TWI652476B - Biological test strip - Google Patents

Abstract

A biosensor test piece comprising a circuit unit and a baffle unit. The circuit unit includes a substrate and an electrode line. The partition unit is disposed on the circuit unit and has a detecting end. The partition unit includes an bottom partition, a middle partition, a top partition and a cover. The bottom baffle is recessed from the detecting end to form a bottom plate groove, and the bottom baffle further has a partition structure spanning the bottom plate groove, the partition structure separating the bottom plate groove into a first detecting for exposing the first electrode group portion And a second detection zone in which a portion of the second electrode group is exposed. The middle partition plate, the top partition plate and the cover plate jointly define a passage connecting the second detection area, and a sample body is separated by the middle partition plate to the first detection area and the second detection area, and is located in the first detection area and the second The specimens in the detection area are not in circulation.

Description

Biological test strip

The invention relates to a detecting device, in particular to a biosensor test piece capable of synchronously detecting components contained in a sample.

With the emphasis on health care, people will always pay attention to their physical health. In today's society, almost every household will purchase testing instruments that can be easily measured, such as blood pressure machines and blood glucose testing machines. In this way, regular testing at home not only saves medical resources, but also keeps abreast of your physical condition.

Taking a blood glucose detecting machine as an example, the principle is that an enzyme reacts with glucose in the blood, and an intermediate product generated by the two reactants reacts with the electron transporting substance to generate electrons. At this time, electrons accumulate on the electrode surface of the blood glucose detecting machine. Finally, the blood glucose detecting machine applies a DC voltage to release the electrons accumulated on the electrodes of the blood glucose detecting machine, thereby obtaining a current value, and the blood sugar level can be known by calculation of the conversion equation. However, the hematocrit ratio in the blood can hinder the action of the enzyme and the electron-transporting substance, so that the measurement result of the blood glucose detector does not necessarily reflect the true physical condition correctly.

Therefore, some blood glucose detecting machines currently on the market are structurally divided into two detection zones, one of which is used for measuring the glucose content in the blood. The other detection area is used for measuring the blood volume ratio in the blood. Therefore, the blood glucose detector compensates and corrects the glucose content according to the detection value of the blood volume ratio, thereby obtaining a more accurate blood sugar value. However, these are currently The blood glucose detector still has the problem that the blood or reactants in the two detection areas interfere with each other, and the credibility of the test results does not really match the actual blood condition. In addition, when one of the detection zones is spotted into a liquid reactant, it is highly likely to contaminate another detection zone and cause the measurement results to be affected. Therefore, how to improve the credibility of the test results is an urgent problem to be solved by various types of testing instruments. In addition, the above problems are not limited to the measurement of blood glucose, and other analyte components such as cholesterol, uric acid, ketone bodies, etc. may have the same condition.

Accordingly, it is an object of the present invention to provide a biosensor test piece which can improve the accuracy of a measurement value of a sample-related component.

It is an object of the present invention to provide a biosensor test strip that can perform two analyte tests simultaneously or two tests on the same analyte.

Therefore, the biosensor test strip of the present invention is suitable for detecting an externally-exposed specimen, the biosensor test strip comprising a circuit unit and a separator unit. The circuit unit includes a substrate and an electrode line disposed on the substrate, the electrode line having a first electrode group and a second electrode group operating independently of the first electrode group. The baffle unit is disposed on the circuit unit and has a detecting end, and the baffle unit includes a The substrate and the bottom partition covering the electrode line, a middle partition disposed on a side of the bottom partition away from the substrate, and a top partition disposed on a side of the middle partition away from the bottom partition And a cover plate disposed on a side of the top partition away from the middle partition, the bottom partition is recessed by the detecting end to form a bottom plate groove, and the bottom partition further has a groove extending across the bottom plate a partition structure that partitions the bottom plate groove into a first detection area for the first electrode group portion to be exposed and a second detection area for the second electrode group portion to be exposed, the middle partition, the top The partition plate and the cover plate jointly define a passage connecting the second detection zone and the outer portion, wherein the sample from the outside is separated by the middle partition plate to the first detection zone and the channel, and flows to the channel The sample correspondingly flows to the second detection area, and the sample located in the first detection area and the sample located in the second detection area do not flow with each other.

