TW202202842A - Production system and manufacturing method of a biological test chip - Google Patents

Abstract

A production system and a manufacturing method of a biological test chip is provided. The production system includes a transporting device, a vacuum film-sputtering device, a laser engraving device, a sealing device and a cutting device. The transporting device conveys a continuous substrate. The film-sputtering device forms a continuous metal film on the surface of the substrate. The laser engraving device engraves a plurality of metal films into a plurality of predetermined patterns. The sealing device provides a insulating film on the predetermined patterns. The cutting device cuts the continuous substrate and the continuous metal film to separate multiple predetermined patterns. The vacuum film-sputtering device, the laser engraving device, the sealing device and the cutting device are set on the same production line in sequence.

Description

Production system and manufacturing method of biological detection test piece

The invention relates to a production system and a manufacturing method of a biological detection test piece, in particular to a production system and a manufacturing method for mass-producing biological detection test pieces using a production line.

At present, there are many biological test strips suitable for home or hospital use on the market, such as blood glucose test strips, blood lipid test strips, virus test strips, and so on. The current biological detection test piece is mainly produced in a single piece after coating, screen printing, baking, masking, and dotting the enzyme, and then the final die is carried out to form a specific shape of the detection test piece.

However, this method of completing a product from upstream to downstream by a production unit has poor production efficiency, and the number of test pieces that can be manufactured is limited. The quality of the test pieces varies.

Therefore, how to overcome the above-mentioned defects through the improvement of the production system, taking into account the production volume and quality of biological detection test pieces, has become one of the important issues to be solved by this business.

The technical problem to be solved by the present invention is to provide a production system for biological detection test pieces in view of the deficiencies of the prior art, which includes: a conveying device for conveying a continuous base material, and the continuous base material includes a plurality of substrates; a vacuum coating device, It is used to form a continuous metal film on the surface of the substrate; a laser engraving device is used to engrave a plurality of metal films into a plurality of predetermined patterns, each predetermined pattern includes a positive lead and a negative lead separated from each other, and the positive lead The two ends of the lead are respectively the positive contact electrode and a first working electrode, and the two ends of the negative lead are respectively the negative contact electrode and the second working electrode; the membrane sealing device is used to provide an insulating film to cover a plurality of predetermined patterns, and each A positive contact electrode, a first working electrode, a negative contact electrode and a second working electrode of a predetermined pattern are exposed from the insulating film; and a cutting device is used for cutting the continuous base material and the continuous metal film to separate a plurality of substrates, and each The surface of a substrate has the metal film; wherein, the vacuum coating device, the laser engraving device, the film sealing device and the cutting device are sequentially arranged on the same production line.

In order to solve the above-mentioned technical problems, another technical solution adopted by the present invention is to provide a production system for biological detection test pieces, which includes: a conveying device for conveying a continuous substrate, and the continuous substrate includes a plurality of substrates; a vacuum A coating device for forming a continuous metal film on the surface of a substrate; a laser engraving device for engraving the continuous metal film into a plurality of predetermined patterns, each predetermined pattern comprising a positive lead and a negative lead separated from each other, The two ends of the positive electrode lead are respectively the positive electrode contact electrode and the first working electrode, and the two ends of the negative electrode lead are respectively the negative electrode contact electrode and the second working electrode, wherein a biologically active substance is arranged between the first working electrode and the second working electrode To electrically connect the first working electrode and the second working electrode; a gas chip removal device, which is used to output or inhale gas to remove the residual metal chips left after engraving by the laser engraving device; a pattern detection device, which uses It is used to detect the contour and depth of the predetermined pattern; an electrical test device is used to detect the impedance value of the positive electrode contact electrode and the negative electrode contact electrode; the film sealing device is used to cover the insulating film on a plurality of predetermined patterns, each predetermined pattern The positive electrode contact electrode, the first working electrode, the negative electrode contact electrode and the second working electrode are exposed from the insulating film; a biologically active substance supply device is used to inject a plurality of biologically active substances onto a plurality of predetermined patterns respectively, so that each The biologically active substance is electrically connected between the first working electrode and the second working electrode; and a cutting device is used for cutting the substrate to separate a plurality of substrates, each substrate has a predetermined pattern, an insulating film and a biological Active material; wherein, vacuum coating device, laser engraving device, gas removal device, pattern detection device, electrical testing device, membrane sealing device, biological active material supply device and cutting device are sequentially arranged on the same production line.

