field emergency pre-transfusion blood screening detection, and can also be applied to various pre-operation blood sampling blood safety screening detection.
Drawings
Fig. 1 is a schematic block diagram of a portable fluorescence immunoassay analyzer.
Fig. 2 is a workflow of a portable fluorescence immunoassay analyzer.
Fig. 3 is an external shape of the portable fluorescence immunoassay apparatus.
Fig. 4 is an internal configuration diagram of the portable fluorescence immunoassay apparatus.
Fig. 5 is a structural diagram of the shape of the upper case of the portable fluorescence immunoassay analyzer (a is a rear perspective structural diagram of the upper case, and B is a front perspective structural diagram of the upper case).
Fig. 6 is a structural view showing the structural parts of the portable fluorescence immunoassay apparatus and the shape of the backlight plate.
Fig. 7 is a structural diagram showing the shape of a fixing plate of the portable fluorescence immunoassay apparatus.
Fig. 8 is a diagram showing the configuration of the bottom plate of the portable fluorescence immunoassay apparatus.
Fig. 9 is a diagram showing the structure of the shape of a detection card tray of the portable fluorescence immunoassay device (a is a rear perspective view of the detection card tray, and B is a front perspective view of the detection card tray).
Fig. 10 is a structural diagram of the shape of the lower case of the portable fluorescence immunoassay analyzer (a is a front perspective structural diagram of the lower case, and B is a rear perspective structural diagram of the lower case).
Fig. 11 is a view showing the shape of the structural member of the upper part of the warm bath module.
FIG. 12 is a view of the shape of the lower structural part of the temperature bath module.
Fig. 13: portable blood test analysis card structure (multiple integrated test reagent card mode).
Fig. 14: portable blood test analysis card structure (single test reagent card mode).
Fig. 15: schematic diagram of blood group detection reagent card structure.
Fig. 16: schematic of blood group testing strip structure.
Fig. 17: the structure of four detection reagent cards for infectious diseases is shown in the schematic diagram.
Fig. 18: the structure of four detection test strips for infectious diseases is schematically shown.
Fig. 19: ALT detection reagent card structure schematic diagram.
Fig. 20: the structure of the hemoglobin detection reagent card is schematically shown.
Fig. 21: schematic diagram of the back structure of the portable blood detection and analysis card.
Detailed Description
The portable blood safety screening immunoassay system is a combination product of a detection reagent and an instrument for blood safety screening detection, completes multiple items of detection of blood safety screening detection on a portable detection reagent card, interprets and analyzes detection results by a portable blood fluorescence immunoassay instrument, outputs data, obtains detection results within ten minutes, and mainly uses the blood safety screening detection with blood screening and other conditions before field transfusion. It comprises two main parts: a portable blood detection analysis card and a portable blood fluorescence immunoassay analyzer.
The portable blood test analysis card and the portable blood fluorescence immunoassay analyzer of the present invention will be described in detail with reference to the following embodiments:
1. Portable blood fluorescence immunoassay appearance:
As shown in the schematic block diagram of the analytical instrument in FIG. 1, the present invention comprises an alanine aminotransferase detection module 817, a hemoglobin detection module 806, a blood group detection module 812, a four-item fluorescent infectious disease detection module 811, a display screen 800, a central processing unit (i.e. a main control board 818), a movement mechanism, a printer 803, a data storage module 810, a PS2 scanner interface 808, a USB interface 807 and the like. Wherein hemoglobin detection module 806, alanine aminotransferase detection module 817, and blood group detection module 812 detect the concentration of the substance being detected using spectrophotometry; the four detection modules 811 for fluorescent infectious disease detect the concentration of the detected object by adopting the principle of photoelectric reflection photometry.
