WO2022096003A1 - 具有识别信息的检测板和用于读取识别信息的分析仪及其识别方法 - Google Patents

具有识别信息的检测板和用于读取识别信息的分析仪及其识别方法 Download PDF

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Publication number
WO2022096003A1
WO2022096003A1 PCT/CN2021/129361 CN2021129361W WO2022096003A1 WO 2022096003 A1 WO2022096003 A1 WO 2022096003A1 CN 2021129361 W CN2021129361 W CN 2021129361W WO 2022096003 A1 WO2022096003 A1 WO 2022096003A1
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WIPO (PCT)
Prior art keywords
detection
board
analyzer
detection switch
identification module
Prior art date
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PCT/CN2021/129361
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English (en)
French (fr)
Inventor
蔡政君
商涛
唐林勇
胡海斌
吉品岚
李龙强
余素云
Original Assignee
利多(香港)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 利多(香港)有限公司 filed Critical 利多(香港)有限公司
Priority to EP21888695.0A priority Critical patent/EP4242913A1/en
Priority to US18/036,054 priority patent/US20230408307A1/en
Publication of WO2022096003A1 publication Critical patent/WO2022096003A1/zh

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01DMEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
    • G01D11/00Component parts of measuring arrangements not specially adapted for a specific variable
    • G01D11/24Housings ; Casings for instruments
    • G01D11/245Housings for sensors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48771Coding of information, e.g. calibration data, lot number
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F18/00Pattern recognition
    • G06F18/20Analysing
    • G06F18/285Selection of pattern recognition techniques, e.g. of classifiers in a multi-classifier system
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F18/00Pattern recognition
    • G06F18/20Analysing
    • G06F18/24Classification techniques
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F2218/00Aspects of pattern recognition specially adapted for signal processing
    • G06F2218/08Feature extraction
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F2218/00Aspects of pattern recognition specially adapted for signal processing
    • G06F2218/12Classification; Matching

Definitions

  • the invention relates to a detection device for measuring clinical physiological indexes, especially a detection device for rapidly measuring biochemical indexes, an analyzer for reading identification information, and a method for identifying the type of detection plate.
  • POCT point-of-care testing
  • test strips for human chorionic gonadotropin (HCG), luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are used to determine hormone levels.
  • This type of detection test paper generally includes a support pad, on which a sample application pad, a marking pad, a detection pad and a water absorption pad are sequentially arranged from upstream to downstream, and they are superimposed on each other.
  • the urine dripped on the sample loading pad flows through the sample loading pad, the labeling pad, the detection pad and the water absorption pad in sequence, and the hormone in the sample is fixed in this area by the conjugate on the detection pad.
  • the color depth of the detection pad in the detection test paper is linearly related to the concentration of the sample to be detected, so as to determine the level of the corresponding hormone in the sample.
  • hormone levels there are also drug detection, allergen analysis, HBV, HCV, HIV, malaria, dengue, influenza, MERS, SARS and 2019-nCoV and other infectious virus detection strips.
  • HBV, HCV, HIV, malaria, dengue, influenza, MERS, SARS and 2019-nCoV and other infectious virus detection strips With the improvement of people's living standards and the emphasis on their own health management, the detection of blood glucose, uric acid, blood ketones, cholesterol, lactic acid and other indicators in the blood is also increasing, corresponding to electrochemical methods, photochemical methods, etc.
  • Test strips suitable for instant detection For the instant detection of urine routine, a variety of combination methods have emerged, such as urine quadruple test strips, urine eleven test strips, and urine fourteen test strips.
  • the test strip can be directly used for detection, or the test strip can be assembled in a casing.
  • the detection result can be obtained by visual observation or read by an electronic device.
  • people can distinguish the detection items by the markers provided on the detection test strips or the outer casings of the detection test strips.
  • one item of test strips is usually used to correspond to a specific instrument. For example, a woman needs to know her HCG, LH or FSH hormone levels at home, not only to prepare HCG, LH and FSH test strips, but also to equip HCG detector, LH detector and FSH detector at home accordingly.
  • test item selection module on the tester, and the tester needs to manually select the test item corresponding to the test paper; although this method realizes "multiple uses for one machine", because the tester is added to manually select the test items. Therefore, the complexity of the operation is increased, as well as the misjudgment of the detection result caused by the manual misoperation.
  • the present invention provides a simple and effective detection board with identification information.
  • the type of the detection board with identification information is easy to be identified and detected by an analyzer used to detect the detection board.
  • the board type is detected when the type is identified, so as to realize the multi-purpose function of one machine.
  • the identification information of the detection board with identification information is also easy to be observed manually, and can be used for secondary inspection to prevent fools.
  • One of the objectives of the present invention is to provide a simple and effective detection board with identification information, including an upper board and a lower board, the upper board and the lower board are assembled together to form a shell of the detection board, and an identification detection board is provided on the shell
  • Types of identification modules that include a recessed portion, or a non-recessed portion, or a combination of recessed and non-recessed portions.
  • At least two identification modules are included, and the identification modules are respectively arranged at different positions of the detection board.
  • the identification module is arranged at the front end or side of the housing of the detection board; or the identification module is arranged at the front and side of the housing at the same time.
  • one identification module is set as a recessed part, and the other identification module is set as a non-recessed part; or both identification modules are set with a recessed part; or both identification modules are set as a non-recessed part .
  • one identification module is located at the upper right corner of the front end of the upper plate and is set as a recessed part, and the other identification module is located at the upper left corner of the front end of the upper plate and is set as a non-depressed part; It is set as a non-recessed part, and another identification module is located at the upper left corner of the front end of the upper board and is set as a recessed part.
  • the identification module includes at least one non-recessed portion and one recessed portion, wherein the non-recessed portion contacts the detection switch of the analyzer earlier than the recessed portion.
  • the identification module is used to trigger the detection switch in the analyzer to identify the type of the detection board.
  • the detection board type is identified by the recessed portion not triggering the detection switch and/or the non-recessed portion triggering the detection switch.
  • an identification module on the detection board corresponds to a detection switch on the analyzer.
  • a detection test paper is provided between the upper board and the lower board of the detection board.
  • test strips can use photochemical methods, electrochemical methods and other suitable detection methods for point-of-care testing requirements for the determination of hormone levels, drugs, allergens, physiological indicators in urine, HBV, HCV, HIV, malaria, dengue fever, Influenza, Middle East Respiratory Syndrome, SARS and 2019-nCoV, blood sugar, uric acid, blood ketones, cholesterol, lactic acid, etc.
  • the present invention also provides another analyzer for reading the identification information of the detection board of the present invention, which includes an upper cover, a lower cover and a detection board insertion opening, and a circuit board assembled between the upper and lower covers is used to identify the detection board
  • a test switch of the type is mounted on the circuit board; the position of the test switch in the analyzer corresponds to the position of the identification module inserted into the test board of the analyzer.
  • triggering the detection switch in the analyzer through the non-recessed part of the identification module of the detection board enables the analyzer to turn on and identify the type of the detection board.
  • the detection board type is identified by the recessed portion not triggering the detection switch and/or the non-recessed portion triggering the detection switch.
  • the non-recessed part of the detection board recognition module will touch the button of the detection switch, and the button will be pressed down to trigger the detection switch; the recessed part of the detection board recognition module will not touch the detection switch. Detect keystrokes of switches.
  • the circuit board includes two detection switches, and the two detection switches are in one-to-one correspondence with the two identification modules of the detection board.
  • the surface of the key of the detection switch facing the detection board is a slope structure.
  • the detection switch also has the function of turning on the analyzer.
  • the circuit board is fixed in the analyzer through the base, and a through hole is provided on the base at the position relative to the detection switch. After the circuit board is assembled on the base, the button of the detection switch passes through the through hole of the base. .
  • the present invention also provides a method for identifying the type of the detection board.
  • the detection switch of the analyzer is triggered by the identification module on the detection board to generate a corresponding signal to identify the type of the detection board, thereby realizing the multi-purpose function of one machine and avoiding artificial Error rate. And easy to operate, easy to use.
  • the method for identifying the type of detection board includes a detection board and an analyzer
  • the detection board includes a casing formed by assembling an upper plate and a lower plate, an identification module is arranged on the outer casing
  • the analyzer includes an upper cover, a lower cover and a detection board inserted into port, a circuit board assembled between the upper and lower covers, and a detection switch installed on the circuit board for judging the type of detection board; wherein, according to whether the detection switch of the analyzer is triggered by the identification module, the analyzer generates and triggers or not. Trigger the corresponding signal to identify the detection board type.
  • the identification module is provided with a non-recessed part and/or a recessed part, and the analyzer can generate a signal corresponding to triggering or non-triggering to identify the detection board type by the recessed part not triggering the detection switch and/or the non-recessed part triggering the detection switch.
