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WO2025025107A1 - Carte de test d'échantillon, ensemble de test et dispositif de test médical - Google Patents

Carte de test d'échantillon, ensemble de test et dispositif de test médical Download PDF

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Publication number
WO2025025107A1
WO2025025107A1 PCT/CN2023/110396 CN2023110396W WO2025025107A1 WO 2025025107 A1 WO2025025107 A1 WO 2025025107A1 CN 2023110396 W CN2023110396 W CN 2023110396W WO 2025025107 A1 WO2025025107 A1 WO 2025025107A1
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WO
WIPO (PCT)
Prior art keywords
electrode
detection
sample
channel
loop
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/CN2023/110396
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English (en)
Chinese (zh)
Inventor
李国霞
罗赛
章星
施明连
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edan Instruments Inc
Original Assignee
Edan Instruments Inc
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.)
Filing date
Publication date
Application filed by Edan Instruments Inc filed Critical Edan Instruments Inc
Priority to PCT/CN2023/110396 priority Critical patent/WO2025025107A1/fr
Publication of WO2025025107A1 publication Critical patent/WO2025025107A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis

Definitions

  • the present application relates to the field of analytical instruments, and in particular to sample test cards, test components and medical test equipment.
  • sample test cards For the sake of hygiene and convenience, commonly used medical testing equipment usually stores samples in sample test cards for testing. Therefore, after the sample leaves the organism, it needs to be input into the sample test card. Since the amount of liquid in the organism itself is limited, in order to avoid adverse effects on the organism, the amount of sample obtained at one time will not be too much, so the liquid path used to test the sample in the sample test card will not be very spacious.
  • sample detection methods include electrochemical methods, which require a circuit to be formed in the sample test card to detect the sample. When there are abnormalities such as bubbles in the liquid path used to detect the sample, the final test result will be inaccurate.
  • the technical problem to be solved by the present application is how to provide a sample test card, a detection component and a medical detection device to improve the accuracy of the detection of electrochemical parameters of the sample.
  • the present application provides a sample test card, including a first channel and a first electrode group.
  • the first electrode group is arranged in the first channel, including a first detection electrode, a second detection electrode and a counter electrode, the counter electrode is arranged between the first detection electrode and the second detection electrode, the counter electrode and the first detection electrode form a part of a first loop, the counter electrode and the second detection electrode form a part of a second loop, the first loop and the second loop are used to simultaneously obtain at least two detection signals of a sample in the first channel during a sample detection process, and the at least two detection signals are used for comparison to determine whether there is an abnormality in the sample in the first channel between the first detection electrode and the second detection electrode.
  • the present application provides a detection component for medical detection equipment, including a sample test card, a contact electrode and a processor.
  • the sample test card includes a first channel and a first electrode group arranged in the first channel, the first electrode group includes a first detection electrode, a second detection electrode and a counter electrode, the counter electrode is arranged between the first detection electrode and the second detection electrode, the counter electrode and the first detection electrode form a part of a first loop, the counter electrode and the second detection electrode form a part of a second loop, the first loop and the second loop are used to simultaneously obtain at least two detection signals of the sample in the first channel during the sample detection process, and the at least two detection signals are used for comparison to determine whether there is an abnormality in the sample in the first channel between the first detection electrode and the second detection electrode;
  • the contact electrode is arranged in the medical detection equipment and is connected to the first electrode group signal;
  • the processor is connected to the contact electrode, and is used to receive the at least two detection signals, and judge whether there is an abnormality in the sample in the
  • the present application provides a sample test card, including a first channel and a first electrode group.
  • the first electrode group is arranged in the first channel, including at least two detection electrodes, the at least two detection electrodes can be connected through the first channel, and are used to obtain at least two detection signals of the sample in the first channel between the at least two detection electrodes during the sample detection process, and the at least two detection signals are used for comparison to determine whether there is an abnormality in the sample in the first channel between the two detection electrodes.