As shown in fig. 3 to 10, the portable blood fluorescence immunoassay analyzer of the present invention comprises a detection mechanism, a main control board 818, a data storage module 810 and a detection card tray 804 for transferring a carrier portable blood detection analysis card 805, wherein the detection mechanism comprises an alanine aminotransferase detection module 817, a four-item fluorescent infectious disease detection module 811, a blood group detection module 812 and a hemoglobin detection module 806;
The hemoglobin detection module 806 is fixed at the bottom of the detection card tray 804, a warm bath module 825 is also installed below the detection card tray 804, and the detection card tray 804 is erected on the bottom plate 823 and is driven to move in and out by the driving device I; the driving device I comprises a direct current motor 822 and a screw rod, wherein the direct current motor 822 is connected with the detection card tray 804 through the screw rod, and the direct current motor 822 drives the detection card tray 804 to move in and out. The test card tray 804 is erected on the bottom plate 823 through two parallel support shafts 824, and two ends of the support shafts 824 are respectively fixed on the bottom plate 823.
The bottom plate 823 is vertically and fixedly provided with a guide rail 816, the alanine aminotransferase detection module 817 is assembled on a sliding block of the guide rail 816 through a structural bracket 813, and the alanine aminotransferase detection module 817 is driven to move up and down above the detection card tray 804 through a driving device II; the driving device II is a stepping motor 815, and the stepping motor 815 is fixedly mounted on a vertical connecting plate 820-1 of the fixing plate 820. In this instrument, the test card tray 804 is used as a transport carrier for a portable blood test analysis card 805.
The blood type detection module 812 is mounted on a module mounting area 819-2 of the structural member support 819, a backlight plate 821 is further mounted on a backlight plate mounting area 819-1 of the structural member support 819 for fluorescence excitation irradiation of four detection items of infectious disease, the structural member support 819 is fixedly mounted below a fixing plate 820 (the blood type detection module 812 and the backlight plate 821 are positioned between the structural member support 819 and the fixing plate 820), the four detection items of fluorescent infectious disease module 811 is fixedly mounted above the fixing plate 820, and the main control board 818 is fixedly stacked above the four detection items of fluorescent infectious disease module 811;
The fixing plate 820 is fixed on the bottom plate 823 through studs 826;
the data storage module 810, the temperature bath module 825 and the detection mechanism are all connected with the main control board 818 through FPC wires.
As a preferred solution, the portable fluorescence immunoassay analyzer is externally provided with a housing 802, and the housing 802 is divided into an upper housing 802-2 and a lower housing 802-8. The base 823 is fixedly mounted on the lower housing 802-8, and the data storage module 810 is fixed on the panel assembly portion 802-5 of the upper housing 802-2. The analyzer also includes a printer 803, a display screen 800, a key panel 801, a power interface 809, a PS2 scanner interface 808, and a USB interface 807. The printer 803 is mounted on the printer assembly portion of the upper housing 802-2 and connected to an interface board 814 through an FPC cable, and the interface board 814 is mounted on the lower housing; the display screen 800 is installed in a display window at the middle position of the upper housing 802-2 and is connected to the main control board 818 through an FPC cable; the key panel 801 is mounted on the key mounting portion of the upper housing 802-2 and connected to the main control board 818 through an FPC cable.
The power interface 809 is used for operating power input and battery backup charging, and the battery backup is assembled in the battery mounting groove of the lower housing 802-8.
The printer 803 is preferably a thermal printer as a data print output device. The display screen 800 serves as an information display and indication device. The key panel 801 is used as a man-machine interaction device for function setting or selection. The PS2 scanner interface 808 serves as a barcode scanner input device. The USB interface 807 is used as a USB master-slave connection device, and can implement a data storage and data transmission function. The power interface 809 is used for power source operation power input, and battery backup charging. The data storage module 810 is preferably an RFID module for detecting the input of information such as card batch, parameters, etc., and storing the detected data after testing. The guide rail 816 is used for guiding the upward and downward movement of the alanine aminotransferase detection module 817. The stepper motor 815 is used to drive the alanine aminotransferase detection module 817 up and down. The main control board 818 is used for comprehensively controlling and coordinating the normal operation of all electrical components in the instrument.
