WO2012006778A1 - Bandelette réactive pour détecter un fluide - Google Patents

Bandelette réactive pour détecter un fluide Download PDF

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Publication number
WO2012006778A1
WO2012006778A1 PCT/CN2010/075153 CN2010075153W WO2012006778A1 WO 2012006778 A1 WO2012006778 A1 WO 2012006778A1 CN 2010075153 W CN2010075153 W CN 2010075153W WO 2012006778 A1 WO2012006778 A1 WO 2012006778A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
detecting test
fluid detecting
test piece
test strip
Prior art date
Application number
PCT/CN2010/075153
Other languages
English (en)
Chinese (zh)
Inventor
谢文彬
王正贤
Original Assignee
红电医学科技股份有限公司
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.)
Filing date
Publication date
Application filed by 红电医学科技股份有限公司 filed Critical 红电医学科技股份有限公司
Priority to JP2013518927A priority Critical patent/JP2013530409A/ja
Priority to PCT/CN2010/075153 priority patent/WO2012006778A1/fr
Publication of WO2012006778A1 publication Critical patent/WO2012006778A1/fr

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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
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels

Definitions

  • the invention relates to a fluid detecting test piece, in particular to a fluid detecting test piece having a special design in a sampling area of a biological sample.
  • a sheet is designed with a flow path or a micro-channel structure on a substrate or a substrate and is subjected to surface hydrophobic treatment, and the fluid to be tested is not soaked with a material such as protein or sugar.
  • a composition with a high hysteresis so when the fluid to be tested flows, it will remain on the flow path, so that the fluid to be tested cannot be completely reacted, which not only causes waste of the fluid to be tested, but also may cause errors in the final test results.
  • the problem of fluid transfer in the conventional fluid detecting test piece is that the originally existing air in the flow channel causes the fluid to be tested to be injected into the flow channel to be generated or entangled in bubbles of different sizes, thereby causing the flow channel to be blocked, resulting in actual The measurement error even caused the test to fail.
  • an electrochemical test strip 9 used in the conventional art includes a substrate 91 which is sequentially stacked, a plurality of electrodes 921, an insulating layer 93, and an upper cap layer 94. Further, a lateral groove 931 parallel to the short axis of the electrochemical test strip 9 is provided in the insulating layer 93. Therefore, after the assembly is completed, the lateral grooves 931, the substrate 91 and the upper cover together constitute a flow path 95 parallel to the short axis of the fluid detecting test piece 9, in which the reaction area 950 is provided.
  • the electrochemical test strip 9 of this design has an opening 951 and 952 on each side of the flow path 95, and both openings 951 and 952 can serve as sample inlets for sampling.
  • the opening 951 When the opening 951 is used as a sample inlet, the opening 952 becomes an exhaust port and vice versa. That is, after the sample to be tested (e.g., blood) enters the flow channel 95 from the opening 951, the sample to be tested flows through the reaction zone 950 by capillary action, and the reaction zone 950 is coated with the reaction material.
  • the analyte such as blood glucose
  • the electrode 921 can conduct the current signal generated by the electrochemical reaction to the rear detection instrument for judgment.
  • the width of the flow path 95 is limited, so that the sizes of the openings 951 and 952 are not too large.
  • the user needs to carefully align the sample to allow the sample to be tested (such as fingertip blood) to flow smoothly into the reaction area 95.
  • users of the electrochemical test strip 9 include patients suffering from chronic chronic diseases (for example, diabetic patients) who often develop complications due to long-term chronic diseases (for example, macular degeneration or peripheral nerve atrophy).
  • chronic chronic diseases for example, diabetic patients
  • long-term chronic diseases for example, macular degeneration or peripheral nerve atrophy.
  • the phenomenon of impaired vision or insufficient coordination of movements can not perform the above-mentioned fine operations requiring hand-eye coordination, and it is also likely to cause measurement errors and user frustration.
  • the flow path 95 of the electrochemical test strip 9 extends rearward from the front end thereof into an approximately U-shaped structure, and the flow path 95 of the U-shaped structure has only one opening 951.
  • the sample to be tested is injected into the flow path 95 from the opening 951 of the flow path 95.
  • the air resistance is blocked by the air resistance, and bubbles are generated in the flow channel 95, and the capillary action and the siphon phenomenon are promoted, so that the sample to be tested can smoothly flow into the reaction region 950, in the flow channel.