In order to solve the above technical problems, a technical solution adopted by the present invention is to provide a method for manufacturing a biological detection test piece, which includes: providing a continuous substrate; forming a continuous metal film on the surface of the substrate; engraving the continuous metal film into a plurality of predetermined patterns, each predetermined pattern includes a positive lead and a negative lead separated from each other, the two ends of the positive lead are respectively the positive contact electrode and the first working electrode, and the two ends of the negative lead are the negative contact electrode and the first working electrode respectively. two working electrodes; perform appearance inspection on a plurality of predetermined patterns; perform electrical tests on at least one of the plurality of predetermined patterns; provide an insulating film to cover the plurality of predetermined patterns and expose the positive contact electrode, the first working electrode, the negative electrode contact electrode and the a second working electrode; and cutting the continuous substrate to separate a plurality of predetermined patterns.

One of the beneficial effects of the present invention is that the production system of the biological detection test piece provided by the present invention can form a continuous metal film on the surface of the continuous substrate through "a conveying device for conveying a continuous substrate" and "a vacuum coating device" "On", "The laser engraving device engraves a plurality of metal films into a plurality of predetermined patterns", "The film sealing device is used to provide an insulating film to cover a plurality of predetermined patterns", "The cutting device is used to cut continuous substrates and continuous metal film to separate a plurality of predetermined patterns” and the technical solutions of “vacuum coating device, laser engraving device, film sealing device and cutting device are sequentially arranged on the same production line”, so that the production system of biological detection test strips can be produced in large quantities Production of biological test strips.

Another beneficial effect of the present invention is that the method for manufacturing a biological detection test piece provided by the present invention can achieve the following steps: "providing a continuous substrate", "forming a continuous metal film on the surface of the continuous substrate", "forming continuous The film is engraved into a plurality of predetermined patterns, each predetermined pattern includes a positive lead and a negative lead separated from each other, the two ends of the positive lead are the positive contact electrode and the first working electrode respectively, and the two ends of the negative lead are the negative contact electrode and the first working electrode respectively. Two working electrodes", "Appearance inspection of a plurality of predetermined patterns", "Electrical testing of at least one of the plurality of predetermined patterns", "Providing an insulating film to cover the plurality of predetermined patterns and exposing the positive contact electrode, the first working Electrode, negative contact electrode and second working electrode” and the technical solutions of “cutting a continuous substrate to separate a plurality of predetermined patterns”, so that the production system of biological detection test strips can mass-produce biological detection test strips.

For a further understanding of the features and technical content of the present invention, please refer to the following detailed descriptions and drawings of the present invention. However, the drawings provided are only for reference and description, and are not intended to limit the present invention.

The following are specific specific examples to illustrate the embodiments of the “production system and manufacturing method for biological detection test strips” disclosed in the present invention. Those skilled in the art can understand the advantages and effects of the present invention from the content disclosed in this specification. The present invention can be implemented or applied through other different specific embodiments, and various details in this specification can also be modified and changed based on different viewpoints and applications without departing from the concept of the present invention. In addition, the drawings of the present invention are merely schematic illustrations, and are not drawn according to the actual size, and are stated in advance. The following embodiments will further describe the related technical contents of the present invention in detail, but the disclosed contents are not intended to limit the protection scope of the present invention. Additionally, it should be understood that, although the terms "first," "second," "third," etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are primarily used to distinguish one element from another. In addition, the term "or", as used herein, should include any one or a combination of more of the associated listed items, as the case may be. In addition, the term "or", as used herein, should include any one or a combination of more of the associated listed items, as the case may be.