The compact arrangement of the portable blood fluorescence immunoassay instrument designed by the invention has excellent shock resistance effect, simple appearance and key layout, and simpler and more visual operation. Each module group constructed can be purchased directly on the relevant market, and the component materials are convenient to obtain.
The assembly process of each component of the portable fluorescence immunoassay analyzer is as follows:
the built-in printer 803 is fixed by 4 screws, mounted to the printer mounting portion 802-3 of the housing 802-2 on the casing 802, and connected to the interface board 814 through FPC lines. The LCD 800 is fixed by two screws, is mounted in a display window 802-1 in the middle of a housing 802-2 on the housing 802, and is connected to a main control board 818 by FPC wires. The key panel 801 is attached to the key panel assembly portion 802-4 by 3M adhesive, and is connected to the main control board 818 by FPC lines. The data storage module (RFID module) 810 is attached to the storage module panel assembly site 802-5 of the upper housing 802-2 by 3M glue and connected to the main control board 818 by FPC lines.
The alanine aminotransferase detection module 817 is mounted on the slide block of the guide rail 816 through the structural support 813, and is driven to move up and down by the stepping motor 815. Alanine aminotransferase detection module 817 is connected to main control board 818 via FPC leads for data collection and control.
The blood type testing module 812 is mounted on a module mounting area 819-2 of the structural member support 819 for testing and data collection of blood types. The backlight 821 is mounted on a backlight mounting area 819-1 of the structural frame 819 for four fluorescent excitation shots of infectious disease.
The structural member support 819 is secured to the underside of the fixing plate 820 by screws. The four fluorescent infectious disease detection modules 811 are fixed above the fixing plate 820 by screws. The main control board 818 is stacked and fixed above the four detection modules 811 for fluorescent infectious diseases by screws.
The stepper motor 815 is fixed to the fixed plate 820-1 by screws.
The hemoglobin detection module 806 and the warming bath module 825 are fixed to the tray 804 by screws.
The tray 804 is erected on the bottom plate 823 through a supporting shaft 824, a direct current motor 822 is connected with the tray 804 through a screw rod, and the direct current motor 822 drives the tray to move in and out.
The fixing plate 820 is fixed to the base plate 823 by a stud 826.
The base plate 823 is fixed to the lower housing 802-8 by screws, and the interface board 814 is fixed to the interface board mounting portion 802-7 of the lower housing by screws.
The spare battery is assembled in the battery groove 802-6 of the lower shell and is fixed through a battery cover and screw holes.
As shown in fig. 2, the workflow of the analyzer is:
After the instrument is started, each functional module in the instrument is subjected to self-inspection, and a constant temperature incubation environment at 37 ℃ is constructed, and the instrument enters a ready state after about 2 minutes, and waits for user operation. After the user puts the card to be tested, the instrument starts to complete the test of each item, and after the test is completed, the result of each detection item is automatically printed.
Detection preparation:
1. The combination test card is placed in the instrument ready state.
2. And adding the blood sample volume of the corresponding item into each sample adding hole of the combination card.
3. And adding a proper amount of auxiliary liquid into each auxiliary liquid sample adding hole of the combination card.
4. After the above steps are completed, it is confirmed that the instrument starts detection sequentially.
The detection sequence is as follows:
According to the reaction time requirements of each item, the instrument sequentially reads four items of hemoglobin, alanine aminotransferase, blood type and infectious disease. The detection time for completing all the items of the single card is 10 minutes.
Recording:
1. the instrument is provided with a strip record storage area, and the test record is automatically stored, so that a user can conveniently check the record at any time.
2. The thermal printer is arranged in the instrument, and a user can freely select whether data is printed or not.
The portable blood fluorescence immunoassay analyzer comprises the following steps:
After the instrument power is turned on and the instrument is ready, the detection card tray 804 stretches out, the detection card 805 is put in, samples and flushing fluid are added, the key panel 801 corresponds to function keys according to screen prompts, the detection card tray 804 is provided with a card to enter the instrument, and the instrument sequentially reads four items of hemoglobin, alanine aminotransferase, blood type and infectious diseases. The detection time for completing all the items of the single card is 10 minutes. After the detection is completed, the instrument sends the result to the liquid crystal display 800 for display, and the result is printed out through the built-in printer 803. The test card tray 804 again extends, at which point the waste card is removed and a new test card 805 is placed for the next round of testing.
