Biochemical detection module and manufacturing method thereof

Abstract

The invention provides a biochemical detection module and a manufacturing method thereof. The biochemical detection module comprises a first reaction sheet and a second reaction sheet. The first reaction sheet comprises a first substrate, a first separation sheet and a first cover; the first separation sheet is positioned on the first substrate and is provided with a first flow channel which exposes at least one part of the first substrate; the first cover covers the first partition sheet and has a first hole communicating with the first flow channel. The first reaction piece is provided with a through hole structure penetrating through the first cover, the first partition piece and the first substrate. The second reaction sheet is arranged on one side, adjacent to the first substrate, of the first reaction sheet and comprises a second substrate, a second separation sheet and a second cover; the second partition sheet is located on the second substrate and is provided with a second flow channel exposing at least one part of the second substrate; the second cover covers the second separator, is bonded to the first substrate, and has a second hole. And the second runner is communicated with the perforated structure through the second hole.

Description

Technical Field

[0001] The invention relates to a biochemical detection module and a manufacturing method thereof. Background Art

[0002] In recent years, due to the increasing phenomenon of population aging, modern people are busy with work and often eat out, but ignore the control of eating habits. In the long run, metabolic-related diseases have gradually become common diseases among modern people, such as diabetes, cardiovascular disease and hypertension. Therefore, in vitro medical measurements play an extremely important role in today's medical industry. Using home clinical detectors to measure changes in biological body fluids is one of the common detection methods today, which can provide indicator information for rapid diagnosis of diseases and treatment. Most of the common biosensor test strips on the market are single-function tests. When the subject needs to obtain multiple test data, it is necessary to purchase two or more biosensor test strips for different samples according to the needs and perform the tests in batches to obtain two different concentrations respectively. However, it may increase the problem that the subject needs to take samples multiple times and must have multiple measuring instruments.

[0003] The prior art discloses an electrochemical test strip with dual reaction zones, where samples enter two different sample chambers from a single sampling port. The two sample chambers are used to independently measure the same or different sample concentrations. However, the two samples of this prior art are located on the same substrate, which not only increases the manufacturing difficulty and production cost, but is also susceptible to current interference from each other during the measurement process, resulting in inaccurate measurements.

[0004] In addition, another prior art has a reaction strip with two reaction areas. Although the two reaction areas are separated by a partition structure, the two reaction areas are located on the same substrate and will still interfere with each other's signals during measurement.

[0005] The above “prior art” description only provides background technology, does not admit that the above “prior art” description discloses the subject matter of the present invention, does not constitute the prior art of the present invention, and any description of the above “prior art” should not be regarded as any part of the present invention. Summary of the invention

[0006] The object of the present invention is to provide a biochemical detection module and a manufacturing method thereof to solve at least one of the above problems.

[0007] One embodiment of the present invention provides a biochemical detection module, comprising a first reaction piece and a second reaction piece. The first reaction piece comprises: a first substrate; a first separator, located on the first substrate, and having a first flow channel exposing at least a portion of the first substrate; and a first cover, covering the first separator, and having a first hole connected to the first flow channel, wherein the first reaction piece has a perforated structure, which passes through the first cover, the first separator and the first substrate, and the perforated structure is separated from the first flow channel and the first hole, wherein the first reaction piece has a first observation area for observing a portion of the first flow channel through the first cover or the first hole. The second reaction piece is arranged on one side of the first reaction piece adjacent to the first substrate, and comprises: a second substrate; a second separator, located on the second substrate, and having a second flow channel exposing at least a portion of the second substrate; and a second cover, covering the second separator and bonded to the first substrate, and having a second hole, wherein the second flow channel is connected to the perforated structure through the second hole, wherein the second reaction piece has a second observation area for observing a portion of the second flow channel through the perforated structure, the second cover or the second hole.

[0008] One embodiment of the present invention provides another biochemical detection module, including a first reaction plate and a second reaction plate. The first reaction plate includes: a first substrate having a first surface and a second surface opposite to the first surface; a first separator, located on the first surface and having a first flow channel; and a first cover, covering the first separator and having a first hole connected to the first flow channel. The first reaction plate has a perforated structure, which runs through the first cover, the first separator and the first substrate. The second reaction plate includes: a second substrate having a third surface and a fourth surface opposite to the third surface, wherein the third surface faces the second surface; a second separator, located on the fourth surface and having a second flow channel; and a second cover, covering the second separator and having a second hole, wherein the second hole is connected to the second flow channel.

[0009] Another embodiment of the present invention provides a method for manufacturing a biochemical detection module, comprising: providing a first reaction plate, which includes: a first substrate, which has a first surface and a second surface facing away from the first surface; a first separator, located on the first surface and having a first flow channel exposing a first portion of the first substrate; and a first cover, covering the first separator and having a first hole communicating with the first flow channel; forming a perforated structure passing through the first cover, the first separator and the first substrate; aligning the second sampling port of the second reaction plate with the first sampling port of the first reaction plate, wherein the second reaction plate includes: a second substrate; a second separator, located on the second substrate and having a second flow channel exposing a second portion of the second substrate; a second cover, which has a third surface covering the second separator and a fourth surface facing away from the third surface and having a second hole communicating with the second flow channel, wherein the second flow channel is communicated with the perforated structure through the second hole; and joining the second reaction plate and the first reaction plate. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] A more complete understanding of the disclosure of the present invention may be obtained by referring to the detailed description and claims in conjunction with the accompanying drawings, in which like reference numerals refer to like elements.

[0011] Figure 1 is a schematic diagram of an exploded view of a biochemical detection module according to some embodiments of the present invention.

[0012] Figure 2 is based on Figure 1 A cross-sectional view of the biochemical detection module along line LL' is shown in the embodiment.

[0013] Figure 3 is a cross-sectional view of a biochemical detection module according to some embodiments of the present invention.

[0014] Figure 4 4 are cross-sectional views of biochemical detection modules according to other embodiments of the present invention.

[0015] Figure 5 and Figure 6 is a schematic diagram of the use of a biochemical detection module according to some embodiments of the present invention.

[0016] Figure 7 is based on Figure 6 The embodiment shown in FIG. 1 is a top view of the biochemical detection module after being filled with a sample.

[0017] Figures 8a to 8j is based on Figure 6 The embodiment shown in FIG. 1 is a top view of the second observation area of ​​the biochemical detection module when no sample is filled in.

[0018] Fig. 9 is a manufacturing flow chart of a biochemical detection module according to some embodiments of the present invention.

[0019] Figures 10 to 12 is based on Fig. 9 The manufacturing method shows cross-sectional views of various manufacturing stages.