  • the upper cover layer 94 is provided with an exhaust opening 94 ⁇ so that the air originally present in the flow path 95 can be discharged by the exhaust opening 941.
  • the present invention provides a fluid detecting test piece for detecting a fluid sample, comprising a substrate stacked in sequence, a plurality of electrodes, a support layer, and an upper cover.
  • the fluid detecting test piece has a longitudinal long axis and a lateral short axis, the longitudinal long axis and the transverse short axis are perpendicular to each other, and the fluid detecting test piece has a first end and a second end opposite to the first end along the longitudinal long axis direction, the electrode
  • the layer has a plurality of electrodes.
  • the fluid detecting test piece has a sensing area at the end of the first end, the sensing area is disposed parallel to the lateral short axis and is jointly defined by the upper cover, the supporting layer and the substrate, and the electrode extends into the sensing area.
  • the sensing region has a maximum depth along the longitudinal long axis direction, and the sensing region has a maximum width along the lateral short axis direction, and the maximum width is greater than the maximum depth.
  • the fluid sample flows within the sensing region after entering and has the longest flow path, and the sensing region has a ⁇ -shaped configuration along a section perpendicular to the longest flow path.
  • the upper cover faces the sensing area and is coated with a hydrophilic material.
  • the main object of the present invention is to provide a fluid detecting test piece whose sensing region is extended In the long-axis direction, the three-sided closed area, when the sample to be tested enters the sensing area, the air originally present in the sensing area can be directly discharged from other directions and positions where the sample to be tested enters. There is no need to provide a venting hole. Therefore, it is not necessary to provide an venting hole in the upper cover or in the support layer or on the electrode layer during the test piece production process, so there is no need to accurately align with the lower flow path (sensing area). Fits with, thus reducing manufacturing costs and increasing manufacturing yield.
  • Another object of the present invention is to provide a fluid detecting test piece whose sensing area is located at the foremost end of the fluid detecting test piece and whose width is greater than the depth, and the sample to be tested can be accepted as long as the opening of the sensing area is acceptable. Injecting, when injecting the sample to be tested, the air originally present in the sensing area is used, which is convenient for long-term chronic patients and elderly people.
  • Another object of the present invention is to provide a fluid detecting test piece, wherein a lead angle structure can be further disposed at the first end and on both sides of the longitudinal long axis, and the user only needs to bring the lead angle structure close to the sampling point, the sample to be tested
  • the capillary enters into the sensing area, and the air originally present in the sensing area is discharged from the front end of the test piece and the other end of the lead, which is convenient for sampling.
  • FIG. 1A is a schematic view showing the combination of fluid detecting test pieces according to a first preferred embodiment of the present invention.
  • Figure 1B is an exploded perspective view of a fluid detecting test strip according to a first preferred embodiment of the present invention.
  • Fig. 1C is an enlarged schematic view showing a first end portion of a fluid detecting test piece according to a first preferred embodiment of the present invention.
  • Fig. 1D is a plan view of a fluid detecting test piece according to the first preferred embodiment.
  • Fig. 1E is a plan view of a fluid detecting test piece according to the first preferred embodiment.
  • Fig. 1 F is a schematic cross-sectional view showing a fluid detecting test piece according to a first preferred embodiment of the present invention.
  • 2A is a schematic view showing the combination of fluid detecting test pieces according to a second preferred embodiment of the present invention.
  • Fig. 2B is an exploded perspective view showing a fluid detecting test piece according to a second preferred embodiment of the present invention.
  • Fig. 2C is an enlarged schematic view showing the first end portion of the fluid detecting test piece according to the second preferred embodiment of the present invention.
  • FIG. 2D is a schematic cross-sectional view of a fluid detecting test strip according to a second preferred embodiment of the present invention.
  • Fig. 3A is a schematic view of an electrochemical test strip according to the conventional art.
  • Figure 3B is a schematic illustration of an electrochemical test strip disclosed in U.S. Patent No. 6,258,229.
  • the upper cover faces one side of the groove 141, 241