The alanine aminotransferase detection module, the hemoglobin detection module, the blood group detection module, the four detection modules of fluorescent infectious diseases and the warm bath module used in the portable blood fluorescence immunoassay analyzer can be obtained by conventional means by a person skilled in the art.
11-12, The warm bath module is composed of an upper half part and a lower half part, wherein the upper half part and the alanine aminotransferase detection module are integrated into a whole, and the warm bath module is composed of a ceramic heating plate (model: P1010, zhuhai Huiyou electronic Co., ltd.), a temperature sensor (model IT503F-3950A-L240, guangdong Aisheng electronic technology Co., ltd.), a structural member 827 and a PCBA assembly; wherein the ceramic heating plate is assembled at 827-3 position of the structural member, the PCBA component is assembled at 827-4 region, and the temperature sensor is assembled at 827-2 position; 827-1 is an optical detection light entry and exit window on the structure. The lower half of the temperature bath sensor consists of a ceramic heating plate (model: P1010, zhuhai Huiyou electronic Co., ltd.), a temperature sensor (model IT503F-3950A-L240, guangdong Aicheng electronic technology Co., ltd.) and a structural member 828, wherein 828-1 is the assembly position of the temperature sensor, and 828-2 is the assembly position of the ceramic heating plate.
The hemoglobin detection module consists of a housing and a PCBA assembly that is assembled to a test card tray 804 and secured with the housing.
The four detection modules for the fluorescent infectious diseases comprise a main component, namely a CMOS linear array sensor S12443 (Pinus maritima photons), a structural component, a PCBA detection plate and a PCBA backlight plate, wherein the CMOS linear array sensor S12443 (Pinus maritima photons) is assembled on the PCB to form the PCBA detection plate, and the PCBA detection plate and the PCBA backlight plate are assembled on the structural component to form the four detection modules for the fluorescent infectious diseases.
The blood group detection module and the four detection modules of the fluorescent infectious diseases are integrated on the structural member and are combined by independent PCBA optical detection plates. The PCBA optical test board is assembled in the module mounting area 819-2 of the structural member support 819 to form a blood group testing module.
2. Portable blood detection analysis card
The portable blood detection analysis card can be used as a plurality of comprehensive detection reagent card modes or can be decomposed to be used as a single detection reagent card mode, and each single card of the single detection reagent card mode is connected through a male and female movable buckle identified by a circular frame in FIG. 14 to form the plurality of comprehensive detection reagent card modes in FIG. 13.
The portable blood detection analysis card can be decomposed into four independent single detection reagent cards: blood group detection reagent card 1, four detection reagent cards 2 for infectious diseases, ALT detection reagent card 3 and four parts of hemoglobin detection reagent card 4. The four single detection reagent cards are sequentially combined and spliced through the male movable buckle 5 and the female movable buckle 6, and the bottoms of the reagent cards are respectively provided with a plate rib 7 for positioning.
As shown in fig. 15, the blood group detection reagent card 1 is divided into three parts, namely an upper cover 101, a base 102 and a blood group detection test strip 103, wherein the upper cover 101 and the base 102 can be tightly embedded into a whole through a plate rib column, the blood group detection test strip 103 is placed in a clamping groove of the base 102, a positioning hole 101-1 and a blood group sampling hole 101-2 are formed in the upper cover 101, and the blood group sampling hole 101-2 corresponds to a blood group sampling area of the blood group detection test strip 103; the base 102 is provided with a positioning plate rib 7 for positioning the placement position of the reagent card on the portable blood fluorescence immunoassay analyzer.