[Example]

Referring to FIGS. 1 to 2 , a first embodiment of the present invention provides a production system for biological detection test pieces, which includes a conveying device 1 , a vacuum coating device 2 and a laser engraving device 3 . The conveying device 1 is used for conveying the continuous base material M1 along the conveying direction A. In the present invention, the continuous base material M1 is an insulating base material, which can be made of any material such as a PET board, a PP board, a glass fiber board or a ceramic board. , however, the present invention is not limited to the above-mentioned examples. The vacuum coating device 2 is used to form the continuous metal film M2 on the surface of the continuous substrate M1.

Specifically, the vacuum coating device 2 has a vacuum chamber (not shown). The continuous base material M1 will enter the vacuum chamber during the conveying process, so that the vacuum coating device 2 coats a continuous metal film M2 on the surface of the continuous base material M1 by means of vacuum sputtering. Next, the laser engraving device 3 emits a laser beam to carry out laser engraving on the continuous metal film M2, and a plurality of predetermined patterns P are engraved on the continuous metal film M2.

Referring to FIG. 3 , each predetermined pattern P includes a positive electrode lead P1 and a negative electrode lead P2 separated from each other, the two ends of the positive electrode lead P1 are respectively the positive electrode contact electrode P11 and the first working electrode P12, and the two ends of the negative electrode lead P2 are respectively The negative electrode contacts the electrode P21 and the second working electrode P22. The positive contact electrode P11 and the negative contact electrode P21 are used to connect an external current sensing device (not shown), and the first working electrode P12 and the second working electrode P22 are used for biological detection. In the present invention, the graphic pattern of the predetermined pattern P (or the pattern of the negative electrode lead P1 and the negative electrode lead P2) can be designed by the user, as long as it includes at least two separate and non-contact anode parts and cathode parts. The graphic style of the predetermined pattern P shown in this embodiment is only an example, and is not limited thereto.

Continuing to refer to FIGS. 1 to 2 , in this embodiment, the production system for the biological detection test piece further includes: a gas removal device 4 , a pattern detection device 5 , an electrical testing device 6 and a membrane sealing device 7 , a biological activity Substance supply device 8 and cutting device 9 . It should be noted that the vacuum coating device 2 , the laser engraving device 3 , the gas removal device 4 , the pattern detection device 5 , the electrical testing device 6 , the membrane sealing device 7 , the biologically active material supply device 8 and the cutting device 9 are in sequence. set up on the same production line.

Since the laser engraving device 3 engraves the continuous metal film M2 into a plurality of predetermined patterns P, excess metal chips will be generated. Therefore, the gas chip removal device 4 is used to output or inhale gas to remove the engraved by the laser engraving device 3. Residual metal shavings left behind. It should be noted that, the gas chip removal device 4 can be used after the laser engraving device 3 engraves the continuous metal film M2 to form a plurality of predetermined patterns P, and can also engrave the continuous metal film M2 in the laser engraving device 3 to form a plurality of predetermined patterns P. use together at the same time (ie, remove excess metal chips while laser engraving).

When the metal film M2 on the substrate M11 has been laser engraved into the predetermined pattern P by the laser engraving device 3, it means that the biological detection test piece has been substantially completed. At this time, in order to ensure the quality of the final produced biological test strips, various performance tests will be performed on them. In the present invention, the biological detection test piece is subjected to an appearance test on the predetermined pattern P by the pattern detection device 5 , and an electrical test of the predetermined pattern P is performed by the electrical test device 6 .

The appearance test refers to detecting the outline and depth of the predetermined pattern P. Specifically, the pattern detection device 5 includes a CCD camera assembly and an atomic force microscope or a laser thickness measurement assembly (not shown in the figure). The CCD camera assembly is used to detect the outline of the predetermined pattern P (X direction and Y direction as shown in Figure 3), and the atomic force microscope or laser thickness measuring assembly is used to detect the depth of the predetermined pattern P (ie the Z direction, not shown in the figure). ). The electrical test refers to using the electrical testing device 6 to detect the impedance of the positive electrode contact electrode P11 and the negative electrode contact electrode P21 .

