WO2018165935A1 - Dispositif et procédé de détection utilisés sur un instrument de diagnostic in vitro et ayant une fonction d'identification - Google Patents

Dispositif et procédé de détection utilisés sur un instrument de diagnostic in vitro et ayant une fonction d'identification Download PDF

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Publication number
WO2018165935A1
WO2018165935A1 PCT/CN2017/076885 CN2017076885W WO2018165935A1 WO 2018165935 A1 WO2018165935 A1 WO 2018165935A1 CN 2017076885 W CN2017076885 W CN 2017076885W WO 2018165935 A1 WO2018165935 A1 WO 2018165935A1
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WO
WIPO (PCT)
Prior art keywords
consumable
detecting
consumables
detection
circuit board
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Application number
PCT/CN2017/076885
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English (en)
Chinese (zh)
Inventor
杨征
邱梦春
王绍阳
林吉君
Original Assignee
杭州凯珥医疗科技有限公司
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Publication date
Application filed by 杭州凯珥医疗科技有限公司 filed Critical 杭州凯珥医疗科技有限公司
Priority to PCT/CN2017/076885 priority Critical patent/WO2018165935A1/fr
Publication of WO2018165935A1 publication Critical patent/WO2018165935A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the present invention relates to the field of medical devices, and in particular, to a detecting device and a detecting method.
  • the in vitro tester can obtain clinical diagnosis information by detecting human samples (for example, blood, body fluids, tissues, etc.) to determine disease or body function.
  • human samples for example, blood, body fluids, tissues, etc.
  • In vitro testers usually contain a variety of disposable test consumables, such as test strips, test strips, test reagents, reagent carriers, and biochips.
  • in vitro testing often requires the use of multiple test consumables, so in vitro test instruments need to identify the type of test consumables.
  • the production batch information needs to be obtained in the in vitro detection, and then the parameter information is obtained to correct the detection result.
  • detecting whether the consumable is out of date, whether it is reused, and whether or not it has anti-counterfeiting information is also information that the in-vitro detection process needs to confirm.
  • some in vitro detectors set barcodes in the inspection consumables, and the consumables information can be obtained by scanning the barcodes.
  • the in vitro detector also needs to set a reflected light path to form a scanning channel, which is complicated in structure and high in cost.
  • the technical problem to be solved by the present invention is to provide a detecting device and a detecting method for acquiring consumable data at a lower cost.
  • the present invention provides a detecting device comprising: a consumable fixture comprising a detecting surface provided with a consumable and a back surface opposite to the detecting surface; the back surface is embedded with a circuit board in the circuit board Providing consumable data; a detecting instrument for reading from the board The consumable data is described, and the consumables are detected based on the consumable data to obtain the detection result.
  • the circuit board includes: a chip embedded in a back surface of the consumable fixture for storing consumable data; and a first connection end located on the back surface electrically connected to the chip.
  • the detecting device comprises: a detecting unit for detecting the consumable; a reading unit for reading the consumable data; the detecting device further comprising: a slot for placing the consumable fixture a second connection end connected to the reading unit is disposed in the slot.
  • the first connection end is a contact piece covering a back surface of the detecting fixture
  • the second connection end is located at a bottom of the socket and a contact matching the contact piece.
  • the first connection end comprises four contacts arranged in a 2 ⁇ 2 matrix
  • the second connection ends are four contacts arranged in a 2 ⁇ 2 matrix.
  • the detecting surface is provided with a detecting area exposing the consumable, and the circuit board corresponds to a position of the detecting area.
  • the consumable data stored in the chip includes: one or more of using a mark, a security screening code, a production date, an expiration date, a consumable number, a batch number, an item category, a calibration curve, a correction parameter, or a measurement unit.
  • a detecting method of the present invention comprises: providing a detecting device; setting a consumable fixture in the detecting instrument; detecting the consumable information by the detecting device; determining whether the consumable meets the detecting requirement based on the consumable information; and when the detecting requirement is met, the detecting device is The consumables are tested to obtain the test results.