The blood group detection test strip 103 adopts a percolation and chromatography integrated structure, the structure is shown in fig. 16, the lowest substrate 103-1 is a polyester fiber board, and the upper layer is sequentially overlapped with water absorption paper III 103-2, water absorption paper II 103-3, water absorption paper I103-4, a buffer pad 103-5 and an antibody pad 103-6. The overlapping portion of antibody pad 103-6 and buffer pad 103-5 forms a blood group loading zone corresponding to blood group loading well 101-2 of FIG. 15. After the sample is added, the sample is contacted with an antibody pad 103-6, then auxiliary liquid is added to assist the sample to percolate from top to bottom, the percolated liquid is drained in a chromatographic manner by a water absorption paper II 103-3, and the excessive liquid is further percolated and drained by a water absorption paper III 103-2 and subjected to reverse chromatography, so that liquid accumulation is prevented, and the normal reaction is promoted.
As shown in fig. 17, the four infectious disease detection reagent cards 2 are divided into three parts, namely an upper cover 201, a base 202 and four infectious disease detection test strips 203, wherein the upper cover 201 and the base 202 can be tightly embedded into a whole through a plate rib column, the four infectious disease detection test strips 203 are arranged in clamping grooves corresponding to the base 202, an observation window 201-1 and a label window 201-2 are arranged on the upper cover 201, a sample loading hole 201-3 and a chromatography auxiliary liquid loading hole 201-4 are formed in the upper cover 201, the observation window 201-1 corresponds to an NC film 203-3 on the four infectious disease detection test strips 203, the sample loading hole 201-3 and the chromatography auxiliary liquid loading hole 201-4 respectively correspond to a loading area and a chromatography auxiliary liquid loading area on the four infectious disease detection test strips 203, and a positioning plate rib 7 is arranged on the base 202 and is used for positioning the placement position of a reagent card on the portable blood fluorescence immunoassay analyzer.
The four detection test strips 203 for infectious diseases adopt a fluorescence immunochromatography method, a basic structure is shown in fig. 18, a glass fiber pad 203-1, an antibody pad 203-2, an NC film 203-3 and a substrate 203-4 are sequentially arranged from top to bottom, one end of the glass fiber pad 203-1 is partially overlapped with one end of the antibody pad 203-2, the other end of the antibody pad 203-2 is partially overlapped with one end of the NC film 203-3, and the other end of the NC film 203-3 is partially covered with a water absorbing paper 203-5; the sample adding area is positioned above the glass fiber pad 203-1 and near the antibody pad 203-2, and the chromatographic auxiliary liquid sample adding area is positioned at the position 4mm below the sample adding area. The four detection test strips 203 for infectious diseases take a polyester plate as a substrate 203-4, adopt a basic structure of a common chromatography, coat protein marked with fluorescent signals on an antibody pad 203-2, carry out immune cross-linking reaction with target detection proteins, and coat test lines and control lines on an NC film 203-3 as test and quality control indexes.
As shown in fig. 19, the ALT detection reagent card 3 is divided into three parts, namely an upper cover 301, a base 302 and an ALT detection test strip 303, wherein the upper cover 301 and the base 302 can be tightly embedded into a whole through a plate rib column, the ALT detection test strip 303 is placed in a clamping groove corresponding to the base 302, an ALT detection window 301-1 is formed in the upper cover 301 and is used for being matched with a portable blood fluorescence immunoassay analyzer, an ALT sample adding hole 301-2 is further formed in the upper cover 301 and is used for detecting the addition of a sample, and a positioning point 301-3 is further formed in the upper cover 301 and is matched with the positioning of the detection card in the portable blood fluorescence immunoassay analyzer. The back of the base 302 is provided with a heating hole 302-1 which is matched with the heating function of the portable blood fluorescence immunoassay analyzer on the ALT detection test strip 303.