In some implementations, the middle partition covers the first detection area, and a middle opening that communicates with the second detection area is formed at a position corresponding to the second detection area, and the top partition is configured by the detection end Forming a top plate groove communicating with the middle opening and the outer portion at a position corresponding to the bottom plate groove and the middle opening, the cover plate covers the top plate groove, and the middle opening and the top plate groove communicate to form the channel .

In some embodiments, the biosensor test strip further includes a fixing unit, and the fixing unit includes two bottom adhesive layers, and one of the bottom adhesive layers is fixed between the electrode line and the bottom partition. The other of the bottom adhesive layers is fixed between the bottom partition and the intermediate partition.

In some embodiments, each of the bottom adhesive layers is adjacent to one end of the detecting end to form a pair of first grooves that should be the first detecting area, a pair of second grooves that should be the second detecting area, and a separation of the first A groove and the second groove correspond to the separation section of the separation structure.

In some embodiments, the fixing unit further includes two top adhesive layers, one of the top adhesive layers being fixed between the middle partition and the top partition, and the other of the top adhesive layers It is fixed between the top partition and the cover.

In some embodiments, one end of each top adhesive layer adjacent to the detecting end is recessed to form a pair of through grooves that should be recessed in the top plate.

In some embodiments, the middle partition is recessed by the detecting end at a position corresponding to the first detecting area to form a gap connecting the first detecting area and the channel, and the notch is for the sample to uniformly flow into the first Detection zone and the channel.

In some embodiments, the cover plate penetrates a hole corresponding to the groove of the top plate at a position corresponding to the second detection area, and the air hole is located in the channel and the second detection area when the sample enters the channel. The gas can be discharged from the air hole to enable the sample to flow to the second detection zone.

In some implementations, the biosensor test strip further includes a second electrode group and/or the first electrode group disposed at a position corresponding to the second detection area and/or the first detection area, and The sample produces a reaction layer that detects the reaction.

In some embodiments, the components of the reaction layer comprise an enzyme.

In some embodiments, the top spacer penetrates a through hole corresponding to the bottom plate groove and the second detection area at a position corresponding to the second detection area, and the through hole is used for the sample to enter the channel. Gas located in the channel and the second detection zone may be discharged from the through hole to enable the sample to flow to the second detection zone.

In some embodiments, the top partition has a body disposed in the middle partition and partially covering the middle opening, the body having a guiding side edge located above the middle opening, and the top plate is concave The specimen of the trough is guided by the guiding side edge to the second detecting zone.

The effect of the present invention is that the biosensor test piece divides the bottom plate groove into the first detection zone corresponding to the first electrode group and the second corresponding to the second electrode group by the partition structure of the bottom spacer The detection area is matched with the middle partition plate so that the samples respectively flowing into the first detection area and the second detection area cannot circulate to each other, so that the samples of the first detection area and the second detection area can be independent The detection can avoid the mutual interference of the detection process, and effectively improve the accuracy of the detection value measured by the biosensor test piece, or can be used for multiple detection purposes.