[0020] The reference numerals are as follows:

[0021] 10: Biochemical detection module

[0022] 11: Biochemical detection module

[0023] 12: Biochemical detection module

[0024] 100: First Reaction Film

[0025] 100F: First front end

[0026] 110: First substrate

[0027] 112: First conductive structure

[0028] 114: First Reagent

[0029] 115: Connecting port

[0030] 120: First separator

[0031] 122: First sampling port

[0032] 123: First notch

[0033] 124: First runner

[0034] 125: Connecting port

[0035] 130: First Cover

[0036] 132: First hole

[0037] 135: Connecting port

[0038] 140: Perforated structure

[0039] 150: Adhesive layer

[0040] 155: Connecting port

[0041] 160: First Observation Area

[0042] 200: Second reaction piece

[0043] 200F: Second front end

[0044] 210: Second substrate

[0045] 212: Second conductive structure

[0046] 214: Second Reagent

[0047] 220: Second separator

[0048] 222: Second sampling port

[0049] 223: Second notch

[0050] 224: Second flow channel

[0051] 226: Identification Area

[0052] 230: Second cover

[0053] 232: Second hole

[0054] 260: Second Observation Area

[0055] D1: Length of the first flow channel

[0056] D2: Length of the second flow channel

[0057] L1: Separation distance

[0058] V1: Volume of the first flow channel

[0059] V2: Second flow channel volume

[0060] Wa, W1, W2: Width DETAILED DESCRIPTION

[0061] Embodiments of the present invention are discussed in detail below. However, it should be understood that the embodiments provide many applicable inventive concepts that can be implemented in various specific environments. The specific embodiments discussed only illustrate the specific ways to make and use the embodiments, and do not limit the scope of the present invention.

[0062] In the various views and illustrative embodiments, the same reference numerals are configured to represent the same elements. Reference will now be made in detail to the exemplary embodiments shown in the drawings. Whenever possible, the same reference numerals are used in the drawings and the specification to represent the same or similar parts. In the drawings, the shapes and thicknesses may be exaggerated for clarity and convenience. This description will be particularly directed to elements that form a part of the device according to the present invention or cooperate more directly with it. It should be understood that elements that are not specifically shown or described can take various forms. References throughout this specification to "some embodiments" or "embodiments" mean that specific features, structures or characteristics described in conjunction with the embodiment are included in at least one embodiment. Therefore, the phrases "in some embodiments" or "in embodiments" that appear in various places throughout this specification do not necessarily refer to the same embodiment. In addition, specific features, structures or characteristics can be combined in any suitable manner in one or more embodiments.

[0063] In the accompanying drawings, the same reference numerals are configured to indicate the same or similar elements in various views, and illustrative embodiments of the present invention are shown and described. The drawings are not necessarily shown to scale, and in some cases, the drawings have been exaggerated and / or simplified and are configured only for illustrative purposes. Based on the following illustrative embodiments of the present invention, those of ordinary skill in the art will understand many possible applications and variations of the present invention.

[0064] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as those commonly understood by those skilled in the art to which the embodiments of the present invention belong. It should be understood that those terms defined in commonly used dictionaries, for example, should be interpreted as having a meaning consistent with their meaning in the context of the relevant art and the present invention, and should not be understood or construed as having an overly formal meaning unless explicitly defined herein.

[0065] In addition, the following provides multiple embodiments of the present invention as examples to illustrate the core value of the present invention, but are not intended to limit the scope of protection of the present invention. For the sake of clarity and ease of understanding, the same or similar functions or elements between different embodiments of the present invention will not be repeatedly described or shown in the figures. Moreover, different elements or technical features in different embodiments, under the premise of not conflicting with each other, can be combined or replaced to obtain a new embodiment, which still falls within the scope of protection of the present invention.

[0066] In the existing stacked biochemical detection module, the upper and lower reaction sheets are stacked on each other, resulting in the lower reaction sheet being blocked by the upper reaction sheet, causing the gas in the lower reaction sheet to be unable to be discharged smoothly, and the user cannot observe the sampling of the sample in the lower reaction sheet. The present invention proposes a biochemical detection module to solve the above problems. Figures 1 to 12 Various embodiments of the present invention are discussed.

[0067] refer to Figure 1 , Figure 1 1 is a schematic diagram of an exploded view of a biochemical detection module 10 according to some embodiments of the present invention. The biochemical detection module 10 may be a biochemical test strip or an electrochemical test strip, and is a device that can provide a chemical reaction. In some embodiments, the biochemical detection module 10 includes a first reaction strip 100, an adhesive layer 150, and a second reaction strip 200. In some other embodiments, the biochemical detection module 10 includes a plurality of reaction strips and an adhesive layer disposed between the plurality of reaction strips.

[0068] In some embodiments, the first reaction sheet 100 includes a first substrate 110, a first separator 120 and a first cover 130, and the second reaction sheet 200 includes a second substrate 210, a second separator 220 and a second cover 230. In some embodiments, the materials of the first substrate 110 and the second substrate 210 can include polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polycarbonate (PC), polyethylene terephthalate (PET ...

[0069] (polyethylene terephthalate, PET), polystyrene (polystyrene, PS), polyolefin (polyolefin, PO), polyimide (polyimide, PI), polyurethane (polyurethane, PU), polyethylene naphthalate (polyethylene naphthalate, PEN), polyethersulfone (polyethersulfone, PES), ethylene vinyl acetate (ethylene vinyl acetate, EVA), glass plate, ceramic, glass fiber (FR-4), polyester (polyester suphone), bakelite, or any combination of the above materials, but the present invention is not limited thereto, and the materials of the first substrate 110 and the second substrate 210 can be adjusted according to actual needs.

[0070] In some embodiments, the first substrate 110 includes a first conductive structure 112, which is disposed on the surface or inside of the first substrate 110, and the second substrate 210 includes a second conductive structure 212, which is disposed on the surface or inside of the second substrate 210. In some embodiments, the materials of the first conductive structure 112 and the second conductive structure 212 are conductive materials, such as palladium, platinum, aluminum, gold, titanium, carbon, silver, copper, or any combination of the above materials. The present invention does not limit the configuration of the first conductive structure 112 and the second conductive structure 212, and the first conductive structure 112 and the second conductive structure 212 can have any shape. In some embodiments, the first conductive structure 112 and the second conductive structure 212 respectively form electrode units, such as working electrodes or counter electrodes, etc., but the present invention is not limited thereto, and the first conductive structure 112 and the second conductive structure can be used as different electrodes according to actual needs. In some embodiments, the first substrate 110 has a communication port 115, and the communication port 115 is located inside the first substrate 110 and penetrates the first substrate 110. In some embodiments, the communication opening 115 is separated from the first conductive structure 112 .