  • the present application provides a medical detection device, including a contact electrode and a processor.
  • the contact electrode is connected to a first electrode group signal in a first channel of a sample test card, at least two detection electrodes can be conducted through the first channel, and the contact electrode is used to transmit a detection signal of a sample in the first channel obtained by the first electrode group;
  • the processor is connected to the contact electrode, and is used to receive the detection signal, and judge whether there is an abnormality in the first channel according to the detection signal.
  • the present application provides a detection method for a sample test card, including obtaining two detection signals obtained by performing sample detection in a first channel, the sample test card including a first channel and a first electrode group arranged in the first channel, the first electrode group including a first detection electrode, a second detection electrode and a counter electrode, the counter electrode being arranged between the first detection electrode and the second detection electrode, the counter electrode and the first detection electrode forming part of a first loop, the counter electrode and the second detection electrode forming part of a second loop, and using the first loop and the second loop to respectively obtain one of the at least two detection signals; in response to the difference between the at least two detection signals being greater than a threshold value, a result of the presence of an abnormality is obtained.
  • the present application discloses a sample test card, a detection component and a medical
  • the medical detection equipment can detect the sample by using the first electrode group arranged in the first liquid circuit, and simultaneously obtain two detection signals in the first channel, so as to judge whether there is an abnormality in the sample of the first channel by comparing the two detection signals, and can detect whether there are bubbles, clots and other abnormalities that affect the fluidity and uniformity of the sample in the first channel, thereby reducing the instability and errors of the measurement results caused by the abnormalities, and can effectively improve the accuracy of the detection of the electrochemical parameters of the sample.
  • FIG. 1 is a schematic diagram of the assembly structure of an embodiment of a sample test card of the present application.
  • FIG. 2 is a schematic diagram of the exploded structure of the sample test card in FIG. 1 .
  • FIG. 3 is a schematic diagram of the substrate structure of the first plate member in FIG. 1 .
  • FIG. 4 is a schematic diagram of the structure of a detection component used in a medical detection device of the present application.
  • FIG. 5 is a partial enlarged schematic diagram of area A in FIG. 4 .
  • test cards are usually used to test biochemical samples, so as to improve test efficiency while keeping samples from being contaminated, thereby ensuring test accuracy.
  • sample test cards can detect samples by measuring electrochemical parameters, and before the test, the sample or other reagents need to be input into the test card, so that the biochemical parameters of the sample can be detected using the devices in the test card.
  • Figure 1 is a schematic diagram of the assembly structure of an embodiment of a sample test card of the present application.
  • Figure 2 is a schematic diagram of the exploded structure of the sample test card in Figure 1.
  • Figure 3 is a schematic diagram of the base plate structure of the first plate in Figure 1.
  • the present application provides a sample test card 9, including a first channel 1 and a first electrode group 41a disposed in the first channel 1.
  • the first electrode group 41a includes a first detection electrode 413, a second detection electrode 414 and a counter electrode 412.
  • the counter electrode 412 is used as an auxiliary electrode to form two loops with the first detection electrode 413 and the second detection electrode 414, respectively, so that the current of the first detection electrode 413 and the second detection electrode 414 is smooth, so as to ensure that the reaction of detecting the electrochemical parameter occurs on the first detection electrode 413 and the second detection electrode 414.
  • the counter electrode 412 is disposed between the first detection electrode 413 and the second detection electrode 414, and the counter electrode 412 and the first detection electrode 413 and the second detection electrode 414 are connected.
  • the detection electrode 413 forms part of the first loop
  • the counter electrode 412 and the second detection electrode 414 form part of the second loop
  • the first loop and the second loop are used to simultaneously obtain at least two detection signals of the sample in the first channel 1 during the sample detection process.
  • the at least two detection signals are used for comparison to determine whether there is an abnormality in the sample in the first channel 1 between the first detection electrode 413 and the second detection electrode 414.