1‧‧‧ circuit unit

11‧‧‧Substrate

12‧‧‧Electrode lines

121‧‧‧First electrode group

122‧‧‧Second electrode group

2‧‧‧Baffle unit

20‧‧‧Detection

21‧‧‧ bottom partition

211‧‧‧Bottom plate groove

212‧‧‧Separate structure

213‧‧‧First detection area

214‧‧‧Second detection area

22‧‧‧ middle partition

221‧‧‧中口口

222‧‧ ‧ gap

23‧‧‧ top partition

231‧‧‧Top plate groove

232‧‧‧ Ontology

233‧‧‧Top extension wall

234‧‧‧ guiding side edges

235‧‧‧through hole

24‧‧‧ Cover

241‧‧‧ stomata

242‧‧‧ channel

3‧‧‧Fixed unit

31‧‧‧ bottom adhesive layer

311‧‧‧First groove

312‧‧‧second groove

313‧‧‧Separation section

32, 32'‧‧‧ top adhesive layer

321‧‧‧through slot

4‧‧‧Reaction layer

Other features and effects of the present invention will be apparent from the following description of the drawings, wherein: Figure 1 is a perspective view of a first embodiment of a biosensor test strip of the present invention. Figure 2 is an exploded perspective view of the embodiment of the circuit unit, a spacer unit and a fixed unit; Figure 3 is an incomplete partial perspective view of the embodiment. It is to be noted that one of the first electrode group and the second electrode group respectively corresponds to a first detection area and a second detection area; FIG. 4 is an incomplete section side along one of the IV-IV lines in FIG. FIG. 5 is a perspective exploded view of a second embodiment of the biosensor test strip of the present invention, illustrating a circuit unit of the embodiment, The structure of a partition unit and a fixed unit; and FIG. 6 is a cross-sectional side view similar to one of FIG. 3, illustrating the structural laminated relationship of the top partition and the middle partition of the second embodiment.

Before the present invention is described in detail, it should be noted that in the following description, similar elements are denoted by the same reference numerals.

Referring to FIG. 1 to FIG. 3, a first embodiment of a biosensor test piece according to the present invention is suitable for detecting a sample from the outside. The sample is exemplified by a human blood but also other human body. A tissue sample comprising a circuit unit 1, a separator unit 2, a fixing unit 3, and a reaction layer 4. In the embodiment, the spacer unit 2 has a laminated structure and the stacked structure is performed by the fixing unit 3. Adhesively fixed and simultaneously adhered to the circuit unit 1 by the fixing unit 3, the spacer unit 2 has a detecting end 20 into which the sample flows.

The circuit unit 1 includes a substrate 11 and an electrode line 12 disposed on the substrate 11. The electrode line 12 has a first electrode group 121 and a second electrode group 122 that operates independently of the first electrode group 121. In the embodiment, the circuit unit 11 is a printed circuit board, and the electrode line 12 is printed on the substrate 11. However, the embodiment of the circuit unit 11 is not limited to the printed circuit board. The first electrode group 121 is used, for example, to detect a blood cell volume ratio in the blood, and the second electrode group 122 is used, for example, to detect a glucose content in the blood. However, the first electrode group 121 and the second electrode group 122 are The sample components that can be detected are not limited to glucose in the blood. In this embodiment, through the structural design of the spacer unit 2, the blood sample measured at the first electrode group 121 and the blood sample measured at the second electrode group 122 are separated, and respectively detected. In order to improve the accuracy of the detection result, the detailed structure of the separator unit 2 will be described below.

Referring to FIG. 2 and FIG. 4, the spacer unit 2 includes a bottom partition 21 disposed on the substrate 11 and covering the electrode line 12, and a middle partition 22 disposed on the top side of the bottom partition 21. a top partition 23 disposed on a top side of the middle partition 22, and a cover 24 disposed on a top side of the top partition 23, the bottom partition 21, the middle partition 22, the top partition 23, and the The cover plates 24 are sequentially stacked to form a laminated structure.

Referring to Figures 2 to 4, more clearly, the bottom partition 21 is from the detecting end The recessed portion 20 defines a bottom plate recess 211, and the bottom partition plate 21 further has a partition structure 212 spanning the bottom plate recess 211. The partition structure 212 divides the bottom plate recess 211 into a first detecting area 213 and a a second detecting area 214, an end of the first electrode group 121 adjacent to the detecting end 20 is exposed in the first detecting area 213, and an end of the second electrode group 122 adjacent to the detecting end 20 is exposed in the second detecting area. 214. The middle partition 22 is disposed opposite to the bottom partition 21 and covers the first detecting area 213, and forms a middle opening 221 communicating with the second detecting area 214 at a position corresponding to the second detecting area 214, and A gap 222 is formed by the detecting end 20 at a position corresponding to the first detecting area 213, and the size of the middle opening 221 is matched with the second detecting area 214. The top partition plate 23 is disposed opposite to the middle partition plate 22, and is recessed by the detecting end 20 at a position corresponding to the bottom plate groove 211 and the middle opening 221 to form a top plate groove communicating with the middle opening 221 and the outer portion. 231. The cover plate 24 is disposed opposite to the top partition plate 23 and covers the top plate groove 231, and a hole 241 communicating with the top plate groove 231 is formed at a position corresponding to the second detecting portion 214.