[0071] In some embodiments, the materials of the first separator 120 and the second separator 220 are insulating materials, such as polyvinyl chloride (PVC), polyethylene terephthalate (PET), heat-drying insulating paint or ultraviolet curing insulating paint, etc., but the present invention is not limited thereto, and the materials of the first separator 120 and the second separator 220 can be adjusted according to actual needs. In some embodiments, the first separator 120 has a first sampling port 122, a first notch 123 and a connecting port 125. In some embodiments, the first sampling port 122 is disposed on one side of the first separator 120 to expose a portion of the inner surface of the first separator 120. The opening direction of the first reaction sheet 100 at the first sampling port 122 can be referred to as the first front end 100F of the first reaction sheet 100. In some embodiments, the connecting port 125 is located inside the first separator 120 and penetrates the first separator 120, and the first notch 123 is located between the first sampling port 122 and the connecting port 125. In some embodiments, the first notch 123 is connected to the first sampling port 122 but is separated from the connecting port 125. In some embodiments, the position of the communication port 125 of the first separator 120 is aligned with the position of the communication port 115 of the first substrate 110 in the vertical direction Z. In some embodiments, the second separator 220 has a second sampling port 222 and a second recess 223. In some embodiments, the second sampling port 222 is disposed on one side of the second separator 220 to expose a portion of the inner surface of the second separator 220. The opening direction of the second reaction sheet 200 at the second sampling port 222 can be referred to as the front end 200F of the second reaction sheet 200. In some embodiments, the second recess 223 is connected to the second sampling port 222.

[0072] In some embodiments, the material of the first cover 130 and the second cover 230 is an insulating material, such as PVC, PET, heat-drying insulating paint or ultraviolet curing insulating paint, etc., but the present invention is not limited thereto, and the materials of the first cover 130 and the second cover 230 can be adjusted according to actual needs. In some embodiments, the first cover 130 and the second cover 230 are made of transparent or translucent materials. In some embodiments, the first cover 130 has a first hole 132 and a communication port 135, and the first hole 132 and the communication port 135 are separated from each other. The first hole 132 and the communication port 135 are respectively located at the position inside the first cover 130 and pass through the first cover 130 respectively. In some embodiments, the position of the first hole 132 is aligned with the position of the first recess 123 in the vertical direction Z. In some embodiments, the position of the communication port 135 of the first cover 130 is aligned with the position of the communication port 125 of the first separator 120 in the vertical direction Z. In some embodiments, the second cover 230 has a second hole 232. The second hole 232 is located at the position inside the second cover 230 and passes through the second cover 230. In some embodiments, the first hole 132 and the second hole 232 are exhaust structures, which can be used to exhaust the gas generated during the detection or the air originally in the first recess 123 or the second recess 223 (to be described in detail below).

[0073] In some embodiments, the adhesive layer 150 has a communication port 155, which is located inside the adhesive layer 150 and penetrates the adhesive layer 150. In some embodiments, the position of the communication port 155 of the adhesive layer 150 is aligned with the position of the communication port 115 of the first substrate 110 and the position of the second hole 232 of the second cover 230 in the vertical direction Z. In some embodiments, the adhesive layer 150 is made of a transparent or translucent material. The adhesive layer 150 may include a solid or liquid adhesive material, such as polyvinyl alcohol, polyvinyl acetate, acrylonitrile, epoxy compound, ultraviolet curable resin, or any combination of the above materials, but the present invention is not limited thereto.

[0074] refer to Figure 2 , Figure 2 is based on Figure 11 is a cross-sectional view of the biochemical detection module 10 shown along the line L-L' of the embodiment. In some embodiments, the first separator 120 in the first reaction sheet 100 is disposed on the first substrate 110, and the first cover 130 is disposed on the first separator 120. In some embodiments, the second separator 220 in the second reaction sheet 200 is disposed on the second substrate 210, and the second cover 230 is disposed on the second separator 220. In some embodiments, the first reaction sheet 100 in the biochemical detection module 10 is disposed on the second reaction sheet 200 and bonded to the second reaction sheet 200 through the adhesive layer 150. The adhesive layer 150 is disposed between the lower surface of the first substrate 110 and the upper surface of the second cover 230. The first sampling port 122 of the first reaction sheet 100 and the second sampling port 222 of the second reaction sheet 200 are vertically aligned and stacked.

[0075] In some embodiments, the first sampling port 122 and the first recess 123 form a first flow channel 124 in the space surrounded by the first substrate 110, the first separator 120 and the first cover 130, and the first flow channel 124 exposes at least a portion of the first substrate 110. In some embodiments, the first flow channel 124 exposes at least a portion of the first conductive structure 112 on the first substrate 110. The first flow channel 124 has a first flow channel length D1 in the length direction X and a first flow channel width (not shown) in the width direction Y. In some embodiments, the first flow channel length D1 is the straight line distance from the first front end 100F to the first hole 132 in the length direction X, that is, the straight line distance from the first front end 100F to the innermost part of the first recess 123. In some embodiments, the second flow channel length D2 is the straight line distance from the second front end 200F to the second hole 232 in the length direction X, that is, the straight line distance from the second front end 200F to the innermost part of the second recess 223. The first channel 124 has a first channel volume V1, which is determined by the first channel length D1, the first channel width, and the thickness of the first separator 120. In some embodiments, the first channel 124 is connected to the first hole 132 of the first cover 130.

[0076] In some embodiments, the second sampling port 222 and the second recess 223 form a second flow channel 224 in the space surrounded by the second substrate 210, the second separator 220 and the second cover 230, and the second flow channel 224 exposes at least a portion of the second substrate 210. In some embodiments, the second flow channel 224 exposes at least a portion of the second conductive structure 212 on the second substrate 210. The second flow channel 224 has a second flow channel length D2 in the length direction X and a second flow channel width (not shown) in the width direction Y. The second flow channel 224 has a second flow channel volume V2, the size of which is determined by the second flow channel length D2, the second flow channel width and the thickness of the second separator 220. In some embodiments, the second flow channel 224 is connected to the second hole 232 of the second cover 230. In some embodiments, the first flow channel 124 of the first reaction plate 100 and the second flow channel 224 of the second reaction plate 200 are independent of each other and are not connected to each other.

[0077] In some embodiments, the first flow channel length D1 of the first reaction piece 100 is different from the second flow channel length D2 of the second reaction piece 200. For example, the second flow channel length D2 is greater than the first flow channel length D1. However, the relationship between the first flow channel width and the second flow channel width is not limited. Therefore, according to actual needs, the first flow channel width and / or the second flow channel width can be adjusted so that the first flow channel volume V1 is greater than, equal to, or less than the second flow channel volume V2.