  • the step of the detecting instrument acquiring the consumables information comprises: obtaining information of whether the consumable fixture is installed in position; and determining, according to the consumables information, whether the consumable fixture meets the detecting requirement comprises: reading from the circuit board when determining that the consumable clamp is installed in position Consumable data; determining whether the consumable meets the detection requirement according to the consumable data.
  • the circuit board stores a usage mark, and determining, according to the consumable data, whether the consumable meets the detection requirement comprises: determining whether the consumable is repeatedly used according to the use mark; and prompting the consumable to be repeatedly used and exiting when determining that the consumable is repeatedly used; Detection, when judging that the consumables are not used repeatedly The line detection is performed; or the anti-counterfeit identification code is stored in the circuit board, and the step of determining whether the consumable material meets the detection requirement according to the consumable data includes: determining whether the consumable is a defective product according to the anti-counterfeiting screening code; and prompting the consumable when determining that the consumable is a defective product For the defective product and exiting the detection, the detection is performed when judging that the consumable is not defective; or the production date and the expiration date are stored in the circuit board, and the step of judging whether the consumable meets the detection requirement according to the consumable data includes: judging the consumable according to the production date and the expiration date
  • the steps of meeting the testing requirements include: determining whether the consumables are located in the product recall according to the consumables number, the batch number and the item category; when judging that the consumables are recalled products, prompting the consumables to be in the product recall and exiting the detection, when judging that the consumables are not recalled Test.
  • the circuit board includes: a chip embedded on the back of the consumable fixture for storing consumable data; a first connection end on the back surface for connecting the chip to an external circuit;
  • the detecting instrument The method includes: a detecting unit, configured to detect a consumable; a reading unit, configured to read the consumable data; the detecting device further includes: a slot for placing the consumable fixture, wherein the slot is provided a second connection end connected to the reading unit; the step of obtaining information on whether the consumable is installed in place includes determining whether the consumable is installed in place by determining whether the second connection end is in a connected state.
  • the step of detecting the consumable by the detecting instrument comprises: the detecting instrument completes the detecting to obtain an initial detecting result; and combining the consumable data, converting or correcting the initial detecting result, and obtaining a final detecting result.
  • the consumable data includes one or more of a calibration curve, a correction parameter, or a measurement unit.
  • the detecting method further includes: updating the consumable data in the circuit board according to the detection result.
  • the step of updating the consumable data in the board comprises: adding a usage tag to the consumable data.
  • the step of updating the consumable data in the circuit board comprises: writing the detection result in the circuit board.
  • the present invention has the following advantages:
  • the present invention is provided with a circuit board storing consumable data in a consumable fixture, and the consumable data in the circuit board can be read by the detecting instrument. Since the circuit board is embedded in the consumable fixture, it does not occupy too much space, and the detection instrument integrates the function of reading the consumable data, and the reading of the consumable data can be realized by electrically connecting with the circuit board, without setting up other devices ( For example, the reflected light path constituting the scanning channel) reduces the volume of the detecting device and can reduce the cost.
  • FIG. 1 is a side view of a consumable fixture in an embodiment of the detecting device of the present invention
  • Figure 2 is a plan view of the consumable clamp shown in Figure 1;
  • Figure 3 is a bottom plan view of the consumable clamp shown in Figure 1;
  • FIG. 4 is a functional block diagram of a detecting instrument in an embodiment of the detecting device of the present invention.
  • Figure 5 is a view showing the state of use of the consumable clamp shown in Figure 1;
  • FIG. 6 is a schematic flow chart of an embodiment of a detecting method of the present invention.
  • FIG. 7 is a schematic flow chart of steps S3 and S4 of FIG. 6.
  • the prior art detecting apparatus for realizing in vitro detection has a problem of obtaining consumables information at a higher cost.