  • the present invention discloses a fluid detecting test piece in which the biological sample detecting principle and the solution coating technique are utilized, which are known to those skilled in the relevant art, and therefore will not be fully described in the following description.
  • the corresponding drawings in the following drawings are schematic diagrams relating to the features of the present invention, and are not required to be completely drawn according to the actual situation, and are previously stated.
  • FIG. 1A is a schematic diagram of a fluid detecting test strip assembly according to a first preferred embodiment of the present invention.
  • the fluid detecting test piece 1 includes a substrate 1 1 , a plurality of electrodes 121, a support layer 13 and an upper cover 14.
  • the substrate 1 1 is preferably made of a bio-inert material.
  • the fluid detecting test piece 1 has a longitudinal long axis X and a lateral short axis Y, and the longitudinal long axis X and the lateral short axis Y are perpendicular to each other.
  • the fluid detecting test strip 1 has a first end 101 and a second end 102 opposite the first end 101 in the longitudinal direction of the longitudinal axis X.
  • the length L2 of the support layer 13 along the longitudinal long axis X direction is smaller than the length L1 of the upper cover 14 along the longitudinal long axis X direction, and the upper cover 14 is disposed on the support layer 13, and the fluid detecting test piece 1 has a feeling at the end of the first end 101
  • the sensing area 15 is defined by the support layer 13 together with the upper cover 14 and the substrate 11, and the upper cover 14 completely covers the sensing area 15.
  • the sensing area 15 is set parallel to the lateral short axis Y. In use, the user only needs to bring the first end 101 of the fluid detecting test piece 1 close to the sampling position (for example, at the skin pin), and the sample to be tested enters the sensing area 15 due to capillary phenomenon, which is convenient for sampling.
  • FIG. 1B is an exploded perspective view of a fluid detecting test piece according to a preferred embodiment of the present invention.
  • Base The board 11, the plurality of electrodes 121, the support layer 13, and the upper cover 14 are sequentially stacked from bottom to top.
  • the electrode 121 is coated on the substrate 11, for example, by printing, coating, or deposition.
  • FIG. 1C an enlarged view of a first end portion of a fluid detecting test piece according to a preferred embodiment of the present invention is shown.
  • the maximum width W of the sensing region 15 along the lateral minor axis in the Y direction is greater than the maximum depth Dmax of the longitudinal long axis in the X direction.
  • the volume of the sensing region 15 is preferably at most 5 microliters, more preferably 1 microliter.
  • the maximum depth Dmax is greater than the maximum width W.
  • the ratio of the maximum depth Dmax to the maximum width W is preferably 1:2 or less, and most preferably 1:
  • the purpose of the above design is to Capillary action can be utilized to enable the sample to be tested to enter from any one of the sensing regions 15, and then fill the entire sensing region 15, and the air originally left in the sensing region 15 is pushed by the sample to be tested. And discharging to the other non-test sample entering region of the sensing region 15.
  • the upper cover 14 does not need to be additionally designed with vent holes, thereby reducing manufacturing costs and improving manufacturing yield.
  • the sample inlet (sensing area 15) of the fluid detecting test piece 1 is located at the end of the front end (first end 101), and the maximum width W of the sensing area 15 along the lateral short axis Y is larger than the edge
  • the maximum depth Dmax of the longitudinal long axis X as long as the opening of the sensing region 15 can accept the injection of the sample to be tested, even if the sample to be tested is injected from the center of the sensing region 15, it is originally left in the sensing region 15.
  • the air will also be discharged from the center to both sides due to the pushing of the sample to be tested.
  • the user does not need to accurately align the fluid test strip 1 with the sampling point, which is convenient for long-term chronic patients and elderly people.
  • FIG. 1D is a top view of the fluid detecting test piece 1 of the first preferred embodiment.
  • the fluid sample seeks the shortest path due to capillary action to enter the sensing region 15 in the entering direction E (parallel to the longitudinal long axis X). Then, after contacting the fluid sample against a side 133 of the support layer 13 toward the first end 101, the fluid sample will follow along due to the interaction between the cohesive force of the fluid sample itself and the contact force between the fluid sample and the side surface 133.
  • the path P (parallel to the lateral minor axis Y) flows.