  • the method provided in this embodiment can utilize the method of dividing the sample between the first detection electrode 413 and the second detection electrode 414 into two sections for detection and measuring two detection signals. Based on the principle that the electrochemical parameters of the same liquid are the same under the same environment, the two detection signals are compared to determine whether there is an abnormality in the samples of the two sections of the first channel 1.
  • the electrochemical parameters obtained by the two detection signals are the same or extremely similar, it can be considered that the samples between the first detection electrode 413 and the second detection electrode 414 are similar or the same, that is, there is no abnormality in the two sections of the sample, so it can be determined that other electrochemical parameters measured at this time are also reliable and accurate; and when the two detection signals are different, it can be determined that there is an abnormality in the sample between the first detection electrode 413 and the second detection electrode 414 that affects the conduction of a certain circuit, such as bubbles or clots, thereby affecting the measured electrochemical parameters.
  • the abnormality may be a factor existing in the sample itself, such as a blood clot in a blood sample.
  • the abnormality may also be an abnormality caused by external environmental factors, such as bubbles generated by turbulence due to the failure to exhaust the gas in the sample test card 9 or the uneven inner wall of the first channel 1.
  • the first detection electrode 413 , the counter electrode 412 , and the second detection electrode 414 are arranged at intervals along the length direction of the first channel 1 .
  • the distance between the counter electrode 412 and the first detection electrode 413 may be greater than the distance between the counter electrode 412 and the second detection electrode 414 , thereby increasing the difference between the detection objects of the two circuits and improving the accuracy of abnormality detection.
  • the first channel 1 can also include a measuring channel 11 for accommodating samples.
  • the measuring channel 11 is also provided with a first electrode 41 to detect other electrochemical parameters of the sample, and the first detection electrode 413 and the second detection electrode 414 are respectively arranged at both ends of the measuring channel 11, so that the first electrode group 41a can perform abnormal detection on the sample in the entire measuring channel 11 to ensure a certain accuracy when other electrodes measure other biochemical parameters of the sample in the measuring channel 11.
  • the first electrode group 41a can measure whether there is any abnormality in the sample in the measurement channel 11 while the first electrode 41 measures other electrochemical parameters of the sample, so as to obtain real-time data during sample detection.
  • an infusion hole 4d is respectively provided at both ends of the measurement channel 11, and the two infusion holes 4d are used to pass samples or other liquids into and out of the measurement channel 11.
  • the first detection electrode 413 and the second detection electrode 414 are respectively arranged at positions close to the two infusion holes 4d, the first detection electrode 413 and the second detection electrode 414 can also be used to detect the liquid level in the measurement channel 11.
  • the first detection electrode 413 can generate a detection signal corresponding to the sample by contacting the sample, and because the sample has not yet flowed to the second detection electrode 414 near another infusion hole 4d, the detection signal generated by the second detection electrode 414 at the same time is a detection signal that does not contact the sample.
  • the two detection signals it can be determined that the sample begins to enter the measurement channel 11.
  • the two detection signals are the same, so it can be determined that the sample has filled the measurement channel 11.
  • the first electrode group 41a can measure whether there is any abnormality in the sample in the measurement channel 11 before, simultaneously and/or after the first electrode 41 measures other electrochemical parameters of the sample to obtain multiple groups of detection signals, thereby comprehensively measuring and judging the abnormality of the sample in sequence over a more accurate period of time.
  • other electrodes can be arranged on the first electrode 41 in the measuring channel 11 between the first detection electrode 413 and the second detection electrode 414, so that the first detection electrode 413, the second detection electrode 414 and the counter electrode 412 can effectively detect whether there is an abnormality in the sample detected by the first electrode 41, further ensuring the accuracy of other biochemical parameters of the sample.
  • the first detection electrode 413 and the second detection electrode 414 may be conductivity electrodes, and the detection signals acquired by the first loop and the second loop may be the first conductivity and the second conductivity, respectively, the first conductivity being the conductivity of the sample between the counter electrode 412 and the first detection electrode 413, and the second conductivity being the conductivity of the sample between the counter electrode 412 and the second detection electrode 414.