  • the present invention provides a detecting device and a detecting method in which a circuit board storing consumable data is disposed, and the consumable data in the circuit board can be read by the detecting device. Since the circuit board is embedded in the consumable fixture, it does not occupy too much space, and the inspection instrument integrates the function of reading the consumable data, and the number of consumables can be realized by electrically connecting with the circuit board. According to the reading, it is not necessary to provide a reflected light path constituting the scanning channel, which further reduces the volume and can reduce the cost.
  • the detecting device of this embodiment includes:
  • the consumable fixture 1 includes a detecting surface A provided with a consumable and a back surface B opposite to the detecting surface A; the back surface B is embedded with a circuit board 3, and the circuit board 3 is provided with consumable data;
  • a detecting instrument (not shown) is configured to read the consumable data from the circuit board 3, and detect the consumable based on the consumable data to obtain a detection result.
  • the consumables disposed in the consumables fixture 1 are test strips, and the test strips can store blood, urine, and the like to achieve in vitro detection.
  • the consumable clamp 1 can also be of other types.
  • the consumable clamp 1 is a flat plate structure.
  • a top view of the consumable clamp of Figure 1 is shown. That is, FIG. 2 shows a schematic structural view of the detecting surface A.
  • a detection area 2 is disposed in the detection surface A, and the detection area 2 is used to place a test paper.
  • the detecting device of the embodiment performs the in vitro detection, the body fluid in the test strip 2 test paper is detected, and the detection result is obtained.
  • a circuit board 3 is embedded in the back surface B of the consumable clamp 1, and the circuit board 3 is provided with consumable data, which can be read during the detection process. Since the board is embedded in the consumable fixture, it does not take up too much space.
  • the inspection instrument can realize the reading of consumable data by electrically connecting with the circuit board, and no additional equipment (such as reflected light path) can be provided, which can reduce the cost.
  • the circuit board 3 includes: a chip 31 embedded in the back surface of the consumable fixture for storing consumable data; the chip 31 is embedded in the consumable fixture and is not easily damaged.
  • the chip 31 is a micro read/write chip, which is small in size and can be embedded in the consumable fixture 1.
  • the consumable data stored by the chip 31 includes one or more of a use mark, a security check code, a production date, an expiration date, a consumable number, a batch number, an item category, a calibration curve, a correction parameter, or a measurement unit.
  • FIG. 3 shows a schematic structural view of the back surface B.
  • the circuit board 3 further includes a first connecting end 32 on the back side for electrically connecting the chip to the detecting instrument.
  • the first connection end 32 is provided as a connection structure that matches the connection end of the detection instrument.
  • the first connecting end 32 covers the contact on the back surface B of the consumable fixture 1, and the contact piece is connected to the chip 31 for guiding the chip 31 to an external circuit (reading of the detecting instrument) unit).
  • the contact piece is a thin metal layer of 4 sheets, which is disposed on the back surface of the consumable fixture in a 2 ⁇ 2 matrix.
  • the circuit board 3 is disposed at a position corresponding to the detection area 2, and the corresponding meaning herein means that the projection of the circuit board 3 on the detection surface A is within the range of the detection area 2.
  • the circuit board 3 can also function to determine whether the detection area 2 is within the detectable range during the detection process.
  • the detecting device of this embodiment further includes a detecting device. Referring to FIG. 4, a functional block diagram of the detecting device in the embodiment is shown.
  • the detecting instrument includes: a detecting unit 101 for detecting a test paper in a consumable fixture.
  • the detecting unit 101 is a microscope system, and can observe the microscopic morphology of the body fluid in the test paper, and issue a test report based on the observation result.
  • the detecting instrument further has a function of reading consumable data in the circuit board 3.
  • the detecting device further includes a reading unit 102 for electrically connecting to the circuit board 3 when the consumable fixture is placed on the detecting instrument, thereby reading consumable data in the circuit board 3.
  • the detection unit 101 includes a data processing instrument, such as a computer, that obtains a test report, which can be integrated into the computer, thereby simplifying the detection device.
  • a data processing instrument such as a computer
  • the detecting instrument further includes: A slot (not shown) for placing the consumable fixture, and a second connection end 4 connected to the reading unit is disposed in the slot.
