WO2012006778A1

WO2012006778A1 - Test strip for detecting fluid

Info

Publication number: WO2012006778A1
Application number: PCT/CN2010/075153
Authority: WO
Inventors: 谢文彬; 王正贤
Original assignee: 红电医学科技股份有限公司
Priority date: 2010-07-14
Filing date: 2010-07-14
Publication date: 2012-01-19
Also published as: JP2013530409A

Abstract

A test strip (1) for detecting fluid includes a substrate plate (11, 21), a plurality of electrodes (121,221), a supporting layer (13, 23) and an upper cover (14, 24), in which one laminates on the other in turn. The test strip (1) for detecting fluid has a long longitudinal axis (X) and a short horizontal axis (Y) which are orthogonal, and has a first end (101,201) and a second end (102,202) which is opposite to the first end (101,201) in the direction of the long longitudinal axis (X). The test strip (1) for detecting fluid has a sensing area (15, 25) at the tip of the first end (101,201). The sensing area (15, 25) is parallel with the short horizontal axis (Y) and is defined by the upper cover (14, 24), the supporting layer (13, 23) and the substrate plate (11, 21). The sensing area (15, 25) has a longest depth in the direction of the long longitudinal axis (X), and has a longest width in the direction of the short horizontal axis (Y). The longest width is longer than the longest depth. The fluid sample has a longest flow path after it enters into the sensing area (15, 25) in which the fluid sample flows. The sensing area has a 匚-shape structure in the cross section which is perpendicular with the longest flow path.

Description

Fluid test strip

Technical field

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. BACKGROUND OF THE INVENTION 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.

In addition, 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.

For example, as shown in Fig. 3A, 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. 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) in the sample to be tested will electrochemically react with the reaction material, and the electrode 921 can conduct the current signal generated by the electrochemical reaction to the rear detection instrument for judgment. Further, to maintain the capillary action of the flow path 95, the width of the flow path 95 is limited, so that the sizes of the openings 951 and 952 are not too large. When in use, 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. However, 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). 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.

In addition, another conventionally designed electrochemical test strip is disclosed in U.S. Patent No. 6,258,229. As shown in Fig. 3B, 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. In use, the sample to be tested is injected into the flow path 95 from the opening 951 of the flow path 95. In order to prevent the sample to be tested from entering the flow channel 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. At the end 954 of 95, the upper cover layer 94 is provided with an exhaust opening 94 Γ so that the air originally present in the flow path 95 can be discharged by the exhaust opening 941. Summary of the invention

In order to overcome the above disadvantages, 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 匸-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.

Therefore, 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. DRAWINGS

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.

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.

[Main component symbol description]

Fluid test strips 1, 2

First end 101, 201

Second end 102, 202

Leading structure 203

Substrate 11, 21

Electrode 121, 221

Support layer 13, 23

Groove 231

Fillet configuration 232

a side of the support layer facing the first end 133

Upper cover 14, 24

The upper cover faces one side of the groove 141, 241

Sensing area 15, 25

At the side of the sensing area 151

Middle of the sensing area 152

Longitudinal long axis X

Transverse short axis γ

The maximum depth of the sensing area along the longitudinal long axis Dmax

Minimum depth of the groove along the longitudinal long axis Dmin

The maximum width of the sensing area along the short axis of the transverse direction W

Opening width of the sensing area W

Height of the sensing area Z

Entry direction E

Path P, Pl, P2

Length Ll, L2

Electrochemical test strips 9, 9,

Substrate 91 Electrode 921

Insulation 93

Lateral groove 931

— t 94, 94,

Exhaust opening 941 '

Runner 95, 95,

Reaction area 950, 950,

Opening 951,

End of flow channel 954, DETAILED DESCRIPTION

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. In the meantime, 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.

First, please refer to FIG. 1A, which 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.

Please refer to FIG. 1B , which 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.

Referring to 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.

Again, as described above, the maximum depth Dmax is greater than the maximum width W. 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: 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.

Therefore, the upper cover 14 does not need to be additionally designed with vent holes, thereby reducing manufacturing costs and improving manufacturing yield. Further, since in use, 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.

For example, please refer to FIG. 1D, which is a top view of the fluid detecting test piece 1 of the first preferred embodiment. When the user brings the fluid sample into contact with the fluid detecting test piece 1 via the side 151 of the sensing region, 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. Due to 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).