  • the maximum width W of the sensing region 15 along the transverse short axis Y direction (fluid sample)
  • the maximum flow distance in the direction P is greater than the maximum depth Dmax along the longitudinal axis X (the maximum flow distance of the fluid sample in the direction E), so the longest flow path of the fluid sample in the sensing region 15 is the path P. . Therefore, while the fluid sample flows along the direction E and the path P, an interface as shown by the broken line curve in FIG. 1D is formed, and the air originally present in the sensing region 15 is pushed by the fluid sample. Other non-fluid samples of the measurement zone 15 are discharged into the direction of the zone (as indicated by the dashed straight arrow in Figure 1D).
  • Fig. 1E is a plan view of the fluid detecting test piece 1 of the first preferred embodiment.
  • the fluid sample seeks the shortest path along the entry direction E due to capillary action (with The longitudinal long axis X is parallel) into the sensing region 15.
  • the fluid sample will then follow along the interaction between the cohesive force of the fluid sample itself and the contact force between the fluid sample and the side surface 133, respectively.
  • the path P1 and the path P2 both parallel to the lateral minor axis Y) flow.
  • the longest flow path in the sensing region 15 is the path P1 plus the path P2.
  • an interface as shown by the dashed curve in Fig. 1E is formed, and the air originally present in the sensing region 15 is pushed through the fluid sample.
  • the squeezing is discharged to the direction in which the other non-fluid sample of the sensing region 15 enters the region (as indicated by the dashed straight arrow in FIG. 1E).
  • FIG. 1F is a cross-sectional view of the fluid detecting test strip 1 along the line AA of FIG. 1A according to the first preferred embodiment of the present invention.
  • the AA line is perpendicular to the longest flow path P of the fluid sample described in the previous paragraph (or P1 plus P2).
  • the upper cover 14 is disposed on the support layer 13 to completely cover the sensing region 15, and therefore, the upper cover 14 is formed with a cantilever structure at the first end 101 (shown in FIG. 1A) of the fluid detecting test strip 1.
  • the electrode 121 extends into the sensing region 15.
  • the sensing region 15 is defined by the support layer 13 together with the upper cover 14 and the substrate 11, and as shown, has a ⁇ -shaped configuration.
  • the ratio Z: Dmax of the two needs to be at least 1: 20, preferably 1 : 10 , that is, when the height Z of the sensing region 15 is ⁇ (micrometer ), the maximum of the sensing region 15 along the lateral minor axis Y
  • the depth Dmax is preferably 1 mm (millmeter).
  • the one side 141 of the upper cover 14 facing the sensing region 15 is coated with a hydrophilic material to facilitate the smooth flow of the sample to be tested into the sensing region 15.
  • the upper cover 14 is preferably a transparent material near the first end 101.
  • the present invention provides a second preferred embodiment, which is also a fluid detecting test piece, please refer to Figs. 2A to 2D.
  • the fluid detecting test piece disclosed in the present embodiment is substantially the same as that described in the first preferred embodiment, and only the differences between the two will be described below.
  • the fluid detecting test piece 2 has a longitudinal long axis X and a lateral short axis Y, and the longitudinal long axis X and the transverse short axis Y are perpendicular to each other.
  • the fluid detecting test strip 2 has a first end 201 and a second end 202 opposite the first end 201 in the longitudinal long axis X direction.
  • the first end 201 of the fluid detecting test piece 2 is provided with a lead angle structure 203 with respect to both sides of the longitudinal long axis X, and the lead angle structure 203 extends from the first end 201 to the second end 202. Further, the lead angle structure 203 shown in Fig.
  • the lead angle structure 203 may also be designed in an arc shape for special needs. Therefore, when in use, the user only needs to bring the lead structure 203 close to the sampling point (for example, at the skin pin), and the sample to be tested enters the sensing area 25 due to capillary phenomenon, which is convenient for sampling.
  • FIG. 2B there is shown an exploded perspective view of a fluid detecting test piece according to a second preferred embodiment of the present invention.
  • the substrate 21, the plurality of electrodes 221, the support layer 23, and the upper cover 24 are sequentially stacked from bottom to top.
  • the support layer 23 has a recess 231 corresponding to the first end 201. Electrode 221 extends into sensing region 25 (shown in Figure 2A).
  • FIG. 2C is an enlarged schematic view showing a first end portion of a fluid detecting test piece according to a second preferred embodiment of the present invention.
  • the groove 231 is not a complete rectangular structure but has an approximately trapezoidal structure, so the adjacent lead angle is along the longitudinal long axis X direction.