  • the analyzer when the detection switch is not pressed and turned on by the recessed part, the analyzer generates a signal 1; when the detection switch is pressed and turned on by the non-recessed part, the analyzer generates a falling signal 2; when the detection switch is first pressed by the non-recessed area to turn on , when the rear detection switch loses the pressing of the non-recessed part and closes, the analyzer generates a signal 3 that first rises and then falls.
  • the detection switch of the analyzer is triggered by the identification module to turn on the analyzer or wake up from the sleep state.
  • the analyzer is turned on or woken up from the sleep state at the same time.
  • the detection switch includes a first detection switch and a second detection switch.
  • the detection board includes two identification modules; the two identification modules correspond to the first detection switch and the second detection switch respectively; one identification module is located in the upper right corner of the front end of the upper plate and is set as a recessed part, and the other identification module is located on the upper plate.
  • the upper left corner of the front end of the board is set as a non-recessed part; alternatively, one identification module is located at the upper right corner of the front end of the upper board and is set as a non-recessed part, and the other recognition module is located at the upper left corner of the front end of the upper board and set as a recessed part.
  • the detection board into the analyzer, make the recessed or non-recessed part of the identification module move to the detection switch, detect that the first detection switch and/or the second detection switch are pressed, and the single-chip microcomputer of the analyzer detects the detection board.
  • the display detection board is the third type; or, when the first detection switch and the second detection switch are not pressed, the signal is 1, and the display detection board is the fourth type.
  • the single-chip microcomputer of the analyzer if the single-chip microcomputer of the analyzer is in a dormant state before the detection board is inserted into the analyzer, the signal triggered by the first or second detection switch will first wake up the single-chip microcomputer, and then the single-chip microcomputer analyzes the trigger signal of the detection switch to determine The detection type of the detection board; if the single-chip microcomputer is in the wake-up state before the detection board is inserted, the single-chip microcomputer will directly analyze the trigger signal of the detection switch to determine the detection type of the detection board.
  • another identification module including a non-recessed portion and a recessed portion, wherein the non-recessed portion contacts the detection switch of the analyzer earlier than the recessed portion; the analyzer is provided with a detection switch corresponding to the identification module switch; when the detection board is advancing in the analyzer, when the detection switch is pressed first and then closed, a signal 3 that first falls and then rises is issued, indicating that the detection board is of another type.
  • the beneficial effects of the present invention are: through the cooperation between the identification module arranged on the detection board and the detection switch on the analyzer, the analyzer can automatically identify the type of the detection board being used without the need for the user to select the type of the detection board, thereby realizing the multi-purpose function of one machine. .
  • the user operation steps are reduced in the detection process, which can reduce the human error operation rate, and is easy to operate and easy to use.
  • the invention can also utilize a switch system to realize the identification of different detection board types and realize the wake-up function of the analyzer at the same time.
  • the cost of hardware resources is significantly reduced, and a better user experience is brought to the user.
  • the identification module set on the detection board of the present invention can not only cooperate with the analyzer to realize the multi-purpose function of one machine, but also can manually identify the identification module on the detection board to identify the corresponding detection board type, so as to realize the secondary defense. to ensure accurate acquisition of test results.
  • Fig. 1 is a schematic diagram of the detection strip with a cover of the present invention.
  • FIG. 2 is a schematic diagram of a detection board without a cover of the present invention.
  • FIG. 3 is an exploded schematic view of the detection board of FIG. 2 according to the present invention.
  • FIG. 4 is a schematic diagram showing that the identification module of the detection board does not include a concave portion.
  • FIG. 5 is a schematic diagram showing that the identification module of the detection board includes a right concave portion.
  • FIG. 6 is a schematic diagram of the identification module of the detection board including the left concave part.
  • Figure 7 is a schematic front view of the analyzer used with the detection board.
  • FIG. 8 is an exploded schematic view of the analyzer shown in FIG. 7 .
  • FIG. 9 is a schematic diagram of the circuit board of the analyzer and the cooperation between the detection switch on the circuit board and the substrate.
  • FIG. 10 is a schematic view of the detection board of the present invention located in the substrate slot.
  • FIG. 11 is a schematic diagram of the corresponding relationship between the detection switch of the circuit board and the identification module on the detection board.
  • FIG. 12 is a schematic diagram showing that after the detection board is inserted into the analyzer, the button of the first detection switch is not pressed by the recognition module, and the button of the second detection switch is pressed by the recognition module.
  • FIG. 13 is an enlarged view of A in FIG. 12 .
  • FIG. 14 is a cross-sectional view of the key of the first detection switch in FIG. 12 when the key is not pressed by the identification module.
  • FIG. 15 is an enlarged view of B in FIG. 14 .
  • FIG. 16 is a schematic cross-sectional view of the combination of the detection board and the analyzer in FIG. 12 .
  • FIG. 17 is an enlarged view of C in FIG. 16 .
  • FIG. 18 is a schematic front view of the identification module disposed on the side of the detection board without a recess, the button of the detection switch is located on the side of the detection switch, and the identification module presses the button of the detection switch.
  • FIG. 19 is a schematic view of FIG. 18 from another angle.
  • the identification module is arranged on the side of the detection board, and one side includes a concave portion, the button of the detection switch is located on the side of the detection switch, and the front schematic diagram of the identification module and the button of the detection switch cooperate.
  • FIG. 21 is a schematic view of FIG. 19 from another angle.
  • Figure 22 is a schematic diagram of the switch detection circuit.
  • Figure 23 The flow chart of the analyzer to determine the type of test board.
  • FIG. 24 is another design schematic diagram of the identification module of the detection board of the present invention.
  • FIG. 25 is another design schematic diagram of the identification module of the detection board of the present invention.
  • Figure 26 is a signal generated by the detection board identification module of the present invention in cooperation with the detection switch.
  • Signal 1 is the signal state of detecting that the switch button has not been pressed;
  • Signal 2 is the signal state of detecting that the switch button is pressed;
  • Signal 3 is the signal state of detecting that the switch button is pressed first and then reset (bounced up).
  • FIG. 27 is a schematic diagram of the detection board including only one identification module, and the identification module is a concave portion.
  • FIG. 28 is a schematic diagram of the detection board including only one identification module, and the identification module is a non-recessed part.
  • the test board 1 shown in Figures 1 to 6 includes an upper board 11, a lower board 12, a test paper 13 assembled between the upper and lower boards, a test result reading window 14, and an identification module 15 indicating the type of the test board, the identification module 15 Used to trigger the test switch in the analyzer 20 to identify the test board type. Specifically, the identification module 15 determines the detection board type by whether there is a recessed portion and the position of the recessed portion; that is, the detection board type is identified by the recessed portion not triggering the detection switch and/or the non-recessed portion triggering the detection switch.
  • the test paper 13 includes a support pad 131 on which a sample application pad 132, a marking pad 133, a detection pad 134 and a water absorption pad 135 are sequentially arranged from upstream to downstream, and they are superimposed on each other. After the liquid sample is loaded on the sample pad, the sample flows through the sample pad, marker pad, detection pad and absorbent pad in sequence.
  • the test strip is installed between the upper plate and the lower plate, and a part of the sample pad is located outside the upper and lower plates for receiving the liquid sample.
  • the test plate may also include a cover 16 for covering and protecting the exposed sample loading pad.
  • the identification module includes a recessed portion, or a non-recessed portion, or a combination of recessed and non-recessed portions.
  • the type of the detection board is identified by the design quantity and design combination of the recessed and non-recessed parts in the identification module, so as to achieve the purpose of identifying the detection type of the detection board.
  • the identification module is provided with at least one recess and/or at least one non-recess.
  • the identification modules are all non-recessed parts, that is, the identification modules are all one or more non-recessed parts; second, the identification modules are all non-recessed parts; Both are recessed parts, that is, the identification modules are all one or more recessed parts; thirdly, the identification module includes both recessed parts and non-recessed parts, the recessed area and the non-recessed area are one or more and so on.
  • the number of identification modules may be one, or at least two, such as two, three, four and so on.
  • the identification module is located on the detection board, especially on the casing of the detection board, that is, on the casing formed by the cover of the upper board and the lower board.
  • the identification module is arranged on the front or side of the detection board housing, and can also be arranged on both the front and the side.
  • the front end described here includes the upper and lower surfaces of the front end portion of the housing, as well as the portion protruding from the front end portion of the housing.
  • identification modules there are various combinations of identification modules, including but not limited to: 1. Including two identification modules, which are respectively arranged at different positions of the detection board; for example, two identification modules are arranged at the front end of the upper plate or two side wall; one of the identification modules is provided with a recessed portion, and the other identification module is provided with a non-recessed portion; or both identification modules are provided with a recessed portion; or both identification modules are provided with a non-recessed portion. 2.
  • It includes two identification modules, one identification module is located at the upper right corner of the front end of the upper plate and is set as a recessed part, and the other identification module is located at the upper left corner of the front end of the upper plate and is set as a non-depressed part; or, one identification module is located at the upper plate
  • the upper right corner of the front end of the upper plate is set as a non-recessed part
  • the other identification module is located at the upper left corner of the front end of the upper board and is set as a recessed part.