As shown in fig. 20, the hemoglobin detection reagent card 4 is divided into three parts, namely an upper cover 401, a base 402 and a Hb detection test strip 403, wherein the upper cover 401 and the base 402 can be tightly embedded into a whole through a plate rib column, the Hb detection test strip 403 is placed in a clamping groove corresponding to the base 402, and a hemoglobin sample adding hole 401-1 is formed in the upper cover 401 and is used for detecting sample adding. The back of the base 402 is provided with a hemoglobin light hole 402-1, and the hemoglobin light hole is matched with a portable blood fluorescence immunoassay analyzer to read data of a hemoglobin detection item.
The blood type detection reagent card 1, the four detection reagent cards 2 for infectious diseases, the ALT detection reagent card 3 and the detection reagent card 4 for hemoglobin can be combined through the male clasp 5 and the female clasp 6, and are spliced into an integrated combined detection reagent card according to the requirement. The back of the four parts is distributed with positioning plate ribs 7 for matching with the placement and positioning of the detection reagent card in the portable blood fluorescence immunoassay analyzer, and the back structure diagram of the portable blood detection analysis card is shown in fig. 21.
The detection card realizes the safety detection of multiple blood screening, can autonomously select single items, and is a portable blood detection analysis card for comprehensive detection of multiple items; the portable blood fluorescence immunoassay analyzer is matched with a portable blood detection analysis card for use, and is used for controlling detection reaction conditions, judging and processing detection results, analyzing the detection results, outputting and storing the detection results, and detecting the portable blood fluorescence immunoassay analyzer by matching with various combined portable blood detection analysis cards.

Claims (8)

1. The portable blood safety screening fluorescence immunoassay system is characterized by comprising a portable blood fluorescence immunoassay instrument and a portable blood detection analysis card;
The portable blood fluorescence immunoassay analyzer comprises a detection mechanism, a main control board, a data storage module and a detection card tray for conveying the portable blood detection analysis card of the carrier, wherein the detection mechanism comprises an alanine aminotransferase detection module, four detection modules for fluorescent infectious diseases, a blood group detection module and a hemoglobin detection module;
the portable blood detection and analysis card is any one of the following (I) to (II):
The detection and analysis card is any one of a blood group detection reagent card, an infectious disease four detection reagent card, an ALT detection reagent card and a hemoglobin detection reagent card;
(II) the detection and analysis card comprises at least two of a blood type detection reagent card, an infectious disease four detection reagent card, an ALT detection reagent card and a hemoglobin detection reagent card, and two adjacent detection reagent cards are combined and spliced together through a connecting piece;
The hemoglobin detection module is fixed at the bottom of the detection card tray, a warm bath module is also arranged below the detection card tray, and the detection card tray is erected on the bottom plate and is driven to move in and out by the driving device I;
The bottom plate is vertically and fixedly provided with a guide rail, the alanine aminotransferase detection module is assembled on a sliding block of the guide rail through a structural bracket, and the alanine aminotransferase detection module is driven to move up and down above the detection card tray through a driving device II;
The blood type detection module is arranged on a module installation area of the structural member support, a backlight plate for fluorescence excitation irradiation for detecting four infectious diseases is also arranged on the backlight plate installation area of the structural member support, the structural member support is fixedly arranged below the fixing plate, the four fluorescent infectious disease detection modules are fixedly arranged above the fixing plate, and the main control plate layer is fixedly arranged above the four fluorescent infectious disease detection modules; the fixing plate is fixed on the bottom plate through a stud;
The data storage module, the warm bath module and each module of the detection mechanism are all connected with the main control board through FPC wires;
the driving device I comprises a direct current motor and a screw rod, wherein the direct current motor is connected with the detection card tray through the screw rod, and the direct current motor drives the detection card tray to move in and out;
the detection card tray is erected on the bottom plate through two support shafts which are arranged in parallel, and two ends of each support shaft are respectively fixed on the bottom plate;
the driving device II is a stepping motor which is fixedly arranged on the vertical connecting plate of the fixing plate.
2. The portable blood safety screening fluoroimmunoassay system according to claim 1, wherein a housing is provided outside the portable blood fluoroimmunoassay device, and the housing is divided into an upper housing and a lower housing; the bottom plate is fixedly arranged on the lower shell, and the data storage module is fixed at the panel assembly part of the upper shell.