  • the first connection end 32 on the back side of the consumable fixture is connected to the second connection end 4, thereby achieving an electrical connection between the reading unit and the circuit board 3.
  • the second connection end 4 is a contact that matches the contact piece.
  • the contact piece is a thin metal foil layer, which is disposed on the back surface of the consumable fixture in a 2 ⁇ 2 matrix manner. Accordingly, the contacts are four metal pillars and are disposed in the 2 ⁇ 2 matrix at the bottom of the slot. When the consumable fixture is placed in the slot, the metal columnar contact can abut against the contact of the thin metal layer, so that the electrical connection between the contact and the contact can be realized, thereby implementing the reading unit 102 and the circuit. Electrical connection of the board 3.
  • the reading unit 102 in the detecting instrument can read the consumable data from the circuit board 3, and detect the consumable based on the consumable data to obtain the detection result.
  • the present invention also provides a detection method by using the detection device of the present invention.
  • FIG. 6 a schematic diagram of an embodiment of the detection method of the present invention is illustrated.
  • the detection method includes:
  • Step S1 providing a detecting device
  • Step S2 the consumable fixture is set in the detecting instrument
  • Step S3 the detecting instrument acquires the consumables information
  • Step S4 determining, according to the consumables information, whether the consumables meet the detection requirements
  • step S5 when the testing requirements are met, the detecting instrument detects the consumables to obtain the detection result.
  • Step S1 is performed to provide a detecting device.
  • the structure of the detecting device refers to the related description of the detecting device in the foregoing embodiment, and details are not described herein again.
  • Step S2 is executed to set the consumable jig 1 in the detecting instrument.
  • the consumable clamp 1 includes a detection surface A provided with a consumable and a detection surface A Opposite back side B; the back side B is embedded with a circuit board 3, and the circuit board 3 is provided with consumable data.
  • a slot is provided in the detecting instrument.
  • the detecting instrument includes a detecting unit 101 for detecting a test paper in a consumable fixture, and a reading unit 102.
  • the step of disposing the consumable jig 1 in the detecting instrument includes placing the consumable jig 1 in the slot with the back side B of the consumable jig 1 facing the bottom of the slot, and the detecting face A facing the detecting unit 101.
  • Step S3 is executed to detect the instrument to obtain consumables information.
  • the step of the detecting instrument acquiring the consumables information includes: Step S41: Obtaining information on whether the consumables are installed in place; and determining, according to the consumables information, whether the consumables meet the detecting requirements: when determining that the consumables are installed in position, performing step S42 to read from the circuit board 3 Consumable data; performing step S43 to determine whether the consumable meets the detection requirement based on the consumable data.
  • Step S41 Obtaining information on whether the consumables are installed in place; and determining, according to the consumables information, whether the consumables meet the detecting requirements: when determining that the consumables are installed in position, performing step S42 to read from the circuit board 3 Consumable data; performing step S43 to determine whether the consumable meets the detection requirement based on the consumable data.
  • the circuit board 3 includes: a chip 31 embedded in the back surface B of the consumable fixture for storing consumable data; a first connection end located on the back surface B for making the chip 31 and an external circuit (in this embodiment)
  • the reading unit of the detecting device is connected; furthermore, the circuit board 3 is disposed at a position corresponding to the detecting area 2, where the corresponding meaning means that the projection of the circuit board 3 on the detecting surface A is located in the detecting area.
  • a second connection end connected to the reading unit 102 is disposed in the slot of the detecting instrument.
  • the step of obtaining information on whether the consumable is installed in place includes determining whether the consumable is installed in place by determining whether the second connection end 4 is in the connected state.
  • the circuit board 3 is disposed at a position corresponding to the detection area 2, and accordingly, the first connection end 32 of the circuit board 3 is also disposed at a position corresponding to the detection area 2.