  • the two detection signals may be detected and acquired at the same time when the first electrode 41 performs a conventional electrochemical parameter detection process, or at different times when the first electrode 41 performs a conventional electrochemical parameter detection process, such as at a short interval.
  • the sample test card 9 provided in the present application may further include a first plate 4, a second plate 5 and a first shell 6.
  • a first electrode group 41a is arranged on the first plate 4.
  • a first through hole 51 is opened on the second plate 5, and the second plate 5 is arranged on the side of the first plate 4 where the first electrode group 41a is arranged, and the first electrode group 41a is exposed through the first through hole 51.
  • the first shell 6 cooperates with the first plate 4 to clamp the second plate 5, so as to form a first channel 1 at a position corresponding to the first through hole 51, so that the first electrode group 41a is exposed in the first channel 1.
  • a third electrode 8 is further disposed on the first plate 4 , and the third electrode 8 is signal-connected to the first electrode group 41 a so as to output a detection signal of the sample acquired by the first electrode group 41 a .
  • the first electrode group 41 a and the third electrode 8 may be connected via a lead 47 b , and the first detection electrode 413 , the second detection electrode 414 and the counter electrode 412 are respectively connected to different third electrodes 8 , thereby outputting a detection signal.
  • the first electrode 41 may also be connected to the third electrode 8 by using a lead 47 b to transmit other electrochemical parameter signals of the sample measured by the first electrode 41 to the third electrode 8 .
  • the third electrode 8 may be disposed on the same side surface or the back side surface of the first electrode group 41 a, so that the third electrode 8 is electrically connected to the medical detection device to transmit signals.
  • Figure 4 is a schematic diagram of the structure of the detection component of the medical detection device used in the present application.
  • Figure 5 is a partial enlarged schematic diagram of the A area in Figure 4.
  • the third electrode 8 is arranged on the same side surface of the first electrode group 41a away from the side edge of the first channel 1, and compared with the first channel 1, the third electrode 8 is located at the front end of the installation direction of the sample test card 9 into the medical detection device 9a.
  • the third electrode 8 can be exposed outside the first shell 6 through the contact notch 64 of the first shell 6 of the sample test card 9, so that the third electrode 8 can be connected to the signal of the medical detection device 9a equipped with the sample test card 9, so as to output the detection signal from the first electrode group 41a to the medical detection device 9a for analysis and/or calculation.
  • the second shell 7 may also be provided with an assembly notch 71 corresponding to the contact notch 64, so that the contact electrode 81 can pass through the assembly notch 71 and connect with the third electrode 8.
  • the assembly notch 71 and the contact notch 64 may be disposed corresponding to the position of the third electrode 8 .
  • the sample test card 9 may further include a second channel 2 and a second electrode 42 located in the second channel 2.
  • the second electrode 42 is configured to obtain electrochemical parameters of a reference solution in the second channel 2.
  • the sample in the first channel 1 is connected to the reference solution in the second channel 2, so that the first electrode 41 and the second electrode 42 can form a loop to measure other electrochemical parameters of the sample.
  • the second channel 2 and the first channel 1 may be connected via a salt bridge 3 .
  • the second electrode 42 may be disposed on a surface of the first plate 4 on which the first electrode 41 is disposed, and a second through hole 52 corresponding to the second channel 2 is opened on the second plate 5 , and the second electrode 42 is exposed through the second through hole 52 .
  • the sample test card 9 may further include a second shell 7 to achieve the overall assembly and fixation of the sample test card 9, so as to press the first plate 4 from the side of the first plate 4 away from the second plate 5, so that the first plate 4, the second plate 5, and the first shell 6 are tightly fixed, thereby avoiding leakage or mutual contamination of liquid in the first channel 1 and the second channel 2, resulting in inaccurate measurement results or damage to instruments and equipment.