[0078] In some embodiments, Figure 1 The communication opening 135 of the first cover 130, the communication opening 125 of the first separator 120, the communication opening 115 of the first substrate 110 and the communication opening 155 of the adhesive layer 150 are connected to form a perforated structure 140, such as Figure 2As shown. The perforated structure 140 penetrates downward from the first cover 130 to the first separator 120, the first substrate 110 and the adhesive layer 150, and exposes at least a portion of the second cover 230 of the second reaction sheet 200. In some embodiments, the perforated structure 140 is separated from the first hole 132 and the first flow channel 124. In some embodiments, the perforated structure 140 is connected to the second flow channel 224 through the second hole 232. In some embodiments, along the vertical direction Z, at least a portion of the second flow channel 224 overlaps the perforated structure 140 and is exposed by the perforated structure 140, for example, the second substrate 210 and the second conductive structure 212 in the second flow channel 224 are exposed by the perforated structure 140. In some embodiments, the width W3 of the perforated structure 140 is greater than the width W1 of the first hole 132 and the width W2 of the second hole 232. Since the width W3 of the perforated structure 140 is greater than the width W2 of the second hole 232, the second hole 232 is exposed by the perforated structure 140. When the sample in the second flow channel 224 undergoes a chemical reaction during detection, gas may be generated, and the gas can be smoothly discharged from the second hole 232 through the perforated structure 140. In some embodiments, the perforated structure 140 also has the function of helping the user observe the sample in the second reaction sheet 200. The purpose of the perforated structure 140 will be described in more detail below.

[0079] refer to Figure 3 , Figure 3 FIG. 1 is a cross-sectional view of a biochemical detection module 11 according to another embodiment of the present invention. The components of the biochemical detection module 11 are substantially the same as those of the biochemical detection module 10 and are omitted for clarity. Figure 3. The difference between the biochemical detection module 11 and the biochemical detection module 10 is that the stacking order of the second substrate 210, the second separator 220 and the second cover 230 in the second reaction plate 200 of the biochemical detection module 11 is different from that of the second substrate 210, the second separator 220 and the second cover 230 in the second reaction plate 200 of the biochemical detection module 10. In some embodiments, the stacking order of the elements of the second reaction plate 200 of the biochemical detection module 11 is opposite to the stacking order of the elements of the second reaction plate 200 of the biochemical detection module 10. In other words, the first substrate 110 of the biochemical detection module 11 is adjacent to the second substrate 210, and the adhesive layer 150 is disposed between the lower surface of the first substrate 110 and the upper surface of the second substrate 210. In such an embodiment, the opening direction of the first hole 132 of the first cover 130 is opposite to the opening direction of the second hole 232 of the second cover 230. In some embodiments, the perforated structure 140 penetrates downward from the first cover 130 to the first separator 120 and the first substrate 110, and exposes at least a portion of the adhesive layer 150. In some embodiments, the perforated structure 140 and the second flow channel 224 are separated by the adhesive layer 150 and the second substrate 210. In some embodiments, at least a portion of the second separator 220 overlaps the perforated structure 140 along the vertical direction Z. In some embodiments, the second substrate 210 is a transparent or at least translucent material.

[0080] refer to Figure 4 , Figure 4 1 is a cross-sectional view of a biochemical detection module 12 of another embodiment of the present invention. The components of the biochemical detection module 12 are substantially the same as those of the biochemical detection module 10 or 11. For the sake of clarity, Figure 4 The biochemical detection module 12 is similar to the biochemical detection module 11, and the main difference is that the perforated structure 140 of the biochemical detection module 12 penetrates the adhesive layer 150 and the second substrate 210 of the second reaction plate 200. In this embodiment, the perforated structure 140 has the functions of both observation and helping the second reaction plate 200 to exhaust.

[0081] refer to Figures 2 to 4 In some embodiments, a portion of the second reaction sheet 200 of the biochemical detection module 10, 11 or 12 can be used as the identification area 226. For example, a portion of the second separator 220 that overlaps the perforated structure 140 in the vertical direction Z can be used as the identification area 226. The purpose of the identification area 226 will be described in detail below.

[0082] Figure 5 and Figure 61 is a schematic diagram of the use of the biochemical detection module 10 according to some embodiments of the present invention. The biochemical detection module 10 is used to collect the sample 190 and perform an electrochemical reaction on it to detect the target analyte therein. The use methods of the biochemical detection modules 11 and 12 are the same or similar to the use method of the biochemical detection module 10, and the use of the biochemical detection module 10 will be described below.

[0083] refer to Figure 5 In some embodiments, the user 170 can pass any medium 180, such as a finger, other body parts or a dropper, close to the first sampling port 122 and the second sampling port 222 to inject the sample 190 into the biochemical detection module 10 for detection. In some embodiments, the sample 190 is a biological collection such as blood, tissue fluid, urine, sweat, tears, etc., but the present invention is not limited to this. In addition, the blood may include whole blood, plasma or serum, etc., but the present invention is not limited to this. In some embodiments, a first reagent 114 is disposed in the first flow channel 124, and a second reagent 214 is disposed in the second flow channel 224. Figure 5 The positions of the first reagent 114 and the second reagent 214 shown in the figure are only for illustration, and they can be respectively arranged at different positions in the first flow channel 124 and the second flow channel 224 due to different types of reaction slices or detection items. The first reagent 114 and the second reagent 214 are used to chemically react with the components in the sample 190, which can be the same or different compounds.

[0084] In order to enable multiple reaction plates to measure different parameters simultaneously without interfering with each other, the biochemical detection module 10 of the present invention uses multiple reaction plates to be stacked on each other, so that the first flow channel 124 and the second flow channel 224 are independent of each other and not interconnected. This can reduce or avoid the interference of signals generated by the sample 190 in the two flow channels 124 and 224 (reaction areas), thereby improving the measurement accuracy and allowing the user 170 to simultaneously measure two identical or different detection data with only a single injection of the sample 190.

[0085] When the liquid sample 190 contacts the first reagent 114 in the first flow channel 124 and the second reagent 214 in the second flow channel 224, chemical reactions will occur in the first flow channel 124 and the second flow channel 224. The chemical reaction is, for example, an oxidation-reduction reaction, and electron transfer will occur. The generated current signal can be respectively transmitted through the first conductive structure 112 on the surface or inside of the first substrate 110 and the second conductive structure 212 on the surface or inside of the second substrate 210 (such as Figure 1 Since the first flow channel 124 and the second flow channel 224 are independent of each other and not interconnected, the current signal transmitted through the first conductive structure 112 does not interfere with the current signal transmitted through the second conductive structure 212, so different analyte concentrations can be accurately and simultaneously detected.