  • 3. include one or more identification modules, wherein one identification module includes at least one non-recessed portion and a recessed portion, wherein the non-recessed portion is closer to the front end of the detection board than the recessed portion, and the non-recessed portion is closer than the other.
  • the recessed portion makes contact with the analyzer's detection switch earlier.
  • It includes four identification modules, which are respectively arranged at the front and both sides of the detection board.
  • the detection board includes an identification module 15 located at the front end of the upper plate 11, and the identification module has the following two setting modes: the first mode is that the front end of the upper plate is not provided with a depression, That is, the identification modules are all non-recessed parts 151 , as shown in FIG. 28 ; in the second mode, the front end of the upper plate is all set to one recessed part 152 , as shown in FIG. 27 .
  • the detection board as shown in FIGS. 4 to 6 includes two identification modules 15 located at the front end of the upper board 11 , and the two identification modules have the following three setting modes: the first mode is that the front end of the upper board is not Set the recessed part, that is, the two identification modules are both non-recessed parts, as shown in Figure 4; the second mode is that there is a recessed part in the upper right corner of the upper board (the first identification module), and there is no recessed part in the upper left corner (the second identification module).
  • the third mode is that there is no depression in the upper right corner of the upper plate (the first identification module), and there is a depression in the upper left corner (the second identification module) shown in Figure 6; among them, the second type
  • the mode and the third mode are the setting manners in which the positional relationship between the recessed portion and the non-recessed portion is changed when the identification module is provided with one recessed portion and one non-recessed portion.
  • the analyzer 20 used in conjunction with the detection board includes an upper cover 21 , a lower cover 22 , a circuit board 23 assembled between the upper and lower covers, and the circuit board 23 is fixed in the analyzer through a base 24 , the upper cover and the lower cover are assembled together to form the casing of the analyzer, and a detection board insertion port 28 is formed at the front end.
  • the other side of the base 24 opposite to the circuit board is provided with a slot 25 into which the detection board is inserted.
  • the detection switch 26 for judging the type of the detection board is installed on the circuit board, and the base 24 is provided with a through hole 241 at the position relative to the detection switch.
  • the detection switch 26 installed on the circuit board is The key 27 of the 100 extends into the slot 25 through the through hole 241 .
  • the identification module 15 of the detection board is located on the button 27 of the detection switch 26 .
  • the non-recessed portion detection board shell will touch the button 27 of the detection switch, and press the button to trigger the detection switch 26 to turn on; if the identification module is relative to the detection switch If it is set as a concave part, the detection board shell of the concave part will not touch the button of the detection switch, and the button will not trigger the switch to be turned on because the button is pressed down by the detection board.
  • the shape of the key 27 can be set as a slope shape, a hemisphere, a rectangular parallelepiped, a cube, or the like.
  • the side of the button facing the detection board has a slope structure, which is more conducive to pushing and pressing the button after the detection board is pushed into the slot and contacts the button.
  • the analyzer 20 can be individually set with a power-on switch.
  • the detection board type detection switch 26 may also have the function of turning on the analyzer. Trigger the detection switch 26 in the analyzer through the non-recessed part of the identification module 15 of the detection board to turn on the analyzer and identify the type of the detection board. That is, when the detection switch 26 is triggered, the analyzer 20 is turned on, and at the same time, the activated analyzer 20 can determine the type of the detection board according to the triggering of the detection switch.
  • the analyzer 20 may also include a test board ejection assembly including an ejection connection block 291 and an ejection button 292 mounted within the analyzer housing.
  • an identification module on the detection board corresponds to a detection switch on the analyzer.
  • two identification modules are set on the detection board, and correspondingly, two detection switches are set on the analyzer, and the positions of the two correspond one by one.
  • the following is an example of using the identification module 15 provided with different modes on the detection board to distinguish the hCG detection board, the FSH detection board and the LH detection board, for further specific description.
  • a test strip for analyzing the content of hCG in urine is stored in the test plate.
  • the identification module 15 of the detection board is not provided with a recessed portion relative to the key 27 of the analyzer detection switch 26 , that is, the identification modules at the front end of the upper plate are all non-recessed portions 151 .
  • the non-recessed portion is a portion of the upper surface of the upper plate 11 extending horizontally to the front end of the upper plate.
  • a test strip for analyzing the LH content in urine is stored in the test plate.
  • a right concave portion 152 (the first identification module) is provided at the position of the identification module 15 of the detection board relative to the button 271 of the first detection switch 261 of the analyzer, that is, a structure is provided with a depression in the upper right corner of the front end of the upper plate;
  • the identification module 15 is not provided with a recessed portion relative to the key 272 of the second detection switch 262 of the analyzer, that is, a non-recessed portion 151 (second identification module) is set at the upper left corner of the front end of the upper plate.
  • test strips for analyzing the FSH content in urine are stored in the detection plate.
  • the identification module 15 of the detection board is provided with a left concave portion 153 at the key position of the second detection switch of the analyzer, that is, a left concave structure is provided in the upper left corner of the front end of the upper plate.
  • the key position of the detection switch is not provided with a recessed portion, that is, a non-recessed portion 151 is provided at the upper right corner of the front end of the upper plate.
  • the depth setting of the recessed portion at least ensures that the bottom of the recessed portion does not touch the detection switch button.
  • the type of the detection board can be determined by whether the detection switch of the analyzer is pressed by the identification module of the detection board.
  • the analyzer and the detection board type detection switch are described in detail below.
  • the tester can also judge the type of the test board currently used by directly observing the test board identification module instead of the analyzer.
  • the test board can be directly observed and judged by the tester.
  • the position of the recessed or non-recessed part on the detection board identification module on the test board may not correspond to the analyzer test switch.
  • the detection board is judged to be the HCG detection board; or when it is detected or observed that the detection board recognition module has only one right recessed part, then It is judged that the detection board is an LH detection board; or when it is detected or observed that the detection board identification module has only one left concave portion, the detection board is judged to be an FSH detection board; or when it is detected or observed that the detection board identification module has both
  • the right concave portion is also provided with a left concave portion, and the detection plate is judged to be an E2 (estradiol) detection plate.
  • Those skilled in the art can set different numbers of identification modules on the detection board, set different numbers of depressions on the identification modules, and set the positions of the modules and depressions on the detection board according to the number of relevant detection items; Correspondingly, a constant number of detection switches are set corresponding to the corresponding positions on the analyzer to correspond to the identification modules.
  • the corresponding relationship between the identification module and the detection category can also be completed by the number of recessed parts, the position of the recessed part, or the arrangement and combination between the number of recessed parts and the location of the recessed part.
  • the recesses can be designed as other structures with similar functions, such as notches.
  • FIGS. 11 to 17 two detection switches are arranged side by side on the circuit board of the analyzer, namely a first detection switch 261 and a second detection switch 262 .
  • the example diagrams of FIGS. 11 and 12 omit the mounting member for mounting the circuit board on the analyzer housing. For example, these diagrams are omitted. Pedestal not shown.
  • the detection board with missing right is inserted into the analyzer, the position of the identification module relative to the analyzer is a right concave portion 152 (the first identification module), and the bottom wall of the concave portion will not touch the first button 271.
  • the first button 271 When the detection board is inserted into the analyzer, the first button 271 will not be pressed down, so the first detection switch 261 cannot be triggered by the first button to turn on, so the signal from the first detection switch 261 to the microcontroller is always high. level signal (Signal 1).
  • the position of the identification module relative to the second button 272 of the second detection switch 262 of the analyzer is the non-recessed portion 151 (the second identification module), and the wall of the non-recessed portion will touch the second button 272.
  • the second button 272 in the middle will be pressed down by the non-recessed part, so the second detection switch 262 will be triggered by the second button 272 to change the pin of the single-chip microcomputer connected to it from high level to low level, resulting in A falling edge of the signal (Signal 2).
  • the analyzer obtains the unchanged first detection switch 261 and the falling edge signal of the second detection switch 262, it can determine that the inserted detection board is the LH detection board.
  • the detection board type identification module 15 can also be arranged on the side of the detection board, and the type of the detection board can be judged by whether there is a concave portion on the side wall and the position of the concave portion, for example, as shown in FIGS. 18 to 21 .
  • the setting mode of the concave part includes but is not limited to the two side walls of the detection board are not provided with a concave part; or one side wall of the detection board is provided with a concave part, and the other side wall is not provided with a concave part; or both side walls are provided with a concave part, etc. .
  • buttons of the detection switch are correspondingly installed on the inner side of the detection switch.
  • the first detection switch 261 and the second detection switch 262 will be triggered by pressing the switch button by the identification module of the detection board.
  • One side of the detection board identification module shown in FIG. 20 and FIG. 21 is provided with a concave portion 154, and the other side of the identification module is provided with a concave portion.