  • Structure 203 further has a minimum depth Dmin.
  • the ratio of the minimum depth Dmin of the groove 231 to the maximum depth Dmax of the sensing region 25 is preferably 3:5 or less, more preferably 2:5 or less.
  • the recess 231 has a rounded configuration 232 toward the second end 202 (shown in FIG.
  • the reason for adopting the above design is that when the sample to be tested flows into the groove 231, the rounded configuration 232 of the groove 231 facing the second end 202 has an R value of at least 0.5 mm, thereby reducing eddy current or turbulence. Avoid creating bubbles here without disturbing the detection or quantification of the sample to be tested.
  • the maximum width W of the sensing region 25 is greater than the maximum depth Dmax, and in the design of the size ratio, the ratio of the maximum depth Dmax to the maximum width W is preferably 1:2 or less, and most preferably 1:5. .
  • the purpose of the above design is to enable the sample to be tested to enter the sensing region 25 by the groove 231 adjacent to any of the two corner structures 203 by capillary action, and the air originally left in the sensing region 25 is caused by the capillary action. The pushing of the sample to be tested is discharged toward the first end 201 and the other corner guide structure 203.
  • the upper cover 24 does not need to be additionally designed with a vent hole, and the upper cover 24 does not need to be accurately aligned with the groove 231 during the manufacturing process, thereby reducing the manufacturing cost and improving the manufacturing yield.
  • the sample inlet of the fluid detecting test piece 2 is located at the front end (first end 201), and the maximum width W and the opening width W of the sensing region 25 along the lateral minor axis Y are larger than The maximum depth Dmax along the longitudinal long axis X, when the sample to be tested is injected, the air originally left in the sensing region 25 is discharged from the center toward the two guiding structures 203 due to the pushing of the sample to be tested, and the user does not need to The fluid test strip 2 is accurately aligned with the sampling site, which is convenient for long-term chronic patients and elderly people.
  • FIG. 2D a cross-sectional view of the fluid detecting test piece 2 of the second preferred embodiment of the present invention taken along line AA of FIG. 2A.
  • the upper cover 24 is disposed on the support layer 23 to completely cover the sensing area 25.
  • the sensing region 25 is defined by the support layer 23 together with the upper cover 24 and the substrate 11.
  • the one side 241 of the upper cover 24 facing the sensing area 25 is coated with a hydrophilic material to facilitate the smooth flow of the sample to be tested into the sensing area 25 along the groove 231.
  • the detection error is caused, and the upper cover 24 is preferably transparent near the first end 201.
  • the proportional relationship between the height of the sensing region 25 and the maximum width Dmax of the sensing region 25 along the lateral minor axis is the same as that described in the first preferred embodiment, and the details are not repeated herein.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La bandelette réactive (1) pour détecter un fluide ci-décrite comprend une plaque formant substrat (11, 21), une pluralité d'électrodes (121,221), une couche de support (13, 23) et un couvercle supérieur (14, 24), stratifiés les uns sur les autres. La bandelette réactive (1) pour détecter un fluide a un axe longitudinal long (X) et un axe horizontal court (Y) qui sont perpendiculaires, et une première extrémité (101, 201) et une seconde extrémité (102, 202), à l'opposé de la première (101, 201) dans le sens de l'axe longitudinal long (X). La bandelette réactive (1) pour détecter un fluide comporte une zone de détection (15, 25) à la pointe de la première extrémité (101, 201). La zone de détection (15, 25) est parallèle à l'axe horizontal court (Y) et est définie par le couvercle supérieur (14, 24), la couche de support (13, 23) et la plaque formant substrat (11, 21). La zone de détection (15, 25) a sa profondeur la plus longue dans le sens de l'axe longitudinal long (X), et sa largeur la plus longue dans le sens de l'axe horizontal court (Y). La largeur la plus longue est plus longue que la profondeur la plus longue. L'échantillon de fluide a le trajet d'écoulement le plus long après qu'il a pénétré dans la zone de détection (15, 25) dans laquelle il s'écoule. La zone de détection a une structure ayant une section en forme de 匚 qui est perpendiculaire au trajet d'écoulement le plus long.
PCT/CN2010/075153 2010-07-14 2010-07-14 Bandelette réactive pour détecter un fluide WO2012006778A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2013518927A JP2013530409A (ja) 2010-07-14 2010-07-14 体液サンプル検出用試験ストリップ
PCT/CN2010/075153 WO2012006778A1 (fr) 2010-07-14 2010-07-14 Bandelette réactive pour détecter un fluide