[0086] refer to Figure 5 and Figure 6 , as the liquid sample 190 gradually fills the first flow channel 124 and the second flow channel 224. There is gas G1 (such as air) in the first flow channel 124 and the second flow channel 224, and the gas G1 will be squeezed as the sample 190 is filled. In some embodiments, the first hole 132 and the second hole 232 can exclude the gas G1 squeezed by the sample 190, so that the sample 190 can continue to flow into the first flow channel 124 and the second flow channel 224. In some other embodiments, the gas G1 generated by the chemical reaction between the sample 190 and the first reagent 114 or the second reagent 214 in the first flow channel 124 or the second flow channel 224 can also be excluded through the first hole 132 and the second hole 232. In some embodiments, the gas G1 can diffuse from the second hole 232 to the perforated structure 140 to leave the biochemical detection module 10.

[0087] In some embodiments, the biochemical detection module 10 has a first observation area 160 and a second observation area 260. The first observation area 160 corresponds to the first flow channel 124 of the first reaction plate 100, for example, a portion of the first flow channel 124 observed through the first cover 130 or the first hole 132, wherein the first observation area 160 exposes at least the first terminal of the first flow channel 124 (i.e., the inner wall of the first separator 120). The second observation area 260 corresponds to the second flow channel 224 of the second reaction plate 200, for example, a portion of the second flow channel 224 observed through the perforated structure 140, the second cover 230 or the second hole 232, wherein the second observation area 260 exposes at least the second terminal of the second flow channel 224 (i.e., the inner wall of the second separator 220). Since the first cover 130 and the second cover 230 are transparent or translucent, the first observation area 160 and the second observation area 260 are both transparent areas, and the user 170 can observe the sampling situation in the first flow channel 124 through the first observation area 160, and observe the sampling situation in the second flow channel 224 through the second observation area 260. In some embodiments, the perforated structure 140 of the first reaction sheet 100 exposes the second observation area 260. In the direction of the XY plane, the area of ​​the perforated structure 140 is greater than or equal to the area of ​​the second observation area 260, so the user 170 can observe the injection situation of the sample 190 in the second flow channel 224 in the second observation area 260 through the perforated structure 140. Therefore, although the second reaction sheet 200 located in the lower layer is blocked by the first reaction sheet 100, the flow situation of the sample 190 in the second flow channel 224 of the second reaction sheet 200 can still be observed.

[0088] In order to allow the user 170 to more clearly view the sampling status of the second observation area 260 from the perforated structure 140, the second observation area 260 exposes the identification area 226, and the user 170 can more clearly identify the injection status of the sample 190 through the visual contrast between the sample 190 and the identification area 226. In some embodiments, the identification area 226 is a partial structure of the second reaction sheet 200, and the visual contrast between the sample 190 and the identification area 226 allows the user 170 to more clearly observe the injection status of the sample 190, so as to determine whether the amount of sample 190 needs to be added, thereby improving the accuracy of the detection.

[0089] Taking the identification area 226 as a partial structure of the second reaction sheet 200 as an example, the identification area 226 can be a part of the second cover 230 or the second separator 220, and the identification area 226 can be translucent or opaque. In a preferred embodiment, the identification area 226 is opaque. Since the second observation area 260 exposes the identification area 226, when the sample 190 enters from the first sampling port 122 and the second sampling port 222 and flows to the second observation area 260, the sample 190 and the identification area 226 will have a clear visual contrast, and the user 170 can visually clearly identify the injection of the sample 190. In other words, when the sample 190 fills the second observation area 260, the user 170 will visually highlight the identification area 226 exposed to the second observation area 260, so as to achieve the effect of clearly identifying the entry of the sample 190, so that the user 170 can visually judge whether it is necessary to further add the sample 190, thereby improving the accuracy of the measurement.

[0090] In some other embodiments, the identification area 226 is an element other than the first reaction sheet 100 or the second reaction sheet 200. For example, the identification area 226 may be a mark or a marking on the first reaction sheet 100 or the second reaction sheet 200 that is different from the color of the sample 190. Any mark in any form that allows the user 170 to visually clearly identify the injection of the sample 190 into the first flow channel 114 and the second flow channel 224 may be defined as the identification area 226.

[0091] Figure 7 is based on Figure 6 The top view of the biochemical detection module 10 after the sample 190 is filled is shown in the embodiment. In some embodiments, the second observation area 260 exposes the identification area 226, and the identification area 226 is translucent or opaque. When the sample 190 in the second flow channel 224 is filled, the sample 190 exposed to the second observation area 260 and the identification area 226 will have a visual contrast. Therefore, the user 170 can visually observe the identification area 226 and judge that the sample 190 has been injected, thereby reducing the judgment error and causing the difference in measurement. The position of the identification area 226 is not limited to the position of the identification area 226. Figure 7The figure is not limited to the above, as long as the flow channel state can be observed in the second observation area 260 and visually clearly identified, it is within the scope of protection of the present invention. In some embodiments, the shape of the second observation area 260 can be elliptical, triangular, diamond, etc., and observation areas of different shapes can expose identification areas 226 of different states, as long as the user 170 can visually clearly identify the injection state of the sample 190, it is within the scope of protection of the present invention.

[0092] refer to Figure 6 and Figure 7 , in order to allow the user 170 to clearly identify the first flow channel 124 and the second flow channel 224 visually, the first terminal does not see through the second terminal, and when the first flow channel 124 and the second flow channel 224 do not visually interfere with each other, the user 170 can identify the sampling conditions of the two flow channels 124 and 224 through the first observation area 160 and the second observation area 260, respectively, so as to reduce the visual interference caused by the mutual perspective of the first flow channel 124 and the second flow channel 224, thereby reducing the measurement error caused by the user 170 misjudging the sampling state. In addition, in order to allow the user 170 to clearly identify the flow state of the sample 190 in the first observation area 160 and the second observation area 260, in the length direction X, the first observation area 160 and the second observation area 260 have a spacing distance L1, that is, the first observation area 160 and the second observation area 260 maintain a distance that does not visually overlap and interfere with each other, so as to reduce the error caused by the user 170 in the process of judging the sampling state due to visual interference during the observation process. In some embodiments, the spacing distance L1 between the first observation area 160 and the second observation area 260 of the biochemical detection module 10 can be greater than or equal to 0.6 mm, preferably greater than or equal to 0.5 mm. This allows the user 170 to be less visually disturbed when observing the sampling conditions of the first observation area 160 and the second observation area 260, thereby improving the accuracy of the user 170 in judging the injection conditions of the sample 190.