  • the first detection switch 261 will be pressed by the recognition module of the detection board to the switch button, and the second detection switch 262 will not be pressed by the recognition module of the detection board and will not be triggered.
  • Figure 22 and Figure 23 are the working principle of an analyzer of the present invention to identify the type of test board.
  • This circuit consists of two circuits: the first circuit includes resistor R1, capacitor C1, detection switch S1, VCC power supply terminal, signal ground and the P0.0 terminal of the microcontroller; the second circuit includes resistor R2, capacitor C2, detection switch S2 , VCC power supply terminal, signal ground and the P0.1 terminal of the microcontroller.
  • the detection switch S1 or S2 is not pressed by the button, the voltages of P0.0 and P0.1 of the single-chip microcomputer are consistent with the VCC voltage, and the detection switch provides a high-level signal (signal 1) that remains unchanged to the single-chip microcomputer.
  • the connected microcontrollers P0.0 and P0.1 When the detection switch S1 or S2 is pressed by the button, the connected microcontrollers P0.0 and P0.1 will be connected to the signal ground, and the voltages of P0.0 and P0.1 will be pulled down by the signal ground, from high to high. The level transitions to a low level, thereby generating a falling edge signal (signal 2) to the microcontroller.
  • the power source of the analyzer can be selected from button battery, alkaline battery, rechargeable lithium battery, solar battery, switching power supply and so on.
  • the analysis method for analyzing an analyte in a sample using the detection board and the analyzer of the present invention includes the following steps: inserting the detection board into the analyzer; at least one detection switch is triggered, and the triggered detection switch generates an external
  • the trigger signal is given to the microcontroller. After the microcontroller receives this trigger signal, it will generate an external interrupt to wake up the microcontroller.
  • the MCU that wakes up from sleep will give priority to the interrupt program triggered by the detection switch, and judge the type of test strip in the interrupt program. If the detection board pops out of the analyzer after the microcontroller wakes up, or the installation position of the detection board is incorrect or loose, the button is not pressed.
  • the detection switch will generate a rising edge signal to the single-chip microcomputer, thereby triggering the detection board position monitoring program of the single-chip microcomputer to inform the single-chip microcomputer that the position of the detection board is abnormal.
  • the single-chip microcomputer will monitor the pressing state of the switch, thereby judging whether the test strip is installed in place and whether other types of test strips have been replaced. Add the sample to the test paper; the analyzer invokes the corresponding algorithm to interpret the test result of the test paper according to the type of the test plate; the analyzer gives the test result.
  • Step 1 Take out the analyzer and test board, and insert the test board into the slot from the insertion port of the analyzer.
  • Step 2 With the insertion of the detection board, the non-recessed part of the detection board identification module will press the button of the detection switch S1 and/or S2, the detection switch whose button is pressed is triggered by the button, and the trigger information of the trigger switches S1 and S2 is transmitted. to the microcontroller.
  • the single-chip microcomputer When the detection board shown in Figure 4 is inserted, the first detection switch S1 and the second detection switch S2 on the circuit board are pressed together by the detection board, and the single-chip microcomputer receives the combination of signals that both S1 and S2 are triggered, and after signal analysis Afterwards, the single-chip microcomputer will determine that the detection board currently inserted in the analyzer is used to detect HCG.
  • the button 271 of the first detection switch S1 (261) on the circuit board is not pressed by the detection board
  • the button 272 of the second detection switch S2 is pressed by the detection board
  • the microcontroller After receiving the signal combination that S1 is not triggered and S2 is triggered, after signal analysis, the single-chip microcomputer will determine that the detection board currently inserted in the analyzer is used to detect LH.
  • the button of the first detection switch S1 on the circuit board is pressed by the detection board, the button of the detection switch S2 is not pressed by the detection board, and the microcontroller receives that S1 is triggered, but S2 is not triggered.
  • the single-chip microcomputer will determine that the detection board currently inserted in the analyzer is used to detect FSH.
  • Step 3 The analyzer starts the test program corresponding to the test board type.
  • Step 4 The test is over and the test result is displayed.
  • the signal triggered by the detection switch will first wake up the single-chip microcomputer, and then the single-chip microcomputer analyzes the trigger signal of the detection switch to determine the detection type of the detection board;
  • the single-chip microcomputer will directly analyze the trigger signal of the detection switch, thereby judging the detection type of the detection board.
  • An optional optional step is for the analyzer to display the assay type of the assay panel on the analyzer's display screen 30.
  • test board The different designs of the test board and the analyzer, some analysis systems have added samples to the test board before the test board is inserted into the analyzer, and other analysis systems are after the test board is inserted into the analyzer and the type of the test board is confirmed, and then to the test board. Add sample to the assay plate.
  • the identification module on the detection board needs to include a non-recessed part to generate signal 2, and the single-chip microcomputer can be woken up and turned on by the change of the signal drop of signal 2. If the identification modules on the test board are all concave parts, the switch of the analyzer cannot be pressed, so the analyzer cannot rely on the identification module alone to determine whether the test strip has been inserted and wake up, and the analyzer needs to add an additional power-on switch.
  • a non-recessed portion 151 and a recessed portion 154 are arranged in sequence on one identification module, and the non-recessed portion is compared with the recessed portion 154. earlier access to the detection switch.
  • the front end of the detection board identification module 15 will first press the button of the detection switch 26, and then the detection board will continue to be inserted until it is fully inserted, and the detection switch will be located in the position shown in FIG.
  • the detection switch 26 previously pressed by the non-recessed portion 151 will pop up again.
  • the analyzer During the whole insertion process, the analyzer generates a pulse signal that changes from high level to low level, and then from low level to high level, and transmits it to the single-chip microcomputer, as shown in Figure 26.
  • Signal 3. The analyzer detects the falling signal of signal 3, determines that the detection board has been inserted and wakes up the analyzer. Next, the analyzer detects the rising signal of signal 3, and the analyzer determines that the detection board has been inserted in place. At the same time, according to the signal 3, the analyzer first appears the falling signal, and then the rising signal, so as to determine the matching detection board type. For example, we can set up the detection plate shown in Figure 24 for drug detection.
  • the detection board shown in FIG. 25 includes two identification modules, wherein the first identification module includes a recessed portion 152 in the upper right corner, and the second identification module is sequentially provided with a non-recessed portion 151 and a recessed portion 154 in the upper left corner, and the non-recessed portion is located in the upper left corner. 151 contacts the detection switch earlier than the recessed portion 154 .
  • the first identification module that is, the upper right corner only includes a concave portion, so the detection switch will not be pressed, and the analyzer detects the detection switch in the first identification area and generates a signal for signal 1.
  • the analyzer detects that the second identification module, that is, the detection switches corresponding to the non-recessed portion 151 in the upper right corner and the other recessed portion 154 generate a signal of signal 3 .
  • the analyzer microcontroller detects these two groups of signals with differences, it determines the type of detection board that matches it. For example, we can set up the assay plate shown in Figure 25 for the analysis of estradiol.