In particular, the middle partition 22, the top partition 23, and the cover 24 may collectively define a passage 242 that communicates with the second detection zone 214 and the exterior after assembly and stacking. Further, as shown in FIG. 2 and FIG. 4, the middle opening 221 and the top plate groove 231 communicate with each other to form the channel 242, wherein the middle partition 22, the partition structure 212 and the substrate 11 cooperate with each other. A detection zone 213 is isolated from the second detection zone 214, thereby enabling the specimens located in the first and second detection zones 213, 214 to achieve lateral circulation, thereby improving the accuracy of the detection results. On the other hand, the septum The notch 222 formed by the recess 22 of the plate 22 at the detecting end 20 communicates with the first detecting area 213 and the channel 242, whereby the sample from the outside can smoothly flow through the detecting end 20 against the surface tension of the sample itself, and The notch 222 can allow the sample to flow into the first detection zone 213 and the channel 242, respectively. In another aspect, the air hole 241 is configured to allow the gas located in the channel 242 and the second detection area 214 to be discharged from the air hole 241 when the sample enters the channel 242, thereby allowing the sample to smoothly flow into the second detection. Area 214.

Referring to FIG. 2 and FIG. 4 , the fixing unit 3 includes two bottom adhesive layers 31 and two top adhesive layers 32 , and the bottom adhesive layer 31 and the top adhesive layer 32 are different in shape and shape from the bottom partition 21 . The intermediate partition 22, the top partition 23 and the cover 24 substantially conform to each other to provide a better adhesion. One of the bottom adhesive layers 31 is fixed between the electrode line 12 and the bottom partition 21, and the other of the bottom adhesive layers 31 is fixed to the bottom partition 21 and the middle partition 22 between. Each of the bottom adhesive layer 31 is adjacent to one end of the detecting end 20 to form a pair of first grooves 311 which should be the first detecting area 213, a pair of second grooves 312 which should be the second detecting area 214, and a first partition a groove 311 and a second groove 312 corresponding to the partitioning portion 313 of the partition structure 212. The shape of the first groove 311 is mainly matched with the first detecting region 213 of the bottom partition plate 21, The two recesses 312 are mainly sized to fit the second detecting portion 214 of the bottom partition 21, and the partitioning portions 312 are mainly sized to fit the partitioning structure 212 of the bottom partition 21. One of the top adhesive layers 32 is fixed between the middle partition 22 and the top partition 23, and the other of the top adhesive layers 32 is fixed to the top partition 23 and the cover 24 between. Each of the top adhesive layers 32 is recessed adjacent to one end of the detecting end 20 to form a pair of through grooves 321 which should be the top plate grooves 231. As a result, the bottom spacer 21, the middle partition 22, the top partition 23 and the cover 24 are mutually coupled by the adhesion provided by the bottom adhesive layer 31 and the top adhesive layer 32. The partitions 312 are firmly bonded to each other, and the partitions 312 of the bottom adhesive layer 31 are respectively adhered between the partition structure 212, the electrode lines 12 and the partition structure 212 and the middle partition 22, so that The gap between the electrode line 12, the bottom partition 21 and the middle partition 22 is filled and sealed, so that the specimen located in the first detection zone 213 and the specimen located in the second detection zone 214 are respectively located The two separate chambers are only connected at the entrance of the detecting end, so that the specimens located in the two detecting areas 213, 214 are not laterally movable to each other. The first grooves 311, the second grooves 312, and the through grooves 321 are formed to allow the separator unit 2 to circulate the sample.

The reaction layer 4 is disposed on the second electrode group 122 and corresponds to the second detection region 214 to generate a detection reaction with the sample. In the present embodiment, the component of the reaction layer 4 contains an enzyme which can react with the glucose component in the blood to perform related detection. In this embodiment, the reaction layer 4 is applied to the second electrode group 122, but the reaction layer 4 is not limited to the coating mode. In another embodiment, the reaction layer 4 may also be a layer. Paper stock or cloth of the reaction substance. The position where the reaction layer 4 is disposed is not limited to the second electrode group 122, but is set according to the composition of the sample to be measured. In another embodiment, by the first electrode group 121 and The second electrode group The reaction layer 4 is laid by 122, whereby the glucose content in the blood can be simultaneously measured, and the glucose content measurement accuracy can be confirmed under the double weight measurement. In still another embodiment, when the sample component other than glucose is to be measured, the reaction layer 4 containing the corresponding reaction substance can be easily replaced in the first electrode group 121 and the second electrode group 122, or The measurement is carried out directly without laying the reaction layer 4.