After the appearance test and electrical test are completed, the insulating film M3 is provided by the film sealing device 7 to cover the plurality of predetermined patterns P, and the positive electrode contact electrode P11, the first working electrode P12, and the negative electrode contact electrode of each predetermined pattern P are The P21 and the second working electrode P22 are exposed from the insulating film M3. More specifically, as shown in FIG. 3 , the insulating film M3 covers the predetermined pattern P, covers most of the areas of the positive electrode lead P1 and the negative electrode lead P2, and only exposes the positive electrode contact electrodes P11 at both ends of the positive electrode lead P1 and the first The working electrode P12, the negative electrode contact electrode P21 and the second working electrode P22 exposing both ends of the negative electrode lead P2.

It should be noted that exposing the first working electrode P12 and the second working electrode P22 includes exposing the region between the first working electrode P12 and the second working electrode P22, that is, between the first working electrode P12 and the second working electrode P22. There is a limiting region in between which is not covered by the insulating film M3. This area is the area for biometric testing.

After the insulating film M3 is covered, the bioactive substance B is injected between the first working electrode P12 and the second working electrode P22 of at least one predetermined pattern P through the bioactive substance supply device 8 to electrically connect the first working electrode P12 and the second working electrode P22 (as shown in Figure 3). At this point, the biological detection test piece has been basically completed. The biologically active substance B can be, for example, an enzyme, an antibody, an antigen, or some conductive media doped, and is used for the electrochemical reaction detection of various samples of the test substance in cooperation with the first working electrode P12 and the second working electrode P22.

It should be noted that, the aforementioned electrical testing device 6 is placed after the pattern testing device 5 in the production line. However, the present invention is not limited to this. In addition to being placed behind the pattern detection device 5 , the electrical testing device 6 may also be placed behind the biologically active substance supply device 8 , or behind the pattern detection device 5 and the biologically active substance supply device 8 at the same time.

Afterwards, at least one biologically active substance B is selected by random sampling for quality control (Quality Control, QC) testing. Quality control refers to the quality inspection of products, such as quality control of incoming materials (IQC), quality control of production lines (IPQC) or quality inspection of finished products (FQC). However, the present creation is not limited to the above-mentioned examples.

After the QC inspection is completed, the continuous base material M1 and the continuous metal film M2 are cut by the cutting device 9, and a continuous base material M1 is cut into multiple bundles of rolled base materials (not shown in the figure), and then the The rolled substrate continues to be cut to separate a plurality of substrates M11 , and each substrate M11 has a predetermined pattern P and a biologically active substance B on the surface. The number of substrates M11 cut from the continuous substrate M1 can be set by the user. In this embodiment, the continuous substrate M1 can cut at least 200 substrates M11 , but the invention is not limited to the above examples. Finally, after the cutting is completed, it can be packaged and shipped.

Referring to FIG. 4 , the first embodiment of the present invention provides a method for making a biological detection test strip, which at least includes the following steps:

Step S10: providing a continuous substrate M1, and forming a continuous metal film M2 on the surface of the continuous substrate M1;

Step S11 : laser engraving the continuous metal film M2 into a plurality of predetermined patterns P, each predetermined pattern P includes a positive lead P1 and a negative lead P2 separated from each other, and the two ends of the positive lead P1 are the positive contact electrode P11 and the first The working electrode P12, the two ends of the negative electrode lead P2 are respectively the negative electrode contact electrode P21 and the second working electrode P22;

Step S12: removing residual metal chips left after laser engraving by outputting gas or inhaling gas;

Step S13: performing appearance detection on a plurality of predetermined patterns P, and detecting the contour and depth of the predetermined patterns P;