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Abstract

一种具有识别信息的检测板和用于读取识别信息的分析仪及其识别方法。检测板包括上板和下板,上板和下板组装在一起形成检测板的外壳,在外壳上设有识别检测板类型的识别模块(15),识别模块(15)至少包括一个识别区,识别区上至少设有一个凹陷部(152)或一个非凹陷部(151)。通过设置在检测板上的识别模块(15)与分析仪上的检测开关配合,即通过分析仪的检测开关是否被识别模块(15)触发,分析仪产生与触发或不触发所对应的信号来识别检测板类型,无需用户选择检测板类型,分析仪可自动识别正在使用的检测板的类型。

Description

具有识别信息的检测板和用于读取识别信息的分析仪及其识别方法 技术领域
本发明涉及用于测定临床生理指标的检测装置,尤其是快速测定生化指标的检测装置及用于读取识别信息的分析仪和识别检测板类型的方法。
背景技术
目前,越来越多能实现现场采样并可立即获得检测结果的产品被研究和应用于临床,这类检测通常被称为即时检验(point-of-care testing,POCT)。
例如,用于判断激素水平的人绒毛膜促性腺激素(human chorionic gonadotropin,HCG)、促黄体生成激素(luteinizing hormone,LH)和促卵泡激素(follicle-stimulating hormone,FSH)的检测试纸。该类检测试纸一般包括支撑垫,在支撑垫上从上游到下游依次设置有加样垫、标记垫、检测垫和吸水垫,它们相互叠加在一起。滴加在加样垫上的尿液顺次流过加样垫、标记垫、检测垫和吸水垫,样品中的激素被检测垫上的结合物固定在该区域。检测试纸中检测垫显色的颜色深度与待检测样本的浓度线性相关,从而判断出样品中对应激素的水平。除了激素水平的测定外,还有毒品类检测、过敏原分析、HBV、HCV、HIV、疟疾、登革热、流感、中东呼吸综合征、SARS和2019-nCoV等传染性病毒检测试纸。随着人们生活水平的提高以及对自身健康管理的重视,针对血液中血糖、尿酸、血酮、胆固醇、乳酸等指标的检测也越来越多,对应的产生了以电化学方法、光化学方法等适合即时检测的检测试纸。对于尿常规的即时检测,出现了多种组合方式,比如尿四联试纸、尿十一联试纸、尿十四联试纸等。检测试纸可以直接用于检测,也可以将检测试纸装配在一个外壳中。
当检测试纸完成检测后,可以通过肉眼观察获知或通过电子设备来读取检测结果。对于肉眼观察的检测试纸,人们可以通过设于检测试纸或检测试纸外壳上的标示物来区分检测项目。利用仪器来判读结果,目前通常采用一个项目的检测试纸对应一种特定的仪器设备。例如一位女性需要在家中了解自己的HCG、LH或FSH激素水平,不仅要准备HCG、LH和FSH检测试纸,还要相应的在家中配备HCG检测仪、LH检测仪和FSH检测仪。这不仅会造成检测硬件资源的浪费,也会让检测过程变得繁琐,因为需要检测者确保正在使用的检测试纸和准备测量的检测仪是相互对应的。目前,有些厂家将HCG、LG和FSH的检测整合在一个检测试纸上,并用一个检测仪完成结果判读。然而,这种“一纸多用”的方式虽然可以简化检测者的操作过程,但当测试者仅需检测其中一个或两个检测项目时,这就会增加测试者的成本;并且,在检测试纸上可以整合检测的项目数量有限,因此“一纸多用”并不适用数量较多的检测结果获取。还有些厂家在检测仪上预设了检测项目选择模块,需测试者通过手动选择与检测试纸相应的测试项目;虽然该方法实现了“一机多用”,但因为增设了测试者人为选择检测项目的步骤,从而增加了操作的繁琐度,以及人工误操作带来检测结果的误判等问题。
为此,非常需要一种改进方案,以简化检测操作过程,让“一机多用”更便捷。
发明内容
为了改进现有技术中存在的不足之处,本发明提供了一种简单有效的具有识别信息的检测板,该具有识别信息的检测板类型易于被用于检测该检测板的分析仪识别出检测板类型,在识别类型时进行检测,从而实现一机多用的功能。该具有识别信息的检测板的识别信息还易于被人工观察,可用于二次检查来防呆。
本发明的目的之一在于提供了一种简单有效的具有识别信息的检测板,包括上板和下板,上板和下板组装在一起形成检测板的外壳,在外壳上设有识别检测板类型的识别模块,识别模块包括凹陷部,或非凹陷部,或凹陷部和非凹陷部的组合。
优选的,至少包括两个识别模块,所述识别模块分别设置在检测板的不同位置。
进一步的,识别模块设置在检测板外壳的前端或侧边;或者识别模块同时设置在外壳的前 端和侧边。
进一步的,两个识别模块中,一个识别模块设置为一个凹陷部,另一个识别模块设置为一个非凹陷部;或者两个识别模块均设置凹陷部;或者两个识别模块均设置为非凹陷部。
进一步的,一个识别模块位于上板的前端右上角并设为凹陷部,另一个识别模块位于上板的前端左上角并设为非凹陷部;或者,一个识别模块位于上板的前端右上角并设为非凹陷部,另一个识别模块位于上板的前端左上角并设为凹陷部。
进一步的,识别模块至少包括一个非凹陷部和一个凹陷部,其中,非凹陷部比凹陷部更早地接触到分析仪的检测开关。
进一步的,所述识别模块用于触发分析仪中的检测开关来识别检测板类型。
进一步的,通过凹陷部不触发检测开关和/或非凹陷部触发检测开关来识别检测板类型。
进一步的,检测板上的一个识别模块对应分析仪上的一个检测开关。
进一步的,在检测板的上板和下板之间设有检测试纸。
检测试纸可以采用光化学方法、电化学方法等合适即时检验要求的各类检测方法,用于测定激素水平、毒品类、过敏原、尿液中的生理指标、HBV、HCV、HIV、疟疾、登革热、流感、中东呼吸综合征、SARS和2019-nCoV、血糖、尿酸、血酮、胆固醇、乳酸等。
本发明还提供另一种用于读取本发明所述检测板识别信息的分析仪,包括上盖、下盖和检测板插入口,装配在上下盖之间的电路板,用于判别检测板类型的检测开关安装在电路板上;所述分析仪中的检测开关位置与插入到分析仪的检测板的识别模块位置相对应。
进一步的,通过检测板的识别模块的非凹陷部触发分析仪中的检测开关使分析仪开机并识别检测板类型。更进一步的,通过凹陷部不触发检测开关和/或非凹陷部触发检测开关来识别检测板类型。
进一步的,当检测板插入至分析仪内,检测板识别模块的非凹陷部会触碰到检测开关的按键,并将按键下压从而触发检测开关;检测板识别模块的凹陷部不会触碰到检测开关的按键。
优选的,电路板上包括两个检测开关,所述两个检测开关分别与检测板的两个识别模块一一对应。
优选的,检测开关的按键朝向检测板的面为一坡面结构。
进一步的,检测开关还具有分析仪开机功能。
进一步的,电路板经基座固定于分析仪内,基座上相对检测开关的位置处设有贯穿孔,电路板装配到基座上后,所述检测开关的按键穿过基座的贯穿孔。
另一方面,本发明还提供识别检测板类型的方法,通过检测板上的识别模块触发分析仪的检测开关产生相应的信号来识别检测板的类型,从而实现一机多用的功能,避免人为的误操作率。且易于操作,使用方便。
本发明提供的识别检测板类型的方法,包括检测板和分析仪,检测板包括上板和下板组装形成的外壳,外壳上设有识别模块,分析仪包括上盖、下盖和检测板插入口,装配在上下盖之间的电路板,以及安装在电路板上的用于判别检测板类型的检测开关;其中,通过分析仪的检测开关是否被识别模块触发,分析仪产生与触发或不触发所对应的信号来识别检测板类型。
进一步的,识别模块设置非凹陷部和/或凹陷部,通过凹陷部不触发检测开关和/或非凹陷部触发检测开关使分析仪产生与触发或不触发所对应的信号来识别检测板类型。
进一步的,当检测开关不被凹陷部按压开启时,分析仪产生信号1;当检测开关被非凹陷部按压开启时,分析仪产生一个下降的信号2;当检测开关先被非凹陷区按压开启,后检测开关在失去非凹陷部的按压而关闭时,分析仪产生一个先上升后下降的信号3。
进一步的,通过分析仪的检测开关被识别模块触发使分析仪开机或从休眠状态唤醒。
进一步的,检测开关被非凹陷部按压开启时,同时使分析仪开机或从休眠状态唤醒。
进一步的,检测开关包括第一检测开关和第二检测开关。
进一步的,检测板包括两个识别模块;两个识别模块分别与第一检测开关和第二检测开关对应;一个识别模块位于上板的前端右上角并设为凹陷部,另一个识别模块位于上板的前端左 上角并设为非凹陷部;或者,一个识别模块位于上板的前端右上角并设为非凹陷部,另一个识别模块位于上板的前端左上角并设为凹陷部。