In use, the sample from the outside flows in from the detecting end 20, is separated by the middle partition 22 and flows to the first detecting area 213 and the channel 242 via the siphon effect, and the corresponding flow direction of the sample flowing to the channel 242 The second detecting area 214, the sample located in the first detecting area 213 is in contact with the first electrode group 121, and the sample located in the second detecting area 214 is in contact with the second electrode group 122, and then is externally connected. A hardware device (not shown) is connected to the first electrode group 121 and the second electrode group 122 to obtain a value of blood glucose content and a blood cell volume ratio. Of course, according to actual needs, the biosensor test piece can also perform biomedical information detection other than blood glucose, which is not limited to the foregoing embodiment.

Referring to FIG. 5 and FIG. 6, a second embodiment of the biosensor test strip of the present invention, in the embodiment, the circuit unit 1, the bottom partition 21, the middle partition 22, the bottom adhesive layer 31 and the top The structure of the adhesive layer 32 is the same as that of the first embodiment, but the implementation structure of the top partition 23, the cover 24, and the top adhesive layer 32' is different from that of the first embodiment, and is mainly embodied in the embodiment. The length of the top plate groove 231, and the top partition 23 shields a portion of the opening area of the middle opening 221, in other words, the top plate groove 231 The overlap of the area and the area of the middle opening 221 is reduced to the vertical sectional area of the adhesive layer like the top plate groove 231 and the lower portion thereof, thereby not only improving the siphon effect, but also the specimen from the top plate groove 231. The flow direction is directed to the middle port 221, and the sample is quickly directed downwardly toward the second detection zone 214 by the guide of the top partition 23. More specifically, the top partition 23 has a body 232 covering the middle partition 22 and covering a portion of the middle opening 221, two spaced apart from each other by a side edge of the body 232 adjacent to the middle opening 221 The detection end 20 extends and covers the top extension wall 233 of the intermediate partition 22. The body 232 has a guiding side edge 234 located above the middle opening 221 and substantially equal to the middle opening 221. The guiding side edge 234 and the inner edge of the top extending wall 233 together define the top plate concave The groove 231 is greatly reduced due to the overlap of the area of the top plate groove 231 and the area of the middle opening 221. When the sample enters the top plate groove 231 by the detecting end 20, the sample rapidly flows through the siphon effect. The guiding side edge 234 is guided to the second detecting area 214 with the guiding side edge 234 for detecting the sample located in the second detecting area 214.

In addition, in the embodiment, due to the structural change of the top partition 23, the cover plate 24 and the top adhesive layer 32' can be reduced in volume, and only the top partition 23 for the alignment portion can be retained and the top plate can be covered. The structure of the groove 231 can achieve the effect that the sample flows from the top plate groove 231 to the second detection area 214 without overflowing. In addition, the cover plate 24 omits the structure of the air hole 241, and a through hole 235 is formed in the top partition plate 23. The through hole 235 is not shielded by the cover plate 24 and the top adhesive layer 32' and the position corresponds to the groove 321 , The middle opening 221, the second groove 312, and the bottom plate groove 211 communicate downwardly with the second detecting area 214. When the sample enters the second detecting area 214, the squeezed air can be The through hole 235 is discharged.

In summary, the biosensor test strip of the present invention separates the bottom plate recess 211 from the first detection region 213 corresponding to the first electrode group 121 by the partition structure 212 of the bottom spacer 21, and correspondingly The second detecting area 214 of the two electrode group 122 cooperates with the middle partition 22 to make the samples of the first and second detecting areas 213 and 214 not circulate, and the first and second detecting areas 213 and 214 are The samples are independently detected, and the accuracy of the measured values measured by the biosensor test pieces is inevitably greatly improved, so that the object of the present invention can be achieved.