  • the detection unit can detect the detection zone 2, and accordingly, the first connection end 32 located below the detection zone 2 It can also be connected to the second connecting end 4 at the bottom of the slot, so that it can be judged that the consumable clamp is installed in position by judging that the second connecting end 4 is in the connected state, and then the consumable data can be read from the circuit board, and judged according to the consumable data. Whether the consumables meet the testing requirements.
  • the first connection end 32 located below the detection area 2 does not correspond to the position of the second connection end 4 at the bottom of the slot, and thus the first connection end 32 and the second The connecting end 4 cannot realize the electrical connection.
  • the second connecting end 4 is in the unconnected state, it can be judged that the consumable clamp is not installed in place, and the consumable clamp is not installed and the detection is exited.
  • whether the consumable clamp is installed in position is determined by whether the second connection end 4 is in the connected state, and further whether the detection area of the consumable is at the detectable position of the detection unit is determined.
  • Step S4 is executed to determine whether the consumable meets the detection requirement based on the consumables information.
  • Step S4 is executed to determine whether the consumable meets the detection requirement based on the consumables information.
  • the circuit board 3 stores a usage mark
  • the step of determining whether the consumable conforms to the detection requirement according to the consumable data includes: performing step S431, determining whether the consumable is repeatedly used according to the use mark; and prompting the consumable when determining that the consumable is repeatedly used. Reuse and exit the test, and detect when the consumables are not used repeatedly. This can prevent the problem of misuse of consumables after use, and improve detection efficiency and accuracy.
  • the circuit board 3 stores an anti-counterfeit identification code
  • the step of determining whether the consumable material meets the detection requirement according to the consumable data includes: performing step S432, determining whether the consumable is a defective product according to the anti-counterfeiting screening code; and determining that the consumable is a defective product, The prompt consumables are defective and exit the test, and the test is performed when judging that the consumables are not defective. This avoids the problem of inaccurate test results caused by the use of defective consumables.
  • the step of storing the production date and the expiration date in the circuit board 3, and determining whether the consumable material meets the detection requirement according to the consumable data includes: performing step S433, determining whether the consumable is expired according to the production date and the expiration date; and prompting the consumable when the consumable expires The consumables expire and exit the test, and the test is performed when it is judged that the consumables have not expired. It can prevent the use of expired consumables and improve detection efficiency and accuracy.
  • the circuit board 3 stores a consumable number, a batch number, and an item category, according to the consumable
  • the step of determining whether the consumables meet the testing requirements includes: performing step S434, determining whether the consumables are located in the product recall according to the consumables number, the batch number, and the item category; and when the consumables are the recalled products, prompting the consumables to be in the product recall and exiting the detecting It is tested when it is judged that the consumables are not recalled. This can reduce the use probability of non-compliant consumables and improve detection accuracy.
  • one or more of the foregoing plurality of consumable data may be stored in the circuit board 3. Accordingly, when determining whether the consumable meets the detection requirement according to the consumable data, the determination may be performed according to the corresponding consumable data.
  • Step S5 is performed, and when the testing requirements are met, the detecting instrument detects the consumables to obtain the detection result.
  • the detecting instrument completes the detection to obtain an initial detection result; and in combination with the consumable data, the initial detection result is converted or corrected, and the final detection result is obtained.
  • the consumable data stored in the circuit board 3 includes one or more of a calibration curve, a correction parameter, or a measurement unit. After obtaining the initial detection result, the detection result of the initial result can be converted or corrected based on the calibration curve, the correction parameter or the measurement unit, thereby outputting a more accurate detection result.
  • the detection result that does not need to be converted or corrected may be directly output as the final detection result.
  • step S6 may be performed after the completion of the detection to update the consumable data in the circuit board 3. Specifically, the data in the chip 31 in the board is updated.
  • the detection result is written in the read/write chip of the board.
  • the detection result can be read, so that the user can effectively know the detection result.
  • the written detection result can also be used as a criterion for judging whether or not the consumable has been used. If the detection result can be read during the detection, it can be judged that the consumable has been used.