进一步的,将检测板插入分析仪,使识别模块的凹陷部或非凹陷部行进至检测开关处,检测到第一检测开关和/或第二检测开关被按下,分析仪的单片机检测检测板类型;当第一检测开关和第二检测开关都被按下,发出两个下降的信号2,显示检测板为第一种类型;或者,当第一检测开关被按下而第二检测开关未被按下,发出第一种下降的信号2,显示检测板为第二种类型;或者,当第一检测开关未被按下而第二检测开关被按下,发出第二种下降的信号2,显示检测板为第三种类型;或者,当第一检测开关和第二检测开关都未被按下,为信号1,显示检测板为第四种类型。
进一步的,若检测板插入分析仪前,分析仪的单片机处于休眠状态,则第一或第二检测开关被触发的信号会先将单片机唤醒,然后单片机对检测开关的触发信号进行分析,从而判别检测板的检测类型;若在检测板插入前,单片机已处于唤醒状态,则单片机会直接对检测开关的触发信号进行分析,从而判别检测板的检测类型。
进一步的,包括另一识别模块,包括一个非凹陷部和一个凹陷部,其中非凹陷部相比凹陷部更早地接触到分析仪的检测开关;分析仪上设有与该识别模块对应的检测开关;检测板在分析仪中前进时,当该检测开关先被按下后再被关闭,发出先下降后上升的信号3,显示检测板为另一类型。
本发明的有益效果是:通过设置在检测板上的识别模块与分析仪上的检测开关配合,无需用户选择检测板类型,分析仪可自动识别正在使用的检测板的类型,实现一机多用功能。在检测过程中减少用户操作步骤,可以降低人为的误操作率且易于操作,使用方便。同时本发明还可利用一种开关系统,同时实现不同检测板类型的识别,以及实现分析仪唤醒功能。从而显著降低了硬件资源的成本,给用户带来更好的使用体验。同时,本发明的检测板上设置的识别模块,除了可以与分析仪配合实现一机多用功能,还可以通过人工来识别在检测板上的识别模块来识别对应的检测板类型,实现二次防呆,保证检测结果的准确获取。
附图说明
图1是本发明带盖子的检测板带示意图。
图2是本发明未带盖子的检测板示意图。
图3是本发明图2检测板的分解示意图。
图4是检测板的识别模块不包含凹陷部的示意图。
图5是检测板的识别模块包含右凹陷部的示意图。
图6是检测板的识别模块包含左凹陷部的示意图。
图7是与检测板配套使用的分析仪正面示意图。
图8是图7所示分析仪的分解示意图。
图9是分析仪的电路板及电路板上的检测开关与基板配合的示意图。
图10是本发明所述检测板位于基板插槽内的示意图。
图11是电路板的检测开关与检测板上的识别模块对应关系的示意图。
图12是检测板插入分析仪后,第一检测开关的按键未被识别模块按下,第二检测开关的按键被识别模块按下的示意图。
图13是图12中A处的放大图。
图14是图12中第一检测开关的按键未被识别模块按下的剖视图。
图15是图14中B处的放大图。
图16是图12中检测板和分析仪配合的一个剖面示意图。
图17是图16中C出的放大图。
图18是识别模块设置在检测板的侧边且不包含凹陷部,检测开关的按键位于检测开关侧边,识别模块按下检测开关按键的正面示意图。
图19是图18另一个角度的示意图。
图20识别模块设置在检测板的侧边,且一侧边包含凹陷部,检测开关的按键位于检测开关侧边,识别模块和检测开关按键配合的正面示意图。
图21是图19另一个角度的示意图。
图22开关检测电路原理图。
图23分析仪判断检测板类型的流程图。
图24是本发明检测板的识别模块的另一种设计示意图。
图25是本发明检测板的识别模块的另一种设计示意图。
图26是本发明检测板识别模块与检测开关配合产生的信号。信号1是检测开关按键一直没有被按下的信号状态;信号2是检测开关按键被按下的信号状态;信号3是检测开关按键先被按下后又复位(弹起)的信号状态。
图27是检测板的仅包括一个识别模块,识别模块为一个凹陷部的示意图。
图28是检测板的仅包括一个识别模块,识别模块为一个非凹陷部的示意图。
具体实施方式
下面结合具体附图对本发明进行详细的说明。这些具体的实施例仅仅是在不违背本发明精神下的有限列举,并不排除本领域的一般技术人员把现有技术和本发明结合而产生的其他具体的实施方案。
如图1至6所示的检测板1,包括上板11、下板12、装配在上下板之间的试纸13、测试结果阅读窗14,以及指示检测板类型的识别模块15,识别模块15用于触发分析仪20中的检测开关来识别检测板类型。具体的,该识别模块15通过是否存在凹陷部以及凹陷部的位置来判断检测板类型;即通过凹陷部不触发检测开关和/或非凹陷部触发检测开关来识别检测板类型。试纸13包括支撑垫131,在支撑垫上从上游到下游依次设置有加样垫132、标记垫133、检测垫134和吸水垫135,它们相互叠加在一起。液体样本加在加样垫上后,样本顺次流过加样垫、标记垫、检测垫和吸水垫。试纸安装在上板和下板之间,加样垫的一部分位于上下板之外用于接收液体样本。检测板还可包括盖子16用于遮盖和保护裸露在外的加样垫。
识别模块包括凹陷部,或非凹陷部,或凹陷部和非凹陷部的组合。通过识别模块中的凹陷部和非凹陷部的设计数量和设计组合来对检测板的类型进行标识,进而达到识别检测板的检测类型的目的。识别模块设置至少设有一个凹陷部和/或至少设有一个非凹陷部。
识别模块内的凹陷部和非凹陷部有多种设置方式,包括但不限于:第一,识别模块均为非凹陷部,即识别模块均为一个或多个非凹陷部;第二,识别模块均为凹陷部,也即识别模块均为一个或多个凹陷部;第三,识别模块既包括凹陷部也包括非凹陷部,凹陷区和非凹陷区为一个及以上等等。
识别模块可以为一个,也可以为至少两个,比如两个,三个,四个等等。识别模块位于检测板上,特别是位于检测板的外壳上,也即位于上板和下板盖合形成的外壳上。识别模块被设置在检测板外壳的前端或侧边,也可以同时设置在前端和侧边。这里所描述的前端包括外壳的前端部上表面和下表面,也包括突出于外壳前端部的部分。
识别模块的组合方式有多种,包括但不限于:1.包括两个识别模块,所述识别模块分别设置在检测板的不同位置;比如,两个识别模块设置在上板的前端或者两个侧壁;其中一个识别模块上设置为一个凹陷部,另一个识别模块上设置为一个非凹陷部;或者两个识别模块均设置凹陷部;或者两个识别模块均设置为非凹陷部。2.包括两个识别模块,一个识别模块位于上板的前端右上角并设为凹陷部,另一个识别模块位于上板的前端左上角并设为非凹陷部;或者,一个识别模块位于上板的前端右上角并设为非凹陷部,另一个识别模块位于上板的前端左上角并设为凹陷部。3.包括一个或多个识别模块,其中,一个识别模块至少包括一个非凹陷部和凹陷部,其中所述非凹陷部相比凹陷部更靠近检测板的前端,以及非凹陷部相比另一凹陷部更早地接触到分析仪的检测开关。4.包括四个识别模块,分别设置在检测板的前端和两侧。
在一个设计方案中,如图27和图28所示,检测板包括位于上板11前端的识别模块15,识别模块有以下两种设置模式:第一种模式为上板前端未设凹陷部,即识别模块均为非凹陷部151,图28所示;第二种模式为上板前端全部设为一个凹陷部152,如图27所示。
在另一个设计方案中,如图4至6所示的检测板包括位于上板11前端的两个识别模块15,两个识别模块有以下三种设置模式:第一种模式为上板前端未设凹陷部,即两个识别模块均为非凹陷部,图4所示;第二种模式为上板的右上角有一个凹陷部(第一识别模块),左上角没有凹陷部(第二识别模块),图5所示;第三种模式为上板的右上角没有凹陷部(第一识别模块),左上角有一个凹陷部(第二识别模块)图6所示;其中,第二种模式和第三种模式为识别模块设置一个凹陷部和一个非凹陷部的情况下,凹陷部与非凹陷部位置关系改变的设置方式。
与检测板配合使用的分析仪20,如图7至10所示,包括上盖21、下盖22,装配在上下盖之间的电路板23,电路板23经基座24固定于分析仪内,上盖和下盖组装在一起成为分析仪的外壳,在前端形成检测板插入口28。基座24相对于电路板安装的另一面设有供检测板插入的插槽25。用于判别检测板类型的检测开关26安装在电路板上,基座24上相对检测开关的位置处设有贯穿孔241,电路板装配到基座上后,安装在电路板上的检测开关26的按键27穿过贯穿孔241伸入至插槽25内。当检测板插入至分析仪的插槽内,检测板的识别模块15位于检测开关26的按键27之上。若识别模块15相对检测开关26处设置为非凹陷部,则非凹陷部检测板外壳会触碰到检测开关的按键27,并将按键下压从而触发检测开关26开启;若识别模块相对检测开关处设置为凹陷部,则凹陷部的检测板外壳不会触碰到检测开关的按键,按键不会因为被检测板按压下行而触发开关开启。
按键27的形状可以设为斜坡状、半球形、长方体或正方体等。例如按键朝向检测板的那一面为一坡面结构,这样更有利于检测板在推入插槽并接触到按键后,推动并下压按键。
分析仪20可以单独设置开机开关。在一个设计方案中,所述检测板类型检测开关26还可兼具分析仪开机功能。通过检测板的识别模块15的非凹陷部触发分析仪中的检测开关26使分析仪开机并识别检测板类型。即当检测开关26被触发后,使得分析仪20开机启动,同时启动后的分析仪20又能根据检测开关触发的情况判断出检测板的类型。