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2010/075153 WO2012006778A1 (fr) 2010-07-14 2010-07-14 Bandelette réactive pour détecter un fluide

Publications (1)

Publication Number Publication Date
WO2012006778A1 true WO2012006778A1 (fr) 2012-01-19

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WO (1) WO2012006778A1 (fr)

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US6258229B1 (en) * 1999-06-02 2001-07-10 Handani Winarta Disposable sub-microliter volume sensor and method of making
CA2481425A1 (fr) * 2002-04-19 2003-10-30 Nova Biomedical Corporation Capteur jetable avec admission par orifice d'echantillon renforce
CN1675537A (zh) * 2002-08-13 2005-09-28 郡是株式会社 生物传感器及其制造方法
WO2004093784A2 (fr) * 2003-04-21 2004-11-04 Home Diagnostics, Inc. Systemes et procedes de detection de glycemie
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CN201355357Y (zh) * 2009-02-18 2009-12-02 五鼎生物技术股份有限公司 生化感测试片、生化感测系统及测量装置

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2501870A (en) * 2012-04-13 2013-11-13 Smartcare Technologies Ltd Sample plate for electrical measurements
GB2501870B (en) * 2012-04-13 2018-07-18 Smartcare Tech Limited Improvements in and relating to sample measurement
US10641724B2 (en) 2012-04-13 2020-05-05 Smartcase Technologies Limited Electrical impedance hematocrit and HBA1C biosensor comprising sample plate and sample apparatus
US11415541B2 (en) 2012-04-13 2022-08-16 Smartcare Technologies Ltd Electrical impedance hematocrit and HbA1c biosensor comprising sample plate and sample apparatus

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