[0093] In some embodiments, when the shapes of the first observation area 160 and the second observation area 260 are the same, the states of the two observation areas 160 and 260 can be identified by the size of the interval distance L1. In some other embodiments, the shapes of the first observation area 160 and the second observation area 260 can also be adjusted to enhance the visual difference between the two observation areas 160 and 260. The shapes of the first observation area 160 and the second observation area 260 are different. The first observation area 160 and the second observation area 260 are, for example, quadrilateral, square, circular, elliptical, triangular, etc. For example, the first observation area 160 is a rectangle and the second observation area 260 is a triangle. Since the shapes of the first observation area 160 and the second observation area 260 are different, when the sample 190 enters the observation area respectively, the user 170 can observe the inflow state of the sample 190 from the first observation area 160 and the second observation area 260 of different shapes respectively, and enhance the visual difference between the two observation areas 160 and 260 to reduce the measurement error caused by misjudgment.

[0094] In addition to using the shape difference between the first observation area 160 and the second observation area 260 to reduce visual interference, the visual difference between the two observation areas 160 and 260 can also be increased by using color differences or graphic marks. The first observation area 160 and the second observation area 260 can have the same or different color marks. For example, the frames of the first observation area 160 and the second observation area 260 have color marks that are different from the color of the sample 190. When the sample 190 is injected, the sample 190 and the color marks of the first observation area 160 and the second observation area 260 will have a significant visual contrast. The sample 190 is, for example, blood, and a green mark and red blood are used to create a visual contrast, thereby improving the visual recognition of the user 170. Furthermore, in order to enhance the visual recognition of the first observation area 160 and the second observation area 260, the color of the second reaction sheet 200 exposed to the second observation area 260 is different from the color of the sample 190; in a preferred embodiment, the colors of the first reaction sheet 100, the identification area 226 exposed to the second observation area 260, and the sample 190 are all different. The different color combinations make the sample 190 visually contrast after injection to reduce visual interference, thereby enhancing the user 170's visual recognition of whether the sample 190 is injected or not; in another embodiment, the colors of the first reaction sheet 100 and the identification area 226 exposed to the second observation area 260 are the same and different from the color of the sample 190. The color differences of the reaction sheet, the identification area 226, and the sample 190 mentioned above are not limited to the enumerated ones, and as long as the user 170 can recognize them during the observation process, they all fall within the scope of protection of the present invention.

[0095] Figures 8a to 8j is based on Figure 6The second observation area 260 of the biochemical detection module 10 shown in the embodiment of the present invention is a top view when the sample 190 is not filled in, which shows the identification area 226 presented by the perforated structure 140. When the user 170 looks down at the perforated structure 140 of the biochemical detection module 10 or 11, since the second cover 230 and the second substrate 210 are transparent or translucent, the area where the second separator 220 overlaps the perforated structure 140 can be seen from the perforated structure 140, and this part of the second separator 220 will have a clear visual contrast with the sample 190 filled in the second flow channel 224, and is therefore called the identification area 226. In some embodiments, the top view of the perforated structure 140 may have different shapes, such as square, quadrilateral, circular, elliptical, triangular, diamond or other irregular geometric shapes. In some embodiments, the top view of the identification area 226 may have different shapes, such as square, quadrilateral, circular, elliptical, triangular, diamond, arched, fan-shaped, annular or other irregular geometric shapes.

[0096] refer to Figure 8a Taking the rectangular perforated structure 140 as an example, the identification area 226 of the exposed second observation area 260 can be a partial structure of the second cover 230 or the second separator 220 , and the identification area 226 can be located on at least one side of the second observation area 260 .

[0097] In some embodiments, the identification area 226 may be located on a single side of the second observation area 260. For example, when the identification area 226 is the second cover 230, the identification area 226 may be located near the connection end (eg, Figure 8a ), near the sampling ports 122 and 222 (such as Figure 8b ) or the other side (such as Figure 8c ); When the identification area 226 is the second separator 220, the identification area 226 may be located near the connection end (eg Figure 8a ).

[0098] In some other embodiments, the identification area 226 may be located on multiple sides of the second observation area 260. For example, when the identification area 226 is the second cover 230, the identification area 226 may be located on both sides (eg, Figure 8d ), three sides (such as Figure 8e ) or around the second observation area 260 (not shown). Taking the elliptical perforated structure 140 as an example, the identification area 226 exposed to the second observation area 260 can be a part of the second cover 230 or the second separator 220, and the identification area 226 can be located on a single side of the second observation area 260, for example: near the connection end (such as Figure 8f ), near sampling ports 122, 222 (such as Figure 8g ) or the surrounding of the second observation area 260 (such as Figure 8hThe shape of the perforated structure 140 may also be a triangle (eg Figure 8i ) or rhombus (such as Figure 8j ) and other geometric figures, not limited to those listed.

[0099] by Figure 8f For example, the perforated structure 140 is an ellipse, the second observation area 260 is a partial ellipse, the identification area 226 exposed to the second observation area 260 is the second cover 230, and the identification area 226 is an opaque area. According to the Gestalt theory, when the user 170 observes the sample 190 flowing into the second observation area 260 through the elliptical perforated structure 140, the user will consciously think that the sample 190 will visually present a complete elliptical shape after filling. However, since the identification area 226 exposed to the second observation area 260 is a semi-transparent or opaque area, the user 170 will visually clearly feel that the sample 190 has not completely filled the elliptical shape, and the user 170 will therefore be confused and unconsciously check the sampling status of the second observation area 260 again, thereby achieving the effect of strengthening the user 170's observation of the second observation area 260.

[0100] In another embodiment, the perforated structure 140 is triangular (eg Figure 8i ), people will think that the sample 190 should be completely triangular in the second observation area 260 after it is filled. However, because the identification area 226 is exposed to the second observation area 260, the sample 190 flows and stops at the identification area 226, presenting an imperfect triangle. After being visually confused, people will check the second observation area 260 again, so that the user 170 can focus on the observation area. In another embodiment, the perforated structure 140 is a diamond shape (such as Figure 8j ); The shape of the second observation area 260 is not limited to the above-mentioned ones, as long as it can make the user 170 visually confused and achieve the effect of looking at the second observation area 260 again, it is within the scope of protection of the present invention. In addition, as long as the user 170 can clearly observe the sampling situation of the second reaction sheet 200 through the perforated structure 140 and help the second reaction sheet 200 to exhaust to reduce capillary phenomena, it is within the scope of protection of the present invention, and the shape of the perforated structure 140 is not limited.