分析仪20还可包括检测板弹出组件,弹出组件包括安装在分析仪壳体内的弹射连接块291和弹射按钮292。
一些设计方案中,检测板上的一个识别模块对应分析仪上的一个检测开关。比如,检测板上设置两个识别模块,与之对应,分析仪上设置两个检测开关,二者位置一一对应。
下面以利用检测板上设置不同模式的识别模块15来区分hCG检测板、FSH检测板和LH检测板为例,进一步具体说明。
如图4所示的检测板内存放了分析尿液中hCG含量的试纸。在该检测板的识别模块15相对分析仪检测开关26的按键27位置未设置凹陷部,即在上板前端的识别模块全为非凹陷部151。在图4的实例中,所述非凹陷部为上板11的上表面水平延伸至上板前端的部分。
如图5所示的检测板内存放了分析尿液中LH含量的试纸。在该检测板的识别模块15相对分析仪的第一检测开关261的按键271位置设有右凹陷部152(第一识别模块),即在上板前端右上角设有一凹陷的结构;检测板的识别模块15相对分析仪第二检测开关262的按键272位置未设置凹陷部,即在上板前端左上角设为非凹陷部151(第二识别模块)。
如图6所示的检测板内存放了分析尿液中FSH含量的试纸。在该检测板的识别模块15相对分析仪第二检测开关的按键位置设有左凹陷部153,即在上板前端左上角设置有一左凹陷的结构,检测板的识别模块15相对分析仪第一检测开关的按键位置未设置凹陷部,即在上板前端右上角设为非凹陷部151。
凹陷部的深度设置至少保证该凹陷部的底部不会触碰到检测开关按钮。
检测板的类型可通过分析仪的检测开关是否被检测板的识别模块按压来判断出检测板的类型。分析仪以及检测板类型检测开关将在下面详细描述。测试者也可以不通过分析仪,而是通过测试者直接观察检测板识别模块来判断当前使用的检测板类型。通过测试者直接观察判断 检测类型的检测板,这类检测板识别模块上的凹陷部或非凹陷部在检测板上的位置可以不与分析仪检测开关相对应。
例如,当仪器检测或人眼观察到检测板的识别模块全为非凹陷部,则判断该检测板为HCG检测板;或当检测或观察到检测板识别模块仅设有一个右凹陷部,则判断该检测板为LH检测板;或当检测或观察到检测板识别模块仅设有一个左凹陷部,则判断该检测板为FSH检测板;或当检测或观察到检测板识别模块既设有右凹陷部,又设有左凹陷部,则判断该检测板为E2(雌二醇)检测板。
本领域技术人员可以根据相关检测项目数量,在检测板设置不同数量的识别模块,在识别模块上设置不同数量的凹陷部,以及设别模块及凹陷部的在检测板上的位置;与之相对应,分析仪上相应位置对应设置不停数量的检测开关来对应识别模块。也可以通过凹陷部数量、或凹陷部位置、或凹陷部数量和凹陷部位置之间的排列组合,完成识别模块与检测类别的对应关系。凹陷部可以设计成其他具有类似功能的结构,比如缺口。
下面以图5所示LH检测板为例,进一步说明检测板识别模块与分析仪检测开关配合以判断检测板类型。
如图11至17所示分析仪的电路板上并排设置两个检测开关,分别是第一检测开关261和第二检测开关262。为了图示能更清楚地表达检测板识别模块和分析仪检测开关之间地配合,图11和图12示例图中省略了将电路板安装在分析仪外壳的安装件,例如这些图中省略了基座未画出。当有右缺的检测板插入至分析仪的过程中,识别模块相对分析仪的处是一个右凹陷部152(第一识别模块),凹陷部的底壁不会接触到第一按键271,在检测板插入分析仪的过程中第一按键271就不会被按压下行,因而第一检测开关261也无法被第一按键触发而开启,所以第一检测开关261给单片机的信号就一直是一个高电平信号(信号1)。识别模块相对分析仪的第二检测开关262的第二按键272处为非凹陷部151(第二识别模块),非凹陷部的板壁会接触到了第二按键272,在检测板插入分析仪的过程中第二按键272会被非凹陷部按压下而行,因而第二检测开关262会被第二按键272触发而将其所连接的单片机引脚由高电平转变为低电平,从而产生了一个下降沿的信号(信号2)。分析仪获得第一检测开关261未变化和第二检测开关262的下降沿信号后,即可判断出插入的检测板为LH检测板。
检测板类型识别模块15还可以设置在检测板的侧边,通过侧壁是否存在凹陷部以及凹陷部的位置来判断检测板的类型,例如图18至21所示。凹陷部的设置模式包括但不限于检测板的两侧壁不设置凹陷部;或检测板的一个侧壁设置凹陷部,另一个侧壁不设置凹陷部;或两个侧壁均设置凹陷部等。图18和图19所示检测板的识别模块未设置凹陷部,检测开关的按键相应地安装在检测开关的内侧面上。在检测板1插入分析仪的过程中,第一检测开关261和第二检测开关262会被检测板的识别模块按压到开关按键而触发。图20和图21所示的检测板识别模块的一侧设置了凹陷部154,在识别模块的另一侧为设置凹陷部。在检测板1插入分析仪的过程中,第一检测开关261会被检测板的识别模块按压到开关按键而触,第二检测开关262不会被检测板的识别模块按压到而不会触发。
图22和图23是本发明的一种分析仪识别检测板类型的工作原理。此电路共由两路电路组成:第一电路包括电阻R1、电容C1、检测开关S1、VCC电源端、信号地和单片机的P0.0端;第二电路包括电阻R2、电容C2、检测开关S2、VCC电源端、信号地和单片机的P0.1端。当检测开关S1或S2未被按键按下的时候,单片机的P0.0和P0.1的电压与VCC电压保持一致,检测开关提供一个保持不变的高电平信号(信号1)给单片机,当检测开关S1或S2被按键按下,它所连接的单片机P0.0和P0.1就会连接到信号地,而P0.0和P0.1的电压就会被信号地拉低,由高电平转变为低电平,从而产生一个下降沿信号(信号2)给单片机。
分析仪的电源可以选自纽扣电池、碱性电池、可充电锂电池、太阳能电池、开关电源等。
利用本发明所述检测板和分析仪对样本中被分析物进行分析的分析方法,包括以下步骤:将检测板插入至分析仪中;至少一个检测开关被触发,被触发的检测开关产生一个外部触发信号给到单片机。单片机接收到这个触发信号后会产生一个外部中断从而唤醒单片机。从休眠中 唤醒的单片机会优先处理由检测开关触发的这个中断程序,在中断程序中判断试纸类型。如果检测板在单片机唤醒后弹出分析仪或者检测板安装位置不正确、松动等导致按钮未被按下。那么检测开关就会产生一个上升沿信号给到单片机,从而触发单片机的检测板位置监测程序,告知单片机检测板的位置异常。在检测板位置监测程序中单片机会监测开关的按压状态,从而判断试纸条是否安装到位、是否更换了其他类型的试纸条。将样品添加到试纸中;分析仪根据检测板类型调取相应算法判读试纸的测试结果;分析仪给出检测结果。
以图4至6所述检测板与分析仪配合为例,并结合图22和图23具体说明样本分析方法。
步骤1:取出分析仪和检测板,检测板从分析仪的插入口插入至槽插内。
步骤2:随着检测板地插入,检测板识别模块的非凹陷部会按压到检测开关S1和/或S2的按键,按键被按下的检测开关被按键触发,触发开关S1、S2的触发信息传递至单片机。
当插入图4所示的检测板,电路板上的第一检测开关S1与第二检测开关S2的按键一起被检测板按下,单片机接收到S1与S2均被触发的信号组合,经过信号分析后单片机会判断出目前插入在分析仪中的检测板是用于检测HCG。
当插入图5所示的检测板,电路板上的第一检测开关S1(261)的按键271未被检测板按下,第二检测开关S2(262)的按键272被检测板按下,单片机接收到S1未被触发,S2被触发的信号组合,经过信号分析后单片机会判断出目前插入在分析仪中的检测板是用于检测LH。
当插入图6所示的检测板,电路板上的第一检测开关S1的按键被检测板按下,检测开关S2的按键未被检测板按下,单片机接收到S1被触发,S2未被触发的信号组合,经过信号分析后单片机会判断出目前插入在分析仪中检测板是用于检测FSH的。
步骤3:分析仪启动与检测板类型对应的测试程序。
步骤4:测试结束,显示测试结果。
若在检测板插入前,单片机处于休眠状态,则检测开关被触发的信号会先将单片机唤醒,然后单片机对检测开关的触发信号进行分析,从而判别检测板的检测类型;
若在检测板插入前,单片机已处于唤醒状态,则单片机会直接对检测开关的触发信号进行分析,从而判别检测板的检测类型。
一个可选择的非必要步骤是分析仪将检测板的检测类型显示在分析仪的显示屏30上。
检测板和分析仪的不同设计,一些分析体系是在检测板插入分析仪前,检测板上已经添加了样本,另一些分析体系是在检测板插入分析仪并确认了检测板类型后,再向检测板上添加样本。