  • a second shell 7 to achieve the overall assembly and fixation of the sample test card 9, so as to press the first plate 4 from the side of the first plate 4 away from the second plate 5, so that the first plate 4, the second plate 5, and the first shell 6 are tightly fixed, thereby avoiding leakage or mutual contamination of liquid in the first channel 1 and the second channel 2, resulting in inaccurate measurement results or damage to instruments and equipment.
  • the detection component includes a sample test card 9, a contact electrode 81 and a processor (not shown in the figure).
  • the sample test card 9 includes a first channel 1 and a first electrode group 41a arranged in the first channel 1.
  • the first electrode group 41a has a first detection electrode 413, a second detection electrode 414 and a counter electrode 412, the counter electrode 412 is arranged between the first detection electrode 413 and the second detection electrode 414, the counter electrode 412 and the first detection electrode 413 form part of the first loop, and the counter electrode 412 and the second detection electrode 414 form part of the second loop.
  • the first loop and the second loop can be used to simultaneously obtain at least two detection signals of the sample in the first channel 1 during the sample detection process, and the at least two detection signals are used for comparison to determine whether there is an abnormality in the sample in the first channel 1 between the first detection electrode 413 and the second detection electrode 414.
  • the contact electrode 81 is disposed in the medical detection device 9a and is signal-connected to the first electrode group 41a, thereby obtaining the detection signal measured by the first electrode group 41a.
  • the processor is connected to the contact electrode 81, and is used to receive at least two detection signals obtained by it, and judge whether the sample in the first channel 1 is abnormal according to the at least two detection signals.
  • the contact electrode 81 can be in contact and communicate with the third electrode 8 of the sample test card 9, so that the detection signal of the sample measured by the first electrode group is output to the processor of the medical detection device 9a using the third electrode 8 and the contact electrode 81.
  • the first channel 1 may also include a measurement channel 11 for accommodating samples, and the first detection electrode 413 and the second detection electrode 414 are arranged at both ends of the measurement channel 11.
  • the detection signals obtained by the first loop and the second loop may be the first conductivity and the second conductivity, respectively, the first conductivity being the conductivity of the sample between the counter electrode 412 and the first detection electrode 413, and the second conductivity being the conductivity of the sample between the counter electrode 412 and the second detection electrode 414.
  • the processor can determine that an abnormality has occurred in the sample in the current measurement channel 11.
  • the processor can also calculate in which section of the measurement channel 11 the abnormality appears according to different conductivity change rules. It is even possible to infer the type of abnormality that causes the conductivity change based on the conductivity, thereby obtaining a more detailed analysis result for the sample and distinguishing between abnormalities caused by external factors such as bubbles and abnormalities inherent in the sample such as clots.
  • the present application also provides a sample test card 9, comprising a first channel 1 and a first electrode group 41a.
  • the first electrode group 41a is arranged in the first channel 1 and comprises at least two detection electrodes.
  • the at least two detection electrodes can be connected through the sample in the first channel 1, so as to obtain at least two detection signals of the sample in the first channel 1 between the at least two detection electrodes during the sample detection process.
  • the at least two detection signals can be used for comparison to determine whether there is an abnormality in the sample in the first channel 1 between the two detection electrodes.
  • the method for obtaining at least two detection signals can be that the partial loop formed by the two fixed detection electrodes detects the same section of the sample at least twice in succession, thereby obtaining at least two detection signals, and then judging according to the difference between the successive detection signals, and then obtaining the input Whether there is any abnormality in the sample before and after the sample is taken or before and after the sample is measured or during the measurement of the sample.
  • the present application also provides a medical detection device 9a, including a contact electrode 81 and a processor.
  • the contact electrode 81 is connected to the first electrode group 41a in the first channel 1 of the sample test card 9, at least two detection electrodes can be connected through the first channel 1, and the contact electrode 81 is used to transmit the detection signal of the sample in the first channel 1 obtained by the first electrode group 41a.