Step S14: conduct an electrical test on at least one predetermined pattern P, and detect the impedance values of the positive electrode contact electrode P11 and the negative electrode contact electrode P21;

Step S15: providing an insulating film M3 to cover the plurality of predetermined patterns P and exposing the positive electrode contact electrode P11, the first working electrode P12, the negative electrode contact electrode P21 and the second working electrode P22;

Step S16: injecting a bioactive substance B between the first working electrode P12 and the second working electrode P22 of the predetermined pattern P, so that the bioactive substance B is electrically connected to the first working electrode P12 and the second working electrode P22;

Step S17: randomly sampling at least one biologically active substance B for quality control (QC) testing; and

Step S18 : cutting the continuous substrate M1 to separate a plurality of substrates M11 , and each substrate M11 has a predetermined pattern P and a biologically active substance B on the surface.

It should be noted that although step S12 is performed after step S11, the present invention is not limited to this, and step S12 can also be performed simultaneously with step S11, that is, when the plurality of metal films M2 are laser engraved into a plurality of predetermined At the same time of pattern P, the residual metal chips left after laser engraving are removed by outputting gas or inhaling gas.

[Advantageous effects of the embodiment]

One of the beneficial effects of the present invention is that the production system of the biological detection test piece provided by the present invention can form a continuous metal film M2 on the continuous substrate through the "conveying device 1 conveying the continuous substrate M1" and the "vacuum coating device 2" "On the surface of M1", "the laser engraving device 3 is used to engrave the continuous metal film M2 into a plurality of predetermined patterns P", "the gas chip removal device 4 is used to output or inhale gas to remove the engraving by the laser engraving device 3 "The pattern detection device 5 is used to detect the contour and depth of the predetermined pattern P", "The electrical test device 6 is used to detect the impedance value of the positive electrode contact electrode P11 and the negative electrode contact electrode P21", "The membrane sealing device 7 is used to provide an insulating film M3 covering a plurality of predetermined patterns P, and the positive electrode contact electrode P11, the first working electrode P12, the negative electrode contact electrode P21 and the second working electrode P22 of each predetermined pattern P are removed from the insulating film M3 is exposed”, “The biologically active substance supply device 8 is used to inject a plurality of biologically active substances between the first working electrode P12 and the second working electrode P22, respectively”, “The cutting device 9 cuts the continuous substrate M1 and the continuous metal film M2, to separate a plurality of substrates M11, and the surface of each substrate M11 has a predetermined pattern P" and "vacuum coating device 2, laser engraving device 3, gas removal device 4, pattern detection device 5, electrical testing device 6. The membrane sealing device 7, the biologically active substance supplying device 8 and the cutting device 9 are sequentially arranged on the same production line", so that the production system of biological detection test strips can produce a large number of biological detection test strips.

Another beneficial effect of the present invention is that the manufacturing method of the biological detection test piece provided by the present invention can be achieved by "providing a continuous base material M1, and the continuous base material M1 includes a plurality of substrates M11", "forming a continuous metal film M2 on the The continuous metal film M2 is engraved into a plurality of predetermined patterns P on the surface of the continuous substrate M1, and each predetermined pattern P includes a positive electrode lead P1 and a negative electrode lead P2 separated from each other, and the two ends of the positive electrode lead P1 are respectively connected to the positive electrode. The two ends of the electrode P11 and the first working electrode P12, and the negative electrode lead P2 are respectively the negative electrode contact electrode P21 and the second working electrode P22", "Appearance inspection of a plurality of predetermined patterns P", "A plurality of predetermined patterns P. Conduct at least one electrical test", "Provide an insulating film M3 to cover a plurality of predetermined patterns P and expose the positive electrode contact electrode P11, the first working electrode P12, the negative electrode contact electrode P21 and the second working electrode P22" and "Cut the continuous substrate M1" , in order to separate a plurality of substrates M11, and each substrate M11 has a predetermined pattern P" on the surface, so that the production system of biological detection test pieces can mass produce biological detection test pieces.