当图4至6所述检测板插入分析仪中会产生图26所示信号1和信号2的两种信号。当检测板识别模块的凹陷部与分析仪的检测开关配合时,分析仪会产生信号1并传输给单片机,信号1不会产生上升或下降信号,即信号1是个不变的高电平信号。当检测板识别模块的非凹陷部与分析仪的检测开关配合时,分析仪会产生信号2并传输给单片机,当开关按键被识别模块的非凹陷区按下后,会产生一个下降信号2。
当检测开关兼具分析仪开机功能时,检测板上的识别模块需要包括非凹陷部,以产生信号2,通过信号2的信号下降的变化来让单片机唤醒开机。如果检测板上的识别模块均是凹陷部,则分析仪的开关是不能被按下,所以分析仪无法单独依靠识别模块来判断试纸是否已经插入并唤醒开机,分析仪需要额外添加一个开机开关。
为了更好的实现检测开关兼具开机开关的功能,在如图24的检测板的优化设计中,在一个识别模块上依次设置非凹陷部151、凹陷部154,非凹陷部相比凹陷部154更早地接触到检测开关。当图24所述检测板插入至分析仪的过程中,检测板识别模块15的最前端会首先按下检测开关26的按键,随之检测板的继续插入至插入到位后,检测开关正好位于图24所示检测板的凹陷部154,此前被非凹陷部151按下的检测开关26又会弹出来。整个插入过程,分析仪产生了先由高电平转变为低电平,再由低电平转为高电平的脉冲信号并传给单片机,如图26所示的信号3。分析仪检测到信号3的下降信号,判断出检测板已经插入并唤醒分析仪。紧接着,分析仪检测到信号3的上升信号,分析仪判断出检测板已经插入到位。同时分析仪根据 信号3先出现下降信号,后出现上升信号,从而判断出与之匹配的检测板类型。例如,我们可以设定图24所示检测板用于毒品检测。
以图25所示检测板包括两个识别模块,其中第一识别模块包括位于右上角凹陷部152,第二识别模块并依次在左上角设置非凹陷部151、和凹陷部154,且非凹陷部151相比凹陷部154更早地接触到检测开关。当图25所述检测板插入至分析仪的过程中,第一识别模块即右上角仅包括凹陷部,因此检测开关不会被按下,分析仪检测到第一识别区的检测开关产生的是信号1的信号。同时分析仪检测到第二识别模块即右上角的非凹陷部151和另一凹陷部154对应的检测开关产生了信号3的信号。当分析仪单片机检测到这两组具有差异性的信号后,从而判断出与之匹配的检测板类型。例如,我们可以设定图25所示检测板用于分析雌二醇。

Claims (25)

  1. 具有识别信息的检测板,包括上板和下板,上板和下板组装在一起形成检测板的外壳,其特征在于:在外壳上设有识别检测板类型的识别模块,识别模块包括凹陷部,或非凹陷部,或凹陷部和非凹陷部的组合。
  2. 根据权利要求1所述的检测板,其特征在于:至少包括两个识别模块,所述识别模块分别设置在检测板的不同位置。
  3. 根据权利要求1或2所述的检测板,其特征在于:识别模块设置在检测板外壳的前端或侧边;或者识别模块同时设置在外壳的前端和侧边。
  4. 根据权利要求3所述的检测板,其特征在于:两个识别模块中,一个识别模块设置为一个凹陷部,另一个识别模块设置为一个非凹陷部;或者两个识别模块均设置凹陷部;或者两个识别模块均设置为非凹陷部。
  5. 根据权利要求4所述的检测板,其特征在于:一个识别模块位于上板的前端右上角并设为凹陷部,另一个识别模块位于上板的前端左上角并设为非凹陷部;或者,一个识别模块位于上板的前端右上角并设为非凹陷部,另一个识别模块位于上板的前端左上角并设为凹陷部。
  6. 根据权利要求1或2所述的检测板,其特征在于:识别模块至少包括一个非凹陷部和一个凹陷部,其中,非凹陷部比凹陷部更早地接触到分析仪的检测开关。
  7. 根据权利要求1-6之一所述的检测板,其特征在于:所述识别模块用于触发分析仪中的检测开关来识别检测板类型。
  8. 根据权利要求7所述的检测板,其特征在于:通过凹陷部不触发检测开关和/或非凹陷部触发检测开关来识别检测板类型。
  9. 根据权利要求7所述的检测板,其特征在于:检测板上的一个识别模块对应分析仪上的一个检测开关。
  10. 根据权利要求1所述的检测板,其特征在于:检测板还包括装配在上板和下板中间的试纸。
  11. 用于读取检测板识别信息的分析仪,包括上盖、下盖和检测板插入口,装配在上下盖之间的电路板,其特征在于,用于判别检测板类型的检测开关安装在电路板上;所述分析仪中的检测开关位置与插入到分析仪的检测板的识别模块位置相对应。
  12. 根据权利要求11所述的分析仪,其特征在于:通过检测板的识别模块的非凹陷部触发分析仪中的检测开关使分析仪开机并识别检测板类型。
  13. 根据权利要求12所述的分析仪,其特征在于:当检测板插入至分析仪内,检测板识别模块的非凹陷部会触碰到检测开关的按键,并将按键下压从而触发检测开关;检测板识别模块的凹陷部不会触碰到检测开关的按键。
  14. 根据权利要求11所述的分析仪,其特征在于:电路板上包括两个检测开关,所述两个检测开关分别与检测板的两个识别模块一一对应。
  15. 根据权利要求11所述的分析仪,其特征在于:检测开关的按键朝向检测板的面为一坡面结构。
  16. 识别检测板类型的方法,其特征在于,包括检测板和分析仪,检测板包括上板和下板组装形成的外壳,外壳上设有识别模块,分析仪包括上盖、下盖和检测板插入口,装配在上下盖之间的电路板,以及安装在电路板上的用于判别检测板类型的检测开关;其中,通过分析仪的检测开关是否被识别模块触发,分析仪产生与触发或不触发所对应的信号来识别检测板类型。
  17. 根据权利要求16所述的识别检测板类型的方法,其特征在于,识别模块设置非凹陷部和/或凹陷部,通过凹陷部不触发检测开关和/或非凹陷部触发检测开关使分析仪产生与触发或不触发所对应的信号来识别检测板类型。
  18. 根据权利要求17所述的识别检测板类型的方法,其特征在于,当检测开关不被凹陷部按压开启时,分析仪产生信号1;当检测开关被非凹陷部按压开启时,分析仪产生一个下降的信号2;当检测开关先被非凹陷区按压开启,后检测开关在失去非凹陷部的按压而关闭时,分析仪产生一个先上升后下降的信号3。
  19. 根据权利要求16所述的识别检测板类型的方法,其特征在于,通过分析仪的检测开关被识别模块触发使分析仪开机或从休眠状态唤醒。
  20. 根据权利要求19所述的识别检测板类型的方法,其特征在于,检测开关被非凹陷部按压开启时,同时使分析仪开机或从休眠状态唤醒。
  21. 根据权利要求16-20中任意一项所述的识别检测板类型的方法,其特征在于,检测开关包括第一检测开关和第二检测开关。
  22. 根据权利要求21所述的识别检测板类型的方法,其特征在于,检测板包括两个识别模块;两个识别模块分别与第一检测开关和第二检测开关对应;一个识别模块位于上板的前端右上角并设为凹陷部,另一个识别模块位于上板的前端左上角并设为非凹陷部;或者,一个识别模块位于上板的前端右上角并设为非凹陷部,另一个识别模块位于上板的前端左上角并设为凹陷部。
  23. 根据权利要求22所述的识别检测板类型的方法,其特征在于,将检测板插入分析仪,使识别模块的凹陷部或非凹陷部行进至检测开关处,检测到第一检测开关和/或第二检测开关被按下,分析仪的单片机检测检测板类型;当第一检测开关和第二检测开关都被按下,发出两个下降的信号2,显示检测板为第一种类型;或者,当第一检测开关被按下而第二检测开关未被按下,发出第一种下降的信号2,显示检测板为第二种类型;或者,当第一检测开关未被按下而第二检测开关被按下,发出第二种下降的信号2,显示检测板为第三种类型;或者,当第一检测开关和第二检测开关都未被按下,为信号1,显示检测板为第四种类型。
  24. 根据权利要求23所述的识别检测板类型的方法,其特征在于,若检测板插入分析仪前,分析仪的单片机处于休眠状态,则第一或第二检测开关被触发的信号会先将单片机唤醒,然后单片机对检测开关的触发信号进行分析,从而判别检测板的检测类型;若在检测板插入前,单片机已处于唤醒状态,则单片机会直接对检测开关的触发信号进行分析,从而判别检测板的检测类型。
  25. 根据权利要求21-24中任意一项所述的识别检测板类型的方法,其特征在于,包括另一识别模块,包括一个非凹陷部和一个凹陷部,其中非凹陷部相比凹陷部更早地接触到分析仪的检测开关;分析仪上设有与该识别模块对应的检测开关;检测板在分析仪中前进时,当该检测开关先被按下后再被关闭,发出先下降后上升的信号3,显示检测板为另一类型。
PCT/CN2021/129361 2020-11-09 2021-11-08 具有识别信息的检测板和用于读取识别信息的分析仪及其识别方法 WO2022096003A1 (zh)

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