3. The portable blood safety screening fluoroimmunoassay system of claim 2, wherein said portable blood fluoroimmunoassay instrument further comprises at least one of a printer, a display screen, a key panel, a power interface, a PS2 scanner interface, and a USB interface.
4. The portable blood safety screening fluoroimmunoassay system of claim 3, wherein said printer is mounted to a printer mounting location of said upper housing and is connected to an interface board through an FPC cord, said interface board being mounted to said lower housing; the display screen is arranged in a display window at the middle position of the upper shell and is connected to the main control board through an FPC wire; the key panel is arranged at the key installation part of the upper shell and is connected to the main control board through an FPC wire; the power interface is used for inputting a working power supply and charging a standby battery, and the standby battery is assembled in a battery mounting groove of the lower shell.
5. The portable blood safety screening fluoroimmunoassay system of claim 1, wherein said portable blood test analysis card comprises a blood group test reagent card, an infectious disease four test reagent card, an ALT test reagent card, and a hemoglobin test reagent card, adjacent two test reagent cards being joined together by a connector assembly.
6. The portable blood safety screening fluoroimmunoassay system according to claim 1 or 5, wherein said blood group testing reagent card comprises three parts, namely an upper cover, a base and a blood group testing strip, said upper cover and base can be tightly embedded into a whole through a plate rib column, said blood group testing strip is arranged in a clamping groove of said base, said upper cover is provided with a positioning hole and a blood group loading hole, said blood group loading hole corresponds to a blood group loading area of said blood group testing strip; the back of the base is provided with positioning plate ribs;
The four detection reagent cards for infectious diseases comprise an upper cover, a base and four detection test strips for infectious diseases, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the four detection test strips for infectious diseases are respectively arranged in a clamping groove of the base, an observation window, a label window, a sample loading hole and a chromatography auxiliary liquid loading hole are formed in the upper cover, the observation window corresponds to NC films on the four detection test strips for infectious diseases, the sample loading hole and the chromatography auxiliary liquid loading hole correspond to a loading area and a chromatography auxiliary liquid loading area on the four detection test strips for infectious diseases respectively, and a positioning plate rib is arranged on the back surface of the base;
The ALT detection reagent card comprises an upper cover, a base and an ALT detection test strip, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the ALT detection test strip is arranged in a clamping groove of the base, and an ALT detection window, an ALT sample adding hole and a positioning hole are formed in the upper cover; the back of the base is provided with a heating hole and a positioning plate rib respectively;
The hemoglobin detection reagent card comprises an upper cover, a base and a Hb detection test strip, wherein the upper cover and the base can be tightly embedded into a whole through a plate rib column, the Hb detection test strip is arranged in a clamping groove of the base, a hemoglobin sample adding hole is formed in the upper cover, and a hemoglobin light hole and a positioning plate rib are respectively formed in the back of the base.
7. The portable blood safety screening fluoroimmunoassay system according to claim 1 or 5, wherein said connector comprises a male connector and a female connector, and two adjacent single detection reagent cards are spliced by a combination of the male connector and the female connector.
8. The portable blood safety screening fluoroimmunoassay system according to claim 6, wherein said blood group test strip is provided with a substrate, a bibulous paper iii, a bibulous paper ii, a bibulous paper i, a buffer pad and an antibody pad in this order from bottom to top, and overlapping portions of said antibody pad and buffer pad constitute a blood group sample-adding region;
The four detection test strips for infectious diseases are sequentially provided with a glass fiber pad, an antibody pad, an NC film and a substrate from top to bottom, one end of the glass fiber pad is partially overlapped with one end of the antibody pad, the other end of the antibody pad is partially overlapped with one end of the NC film, and the other end of the NC film is partially covered with water absorbing paper; the sample adding area is positioned at the part, close to the antibody pad, above the glass fiber pad, and the chromatographic auxiliary liquid sample adding area is positioned at the position, 3-5 mm below the sample adding area.
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