However, the above is only the embodiment of the present invention, and the scope of the invention is not limited thereto, and all the equivalent equivalent changes and modifications according to the scope of the patent application and the patent specification of the present invention are still The scope of the invention is covered.

Claims (12)

A biosensor test piece is suitable for detecting an externally-exposed sample. The bio-sensing test piece comprises: a circuit unit comprising a substrate and an electrode line disposed on the substrate, the electrode line having a first electrode group and a second electrode group that is non-conducting with the first electrode group; and a spacer unit disposed on the circuit unit and having a detecting end, the spacer unit including a bottom portion disposed on the substrate and covering the electrode line a partition, a middle partition disposed on a side of the bottom partition away from the substrate, a top partition disposed on a side of the middle partition away from the bottom partition, and a top partition disposed away from the top partition a cover plate on one side of the middle partition plate, the bottom partition plate is recessed by the detecting end to form a bottom plate groove, and the bottom partition plate further has a partition structure spanning the bottom plate groove, the partition structure is the bottom plate The groove is divided into a first detection area for the first electrode group portion to be exposed and a second detection area for the second electrode group portion to be exposed. The middle partition plate, the top partition plate and the cover plate jointly define Connecting the second detection zone and the outside a track, wherein the sample from the outside is separated from the first detection zone and the channel by the middle partition, and the sample flowing to the channel corresponds to the second detection zone, and is located in the first detection zone. The specimen and the specimen located in the second detection zone are not in circulation with each other. The biosensor test strip of claim 1, wherein the middle partition covers the first detection area, and a middle opening that communicates with the second detection area is formed at a position corresponding to the second detection area, The top partition is recessed by the detecting end at a position corresponding to the bottom plate groove and the middle opening, and is connected to the middle opening and An outer top plate groove covering the top plate groove, the middle opening and the top plate groove communicating to form the passage. The biosensor test strip of claim 2, further comprising a fixing unit, wherein the fixing unit comprises two bottom adhesive layers, one of the bottom adhesive layers being fixed between the electrode line and the bottom partition. The other of the bottom adhesive layers is fixed between the bottom partition and the intermediate partition. The biosensor test strip of claim 3, wherein each of the bottom adhesive layers is adjacent to one end of the detecting end to form a pair of first recesses corresponding to the first detecting area and a pair of second recesses corresponding to the second detecting area. a slot, and a partition separating the first groove from the second groove and corresponding to the partition structure. The biosensor test strip of claim 3, wherein the fixing unit further comprises two top adhesive layers, one of the top adhesive layers being fixed between the middle partition and the top partition, The other of the top adhesive layer is fixed between the top partition and the cover. The biosensor test strip of claim 5, wherein one end of each of the top adhesive layers adjacent to the detecting end is recessed to form a pair of through grooves of the top plate groove. The biosensor test strip of claim 2, wherein the middle partition is recessed by the detecting end at a position corresponding to the first detecting area to form a gap connecting the first detecting area and the channel, the gap is for the inspection Physical energy flows into the first detection zone and the channel. The biosensor test strip of claim 2, wherein the cover plate penetrates a hole corresponding to the recess of the top plate at a position corresponding to the second detecting area, and the air hole is located when the sample enters the channel The gas of the channel and the second detection zone may be discharged from the air hole to enable the sample to flow to the second detection zone. The biosensor test strip of claim 1, further comprising a second electrode group and/or the first electrode group disposed at a position corresponding to the second detection area and/or the first detection area, and capable of The sample produces a reaction layer that detects the reaction. The biosensor test piece according to claim 9, wherein the component of the reaction layer contains an enzyme. The biosensor test strip of claim 1, wherein the top partition penetrates a through hole corresponding to the bottom plate groove and the second detection area at a position corresponding to the second detection area, and the through hole is provided for When the sample enters the channel, gas located in the channel and the second detection zone may be discharged from the through hole, so that the sample can flow to the second detection zone. The biosensor test strip of claim 2, wherein the top partition has a body disposed in the middle partition and partially covering the middle opening, the body having a guiding side above the middle opening The edge of the sample in the top plate groove is guided by the guiding side edge to the second detecting area.