  • the detection method provided by the invention can obtain the consumable data directly through the consumable fixture or the detecting instrument, and the consumable data is obtained without using additional equipment, thereby improving the accuracy of the detection result and the detection efficiency.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

La présente invention concerne un dispositif de détection et un procédé de détection. Le dispositif de détection comprend un accessoire de matériau consommable (1) et un instrument de détection. L'accessoire de matériau consommable (1) comprend une surface de détection (A) pourvue d'un matériau consommable et une surface arrière (B) en face à la surface de détection (A). Une carte de circuit imprimé (3) est incorporée dans la surface arrière (B), et des données de matériau consommable sont établies dans la carte de circuit imprimé (3). L'instrument de détection est utilisé pour lire les données de matériau consommable à partir de la carte de circuit imprimé (3), et détecter le matériau consommable en fonction des données de matériau consommable, de façon à obtenir le résultat de détection. Le procédé de détection consiste : à fournir un dispositif de détection (S1) ; à agencer un accessoire de matériau consommable (1) dans l'instrument de détection (S2) ; l'instrument de détection obtient des informations de matériau consommable (S3) ; à déterminer si un matériau consommable satisfait une exigence de détection selon les informations de matériau consommable (S4) ; et lorsque le matériau consommable satisfait l'exigence de détection, l'instrument de détection détecte le matériau consommable pour obtenir le résultat de détection (S5). Dans le dispositif de détection et le procédé de détection, des données de matériau consommable sont obtenues à faible coût, et la précision et l'efficacité de détection sont améliorées.
PCT/CN2017/076885 2017-03-16 2017-03-16 Dispositif et procédé de détection utilisés sur un instrument de diagnostic in vitro et ayant une fonction d'identification WO2018165935A1 (fr)

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Citations (7)

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Publication number Priority date Publication date Assignee Title
US20080159911A1 (en) * 2007-01-03 2008-07-03 Tien-Tsai Hsu Identification notation-containing test strip and test instrument thereof
CN201707690U (zh) * 2010-01-20 2011-01-12 璞实生物科技股份有限公司 检测芯片卡
CN102608339A (zh) * 2012-02-28 2012-07-25 艾康生物技术(杭州)有限公司 自动识别生物传感器身份信息的分析仪及其检测方法
CN102967637A (zh) * 2012-03-31 2013-03-13 艾康生物技术(杭州)有限公司 自动编码装置和具有自动编码装置的生物传感器
CN102967636A (zh) * 2012-03-31 2013-03-13 艾康生物技术(杭州)有限公司 自动编码装置和具有该装置的生物传感器和制造方法
CN205263094U (zh) * 2015-12-09 2016-05-25 桂林优利特医疗电子有限公司 一种生物传感器试纸的电极代码和识别装置
CN107402310A (zh) * 2016-05-19 2017-11-28 杭州凯珥医疗科技有限公司 一种用于体外诊断仪的具有识别功能的检测装置和方法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080159911A1 (en) * 2007-01-03 2008-07-03 Tien-Tsai Hsu Identification notation-containing test strip and test instrument thereof
CN201707690U (zh) * 2010-01-20 2011-01-12 璞实生物科技股份有限公司 检测芯片卡
CN102608339A (zh) * 2012-02-28 2012-07-25 艾康生物技术(杭州)有限公司 自动识别生物传感器身份信息的分析仪及其检测方法
CN102967637A (zh) * 2012-03-31 2013-03-13 艾康生物技术(杭州)有限公司 自动编码装置和具有自动编码装置的生物传感器
CN102967636A (zh) * 2012-03-31 2013-03-13 艾康生物技术(杭州)有限公司 自动编码装置和具有该装置的生物传感器和制造方法
CN205263094U (zh) * 2015-12-09 2016-05-25 桂林优利特医疗电子有限公司 一种生物传感器试纸的电极代码和识别装置
CN107402310A (zh) * 2016-05-19 2017-11-28 杭州凯珥医疗科技有限公司 一种用于体外诊断仪的具有识别功能的检测装置和方法

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