[0101] In summary, the biochemical detection module 10 or 11 includes a plurality of reaction sheets, and the reaction sheets are arranged overlapping each other. This configuration can reduce the mutual interference of each reaction sheet during the reaction process, thereby obtaining more than two measurement values. The biochemical detection module 10 has a perforated structure 140 that can see through the lower flow channel, and the perforated structure 140 is connected to the second hole 232. The perforated structure 140 exposes the second observation area 260, allowing the user 170 to visually more clearly identify the flow of the sample 190 in the second flow channel 224 from the second observation area 260, so as to solve the problem that the second flow channel 224 of the second reaction sheet 200 located in the lower layer is blocked due to the overlap of the first reaction sheet 100 and the second reaction sheet 200, and the inflow state of the sample 190 cannot be directly observed. In addition, the perforated structure 140 also has the function of helping the second reaction sheet 200 to remove the gas G1.

[0102] Fig. 9 is a flow chart of a method 300 for manufacturing a biochemical detection module 10 according to some embodiments of the present invention. Figures 10 to 12 is based on Fig. 9 The manufacturing method 300 shows cross-sectional views of various manufacturing stages.

[0103] refer to Fig.10 , Fig.10301, 303 and 305 of the manufacturing method 300 are cross-sectional views. In step 301, a first reaction sheet 100 is provided. The first reaction sheet 100 at least includes a first substrate 110, a first separator 120 and a first cover 130. The first separator 120 covers the first substrate 110, and the first cover 130 covers the first separator 120. A first conductive structure 112 is disposed on the surface or inside of the first substrate 110. The material of the first conductive structure 112 is, for example, conductive glue, such as palladium glue, platinum glue, aluminum glue, gold glue, titanium glue, carbon glue, silver glue, copper glue or any combination of the above materials. The first conductive structure 112 is formed by, for example, but not limited to, screen printing, imprinting, thermal transfer printing, spin coating, ink-jet printing, laser stripping, deposition or electroplating. The first separator 120 has a first sampling port 122 and a first recess 123 connected to the first sampling port 122. The first sampling port 122 is disposed on the front side of the first separator 120 to expose a portion of the inner surface of the first separator 120. The first cover 130 is made of a transparent or translucent material. The first cover 130 has a first hole 132 that penetrates the first cover 130. The first sampling port 122 and the first recess 123 form a first flow channel 124 in a space surrounded by the first substrate 110, the first separator 120 and the first cover 130. The first flow channel 124 exposes at least a portion of the first substrate 110 and at least a portion of the first conductive structure 112. The first flow channel 124 is connected to the first hole 132 of the first cover 130.

[0104] In step 303, an adhesive layer 150 is disposed on the surface of the first substrate 110 of the first reaction sheet 100, such as Fig.10 Specifically, the adhesive layer 150 is disposed on the surface of the first substrate 110 facing away from the first separator 120. The adhesive layer 150 includes a solid or liquid adhesive material, such as polyvinyl alcohol, polyvinyl acetate, acrylonitrile, epoxy compound, ultraviolet curable resin or any combination of the above materials, but the present invention is not limited thereto.

[0105] In step 305, a portion of the first reaction sheet 100 and a portion of the adhesive layer 150 are removed to form a perforated structure 140, such as Fig.10As shown. The perforated structure 140 can be formed by a punching machine, but is not limited to the punching machine. For example, laser engraving, punching or rolling cutter can be used, but it is not limited to the above. However, the preferred method of forming the perforated structure 140 of the present invention is to use a punching machine. Since the punching machine uses pressure to form an object into a specific shape and structure, the punching machine can more accurately punch the shape of the perforated structure 140, and it is less likely to damage the original structure of the first reaction sheet 100 during operation. The perforated structure 140 passes through the first cover 130, the first separator 120, the first substrate 110 and the adhesive layer 150. The perforated structure 140 is separated from the first hole 132 and the first flow channel 124. In some other embodiments, the order of step 303 and step 305 can be reversed. For example, a part of the first reaction sheet 100 can be removed first to form the perforated structure 140, and then a solid or liquid adhesive material can be applied to the surface of the first substrate 110 facing away from the first separator 120 to form the adhesive layer 150. In some other embodiments, a connecting hole may be formed in advance in a film-like adhesive layer 150, for example Figure 1 The connecting hole 155 shown in FIG. 1 is provided, wherein the hole area of ​​the connecting hole 155 is substantially greater than or equal to the hole area of ​​the perforated structure 140, and then the adhesive layer 150 having the connecting hole 155 is adhered to the surface opposite to the first separator 120. In such an embodiment, when the first reaction sheet 100 and the adhesive layer 150 are aligned and adhered, the projection of the perforated structure 140 will fall within the projection of the connecting hole 155.

[0106] refer to Fig.11 , Fig.11 307 is a cross-sectional view of step 307 of the manufacturing method 300. In step 307, a second reaction sheet 200 is provided. The second reaction sheet 200 at least includes a second substrate 210, a second separator 220 and a second cover 230. The second separator 220 covers the second substrate 210, and the second cover 230 covers the second separator 220. A second conductive structure 212 is disposed on the surface or inside of the second substrate 210, and the material and forming method of the second conductive structure 212 can be the same or similar to the material and forming method of the first conductive structure 112. The second separator 220 has a second sampling port 222 and a second recess 223 connected to the second sampling port 222. The second sampling port 222 is disposed on the front side of the second separator 220 to expose a portion of the inner surface of the second separator 220. The second cover 230 is made of a transparent or translucent material. The second cover 230 has a second hole 232, which runs through the second cover 230. The second sampling port 222 and the second notch 223 form a second flow channel 224 in a space surrounded by the second substrate 210, the second separator 220 and the second cover 230. The second flow channel 224 exposes at least a portion of the second substrate 210 and at least a portion of the second conductive structure 212. The second flow channel 224 is connected to the second hole 232 of the second cover 230.

[0107] refer to Fig.12 , Fig.12 309 is a cross-sectional view of step 309 of the manufacturing method 300. In step 309, the second reaction film 200 is bonded to the first reaction film 100 through the adhesive layer 150. Before the first reaction film 100 and the second reaction film 200 are bonded, the first sampling port 122 of the first reaction film 100 and the second sampling port 222 of the second reaction film 200 need to be vertically aligned, and the second hole 232 of the second cover 230 needs to be located within the vertical projection range of the first reaction film 100. When the first reaction film 100 and the second reaction film 200 are bonded by the adhesive layer 150, the adhesive layer 150 is located between the lower surface of the first substrate 110 and the upper surface of the second cover 230. Next, the detection reagent can be respectively set in the first reaction film 100 and the second reaction film 200. The detection reagent can be respectively set at different positions in the first flow channel 124 and the second flow channel 224 due to different types of reaction films or test items. The detection reagent disposed in the first flow channel 124 and the detection reagent disposed in the second flow channel 224 may be the same or different reagents, and are used to provide biochemical tests of the same or different items, such as blood fat, cholesterol, triglycerides, blood sugar or electrolytes, but the present invention is not limited thereto.