  • the processor is connected to the contact electrode 81, and is used to receive the detection signal, and judge whether there is an abnormality in the first channel 1 according to the detection signal.
  • the present application also provides a detection method for a sample test card, including obtaining at least two detection signals obtained by a medical detection device in a first channel for sample detection, wherein the sample test card includes a first channel and a first electrode group arranged in the first channel, the first electrode group includes a first detection electrode, a second detection electrode and a counter electrode, the counter electrode is arranged between the first detection electrode and the second detection electrode, the counter electrode and the first detection electrode form a part of a first loop, the counter electrode and the second detection electrode form a part of a second loop, and one of the at least two detection signals can be obtained by using the first loop and the second loop respectively.
  • the processor of the medical detection device obtains a result of an abnormality.

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente demande se rapporte au domaine des instruments analytiques, et concerne en particulier une carte de test d'échantillon, un ensemble de test et un dispositif de test médical. La carte de test d'échantillon de la présente invention comprend un premier canal et un premier jeu d'électrodes. Le premier jeu d'électrodes est agencé dans le premier canal et comprend une première électrode de test, une seconde électrode de test et une contre-électrode ; la contre-électrode est agencée entre les première électrode et seconde électrode de test ; la contre-électrode et la première électrode de test font partie d'une première boucle ; la contre-électrode et la seconde électrode de test font partie d'une seconde boucle ; les première et seconde boucles sont utilisées pour acquérir simultanément au moins deux signaux de test d'un échantillon du premier canal dans un processus de test d'échantillon ; et lesdits au moins deux signaux de test sont configurés pour être comparés l'un à l'autre afin de déterminer la présence d'une anomalie dans l'échantillon entre les première et seconde électrodes de test dans le premier canal. Sur la base des signaux de test, il est possible de déterminer la présence d'une anomalie dans un échantillon entre deux électrodes de test, ce qui permet d'améliorer la précision de mesure de paramètres électrochimiques de l'échantillon.
PCT/CN2023/110396 2023-07-31 2023-07-31 Carte de test d'échantillon, ensemble de test et dispositif de test médical Pending WO2025025107A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2023/110396 WO2025025107A1 (fr) 2023-07-31 2023-07-31 Carte de test d'échantillon, ensemble de test et dispositif de test médical

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Application Number Priority Date Filing Date Title
PCT/CN2023/110396 WO2025025107A1 (fr) 2023-07-31 2023-07-31 Carte de test d'échantillon, ensemble de test et dispositif de test médical

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WO2025025107A1 true WO2025025107A1 (fr) 2025-02-06

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040232009A1 (en) * 2001-10-12 2004-11-25 Hisashi Okuda Concentration measuring method and concentration measuring device
US20070102292A1 (en) * 2005-05-10 2007-05-10 Roche Diagnostics Operations, Inc. Method and system for error checking an electrochemical sensor
CN113125528A (zh) * 2020-01-14 2021-07-16 利多(香港)有限公司 一种用于多指标参数检测的电化学测试条及检测方法
CN114646678A (zh) * 2020-12-21 2022-06-21 豪夫迈·罗氏有限公司 传感器组件
US20220196632A1 (en) * 2020-12-21 2022-06-23 Roche Diagnostics Operations, Inc. Sensor device and method of use

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040232009A1 (en) * 2001-10-12 2004-11-25 Hisashi Okuda Concentration measuring method and concentration measuring device
US20070102292A1 (en) * 2005-05-10 2007-05-10 Roche Diagnostics Operations, Inc. Method and system for error checking an electrochemical sensor
CN113125528A (zh) * 2020-01-14 2021-07-16 利多(香港)有限公司 一种用于多指标参数检测的电化学测试条及检测方法
CN114646678A (zh) * 2020-12-21 2022-06-21 豪夫迈·罗氏有限公司 传感器组件
US20220196632A1 (en) * 2020-12-21 2022-06-23 Roche Diagnostics Operations, Inc. Sensor device and method of use

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