Further, the production system and manufacturing method of the biological detection test piece provided by the present invention are to solve the problem that the existing production technology cannot take into account the quality when mass production is encountered. The biological detection test piece is then passed through the performance test and sampling test to confirm whether its quality meets the standard. Finally, the film is sealed to make the finished product. Compared with the single-chip production method in the prior art, the production system and manufacturing method of the biological detection test piece adopted in this case can take into account both the production efficiency and the manufacturing quality.

The contents disclosed above are only preferred feasible embodiments of the present invention, and are not intended to limit the scope of the present invention. Therefore, any equivalent technical changes made by using the contents of the description and drawings of the present invention are included in the application of the present invention. within the scope of the patent.

1: Conveying device 2: Vacuum coating device 3: Laser engraving device 4: Gas chip removal device 5: Pattern detection device 6: Electrical test device 7: Membrane sealing device 8: Bioactive Substance Supply Device 9: Cutting device A: Conveying direction B: biologically active substances M1: Continuous substrate M11: Substrate M2: Metal film M3: insulating film P: Predetermined pattern P1: positive lead P11: Positive Contact Electrode P12: The first working electrode P2: negative lead P21: Negative contact electrode P22: Second working electrode S10~S18: Steps

FIG. 1 is a first schematic diagram of a biological detection test strip production system according to an embodiment of the present invention.

FIG. 2 is a second schematic diagram of a biological detection test strip production system according to an embodiment of the present invention.

FIG. 3 is a schematic top view of the biological detection test piece of the present invention.

FIG. 4 is a schematic diagram of a manufacturing method of a biological detection test piece according to an embodiment of the present invention.

1: Conveying device

7: Membrane sealing device

8: Bioactive Substance Supply Device

9: Cutting device

A: Conveying direction

M1: Continuous substrate

M11: Substrate

M3: insulating film

P: Predetermined pattern

Claims (16)