[0108] The biochemical detection module of the present invention includes a plurality of reaction plates, and each reaction plate has an independent detection function, and can measure the parameter values ​​of different samples respectively. In addition to having an independent detection function, a plurality of reaction plates can be stacked to form a biochemical detection module capable of simultaneously detecting parameters of multiple samples. According to the concept of modularization by technicians in the relevant technical field, modularization refers to a component with specific functions composed of several functional basic elements, each of which has an independent specific function, and a plurality of basic elements can be used to form a system, device or program with complete functions. For the biochemical detection module, the first reaction piece and the second reaction piece are basic elements with independent functions respectively. The first reaction piece and the second reaction piece are superimposed to form a biochemical detection module. The biochemical detection module can obtain multiple detection values ​​under the premise of reducing the signal disturbance of each other. In addition, because the biochemical detection module has a perforated structure corresponding to the second observation area and exposing the second flow channel, the user can view the sampling state from the first observation area and the second observation area, allowing the user to observe the sampling situation of the lower reaction piece covered by the upper reaction piece from the perforated structure. Because the perforated structure is connected to the hole of the lower reaction piece, the lower reaction piece can remove gas through the perforated structure, so the design of the perforated structure can solve the problem that the lower reaction piece is blocked by the upper reaction piece and cannot remove gas and cannot observe the sample injection state. Therefore, each reaction piece of the biochemical detection module of the present invention, in addition to having an independent detection function, can also combine two functions to form a biochemical detection module with simultaneous detection of two samples. Compared with the electrochemical test piece with only a single detection function, it can allow users to use it according to detection needs.

[0109] The features of several embodiments have been summarized above so that those skilled in the art can better understand the manner of the present invention. Those skilled in the art will appreciate that they can easily use the present invention as a basis for designing or modifying other programs and structures to implement the same purpose and / or achieve the same advantages of the embodiments introduced herein. Those skilled in the art will also appreciate that such equivalent constructions should not depart from the spirit and scope of the present invention, and that they can make various changes, substitutions and modifications to this document without departing from the spirit and scope of the present invention.

Claims

1. A biochemical detection module, comprising: A first reaction sheet, comprising: a first substrate; a first separator, located on the first substrate and having a first flow channel exposing at least a portion of the first substrate; and a first cover, covering the first separator and having a first hole communicating with the first flow channel, The first reaction sheet has a perforated structure that penetrates the first cover, the first separator and the first substrate, and the perforated structure is separated from the first flow channel and the first hole. The first reaction sheet has a first observation area where a portion of the first flow channel is observed through the first cover or the first hole; and The second reaction sheet is disposed on a side of the first reaction sheet adjacent to the first substrate and includes: a second substrate; a second separator, located on the second substrate and having a second flow channel exposing at least a portion of the second substrate; and A second cover covers the second separator and is bonded to the first substrate, and has a second hole, wherein the second flow channel is connected to the perforated structure through the second hole, wherein the second reaction plate has a second observation area for a portion of the second flow channel observed through the perforated structure, the second cover or the second hole. 2 . The biochemical detection module as claimed in claim 1 , wherein in a length direction, the first observation area and the second observation area are spaced apart from each other. 3 . The biochemical detection module as described in claim 1 , wherein the perforated structure exposes at least a portion of the second cover. 4 . The biochemical detection module as claimed in claim 1 , wherein a width of the perforated structure is greater than a width of the first hole. 5 . The biochemical detection module as claimed in claim 1 , wherein a length of the second flow channel is different from a length of the first flow channel. The biochemical detection module as claimed in claim 1 , wherein the length of the second flow channel is greater than the length of the first flow channel. 7 . The biochemical detection module as claimed in claim 1 , further comprising an adhesive layer located between the first substrate and the second cover, wherein the perforated structure penetrates the adhesive layer. 8 . The biochemical detection module as claimed in claim 1 , wherein the first flow channel and the second flow channel are not connected to each other.

9. A biochemical detection module, comprising: A first reaction sheet, comprising: A first substrate having a first surface and a second surface opposite to the first surface; A first separator, located on the first surface and having a first flow channel; and a first cover, covering the first separator and having a first hole communicating with the first flow channel, wherein the first reaction sheet has a perforated structure that penetrates the first cover, the first separator and the first substrate; and The second reaction piece comprises: A second substrate having a third surface and a fourth surface opposite to the third surface, wherein the third surface faces the second surface; A second separator, located on the fourth surface and having a second flow channel; and The second cover covers the second separation sheet and has a second hole, wherein the second hole is communicated with the second flow channel. 10 . The biochemical detection module as claimed in claim 9 , further comprising an adhesive layer located between the second surface and the third surface and bonding the first reaction sheet and the second reaction sheet.

11. The biochemical detection module as claimed in claim 9, wherein the second reaction plate is aligned with the first reaction plate. 12 . The biochemical detection module as claimed in claim 9 , wherein the sampling port of the second flow channel is vertically aligned with the sampling port of the first flow channel. 13 . The biochemical detection module as claimed in claim 9 , wherein at least a portion of the second flow channel overlaps the second hole in the perforated structure. 14 . The biochemical detection module as claimed in claim 9 , wherein at least a portion of the second separator overlaps the perforated structure.

15. A method for manufacturing a biochemical detection module, comprising: A first reaction sheet is provided, comprising: A first substrate having a first surface and a second surface opposite to the first surface; A first separator, located on the first surface and having a first flow channel exposing a first portion of the first substrate; and A first cover, covering the first separation sheet and having a first hole communicating with the first flow channel; Forming a through-hole structure penetrating the first cover, the first separator and the first substrate; Aligning a second sampling port of a second reaction sheet with a first sampling port of the first reaction sheet, wherein the second reaction sheet comprises: a second substrate; A second separator, located on the second substrate and having a second flow channel exposing a second portion of the second substrate; A second cover having a third surface covering the second separator and a fourth surface facing away from the third surface, and having a second hole communicating with the second flow channel, wherein the second flow channel communicates with the perforated structure through the second hole; and The second reaction sheet is joined to the first reaction sheet. 16 . The method for manufacturing a biochemical detection module as claimed in claim 15 , further comprising disposing an adhesive layer on the second surface before forming the perforated structure, wherein the perforated structure penetrates the adhesive layer. 17 . The method for manufacturing a biochemical detection module as claimed in claim 15 , further comprising disposing an adhesive layer on the second surface after forming the perforated structure, and the second reaction sheet is bonded to the first reaction sheet through the adhesive layer. 18 . The method for manufacturing a biochemical detection module as claimed in claim 15 , wherein a method of forming the perforated structure comprises punching, laser engraving, piercing or rolling cutter.

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