Further, please refer to Fig. 1E, which is a plan view of the fluid detecting test piece 1 of the first preferred embodiment. When the user touches the fluid sample from the middle of the sensing region 15 (not necessarily the center) to the fluid detecting test strip 1, similarly to the foregoing, 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. After the fluid sample contacts the side 133 of the support layer 13 facing the first end 101, 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. Fluid sample In this case, the longest flow path in the sensing region 15 is the path P1 plus the path P2. Similarly, while the fluid sample flows along the direction E and the path P1 or 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).

Please refer to FIG. 1F, which 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 匸-shaped configuration. Further, when the surface tension of the sample to be tested is larger than the capillary force generated between the sample and the sensing region 15, the entry of the sample to be tested becomes slow. Therefore, in order to maintain the sensing region 15 with a better capillary force, the height Z of the sensing region 15 and the maximum depth Dmax (as shown in FIG. 1C), 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 ΙΟΟμηι (micrometer ), the maximum of the sensing region 15 along the lateral minor axis Y The depth Dmax is preferably 1 mm (millmeter).

Further, 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. In order to facilitate the observation of the condition of the sample to be tested flowing into the sensing region 15 to prevent the sample to be tested from being insufficient to fill the area to be tested 15 and causing a detection error, the upper cover 14 is preferably a transparent material near the first end 101.

Further, 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.

Referring first to Fig. 2A, 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. 2A is a straight line; however, 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.

Referring to 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).

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. Since the first end 201 of the fluid detecting test piece 2 has the lead structure 203 on both sides, 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. Moreover, 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. Additionally, the recess 231 has a rounded configuration 232 toward the second end 202 (shown in FIG. 2A) and on either side of the longitudinal major axis X. 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.

Again, as described above, 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. Therefore, 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. Further, since in use, 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.

Referring to 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. Moreover, 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. In order to facilitate the observation of the condition of the sample to be tested flowing into the sensing region 25 to prevent the sample to be tested from being insufficient to fill the sensing region 25, 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.

The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention. The above description should be understood and implemented by those skilled in the art, and thus, without departing from the spirit of the present invention. Equivalent changes or modifications made below are intended to be included within the scope of this application.

Claims

Claim

A fluid detecting test piece for detecting a fluid sample, comprising sequentially stacking a substrate, a plurality of electrodes, a supporting layer and an upper cover, the fluid detecting test piece having a longitudinal long axis and a transverse 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, wherein:

The fluid detecting test piece has a sensing area at the end of the first end 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 electrodes extend to The sensing area i or inside;

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, the maximum width being greater than the maximum depth;

The fluid sample flows in the sensing region after entering and has a longest flow path, and the sensing region has a 匸-shaped configuration along a section perpendicular to the longest flow path;

The upper cover is coated with a hydrophilic material on one side of the sensing region.

The fluid detecting test piece according to claim 1, wherein a ratio of the maximum depth to the maximum width is 1:2 or less.

3. The fluid detecting test strip according to claim 1, wherein the fluid detecting test piece is provided with a lead angle structure on both sides of the first end with respect to the longitudinal long axis, and the lead angle structure is from the first One end extends toward the second end.

4. The fluid detecting test strip according to claim 3, wherein the support layer has a groove formed at the corresponding first end, and the groove further has a minimum depth along the longitudinal long axis direction, and the minimum The ratio of the depth to the maximum depth of the sensing region is 3:5 or less.

The fluid detecting test piece according to claim 4, wherein a ratio of the minimum depth to the maximum depth is preferably 1:5 or less.

6. The fluid detecting test strip according to claim 4, wherein the groove has a rounded configuration toward the second end and opposite sides of the longitudinal long axis, wherein the rounded configuration The radius of curvature (R) value is at least 0.5 mm.

7. The fluid detecting test strip according to claim 3, wherein the two lead angle structures are circles Solitary or straight line.

8. The fluid test strip of claim 1 having a volume of at least 5 microliters.

9. The fluid detecting test strip according to claim 1, wherein the substrate is a biologically inert material.

10. The fluid detecting test strip according to claim 1, wherein the upper cover is made of a transparent material near the first end.