A production system for biological detection test pieces, comprising: a conveying device for conveying a continuous base material, the continuous base material including a plurality of substrates; a vacuum coating device for forming a continuous metal film on the surface of the continuous substrate; A laser engraving device for engraving the continuous metal film into a plurality of predetermined patterns, each of the predetermined patterns includes a positive wire and a negative wire separated from each other, and the two ends of the positive wire are respectively a a positive contact electrode and a first working electrode, and two ends of the negative lead are respectively a negative contact electrode and a second working electrode; A film sealing device, which is used for providing an insulating film covering a plurality of the predetermined patterns, the positive contact electrode, the first working electrode, the negative contact electrode and the negative electrode of each predetermined pattern The second working electrode is exposed from the insulating film; and a cutting device for cutting the continuous base material and the continuous metal film to separate a plurality of the substrates, and each of the substrates has the predetermined pattern on the surface; Wherein, the vacuum coating device, the laser engraving device, the film sealing device and the cutting device are sequentially arranged on the same production line. The production system for biological detection test pieces according to claim 1, further comprising: a gas chip removal device for outputting or inhaling gas to remove residual metal chips left after engraving by the laser engraving device . The production system for biological detection test strips according to claim 1, further comprising: a pattern detection device for detecting the contour and depth of the predetermined pattern. The production system for biological detection test strips according to claim 3, wherein the pattern detection device includes a CCD camera assembly for detecting the outline of the predetermined pattern. The production system for biological detection test pieces according to claim 3, wherein the pattern detection device further comprises an atomic force microscope or a laser thickness measurement component for detecting the depth of the predetermined pattern. The production system for biological detection test strips according to claim 1, further comprising an electrical testing device for detecting the impedance values of the positive electrode contact electrode and the negative electrode contact electrode. The production system for biological detection test strips according to claim 1, further comprising: a biologically active substance supply device for injecting a plurality of biologically active substances into the plurality of predetermined patterns, so that each The biologically active substance is electrically connected between the first working electrode and the second working electrode. A production system for biological detection test pieces, comprising: a conveying device for conveying a continuous base material, the continuous base material including a plurality of substrates; a vacuum coating device for forming a continuous metal film on the surface of the continuous substrate; A laser engraving device for engraving the continuous metal film into a plurality of predetermined patterns, each of the predetermined patterns includes a positive wire and a negative wire separated from each other, and the two ends of the positive wire are respectively a a positive contact electrode and a first working electrode, and two ends of the negative lead are respectively a negative contact electrode and a second working electrode; a gas chip removal device, which is used for outputting or inhaling gas to remove the residual metal chips left after engraving by the laser engraving device; a pattern detection device for detecting the contour and depth of the predetermined pattern; an electrical testing device for detecting the impedance values of the positive electrode contact electrode and the negative electrode contact electrode; a film sealing device, which is used for covering an insulating film on a plurality of the predetermined patterns, the positive contact electrode, the first working electrode, the negative contact electrode and the The second working electrode is exposed from the insulating film; a biologically active substance supply device for injecting a plurality of biologically active substances onto a plurality of the predetermined patterns respectively, so that each of the biologically active substances is electrically connected to the first working electrode and the second working electrode between the working electrodes; and A cutting device is used for cutting the continuous base material to separate a plurality of substrates, and the surface of each substrate has the predetermined pattern, the insulating film and the biologically active substance. The production system for biological detection test pieces according to claim 8, wherein the vacuum coating device, the laser engraving device, the gas chip removal device, the pattern detection device, the electrical testing device, The film sealing device, the biologically active substance supply device and the cutting device are sequentially arranged on the same production line. A method for manufacturing a biological detection test piece, comprising: providing a continuous substrate comprising a plurality of substrates; forming a continuous metal film on the surface of the continuous substrate; The continuous metal film is laser engraved into a plurality of predetermined patterns, each of the predetermined patterns includes a positive lead and a negative lead separated from each other, and the two ends of the positive lead are respectively a positive contact electrode and a first a working electrode, the two ends of the negative lead are respectively a negative contact electrode and a second working electrode; providing an insulating film covering a plurality of the predetermined patterns and exposing the positive contact electrode, the first working electrode, the negative contact electrode and the second working electrode; injecting a biologically active substance between the first working electrode and the second working electrode of at least one of the plurality of predetermined patterns; and The continuous substrate is cut to separate a plurality of the substrates, and each of the substrates has the predetermined pattern on the surface. The method for manufacturing a biological detection test piece according to claim 10, after laser engraving the continuous metal film into a plurality of predetermined patterns and before providing an insulating film to cover the plurality of predetermined patterns, further comprising: A plurality of the predetermined patterns are subjected to appearance inspection. The method for manufacturing a biological detection test piece according to claim 11, wherein the appearance detection includes performing contour detection and depth detection on a plurality of the predetermined patterns. The method for manufacturing a biological detection test piece according to claim 10, after laser engraving the continuous metal film into a plurality of predetermined patterns and before providing an insulating film to cover the plurality of predetermined patterns, further comprising: At least one of the plurality of predetermined patterns is electrically tested. The method for manufacturing a biological detection test strip according to claim 10, after injecting a biologically active substance between the first working electrode and the second working electrode in at least one of the plurality of predetermined patterns Before cutting the continuous substrate to separate a plurality of the substrates, the method further includes: randomly sampling at least one biologically active substance for quality control testing. According to the method for manufacturing a biological detection test piece according to claim 10, while the continuous metal film is laser-engraved into a plurality of the predetermined patterns, the gas is outputted or the gas is inhaled to remove the residue left after the laser engraving. Residual metal shavings. According to the manufacturing method of the biological detection test piece according to claim 10, after the continuous metal film is laser engraved into a plurality of the predetermined patterns, the gas left after the laser engraving is removed by outputting gas or inhaling gas. of residual metal shavings.

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